February 17, 2015
By Alex Keown, BioSpace.com Breaking News Staff
MUMBAI, INDIA – India-based CLARIS Lifesciences Ltd., which operates a generic sterile injectables business, has become the belle of the ball as multi-national companies such as Pfizer Inc. , Amneal, Novartis AG and Indian companies such as Lupin and Cipla, are lining up to play the possible role of suitor in an acquisition bid.
However, on Feb. 12 Claris officials said they are not in talks to sell its injectable drugs business, nor have they considered such an action.
In a company statement Claris said it had “either considered not taken any decision in this regard.”
Claris’s injectables business was spun off into its own entity, Claris Injectables Limited, in October of 2014. The Economic Times of India reported this was a sign to many potential investors that Claris as seeking to divest itself of the injectables business.
While company officials have denied they are attempting to sell off the injectables business, those rumors have sparked a bump in stock, with shares closing 20 percent higher last week.
Claris reported strong fourth quarter profits of Rs 17.75 crore, about $2.8 billion. Company officials are expecting a strong 2015 after having filed 36 ANDAs (abbreviated new drug applications), with an estimated value of $2 billion. So far 13 ANDAs have been approved and the remainder is subject to approval. The Economic Times reported the company is being contested in a lawsuit seeking to prevent the company from commercializing its ANDA prior to the expiration of its patent on Dec. 1 2024, the Times reported.
Claris Injectables manufactures products that “range across various therapeutic segments, including anesthesia, blood products, anti-infectives, and plasma volume expanders.” The company operates three manufacturing facilities at a campus located in Ahmedabad, India.
Pfizer and Claris already have an established relationship, but that coupling soured n 2010 when the New York-based company recalled metronidazole, ciprofloxacin and ondansetron IV products due to the presence of floating matter and non-sterility discovered by the Claris Laboratories. Non-sterility of a product administered via the intravenous route can lead to illness or even death.
The injectables business has been seen as an area of growth, following Mylan Pharmaceuticals, Inc. ’s 2013 decision to acquire Strides Arcolab‘s injectables unit for $1.6 billion and Hospira’s 2009 acquisition of Orchid’s injectables business for $400 million.
Claris Injectables is one of the few independently owned injectables businesses remaining in India.
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