The major objection from the CHMP was the lack of a comparator arm without Avastin in the BRAIN study, an investigational phase II trial. The CHMP tends to base its approval decisions on Phase III studies only. Roche decided to submit this data set to regulatory authorities globally based on Avastin's remarkable clinical activity seen in BRAIN. Roche remains convinced that the results of the BRAIN study, which were published in the Journal of Clinical Oncology in October 20091 are robust and remain valid. Adverse events in the BRAIN study were consistent with those previously seen with Avastin and no new safety signals were reported.1

'We are very disappointed with the CHMP opinion which will result in a delay to patients receiving an important new treatment option. We strongly believe that Avastin is a new treatment option for physicians within the EU which would bring hope to GBM patients and their families as it is today in the US and other countries,' said William M. Burns, CEO of Roche's Pharmaceuticals Division. 'Relapsed glioblastoma is a rare condition and represents a very high unmet medical need. These patients deserve effective additional therapies to manage this devastating disease. We remain committed to bringing Avastin to patients with newly diagnosed GBM in Europe'.

In May 2009 Avastin was granted accelerated approval for the treatment of GBM patients with progressive disease following prior therapy from the US Food and Drug Administration (FDA) based on data from the BRAIN study (AVF3708g) and an NCI study (NCI 06-C-0064E). Switzerland and ten other countries have already recognised the significant clinical benefits Avastin offers to GBM patients by giving approval.

Roche continues to further explore the role of Avastin in GBM through various investigator-led studies. In addition, a large phase III study (AVAGLIO) in over 900 patients with newly diagnosed GBM is currently underway with the aim of a global filing5.

Avastin has proven survival benefits across several types of cancer. It is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause over 2.5 million deaths each year6,7,8. Over half a million patients have been treated with Avastin so far.
About Glioblastoma

Glioma is the most common type of primary brain tumour, accounting for approximately one third of all cases diagnosed9. Glioma also represents around 80% of all primary malignant brain tumour cases9. Glioblastoma (or glioblastoma multiforme; GBM) is the most common and the most aggressive type of glioma9. The prognosis for patients with GBM is poor. The treatment options for GBM depend on many factors including the location and size of the tumour, and the overall health and age of the patient10.

Glioblastoma affects approximately 17,000 people per year in the EU2. Following initial treatment, glioblastoma tumours nearly always return and currently, there are limited treatment options for patients when these relapses occur and their prognosis is particularly poor3. According to historical estimates, less than 10 percent of patients with recurrent GBM respond to treatment and approximately 15 percent will live six months without their disease getting worse1,5. GBM is a compelling therapeutic target for Avastin as these tumours have very high levels of vascular endothelial growth factor (VEGF)11.
About the BRAIN study (AVF3708g)

The BRAIN study was a US based open-label, multicentre, non-comparative phase II study including 167 patients with histologically confirmed GBM that had progressed following initial treatment with temozolomide and radiation. The primary endpoints of the BRAIN trial were progression free survival-6 (PFS-6), (defined as the percentage of patients who remained alive and progression free at 24 weeks) and objective response rate (ORR), (defined as a complete or partial response on two consecutive MRIs obtained 4 weeks apart). Secondary endpoints explored included OS, PFS, duration of response to treatment and safety. The BRAIN study evaluated Avastin at a dose of 10mg/kg every two weeks, as a single agent (BEV), or in combination with irinotecan chemotherapy (BEV-IRI).

The BRAIN study demonstrated that:

* When Avastin was evaluated as a single agent, the study showed that at six months over 40% (42.6%) of the patients were alive without their disease getting worse, as defined by PFS-6. When Avastin was combined with irinotecan, this figure increased to 50.3%1.
* In the study, over a quarter (28%) of patients responded to Avastin as a single agent, meaning tumours decreased in size by at least 50%. When Avastin was combined with irinotecan, 38% of patients responded to Avastin1.
* Patients receiving Avastin alone had a median overall survival of 9.2 months; this was 8.7 months for those receiving Avastin in combination with irinotecan, which was a secondary endpoint in the study1.
* Adverse events in the BRAIN study were consistent with those previously seen with Avastin and no new safety signals were reported1.
* Recent results showed the potential for additional positive impact on patients' daily lives. Of those patients who responded to Avastin-based therapy, a majority had a stabilisation or improvement in neurocognitive function at the time of the response and a reduction in their dose of steroids from baseline4.

About the AVAGLIO study

The AVAGLIO study is an international, multicentre, randomised, double blind, phase III study including over 900 patients with newly diagnosed histologically confirmed GBM which will investigate the efficacy and safety of treatment with Avastin combined with standard of care (temozolomide chemotherapy and radiotherapy) following surgery.

The primary endpoints of the AVAGLIO trial are progression free survival, (defined as the duration for which patient remains alive without their disease worsening) and overall survival. Secondary endpoints that will be explored include one and two year survival rates, safety and health related quality of life.
About Avastin

Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is a key driver of tumour angiogenesis – an essential process required for a tumour to grow and to spread (metastasize) to other parts of the body. Avastin's precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumour growth and extend survival with only a limited impact on the side effects of chemotherapy.

Avastin has proven survival benefits across several types of cancer. It is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause over 2.5 million deaths each year6,7,8. In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and it is now approved for the treatment of five tumour types: colorectal cancer, non-small cell lung cancer, breast cancer, brain (glioblastoma) and kidney (renal cell carcinoma).

Over half a million patients have been treated with Avastin so far. A comprehensive clinical programme with over 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease).
About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
1.Friedman H et al. J Clin Oncol 2009; 31 August [Epub ahead of print as doi/10.1200/JCO.2008.19.8721] Last accessed 1 September 2009 at http://jco.ascopubs.org/cgi/content/abstract/JCO.2008.19.8721v1.
2.Decision Resources, Cancer Incidence in 5 Continents Version IX, CI5 IX, World Population Prospects, Central Brain Tumor Registry of the United States, National Swedish Brain Tumour Registry
3.Medscape. Recurrent Glioblastoma Multiforme: Definition of Recurrent GBM. Last accessed 10 August 2009 at: http://www.medscape.com/viewarticle/540150_2
4.Vredenburgh, J. et al. ECCO 15 ESMO 34 2009; Abstract #8707.
5.Chinot, O. et al. ECCO 15 ESMO 34 2009; Poster #46
6.Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American Cancer Society, 2007
7.WHO Cancer Factsheet N°297 – updated July 2008. Last accessed 24 March 2009 at http://www.who.int/mediacentre/factsheets/fs297/en/index.html.
8.Parkin DM et al. CA Cancer J Clin 2005; 55: 74-108.
9.Central Brain Tumor Registry of the United States (CBTRUS). Primary Brain Tumours in the United States Statistical Report.
10.Stupp R et al. Ann Oncol 2007; 18 (supplement 2): ii69–ii70.
11.Takano S et al. Cancer Res 1996; 56: 2185-2190.

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For business inquiries, please contact Chris Dowd, EVP Business Development, at (609) 896-4764 or email Chris.Dowd@pSellingSolutions.com.

