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India’s Natco Pharma gets a boost following US approval of generic glatiramer (Capaxon R) injection

Tuesday, September 15, 2009, 19:12 This news item was posted in Industry category and has 1 Comment so far.

Natco supplies generic glatiramer acetate pre-filled syringes to Mylan.

Indian generic firm Natco Pharma Ltd’s shares rose to an eight-year high following US FDA approval for the multiple sclerosis drug generic glatiramer acetate injectable application filed by its partner Mylan Inc.

Last year, 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 includes an option to potentially expand into additional territories.

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

US FDA has given approval for Mylan Inc’s abbreviated new drug application (ANDA) for glatiramer acetate injection (20 mg/mL) indicated for the treatment of multiple sclerosis.

Natco’s glatiramer acetate is the generic version of Israeli generic drug maker Teva’s Capaxone.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, a generic version of Teva Pharmaceutical Industries Ltd.’s treatment for multiple sclerosis.

What is multiple sclerosis?
Multiple sclerosis is a nervous system disease that affects brain and spinal cord. It damages the myelin sheath, the material that surrounds and protects your nerve cells. This damage slows down or blocks messages between the brain and the body. Major symptoms of MS can include: visual disturbances, muscle weakness; trouble with coordination and balance; sensations such as numbness, prickling, or “pins and needles; thinking and memory problems.Multiple sclerosis affects woman more than men.

Multiple Sclerosis  often begins between the ages of 20 and 40. Usually, the disease is mild, but some people lose the ability to write, speak or walk. There is no cure for MS, but medicines may slow it down and help control symptoms. Physical and occupational therapy may also help.

Based in The Woodlands, Texas,Opexa Therapeutics, Inc focuses on patient-specific cellular therapies for the treatment of autoimmune diseases.

Novartis AG, based in Basel, Switzerland, and Merck KGaA of Darmstadt, Germany, are reportedly developing oral drugs for multiple sclerosis that may be introduced as early as next year.

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.

US based Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. Mylan maintains one of the industry’s broadest product portfolios, supported by a robust product pipeline. Mylan owns a controlling stake in India’s Matrix, the world’s second largest active pharmaceutical ingredient manufacturer. Mylan operates a specialty business focused on respiratory and allergy therapies.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates the world’s third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies.

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One Response to “India’s Natco Pharma gets a boost following US approval of generic glatiramer (Capaxon R) injection”

  1. mark eisenberg said on Wednesday, September 16, 2009, 5:28

    To whom it may concern:
    This information is wrong. Natco now Mylan did NOT receive an FDA approval for their generic glatiramer acetate; the FDA only accepted their application to be reviewed according to many other souces and according to Mylan’s press release on Monday (14th) Where did you get this from?

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