Indian generic firm Natco Pharma has sought US FDA’s permission to market a low-cost version of the thalidomide based medicine Revlimid to treat multiple myeloma.
Revlimid marketed by Celgene Corporation contains lenalidomide, a derivative of thalidomide.
Besides multiple myeloma, lenalidomide is used in the treatment of the class of hematological disorders known as myelodysplastic syndromes (MDS).
The Hyderabad-based Natco Pharma has filed an abbreviated new drug application (ANDA) with the US FDA for approval to market lenalidomide capsules in 5, 10, 15 and 25 mg strengths.
Sales of lenalidomide (Revlimid) is reportedly growing at 44 per cent compared to last year and the market size of Revlimid is estimated to be around US$1.5 billion in US, according to a Natco release.
Natco Pharma expects to grab 180 days of generic market exclusivity for lenalidomide tablets in 25 mg strength, the release said.
Recently, Natco Pharma launched a low-cost generic versions of Baraclude (entecavir) for the hepatitis B treatment in India.
Baraclude, which contains the anti-viral drug entecavir is developed by Bristol Myers Squibb (BMS).
X-vir is the brand name of Natco Pharma’s entecavir version.
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.