The Hindu Business Line : Cipla bringing in Novartis’ iron-overload drug

Mumbai, March 31 Cipla is set to sell its generic version of Deferasirox, a once-a-day oral iron chelator used to treat iron overload that occurs due to blood transfusions. Beneficial to patients with conditions such as thalassemia, the once-daily format of the drug ensures better compliance.

But the drug comes from the Novartis stable, and is internationally sold under the Exjade brand name. Though Novartis does not at present sell its Deferasirox (Exjade) in India, a company spokesperson told Business Line that Novartis was planning to launch Defarasirox in the second quarter of 2008.

Cipla’s version of Deferasirox will be sold locally under the brand name Desirox.

Prices and patents

The drug, available as tablets, will cost the consumer about Rs 1,000 a month. It will be sold locally at a fraction of the price at which it is sold internationally, said Mr Amar Lulla, Cipla’s Chief Executive Officer.

Novartis points out that it has applied for patent protection on Defarasirox formulation in India, which is under review by the Indian Patent Office. Globally, the drug was first approved in the US in November 2005. The price varies internationally and depends on dosage and weight of the patient.

“The price is, however, comparable with the total costs of treatment with deferoxamine when drug and associated drug delivery costs are considered,” the official added.

And with the originator, Novartis, also planning to bring its medicine into the country, this drug too could witness patent-related litigation, a pharma analyst observed.

Side-effects

Side-effects associated with the drug include concerns of liver/kidney toxicity. But Mr Lulla pointed out that the benefits of the drug outweigh its risks. The labelling would be similar to other medicines in the segment, he clarified.

And since the medicine is an already tested drug, Cipla would now undertake post-marketing surveillance on the medicine, he said.

The drug would be sold only on prescription, through specialists like haematologists and paediatricians who treat thalassemic children, a Cipla official familiar with the drug said. There are few medicines in this segment, he said, adding that Cipla has been in this space for about 12 years, since its launch of Kelfer (deferiprone) in 1995.

Thalassemia is a genetic disorder set apart by the inability of the individual to produce normal haemoglobin. Every year approximately 100,000 children with Thalassemia Major are born worldwide, of which 10,000 are born in India, Cipla said. It is estimated that there are about 65,000-67,000 beta-thalassemia patients in the country, with around 9,000-10,000 cases being added every year, it added.

A few ethnic groups, such as Sindhis, Gujarathis, Punjabis, Jains and Marwadis, are considered high-risk communities for this disease, the company said.

Thalassemic children are anaemic and require regular blood transfusions. And though blood transfusions help extend life, complications like excess iron deposition in the body arise. This needs to be removed to prevent it from being deposited in vital organs such as the heart, liver and pancreas. About 50 per cent of thalassemics die because of cardiac complications, making it necessary to give drugs that remove iron (iron chelators) to these patients, the Cipla note explained.

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