BioDelivery Sciences pockets $27M milestone; Depomed gets $10M upfront in licensing deal

> BioDelivery Sciences has garnered a $26.7 million milestone payment on the recent approval of cancer pain product ONSOLIS (fentanyl buccal soluble film). BioDelivery news

> Depomed will pocket $10 million in a new licensing deal with Merck which covers some of its patents for metformin extended release technology, Depomed also stands to gain milestones and royalties. Depomed News

> Profectus BioSciences has closed on a $5 million Series C venture financing round. Current investor Cross Atlantic Capital Partners led the round, which brings the total venture investment in Profectus to $19 million to date. Profectus release

> Peregrine Pharmaceuticals and Affitech have forged a licensing agreement for antibody therapeutic rights under Peregrine's preclinical anti-VEGF antibody program. Peregrine news

> Cellceutix says it has wrapped acute toxicity studies in mice and rats with Kevetrin and found no significant indications of toxicity. Release

> Japan's Chugai Pharmaceutical has filed for approval of its renal anemia drug R744 with the Japanese health ministry. Chugai, which is partnered with Roche, said that trials had demonstrated the efficacy and tolerability of R744 in patients with chronic kidney disease. Story

> Poniard Pharmaceuticals reported positive results from a Phase I cardiac safety study of its cancer drug picoplatin. Release

> Provectus Pharmaceuticals has launched a new Phase II clinical trial of PH-10 for psoriasis involving daily dosing of patients for 28 days. Announcement

> Ardea Biosciences has initiated a Phase IIb clinical trial of RDEA594, its lead product candidate in development for the management of hyperuricemia and gout. Release

Pharma News

> Procter & Gamble is in late-stage talks to sell its prescription drugs business, a deal that could be worth some $3 billion. The Wall Street Journal reports that drugmaker Warner Chilcott and private-equity firm Cerberus Capital Management are both working on a buyout. Report

> Tysabri rumors have smoked out Elan CEO Kelly Martin (photo). The flurry of talk about Johnson & Johnson's "arrangement" with Elan on the MS drug prompted Martin to come out with details. Report

> Earnings season is in full swing now, with a coterie of Big Pharma putting out their numbers. The strong dollar is weighing on many drugmakers, while others are beating expectations on currency gains. Here's the rundown. Earnings

> Schering-Plough may have won an off-label marketing suit, but not without some flogging from the federal judge in charge. Report

> Cost-cutting saved the quarter at Merck--and with the Schering-Plough deal set to close by year's end, the restructuring has only just begun. Meanwhile, CEO Dick Clark (photo) is already talking about growth plans for Schering's consumer health business. Report

Manufacturing News


> Takeda's first manufacturing facility outside of Japan, an API plant, has opened in Dublin, thanks in part to the efforts of investment promotion agency IDA Ireland and the South Dublin County Council. Report

> SAFC, which we reported last week had a manufacturing suite in its St. Louis facility certified in the safe handling of potent APIs, has entered the molecular diagnostics market by providing regulatory-compliant and custom-manufactured raw materials. Report

> More woes for Caraco, the generic drug maker whose recent FDA visits led to the seizure of more than 30 medications and drug ingredients for violations of good manufacturing practices: It is now the target of the profession known for its use of the ampersand in company names. Report

> API maker Hovione, following a successful FDA pre-approval inspection of its manufacturing plant in Macau, near Hong Kong, notes that "the FDA is looking in far greater detail to aspects like Quality by Design and supply chain management." Report

And Finally... Countries are casting about for ways to slow the spread of swine flu until a vaccine is ready. Report