Sanofi’s rumored buyout plans inspire guessing game

The scuttlebutt from Bloomberg late last week about Sanofi-Aventis' interest in acquiring an unidentified drug developer in the pricey neighborhood of $20 billion has triggered a fevered new game of name-the-target. For its part, the Wall Street Journal's Michael Corkery ran a slate of five potential developers that fit the general profile: Genzyme ($13 billion market cap); Biogen Idec ($13 billion); Celgene ($23 billion); Gilead Sciences and Amgen. With a market cap of $50 billion,...

Hospira gains EMA OK for Neupogen biosimilar

Hospira says that it won European approval for its follow-on therapy to Amgen's blockbuster Neupogen. In winning the OK, Hospira provided late-stage data demonstrating that its therapy, Nivestim (filgrastim), had a comparable efficacy and safety profile to Neupogen. Europe has sprinted ahead of the U.S. in its approval of biosimilars, follow-on therapies to the biologics like Neupogen that have dominated the market for years. This is the fifth European approval for a biosimilar to...

AMG 479 shows “promising activity” in pancratic cancer

Data from a small, randomized, placebo-controlled Phase II study of Amgen's (NASDAQ: AMGN) AMG 479 plus gemcitabine showed that metastatic pancreatic cancer patients receiving the combination experienced improved overall survival at six months. The promising candidate now is moving into Phase III testing in this patient population. In the study, patients received either AMG 479 plus Gemzar (gemcitabine), conatumumab plus gemcitabine, or placebo plus gemcitabine. The addition of AMG 479 to...

Amgen wins FDA approval of D-mab

Two months ahead of schedule and just days behind European regulators, the FDA has approved Amgen's denosumab for postmenopausal women with osteoporosis. Once the drug hits the market as Prolia, analysts expect that it will evolve into a multibillion-dollar franchise product--marking a key turning point for the world's biggest independent biotech. Patients will be able to get the two annual injections at a cost of about $1,650. At that price Amgen believes it can snare a significant chunk of...

Amgen eyes deals in global expansion

Amgen (NASDAQ: AMGN) has about $20 billion on hand to finance new deals. But while the U.S. and Europe are the biggest markets, CEO Kevin Sharer says his company will be looking for deals in emerging markets due to the greater potential for growth there. "We seek good companies at a fair price. We are looking for quality. If we find the right company, we could be quite aggressive. Now is a good time. We would not hesitate if we thought we had the right opportunity," the CEO tells the Financial...

Amgen’s D-mab wins blockbuster approval in Europe

Amgen (NASDAQ: AMGN) can soon start watching the cash roll in for denosumab. After testing the bone-loss drug in a battery of late-stage trials, the therapy--to be sold as Prolia--won its first regulatory approval in Europe. GlaxoSmithKline (NYSE: GSK) will now collaborate with Amgen on the commercialization work on the continent for a drug that is expected to earn billions of dollars a year and help position the big biotech for the decade ahead. Regulators approved the drug as a treatment...

ASCO: Lilly tracks partial melanoma response, Celldex shares sink

Last night's data dump ahead of ASCO produced a treasure trove of information, but few signs of any dramatic leap or pratfall. Among the highlights: Eli Lilly (NYSE: LLY) reported that a handful of patients in a small mid-stage study of its melanoma drug tasisulam demonstrated a partial response--in which a tumor or lesion shrank--to the therapy. Tested in patients with metastatic melanoma, a virtual death sentence, 24 of 68 patients experienced no disease progression after two treatment...

Amgen eyes wider Dmab approval

Amgen wants the FDA to grant wider approval for denosumab, the company's osteoporosis drug. The company has submitted a BLA for Dmab for the reduction of fractures and other skeletal problems in advanced cancer patients. Additional filings are planned in several other markets, including Europe and Japan....