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These five small-cap pharma stocks were in the news on Monday following company announcements.
Antares Pharma (AIS) traded as much as 4% higher but ended closing just 1% higher as the tumbling market took down shares of the stock despite the company signing a licensing agreement for its gel product. The company and Watson Pharmaceuticals (WPI) 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.
Under terms of the agreement, Watson will make milestone payments based on the achievement of regulatory approval and certain sales levels, and will also be responsible for certain manufacturing start-up activities. Upon launch of the product, Antares will receive escalating royalties based on product sales in the U.S. and Canada.
Micromet (MITI) closed up 7% after it entered into a collaboration with Amgen (AMGN). Micromet announced that it entered into a collaboration agreement with Amgen 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 €10 million upon deal execution. If milestones in multiple indications and tumor types are achieved, Micromet is eligible to receive up to €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 €695 million. The initial development plan contemplates €25 million in funding of Micromet R&D activities if two BiTE antibodies are advanced to IND. All expected costs associated with the research, development and commercialization of the BiTE antibodies will be borne by Amgen.
China Biologic Products (CBPO) tumbled 7% after the Guizhou Province issued a plan that led the company to believe that the licenses for some of their plasma collection stations may be not renewed. The company said that the Guizhou Provincial Health Department issued a "Plan for Guizhou Provincial Blood Collection Institutional Setting (2011-2014)." The Plan, in the relevant part, states that "in accordance with the demographic distribution, economic development condition, disease prevalence, and actual situation of plasma supply for the manufacturing of blood-based products, plasma collection stations will be set up in 10 counties, including Xi Feng, Kai Yang, Zi Yun, Pu Ding, Du Shang, Long Li, Chang Shun, Huang Ping, Qing Long, and Na Yong, etc." Currently, there are 18 plasma collection stations, in 18 separate counties, operating in Guizhou Province. China Biologic's 54% indirectly owned subsidiary, Guizhou Taibang Biological Technologies, currently has 6 active plasma collection stations in the Guizhou Province. Among the 6 active plasma collection stations, 3 are located in the counties included in the Plan (Pu Ding, Huang Ping, and Na Yong) and are currently expected not to be affected directly by the Plan.
Based on the company's preliminary understanding of the Plan, the company currently anticipates the licenses of its 3 other plasma collection stations in Dan Zhai, Wei Ning, and San Sui counties may not be renewed (until at least 2014) after their respective plasma collection permits expire at the end of July 2011. The company's 3 stations in Dan Zhai, Wei Ning, and San Sui counties together accounted for about 24.5% of the Company's total plasma collection by volume in 2010. In addition, 1 inactive plasma collection station that the company purchased from the government is unlikely to be licensed as planned, because it is in Zhengyuan County, a location not included in the Plan.
Celsion (CLSN) rose 3% after it announced that the independent Data Monitoring Committee (DMC) for the company's pivotal Phase III clinical study of ThermoDox in combination with radio frequency ablation (RFA) for primary liver cancer (the HEAT study), completed a review of 535 randomized patients and unanimously recommended that the study continue according to protocol. The company 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 study's design and statistical plan incorporate a pre-planned interim efficacy analysis by the DMC (after patient enrollment is complete and 190 progression-free survival 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.
PDL BioPharma (PDLI) closed 10% higher after it received positive news from a Nevada Judge. The company announced a favorable ruling, specifically, that on July 7, 2011, the Second Judicial District Court of Nevada ruled in favor of PDL on two motions to dismiss filed by Genentech and Roche in PDL's lawsuit related to the 2003 settlement agreement with Genentech. The court denied Genentech and Roche's motion to dismiss four of PDL's five claims for relief and, further, denied Roche's separate motion to dismiss for lack of personal jurisdiction. The court dismissed one of PDL's claims that Genentech committed a bad-faith breach of the covenant of good faith and fair dealing stating that, based on the current state of the pleadings, no "special relationship" had been established between Genentech and PDL as required under Nevada law.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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