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BIOCENTURY EXTRA LATEST HEADLINES


   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. more >>

   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. more >>

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. more >>

   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. more >>

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. more >>

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). more >>

   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. more >>

   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. more >>

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). more >>

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. more >>

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COVER STORY

Eyeing the inflammasome

Two academic teams have independently shown that targeting the inflammasome reduces retinal damage in mouse models of age-related macular degeneration. One study favors inhibiting inflammasome activation to treat dry AMD, and those findings are licensed to iVeena Pharmaceuticals. The other approach suggests boosting the inflammasome to treat wet AMD.

TARGETS & MECHANISMS

Paradoxical P2X7

Italian researchers have shown that inhibiting the P2X7 receptor can treat cancer. The findings could open up a new disease area for companies developing P2X7 antagonists to treat pain, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

K-Ras in cancer metabolism

Researchers from the Dana-Farber Cancer Institute have identified a glucose metabolism pathway that is activated by the K-Ras oncogene in pancreatic cancer. Based on the findings, it may be possible to target proteins in the pathway to block proliferation of K-Ras-driven cancers

TOOLS

PROTAC the protein

GSK and Yale researchers have announced a collaboration to develop a platform that selectively tags disease-associated proteins with an E3 ubiquitin ligase ligand, thus targeting them to a cell's protein degradation machinery. GSK hopes the platform could be a cornerstone for a new Discovery Performance Unit at the pharma, and the partners are aiming to have proof-of-principle results in cell culture by year end.

THERAPEUTICS

This Week in Therapeutics

Preventing inflammation-induced heart failure by blocking TLR9; increasing antibiotic efficacy by inhibiting DNA repair; treating pain with cyclic peptide-based B1R antagonists; and more...

TECHNIQUES

This Week in Techniques

Using 2'-F antisense oligonucleotides to modulate splicing; and more...

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