AstraZeneca signs collaboration deal with Fibrogen to develop anemia drug
AstraZeneca (AZN +0.9%) inks a collaboration deal to develop an oral anemia drug with privately held U.S. biotechnology company FibroGen that could potentially be worth more than $815M.
The collaboration includes the development and commercialization of FG-4592, a drug that mimics the body's response to being at high altitude, which stimulates production of red blood cells and would be used to treat anemia.
AZN's is making an initial $350M payment to FibroGen, will could rise to as much as $815M if development milestones are reached, and possibly even exceed that with royalty payments on future sales in the low 20% range.
AZN has made $2.8B worth of acquisition and collaboration deals in the last six months alone in a bid to counteract the revenue-sapping effect of generic competition.
The deal is limited to the U.S., China and a few other markets, but excludes Europe, Japan and other markets where FibroGen already has an agreement with Astellas Pharma (ALPMY.PK).
Medivation (MDV) and Astellas (ALPMF.PK) enroll the first patient in a Phase II trial for enzalutamide, a treatment for triple-negative breast cancer, for which "there are no approved targeted therapies." The trial will recruit approximately 80 patients, who will take enzalutamide orally once a day. (PR)
Cytokinetics (CYTK +9.8%) grants Astellas (ALPMF.PK) an exclusive license to co-develop and commercialize Cytokinetics' CK-2127107 treatment for muscle weakness, which is in Phase I trials. Cytokinetics will receive $16M up front and is eligible to receive over $24M in reimbursements during the first two years. Astellas could also pay $450M in R&D and sales milestones and royalties, as well as make other milestone payments. (8-K)
Health Canada approves Medivation (MDVN) and Astellas' (ALPMY.PK) XTANDI (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer. (Previous: XTANDI submitted to Japanese regulators; XTANDI sales rise)
Amgen (AMGN -0.6%) forms a JV with Japan's Astellas Pharma (ALPMF.PK) to develop and sell five new drugs in the latter's home country, with the hope being to launch the first medicine in 2016. The JV should help Amgen partly fill what it has described as "a noticeable gap" - its absence from China and Japan. (PR)
Astellas (ALPMY.PK) and Medivation (MDVN) say a marketing approval application for enzalutamide (its friends call it XTANDI and it's FDA approved) has been submitted to Japan's Ministry of Health, Labour, and Welfare for the treatment of prostate cancer. (PR)
AVEO Pharmaceuticals (AVEO) has been informed by its partner, Astellas Pharma (ALPMY.PK), that it no longer intends to submit a Marketing Authorization Application to the European Medicines Agency for tivozanib, its treatment for advanced renal cell carcinoma, nor does not intend to fund any future trials under its strategic collaboration agreement. AVEO says it's evaluating the impact of the news and its options for the drug going forward. AVEO -14.7% AH.
Japanese stocks move higher in early trading after a record finish for the S&P 500 overnight. The Nikkei Average gained 0.3% to 14,822, extending its gains after finishing at its highest level yesterday since December 2007. Big gainers include: Hino Motors (HINOY.PK +2.2%), Isuzu Motors (ISUZY.PK +1.7%) and Astellas Pharma (ALPMY.PK +3.9%).
Shares of Optimer Pharmaceutical (OPTR +14%) ramped up into the close on reports that AstraZeneca (AZN), Astellas Pharma (ALPMY.PK) and Cubist Pharmaceuticals (CBST) are among the first round bidders for the antibiotic manufacturer. OPTR disclosed almost three months ago that they were working with Centerview Partners and JPMorgan to explore its strategic options, including a potential sale.
The FDA has given early approval to enzalutimide, a new prostate-cancer drug developed jointly by Medivation (MDVN +1.4%) and Astellas Pharma (ALPMY.PK). The drug - which was approved to treat men with prostate cancer that has spread or returned after prior treatment with another drug, docetaxel - will be sold under the brand name Xtandi. Dendreon (DNDN -0.6%), whose already struggling with lagging sales of its own prostrate drug, Provenge, trades down on the news.
Medivation (MDVN) and Astellas Pharma (ALPMY.PK) say the FDA has assigned a PDUFA action date of November 22 for the review of their New Drug Application for enzalutamide, an investigational agent for the potential treatment of prostate cancer. MDVN +0.6% AH.