About Publicis Strategic Solutions Group
Publicis Strategic Solutions Group (PSSG) aligns four high-performing Publicis message delivery companies—Publicis Selling Solutions, Scientific Voice, Pharmagistics, and Arista Marketing Associates—under one cohesive leadership team. PSSG provides a comprehensive array of multichannel message delivery solutions—from field teams to virtual representatives, and from speaker bureau management to sample compliance. More importantly, PSSG provides the power and intellect to create and implement a flexible, highly customized message delivery mix designed to match any product situation from prelaunch to late life cycle. Websites: www.pSellingSolutions.com, www.ScientificVoice.com, www.Pharmagistics.com, www.AristaMktg.com

About Publicis Healthcare Communications Group
Publicis Healthcare Communications Group (PHCG), a member of Publicis Groupe SA, is one of the largest healthcare communications groups in the world with over 2,700 employees located in 10 countries. Worldwide healthcare services include advertising, medical education, sales and marketing, and medical and scientific affairs. PHCG offers its clients a strategic partnership, a strong focus on ensuring value for their marketing spend, and exceptional performance on their assignments. Website: www.PublicisHealthcare.com

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Obtaining drug particle size information in respiratory products is important to understand the deliverable drug load, respirable fraction, and overall quality as well as from a cost perspective. Prior to entering clinical trials, this additional data can provide invaluable information, raising confidence and lowering risk of failure in vivo biostudies. The value and importance of gaining this information before taking the expensive step of beginning clinical development cannot be emphasised enough.

'We are excited to be able to provide our customers with information that can both improve the quality of their respiratory products as well as save them time and money in the long run,' said Dr. Thomas Voigt, Executive Vice President of ChemImage Corporation.

The technique uses ChemImage's unique technology combination of Raman chemical imaging, optical microscopy, and semi-automated data gathering and analysis software to identify particles based on their unique chemistry (for example, active pharmaceutical ingredient(s) versus excipients) as well as to analyse the particle size distribution in one step. Chemical information is based on the component chemistry identified by the unique Raman signature. This technique addresses the need for a fundamental understanding of API particles in the presence of other undissolved excipients in the formulation and can be used to study ISPS, aggregation and dispersion characteristics.

'We see a growing trend in the pharmaceutical industry of orally inhaled and nasal drug products with more than one active pharmaceutical ingredient,' said Dr. Voigt. 'In this case, morphological indications will not be enough to identify chemistry of particles in these formulations. Raman chemical imaging provides a much more objective method for ingredient-specific particle sizing.'

As one of the premiere meeting venues for the inhalation community, DDL provides an avenue for ChemImage to interface with researchers and business representatives regarding their product development challenges. ChemImage will be available at booth #9 to discuss chemical imaging product and service offerings.

About ChemImage
ChemImage Corporation is a world leader in Chemical Imaging technologies, providing laboratory services, instrumentation, software and expert consulting to government, industrial and academic organizations. ChemImage offers these products and services for a range of applications including defense, security, pharmaceuticals, forensics and biomedical diagnostic research. Our state-of-the-art Chemical Imaging technology can help to reveal critical chemical and biological information about processes, products and services.

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The researchers sequenced the exons and potential regulatory elements of 622 genes distributed across the genome that are candidate intervals for playing a role in healthy aging. They also included three contiguous genomic intervals containing variants associated with age-related diseases for a total of 3.6Mb using only standard molecular biology equipment and the Agilent SureSelect Target Enrichment System. They were able to call known SNPs with 99.7% accuracy, as well as tens of novel variants, the vast majority of them heterozygotes.

The researchers performed the sequencing on an Illumina Genome Analyzer and used SureSelect capture probes in-solution manufactured by Agilent Technologies for target enrichment. The findings are published in the on-line journal GenomeBiology, and can be accessed at http://genomebiology.com/content/pdf/gb-2009-10-10-r116.pdf

The article states that, in recent years, genome-wide association studies have identified "compelling" associations between more than 350 locations along the human genome and common complex traits. But a much larger number of samples must be analyzed to move beyond statistical associations to pinpoint the exact causes of these traits. The article explains that current methods of DNA sequencing cost too much for such large-scale population studies.

The authors write, "Next-generation sequencing technologies and their increased capacity have made it feasible to efficiently sequence hundreds of megabases of DNA. However, the current costs for sequencing entire human genomes make this approach prohibitively expensive for population studies."

"SureSelect is a very scalable capture method," said Olivier Harismendy, Ph.D., project scientist at the Moores UCSD Cancer Center. "It allows you to process multiple samples simultaneously. All you need is already in your lab: a 96-well plate, a magnet and a multichannel pipetter, and here is your high-throughput."

"The product we tested is very mature and the uniformity of the capture went up when compared to the proof-of concept experiment published earlier this year," said Kelly Frazer, Ph.D, Professor and Chief, Division of Genome Information Science, Pediatrics. "In the end, this comes out to less sequencing for an increased sensitivity to detect variants. With these experiments, we now understand better the impact of probe design and tiling frequency which are key parameters to improve capture uniformity and SNP calling."

"We were thinking about improving the economics of very large scale, automated studies from the very first days of SureSelect Target Enrichment, and it's gratifying to see investigators accomplish this without compromising accuracy or reproducibility," said co-author Emily LeProust, Ph.D., Agilent R&D Chemistry and Genome Partitioning program manager.

The conclusion is that the solution-hybridization-based method can generate highly uniform coverage of sequence targets that is reproducible across a large number of samples. This means that large-scale population studies using next-generation sequencing could become economically feasible, fueling breakthroughs in health research.

More information about Agilent SureSelect Target Enrichment System is available at www.opengenomics.com/SureSelect.
About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is the world's premier measurement company and a technology leader in communications, electronics, life sciences and chemical analysis. The company's 17,000 employees serve customers in more than 110 countries. Agilent had net revenues of $4.5 billion in fiscal 2009. Information about Agilent is available on the Web at www.agilent.com.

About Moores UCSD Cancer Center

The Moores UCSD Cancer Center is one of the nation's 40 National Cancer Institute-designated Comprehensive Cancer Centers, combining research, clinical care and community outreach to advance the prevention, treatment and cure of cancer. For more information, visit http://health.ucsd.edu/cancer

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"Heart failure is one of the most costly medical conditions in the world, with 37 percent of U.S. Medicare dollars alone spent on heart conditions each year," said Michael Warmuth, senior vice president, diagnostics products, Abbott. "Novel markers like galectin-3 have the potential to make important contributions to improving patient and economic outcomes as we work to better understand this deadly and costly disease."

Galectin-3 is a protein that plays an integral role in the biological functions related to the initiation and progression of cardiac fibrosis and scarring which is a leading cause of heart failure (HF). Several studies have shown that galectin-3 may provide valuable insight about heart failure and its underlying disease processes.

"This development and commercialization partnership with Abbott is an exciting opportunity to explore a promising diagnostic test with broad applicability in cardiovascular disease on a leading laboratory platform," said Pieter Muntendam, MD, president and CEO of BG Medicine. "BG Medicine's strong life science discovery research program combined with Abbott's scientific and development leadership will enable us to bring important new tests to patients and laboratories."
About Abbott Diagnostics

Abbott Diagnostics is a global leader in in vitro diagnostics, with expertise in cardiac, metabolic and renal testing. Abbott's comprehensive portfolio of cardiac tests includes biomarkers that help thousands of labs and doctors around the world to diagnose and assess heart failure and myocardial infarction. With more than 69,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers quick processing of results, automation, convenience, cost effectiveness and flexibility.
About BG Medicine

BG Medicine is a life sciences company focused on the discovery, development, and commercialization of novel diagnostics based on biomarkers to improve patient outcomes and contain healthcare costs. BG Medicine's proprietary technology platform enables rapid and cost-effective discovery of new high-value diagnostics biomarkers over a broad range of therapeutic areas. More information regarding BG Medicine is available on the company's Web site at www.bg-medicine.com
About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

ARCHITECT, i1000SR and i2000SR are trademarks of Abbott Laboratories.

