Natco Pharma's recently launched generic version of Imatinib Mesylate, brand named Veenat, for the treatment of cancer of the bone marrow (chronic myelogenous leukemia- CML) would become a boon for lakhs of patients not only in India but also across the world. Newspapers and the electronic media in the world reported the major breakthrough in the treatment of CML and the significant savings because of its lower pricing. New York Times had published an interview regarding the launch and the low cost. The drug had been approved by US FDA.
Rajeev Nannapaneni, vice-president, business development, Natco Pharma Ltd, told Pharmabiz that the only other Imatinib Mesylate capsule marketed by Novartis under the brand name Glivec (Gleevec in the US) costs Rs 1,20,000 ($2,500) for 120 capsules, whereas Veenat is priced at Rs 18,000 for 120 capsules. This is the cost for one month since the patient has to take 4 capsules per day. Rajeev said Natco would bring down the price further when the company achieved economy of scales in production. “ We intend to make the drug affordable to every one, including the common man,” he said. For 90 per cent of the patients, even in the US, the average cost of $2,500 per month for Glivec, is prohibitive. The other option is Interferon injections. But according to Rajeev, the new capsule was far superior to Interferon. He was confident that Interferon would be replaced by the capsule.
According to a study by the Department of Medical Oncology, NIMS, there were 6 to 8 lakh patients living with this disease in India and every year about 1,20,000 new patients were added.
Chronic myelogenous leukemiate occurs when two different chromosomes break off and reattach on the opposite chromosome, forming the so-called 'Philadelphia Chromosome'. This chromosome's translocation leads to a blood cell enzyme being 'turned on' all the time. As a result, potentially life-threatening levels of both mature and immature white blood cells in large numbers occur in the bone marrow and the blood, causing a variety of complications. Unlike other cancers, CML is not solid cancer, and thus it cannot be removed by surgery.
While medications, including chemotherapy, can help stabilise a patient for several years, the only known potential cure is a bone marrow transplant. Now with the launching of Veenat, CML could become more like a chronic disease, instead of a certain death sentence for lakhs of patients. The life span of the patients afflicted by this disease was 5-10 years. The new capsule would improve their quality of life and survival. However, it was too early to predict any permanent cure.
When Novartis launched Gleevec in May 2001, it was referred to in the media as a “ Magic Bullet”, because it was thought to target only the enzymes in the patient's body that allowed cancerous cells to grow and not normal healthy cells.
The traditional chemo drugs and Interferon are 'generalists', that is, they can affect or hurt all the cells in the body, not just the cancerous ones. People around the world were scrambling to get their hands on Glivec, even people with other cancers, believing that Glivec might offer them one last hope.
Glivec has been effective in cancers that express a certain protein, called C-Kit, which includes Gastrointestinal Stromal Tumours (GIST) and CML. Since Glivec is cost-prohibitive Veenat will be a boon for such patients the world over.
Asked how the company was able to offer the drug at a very cheap price when compared to Glivec, Rajiv said Natco was the first pharmaceutical company in the world to manufacture both bulk active pharmaceutical ingredients and the finished dosage formulation for the drug. This resulted in substantially lower production costs, enabling the company to adopt a pricing structure that can comfort thousands of patients in India. The company has also firmed up plans to make the drug available free of cost to a section of poor CML patients.
On the brand name, Rajeev said it was based on the colloquial interpretation of an Indian language, meaning 'Music of Life.' Veenat capsule is coloured green, signalling promise of life and vitality.
The common side-effects of the capsule, as reported in the case of Glivec, include nausea, vomiting, edema (fluid reytention), muscle cramps, fatigue, skin rash and headache. The patients treated with Glivec after one year had significantly fewer cancerous cells in their blood and bone marrow. The rate of progression of the disease was also decreased in patients treated with Glivec.
The company has lined up about 15 such novel drugs, most of which will be first time launches in the country. The company will focus on niche segment products in the areas of cancer, urology and psychiatry. The 15 drugs include 8 in cancer, 3 in urology and 4 in psychiatry. The company is also currently in the process of finalising a couple of products against diabetes.
According to Rajeev, most of the products will be launched by the close of this fiscal and will add significant value to the topline of the company. The company has already obtained licences for five products from the Drug Controller General of India (DCGI), of which one anti-cancer drug, Veenat, had been launched. Natco is expecting licences for another six drugs in the near future.
The portfolio of drugs that obtained DGCI clearances includes four products in the anti-cancer segment and one in psychiatry. For most of the proposed formulations Natco plans to manufacture the bulk actives in-house, which will enable it to earn better margins.
The company expects a turnover of Rs 70 to Rs.75 crore from the new product portfolio, taking the total turnover to Rs 175 to Rs.200 crore by March 31, 2004. For the current fiscal ending March 2003, the company expects a turnover of Rs 125 crore, with equal contribution from bulk drugs and formulations. For the nine months ended December 31, 2002, the company registered a turnover of Rs 86.18 crore.