Morepen Labs has added three new drugs Rivaroxaban (cardiac segment), Vildagliptin (diabetes segment) and UDCA (for liver ailments) to its Active Pharmaceutical Ingredients (API) portfolio, according to a press statement released by the company. Commercial launch of all three drugs was announced by the company and it said that supplies will commence soon.

While Rivaroxaban is a powerful anticoagulant which is a blood thinner, Vildagliptin is a strong oral anti-diabetic drug for Type 2 diabetes treatment.

Global market size of Rivaroxaban is $7.19 billion (₹51,000 crore) and that of Vildagliptin is $1.28 billion (₹9,000 crore). Rivaroxaban is the 10th largest selling drug worldwide. The drug enjoys 25 per cent share of the Indian Gliptins market valued at ₹3,500 crore. The three drugs will currently be sold in India and patent-free markets worldwide. Drug Master File (DMF) filing in the regulated markets likely within the next 12 months. UDCA is used for the treatment of Primary Biliary Cirrhosis, a liver disease that occurs due to improper functioning of liver. UDCA has a niche market of $200 million (₹1,400 crore). The drug is already patent-free worldwide.

API exports rise

The bulk drugs (API) segment contributed marginally over 60 per cent to the company’s total turnover in Q1 FY 2019-20. API exports grew by 50 per cent during the first quarter and domestic API business grew by 33 per cent in the quarter.

Sushil Suri, Chairman and Managing Director, Morepen Laboratories, said, “The company has already built-up additional capacities and is now all set to commercially launch these three new APIs under its portfolio. Dedicated efforts of Morepen’s in-house R&D Centre at Baddi (Himachal Pradesh), which was recently approved by Department of Scientific & Industrial Research of the Indian government, has led to the release of these three products,” he said.

“With a focus on new molecules and new patented processes, we now look forward towards investing more in our R&D Infrastructure for future growth of the company,” Suri further pointed out.

Rivaroxaban was initially developed and patented worldwide by Bayer. Morepen already has substantial presence in this category with two leading statins – Atorvastatin and Rosuvastatin that are being used for lowering cholesterol. Now with the addition of Rivaroxaban in Morepen’s portfolio, company gets an added advantage in the cardiac market. The Indian patent for the drug is going to expire in December 2019, which opens floodgates for the company to export the drug to all the patent-free markets worldwide and also supply the product to the large domestic market where it is commonly used to prevent blood clots and used for cardiovascular symptoms such as angina, heart failure and rheumatic heart disease.

Vildagliptin caters to the diabetics market worldwide. Morepen footprint in diabetic sector is well established with a series of “glilptins” such as Sitagliptin, Linaglitptin, Saxagliptin and new series of “gliflozins” such as Empagliflozin and Dapagliflozin, already developed by Morepen’s R&D Centre. Development of low-cost Vildagliptin, which is used for the treatment of metabolic disorders such as obesity, diabetes, PCOD and fatty liver, is a nice addition to growing diabetic portfolio of the company, the statement said.

Vildagliptin patent is presently held by Novartis and this is set to expire worldwide in December 2019. Vildagliptin has about 25 per cent share of the Indian “gliptins” market of ₹3,500 crore. Vildagliptin is the first molecule in the most commonly prescribed “gliptins” series that is going off patent and is certainly going to get good traction in the market.

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