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COPD is a chronic lung disease associated with a high level of mortality. According to the latest World Health Orgainzation (WHO) estimates, 210 million people suffer from COPD and it currently ranks as the fourth leading cause of death. However, the WHO predicts that it will become the third leading cause of death worldwide by 2030.1 In 2005 COPD was estimated to have killed over 3 million people2 – more than HIV/AIDS or lung and breast cancer combined.1,3 Despite this, COPD remains a scarcely known, under-diagnosed and under-treated disease that demands a changed approach to diagnosis and treatment.4 Fewer than half of patients with the condition have a proper diagnosis and only 35% of patients receive a regular prescribed medication.5,6

These issues, among others, have been highlighted by EFA who collected European data for the first time from patient groups` perspectives and are now calling for more to be done to reduce the burden of COPD and improve patient care. Over 11 million Europeans are affected by COPD and face its debilitating consequences on a daily basis.7

EFA`s book recognises that even in its early stages, COPD has a devastating impact on patients` quality of life as it begins to damage the lungs irreversibly causing sufferers to struggle for breath and with simple daily tasks.8 In addition, patients are frustrated about the difficulty in gaining effective management of their condition including early diagnosis, education, support services and access to the best treatments available. The goal of EFA`s efforts in the coming months will be to reduce the impact of COPD on patients and their caregivers and to focus efforts on a call to action for real improvements.

BI and GSK, who sponsored the project, support EFA`s conclusion that there is an urgent need for a coordinated strategy of advocacy both at European and national level. To improve overall COPD management, the following four areas of focus were identified:

* Increase the awareness of the public at large about COPD, its symptoms and risk factors in order to prevent the disease and to encourage sufferers to seek early diagnosis
* Raise the priority of COPD with policy makers to encourage the creation of screening guidelines and mandates for early diagnosis and management of the disease
* Improve the access to care and management for diagnosed COPD patients
* Safeguard the respiratory health of future generations.

Notes to Editors
The development and publication of the EFA Book on COPD in Europe: Sharing and Caring has been funded by an educational grant from Boehringer Ingelheim and GlaxoSmithKline. It aims to: Inform policy makers (EU and national) about COPD thereby prompting action where necessary Encourage healthcare professionals to collaborate with patient organisations to increase diagnosis, assessment and treatment of COPD patients Raise the awareness and prioritisation of this disabling disease.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world`s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

GlaxoSmithKline – one of the world`s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

References:
1 World Health Organization. Immunizations, Vaccines and Biologicals Available from: http://www.who.int/immunization/topics/hiv/en/index1.html (last accessed 12th November 2009).
2 World Health Organization. COPD Available from: http://www.who.int/respiratory/copd/en/(last accessed 2nd November 2009).
3 World Health Organization. Factsheet 297 Cancer Available from: http://www.who.int/mediacentre/factsheets/fs297/en/ (last accessed 12th November 2009).
4 Wouters EFM. Economic analysis of the Confronting COPD survey: an overview of results. Respiratory Medicine 2003; 97:S3-S14.
5 Mannino DM, Homa DM, Akinbami LJ, et al. Chronic obstructive pulmonary disease surveillance. United States, 1971-2000. MMWR Surveill Summ 2002; 51: 1-16.
6 National Library for Health. National Knowledge Week for COPD 2008 – Raising awareness of lung disease. http://www.library.nhs.uk/respiratory/ViewResource.aspx?resID=278341. Accessed 22 October 2008.
7 World Health Organization. Global Burden of Disease Report 2004. Part 3. Available from: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_part3.pdf (last accessed 12th November 2009).
8 World Health Organization. Factsheet 315 Chronic Obstructive Pulmonary Disease (COPD) Available from: http://www.who.int/mediacentre/factsheets/fs315/en/index.html (last accessed 2nd November 2009).

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* Data also show that Novartis MF59® adjuvant was well tolerated and could potentially quadruple the Novartis A(H1N1) 2009 influenza vaccine supply

* MF59® adjuvant has an established safety profile supported by clinical data from more than 33,000 study participants and 12 years of real life safety data with more than 45 million doses of influenza vaccine administered since 1997 in Europe

Basel - Novartis announced today new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (mote than or equal 65 years of age).

The data also showed a single 3.75µg dose of MF59-adjuvanted A(H1N1) 2009 vaccine met serologic protection criteria against influenza A(H1N1) in children ages 3 to 8, adults ages 18 to 64, and the elderly. All A(H1N1) 2009 influenza study vaccines were manufactured using the Novartis established seasonal Fluvirin® manufacturing platform. Novartis has discussed these new data with the US Food and Drug Administration (FDA) and is performing additional statistical analysis suggested by the agency. It is still under evaluation whether the antigen content per dose can be reduced in the US.
Current US guidelines for A(H1N1) 2009 vaccine use state that adolescents, adults and the elderly are required to receive one 15µg dose to achieve adequate protective antibody levels against the A(H1N1) virus, and children 9 years of age and under are required to receive two 15µg doses four weeks apart.

"These promising data suggest that many more people could potentially be vaccinated with our current vaccines supply, protecting more people earlier against the current pandemic," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "The data also confirms the antigen sparing potential of our proprietary adjuvant, MF59®. The vaccines output of our Liverpool, U.K., based flu manufacturing facility, fully dedicated to the US since the emergence of the pandemic, could be quadrupled if vaccines are adjuvanted."

These interim data were generated from pivotal clinical studies designed to evaluate the immunogenicity, safety and reactogenicity of both MF59-adjuvanted and unadjuvanted, inactivated novel swine origin A(H1N1) 2009 monovalent subunit influenza virus vaccine in 4,080 US subjects. In the pediatric trial, the findings are based on 80% of first dose data from 1,360 subjects ages 3 to 8 at day 22. In the adult trial, the findings are based on 95% of first dose data at day 1 and day 8 and approximately 40% of first dose data at day 22 from 1,360 adult subjects and 1,360 elderly subjects. Second dose data and data in ages 6-36 months of age are expected in December 2009.

About MF59

Novartis proprietary MF59 adjuvant has an established safety profile, supported by more than 12 years of clinical safety data and more than 45 million doses of commercial use in Europe. The adjuvant has been studied in clinical trials involving more than 33,000 people, including children, and has been licensed for use in people 65 years of age and over in the seasonal influenza vaccine Fluad® since 1997 in the European Union. Novartis also produces two A(H1N1) vaccines, Focetria® and Celtura®, which contain MF59 and are available outside the US. Currently, there are no approved vaccines in the United States that contain MF59.

Novartis has been contracted by the US Department of Health and Human Services (HHS) to produce 90 million doses of MF59 by the end of November.[1]

About A(H1N1) 2009 Vaccine

Novartis influenza A(H1N1) 2009 monovalent vaccine, manufactured using the established seasonal Fluvirin platform, is an inactivated influenza virus egg-derived vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by pandemic A(H1N1) 2009 virus. The vaccine was approved by the FDA on September 15, 2009 as an unadjuvanted 15µg dose.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "may," "suggest," "could," "potentially," "promising," "potential," "expected," or similar expressions, or by express or implied discussions regarding regarding potential additional marketing approvals for Novartis' A(H1N1) vaccines and adjuvants, potential new indications or labeling for Novartis' A(H1N1) vaccines and adjuvants, potential future deliveries of influenza vaccines and adjuvants, or regarding potential future revenues from Novartis' A(H1N1) vaccines and adjuvants. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Novartis' A(H1N1) vaccines and adjuvants to be materially different from any future results, performance or achievements expressed or implied by such statements. Novartis' A(H1N1) vaccines will achieve any additional marketing approvals. Nor can there be any guarantee that Novartis' A(H1N1) vaccines and adjuvants will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Novartis will successfully meet its delivery obligations for its A(H1N1) vaccines and adjuvants. Neither can there be any guarantee that Novartis' A(H1N1) vaccines and adjuvants will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Novartis' A(H1N1) vaccines and adjuvants could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing difficulties or delays, including continued unexpected difficulties with seed virus yields, and unexpected difficulties with our flu cell culture manufacturing facility and processes; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in each of these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

References
[1] This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHS100200800072I.

