MUMBAI - Known for supplying low-priced anti-retroviral cocktail therapy to frontline African nations to combat the spread of HIV/AIDS, Cipla - India's largest drug maker by market share - is in discussions with U.S. health agencies to boost production of antiviral oseltamivir, the generic for Roche's Tamiflu for treating the rapidly spreading H1N1 virus.
Cipla Chairman Yusuf Hamied told local media at the launch of Cipla's H1N1 treatment drug Antiflu that his company is eager to supply the antiviral medication to the U.S. if there is interest to procure generic forms of the drug. Recent reports indicate there could be a shortage of oseltamivir in the United States that may lead the Centers for Disease Control and Prevention to look at options of stockpiling more Tamiflu or its generic versions.
However, Hamied cautioned the patent status of Tamiflu in the U.S. may block the entry of generics. Tamiflu patents are valid in the U.S. until 2016.
[Editor's note: This story is reprinted from PharmAsia News, Nov. 12, 2009. Not a subscriber? Click here for a 30-day free trial to PharmAsia News - providing daily regulatory, reimbursement and business intelligence from India, China, Japan and The Pacific Rim.]
In October 2001, a similar situation arose when the U.S. government had expressed interest in stocking up on generic antibiotic ciprofloxacin in the wake of deaths caused by anthrax, but Bayer, the German innovator of the drug, trebled the production to meet the rising demand. At that time, ciprofloxacin was covered under patents and the U.S. authorities considered invoking compulsory licensing to import generic variants.
U.S. health authorities have asked Roche, the manufacturer of Tamiflu, to accelerate its supplies to cope with any expected shortages in the future, media reports said.
Senior Cipla officials said the company received orders for oseltamivir from Latin America and the shipments have been continuing for the last few months.
On the launch of its oral and liquid forms of Antiflu brands, Hamied said, "Cipla has always been passionate about providing quality drugs to the country at affordable rates. With the World Health Organization declaring flu as 'pandemic' it becomes imperative that the drug is available." Notably, Cipla's is the only H1N1 product having a pre-qualification from the WHO.
Along with Antiflu, Cipla markets Virenza in India, a copy of GlaxoSmithKline's Relenza (zanamavir) inhalers prescribed for influenza, but the company has not been able to play a major role in the Indian government's nationwide program to stockpile generic versions of the flu drug.
Roche and Hyderabad-based Hetero Drugs, which has a license from the innovator, secured large orders to distribute oseltamivir in India, followed by Cipla, Ranbaxy and Strides Arcolab (PharmAsia News, Aug. 12, 2009).
-Vikas Dandekar (v.dandekar@elsevier.com)
