HGS faces skeptics as it boasts of a crowded bargaining table

Posted under albiglutide, Blog, Companies, darapladib, Diabetes, Diagnostics, Funding, GlaxoSmithKline, Human Genome Sciences, M&A, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Human Genome Sciences has prescribed a poison pill for GlaxoSmithKline's hostile takeover bid. And after making a detailed case for a much better buyout deal, the biotech says it's already engaged in talks with other pharma and biotech companies interested in bidding on the company. 

In a lengthy statement, HGS ($HGSI) asserts that it "has entered into confidentiality agreements with certain parties and is providing those parties an opportunity to engage in a due diligence review of confidential information." And the company goes on to complain that GSK ($GSK), its long-time development partner with an intimate understanding of the company's potential, simply waited until its share price hit a 52-week low before pouncing.

The biotech's remarks include a detailed case for its pipeline, which includes the potential blockbuster darapladib, a heart drug. Albiglutide, an experimental treatment for diabetes, is tied to $150 million in potential milestones alone. But the argument made little headway with at least one key analyst.

"This is all the usual and expected posturing," Cowen's Eric Schmidt noted to Bloomberg. "I believe GSK remains committed to buying HGSI and do not expect others to have much interest." 

- here's the press release
- read the Bloomberg report
- get the story from The New York Times

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UPDATED: Novo Nordisk hiring R&D, other workers in U.S. recruitment blitz

Posted under Blog, Companies, Diabetes, Diagnostics, Funding, Medical Devices, Medical Supply, Novo Nordisk, Pharmaceuticals, Pipeline, R&D, Startups, Universities, Videos by rmcbride

In a nice change from the drumbeat of pharma layoff news, Novo Nordisk ($NVO) says it plans to boost its U.S. workforce almost 15% this year amid growth in the Danish drugmaker's diabetes business. And a portion of the hires will be made at a new R&D site focused on new treatments for Type 1 diabetes.

This summer Novo, which employed 4,000 workers in the U.S. at the start of 2012, plans to open the R&D facility in Seattle, where it expects to create 20 research jobs, according to a company representative. 

While Big Pharma companies like Pfizer ($PFE) and Merck ($MRK) have been cutting U.S. workers, Novo has been beefing up its workforce at a clip of about 10% annually over the past 5 years, the company said. Its initial hires are expected within weeks as the company recruits for medical liaisons, diabetes educators, sales positions and other commercial posts. At the same time, the company says it continues to seek new scientists in Seattle and staff for its plant in Clayton, NC.

The company appears to be bullish about the future of its business, which includes three products under FDA review and a pipeline of mid-stage and late-stage drug candidates. Diabetes remains one of the hottest areas of drug development, as cases of the metabolic disorder in the U.S. and around the world skyrocket. There are now more than 20 million Americans diagnosed with diabetes, according to the Centers for Disease Control and Prevention, and the ailment has been tied closely to the obesity epidemic in the country.

"This announcement signals the strength of our business model, the increasing demand for our world-class diabetes products, and the steady output of our robust pipeline," Jerzy Gruhn, president of Novo's U.S. affiliate, stated. "Expanding will provide us the opportunity to better support current business as well as the right structure to meet the future needs of our customers."

- here's the release

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Takeda rebuffed (again) in long quest for FDA drug OK

Posted under Actos, alogliptin, Blog, Companies, Diabetes, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Takeda, Universities, Videos by john

Four months before Japan's Takeda will get hit with a tsunami of generic competition for the diabetes blockbuster Actos, the FDA has once again rebuffed the company's application to sell the experimental drug alogliptin. More than 5 years since it originally sought an approval, the drug giant says that the agency wants more data before it can issue an approval for the treatment, which was intended to replace Actos.

The move to re-file the drug was always considered something of a gamble. Takeda and its partner Furiex ($FURX) launched new studies after the treatment was turned down in 2009. Those trials won't be complete until 2014, though the companies had hoped that interim cardio data would suffice for an approval.

Takeda says those ongoing studies, along with data gathered in markets outside the U.S., should satisfy the regulators. "We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues," said Takeda regulatory chief Thomas Harris in a statement. "We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved."

The FDA has never been easy on diabetes drugs, and in recent years regulators have toughened up even more with demands for extensive safety data. Shares of Furiex plunged more than 20% on this latest setback.  

- get the press release
- here's the story from Bloomberg

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Buzz: Amylin brings in the bankers to spur an auction

Posted under Amylin pharmaceuticals, AstraZeneca, Blog, Bristol-Myers Squibb, Companies, Diabetes, Diagnostics, Funding, lixisenatide, M&A, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by john

Amylin ($AMLN) has never confirmed or denied the much repeated story that it rejected a $22 per share bid for the company by Bristol-Myers Squibb ($BMY). And today it's refusing to comment on a fresh round of reports by Bloomberg and Reuters that the company has put itself on the auction block, bringing in the investment bankers to find a buyer willing to put up sufficient cash to close a deal.

Quoting sources, Bloomberg reports that Sanofi ($SNY) may be on the short list of potential bidders. The pharma giant has been hesitating, though, because it has a GLP-1 diabetes drug--lixisenatide--which would compete with Amylin. Product-hungry AstraZeneca ($AZN), which almost immediately was linked to a possible bid by analysts, told the business news service that it's scouting the field, but wouldn't comment directly on a possible offer for Amylin. And Reuters, which initially broke the story, added Merck ($MRK) and Takeda Pharmaceutical as possible bidders in its coverage.

All of the inside news on a buyout has been through sources, since Amylin has consistently refused to discuss the matter. That hasn't stopped Carl Icahn from moving in for a fresh kill, though. Icahn has sued Amylin to push a sale, looking to get into a proxy fight over a merger deal. Now Credit Suisse Group AG and Goldman Sachs Group can start moving behind the scenes to see if they can get a deal going that Amylin would like to talk about.

Amylin's shares had been suffering until BMS stepped up to make the rumored offer, starting a rally that has pushed the price past the $22 mark. Amylin is likely to be after the $31 or $32 price that Jefferies and BMO Capital Markets believe it's worth.

- here's the story from Reuters
- read the Bloomberg report

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Icahn sues Amylin in hopes a proxy fight will trigger sale
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