Morepen Labs readies multi-billion APIs for manufacturing from Dec

Morepen Labs’ Baddi plant | Source: Company

Pharmaceuticals manufacturer Morepen Laboratories Ltd said it is ready to start manufacturing and selling three multi-billion dollar drugs, two of which are set to go off-patent in December this year.

The current global market size for Rivaroxaban, a powerful anticoagulant (blood thinner), is $7.19 billion (Rs. 51,000 cores). It is the 10th largest selling drug worldwide.

Vildagliptin, which is a strong oral anti-diabetic drug used for the treatment of type 2 diabetes, has a market size of $1.28 Billion (Rs. 9,000 cores).

The third molecule, UDCA, has a niche market of $200million (Rs. 1,400 cores) and is expected to touch $300 million (Rs. 2,100 crore) by 2023.

The global market size for Rivaroxaban is likely to touch $9.00 billion (Rs. 64,000 crore) by year 2023 and that of Vildagliptin $1.35 Billion (Rs. 9,600 crore) by 2021, the company said.

APIs are pharmaceutical molecules that form the core components of drugs and medicines, either singly or in combination. The three bulk drug APIs developed by Morepen Labs are Rivaroxaban, to be marketed as Xarelto, Vildagliptin (Galvus, Zomelis) and UDCA (Ursodeoxycholic Acid).

While Rivaroxaban and Vildagliptin are for the cardiac and diabetic segments respectively, UDCA will be used for treating liver diseases.

Morepen Labs will initially target patent free markets for these two drugs globally. The Drug Master File (DMF) for regulatory markets like US etc will be filed within the next 12 months’ time frame, it added.

“The company has already built-up additional capacities and is now all set to commercially launch these three new API’s under its portfolio,” said Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd..

He said the drugs were developed at Morepen’s in-house R&D Centre at Baddi (Himachal Pradesh).

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

Rivaroxaban caters to the Cardiac market and 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 aggressively 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 Dec’ 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, rheumatic heart disease etc,” it added.

Vildagliptin caters to the Diabetics market worldwide. In this segment, Morepen has come out with a series of “glilptins” like Sitagliptin, Linaglitptin, Saxagliptin and new series of”gliflozins” like Empagliflozin and Dapagliflozin, 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 & fatty liver etc., is a nice addition to growing Diabetic portfolio of the company,” it 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 Rs. 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.

UDCA is a niche product and has lot of technical challenges to synthesize. It is a naturally occurring product in the bile acid, found in normal human bile in small quantities. UDCA is used for the treatment of Primary Biliary Cirrhosis, a liver disease which occurs due to improper functioning of liver. It is also prescribed for the decrease in bile absorption, reduction in gallstone formation and also to relieve the symptoms of itching.

UDCA is already patent-free worldwide and ready for exporting across all the continents.

The bulk drugs (API) segment of Morepen contributed marginally over 60 per cent to the company’s total turnover in Q I FY 2019-20.

API Exports grew by 50 percent during Q I and domestic API business grew by 33 per cent in the quarter.

Morepen Labs said it has plans to invest in the areas of advance research related to new API molecules, patented technologies and new polymorphic form of the existing products.

Morepen Laboratories Ltd, a 35 year old company with Rs 800 cr of turnover, is engaged in the manufacturing and sale of APIs/bulk drugs, home diagnostics, formulations and OTC products.

The company has a manufacturing facility at Baddi (Himachal Pradesh) with 10 plants.

The manufacturing facility at Baddi has EU GMP & WHO GMP Standards and manufactures latest and much in demand APls like Atorvastatin, Rosuvastatin, Fexofenadine and others for regulated markets of Europe, USA and also for non-regulated markets across the globe.

The US FDA approved plant at Masulkhana is for manufacture of Loratadine, an anti-allergy drug – internationally known as Claritin. Desloratadine and the new blockbuster drug Montelukast is also manufactured at this FDA approved site.

Morepen markets over 100 branded formulations under six major therapeutic segments in the domestic market.

Morepen also sells glucose and blood pressure monitors in India, and also has over-the-counter products like Burnol, Lemolate, Sat-Isabgol, Pain-X and others.