|Mylan Drops Out of Rottapharm Talks; Shire Pulls FDA Application for Second Time|
|By Staff and Wire Reports|
|Thursday, 15 March 2012 19:22|
Generics drug maker Mylan (NASDAQ:MYL) has pulled out of talks to buy a stake in Italian pharmaceuticals firm Rottapharm, two people familiar with the situation said, posing another setback to the arduous sales process that has been dragging on since the middle of last year.
The Rovati family had been looking to find an investor among rival pharma groups such as Mylan, Forest Laboratories (NYSE:FRX) and Watson Pharmaceuticals (NYSE:WPI), after it failed to sell a minority stake to private equity houses.
But the sources said the selling family has not been able to agree to give up control of the company and was not prepared to compromise enough on price either.
As a result Mylan, based in Canonsburg, Pennsylvania, and the world's third largest generic drugs maker, is no longer in talks with Rottapharm's owner, two of the people said.
"If you want to keep control you need to compromise on price," one said. "If you want a high price, you need to give away some control."
Rottapharm founder Luigi Rovati put a stake of up to 50 percent in the group on the market last year, looking for a deal that would value the business at 2 billion euros ($2.6 billion).
Rovati first looked to sell part of the equity to Italian fund Clessidra in order to keep control of the company in Italian hands, and sell about 40 percent to an international buyouts group, the people said.
But it could not agree on those conditions with private equity firms including Carlyle Group and Avista and the talks stalled at the end of January.
The company has since had talks with other U.S. generic and branded drugs groups Watson Pharmaceuticals and Forest Laboratories, several people close to the process said.
One of the sources, who is familiar with Watson, said the group was unlikely to buy Rottapharm because their existing European presence means they would extra only few synergies.
And Forest -- which makes the antidepressant Lexapro -- is having problems of its own. It is expected to see its revenue drop by about one-fourth, after its flagship drug loses patent protection early next year.
The company is also under pressure from billionaire activist investor Carl Icahn who built a holding of over 9 percent in the company in an attempt to change its boss and bring in new board members.
Rottapharm, Mylan, Watson, and Forest either declined to comment or officials were not immediately available for comment.
Shire plc (Nasdaq: SHPGY) has decided to pull its Fabry drug application from the FDA. This is the second time the U.K.-based company, whose rare disease unit is headquartered in Lexington, Mass., has applied and then withdrawn the approval application for this drug, called Replagal.
Replagal is approved in Europe, and has been prescribed to U.S. patients free of charge since 2009.
U.S. authorities allowed the drug to be given to patients prior to approval because the only FDA-approved therapy for Fabry disease — Fabrazyme made by Genzyme Corp. — has been in short supply since viral contamination forced Genzyme to close its Allston plant for six weeks in the summer of 2009.
“Shire has had a close partnership with the global Fabry patient community for over 10 years, and we are extremely disappointed that we feel compelled to make this decision,” Sylvie Grégoire, president, Shire Human Genetic Therapies, said in a statement.
The company said the FDA encouraged Shire to submit an application for the approval of Replagal in 2009, and again in 2011, and initially indicated new clinical trials would not be required, but later reversed course. The FDA did not immediately return a request for comment.
Shire also said the FDA did not raise any concerns about Replagal's safety. Shire executives said additional studies would cause a significant delay, and a U.S. approval would only be possible in the distant future. The withdrawal is good news for Genzyme, now owned by French drug maker Sanofi (NYSE: SNY). The company has recently started shipping Fabrazyme from its new plant in Framingham, Mass., and plans to have the shortage resolved before the end of the year
The company said the withdrawal would not have any impact on Shire’s 2012 financial guidance.
The announcement was made about an hour before the markets closed in the U.S. Shire’s stock fell 2 percent in the last hour of trading to $103.31 from $105.43 at the previous close.
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