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London UK, Rockville US - GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) today announced an exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAX®), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.

Under the terms of the agreement GSK will pay to Nabi an upfront non-refundable fee of $40 million at closing and will receive an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-generation nicotine vaccines using Nabi's intellectual property. Together with the upfront payment, Nabi is eligible to receive over $500 million in option fees and regulatory, development and sales milestones for NicVAX and follow-on nicotine vaccines. Nabi will also receive double-digit royalties on global sales of NicVAX should GSK exercise its option as well as royalties on global sales of next generation nicotine vaccines.

NicVAX has recently entered the first of two Phase III clinical trials. Nabi will be responsible at its cost for the Phase III development of this candidate vaccine. Upon successful completion of the Phase III studies, if GSK exercises its option, GSK will take responsibility for further development and commercialisation of NicVAX. In parallel with the Phase III studies, and independent of whether it exercises its option to in-license NicVAX, GSK will be developing a next-generation nicotine vaccine based on Nabi's intellectual property together with GSK's own technology.

'If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent; a habit that is well documented to be very hard to stop permanently' said Jean Stephenne, President of GSK Biologicals. 'This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio.'

'We are very pleased with this deal and proud it is with GSK, one of the world's leading vaccine companies, to further develop and commercialise NicVAX.' said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. 'We look forward to addressing one of the largest unmet medical needs of our time with what we believe will be an effective tool to help people quit smoking and remain smoke-fee for the rest of their lives.'

Tobacco use is the leading cause of preventable death in the world. Smoking is a global epidemic, affecting an estimated 1.2 billion smokers worldwide and is responsible for 5.4 million deaths per year worldwide. Nicotine dependence is a chronically relapsing condition with only a minority of smokers achieving permanent abstinence in the first attempt to quit. Tobacco has been recognised by the Royal College of Physicians as being on par, from an addictive standpoint, with heroin and cocaine [1] and as such, many tobacco users need support to stop.

The vaccine is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products.

Pre-clinical and clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes the candidate vaccine could also be effective in preventing smoking relapse. Relapse is a significant challenge facing smokers. Currently available smoking cessation therapies have relapse rates that can be as high as 90% [2] in the first year after a smoker quits.

The transaction is subject to approval by Nabi shareholders and customary closing conditions, and is expected to be completed in the first quarter 2010.

How NicVAX works
When nicotine enters the bloodstream, it quickly crosses the blood-brain barrier and binds to nicotinic receptors in the brain, triggering the release of stimulants like dopamine that provide the smoker with a positive sensation that eventually leads to addiction. NicVAX stimulates the immune system to produce antibodies that bind to nicotine creating an antigen/antibody complex that is too large to cross the blood-brain barrier. In this way, NicVAX blocks nicotine from reaching these receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. Pre-clinical and previous clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the nicotine antibodies circulate for long periods of time, Nabi believes NicVAX may also be effective in preventing smoking relapse. This is a very important difference between NicVAX and existing anti-smoking treatment therapies. Relapse is a significant challenge facing smokers and, with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Nabi Biopharmaceuticals - leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit www.nabi.com

GlaxoSmithKline Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

Nabi Biopharmaceuticals Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements and include statements about products in development, results and analyses of clinical trials and studies, research and development expenses, cash expenditures, licensure applications and approvals, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, projections, anticipations, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to: complete the PentaStaph sale milestones; successfully close the licensing agreement transactions for NicVAX; initiate and conduct clinical trials and studies; raise sufficient new capital resources to fully develop and commercialize our products in development; attract, retain and motivate key employees; collect further milestone and royalty payments under the PhosLo Agreement; obtain regulatory approval for our products in the U.S. or other markets; successfully contract with third party manufacturers for the manufacture and supply of NicVAX; and comply with reporting and payment obligations under government rebate and pricing programs. Some of these factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 27, 2008 and our Quarterly Reports on Form 10-Q for the period ended March 28, 2009 and June 27, 2009 filed with the Securities and Exchange Commission.

[1] www.who.int/tobacco/research/cessation/about/en/index.html

[2] American Lung Association report 2007

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

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"Today's Merck has a robust portfolio and pipeline of cardiovascular medicines for conditions ranging from heart disease to metabolic syndrome. More than ever, our new company is committed to improving patient outcomes and providing comprehensive solutions to prevent and treat heart disease," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We're confident more can be done through science and education to save and improve the lives of people suffering from cardiovascular disease." Cardiovascular diseases are the number one cause of death globally. More people die annually from cardiovascular diseases than from any other cause.

The company's renewed commitment builds on a deep heritage of scientific excellence in cardiovascular medicine. In the past 50 years, Merck and Schering-Plough have, when combined, introduced more than 40 products targeting cardiovascular diseases. Today's Merck offers a range of products and tools for cholesterol management and hypertension to address the needs of diverse patient types. We also are transforming how our commercial organization interacts with health care providers and patients by aligning those interactions around the common goal of improving patient outcomes.

Developing Breakthrough Cardiovascular Medicines
Today's Merck is investing billions of dollars annually in research and development. More than 1,000 of our scientists and professionals are engaged in the fight against heart disease, and the companies' combined pipeline creates a strong and promising future of breakthrough cardiovascular medicines. Our researchers are using diverse science -- from integrated genomics to experimental medicine -- to identify novel targets and to map the links between heart disease and illnesses like diabetes and metabolic syndrome.

Our mid- to late-stage pipeline includes more than eight innovative investigational candidates for the treatment of a wide range of cardiovascular diseases including atherosclerosis, atrial fibrillation and thrombosis, ischemic reperfusion injury and hypertension.

Merck also continues to lead the way in implementing large clinical studies with the potential to advance understanding of the role of medicines in cardiovascular outcomes and has over six large cardiovascular outcomes trials underway.

"No other health care company is doing more to study cardiovascular disease than today's Merck," said Dr. Kim. "Our outcomes trials alone include more than 90,000 patients and are being conducted in approximately 40 countries. And, we have more than 50 other ongoing trials focused on testing investigational medicines for cardiovascular disease."

Collaborating and Partnering to Advance Cardiovascular Care
Today's Merck is strengthening and forming new strategic alliances to advance cardiovascular research and development. The company has ongoing cardiovascular collaborations with Actelion Pharmaceuticals, Arena Pharmaceuticals, Cardiome Pharma Corp., Galapagos NV, NicOx, Mochida Pharmaceutical Co., Ltd., Millennium, PeriCor Therapeutics, Inc., Portola Pharmaceuticals, and Xenon Pharmaceuticals. Merck also is partnering with academic institutions such as Oxford University; Duke Clinical Research Institute; Harvard University, The TIMI Study Group, Brigham and Women's Hospital; Columbia University, Atherosclerosis Research Center; University of Pennsylvania; Baylor School of Medicine, University of Washington; and Montreal Heart Institute. In addition Merck is a founding member of the HRP Initiative, a joint research and development effort to advance the understanding, recognition and management of high-risk plaque.

"Innovation depends on thousands of scientists building on each other's breakthroughs and scientific collaboration speeds up the innovative process," said Dr. Kim. "Merck has a renewed sense of urgency and focus and, through new and existing collaborations, we will bring resources to the best external science wherever it emerges."

