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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.
On Friday, an FDA advisory committee voted 18-4, with one abstention, that the benefit-risk profile for Arena's lorcaserin supports approval to treat obesity. The PDUFA date for the serotonin (5-HT2C) receptor agonist is June 27 (see BioCentury, May 14).
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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.
Amgen defined high c-MET expression as more than 50% of tumor cells testing positive for the c-MET protein. Last year, Amgen reported data from all 121 patients in the Phase II trial showing that rilotumumab plus chemotherapy led to median progression-free survival of 5.6 months and OS of 11.1 months, compared to PFS of 4.2 months and OS of 8.9 months for chemotherapy alone.
Earlier this year, Amgen and Dako A/S (Glostrup, Denmark) partnered to develop and evaluate the use of a companion diagnostic in the development of rilotumumab. Amgen was up $0.30 to $70.98 on Wednesday.
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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.
In an analysis of 20,913 MI cases and 95,407 controls, carriers of the LIPG 396Ser allele had significantly higher HDL-C but similar levels of other lipid and non-lipid risk factors for MI compared with non-carriers. The researchers said the difference in HDL-C was expected to decrease MI risk by 13%, but they instead found no association between the allele and MI risk. Additionally, the researchers said a genetic score combining 14 genetic variants related to HDL-C failed to show an association with MI risk.
The study was funded by NIH, the Wellcome Trust, the EU, the British Heart Foundation and the German Federal Ministry of Education and Research.
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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.
Piramal said the acquisition is part of the Indian company's strategy to buy global growth businesses with sustainable returns following the 2010 sale of its domestic formulation business to Abbott Laboratories (NYSE:ABT) for $3.8 billion. Last month, Piramal's Piramal Imaging S.A. subsidiary said it will acquire worldwide rights to the PET imaging tracer assets of Bayer AG (Xetra:BAYN). Piramal had revenues of $450 million in FY12 (see BioCentury Extra, April 16).
Piramal was off Rs1.35 to Rs428.40 on Wednesday.
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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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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).
Dendreon is also a defendant in a securities class action suit in the U.S. District Court for the Western District of Washington related to the Provenge launch. Dendreon was down $0.22 to $8.62 on Wednesday.
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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.
Ra is developing peptide-like molecules called cyclomimetics that the company said could have clinical utility as oral alternatives for marketed injectable biologics and could address previously undruggable targets, such as intracellular protein-protein interactions. The company is initially developing cyclomimetics against plasma kallikrein to treat hereditary angioedema (HAE).
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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.
The panel felt a CED should be reviewed when sufficient data has been gathered to address the question of whether or not the product or service is "reasonable and necessary," and that the specific threshold should be determined when the CED is first issued.
The panel voted 13-1 that an evidentiary threshold can be defined to invoke CED but felt the level of required evidence would vary depending on the severity of disease, the level of unmet need and safety profile of the product or service.
CMS said it would consider the panel's feedback as it drafts new guidance on the CED process. Last November, CMS began reviewing potential improvements to the CED process and solicited public comments (see BioCentury, Nov. 21, 2011).
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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).
For products approved in the U.S. and Europe, 64% were first approved in the U.S. For products approved in the U.S. and Canada, 86% were first approved in the U.S. EMA did approve 96% of products after just one review cycle, compared to 62% of products approved by FDA and 69% of products approved by Health Canada. Data were published in the New England Journal of Medicine.
The authors said the results contradict recent criticisms of FDA's review speed and raise questions about whether the speed of the review process should be an emphasis of PDUFA reauthorization. The study comes as congress is considering PDUFA V legislation (see BioCentury Extra, May 14).
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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.