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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Bristol stays in hunt for Amylin

Posted under Amylin pharmaceuticals, Blog, Bristol-Myers Squibb, Bydureon, Byetta, Companies, dapagliflozin, Diabetes, Diagnostics, Funding, M&A, Medical Devices, Medical Supply, Onglyza, Pharmaceuticals, Startups, Universities, Videos by rmcbride

Bristol-Myers Squibb ($BMY) still has eyes for Amylin Pharmaceuticals ($AMLN). After Amylin reportedly declined BMS' recent buyout offer, Bristol isn't giving up on its plans to gobble up the diabetes drugmaker, The Wall Street Journal reported Thursday, citing unnamed sources familiar with the situation.

The news comes after Amylin balked at Bristol's $22-per-share cash offer, which company leaders deemed too low. Major Amylin shareholder and activist investor Carl Icahn is now on the case, calling for Amylin's management to launch a sales process and entice the kind of bidding that can ultimately benefit shareholders. 

Amylin, the maker of the diabetes drug Byetta and the long-acting version Bydureon, is a company with sales growth and products that large pharma players desperately need. And the San Diego-based biotech is no behemoth, with 2011 revenue of $650.7 million and a market cap as of this morning of about $3.6 billion.

Amylin fits the size profile that New York-based Bristol has been known to target in previous buyouts, with its industry-famous "string of pearls" acquisition strategy that avoids megamergers and favors deals that can be easily digested organizationally. Bristol also has a stake in the growing diabetes market with the drug Onglyza and its experimental treatment dapagliflozin, and both of those drugs are partnered with AstraZeneca ($AZN), the WSJ reported.

- read the WSJ article

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Bristol-Myers taps gas on ambitious 2012 R&D strategy

Posted under Blog, Bristol-Myers Squibb, Companies, dapagliflozin, Diagnostics, Funding, Hepatitis C, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Don't look for Bristol-Myers Squibb ($BMY) to back away from its ambitious, multibillion-dollar R&D strategy anytime this year. After racking up a billion dollars in research expenses for the fourth quarter--flat compared with the same period a year ago, the impressive biotech company says that it is planning to boost R&D spending this year in the "low single digits."

BMS is coming off a mixed fourth quarter. After boasting a string of successes in the clinic, the developer was forced to concede that its late-stage cancer drug brivanib failed a Phase III study. And after losing an expert panel vote on the diabetes drug dapagliflozin, the agency formally rejected the treatment earlier this month with demands for more clinical data. But BMS is off to an ambitious start of the year with its $2.5 billion Inhibitex ($INHX) buyout and an ongoing hep C drug partnership with Pharmasset ($VRUS), recently acquired by Gilead Sciences ($GILD), putting it squarely in the front of a hot race to the next game-changing therapy.

Its R&D budget, a bellwether among large developers, swelled to $3.8 billion, up from $3.5 billion in 2010. And based on company projections it looks to keep growing at a somewhat slower pace this year. In its release today, BMS said 30% to 40% of its total R&D budget was being earmarked for late-stage development work, fueling new programs that should continue to beef up the revenue potential at the company.

"Our delivery of several important new products to patients, the ability of our productive R&D organization to build an innovative and diverse pipeline, and our continued commitment to business development gives us confidence in our future," says BMS CEO Lamberto Andreotti, one of the few biotech execs with plenty to boast about. "In 2012, we will build on the momentum of 2011 as we transition beyond the loss of exclusivity of Plavix and Avapro."

- here's the press release

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FDA rejects dapagliflozin for diabetes, raising concerns for a class

Posted under AstraZeneca, Blog, Bristol-Myers Squibb, Companies, dapagliflozin, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

The FDA has surprised no one with its decision to bat down dapagliflozin, an innovative but potentially risky new approach to treating diabetes. AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) reported the agency has spelled out a demand for new data that could include the need for new clinical trials--potentially pushing any final resolution far down the R&D road.

A majority of the agency's expert panel voted against an approval last July after raising concerns about cancer cases seen in studies in addition to evidence of toxicity. Given the agency's vigilance over any safety concerns linked to diabetes treatments--a position that dates back to the storm of controversy that broke out over Avandia's side effects four years ago--most analysts were quick to write off any near-term approval. And in this case the rejection also spells trouble for an entire class of diabetes drugs in the clinic known as SGLT2 inhibitors, which spur the body to excrete sugar in urine. Johnson & Johnson ($JNJ), Pfizer ($PFE), a Lilly and Boehringer partnership, Lexicon and others have their own SGLT2 inhibitors in development.

Analysts were quick to note this is AstraZeneca's third pipeline setback in recent months and a second for BMS, which earned a string of notable successes last year. The rejection has to be particularly stinging for AstraZeneca, which has failed to impress observers with its late-stage pipeline. Now that analysts are further discounting the potential of a drug once thought to be worth $600 million to $700 million a year in peak sales, pressure will mount on the pharma company to show it can deliver new and important drugs.

Dapagliflozin does have some high profile defenders. The Cleveland Clinic picked the drug, which works independently of insulin, as one of the best potential game-changing technologies in healthcare. The prominent cardiovascular expert Steve Nissen has discounted any link with cancer and highlighted the therapeutic effects of the drug. And Savvas Neophytou of Panmure Gordon told Reuters he hasn't given up hope on seeing an approval as the first Type 2 diabetes drug given without insulin.

"To us, this product either becomes multi-billion (dollar) or it never sees the light of day in the market," he said. Others still hold out hope for an approval, but potential sales estimates are dwindling as drugmakers advance other treatments into an already crowded market.

- here's the press release
- get the story from Reuters
- check out the Bloomberg report

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