ROCKVILLE, Md., Sept. 1, 2010 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. (Diosynth) for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.
Under the agreement, Diosynth will produce the Drug Substance AMNic-rEPA. The Drug Substance is produced by conjugating nicotine hapten, which is sourced from another contract manufacturing organization, with the carrier protein, rEPA, produced at Diosynth. The resulting Drug Substance is then combined with an adjuvant and filled in syringes at a filling facility to produce NicVAX. The term of the agreement is for five years from the effective date of the agreement with provisions for supply extension beyond the initial term. In collaboration with Nabi, Diosynth has already validated the NicVAX manufacturing process and produced commercial-scale lots of NicVAX Drug Substance under contract for Nabi.
"This agreement is an important and exciting step in the event that the Phase III trials for NicVAX are positive and we subsequently receive regulatory approval," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "We are pleased to enter into this agreement with Diosynth, an experienced manufacturer of licensed biological products with a regulatory approved facility and available capacity to perform bulk manufacture of the NicVAX Drug Substance."
How NicVAX Works
Nicotine is a small molecule that, upon inhalation into the lungs, quickly passes into the bloodstream and subsequently reaches the brain by crossing the blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine receptors, resulting in the release of stimulants, such as dopamine, a chemical linked to pleasure and 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, fewer stimulants are released, and the pleasurable, highly-addictive effects of nicotine are diminished, thereby making it easier to quit smoking. 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 and support long-term abstinence. This is a very important difference between NicVAX and existing anti-smoking treatment therapies. Relapse is a significant challenge facing smokers; with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.
About Nabi Biopharmaceuticals
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.
About Diosynth RTP, Inc and Merck Biomanufacturing Network
Diosynth RTP Inc., located in Research Triangle Park NC (USA) is a contract development and manufacturing services company that is part of the Merck BioManufacturing Network of Merck & Co., Inc., known as MSD outside the US and Canada. The Biomanufacturing Network also includes MSD Biologics (UK) Ltd., located in Billingham, England. Merck BioManufacturing Network is a leader in development and manufacturing of fermentation and cell culture based recombinant proteins and monoclonal antibodies, leveraging experience with more than 140 molecules for third party clients across multiple technology platforms. For additional information about Merck Biomanufacturing Network, please visit www.biomanufacturingnetwork.com.
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 conduct and obtain successful results from our two Phase III clinical trials for NicVAX; GlaxoSmithKline Biologicals' (GSK) failure to exercise its option for and successfully commercialize NicVAX; GSK's failure to successfully develop and commercialize any future generation candidate nicotine vaccine utilizing our intellectual property; our ability to commercialize NicVAX if GSK does not exercise its option for NicVAX; our ability to raise sufficient new capital resources to fully develop and commercialize NicVAX if GSK does not exercise the NicVAX option; our ability to attract, retain and motivate key employees; our ability to collect any further milestones and royalty payments under the PhosLo and PentaStaph agreements; the ability to obtain regulatory approval for NicVAX and any future generation candidate nicotine vaccine in the U.S. or other markets; our ability to successfully contract with contract manufacturing organizations for the manufacture and supply of NicVAX and the risk that these organizations will not fulfill their obligations to us; our ability to comply with reporting and payment obligations under government rebate and pricing programs; and loss of full use of our net operating loss carryforwards. 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 26, 2009 filed with the Securities and Exchange Commission. We do not undertake to update any of these forward-looking statements or to announce the results of any revisions to these forward-looking statements except as required by law.