Last week, the USFDA approved US drug maker Biogen’s Aducanumab -- the first Alzheimer’s treatment in 18 years. Aducanumab clears the plaque -- a clump of proteins that build up between nerve cells, disrupting the smooth function of the brain.
The approval became controversial as three members of the USFDA's expert panel that reviews the data and advises the regulatory agency resigned in protest. The panel overwhelmingly decided against approving the drug.
How Biogen success raises hope in India
Back in India, Venkat Jasti, Chairman and CEO of Suven Life Sciences, has been keenly watching the developments. Jasti has been overseeing Suven's drug discovery efforts for almost two decades, and has spent millions of dollars to find a cure for Alzheimer’s without much success.
The latest success of Biogen has raised Jasti’s hopes, who is preparing to spend $40 million to begin the clinical trials of a key molecule, SUVN-502, by September and plans to complete the trials of another molecule by the end of next year.
Jasti told Moneycontrol that the USFDA may have taken a leaf out of the COVID-19 situation, referring to the agency approving several drugs and vaccines against COVID-19 for emergency use, sometimes with limited evidence. Some approvals like HCQ and Remdesivir did become controversial.
“The approval was purely based on some risk-benefit analysis. There was nothing available in the market,” Jasti said. “There may not be good evidence that the drug works,” he added.
Biogen set to rake in millions, Suven suffers ‘painful setback’
]Jasti says Biogen is set to reap big money. Analysts predict Aducanumab will rake in $10 billion in peak sales.
The development of an Alzheimer’s drug has been marred by a failure rate as high as 95 percent.
Jasti’s own molecule against Alzheimer’s, Masupirdine or SUVN-502, in November 2019, failed to meet the primary endpoint in the proof of concept (PoC) phase two study in the US. As part of the PoC study, Suven tested the drug as a triple combination with Aricept (donepezil) and Namenda (memantine) on 563 patients in the US, aged between 50 and 80 years. Jasti had spent over $25 million. For a company of Suven's size, that's a huge hole.
Jasti called it a “painful setback”. “We knew all along that it was and will always be zero or one,” he said.
Not retiring hurt
Jasti said as they were reviewing the SUVN-502 trial data, there were some interesting facts.
“The drug did show some promising results on agitational (psychiatric) symptoms of Alzheimer’s patients," he said. “This meant that all was not lost," Jasti said.
Jasti took the new findings to several experts, and most of them were of the view that this new indication also needs to be tested. Suven is finalising the protocol for a fresh clinical trial in the US. If everything goes as per the plan, Jasti wants to hit the clinic by September.
Jasti says the trial would take about 3.5-4 years and may cost over $25 million.
In addition to SUVN-502, the company has another molecule SUVN-G3031 in Phase-2 clinical trials in the US targeted at Excessive Daytime Sleepiness(EDS) in narcoleptic patients. The trial, which was expected to be completed by March 2021, was hit by COVID-19 in the US.
Now, this would take another year and a half to complete, Jasti said.
He says the clinical trials of both molecules would need about $40 million.
Jasti's appetite for risk, however, isn’t shared by most of his shareholders.
To insulate his cash-generating CRAMS (Contract Research and Manufacturing Services) business from high-risk drug discovery, he carved out that business into a separate entity called Suven Pharma.
That business has registered a year-on-year growth of 21.1 percent in net revenues to Rs 1,010 crore in FY21 and a net profit of Rs 362 crore with a healthy EBITDA of 43.6 percent.
Meanwhile, Jasti is on now the look-out to raise funds for Suven Life Sciences, which houses the drug discovery business.
He said the Rs 140 crore raised through promoter warrants would be sufficient till next September. Beyond that, he is looking at raising funds through sales of shares to strategic investors or possibly even an initial public offering (IPO) of the US subsidiary.
He is also open to licensing partnerships by other drug makers to take over his molecules for further development. Most of his funding plans, however, are linked to the positive outcomes of clinical trials