Dr Reddy’s Laboratories, India’s second-biggest pharmaceuticals company, has pushed back by a year large-scale human trials of a new diabetes drug. This could potentially hold up the much-delayed entry of the medicine in the market.
The drug, called balaglitazone, will now be tested on hundreds of patients—a stage referred to as Phase III trials—in 2008, a top company executive said. Earlier trials on a smaller set of patients has been completed, and studies to test the cancer-causing properties or “carcinogenicity” of the drug on animals are on, G.V. Prasad, vice-chairman and chief executive officer of Dr Reddy’s, said in an interview.
Food and Drugs Administration (FDA), the US drugs regulator, has made it mandatory for the ‘glitazone’ class of drugs to undergo two years of rigorous carcinogenicity studies before taking up Phase III trials. This will delay the drug-development process, Prasad said.
Last month, Dr Reddy’s had said the drugs it was developing at present would hit the market only by fiscal 2011. This will also include balaglitazone, Prasad confirmed. Dr Reddy’s spends about $20 million annually on drug research.
The delays don’t augur well for Hyderabad-based Dr Reddy’s, an analyst said. “Merck, Novartis and Eli Lilly are expected to introduce diabetes drugs by 2009,” said Nimish Mehta, assistant vice-president at Edelweiss Capital.
Mehta added that Dr Reddy’s may find it difficult to get FDA approval because the balaglitazone class of drugs will be closely monitored for carcinogenicity.
“At this stage, we can hypothesize that balaglitazone is safe and the results from Phase III will tell how safe the drug will be,” Prasad told Mint.
Balaglitazone, codenamed ‘DRF-2593’, is expected to improve glucose and cholesterol control in patients with type II diabetes, a disorder that shows up as poorly controlled blood sugar levels. As many as nine in 10 diabetics have type II diabetes.
The global anti-diabetic drug market, estimated at $20 billion today, is expected to increase to $30 billion by 2014.
India is home to the most number of diabetics in the world: Its nearly-41 million diabetic population is expected to grow to around 70 million by 2025.
Balaglitazone is being developed by Dr Reddy’s, together with Denmark-based Rheoscience. As part of a 10-year agreement signed in September last year, Rheoscience will hold the marketing rights for the drug in Europe and China, while Dr Reddy’s will own the rights in the US and the rest of the world. Rheoscience is responsible for obtaining FDA approval.
Dr Reddy’s drug-development efforts hit trouble when Novo Nordisk, licensed by the Hyderabad company on an earlier anti-diabetes molecule ragaglitazar—belonging to the same class as balaglitazone—decided to suspend its development, following adverse reactions in animal studies in July 2002.
Novo Nordisk, in lieu of ragaglitazar, took up trials of balaglitazone and, in February 2003, Dr Reddy’s announced that the Danish company had completed small sample human trials and was satisfied with its safety and efficacy.
But in October 2004, Novo Nordisk, the world’s largest maker of insulin used in injectable form to treat diabetics, decided to halt clinical development of balaglitazone because it did not see an edge in the drug over those that were already in the market for type II diabetes.
New type II diabetic drugs have come into the market in recent years. Actos, made by Japan’s Takeda Pharmaceutical, and avandia, owned by Glaxosmithkline, account for more than $5.6 billion in global sales, replacing older-generation medicines such as glucophage as the most-prescribed anti-diabetic medicines.