Generic Antiflu Clashes With Drug Giants’ Tamiflu: David Vs. Goliath?

May 14, 2009

(ChattahBox)— With a swine flu epidemic on the rise around the globe, an Indian upstart pharmaceutical company, named Cipla is about to take on the giant drug companies by manufacturing a cheaper generic version of Tamiflu, called Antiflu.

The Mumbai based drug company, recently won a court case brought in India against Gilead Sciences, Inc, the California based biotech company and the patent owner of Tamiflu, allowing Cipla to produce a generic version of the antiviral drug, and the big pharmaceutical companies are not happy about it.

Gilead and the giant Swiss drug company, Roche Holdings have already engaged in a contentious battle over the distribution of Tamiflu. Tamiflu, the only oral antiviral for the treatment and prevention of influenza A and B, was invented by Gilead and licensed to Roche in exchange for royalties in 1996.

Gilead became unhappy with the agreement, charging Roche with failing to adequately promote Tamiflu and produce it in adequate quantities and sought to take back the distribution rights. The two companies settled their differences in 2005 to work together to increase distribution of the antiviral drug in the wake of a bird flu epidemic.

Now, comes along the Indian upstart company that has the manufacturing capabilities to supply developing countries with a cheaper version of the antiviral drug. Soon after its court victory against Gilead, the Indian drug company filed for, and won approval from WHO certifying that its drug Antiflu was as effective as Tamiflu.

With the WHO approval in hand, Cipla entered into a deal to sell its Antiflu to Mexico at $10.00 per dose as opposed to Roche’s prices from $12.00 to $20.00 per dose. The higher prices ar charged to wealthier countries.

In a quirk in the international drug patents laws, if Mexico grants what’s known as a compulsory license to waive the patent on the drug, existing international trade rules would allow purchases of Antiflu. Lobbying by giant pharmaceutical companies has prevented countries issuing compulsory licenses, until now.

With a looming swine flu pandemic about to infect the entire planet, the clash between giant pharmaceutical companies holding patents, and companies able to produce cheaper generic versions of a drug needed to combat a global health crisis, raises critical ethical and legal questions.

With Roche, as the only patent holder of Tamiflu, governments are already stockpiling it to prevent fatalities from complications associated with the swine flu. Nations are already setting plans in place to make Tamiflu available to its most vulnerable citizens first, such as pregnant women and children.

With projections estimating that nearly a third of the world’s population would become infected with swine flu, Roche and its affiliates can’t possible produce sufficient quantities of its Tamiflu to protect the world’s population.

With Cipla now in the mix, capable of increasing production and offering cheaper generic versions of Tamiflu to poorer nations, Roche and Gilead will appear as greedy corporations not interested in the public’s welfare during a pandemic, if they attempt to stop Cipla with legal action.

Amar Lulla, Cipla’s managing director, announced the company would only sell Antiflu to Mexico and other countries, providing they indemnified Cipla against any legal action over patents.

Roche is not saying whether the company plans legal action against Cipla to protect its exclusive distribution rights. Roche just recently supplied Mexico with a large stock of Tamiflu and doesn’t see a reason for Mexico to issue compulsory licensing, opening up the floodgates to upstart companies like Cipla offering cheaper generic drugs.

The infection rate and deaths from swine flu are on the rise and expected to reach crisis levels in the fall during the seasonal flu season. The latest swine flu global statistics have an estimated 6,298 confirmed cases in 33 countries and 63 deaths, so far.

As the swine flu epidemic worsens, and countries scramble for a dwindling supply of Tamiflu, Cipla’s generic Antiflu may just prove to be a lifesaver.

Roche is now in a quandary. If Roche decides to tie up Cipla’s production of Antiflu in lengthy court proceedings, while people around the world succumb to swine flu, the Swiss drug maker would face a public relations nightmare.



2 Responses to “Generic Antiflu Clashes With Drug Giants’ Tamiflu: David Vs. Goliath?”

  1. Tamiflu vs Antiflu. È guerra commerciale sui farmaci per l’A/H1N1 - GREG NOTIZIE on May 15th, 2009 6:31 am

    […] della sanità, ndr) ma che viene venduta a prezzi molto più bassi rispetto alla pillola americana. L’azienda, che ha sfidato le multinazionali del farmaco già una volta con una “versione low […]

  2. shaik farhan on January 5th, 2011 6:43 am

    Please send me update information Cipla.

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