Stringent regulatory norms and the financial impact of the global credit crisis on some research companies may hurt half a dozen molecules of Indian companies, such as Glenmark, Nicholas Piramal and Ranbaxy Laboratories, that are close to launch, experts and analysts said.
The concern has heightened after Hyderabad-based Dr Reddy's Laboratories' flagship diabetes drug, Balaglitazone, was reported to be delayed as the company's Danish partner, involved in conducting clinical trials, is in financial trouble.
| TRAILING TRIALS |
"The strategy of out-licensing or partnership drug development always involves the risk of the partner losing interest in the molecule. When they have financial trouble or find a better molecule, they may put our molecule on the back-burner and pursue their own pipeline or the new programme,'' said Swati Piramal, director, Piramal Healthcare.
Sources cite that glitazones, the drug category of Dr Reddy's Balaglitazone, are already facing trouble such as side-effects and resultant regulatory issues.
"Glitazones are under the scanner due to severe side-effects and the regulatory standards of agencies such as the US Food and Drug Administration (USFDA) for drugs such as glitazones will be tougher. This will be the major challenge for Dr Reddy's than the financial issues of Rheoscience," noted Ranjit Kapadia, head of research of PCG, Prabhudas Lilladher.
Dr Reddy's sees a $6-billion opportunity in Balaglitazone when it reaches the market. With Takeda Pharmaceutical Co's Actos and GlaxoSmithKline's Avandia going off-patent, Balaglitazone may remain the only patented glitazone with better results like less side-effects, no weight gain and oedema (swelling caused by fluid in body tissues).
"It is difficult to predict and stick to deadlines in the drug discovery process as this is a complex science and involves huge spending, human trials in multiple locations and stiff regulatory monitoring," noted Sarabjit Kaur Nagra, vice-president (research), Angel Broking.
The progress of Glenmark Pharmaceuticals’ asthma and chronic obstructive pulmonary disease (COPD) drug Oglemilast has also fallen behind schedule as the regulator USFDA has sought additional trial data.
Glenmark licensed this drug to Forest Laboratories of the US in September 2004, when the drug was in the second phase of trials, with hopes of commercialising the drug before 2010.
So far, the drug has reached only the advanced phase-II stage since the USFDA asked for additional trial data and has at least three to four years to go for commercialisation.
"We are confident of launching more than one drug in the 2011-12," said a Glenmark spokesperson.
Adding more woes to Glenmark, in February this year, Merck Serono, a division of Merck, returned Melogliptin (GRC 8200), its drug candidate for the treatment for type-II diabetes in phase-II of clinical development. This was due to Merck Serono's decision to re-focus its portfolio and its intention not to invest further into diabetes research and development. Glenmark is yet to find a new partner for this drug.
India's leading drug-maker Ranbaxy Laboratories' plans of launching the first synthetic, rapid-acting, anti-malarial NCE has also been delayed due to partnership issues.
A year ago, its partner, Geneva-based Medicines for Malaria Venture (MMV), walked out of the joint malarial drug research programme. Then Ranbaxy Laboratories roped in the Department of Science and Technology (DST) to part-fund the second phase of the clinical trials for its anti-malarial combination medicine (Arterolane + Piperaquine).
Arterolane, the anti-malarial drug candidate, is still undergoing phase-IIb studies (dose range finding studies) in Africa, Thailand and India and is still years away from commercialisation.
"It does not matter whether we, Glenmark or Dr Reddy's are the first to commercialise a new chemical entity (NCE) from India, since all are patented products with a 20-year product patent. The patent itself is for a new innovation, which will benefit the humanity. But we cannot predict when that can happen because the drug discovery process is painful and involves lots of risk," sums up Piramal.
