TOP STORY
Arena raises $60.5M in follow-on
Arena Pharmaceuticals Inc. (NASDAQ:ARNA) raised $60.5 million through the sale of 11 million shares at $5.50 in a follow-on underwritten by Jefferies; Piper Jaffray; and BMO Capital Markets. The company proposed the offering late Tuesday, when its share price was $6.06. Arena was off $0.39 to $5.67 on Wednesday.
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CLINICAL NEWS
Amgen's anti-HGF/SF mAb improves OS in high c-MET patients
Amgen Inc. (NASDAQ:AMGN) said rilotumumab plus chemotherapy significantly improved median overall survival vs. chemotherapy alone in patients with gastric tumors exhibiting high c-MET expression (11.1 vs. 5.7 months, p=0.012). The results came from an exploratory analysis of a subset of 90 patients in a completed Phase II trial of the mAb against human hepatocyte growth factor/scatter factor. In patients with low c-MET expression, rilotumumab plus chemotherapy was associated with a trend towards unfavorable OS compared to chemotherapy alone. Based on the results, Amgen plans to move rilotumumab into Phase III testing this year to treat advanced gastric and gastroesophageal junction cancer in patients whose tumors have high c-MET expression. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June.
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Researchers question concept of raising HDL to reduce MI risk
Some genetic variants that increase plasma HDL-C do not also reduce the risk of myocardial infarction, according to a study published in The Lancet. In the paper, researchers from the Massachusetts General Hospital and colleagues said the data challenge the concept that raising HDL-C will translate into reductions in MI risk.
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COMPANY NEWS
Piramal to acquire healthcare analytics firm
Piramal Healthcare Ltd. (BSE:500302; NSE:PIRHEALTH) will acquire healthcare information and analytics company Decision Resources Group (Burlington, Mass.) for about $635 million. Decision Resources, which offers services to forecast trends in drug and medical device markets, expects $160 million in 2012 revenue. The deal is expected to close by June 30.
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OraSure gains after FDA panel backs OTC HIV test
OraSure Technologies Inc. (NASDAQ:OSUR) gained $1.85 (20%) to $10.95 on Wednesday after FDA's Blood Products Advisory Committee voted 17-0 late Tuesday that data show the OraQuick In-Home HIV test is safe and effective. The panel also unanimously voted that the test's projected benefits outweigh the potential risks of false positive and false negative results. The test is an OTC version of OraSure's OraQuick Advance Rapid HIV-1/2 point-of-care test. OraQuick Advance is an oral fluid, finger-stick or venipuncture whole blood or plasma specimen HIV-1 and HIV-2 antibody diagnostic. FDA said if the OTC test is approved, it would be the first OTC home-use test kit for any infectious agent.
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SEC investigating Dendreon
Dendreon Corp. (NASDAQ:DNDN) disclosed in a 10Q filing that the SEC is investigating the company. Dendreon said it does not know the specific focus of the investigation, but believes it may be related to statements and predictions the company made about the launch of prostate cancer therapy Provenge sipuleucel-T. Dendreon said it is cooperating with the SEC. Last August, Dendreon pulled its 2011 revenue guidance of $350-$400 million as a result of lower-than-expected uptake of Provenge, which is the company's only drug on the market (see BioCentury, Aug. 8, 2011).
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FINANCIAL NEWS
Ra raises $8.6M in second tranche of series A
Ra Pharmaceuticals Inc. (Cambridge, Mass.) raised $8.6 million in the second tranche of a planned $27 million series A round. Ra raised $10.3 million in the first tranche in February 2010. New Enterprise Associates led the tranche, with participation from Morgenthaler Ventures; Novartis Venture Funds; and Amgen Ventures.
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POLITICS & POLICY
MEDCAC provides input on CED process
CMS's Medicare Evidence Development & Coverage Advisory Committee voted 14-0 that an evidentiary threshold can be defined to trigger a review of coverage with evidence development for a product or service to determine if the coverage should be stopped, continued or modified. CMS uses CED to provide coverage that is contingent on some form of new clinical data collection in the Medicare population. CMS convened the panel to provide feedback on the characteristics of evidence that are appropriate for the CED process.
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Study shows FDA faster at reviews than EMA, Health Canada
FDA reviewed novel therapeutics significantly faster than EMA and Health Canada during 2001-10, and the majority of those products were first approved in the U.S., according to a study by Yale University researchers. The median length of time to complete the first review was 303 days for applications approved by FDA, compared with 366 days for EMA and 352 days for Health Canada (p<0.0001). The median total review time, which includes multiple review cycles, was also significantly shorter at FDA compared with both EMA and Health Canada (322 days vs. 366 and 393; p=0.002).
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Harkin adds patient input requirement to PDUFA bill
Sen. Tom Harkin (D-Iowa) introduced a provision to the PDUFA reauthorization bill that would require HHS to include patient input during product development and regulatory discussions. The bill is under consideration by the full U.S. Senate. A vote has yet to be scheduled.
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