Improving Patient Outcomes with Education and Philanthropy
Today's Merck is committed to improving cardiovascular care through medical education, and philanthropy. The company supports a variety of patient, medical and scientific education initiatives for the purpose of helping health care professionals achieve improved cardiovascular outcomes for their patients.

For example, Merck supports American Heart Association (AHA) initiatives such as the Pharmaceutical Roundtable, Go Red For Women, and the AHA Annual Scientific Sessions. Additionally, we have supported the American College of Cardiology's Fellowship program for nearly 30 years as well as the Future Leaders in CV Medical Research for the past four years.

Since 2008, the company has taken important steps to increase the public's level of knowledge and understanding of how Merck supports and advances medical and scientific education. Merck believes that increasing the visibility of its educational and philanthropic activities across all aspects will enhance the public trust in the company and increase the level of knowledge and understanding of how Merck helps advance medical and scientific education and health care overall.

"Our reputation, and the trust that health care providers and patients place in us, depends in large part on how we conduct ourselves as a business," said Dr. Kim. "We strive to operate openly and transparently in everything we do and to apply the highest standards of ethics and scientific integrity to everything we do."

Merck also is fighting cardiovascular disease by helping uninsured and financially-struggling patients who lack prescription coverage gain access Merck's patient assistance programs (PAP). Merck's PAP provides free or discounted medicines for chronic conditions like hypertension and diabetes. In 2008 alone, approximately 1.5 million prescriptions were filled under the Merck Patient Assistance Program. More information about Merck's PAP is available at www.merckhelps.com.

About Merck
Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com

Forward Looking Statement
This news release includes 'forward-looking statements' within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's and Schering-Plough's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended Sept. 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

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In the BABYDIAB study led by Professor Anette-Gabriele Ziegler, director of the Institut für Diabetesforschung der Forschergruppe Diabetes e.V. at Helmholtz Zentrum München and Forschergruppe Diabetes at the Technische Universität München analyzed the data of 729 children whose mothers had type 1 diabetes and who thus had a higher diabetes risk.
The scientists investigated the genetic background of fetuses for alterations in individual DNA bases, termed single nucleotide polymorphisms (SNPs). Here they focused on three gene regions which are known to be risk alleles for diabetes caused by reduced insulin secretion. They looked at these in relation to birth weight.

It turned out that there was a significant association between the two SNPs of the HHEX-IDE gene region and low birth weight. This was independent of HbA1c levels (long-term blood glucose levels) of the expectant mother, indicating a lesser correlation between maternal nutrition and blood glucose regulation. 'Interestingly, we found this effect in children whose mothers had type 1 diabetes. This could mean that an a priori reduced insulin secretion also plays a role in the development of autoimmune type 1 diabetes," explained Dr. Christiane Winkler of the Forschergruppe Diabetes at Helmholtz Zentrum München and first author of the publication.

In contrast, the researchers found no correlation between the two SNPs of the other gene regions that were studied (CDKAL1 and SLC30A8) and birth weight. However, this does not entirely exclude an association – such an effect could become apparent with higher numbers of participants. "Indications of genetic associations are usually only found in very large populations. As we see here, it is important to substantiate these in smaller, but very well-phenotyped study populations. We can thus gain information about the possible mechanism of the original results", emphasized PD Dr. Thomas Illig, head of the Epidemiology – Biological Samples – Genomics research unit at Helmholtz Zentrum München.

With their findings, the Munich researchers have come a step closer to understanding the underlying genetic mechanisms of diabetes diseases. 'Next, we want to investigate whether the genetic associations observed in this study could also have an effect on body weight later in life. Due to the long-term BABYDIAB study, which has run continuously since 1989, this data already exists,' Christiane Winkler explained.
Further information

Original Publication:
Christiane Winkler, Thomas Illig, Kerstin Koczwara, Ezio Bonifacio, Anette-Gabriele Ziegler. HHEX-IDE polymorphism is associated with low birth weight in offspring with a family history of type 1 diabetes. Journal of Clinical Endocrinology & Metabolism 2009, doi:10.1210/jc.2009-0970

Helmholtz Zentrum München is the German Research Center for Environmental Health. As leading center oriented toward Environmental Health, it focuses on chronic and complex diseases which develop from the interaction of environmental factors and individual genetic disposition. Helmholtz Zentrum München has around 1680 staff members. The head office of the center is located in Neuherberg to the north of Munich on a 50-hectare research campus. Helmholtz Zentrum München belongs to the Helmholtz Association, Germany's largest research organization, a community of 16 scientific-technical and medical-biological research centers with a total of 26,500 staff members. Further information: www.helmholtz-muenchen.de

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Blood glucose levels are tightly regulated by secretion of insulin from beta cells in the pancreas. Defective insulin secretion results in poorly regulated blood glucose levels and diabetes.

The work of the multi-national research team explored the role of LKB1, a gene involved in many cellular functions, whose role in the pancreas was not examined before. Specifically, they studied the implications of beta cell-specific loss of the LKB1 gene, using a mouse model system. They were able to show that eliminating this gene from beta cells causes the production and secretion of more insulin than normal beta cells, resulting in an enhanced response to increases in blood glucose levels.

The findings have potentially great implications for those suffering from diabetes (excessive blood sugar) due to insufficient production of insulin in the pancreas.

Since it was shown that LKB1 negatively regulates both insulin content and secretion, the way has now been opened to possible development of a novel therapy that would limit the presence of this gene in pancreas beta cells, thus enhancing insulin secretion.

The researchers involved in the project, whose findings were published recently in the journal Cell Metabolism, were led by Dr. Yuval Dor of the Institute for Medical Research Israel-Canada of the Hebrew University-Hadassah Medical School and included students Zvi Granot, Avital Swisa, Judith Magenheim and Miri Stolovitch-Rain, as well as scientists from Kobe University in Japan, and American researchers from the University of Pennsylvania, Washington University in St. Louis and Massachusetts General Hospital in Boston.

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Abbott Park, Illinois (NYSE: ABT) — Abbott announced today a definitive agreement to acquire the global rights to PanGenetics BV's PG110 fully humanized antibody to Nerve Growth Factor (NGF), expanding the company's pain care portfolio and leveraging its expertise in biologics. PG110 is a novel biologic in Phase I clinical trial development that targets NGF for the treatment of chronic pain. NGF is released at sites of tissue damage and inflammation, and plays a significant role in the transmission of pain signals by the central nervous system.

"The goal for treatment of chronic pain continues to be potent, long-lasting analgesia that is tolerable for patients without the potential for dependence and abuse," said John Leonard, M.D., senior vice president, global research and development, Abbott. "NGF blockers have demonstrated the potential to address all of these needs, making them a promising treatment for chronic pain patients."

Pain is the number one reason people go to see a doctor. There are an estimated 72 million diagnosed chronic pain patients in the U.S. and EU, and up to 30 percent of chronic pain patients get inadequate relief. Current treatments consist of NSAIDs, selective Cox-2 inhibitors, opioids and other analgesics that are dosed daily and have various tolerability and safety issues, including the potential for abuse and addiction.

PG110 is currently being studied in a Phase I clinical trial in patients with osteoarthritis. If the Phase I trial is successful, Abbott anticipates evaluating the compound in a number of other pain states, including chronic lower back pain, cancer pain and diabetic neuropathic pain.

This new NGF inhibitor complements Abbott's robust early-stage pipeline of candidates in development for chronic pain, which spans multiple mechanisms, including vanilloid cellular receptors (TRPV1), cannabinoid receptors (CB2), Histamine H3 receptors and preclinical work on a number of promising ion channel targets.

