Glenmark settles patent litigation over anti-depressant drug

Glenmark Pharmaceuticals today announced a patent litigation settlement with Forest Laboratories and Royalty Pharma Collection Trust over anti-depressant drug Savella.
The company and its US arm Glenmark Pharmaceuticals Inc have entered into a settlement agreement with Forest Laboratories LLC, Forest Laboratories Holdings Ltd and Royalty Pharma Collection Trust to settle the litigation.
Following the agreement, the outstanding patent litigation related to Glenmark's abbreviated new drug application (ANDA) for Milnacipran Hydrochloride 12.5 milligram, 25 mg, 50 mg, and 100 mg tablets, the generic version of Forest's Savella, will be dismissed.
"Under the terms of the settlement agreement, Glenmark will have the option to market and distribute its Milnacipran Hydrochloride tablets or an authorised generic version of Savella tablets," the company said in a BSE filing.

Other terms of the agreement are confidential, it added.
Citing IMS Health sales data for the 12-month period ending October 2015, Glenmark said Savella achieved annual sales of approximately USD 134.7 million.

Glenmark's current portfolio consists of 103 products authorised for distribution in the US marketplace and 63 ANDAs' pending approval with the USFDA, the company said.
"Over the last 16 years, we have created significant
shareholder value and this has been possible because of our continuous investments in R&D. As we prepare for the next wave of growth, we have built strong capabilities that uniquely position us to differentiate our product offerings primarily in our core therapy areas and will invest across the value chain from generics to new molecular entities in our effort to build a truly global pharmaceutical organization," added Glenn Saldanha.

Glenmark is an early leader at the point of convergence of generic and innovative pharmaceutical
R&D, with end-to-end capabilities in R&D to full-scale manufacturing, both in small molecules and novel biologics. The company enjoys an enviable market position of self-reliance, strong IP leadership and a global footprint for rapid market penetration. These intellectual assets are already producing results for the company with a specialty and New Molecular Entity (NME) pipeline consisting of nine assets in the three core areas, four of which are in clinical or late pre-clinical development. The company expects to launch its specialty business in the U.S. With its first FDA NDA approval in respiratory within 3-5 years. The strategic blueprint also outlines aggressive plans to increase Glenmark's presence worldwide by strengthening focus on complex generics including injectables, expanding its manufacturing footprint (growing from two formulation facilities to 17). Currently, the company has more than 110 Abbreviated New Drug Application (ANDAs) approved and an additional 135 products in regulatory review or in development in the US. Based on the power of the pipeline, Glenmark expects to file 20-25 ANDAs and launch 20 generic products annually in the US. Its business in emerging markets is also well positioned for continuous and sustained growth over a long period in time.

"Building from our enviably strong foundation has given us operational and financial flexibility that allows us to execute on our ambitious plans; we expect the next wave of our growth to be as impressive as our first," added Saldanha. About Glenmark Pharmaceuticals Ltd.:
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 80 Pharma and Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2016).
Glenmark is a leading player in the discovery of new molecules both NCEs (New Chemical Entity) and NBEs (New Biological Entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain]. The company has a significant presence in the branded generics markets across emerging economies including India.

GPL along with its subsidiaries operate 17 manufacturing facilities across four countries and has five R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries including the US, EU, South America and India. For more details, visit: https://bsmedia.business-standard.comwww.Glenmarkpharma.Com
Media Contact:
Ramkumar Uppara/Shibani Shah
Glenmark Pharmaceuticals Ltd.
Ramkumar.Uppara@glenmarkpharma.Com
+91-22-40189984/9348
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