BackSuven to invest $25 mn to test Alzheimer’s drug
The drug will be tested on nearly 540 patients over two years in the US
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Mumbai: Suven Life Sciences Ltd will invest $25 million in human clinical trials to test the efficacy and safety of its drug candidate for Alzheimer’s disease, a top company executive said.
The company completed the first phase of the trial of its drug candidate SUVN-502 in April 2009 and was trying to license out further development to other companies. Suven was asked by some interested firms to provide proof of concept, which the proposed human clinical trials seek to establish, before they stepped in, according to chairman and chief executive Venkat Jasti.
The molecule has been tested on healthy volunteers and in the proposed phase, it will be tested on nearly 540 patients over two years in the US. The company is trying to join hands with a US-based clinical research organization to conduct the trial.
“We can expect the results sometime in 2017," said Jasti in an interview. “Based on that, we expect to out-license the molecule."
The company will fund the trials with money it had raised by selling shares to institutional investors in December. The promoters led by Jasti had diluted about 9% of their stake. They held 59.44% stake on 31 December. The firm had ended 2013-14 with revenue of ₹ 510.31 crore and net profit of ₹ 144.15 crore.
Alzheimer’s Disease is an irreversible, progressive brain ailment that slowly destroys memory and thinking skills. In most cases, symptoms first appear after 65 years of age. SUVN-502 tries to enhance nuero-tranmission in brain.
A similar molecule Lu AE58054 of Denmark’s H. Lundbeck AS was licensed to Japanese drug maker Otsuka Pharmaceutical Co. Ltd in July 2013 for an upfront $150 million, milestone payments of up to $675 million and royalty on sales if it is launched successfully in the market.
“The delay in taking SUVN-502 into phase II A (trials) could be a concern, as competition molecule (Lu AE58054) is clearly ahead in the race," said a research analyst at a Hyderabad-based brokerage house on condition of anonymity.
However, Jasti claimed SUVN-502 scored better than the competition in terms of safety, and that it works solo as well as with add-on therapy.
The odds might be stacked against Suven, as drug candidates for the disease have a higher failure rate than the pharmaceutical industry average, according to GBI Research, a London-based business intelligence firm.
Jasti is unperturbed.
“It’s always a huge bet, it’s zero and one, there is no in-between," he said.
The total number of active drugs in the treatment pipeline of Alzheimer’s is relatively large, at 583. It means there is high commercial interest in the disease, second only to cardiac treatment. The potential payoff is huge due to the increasingly ageing population.
The market for therapies for Alzheimer’s is expected to touch nearly $12 billion by 2023, according to Decision Resources Group, a healthcare research and analytics firm.
“We believe that there will be good demand for such molecules from MNCs on successful completion of phase II trials, considering the huge unmet medical requirement for these diseases in the US and non-availability of many drugs," said Sriram Rathi, analyst at Mumbai-based Anand Rathi Financial Services Ltd.
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