|FDA Approves Kalydeco to Treat Rare Form of CF; Glaxo, Lilly, Pfizer Said to Be Interested in Turkey’s MN Pharma|
|By Staff and Wire Reports|
|Tuesday, 31 January 2012 19:08|
The U.S. Food and Drug Administration today approved Vertex Pharmaceuticals Inc's, (NASDAQ:VRTX) Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.
CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation.
“Kalydeco is an excellent example of the promise of personalized medicine – targeted drugs that treat patients with a specific genetic makeup,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development.”
The FDA reviewed and approved Kalydeco in approximately three months under the agency’s priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.
Kalydeco was approved ahead of the drug’s April 18, 2012 prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.
GlaxoSmithKline Plc (NYSE:GSK), Eli Lilly & Co. (NYSE:LLY) and Pfizer Inc. (NYSE:PFE) are among about half a dozen companies interested in buying a stake in Mustafa Nevzat Ilac Sanayii AS in a deal that may value the Turkish drugmaker at $1 billion, three people with knowledge of the situation said.
The owners of Mustafa Nevzat, or MN Pharmaceuticals as the Istanbul-based generic drugmaker is known, have hired Bank of America Merrill Lynch to advise on the stake sale, said the people, who declined to be identified because the plans are confidential.
Mylan Inc (NASDAQ:MYL). and Abbott Laboratories (NYSE:ABT) are also among the companies interested in bidding, they said. Merrill Lynch has sent so-called teasers to potential bidders and non-binding bids have begun to arrive, one of the people said, adding that the process started late last year. Preliminary bidding may be completed within two months, one of the people said.
Two other Turkish pharmaceutical companies -- Abdi Ibrahim Ilac Sanayi & Ticaret, the country’s largest, and Biofarma Pharmaceutical Industry Co. -- have failed in efforts to sell stakes over the past two years. While Glaxo is seeking deals in emerging markets, it’s becoming harder to find acquisitions that make “financial sense,” Chief Executive Officer Andrew Witty said last year.
MN’s owners, the children and grandchildren of the founder Mustafa Nevzat Pisak, have yet to decide whether to sell a minority or majority stake in the closely held company, two of the people said. The owners are seeking a price that values the company at 15 to 20 times earnings before interest, tax, depreciation and amortization, or Ebitda, one of the people said.
Astro-Med, Inc. (NASDAQ: ALOT) announced today the divestiture of its label manufacturing operations in Asheboro, North Carolina. The sale was made to the original owners of Label Line, Ltd.
Biomerica, Inc. (OTCBB: BMRA) announced that it has launched a new patented Thiopurine methyltransferase (TPMT) test to detect patients who are at risk of developing severe or fatal side effects if treated with the class of thiopurine drugs that includes azathioprine, mercaptopurine, and thioguanine.
Global Health Voyager, Inc. (OTCBB: GLHV), a publicly-traded, full-service, international medical tourism company, today announced that it has begun development of a Medical Tourism related smart phone application (the "App").
Oracle (NASDAQ: ORCL) News Facts: Oracle Health Sciences Institute, in partnership with Oracle Labs, today announced its first group of research projects, which includes initiatives with Brigham and Women's Hospital and Harvard Medical School; the Coalition Against Major Diseases (CAMD) at the Critical Path Institute; the Human-Computer Interaction Lab (HCIL) at the University of Maryland.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced that it will release fourth quarter 2011 financial results before the market opens on Thursday, February 9, 2012.
Tibet Pharmaceuticals, Inc. (NASDAQ: TBET), an emerging specialty pharmaceutical company engaged in the development, manufacturing and marketing of traditional Tibetan medicine in China, today announced that it has signed a Letter of Intent ("LOI") to cooperate with Anhui Taihe Pharmaceutical Group Co., Ltd. ("Anhui Taihe Pharmaceutical Group"), a wholesale pharmaceutical distribution company based in Anhui province with a network across 16 provinces and municipalities in China.