The Hindu Business Line : GlaxoSmithKline gets nod to import bird flu drug

Bird flu remedy
Relenza is developed by Australian biotech company Biota and marketed globally by GSK.
Unlike Tamiflu, Relenza does not involve patent-related heartburn, as it is a pre-1995 drug.

Mumbai , March 24

GlaxoSmithKline (GSK) has got the regulatory permission to import its bird flu drug Relenza into India. The Drug Controller-General of India (DCGI) has "fast-tracked" the approval process to allow the import of Relenza, a DCGI official confirmed.

Relenza is the brandname for Zanamivir, a drug that has to be inhaled. It is the other drug besides Roche's Tamiflu recommended to treat humans infected with bird flu.

However, Relenza is not expected to be available in India in the near future despite the regulatory clearance because of the global pressure on supplies, as more countries stockpile it in anticipation of a pandemic.

"GSK has been granted permission to import Relenza. As stated earlier, the company is in dialogue with the Government to assess its requirement of the product. Relenza is manufactured at a European facility and the current demand is far in excess of our ability to supply. We expect the demand-supply position to improve for better as efforts are on to augment Relenza supplies. In view of this, we have no near term plans for Relenza in India," a company official told Business Line.

In fact, in previous reports from London, GSK Plc's Chief Executive Officer, Mr Jean-Pierre Garnier, said: "We also have to be realistic, even going at it seven days a week, 24 hours a day, we can't come close to the demand the world might need."

Relenza is developed by Australian biotech company Biota and marketed globally by GSK. Biota gets a seven per cent royalty on the sales of Relenza. But the two companies are currently locked in a legal battle over the promotion of Relenza before the bird-flu outbreak.

Similar issues had been witnessed with the other bird-flu drug Tamiflu, as well. Gilead Sciences had developed the drug and assigned its global marketing to Roche for a royalty payment.

But unlike Tamiflu, Relenza does not involve patent-related heartburn, as it is a pre-1995 drug. This means it does not get product-patent protection in India under the new patent regime. Also, generic Indian companies would be able to make copies of the same drug. But the process involved in making Zanamivir is difficult, GSK top brass said.

Mumbai-based drug company Cipla is said to have commenced work on Zanamivir, while Nicholas Piramal had indicated its interest to contract-manufacture the product for GSK.