|Antares Enters Licensing Agreement with Pfizer; AstraZeneca and Targacept Announce Top-line Phase 3 Results|
|By Staff and Wire Reports|
|Tuesday, 20 December 2011 19:17|
Antares Pharma, Inc. (NYSE:AIS) announced it has licensed to Pfizer Inc.s Consumer Healthcare Business Unit one of its drug delivery technologies to develop an undisclosed product on an exclusive basis for North America. Pfizer will assume full cost and responsibility for all clinical development, manufacturing, and commercialization of the product in the licensed territory, which also includes certain non-exclusive territories outside of North America. Antares will receive undisclosed upfront payments, development milestones and sales based milestones, as well as royalties on net sales for three years post launch in the US.
We are very pleased to enter this collaboration with Pfizer Consumer Healthcare for an important product opportunity targeting a growing therapeutic area which utilizes one of our technology platforms, said Paul K. Wotton, Ph.D., Antares President and CEO. We continue to significantly diversify our existing and future product portfolio through both internal product development programs and Pharma partnerships.
Our internal programs have yielded VIBEX MTX in development for the treatment of rheumatoid arthritis and our recently FDA approved oxybutynin gel 3% product for the treatment of OAB which will be launched in 2012. In addition to this new collaboration our key partnerships include products and product opportunities with world leading companies such as Teva (TEVA), Ferring and Watson. This combination of marketed products, internal development and Pharma partnerships should provide for potential significant business growth in the future.
Antares Pharma (AIS +5.8%) moves higher today after announcing it's agreement with Pfizer's consumer healthcare unit.
AstraZeneca (NYSE:AZN) and Targacept (NASDAQ:TRGT) announced top-line results from the second of four RENAISSANCE Phase 3 studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant treatment. The study, RENAISSANCE 2, did not meet its primary endpoint, change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo.
These results follow the recent announcement of top-line results from RENAISSANCE study 3, which also did not meet its primary endpoint. Both RENAISSANCE 2 and RENAISSANCE 3 were flexible dose trials. The two remaining efficacy studies in the RENAISSANCE Program for TC-5214 are fixed dose trials. Top-line results for both fixed dose trials, as well as for a long-term study designed primarily to evaluate safety, are expected to be available in the first half of 2012.
TC-5214 was overall well tolerated in RENAISSANCE study 2 and showed an adverse event profile generally consistent with prior clinical trials of TC-5214. Analyses of the full data set from the RENAISSANCE study 2 remain ongoing.
Regulatory filing targets will be reviewed following results of the remaining RENAISSANCE Program studies. A potential New Drug Application filing in the United States is planned for the second half of 2012, with a potential EU Marketing Authorization Application filing targeted for 2015.
Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI) today announced that is has completed its planned transaction to sell the assets and business of its non-strategic business unit, Analytica International, Inc., a healthcare economics consulting firm, for up to $10 million (USD) being paid in a combination of fixed and contingent payments by the purchaser, LA-SER Alpha Group Sarl.
Agenus Inc. (NASDAQ: AGEN), a biotechnology company working to develop treatments for cancers and infectious diseases, and NewVac LLC (a subsidiary of ChemRar High Tech Center and resident of the Skolkovo Innovation Center in Russia), a company focused on the development of innovative technology for cancer immunotherapy, announced today that they have entered into a license, development and manufacturing technology transfer agreement for Agenus' Oncophage® (HSPPC-96; vitespen) vaccine.
Amgen (NASDAQ: AMGN) and Watson Pharmaceuticals, Inc. (NYSE: WPI) announced today that they will collaborate to develop and commercialize, on a worldwide basis, several oncology antibody biosimilar medicines.
Biostar Pharmaceuticals, Inc. (NASDAQ GM: BSPM) ("Biostar" or "the Company"), a developer, manufacturer and marketer of pharmaceutical and health supplement products for a variety of diseases and conditions, today announced that its newly acquired subsidiary, Shaanxi Weinan, signed a 12-month distribution agreement with Shaanxi Huikang Pharmaceuticals Co. ("Huikang Pharmaceuticals") effective January 1, 2012.
China Cord Blood Corporation (NYSE: CO) ("CCBC" or the "Company"), the first and largest umbilical cord blood banking operator in China, today announced the results of its 2011 Annual General Meeting, which was held on December 19, 2011, in Hong Kong.
Compugen Ltd. (NASDAQ: CGEN) announced today that it will significantly broaden and accelerate its monoclonal antibody (mAb) activities for oncology and immunology within its ongoing Pipeline Program.
Genzyme (EURONEXT: SAN and NYSE: SNY), today reported top-line results from TENERE, a Phase III clinical trial comparing the effectiveness, safety and tolerability of once-daily oral teriflunomide to interferon beta-1a (Rebif®), an approved injectable therapy, in people with relapsing forms of multiple sclerosis (RMS).
Generex Biotechnology Corporation (OTCBB: GNBT.OB) today announced that the Bloomberg Television segment on the Antigen Express breast cancer vaccine did not air yesterday as originally scheduled (and announced in Bloomberg Television's December 16, 2011 promotional spot).
Mindray Medical International Limited (NYSE: MR), a leading developer, manufacturer and marketer of medical devices worldwide, announced today an agreement to acquire a controlling stake of Hunan Changsha Tiandiren Biotech Co., Ltd. ("TDR").
Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that the Company's Chief Executive Officer, Rik J. Deitsch, had published a Shareholder Letter on the Company's website.
Nuvilex, Inc. (OTCQB:NVLX) through their associate, Singapore based biotechnology group SG Austria, announced the expanded ownership of patents controlling production of therapeutic antibodies.
Oncothyreon Inc. (Nasdaq: ONTY) today announced the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that it and its five wholly owned subsidiaries, Pure-ific Corporation, Provectus Biotech, Inc., Provectus Devicetech, Inc., Provectus Imaging, Inc., and Xantech Pharmaceuticals, Inc. (the “Subsidiaries”), have completed an unregistered offering of Units pursuant to the exemption from registration requirements under Rule 506 of Regulation D and Section 4(2) of the Securities Act of 1933, as amended (the “Act”), with each Unit consisting of (i) the right to receive one share of common stock of up to all five Subsidiaries, and (ii) a warrant to purchase three-fourths (3/4) of one share of the Company’s common stock.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Oceana Therapeutics, LLC today closed a transaction whereby Salix acquired all of the outstanding stock of Oceana Therapeutics, Inc., a privately-held global provider of gastroenterology and urology therapeutics.