Indian pharma companies gear up to fight bird flu

Can Cipla do for bird flu what it has already done for Aids?

Google the words Tamiflu and India on any pharma or life sciences blog and the plans of various Indian pharmaceutical majors (Cipla, Ranbaxy, Nicholas Piramal) to produce a version of Tamiflu will be among the topics being hotly discussed. Some of the more forthright sites such as, for example, suggest that, "taking star anise to prevent bird flu is not a good idea."

This blog is one of many to be openly supportive of Cipla's stated intention to produce a generic version of a bird flu medicine. "What are you going to do about it, Roche," says one blogger? "Sue Cipla for saving people's lives? Protest to the WTO?"

Indirect supporters of Indian companies' efforts include the UN and Medecins Sans Frontieres (MSF). Kofi Annan has said that, "intellectual property" should not impede "access of the poor to medication".

MSF executives have been more outspoken and termed Swiss company Roche's executives "control freaks". This is despite Roche's volte-face a few weeks ago when it agreed to license the drug to interested manufacturers.

Roche, meanwhile, has been trying to stave off a PR disaster as a result of being perceived to be earning profits at the cost of millions of lives. It recently invited reporters to its headquarters to demonstrate the manufacturing process of Tamiflu.

Roche insists the ten step process is complex and this is the only reason it needs to be safeguarded. Roche has also issued press releases stating that there should be no cause for scarcity related fears since it is producing enough Tamiflu to treat 55 million people this year, increasing to 150 million treatments in 2006 and 300 by 2007.

Roche has been attempting to allay fears that the bird flu may enter epidemic proportions by citing the wide scale culling of birds in affected areas. Yet, Roche's motives go deeper than preventing widespread hysteria.

In 2001 WTO members allowed patent rights to be infringed for reasons of public health, national emergency or extreme urgency. Cipla was a moving force behind this relaxation.

The company now supplies a majority of the AIDS retroviral drug to Africa and is credited with making the drug cheaply available to patients of the disease. The 2001 rules stated that countries with a low purchasing power should still have access to affordable medicines.

Roche clearly has a great deal at stake in the case that governments declare bird flue a national emergency and the company's patent is overturned. For example, the company derived sales of $215 million from Tamiflu in the third quarter of 2005. Full year sales for 2004 were $266 million.

Meanwhile, confusion also persists over the geography of the patent. In the US, the Tamiflu patent is owned by Gilead, not Roche.

Analysts also say it is not clear whether Roche has a product patent in India and if it does not, Indian manufacturers may be able to manufacture a generic version of the drug. Roche has stated that its India patent application is pending.

At a seminar organized by Tufts University in Bombay last week on the "Future of the Pharmaceutical Industry in India," Cipla chairman, Dr. Yusuf Hamied, said that, "Cipla has taken up the challenge of avian/bird flu."

He added that, "Cipla's aim is not to infringe valid IPR, but to provide this drug in India and those third world countries that can legally avail of this offer". Dr. Hamied has stated that Cipla's pricing of the drug will be humanitarian.

Cipla is said to be in trials to develop the active ingredient, zanamavir for Glaxo SmithKline's flu medicine, which is sold under the name Relenza and which may not fall under the purview of the patent guidelines India has adopted.

Ranbaxy has issued statements that it will also be in a position to manufacture a copycat version of Tamiflu by mid-2006. Ranbaxy is one of four companies (the others are Teva Pharmaceuticals, Barr laboratories and Mylan Laboratories) currently in discussion with Roche regarding licensing the drug.

The most recent entrant to the field has been Nicholas Piramal, which announced on November 14 that it has approached Roche regarding "toll manufacture" of Tamiflu. Nicholas Piramal clearly stated that it would not be interested in making generic copies of the drug and would only manufacture under license from Roche. Nicolas Piramal and Roche have had a decade long association with Nicholas manufacturing and marketing Roche products in India from 1993 to 2003.

In cities like Hong Kong where nervous residents' stock piling of Tamiflu has led to a situation of shortage of the drug, many people must be hoping that one of the Indian pharmaceutical companies will soon have success.