Tuesday 14 June 2016

Drugmakers get NPPA notice for pricing violation and other top pharma news

It is one company in the troubled largecap pharmaceuticals space, which has neither created shareholder wealth nor performed on fundamentals in the last one year.

Doctor prescription and medicine
Concerned over ‘wilful violation’ of its drug pricing control rules, the National Pharmaceutical Pricing Authority (NPPA) has slapped showcause notices on ten top drugmakers for failing to register their products on its online database and submit the mandatory disclosures. The authority, which plans to issue notices to more firms that have not furnished the information so far, warned that it would have to launch prosecution, among other legal actions, under the Essential Commodities Act. 

It is one company in the troubled largecap pharmaceuticals space, which has neither created shareholder wealth nor performed on fundamentals in the last one year. Sun Pharma is seen to be swallowing a pill far more bitter than most of its four large-cap peers — Aurobindo Pharma, Cipla, Dr Reddy’s and Lupin. This is has been revealed in an FC Research Bureau analysis of share price movement over the last one year and the fundamentals performance in financial year 2015-16 (FY16), based on data from Capitaline database. 

Drug major Lupin has committed to close the corrective action at its Goa facility, which had received nine observations from US health regulator, by December. It said that even if the US Food and Drug Administration decides to hold back appro val s from the Goa facility it won't have much impact on the company as majority of pending approvals are from its other manufacturing sites. “We have actually committed till December to the FDA, but we are trying internally to actually make it happen even sooner,” Lupin M D Nilesh Gupta said. 

Granules announced an in-licensing deal with US pharma Windlas for four abbreviated new drug applications (ANDAs) awaiting approval in the US. Granules will make milestone payments and commit share of the profits from commercial sales to US pharma Windlas. Granules expects to be a co-first-to-file (FTF) for each of products, though eventually we expect intense generic competition once other Para IV’s launch after the exclusivity period. 

Dr Reddy’s Laboratories Ltd, India’s second largest drug maker, said it plans to commercialise by 2017-18 at least four of the eight generic drugs it acquired from Israel-based Teva Pharmaceutical Industries Ltd.  Of the eight products the Indian drug maker acquired from Teva for $350 million, one has been approved by the US Food and Drug Administration (FDA) and the rest are awaiting the agency’s green light. In an email reply to questions from Mint, Hyderabad-based Dr Reddy’s said on Monday that the portfolio of acquired drugs comprised complex generic products across dosage forms and therapeutic areas with annual sales of around $3.5 billion. 

Teva Pharmaceutical says it will stop selling its migraine patch treatment Zecuity after users reported burns and scars where it was applied. The company says anyone who has a patch should not use it. Zecuity is a disposable battery-powered patch that is applied to the upper arm or thigh to ease migraine headaches. 

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