12:00 AM
Jan 28, 2013
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) lost $2.74 to $94.68 last week after announcing the U.K. Ministers of Health deferred a decision to cover Soliris eculizumab on the NHS for atypical hemolytic uremic syndrome (aHUS). According to the company, the ministers overruled a positive recommendation to cover the drug from the Advisory Group for National Specialised Services (AGNSS), which was tasked with assessing high-cost drugs for rare conditions. AGNSS was disbanded last year.

Alexion said a reimbursement decision will be deferred until NICE begins assessments during the next fiscal year, which begins in April.

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) fell $0.95 (10%) to $8.82 on Tuesday after disclosing in an SEC filing that EMA's CHMP requested that the company "further justify" the overall benefit-risk balance of Belviq lorcaserin in light of previously identified non-clinical and clinical issues. Arena said the request came in a list of outstanding questions on an MAA for the obesity drug. According to the company, the issues included tumors in rats, valvulopathy and undisclosed psychiatric events. Arena continues to expect a final opinion from CHMP this half,

Last week, the stock was off $1.06 (11%) to $8.71.

Impax Laboratories Inc. (NASDAQ:IPXL) lost $0.87 to $20.15 last week after FDA issued a complete response letter for an NDA for Rytary extended-release carbidopa/levodopa to treat idiopathic Parkinson's disease (PD). According to the company, the agency is requiring a "satisfactory re-inspection" of Impax's Hayward, Calif., manufacturing facility.

Meda AB (SSE:MEDAA) gained SEK1.65 to SEK74.25 last week after Dymista azelastine/fluticasone was approved under the EU's decentralized procedure to treat seasonal and perennial allergic rhinitis. Germany acted as the reference member state. Meda plans to launch the drug this year.

Clinical milestones

Biogen Idec Inc. (NASDAQ:BIIB) gained $1.92 to $146.20 last week after subcutaneous peginterferon beta-1a given every...

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