The agreement includes an upfront payment of $170 million plus additional milestone payments, for a total of up to $190 million. This transaction is subject to customary closing conditions and regulatory approvals and is expected to close in the fourth quarter of 2009. Abbott would expect to incur one-time specified items upon the closing of the acquisition, primarily related to in-process research and development. This transaction does not impact Abbott's previously issued ongoing earnings-per-share guidance for 2009.
About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

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The team of scientists from DeveloGen AG in cooperation with Prof. Conrad Kunick's laboratory at the Technical University Braunschweig, Germany, published results which demonstrate that small synthetic molecules can promote the regeneration of insulin producing beta cells. In cell culture experiments the team of scientists demonstrated that highly potent and specific glycogen synthase 3 beta inhibitors are able to protect beta cells from apoptosis and stimulate their proliferation.

Cord Dohrmann, CEO of DeveloGen AG, said: "Receiving the Phoenix Science Award is further confirmation of the worldwide leading work conducted at DeveloGen in the field of beta cell regeneration. Together with Prof. Kunick we were able to generate important insights about how beta cells can be protected from apoptosis and stimulated to proliferate. This is an important step towards the discovery and development of innovative and potentially disease modifying therapies for the treatment of diabetes."

The title of the publication is: "9-Cyano-1-azapaullone (Cazpaullone), a Glycogen Synthase Kinase-3 (GSK-3) Inhibitor Activating Pancreatic Beta Cell Protection and Replication". The article was published in April 2008 in the Journal of Medicinal Chemistry.

About Diabetes

Diabetes is a global epidemic with devastating human, social and economic consequences. In 2007 it was estimated that 246 million people worldwide have diabetes, representing roughly 6% of the adult population. The number is expected to reach 380 million by 2025, representing over 7% of the adult population. Diabetes/obesity is the fastest growing disease in the USA, afflicting one in four Americans and accounting for well over 30% of the Medicare budget.

About DeveloGen

DeveloGen AG is a biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of metabolic and endocrine diseases. The Company has a highly innovative and deep preclinical discovery pipeline addressing the key drivers in the development of diabetes and obesity such as insulin resistance and loss of insulin-producing beta cells. This pipeline includes programs for the potential treatment of obesity through orally available small molecules based on novel and proprietary targets as well as growth factors targeting beta-cell regeneration (type 1 and type 2 diabetes). In addition, the Company is developing DG3173 (Somatoprim), a potentially best-in-class somatostatin analogue for the treatment of acromegaly, carcinoid tumors and diabetic retinopathy, which has recently successfully completed a Phase 1 clinical trial. DeveloGen is based in Göttingen, Germany. For more information on DeveloGen, please visit www.develogen.com.

About Phoenix Science Award ("Phoenix Wissenschaftspreis")

Each year, Phoenix Pharma AG awards a price for scientific work in the areas pharmacology, pharmaceutical biology, pharmaceutical chemistry and pharmaceutical technology, which has been published in a German or English journal.

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The data from this study confirm previously reported results in an elderly population, which showed that the immune response elicited by Pandemrix exceeded the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. Additionally the subjects in this trial also demonstrated a strong immune response to the seasonal influenza vaccine, again exceeding the three immunogenicity criteria as defined by international licensing authorities for a seasonal trivalent vaccine.

"These results provide key information to public health organisations. These new data on the co-administration of both the seasonal and pandemic influenza vaccines could help simplify the influenza vaccination programmes that countries are now starting to initiate,' said Jean Stéphenne, President of GSK Biologicals. 'This provides the valuable insight into vaccination in this specific age group that generally benefits from the annual seasonal vaccination.'

In this trial, 89.3% of the subjects receiving both vaccines at the same time demonstrated a response for the H1N1 virus that was above the regulatory threshold of 1:40 seroprotection, which is considered indicative of protection. The immune response for the seasonal vaccine exceeded the regulatory threshold defined by international licensing authorities for registration of the seasonal influenza vaccine each year (69.0%, 78.6% and 100% for A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Brisbane respectively). The annual seasonal influenza vaccine contains 3 strains of influenza identified by public health organisations in advance of an upcoming influenza season. For the Northern Hemisphere 2009 / 2010 influenza season the composition of the seasonal influenza vaccine was determined before the appearance of the pandemic H1N1 strain.

The tolerability of the vaccine in this study was shown to be in line with that observed in the previously EMEA approved H5N1 adjuvanted vaccine as well as in the pandemic H1N1 trials to date. Local reactions such as pain, redness, and swelling at the site of injection were observed in this trial. General reactions such as fatigue, low grade fever, headache, and muscle ache were also observed in this trial, and were similar between the group that received both vaccines at the same time to those in a comparison group receiving the adjuvanted pandemic influenza vaccine with co-administration of a placebo injection.

Further information on GSK's development of a vaccine to protect against pandemic 2009, including explanation of the vaccine development process and background information on adjuvants is available on: www.gsk.com/media/pandemic-flu.htm

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

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London UK - The World Health Organization (WHO) has awarded prequalification for global use of Synflorix™ , GlaxoSmithKline Biologicals' pneumococcal conjugate vaccine. This is the first prequalification for a vaccine against pneumococcal disease, which is a life-threatening disease affecting many children under five in developing countries. The WHO prequalification allows UN agencies to purchase vaccines on behalf of developing countries and will accelerate global access to Synflorix™. This endorsement comes less than a year after the vaccine's first licensure and just a few days after the First World Pneumonia Day, marked on November 2.

'GSK developed Synflorix™to offer protection against pneumococcal disease to children all over the world," said Jean Stéphenne, CEO of GSK Biologicals. 'The vaccine helps protect against 10 strains of the pneumococcal bacterium and can make a lasting public health impact in developing countries, where the disease burden is greatest. GSK is especially proud to be the first company to receive prequalification for a pneumococcal vaccine that can save so many lives and dramatically alter the world's fight against pneumonia."

The WHO awarded prequalification for global use of a one-dose vial presentation of Synflorix™. GSK is working closely with the WHO to review a file for the prequalification of a two-dose vial, a presentation that could make more efficient use of limited refrigeration space in low-resource settings.

Among the 10 pneumococcal strains for which Synflorix™ offers protection, three – 1, 5 and 7F – are common in developing countries and are not currently prevented by the widely available pneumococcal vaccines. These strains must be addressed to significantly help reduce the global burden of pneumococcal disease, which results in nearly one million children fatalities in developing countries each year.

The WHO prequalification process began in early 2008, when GSK submitted for this prequalification within weeks of filing for approval from the European Medicines Agency (EMEA). To receive WHO approval, new vaccines must demonstrate clinical impact in relevant settings and meet high international production standards. Before approval is granted, the WHO conducts quality assurance tests on individual vaccine batches, inspects manufacturing sites and consults closely with the relevant regulatory agency where the vaccine will be manufactured, in this case, the EMEA.

'Today's WHO prequalification of Synflorix™ is an important step towards universal access to life-saving pneumococcal vaccines for children everywhere,' said Orin Levine, Executive Director of PneumoADIP at Johns Hopkins Bloomberg School of Public Health. 'Now, suppliers, international agencies, donors, and local governments must assure that these vaccines reach the children who need them most.'

GSK currently manufactures Synflorix™at its plant in Belgium. In June 2009, GSK opened a new $411 million plant in Singapore, which will have the capacity to meet the need for pneumococcal vaccines in global markets in the coming years.

Today's WHO endorsement of Synflorix™ continues GSK's track record of seeking WHO prequalification for its life-saving vaccines. GSK was also awarded prequalification for Cervarix®, its cervical cancer vaccine, in July 2009 and received an extended prequalification for Rotarix™, a vaccine against rotavirus, in June 2009. Together, these three endorsements will provide access to vaccines for major global health threats and save millions of lives over the coming years.

