Pharma news in brief

1. Aurobindo Pharma Ltd has received an approval from the USFDA to market its 300mg cefdinir capsules in the US market. This is company's 62nd ANDA approval. The drug falls under the anti-bacterial segment and is a generic equivalent of Abbott Laboratories' Omnicef. Earlier, the company also received the final approval for 125 mg/5 mL and 250 mg/5 mL oral suspension of this drug from the US FDA.
   
2. Daiichi Sankyo, Inc., announced today that the United States Food and Drug Administration (FDA) has approved Welchol(TM) (colesevelam HCl) to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents. Welchol is now the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C). The ADA estimates that 20.8 million people in the United States have diabetes with more than 90 percent of these people having type 2 diabetes.(1) Forty percent of patients with type 2 diabetes also have high LDL-cholesterol.(2) Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes
3. Cipla (News from blog site patent circle) has finally launched a generic onslaught on anti-cancer patented drug Tarceva and reported to be convinced that Tarceva is not patentable and has strong case to oppose despite patent granted in India. Following the generic launch, Roche has filed an infringement case against Cipla in the Delhi High Court, which came up for its first hearing on Friday. Cipla launched generic Tarceva at Rs. 1600 compared to Roche Rs. 4800 per tablet.Erlotinib hydrochloride, an active ingredient of Tarceva is granted Indian Patent No. 196774 (the ‘774 patent) by the Delhi Patent Office against the mail-box Application No. 537/DEL/1996 filed March 13, 1996. Under section 25(2) of the Patents Act 1970, the ‘774 patent statutorily can be opposed within one year from the date of grant of patent, which Cipla may likely consider opting for. Interestingly, Hyderabad-based generic company Natco filed a pre-grant opposition against the Tarceva mail-box Application but subsequently rejected by the Delhi Patent Office. According to Dr. Gopakumar Nair, “Erlotinib is a derivative of another known cancer drug gefitinib, a pre-1995 invention of European drug maker AstraZeneca. Since the Delhi Patent Office had denied a patent for this drug, a patent for its derivative will not be strong, and the generic company can get the patent revoked through a post-grant opposition.” Under section 25(2) the ‘774 patent can be opposed on any of the eleven grounds
   - wrongfully obtained the invention,- prior publication,- subject-matter claimed in already claimed in patent of earlier priority,- publicly known or publicly used in India before the priority date,- obvious and does not involve inventive step,- not patentable subject-matter under the Act,- lack sufficient and clear description of the invention, or method by which it is to be performed,- filed not within 12 months from the priority date,- failure to disclose information under section 8 of the Act,- fail to disclose or wrongly disclose the source and geographical origin of biological material used in the invention, and- anticipated having regard to the knowledge, oral or otherwise.
4. Ranbaxy succeded in invalidating enatiomer (On 10th January 2008) patent of Pfizer in Germany. The basic patent covering Atorvastatin still stands and there will be no change in marketing status of Lipitor in Germany.