Novartis modifies GIPAP with immediate effect

EPP News Bureau - Mumbai

NOVARTIS announced that the Glivec International Patient Assistance Program (GIPAP) has been modified to begin accepting new patients immediately, including patients that have been enrolled in generic imatinib patient assistance programmes. The GIPAP India program continues to provide Glivec r at no cost to 580 existing patients in India. Glivec is used to treat patients suffering from Chronic Myeloid Leukaemia (CML) and Gastrointestinal Stromal Tumours (GIST).

The GIPAP India Modification follows the grant of Exclusive Marketing Rights (EMR) for Glivec by the Controller General of Patents and Trademarks of India. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited said, “GIPAP is one of the most generous and far reaching patient assistance programmes ever developed for a breakthrough cancer therapy.”

GIPAP is administered on behalf of Novartis by The Max Foundation, an international non - profit organisation dedicated exclusively to helping people with leukaemia and other blood - related diseases. The programme had earlier stopped taking new patients once the generic version had entered the market and now has been modified with immediate effect. GIPAP provides Glivec at no cost to eligible adult and paediatric patients diagnosed with CML and GIST who meet the following criteria:

- are properly diagnosed - are not insured - not reimbursed - and have no other financial recourse.

In the year 2003 alone, Novartis has given away US $22 million worth of the cancer drug, while only US $ 2.43 million has been sold. While addressing the press about this controversial drug, Shahani commented on the EMR that the product has recently received and said, “ We are happy that the we have been granted the EMR and we will vigorously defend the right.” He expected that once Novartis decides to enforce the EMR, the generics mostly would have to recall their products. He, however, did not state as to when will the product be marketed.

When asked about the pricing of the drug, he said that pricing was not much of an issue, as those who are unable to afford the drug can get it free of cost under GIPAP. The drug costs US $ 27,000 per annum, while the generic costs a tenth of it, at US$ 2,700.