Horizon Pharma, Inc. (Nasdaq: HZNP) today announced the pricing of its initial public offering of 5,500,000 shares of common stock at a price to the public of $9.00 per share. Its common stock is scheduled to begin trading on The NASDAQ Global Market on July 28, 2011 under the symbol HZNP.
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Center for Biologics Evaluation and Research (CBER) of the FDA advised the company that it agrees that clinical consistency of three consecutively manufactured lots of HEPLISAV has been demonstrated. In a written communication to Dynavax, FDA noted that although lot consistency criteria were not met at the pre-specified time point of 4 weeks PLD (post last dose), lot consistency criteria were met 8 weeks PLD, the time point corresponding to the primary immunogenicity endpoint, as well as at several other time points. It now plans on preparing a BLA for submission by the end of the year for yporesponsive populations aged 40 and older.
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the FDA regarding BYDUREON, an investigational medication for type 2 diabetes. The companies expect to receive an updated PDUFA action date from the FDA within the next two weeks. Since the reply included additional data, it will likely be categorized as a Class 2 resubmission requiring up to six months for review.
POZEN Inc. (NASDAQ: POZN) said today that its PA32540 Phase 3 pivotal studies are expected to be fully enrolled this quarter as planned. The primary endpoint in both studies is the cumulative incidence of gastric ulcers following administration of either PA32540 or 325 mg enteric-coated aspirin in subjects at risk for developing aspirin-associated ulcers. Completion of the 6-month studies is anticipated in Q1 2012 and the NDA filing is targeted for Q3 2012. The long term safety study, a 12-month, Phase 3 study to evaluate the long-term safety of PA32540 in subjects who are at risk for developing aspirin-associated gastric ulcers has been completed and they are currently in the process of reviewing the data.
QLT Inc. (Nasdaq:QLTI) said that it expects data from its Phase II clinical trial examining the safety and efficacy of the latanoprost punctal plug drug delivery system (L-PPDS) in glaucoma patients, during 3Q 2011.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today said it expects topline data from its Phase 2 trial of ficlatuzumab in combination with gefitinib versus gefitinib monotherapy as first-line therapy for patients with both wild-type and mutant EGFR non-small cell lung cancer (NSCLC).
Incyte Corporation (Nasdaq: INCY) today gave a pipeline update. It noted that its Marketing Authorization Application (MAA) for ruxolitinib as a treatment for myelofibrosis (MF) was submitted to the European Medicines Agency by Novartis in June. It also said that it is currently evaluating data of its Sheddase Inhibitor: INCB7839, in HER2-positive breast cancer patients. The data, together with a thorough assessment of the current breast cancer market, will be used to determine whether moving into Phase 3 development is warranted. Enrollment continues in a six-month dose-ranging Phase 2b trial of LY3009104 in patients with rheumatoid arthritis, conducted by Lilly. The three-month, double-blind, placebo-controlled phase of the trial is expected to be completed in early 2012.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) said yesterday that results from its double-blind, placebo-controlled Phase 2b trial (SB-509-901) of SB-509 for the treatment of moderately severe diabetic neuropathy will be released during 4Q 2011. It had previously noted that data would be released during 2H 2011. It also said that presentation of additional data from its SB-728-T clinical trials and data from all dosing cohorts of the SB-728-902 study in aviremic subjects will be presented at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) which will be held September 17- 20, 2011, in Chicago.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Depomed, Inc. (NASDAQ:DEPO) announced that Ironwood has licensed worldwide rights to utilize Depomeds Acuform(TM) gastric retentive drug delivery technology. Under the terms of the agreement, Depomed will assist with initial product formulation and Ironwood will be responsible for all development and commercialization of the product. Depomed will be paid an upfront license fee and will receive additional payments pending achievement of certain development and regulatory milestones, as well as royalties on product sales.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the pricing of its previously announced underwritten public offering of 16.0 million shares of its common stock, offered at a price of $3.00 per share to the public. The net proceeds to BioSante from this offering are expected to be approximately $45.0 million
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that Genzyme has submitted a marketing authorization application (MAA) to the European Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for the treatment of homozygous and severe heterozygous familial hypercholesterolemia.