It is being lined up as a competitor to both Prograf, a twice-daily formulation marketed by Astellas Pharma Inc., of Tokyo, and to AdvaGraf, its once-daily successor, which gained European approval in 2007, but is not marketed in the U.S

The drug is partnered with Astellas Pharma Inc., of Tokyo. (See BioWorld Today, Nov. 4, 2011

Other second-line drugs – including docetaxel, Alimta (pemetrexed, Eli Lilly and Co.) and Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG) – received approval based on much larger studies

Ltd., of Tokyo, said they completed patient recruitment in the Phase III MARQUEE pivotal study of selective c-MET inhibitor tivantinib, in combination with Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG) in previously treated patients with locally advanced or metastatic, nonsquamous non-small-cell lung cancer

Among the more highly anticipated data for ASCO 2012 were further results of the Phase III TIVO-1 trial, which compares AVEO Pharmaceuticals Inc.'s and Astellas Pharma Inc.'s VEGF inhibitor tivozanib to Nexavar (sorafenib, Bayer AG and Onyx Pharmaceuticals Inc.) for the treatment of kidney cancer

Andromeda Biotech Ltd., of Yavne, Israel, disclosed data, which supported an achieved primary endpoint in its pivotal Phase III study of its Type I diabetes treatment. The 24-month trial was a randomized, placebo-controlled, designed to assess the safety and efficacy of DiaPep277, an immunotherapeutic agent for the treatment of newly diagnosed patients with Type I diabetes. The primary endpoint, defined as the change from baseline in C-peptide levels at the end of the study as measured by GST

After a first phase where the team will look for good biomarkers, patients will be randomized into one of four treatment arms, receiving Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG), Nexavar (sorafenib, Bayer AG and Onyx Pharmaceuticals Inc.), a combination of Tarceva and an Akt inhibitor, or a combination of an Akt inhibitor and a MEK inhibitor

Company (Location) Product Description Indication Status Date Abbott (Abbott Park, Ill.) LCIG Levodopa-carbidopa intestinal gel Advanced Parkinson's disease Phase III data showed that patients treated for 12 weeks had clinically meaningful and statistically significant improvements in "off" time, compared to levodopa-carbidopa immediate-release tablets 4/19/12 Astellas Pharma Inc. (Tokyo) YM178 Mirabegron Overactive bladder FDA's Reproductive Health Drugs Advisory Committee voted 7 to 4, with

The drug will be marketed there by Astellas Pharma Taiwan Inc., part of Astellas Pharma Inc., of Tokyo, under the brand name Feburic

MediGene AG, of Martinsried, Germany, received a €5 million (US$6.5 million) milestone payment from Astellas Pharma Inc...subsidiary Astellas Pharma Europe Ltd., of London, related to the transfer of European rights to prostate cancer drug Eligard (leuprolide acetate

MediGene AG, of Martinsried, Germany, received a €5 million (US$6.5 million) milestone payment from Astellas Pharma Inc...subsidiary Astellas Pharma Europe Ltd., of London, related to the transfer of European rights to prostate cancer drug Eligard (leuprolide acetate

Astellas Pharma Inc. (Tokyo) $10 For finalizing the design for a pivotal Phase III trial of TransVax cytomegalovirus vaccine for transplant recipients 4/3/12 Xencor Inc. (Monrovia, Calif.) Boehringer Ingelheim GmbH (Ingelheim, Germany) ND For a regulatory submission to begin Phase I trials of a monoclonal antibody optimized using Xencor's XmAb antibody engineering technology 4/5/12 Xencor Inc. (Monrovia, Calif.) CSL Ltd. (Melbourne, Australia) ND For CSL's filing of an investigational new drug

Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II data published in the Journal of Clinical Oncology confirmed preclinical findings and demonstrated an improved overall survival in a subset of non-small-cell lung cancer (NSCLC) patients with tumors expressing elevated levels of E-cadherin treated with the company's HDAC inhibitor entinostat in combination with EGFR inhibitor Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG

and Astellas Pharma Inc

Drais Pharmaceuticals Inc., of Bridgewater, N.J., said it entered a partnership with Astellas Pharma Inc., of Tokyo, to develop and commercialize an Astellas compound

NeurogesX and Astellas Pharma Europe continue their commercial partnership for Europe, the Middle East and Africa, while parent company Astellas Pharma Inc., of Tokyo, is commercializing Qutenza in certain countries

IL-3R is overexpressed on both leukemia blasts as well as leukemia cancer stem cells. (See BioWorld Today, April 4, 2012.) Astellas Pharma Inc., Sanofi SA, GlaxoSmithKline plc, Boehringer Ingelheim GmbH, Pfizer Inc., Verastem Inc

Astellas Pharma Inc., of Tokyo, said the FDA's Reproductive Health Drugs Advisory Committee voted 7 to 4, with one abstention, that the overall risk/benefit assessment supported approval of mirabegron (YM178) in overactive bladder

Astellas Pharma Inc., of Tokyo, said the FDA's Reproductive Health Drugs Advisory Committee voted 7 to 4, with one abstention, that the overall risk/benefit assessment supported approval of mirabegron (YM178) in overactive bladder