About Synflorix™

GSK's Synflorix™ is a complex 10-valent conjugate vaccine which was developed to protect children from invasive pneumococcal disease and acute otitis media caused by Streptococcus pneumoniae, and is licensed for children and infants aged 6 weeks to 2 years. The vaccine is expected to protect against an estimated 80 percent of invasive pneumococcal disease in children younger than five worldwide, including strains 1, 5 and 7F, which account for 3-23 percent of invasive pneumococcal diseases globally. The non-profit PneumoADIP estimates that widespread pneumo vaccination could save more than 5.4 million lives by 2030.

Synflorix is a complex conjugate vaccine that requires nearly 18 months to manufacture. The complexity of Synflorix™ stems from the innovative conjugation process used to manufacture the vaccine. During the production process, the vaccine's ten 'valents' – all of which help protect against a different strain of pneumococcal disease – are produced separately and then attached to individual 'carriers'. The main carrier is a protein derived from non-typeable Haemophilus influenzae (NTHi). In turn, these carriers help stimulate immune responses to the ten strains of pneumococcal disease that Synflorix protects against.

The clinical development programme of Synflorix™ has spanned four continents, with more than 100,000 doses administered to date. Clinical trials have demonstrated the vaccine has an acceptable safety profile and immunogenicity level when vaccinating infants both pre- and full-term. Synflorix™ was approved by the European Medicines Agency in March 2009. The vaccine is currently approved in more than 40countries.

About GlaxoSmithKline Biologicals

GlaxoSmithKline—one of the world's leading research-based pharmaceutical and healthcare companies—is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media.

GSK Biologicals is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. In 2008, GSK Bio distributed more than 1.1 billion doses of vaccines to 176 countries. Close to 80 percent of these doses were distributed in developing countries.

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

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All fifty-eight patients, with a median age of 63 and all with advanced acute myeloid leukemia or high-risk myelodysplastic syndrome - a pre-leukemic condition - saw their blood cancers go into remission using a novel combination of low-intensity chemotherapy, targeted radiation delivery by an antibody and a stem-cell transplant. Forty percent of the patients were alive a year after treatment and approximately 35 percent had survived three years, about the same rates as patients who received similar treatment but whose disease was already in remission and who had much more favorable risk for relapse when therapy began.

Results of the research appear online in the journal Blood. The principal investigator and corresponding author of the paper is John Pagel, M.D., Ph.D, a transplant oncologist and assistant member of the Hutchinson Center's Clinical Research Division.

The purpose of the study was to find the maximum dose of radiation that patients could tolerate with acceptable toxic side effects, not to assess how effective the novel treatment was, according to Pagel and colleagues. However, "the results appear to be very encouraging and warrant us to study it further for patients who really have no significant other curative options," Pagel said.

Older (over age 50) patients with active, advanced leukemia and myelodysplastic syndrome pose the most difficult treatment challenges because standard transplant therapy rarely works, according to Pagel. Both standard and low-dose therapies (a process sometimes known as a "mini transplant" and pioneered at the Hutchinson Center) used to kill leukemia cells in the bloodstream in preparation for a transplant usually require that patients be in remission.

The patients in this study, who came from all over the world to participate in the Phase 1 clinical trial, were in large part those with active relapsed disease that in many cases had failed to respond to standard therapies. Eighty-six percent of the 58 patients had active disease and only 10 percent were in remission when therapy was begun. Their cancers had failed previous treatment attempts. "These were people who had extremely advanced high-risk disease, they were typically older - most of them were in their 60s and some were in their 70s - and had few or no other options for a potential cure. In fact most, if not all, would not been offered a stem cell transplant here or elsewhere. It is fair to say that these patients would likely have died without a transplant being performed if they had not been given the opportunity to participate in this study."

To find the optimal dose of radiation, researchers began at 12 Gy (Gray, a unit of measurement of absorbed radiation dose) and escalated the dosages in increments of 2 Gy up to a Gy of 26. At that dose, some toxicity to the heart and lungs was found so they concluded 24 Gy to be the maximum effective dosage. The 21 patients who received the maximum radiation dose have survived the longest, researchers reported.

The key to success in this study was use of a radiolabeled antibody that has therapeutic iodine 131 attached and is designed to target leukemic bloods cells that carry a marker on the surface of the cell known as CD45. Its use in delivering targeted amounts of radiation was developed several years ago at the Hutchinson Center. Delivered intravenously, the radiation looks for the CD45 antigen receptor on the surface of blood cells. This approach results in a two- to four-fold increase in the amount of radiation that reaches cancerous cells as compared to standard external beam radiation, which also radiates normal surrounding organs and tissue. The more radiation that can be applied, the more cancer cells will be killed in preparation for donor stem cells to take over the diseased immune system and kill off the remaining cancer cells.

Pagel said further research is needed to test more patients at the highest radiation dose both at the Hutchinson Center and at other transplant centers around the country.

Joining Pagel in the study were colleagues from the Hutchinson Center, the Pacific Northwest Laboratory and the departments of Medicine, Pediatrics and Nuclear Medicine at the University of Washington School of Medicine.

Grants from the National Institutes of Health, the Leukemia and Lymphoma Society of America, the Damon Runyon Cancer Research Foundation, the Edson Foundation and the Frederick Kullman Memorial Fund supported this research.

At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit fhcrc.org.

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The molecules — called 'antibody-recruiting molecule targeting HIV' (ARM-H) and 'antibody-recruiting molecule targeting prostate cancer' (ARM-P) — work by binding simultaneously to an antibody already present in the bloodstream and to proteins on HIV, HIV-infected cells or cancer cells. By coating these pathogens in antibodies, the molecules flag them as a threat and trigger the body's own immune response. In the case of ARM-H, by binding to proteins on the outside of the virus, they also prevent healthy human cells from being infected.

'Instead of trying to kill the pathogens directly, these molecules manipulate our immune system to do something it wouldn't ordinarily do,' said David Spiegel, Ph.D., M.D., assistant professor of chemistry and the corresponding author of both papers.

Because both HIV and cancer have methods for evading the body's immune system, treatments and vaccinations for the two diseases have proven difficult. Current treatment options for HIV and prostate cancer — including antiviral drugs, radiation and chemotherapy — involve severe side effects and are often ineffective against advanced cases. While there are some antibody drugs available, they are difficult to produce in large quantities and are costly. They also must be injected and are accompanied by severe side effects of their own.

By contrast, the ARM-H and ARM-P molecules, which the team has begun testing in mice, are structurally simple, inexpensive to produce, and could in theory be taken in pill form, Spiegel said. And because they are unlikely to target essential biological processes in the body, the side effects could be smaller, he noted.

'This is an entirely new approach to treating these two diseases, which are extraordinarily important in terms of their impact on human health,' Spiegel said.

HIV is a global pandemic that affects 33 million people worldwide, while prostate cancer is the second leading cause of cancer-related death among American men, with one out of every six American men expected to develop the disease.

Funding for this research was provided by the National Institutes of Health.

— WebWireID107192 —

Toronto, Canada (November 4, 2009) — An article entitled 'Computer-assisted methods for molecular structure elucidation: realizing a spectroscopist's dream' written by scientists at Advanced Chemistry Development, Inc., (ACD/Labs), The Russian Academy of Sciences, and ChemZoo Inc., has become one of the Top 10 Most Accessed Articles on the Journal of Cheminformatics website. The article coincides with the 40th anniversary of the first published works dealing with the creation of algorithms for computer-assisted structure elucidation (CASE).

