Key Developments For Nabi Biopharmaceuticals
Nabi Biopharmaceuticals (NABI.O) (Consolidated Issue listed on NASDAQ Global Market)
Nabi Biopharmaceuticals and GlaxoSmithKline Plc Unit Sign Nicotine Addiction Vaccine Deal-Reuters
Reuters reported that Nabi Biopharmaceuticals and a unit of GlaxoSmithKline Plc signed a licensing agreement for Nabi's experimental vaccine to treat nicotine addiction and the prevention of smoking relapse. Nabi will get $40 million upfront and is eligible to get more than $500 million in option fees and milestones for the vaccine, NicVAX, and follow-on nicotine vaccines. In return, GlaxoSmithKline will get an option to exclusively in-licence NicVAX on a worldwide basis and a licence to develop follow-on nicotine vaccines. Nabi will be responsible for the first of two NicVAX late-stage trials, and upon successful completion GlaxoSmithKline Biologicals SA could take responsibility for further development of the vaccine. The companies expect to complete the deal in the first quarter of 2010.
Nabi Biopharmaceuticals Completes Sale Of PentaStaph To GlaxoSmithKline PLC
Nabi Biopharmaceuticals announced that t has completed the sale of PentaStaph (Pentavalent S. aureus Vaccine) and related assets to GlaxoSmithKline PLC. The sale was announced in August of this year. Under the terms of the agreement, Nabi will receive cash payments of $21.5 million of which $20 million is associated with the PentaStaph transaction close, $1 million associated with the sale of a separate pre-clinical program for a vaccine against S.epidermedis, as well as $0.5 million as reimbursement for license fees and clinical materials previously manufactured for use in the Phase I trial. The remaining $26 million in payments contemplated in the transaction are associated with the completion of four milestones which the Company expects to complete within the next 16 months. These remaining milestones include initiation and completion of the Phase I trial, the successful transfer of specified materials and the successful transfer of technology. In connection with the sale, Nabi agreed to provide services to GSK related to the conduct of the Phase I trial and the transfer of the Staph program in exchange for reimbursement of Nabi's expenses.
Nabi Biopharmaceuticals Participates In NicVAX Phase IIb Study
Nabi Biopharmaceuticals announced that it is participating in an investigator initiated Phase IIb study to evaluate the safety and efficacy of NicVAX (Nicotine Conjugate Vaccine) when co-administered with varenicline as an aid to smoking cessation and relapse prevention. This study will be conducted by The Research School CAPHRI of the Maastricht University Medical Center in Maastricht, The Netherlands and will be funded primarily by The Netherlands Organization for Health Research and Development and Maastricht University with Nabi providing some additional support. The Phase IIb study for NicVAX is a double-blinded, placebo-controlled parallel-arm study comprised of approximately 600 patients randomized in a 1:1 ratio to one of two treatment groups. One group will receive NicVAX and varenicline and the other group will receive placebo and varenicline. The primary endpoint of the study is the long-term smoking abstinence rate at one year. Abstinence will be evaluated by self-reported cigarette consumption and measurement of exhaled carbon monoxide. Secondary endpoints include the abstinence rate at various interim periods, smoking lapse and relapse, safety, immunogenicity and withdrawal symptoms. The study also will involve behavioral counseling as with other smoking cessation programs which likely will enhance efficacy rates in this study. NicVAX is an investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse
Nabi Biopharmaceuticals Announces Sale of PentaStaph To GlaxoSmithKline PLC
Nabi Biopharmaceuticals announced that it has signed a definitive agreement for the sale of PentaStaph (Pentavalent S. aureus Vaccine) and related assets to GlaxoSmithKline plc (GSK) for a total consideration of up to $46 million. Under the terms of the agreement, Nabi will receive an initial cash payment of $20 million when the transaction closes plus an additional $26 million contingent upon four milestone accomplishments. Nabi anticipates closing the sale before year end 2009 and completing the milestones within the next 18 months.
Nabi Biopharmaceuticals Receives Scientific Advice On NicVAX From the European Medicines Agency
Nabi Biopharmaceuticals announced that it has received scientific advice from the European Medicines Agency (EMEA) on NicVAX regarding the requirements for marketing authorization submission as it relates to the appropriate design of the pivotal phase III clinical studies and safety data base . This advice helps ensure the performance of appropriate clinical studies so that no major objections regarding the design of the studies are likely to be raised during evaluation of the marketing authorization application.
