Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013
News, Views & Analysis
Novartis obtains FDA clearance for Signifor ® Novartis has obtained FDA clearance Signifor® (pasireotide) injection for use in Cushing’s disease adult patients for whom pituitary surgery may not be a suitable alternative. Signifor® is the first drug that received approval in the US, which addresses the underlying mechanism of Cushing’s disorder that is a serious, debilitating endocrine disease induced by the development of a non-cancerous pituitary
tumor leading to excess cortisol in the body. This clearance follows a unanimous recommendation from the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) for using Signifor®. Hervé Hoppenot, President, Novartis Oncology, informed, “The FDA approval of Signifor® for Cushing’s disease brings a novel pituitary-directed therapy to patients with limited
treatment options. Today’s milestone reinforces Novartis’ commitment to addressing unmet needs and advancing treatments for rare pituitaryrelated disorders.”
“Patients with Cushing’s disease may suffer from debilitating manifestations, and there are many serious health complications associated with the disease. The FDA approval of Signifor® offers the option of a medical therapy that may help certain patients with Cushing’s disease,” commented Mary Andrews, CEO and Co-Founder of the US non-profit, The MAGIC Foundation.
Cushing’s disease generally affects adults between 20 to 50 years of age with three times more prevalence in women over men. Common symptoms include weight gain, severe fatigue and weakness, central obesity, red full face, striae, high blood pressure, anxiety and depression. Cushing’s disease may lead to severe illness and death with more than four times higher mortality rates in the healthy population.
Gerresheimer acquires majority stake in Triveni Polymers Gerresheimer AG, a major global partner in healthcare and pharma sector, has acquired the majority interests in Triveni Polymers Ltd, a leading Indian supplier of plastic containers and closures in pharmaceutical industry. Subsequent to the deal, Gerresheimer is now looking at expanding its footprint
in Indian market. Post acquisition, Gerresheimer will own 75 per cent interest in the company, while remaining stake will be held by Triveni. Subodh Gupta will continue to manage the Indian operation. Speaking on the development, Hans-Jürgen Wiecha, CFO, Gerresheimer
Merial to acquire the animal health division of Dosch in India
Barella
Merial, the animal health division of Sanofi, has entered into a binding agreement to acquire the animal health division of the Indian company Dosch Pharmaceuticals Pvt Ltd, creating a market entry for Merial in that country’s strategically important and growing animal health sector. The agreement is subject to regulatory approval and is expected to finalise by the first half of 2013. Financial details were not disclosed. “The acquisition of Dosch’s Animal Health Division will be a significant milestone for Merial and give us a strategic platform for our development in the Indian market,” said Jose Barella, CEO, Merial. “We are convinced that the combination of Dosch’s animal health brands and distribution strength, along with the robust new product pipelines from both Merial and Dosch, will strongly position Merial to become rapidly a major animal health player in India.” “The strong nationwide sales, marketing and distribution network of Dosch, along with established products and people will be an ideal platform for Merial to enter the fast developing animal health market of India,” said Sanjay Doshi, CMD, Dosch. “Merial’s entry will further strengthen the existing offering of Dosch’s animal health business and provide a larger canvas for the market and the Dosch team.”
Gerresheimer will own 75 per cent interest in the company, while remaining stake will be held by Triveni.
said, “This acquisition is well aligned to our strategy of enhancing our footprint in the emerging markets. Triveni is a leading and fast growing company with excellent profitability that provides high value for us. Our global expertise combined with the excellent local manufacturing
capabilities of Triveni will speed up our growth in the emerging countries.” Subodh Gupta, MD, Triveni Polymers, commented, “Triveni’s product portfolio ideally complements Gerresheimer’s plastic packaging range and will enable us to better support our customers in their business.”
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