The article aims to illustrate that CASE systems are finally approaching the goal of fully automated structure elucidation—a spectroscopist's dream come true—and describes the main principles of CASE systems along with some of the challenges encountered in developing an effective system. The expert system, ACD/Structure Elucidator, using 2D NMR data is used to illustrate the principles of a modern CASE system.

CASE has traditionally attempted to employ a variety of types of analytical spectra to elucidate chemical structure including 1H and 13C NMR, IR, and UV, but without significant success. Only in the past two decades, with the increased availability and use of 2D NMR, has development of expert systems based on 2D NMR been possible.

The abstract and full article text is available on the Journal of Cheminformatics website. http://www.jcheminf.com/content/1/1/3

For more information about ACD/Structure Elucidator software, visit our website. http://www.acdlabs.com/se/.

About Advanced Chemistry Development

Advanced Chemistry Development, Inc., (ACD/Labs) develops desktop and enterprise software solutions for chemical, biochemical, and pharmaceutical R&D. Our expertise lies in vendor-neutral spectroscopic data processing and prediction, physicochemical and ADMET property prediction, analytical knowledge management, interactive reporting, and integrating analytical data with chemical structures to help protect and leverage valuable research knowledge.
www.acdlabs.com.

— WebWireID107080 —

WHITEHOUSE STATION, N.J.– Merck & Co., Inc. (NYSE: MRK) today outlined its global plans following the completion of Merck's merger with Schering-Plough Corporation announced yesterday. The new Merck is a global health care leader aimed at providing innovative, distinctive products and services that save and improve lives, while satisfying customer needs and creating long term shareholder value.

'With our merger now complete, we are ready to deliver on the promise of a new Merck built on a foundation of scientific innovation and dedication to the well-being of patients around the world,' said Richard T. Clark, chairman, president and chief executive officer of Merck. 'On 'Day One' for the new Merck, we are stronger and better equipped to make a difference in the lives of people globally through our broadened, diversified portfolio of innovative medicines and vaccines, and products for consumer and animal health.

"Our integration teams prepared us well for a strong start today, with thorough plans designed to ensure a seamless transition for our customers and employees," added Mr. Clark. "The combination of the considerable talents of Schering-Plough and Merck employees across the globe positions Merck to move through this dynamic time for our industry with a clear vision for the future."

From the outset, Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal and consumer health products. This portfolio is complemented by a robust pipeline with more than 15 promising late-stage candidates spanning critical therapeutic categories. Merck now has approximately 106,000 employees and operates in more than 140 countries around the world, including emerging markets. The company expects to generate more than 50 percent of its revenue outside the United States.

"The people of the new Merck share a passion for the good our medicines and vaccines can do for patients and a commitment to pursuing high-quality results with our customers and partners," Mr. Clark said. "Thanks to the talent and dedication of scientists at both companies, the combined company offers an outstanding clinical development pipeline that will greatly increase our ability to deliver important new medicines to patients.'

The company's corporate headquarters will be in Whitehouse Station, NJ, as previously indicated. In addition, the company's U.S. organization for the Global Human Health division and Merck Research Laboratories will be headquartered in Upper Gwynedd, PA. The former Schering-Plough headquarters in Kenilworth, NJ and Merck's operations in Rahway, NJ, will continue to be important sites, with large and diverse operations encompassing marketing, manufacturing and research. At this time, all other sites will continue to operate as they did before the merger.

Key Therapeutic Areas
The new Merck has a broad portfolio of medicines – an engine for consistent, sustainable growth – driven in part by the addition of valuable products with long periods of exclusivity. By leveraging Merck's expanded product offerings, the company expects to benefit from additional revenue growth opportunities. For example, Merck will pursue expanded life-cycle management through the introduction of potential new combinations and formulations of existing products.

The company's diverse portfolio of adult, adolescent and pediatric vaccines and medicines spans important therapeutic areas, including cardiovascular, diabetes, obesity, bone, respiratory, immunology, dermatology, infectious disease, oncology, neurosciences, ophthalmology, women's health and endocrinology.

Diversified Businesses
The new Merck's expanded portfolio also includes leading products from its Animal Health and Consumer Health Care business units.

Merck's Animal Health business is a world leader with market-leading products for a broad range of species and strong growth potential. The division has more than 1,000 marketed products and generates approximately $3 billion in revenues.

The company's Consumer Health Care business has a number of attractive brands such as CLARITIN, COPPERTONE, DR. SCHOLL'S and MIRALAX.

Financial Highlights
Merck is targeting a high single digit non-GAAP EPS¹ compound annual growth rate from 2009 to 2013 (with the 2009 base representing Merck's previous stand-alone non-GAAP EPS guidance of $3.20 - $3.30). Additionally, in 2013, Merck is targeting free cash flow to be approximately $15 billion. The combined company will have a strong balance sheet with cash and investments of approximately $8 billion at the time of the closing. As previously indicated, Merck expects the transaction to be modestly accretive in 2010.

Merck also continues to expect to achieve substantial incremental cost savings of approximately $3.5 billion annually beyond 2011 which are expected to come from all areas across the combined company.

The strong cash flow and substantial cost savings will enable the company to continue to invest in some of the best investment opportunities, including pipeline candidates with the greatest probability of success, as well as licensing opportunities. By optimizing its investments, the new Merck will maximize the benefits of strategic growth initiatives and R&D efforts to solidify its position at the forefront of innovation and enhance its scientific and technological leadership.

Additionally, Merck's Board of Directors continues to be committed to maintaining the dividend at the current level.

Organizational Structure
During the past six months, Merck and Schering-Plough merger integration teams worked hard to successfully maintain the business momentum of the two companies while ensuring operational readiness and business continuity for the merged company.

The integration plans are focused on these priorities: an effective transition for customers and employees; putting the right people in the right jobs; realizing projected merger synergies in the form of cost savings and revenue growth opportunities; and maintaining momentum in the company's late stage pipeline.

The company took significant steps prior to the merger's completion to advance its integration planning objectives. In August, Merck announced the new organizational structure and top leadership team for the combined company. Last month, approximately 300 executives from Merck and Schering-Plough were named to key country leadership positions to ensure that all markets around the world would be ready for business on the first day of operations for the new Merck.

The company's previously announced organizational structure takes advantage of the combined strengths of Merck and Schering-Plough to create a more customer-focused, innovative, and diversified global health care company positioned to capitalize on the company's greatest opportunities for growth, particularly in emerging markets, biologics and vaccines. Merck has five primary divisions: Global Human Health, Animal Health, Consumer Health Care, Merck Research Laboratories and Merck Manufacturing.

Leadership
The new Merck will benefit from the unparalleled industry experience of senior leaders from both Schering-Plough and Merck, with approximately 40 percent of Schering-Plough's senior leaders joining the combined company.

As announced in August, the Executive Committee, reporting directly to CEO Dick Clark, includes the following individuals, as well as a Chief Medical Officer who will be named at a later date: Stanley F. Barshay, EVP and president, Consumer Health Care; Richard S. Bowles, Ph.D., chief compliance officer; Willie A. Deese, EVP and president, Merck Manufacturing; Kenneth C. Frazier, EVP and president, Global Human Health; Mirian Graddick-Weir, Ph.D., EVP, Human Resources; Peter N. Kellogg, chief financial officer; Peter S. Kim, Ph.D., EVP and president, Merck Research Laboratories; Raul E. Kohan, president, Animal Health; Bruce N. Kuhlik, general counsel; J. Chris Scalet, chief information officer, Global Services; and Mervyn Turner, Ph.D, chief strategy officer.

Corporate Branding
With the merger complete, Merck will take a global approach to unify and simplify use of its trade name. The company will use the trade name 'Merck' in the United States and Canada and elsewhere use the trade name 'MSD.'

— WebWireID107066 —