Astellas scores FDA panel nod for overactive bladder drug

Posted under Astellas, Blog, Companies, Diagnostics, FDA, Funding, Medical Devices, Medical Supply, Mirabegron, overactive bladder, Pharmaceuticals, Regulatory, Startups, Universities, Vesicare, Videos by rmcbride

Astellas Pharma is one step closer to building its blockbuster business in overactive bladder meds. An FDA panel has backed approval of the Japanese drugmaker's treatment mirabegron, voting 7-4 that the benefits outweigh the safety risks, the company said Thursday.

Tokyo-based Astellas hopes the FDA takes the panel's recommendation, as the agency often does, and provides the company with its second drug approved for overactive bladder in the U.S. Some 42 million Americans have the condition, which causes them to need to urinate frequently. It is most common in elderly patients. The agency is expected to take action on its review of mirabegron by June 29.  

However, the future success of the drug, which is already approved in Japan, remains uncertain in the U.S. market. The med poses safety risks to the heart and liver, and some panelists expressed concern over the treatment's marginal benefits, according to a Reuters report. Taken orally once a day, mirabegron targets B3-receptors in bladder muscles to prevent the uncontrolled contractions that cause frequent trips to the bathroom.

Astellas already markets the blockbuster overactive bladder drug Vesicare, but that med faces loss of patent protection in three years. Mirabegron could ease the pain of declining revenue from Vesicare, Bloomberg reports. Reuters says Astellas is aiming to reach $1.9 billion in sales from both Vesicare and mirabegron by the end of its fiscal year that ends in March 2015.

- here's the company's release
- read the Reuters article
- and Bloomberg's report

AZ commits $140M to cancer pact as it inks back-to-back deals

Posted under Astellas, AstraZeneca, Blog, Chi-Med, China, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, olaparib, ovarian cancer, Pharmaceuticals, Startups, Type 2 Diabetes, Universities, Videos by John Carroll

A day after AstraZeneca ($AZN) managed to raise fresh doubts about its ability to efficiently develop new therapies with twin setbacks in the clinic, the pharma company is back with a pair of new pipeline pacts. The pharma giant paid $20 million upfront and pledged up to $120 million in milestones for the rights to develop a preclinical cancer treatment discovered in China. And it snagged an option on a pair of diabetes drugs in Astellas' pipeline.

AstraZeneca's deal with Chi-Med revolves around volitinib (HMPL-504), an inhibitor of the c-Met receptor tyrosine kinase, now slated to begin a near-term Phase I study. And AstraZeneca highlighted the role Chinese investigators will play in the development of the treatment. "Volitinib represents a highly attractive global opportunity for AstraZeneca as we seek to develop and commercialise novel, targeted cancer therapies," says Susan Galbraith, head of AstraZeneca's Oncology Innovative Medicines. "This collaboration with HMP represents our commitment to China and brings together two groups with highly complementary capabilities."

AstraZeneca simultaneously completed an option deal with Japan's Astellas for the acquisition of PSN821, a mid-stage treatment, and the pre-clinical PSN842--both for type 2 diabetes. The drugs are oral G protein-coupled receptor GPR119 agonists, "a potential new class of medicines for diabetes." There's no word on exactly how much AstraZeneca is paying for the option to buy the drugs.

Neither of these deals are likely to compensate for the demise of AstraZeneca's ovarian cancer study for olaparib or the news yesterday that the second Phase III study of TC-5214 proved a bust, just like the first one. Olaparib was in Phase II for ovarian cancer when investigators decided to scuttle the program. And TC-5214 was one of the late-stage prospects that AstraZeneca needed to generate fresh revenue.

- read the release on the Chi-Med deal
- here's the release on the pact with Astellas

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