• Abraxis BioSciences Inc., of Los Angeles, received approval for Abraxane (paclitaxel powder for injectable suspension) (nanoparticle albumin-bound paclitaxel) from Health Canada in metastatic breast cancer. The approval includes the use of Abraxane in first-line treatment. The company anticipates launching the drug through its Canadian affiliate of Abraxis Oncology late in the third quarter.
• ICOS Corp., of Bothell, Wash., said Lilly ICOS LLC, its joint venture with Indianapolis-based Eli Lilly and Co., submitted a marketing application in Europe for Cialis (tadalafil) 2.5 mg and 5 mg once-a-day dosing to treat erectile dysfunction. Lilly ICOS plans to file in the U.S. and Canada later in 2006. If approved, the first launches could occur in late 2007.
• MorphoSys AG, of Martinsried, Germany, agreed to license its HuCAL technology to OncoMed Pharmaceuticals Inc., of Mountain View, Calif., for the research and development of therapeutic antibodies in cancer. Under the terms, MorphoSys grants OncoMed access to its antibody library HuCAL GOLD for drug discovery purposes. The two-year contract includes an up-front payment and annual user fees to MorphoSys. Further financial details were not disclosed.
• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., received a $7 million payment for attaining a development milestone under the company's collaboration with Procter & Gamble Pharmaceuticals Inc., a division of The Procter & Gamble Co., of Cincinnati, for development and commercialization of parathyroid hormone nasal spray for osteoporosis. The companies entered the collaboration in February. The milestone will be recognized as revenue this quarter.
• Novacea Inc., of South San Francisco, said the underwriters of its initial public offering have exercised their overallotment option to buy an additional 657,500 shares of common stock. The exercise increases the number of shares sold in the IPO to 6.9 million shares, resulting in gross proceeds of about $44.9 million. Bear Stearns & Co. Inc. and Cowen and Co. LLC acted as joint book-running managers, while Pacific Growth Equities LLC and HSBC Securities (USA) Inc. were co-managers. The company has three product candidates in clinical trials: DN-101 in a Phase III trial for androgen-independent prostate cancer; oral vinorelbine, which is set to enter a registration trail for metastatic breast cancer in the second half of 2006; and AQ4N, which is expected to advance into a Phase I/II trial in the second half of 2006 for glioblastoma multiforme in combination with radiation and chemotherapy. Separately, Novacea said Phase I/II data of DN-101 as a second-line treatment of non-small-cell lung cancer showed the therapy was well tolerated at all doses and displayed a tumor response rate of 6.6 percent with a median overall survival of 6.9 months among 61 patients who received the three weekly dosing regimens of DN-101 and docetaxel.