The Tightrope of Drug Approval
Throw one's lot in with R. William Soller to explore the finicky balance of scientific, economic and state forces shaping the development of drugs and their ...
Vasella's Persistence Pays Off as Novartis Gains Alcon's Growth
By Kerry Capell and Dermot Doherty
Jan. 6 (Bloomberg) -- Novartis AG Chief Executive Officer Daniel Vasella spent years persuading fellow Swiss company Nestle SA to part with Alcon Inc. for the eye-care business’s higher growth rate. His persistence has paid off.
Novartis this week announced a plan to acquire the 75 percent of Alcon that it doesn’t own for $38.3 billion. The drugmaker will purchase Nestle’s 52 percent stake, and offered to buy out the minority shareholders who own the rest. Vasella said in a Jan. 4 telephone interview that he persevered “off and on for several years” before Nestle Chairman Peter Brabeck- Letmathe agreed to the deal.
Acquiring Alcon gives Novartis a third of the $26 billion global eye-care market as Vasella seeks to replace revenue that will be lost when patents on hypertension drug Diovan and the Gleevec leukemia treatment, the company’s best sellers, start to expire in 2012. He estimates that the global eye-care business will increase at 7 percent a year through 2015, more than the 5 percent growth forecast for prescription medicines, as the world’s aging population suffers from glaucoma and cataracts.
Fibrosis drug pirfenidone fast-tracked for approval in US, says ...
Pirfenidone is indicated for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
Pirfenidone granted Seniority Reviewing designation for the New Narcotize Bearing (NDA), InterMune, Inc said.
Immediacy Inspection designation may be granted by the FDA to an NDA for drugs that make available biggest advances in treatment, or anticipate a treatment where no all right psychoanalysis exists.
Immediacy Look at designation has the unrealized to speed the NDA approval process by reducing the aim comment on years for the relevancy from close to 10 months to six months. Based on the Formula Upper Buyer Fee Act (PDUFA), the FDA has set an encounter era for the NDA of May 4, 2010.
Preclinical and in-vitro prove had shown that pirfenidone has both anti-fibrotic and anti-rousing effects.
Results from three Form 3 studies have shown that pirfenidone treatment is striking in IPF patients.
Pirfenidone has been suitable and as a rule well tolerated, with the most banal side effects including photosensitivity precipitate and gastrointestinal symptoms.
“We are satisfied to have begun the inspect process of the first NDA submitted to FDA for a panacea for IPF patients and we look promote to working with the Pulmonary-Allergy Partitioning to executed the look at as expeditiously and thoughtfully as on,” Dan Welch, chairman, chief governmental tec and president of InterMune stated.
InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased from Marnac and KDL the rights to traffic in the multiply in the Shared States, Europe and other territories except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi & Co. Ltd. of Japan.
In October 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa by Shionogi in that mother country.
What is idiopathic pulmonary fibrosis?Idiopathic pulmonary fibrosis (IPF) is a disabling and fundamentally fateful disorder that affects generally 200,000 patients in the Of one mind States and Europe combined, with give 30,000 new cases reported per year in each of the Pooled States and Europe.
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