Buzz: Big Pharma suitors line up for a look at Amylin’s books

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

One of the cardinal rules involved in deal-making focuses on the need to get as many buyers to the negotiating table as possible. The next big rule: Make sure everyone knows who's interested in bidding.

Amylin--while maintaining a strict no comment policy ever since initial reports appeared the Bristol-Myers Squibb ($BMY) had made an offer--has scored on both points with a Bloomberg report out this morning assessing the line of potential bidders queuing up to take a confidential look at the books. By the business news service's count, fed by an inside source, Pfizer ($PFE), AstraZeneca ($AZN) and Sanofi ($SNY) have all signed confidentiality agreements, joining Merck ($MRK), Takeda, Roche ($RHHBY) and Bristol-Myers Squibb at the auction block.

With a market cap of $4 billion, Amylin ($AMLN) can be bought for a reasonable enough sum, offering up product revenue and a background in diabetes development that would complement quite a few potential acquirers. Amylin spent $162 million last year on R&D. But its newly approved Bydureon could prove a much tougher sale than some would like to take on.

"Diabetes is an area companies either want a position in or want a stronger position in," Deutsche Bank analyst Mark Clark tells Bloomberg. "Amylin is not a massive financial stretch so it comes down to what companies' alternatives are, whether there are other synergies involved and who it makes the most sense to. Some companies are more desperate for revenue sources than others."  

That last point on desperation indicates that AstraZeneca, at least, may be more willing than the others to pay a premium for Amylin. Sanofi, meanwhile, is reportedly undeterred that its experimental lixisenatide would compete with Amylin's drug roster. And that could leave Amylin--along with its advisers from Credit Suisse and Goldman Sachs--right where it wants to be: At the center of a bidding war. Even Carl Icahn would have to admire that strategy.

- here's the story from Bloomberg

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Indian gov’t probes drug regulator after scathing review

Posted under Bayer, Blog, Central Drugs Standard Control Organization, Companies, Diagnostics, Emerging Markets, Funding, GlaxoSmithKline, india, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Regulatory, Sanofi, Startups, Universities, Videos by rmcbride

India's drug regulators are ensnared in a scandalous fix. Days after a parliamentary report noted shoddy oversight of approvals, the Indian government has mounted an investigation into the alleged misdeeds. Meanwhile, big names in biopharma have surfaced in the sea of allegations.

As The Wall Street Journal reports, India's ministry said Friday it has created a special group to probe the long list of grievances in the report, with an eye toward repairing the infrastructure in place for approving drugs in the country. If the allegations in the parliamentary review are true, the Indian government believes that laws were broken and drugs arrived in pharmacies without undergoing required clinical studies.

Drugs from several of the largest drug companies--including Bayer, GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY)--were listed among those that were approved without standard clinical evaluation. Many of the drug manufacturers have professed their innocence after the report cited alleged collusion between pharma groups and India's drug regulator, Central Drugs Standard Control Organization.

- read the WSJ's article (sub. req.)
- see Reuters' report

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Subpar clinical trials probed in India’s review of regulation

Posted under aliskiran, ambrisentan, Blog, Clinical Trials, Companies, Diagnostics, dronedarone, Emerging Markets, Funding, GSK, india, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Sanofi, Startups, Universities, Videos by rmcbride

Indian lawmakers and patient advocates charge that their regulator rubber-stamped drugs to be sold in the county without required clinical trials. And a parliamentary report heaps blame for poor adherence to trials standards on Big Pharma groups, the national regulator and other stakeholders in a scathing review of approvals in the country.

The investigation probed the approvals of 42 drugs from groups such as the global heavyweights GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY), finding that certain meds were cleared for the market in India after being banned in developed countries or got approvals without being studied in enough patients, Bloomberg reported. For instance, India's Central Drugs Standard Control Organization approved Sanofi's dronedarone and Novartis' aliskiren based on trials with fewer than 50 patients, allegedly allowing the companies to skirt the minimum 100-patient requirement.

"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said, as quoted by Bloomberg. "Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk."

Novartis and GSK, for starters, reacted quickly to the news. Switzerland-based Novartis stated that the company follows the same ethical standards for all of its studies around the world, and has mounted an investigation of its own into regulatory activity in India. In its own defense, GSK got Indian regulators to waive trial requirements for the London-based drugmaker's niche hypertension drug ambrisentan, the London-based drug giant told Bloomberg.

The report is a clear signal that Indian lawmakers and advocates are pushing for tighter control of drug regulation in the country, which has been a rapidly growing market for drug development and pharma sales.

- see Bloomberg's report
- check out Reuters' story

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Ex-Sanofi chemist locked up after theft

Posted under Blog, Companies, Diagnostics, Funding, Legal, Medical Devices, Medical Supply, Pharmaceuticals, R&D, Sanofi, Startups, Universities, Videos, Yuan Li by rmcbride

After being accused of bilking her former employer, a court sentenced ex-Sanofi chemist Yuan Li to serve a year and half in prison and pay $131,000 in restitution, Pharmalot reported, citing court documents. Li, a Chinese national who worked for Sanofi's ($SNY) operation in Bridgewater, NJ, for 6 years, was linked with the theft of data on chemical compounds that were registered to a company called Abby Pharmatech, of which she was listed as a partner. Report