European committee backs AZ, BMS and Novartis drugs for approval

Posted under AMAG Pharmaceuticals, AstraZeneca, Blog, CHMP recommendation, Companies, dapagliflozin, Diagnostics, Europe, Funding, INC424, JAK inhibitors, Medical Devices, Medical Supply, myelofibrosis, Novartis, Pharmaceuticals, Pipeline, Regulatory, Startups, Type 2 Diabetes, Universities, Videos by rmcbride

Several drug companies received nods of support for getting their prized drugs approved for the European market. The Committee for Medicinal Products for Human Use (CHMP) revealed its recommendations today, with positive news for Amag Pharmaceuticals ($AMAG), AstraZeneca ($AZN), Bristol-Myers Squibb ($BMY), Novartis ($NVS), Incyte ($INCY), and Takeda Pharmaceutical.

The CHMP backed AZ and BMS's dapagliflozin for approval to treat Type 2 diabetes, after the FDA shot down the companies' bid to gain an OK to sell the drug in the U.S. in January because of regulators' safety concerns about the program. The EU committee, however, noted the need for new diabetes drugs, citing the World Health Organization's estimate last year that 346 million people worldwide have the disease, which often leads to serious health problems such as cardiovascular disease. 

Incyte and Novartis got more good news for the companies' JAK inhibitor known as INC424, with the CHMP pushing for approval of the drug in the EU for treating a blood cancer known as myelofibrosis. Incyte, which controls U.S. marketing of the drug, grabbed FDA approval for the product in November. Patients with the disease have few treatment options, giving the drug a leg up with regulators.

Amag and Takeda scored the CHMP's backing for the drug ferumoxytol for treating anemia in patients with kidney disease. Takeda is taking the lead on European development of the drug, which it plans to sell under the name Rienso.

- see the CHMP release
- here's Novartis' release
- check out the Reuters report on dapagliflozin

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Targacept scuttles diabetes drug program in fresh setback

Posted under asthma, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Phase II, Startups, Targacept, TC-6987, Type 2 Diabetes, Universities, Videos by John Carroll

A beleaguered Targacept ($TRGT) took one step forward and two steps back today, killing a development program for TC-6987 as a treatment for type 2 diabetes while signaling that a separate study for the same drug hit its primary endpoints in a mid-stage study for asthma.

Investigators for the Winston-Salem, NC-based Targacept had been hoping to track a significant improvement in fasting plasma glucose among the patients taking the treatment in the Phase II diabetes trial. But when that didn't pan out, Targacept decided to dump the diabetes work and push ahead on asthma.

"The exploratory asthma trial of TC-6987 as an adjunct to a low-dose inhaled corticosteroid showed a drug effect that was seen at the first assessment point, 30 minutes after initial dosing, and was sustained throughout the duration of the study, suggesting that TC-6987 has promise and may also have benefit in a monotherapy setting," said James F. Donohue, a professor at the University of North Carolina School of Medicine.

News of the diabetes setback cost Targacept another bite out of its share price this morning. Its shares have been battered in recent days after its depression drug TC-5214--partnered with AstraZeneca ($AZN)--failed the last two of four late-stage studies. With an 0-and-4 record in Phase III, Targacept was forced to write off a program that AstraZeneca had offered to pay more than a billion dollars for in milestones.

- get the release
- here's the story from Dow Jones

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Amid pharma talks, Ember Therapeutics notches win for obesity program

Posted under Blog, Companies, Diagnostics, Ember Therapeutics, Funding, irisin, Medical Devices, Medical Supply, obesity, Pharmaceuticals, Startups, Third Rock Ventures, Type 2 Diabetes, Universities, Videos by Ryan McBride

Boston-based startup Ember Therapeutics scored new data on its brown fat program to take into partnership talks at the J.P. Morgan conference this week in San Francisco, giving the young biotech's executives proof that its early-stage work could lead to breakthrough drugs for obesity and type 2 diabetes.

The company--which landed a $34 million Series A round of funding late last year from founding backer Third Rock Ventures--said today that its scientific founder's latest study published in Nature shows that a hormone called irisin, injected into rotund mice, helped the rodents drop weight and get their blood sugar levels under control. Importantly, there were no toxicity issues associated with the injections that would raise red flags about safety, which is always a key concern for diet drugs tested in humans.

The hormone appeared to trigger white fat, the energy-packing fat that builds into flab, to act like brown fat, which actually burns energy to keep the body warm, according to the study led by researchers at Dana-Farber Cancer Institute.

With a number of programs targeting brown fat pathways, Ember offers an early-stage opportunity in the alluring obesity and diabetes fields. Even in its infancy, the company is attracting attention from some deep-pocked parties in pharma, CEO Lou Tartaglia indicated in an interview with Bloomberg.

"We are in fact seeing quite a lot of major pharma companies and have been approached by quite a number, and have been in discussions to see what deal structure makes sense for us," Tartaglia told Bloomberg. "Perhaps there will be a partner in the future to develop a broad relationship in brown fat."

- here's the release
- get more in the Bloomberg article

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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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