12:00 AM
Jan 14, 2013
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) was off Rs9.10 to Rs282.45 last week on India's National Stock Exchange after the Drugs Controller General of India approved Alzumab itolizumab to treat chronic plaque psoriasis. The company plans to launch the product this year.

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) was up $0.24 to $2.97 last week after announcing partner Japan Tobacco Inc. (Tokyo:2914; Osaka:2914) submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Zerenex ferric citrate to treat hyperphosphatemia in patients with chronic kidney disease (CKD). The submission triggered a $7 million payment to Keryx.

The product is in a Phase III trial in the U.S. to treat hyperphosphatemia in end-stage renal disease (ESRD) patients who are on dialysis. Keryx plans to submit an NDA to FDA and an MAA to EMA for the indication this quarter.

Savient Pharmaceuticals Inc. (NASDAQ:SVNT) was off a penny to $1.15 last week after the European Commission approved Krystexxa pegloticase to treat severe chronic tophaceous gout in adult patients. EMA's CHMP backed approval of the drug last October. The biotech, which markets the drug in the U.S., plans to launch in Europe by mid-year.

Swedish Orphan Biovitrum AB (SSE:SOBI) gained SEK0.30 to SEK39.20 last week after FDA approved a label expansion for Kineret anakinra to include neonatal onset multisystem inflammatory disease (NOMID), the most severe form of cryopyrin-associated periodic syndromes (CAPS). The company, which markets the product to treat rheumatoid arthritis, has exclusive, worldwide rights from Amgen Inc. (NASDAQ:AMGN) for RA and undisclosed Orphan indications.

Amgen was off $2.02 to $86.96 for the week, when it partnered to develop and commercialize a therapeutic for solid tumors based on the Accurin targeted therapeutic platform at Bind Biosciences Inc. Amgen will provide an undisclosed kinase inhibitor, and Bind will use its Medicinal Nanoengineering technology to develop an Accurin based on the inhibitor. Amgen will have exclusive, worldwide rights and will be responsible for all clinical development and commercialization.

Theravance Inc. (NASDAQ:THRX) added $1.70 to $23.27 last week after it and GlaxoSmithKline plc (LSE:GSK, NYSE:GSK) said they submitted an MAA to...

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