The Hindu Business Line : Cipla develops combination drugs for US, Europe

A basket of combination-drugs, including medicines for allergic rhinitis, asthma and cardiac-problems, are some of the innovative products being developed by Cipla for the developed markets.

Clinical trials for these combination drugs are at present being done in the US and Europe, for these markets, Cipla’s Chief Executive Officer, Mr Amar Lulla, told Business Line.

The company hopes to get the allergic rhinitis drug into the market next year, he said, adding that the timeline could vary given uncertainties of clinical studies and regulatory approvals. The other two combination drugs, in the asthma and cardiac segments, are projected to be in the market by 2010.

The company is conducting Phase III trials on these drugs, where the combination medicine will be given to a large number of patients to test for safety, efficacy and adverse reactions. A combination medicine combines two or more known drugs to provide the consumer convenience and help better compliance to the drug regime.

As a result, a consumer will need to take just a pill a day, for instance, in the place of possibly two or more pills three times a day.

Asthma-inhaler

Combination drugs are not new to Cipla, and the Mumbai-based drug-maker had an early start in this space with its combination AIDS drugs some years ago. In a more recent development, the company has launched Triohale, its triple-drug combination inhaler for patients with asthma or chronic obstructive pulmonary disease (COPD).

The drug combines triotropium, formoterol, and ciclesonide. Patents on these medicines are held by Nycomed, Novartis and Pfizer and Boehringer Mannheim, respectively; and the patents expire in turn, in 2023, 2020 and 2013.

But Mr Lulla said that Cipla did not have a patent on its combination inhaler and looks to sell the product in semi-regulated markets like Latin America and Africa. The registration process has begun, he said. The product is priced in India at Rs 570 for 120 doses. Explaining the benefits of the product, he said, the patient will save money, besides it aids in better compliance as patients require multi-dimensional doses.

NPPA notice

Meanwhile, the company has received another notice from the National Pharmaceutical Pricing Authority demanding an amount of Rs 62.85 crore towards interest for the period April 2007 to January 2008 on alleged overcharged amounts in respect of the drugs Ciprofloxacin, Norfloxacin, Salbutamol and Theophylline.

The NPPA has also made a fresh demand of Rs 4.12 crore as alleged overcharged amounts inclusive of interest in respect of the drug Doxycycline and additional packs of the drug Norfloxacin, the company said.

The company, however, maintains that the amounts demanded were “not tenable and sustainable”, besides being contrary to earlier Supreme Court orders on the issue.

Cipla shares remained flat at Rs 206.15 on the Bombay Stock Exchange.

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