Ranbaxy gets nod for Alzheimer’s drug

Posted Atlivemint.com

Ranbaxy Laboratories Ltd, India’s largest pharmaceutical company by revenue, has received the US drug regulator’s nod to launch its generic version of Pfizer Inc. and Eisai Co. Ltd’s Alzheimer’s drug Aricept (Donepezil hydrochloride), two people familiar with the development said.

Analysts expect the company to launch the drug on Monday.

Aricept has estimated sales of about $1.6 billion (`7,312 crore) in the US. Its patent expired on 25 November. In September, the US Food and Drug Administration (FDA) informed Ranbaxy that it had first-to-file status for Aricept in the US. This gives Ranbaxy 180 days of marketing exclusivity for the drug.

While Arun Sawhney, managing director of Ranbaxy, had said in a recent conference call that the company was confident of monetizing the opportunity, FDA’s final approval for Ranbaxy to launch the drug was uncertain. A Ranbaxy official said the company had received approval.

“We expect the company to launch the product on Monday,” a Mumbai-based analyst said, requesting anonymity.

“This is good news for Ranbaxy,” said another analyst with a Mumbai-based brokerage, who also did not want to be named. “We expect it to make approximately $300 million in revenues from the sale of the drug in the exclusivity period. This also gives confidence to investors that the company may be able to get approvals for future first-to-file drugs in the light of FDA and DoJ (department of justice) issues.”

US-based Mutual Pharma got approval to sell its generic version of Aricept orally disintegrating tablets in 2009 for the treatment of dementia. These, however, are different from Ranbaxy’s version. Ranbaxy will also face competition from Greenstone Pharma, the generic pharmaceutical subsidiary of Pfizer Inc, which will launch the authorised generic of Aricept.

Ranbaxy faces an import alert in the US for 30 products and a warning on two of its plants—Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh. FDA has also halted all application reviews from Ranbaxy’s Paonta Sahib plant. Ranbaxy had previously failed to get approval for the generic version of Flomax, which it planned to launch in March.

According to the first analyst, Ranbaxy will manufacture and distribute Aricept from its US facility ,Ohm Laboratories.

Nov 30, 2010