Will India's search for a blockbuster drug end at Suven?

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26 Aug, 2025 12:21

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Viswanath PillaMoneycontrolVenkat Jasti, 67, has been working hard for twelve years to find new drugs to treat Alzheimer’s Disease. Suven Life Sciences, the company which he founded in 1989, is shopping for answers in a market which has been struggling to find a saleable --- and workable -- treatment for the degenerative brain disease that afflicts 46 million people in the world. His journey, which in many ways mirrors Suven’s evolution, has not been easy. A total of Rs 600 crore has so far been spent on research alone and payoffs still remain elusive.Suven’s efforts to make its research pay dividends will bear fruit if its molecule SUVN-502, now getting tested on patients in the United States, manages to demonstrate safety and efficacy in patients. For that to happen we need to wait for at least a year, if not more.“The results are expected to come out by end of 2017, but may stretch by another three months,” Jasti, Founder and Chief Executive Officer of Suven, said in a telephonic interview to Moneycontrol.com.Suven completed phase-1 trial of SUVN-502 in April 2009, and was trying to license the molecule for further development to other companies.But some interested firms insisted that the company should provide proof of concept, before they stepped in. Consequently, the company began its proof-of-concept testing.In a proof-of-concept trial Suven’s drug will be tested in combination with two other popular Alzheimer’s drugs donepezil HCL (Aricept) and memantine HCL (Namenda) on 537 patients.As on November 30 Suven has recruited about 140 patients in the US. The company plans to quickly ramp up that number to 537.What is At StakeSuven is spending USD 25 million on the proof-of-concept trial. It will be tapping into a war chest of Rs 200 crore which it received on selling shares to institutional investors two years ago. It is a pretty large bet for a company of Suven’s size which ended FY16 with revenues of Rs 500 crore earned largely from contract research and manufacturing services (CRAMS).It takes about 10 years and USD 2.6 billion (inclusive of failures) on an average to develop a new medicine, according to a study by the Tufts University Center for the Study of Drug Development.Only one out of 10 investigational drugs that enter phase-1 clinical trial will ever get as far as the US FDA approval stage. Very few companies in the world have the wherewithal and risk appetite to take a drug from the lab to the market. With a shrinking pipeline of patented products and poor R&D productivity, the big pharmaceutical companies are always on the prowl to develop clinical-phase drugs. It is to these companies that Suven is hoping to out-license its molecule.But all it needs is a positive outcome from the trial to help find an out-licensing partner who will not just take the drug into a late-stage development or phase-3 trial, but also pay Suven an upfront fee, milestone payments based on drug’s progress and royalties on sales if it ever commercialised.A phase-3 is the costliest and time-consuming global clinical trial which requires patients between 1000 and 3000 for the drug to be tested on in order to firmly establish its efficacy and safety. Only then can the data be submitted to the regulator for approval. A phase-3 doesn’t guarantee a sure-shot success; in fact, the probability of success is around 58 percent. To recruit a single patient, on an average, it costs about USD 42,000, which is beyond the means of small companies such as Suven. The only option left for them is to out-license the molecule to a partner who can take the risk.Other AttemptsA similar class of molecule -- idalopirdine or Lu AE58054 -- of Danish drug maker Lundbeck created history in July 2013. Japanese drug maker Otsuka Pharmaceutical struck a deal with Lundbeck for an upfront fee of USD 150 million, milestone payments of up to USD 675 million and royalty on sales if it was launched successfully in the market.Three and half years later idalopirdine failed to prove its efficacy in its late stage clinical trial dealing a blow to Lundbeck’s dream of bringing a first-in-class drug to treat Alzheimer’s. It also put the viability of the entire class of drugs under a cloud.Lundbeck said the two remaining studies, in the phase-3 programme, will continue as planned and data are expected in the first quarter of 2017.In December 2014, UK-based drug giant GlaxoSmithKline (GSK) had given up on a similar class of drug called Intepirdine or SB742457 after less than encouraging trial data. GSK offloaded the drug to Roivant Neurosciences, a US-based biopharmaceutical upstart founded by Indian-American Vivek Ramaswamy.Roivant is still pursuing the drug into phase-3 trial with funds raised from a USD 315 million IPO. The company has received fast track designation for its investigational new drug (IND) application by US Food and Drug Administration.Jasti isn’t perturbed by the development. He says he is confident that his molecule will score better than competition in terms of superior safety profile. He believes it can work on its own as well as in combination therapy.“The target we are chasing is well established since the 1960s, and ours is a different molecule,” Jasti said.Pot of GoldAccording to Alzheimer’s Disease International, 4 million people in India are said to be afflicted by AD. Of all the known forms of dementia, Alzheimer’s is the most common type.The total number of active drugs in the treatment pipeline of Alzheimer’s is relatively large at 583. It means there is a high commercial interest in the disease, second only to cardiac treatment.The potential payoff is huge due to the increasingly ageing population.The bonhomie ends there. Drug discovery is a 'risky' business. Prospective drugs to treat neurological conditions meet with failure rates as high as 95 percent.In fact, in the past one decade, there was not a single novel drug to treat Alzheimer’s which has hit the market.The scientific understanding of the disease is still evolving and, currently, the drugs available in the market treat symptoms and not the underlying causes.Also, researchers struggle to design a trial to show efficacy in cognition and the endpoints are not easily measurable unlike other diseases.But if the drug candidate manages to cross the approval line – there is a pot of gold, as the market for Alzheimer’s disease therapies is expected to reach nearly USD 12 billion by 2023, according to healthcare research and analytics firm Decision Resources Group.That’s the promise (big bucks and unmet need) that keeps Jasti’s passion for drug discovery alive. “It is a high risk and even though we are very optimistic about our success but until the data comes out, we cannot give you any guidance on that. When it comes you know the value that you can get in addition to solving the unmet need of patients,” Jasti said.If Jasti succeeds, India can lay claim to its first blockbuster drug.Way ForwardIn addition to SUVN-502 Suven has a pipeline of three more potential drugs two of which are to treat Alzheimer’s. They have completed phase-1 trial and another one for depression is in the process of entering phase-1 trial. In phase-1 the drug will be tested on healthy volunteers to establish safety.Jasti said he has funds to cover expenses of drug discovery for the next two years, beyond which he may look for an IPO in US or raise funds from private equity investors.“It’s a risky bet, if the drug fails - all the money that Suven spent so far on one single drug goes down the drain, and the stock could get punished,” said Afzaal Mohammed, an analyst tracking the company at Karvy.Jasti defends himself saying that he insulated the company’s normal business operations from the risks of drug discovery as the entire funding for R&D comes from internal accruals and not debt proceeds.The debt-equity ratio of 0.10 on March 31, 2016 is just an indicator of it, Jasti said.Jasti is determined to test the limits of his research and end up where no one has so far gone – a world where AD can be cured.