Mylan Drops Out of Rottapharm Talks; Shire Pulls FDA Application for Second Time

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By Staff and Wire Reports   
Thursday, 15 March 2012 19:22
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 15, 2012.

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.


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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.



Also Thursday:



AdCare Health Systems, Inc. (NYSE Amex: ADK)
, a leading long-term care provider, has signed definitive purchase agreements for two skilled nursing facilities in Oklahoma for a total consideration of $11.6 million.

Allezoe Medical Holdings (OTCBB:ALZM)
today announced that Caroline Pinell has agreed to join the Company on a full time basis and has been named as the President and CEO of SureScreen Medical, Inc., a wholly-owned subsidiary of the Company.

Exactech, Inc. (Nasdaq:EXAC)
, a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that the Deferred Prosecution Agreement (DPA) entered into effective December 7, 2010 with the United States Attorney’s Office for the District of New Jersey (USAO) has expired.

GenMark Diagnostics, Inc. (Nasdaq:GNMK)
today reported additional financial information for the fourth quarter ended December 31, 2011 that was unavailable at the time it released preliminary financial results on March 8, 2012.

Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that Yuval Yanai, Chief Financial Officer, will present at the Maxim Group Growth Conference taking place on March 26, 2012 in New York City.

iCAD, Inc. (Nasdaq: ICAD)
, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, announced today the launch of a post-market study to assess the safety and efficacy of the company’s FDA-cleared Xoft Axxent® eBx™ System when used for single-fraction, intra-operative radiation therapy (IORT) at the time of lumpectomy for early stage breast cancer.

IntelliCell BioSciences, Inc. (OTCQB: SVFC.PK) (PINKSHEETS: SVFC.PK)
announces Ray Dirks Research Article published on www.CPreports.com .

InVivo Therapeutics Holdings Corp. (OTCBB: NVIV)
, a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported the financial results for the year ended December 31, 2011 and provided a business update.

Medtronic, Inc. (NYSE: MDT)
today announced that it has received from Health Canada a license for Medtronic Deep Brain Stimulation (DBS) Therapy for refractory epilepsy patients. Medtronic DBS therapy for refractory epilepsy delivers controlled electrical pulses to a location inside the brain which is involved in seizures.

Nuvilex, Inc. (OTCQB:NVLX)
, an emerging biotechnology provider of cell and gene therapy solutions through its ongoing acquisition of the assets of SG Austria, realizes the important role for Cell-in-a-Box® technology, and what it offers the medical community, and aims today to discuss the potential it will serve as a treatment option for a variety of solid tumors.

Prestige Brands Holdings, Inc. (NYSE:PBH)
today issued the following statement in response to receipt of notice that Genomma Lab Internacional, S.A.B. de C.V. is seeking to nominate five individuals for election to Prestige Brands’ Board of Directors at the Company’s 2012 Annual Meeting of Stockholders, scheduled for June 29, 2012.

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, announced today that Craig Dees, Ph.D., CEO of Provectus will present at the 2012 Maxim Group Growth Conference in New York City on March 26, 2012 at 4:00 p.m. EST.

With the global demand for biotechnology solutions to mounting health concerns growing every day, Rainbow Coral Corp. (OTCBB: RBCC) has been working hard to deliver the kinds of breakthroughs that doctors, scientists, and researchers the world over are begging for.

Simulations Plus, Inc. (NASDAQ:SLP)
, a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that preliminary testing shows that one of the molecules it has designed to inhibit the malaria parasite has been shown to be a potent inhibitor of the malaria parasite.

Spire Corporation ("Spire") (Nasdaq: SPIR)
, a diversified global company providing solar photovoltaic (PV) equipment and systems, biomedical processing services and optoelectronic components announced today revenues from continuing operations for the year ended December 31, 2011 of $61.6 million, a 22.8% decrease from $79.8 million in 2010.

Syneron Medical Ltd. (NASDAQ: ELOS)
, www.syneron.com,the global leader in medical aesthetic products and technology, plans a significant presence at the 2012 American Academy of Dermatology conference to be held on March 16-20, 2012 in San Diego, California.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA)
and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the publication of results from the laquinimod Phase III ALLEGRO study in the March 15 issue of The New England Journal of Medicine (http://www.nejm.org/).

Trim Holding Group ("the Company") (PINKSHEETS: TRHG) (OTCQB: TRHG) is pleased to announce that, on March 12, 2012, the Audit Committee of the Board of Directors of the Company engaged the services of UHY LLP ("UHY") as the Company's new independent registered public accounting firm.



BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section

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