Natco faces lawsuit from Teva on multiple sclerosis drug generic glatiramer (Capaxone)

Indian generic firm Natco is facing a lawsuit from Israeli drug maker Teva on a generic version of the multiple sclerosis drug glatiramer acetate (Capaxone).

Teva Pharmaceutical Industries has initiate legal proceedings against the commercialization of a generic version of its blockbuster glatiramer acetate (Capaxone) by Mylan and Natco, alleging that their application was infringing on certain patents in the U.S. District Court for the Southern District of New York.

The lawsuit could restrict approval of Mylan’s generic version of the drug for up to 30 months – April 2012 – or until a court ruling in favor of Mylan, whichever comes first.

Mylan’s application relates to Teva’s U.S. patents, which cover the chemical composition of the blockbuster drug, pharmaceutical compositions containing it, and methods of using it.

The patents are listed in the U.S. Food and Drug Administration’s Orange Book and extend through May 24, 2014, Teva said in a statement.

In 2008, Natco entered into a license and supply agreement with Mylan which granted Mylan exclusive distribution rights for glatiramer acetate pre-filled syringes in the US and all major markets in Europe, Australia, New Zealand, Japan and Canada. The agreement also included an option to potentially expand into additional territories.

Natco has already commercialized its glatiramer acetate product in India and the Ukraine.

Glatiramer acetate is currently being sold as Copaxone R, a registered trade mark owned by Teva Pharmaceutical Industries Limited. Teva has reported that worldwide sales of Copaxone-R were more than US $1.7 billion in 2007.

With the approval of glatiramer acetate generic injectable, global sales of the drug may reach as much as $3 billion this year, Natco Pharma said in a statement.

Teva also received the USFDA approval for its abbreviated new drug application (ANDA) for glatiramer acetate Injection.

Teva’s lawsuit comes exactly one month after U.S. regulators accepted an application by Mylan and Natco for review.

Copaxone is responsible for roughly 20% to 25% of Teva’s net profit, a proportion expected to increase after April 2010, which is when Teva will stop paying royalties to Sanofi-Aventis.

In April 2008 Teva and Sanofi-Aventis entered into a new agreement that gives Teva sole responsibility for marketing Copaxone in North America. But it agreed to continue to pay royalties to Sanofi-Aventis for two years.

Teva pays Sanofi Aventis a quarter of its Copaxone sales figures in North America as royalties, as part of a marketing pact signed in 1996. They share sales costs and gross profit for Copaxone in equal parts.

Capaxone’s share of the market is 32%, while rival drug Avonex made by Biogen Idec commands a 30% market share. Teva’s sales of Copaxone jumped 32% during the second quarter of 2009, against the same period of 2008, to $438 million.

Global sales of Copaxone grew by 21% in the second quarter year-over-year to $682 million.

Copaxone’s market share is 28% outside the United States, compared with 25% for Avonex.

Based in Hyderabad, southern India, Natco Pharma Limited is one of the fast growing pharmaceutical companies from India. Natco has introduced several first time generic drugs in India. Natco currently ranks as number  1 in terms of revenues from among the Indian companies in the oncological segment.  Natco has US FDA approved manufacturing facilities both for APIs as well as finished dosage pharmaceutical formulations.

Natco recorded a jump in its revenues and profits for the year ended on 31st March, 2009.

Natco registered an increase of 28% in its consolidated revenues, which have gone up to Rs. 465 Crores from Rs. 364 crores.

Natco’s profit after tax, has also gone up to Rs. 4398 lakhs from Rs. 4052 lakhs, recording an increase of 8%. The growth in profits has been lower on account of expenses on Phase I clinical trials of the new chemical entity being developed by the company.

Natco is in the final stages of Phase I clinical trials for its new chemical entity with multiple oncological indications and intends to undertake phase II trials shortly.

Natco’s oncology business recorded a 23% jump in earnings (from Rs. 79 Crores to Rs. 97 Crores) as compared to last year. Natco has made significant inroads in its efforts to introduce its products in European and US markets and this has been reflected in its
formulations exports, which have grown (from Rs. 14 Crores to Rs. 31 Crores) by nearly 114% over last year.

Natco has already tied up with Lupin Limited for para IV litigation on Fosrenol (lanthanum carbonate) of Shire PLC and with Dr. Reddy’s Laboratories Limited for a basket of oncology products, apart from Mylan.