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    <title>WebWire | News by Industry : Tobacco</title>
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     <title>GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction</title>
     <link>http://www.webwire.com/ViewPressRel.asp?aId=107821</link>
     <pubDate>Mon, 16 Nov 2009 11:07:21 EST</pubDate>
     <description><![CDATA[Upfront and potential consideration of over $500 million -   -  London UK, Rockville US - GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) today announced an exclusive worldwide opt...]]></description>
     <content:encoded><![CDATA[<p>Upfront and potential consideration of over $500 million</p><p>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&#174;), 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.</p><p>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&#39;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.</p><p>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&#39;s intellectual property together with GSK&#39;s own technology.</p><p>&#39;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&#39; said Jean Stephenne, President of GSK Biologicals.  &#39;This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio.&#39;</p><p>&#39;We are very pleased with this deal and proud it is with GSK, one of the world&#39;s leading vaccine companies, to further develop and commercialise NicVAX.&#39; said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals.  &#39;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.&#39;</p><p>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.</p><p>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.</p><p>Pre-clinical and clinical data show that NicVAX&#39;s ability to block nicotine from reaching the brain could help people quit smoking. Because the body&#39;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. </p><p>The transaction is subject to approval by Nabi shareholders and customary closing conditions, and is expected to be completed in the first quarter 2010.</p><p>How NicVAX works<br />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&#39;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.</p><p>GlaxoSmithKline &#8211; one of the world&#39;s leading research-based pharmaceutical and healthcare companies &#8211; 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 <a href="http://www.gsk.com" target="_blank">www.gsk.com</a></p><p>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 <a href="http://www.nabi.com" target="_blank">www.nabi.com</a></p><p>GlaxoSmithKline Cautionary statement regarding forward-looking statements<br />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&#39; s operations are described under &#39;Risk Factors&#39; in the &#39;Business Review&#39; in the company&#39; s Annual Report on Form 20-F for 2008.</p><p>Nabi Biopharmaceuticals Forward-Looking Statements<br />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.</p><p> [1] <a href="http://www.who.int/tobacco/research/cessation/about/en/index.html" target="_blank">www.who.int/tobacco/research/cessation/about/en/index.html</a></p><p>[2] American Lung Association report 2007</p><p>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.</p><p>&mdash; WebWireID107821 &mdash;</p><div class="related" style="float:left; margin-right:10px; margin-bottom:10px;"><ul><li><a href="http://www.webwire.com/industry-news.asp?indu=BIO">Biotechnology</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=BUA">Business Announcements</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=HEA">Health Care / Hospitals</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=MTC">Medical / Pharmaceuticals</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=TOB">Tobacco</a></li></ul></div><div class="terms" style="clear:both; float:left; margin-right:10px; margin-bottom:10px;"><a href="http://www.webwire.com">WebWire&reg;</a> Copyright &#169; 2009 Warmtone Corp. | Use of this content is subject to our <a href="http://www.webwire.com/ServTerms.asp">Terms of Service</a> | <a href="http://www.webwire.com/webwire-industries-rss-feeds.asp">More Feeds</a></div><br /><img src="http://feeds.feedburner.com/~r/WebWire-News-Tobacco/~4/kUKZ08GI9Ng" height="1" width="1"/>]]></content:encoded>
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     <title>FDA Warns Companies against Marketing Illegal Flavored Cigarettes</title>
     <link>http://www.webwire.com/ViewPressRel.asp?aId=107228</link>
     <pubDate>Sat, 7 Nov 2009 13:15:54 EST</pubDate>
     <description><![CDATA[The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letter...]]></description>
     <content:encoded><![CDATA[<p>The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.</p><p>The warning letters directed the companies to cease the marketing and sale of these products immediately or to take other appropriate action to bring the products into compliance with the law. Failure to do so may result in additional regulatory actions such as seizure or injunction. In addition, FDA requested a written response from each of the companies within 15 days outlining the corrective actions taken.</p><p>Enforcement of the flavored cigarette ban is FDA&#39;s effort to remove cigarettes that contain certain candy or fruit flavors from the marketplace. Removal of these products from the market will assist in the prevention of children and adolescents from starting to smoke and in the reduction in death and disease caused by smoking. </p><p>&#39;FDA takes the enforcement of this flavored cigarette ban seriously,&#39; said Lawrence R. Deyton, M.S.P.H, M.D., director of FDA&#39;s Center for Tobacco Products. These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.&#39;</p><p>The Tobacco Control Act, which was passed by Congress and signed by the President in June 2009, specifically called for a ban on cigarettes containing certain characterizing flavors. On Sept. 14, 2009, FDA sent a letter to regulated industry reminding them that the ban would go into effect on Sept. 22, 2009. FDA also stated in the letter that any company who continued to sell such products after the Sept. 22, 2009, effective date may be subject to FDA enforcement actions.</p><p>Since the effective date of the ban, FDA has examined products offered for import and searched the Internet to identify illegal products. As a result, FDA issued several warning letters to companies and Web sites that continued to market and sell these illegal products over the Internet to consumers in the United States. The warning letters were the result of Internet searches conducted by FDA&#39;s Office of Enforcement and the Center for Tobacco Products.</p><p>FDA posted the warning letters that detail the offending websites and flavored cigarette products on the agency&#39;s Web site. Review warning letters issued by FDA:<br /><a href="http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm" target="_blank">http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm</a></p><p>Report possible violations of the flavored cigarette ban:<br /><a href="http://www.fda.gov/flavoredtobacco" target="_blank">www.fda.gov/flavoredtobacco</a></p><p>&mdash; WebWireID107228 &mdash;</p><div class="related" style="float:left; margin-right:10px; margin-bottom:10px;"><ul><li><a href="http://www.webwire.com/industry-news.asp?indu=ADV">Advertising / Marketing</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=GOV">Government</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=HEA">Health Care / Hospitals</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=POL">Politics</a></li><li><a href="http://www.webwire.com/industry-news.asp?indu=TOB">Tobacco</a></li></ul></div><div class="terms" style="clear:both; float:left; margin-right:10px; margin-bottom:10px;"><a href="http://www.webwire.com">WebWire&reg;</a> Copyright &#169; 2009 Warmtone Corp. | Use of this content is subject to our <a href="http://www.webwire.com/ServTerms.asp">Terms of Service</a> | <a href="http://www.webwire.com/webwire-industries-rss-feeds.asp">More Feeds</a></div><br /><img src="http://feeds.feedburner.com/~r/WebWire-News-Tobacco/~4/V5i1yFiWhXs" height="1" width="1"/>]]></content:encoded>
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