Updates for CLSN PARD AIS MITI

Jul 12, 2011 No Comments by

Poniard Pharmaceuticals, Inc. (NASDAQ: PARD) announced today that it reconvened its annual meeting of shareholders on July 8, 2011 for a second time and adjourned the meeting until 9:00 a.m. Pacific Time, on July 22, 2011 due to insufficient votes cast for its reverse split proposal. Votes representing approximately 2.2 million more shares are needed for the reverse stock split proposal to pass.

Micromet, Inc. (NASDAQ: MITI) announced today that it has entered into a collaboration agreement with Amgen Inc. for the research of BiTE antibodies against three undisclosed solid tumor targets. Amgen will have the right to pursue development and commercialization of BiTE antibodies against up to two of these targets, to be selected by Amgen. Under the terms of the agreement, Amgen is expected to pay EUR 10 million upon deal execution. If milestones in multiple indications and tumor types are achieved, Micromet is eligible to receive up to EUR 342 million in clinical and commercial milestone payments. Micromet is also eligible to receive up to double-digit royalties on worldwide net sales. For the second BiTE program, Micromet is eligible to receive an additional cash payment upon initiation of the program, milestones, royalties and development funding comparable to the first program. The combined potential payments to Micromet from both programs, excluding reimbursement of research and development costs, are approximately EUR 695 million.

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Antares Pharma, Inc. (NYSE Amex: AIS) today announced an exclusive licensing agreement for Watson to commercialize Antares topical oxybutynin gel product in the U.S. and Canada. A New Drug Application for the oxybutynin gel product is currently under review by the FDA. The FDA has assigned a PDUFA date of December 8, 2011.

Celsion Corporation (NASDAQ: CLSN), today announced that the independent Data Monitoring Committee (DMC) for its multinational, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox in combination with radio frequency ablation (RFA) for primary liver cancer (the HEAT study), has completed a review of 535 randomized patients and unanimously recommended that the study continue according to protocol. It also announced that enrollment in the HEAT study has reached 98% of the 600 patients necessary to ensure that its primary end point, progression free survival, can be achieved with statistical significance. The design and statistical plan incorporate a pre-planned interim efficacy analysis by the DMC (after patient enrollment is complete and 190 progression-free survival (PFS) events are realized in the study population) with the intent of evaluating safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study. Completion of the interim analysis is expected by the end of the third quarter of 2011.

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Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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