In what may be a surprise for dengue vaccine hopefuls, India's Pune-based Serum Institute is seeking in-country fast-track approval for a biologic drug candidate to treat all four strains, the Times of India reported, with the news coming amid speculation over an equity offering by the company and a massive virus outbreak in India.
The company, Asia's largest vaccinemaker, with deep ties to World Health Organization prequalified vaccination efforts, is in the process of applying to the Ministry of Science and Technology for the quick nod, the Times of India said, adding that the monoclonal antibody treatment would be given as an single-dose injection to cure dengue, and cost between INR5,000 ($75) to INR10,000 ($152).
|Serum CEO Adar Poonawalla|
The Serum Institute has tied up with U.S.-based biotechnology company Visterra to use its technology and has set a schedule to commercialize the treatment within 12 to 18 months of getting regulatory approvals, CEO Adar Poonawalla told the Times of India.
"We hope that the government will give a fast-track approval to our application as dengue has assumed alarming proportions, and could become a public health crisis", Poonawalla told the Times of India, adding it would then initiate clinical trials to prove its safety and efficacy on a few hundred to 1,000 subjects.
Last week, a populist government in New Delhi threatened to shut down private hospitals in the city that refused patients with dengue fever, with an outbreak across 27 states reaching crisis proportions, killing more than four dozen with more than 3,300 cases reported.
In May, Singapore's research agency and Duke-National University of Singapore signed an agreement to collaborate with U.S. biotech Visterra on getting a promising treatment against dengue fever to the clinical-trial stage.
The Agency for Science, Technology and Research (A*STAR) said the trials would also be conducted in Singapore, which is the middle of a region plagued by the virus. There is no specific drug to attack the virus, the agency said.
The work is to be carried out on one of Visterra's antibodies, this one called VIS513, which has shown in animal trials that it is capable of providing a single treatment to slow development of the virus and neutralize all four types of it.
Last week, Bloomberg reported that the Serum Institute was in talks with private equity firms to sell a stake of as much as 10% in the unlisted group, seeking a valuation of as much as INR800 billion ($12.16 billion).
A company spokesman declined to comment to FiercePharmaAsia.
Earlier this month, two dengue treatment options were said to be slated for Phase II trials in Singapore next year as efforts to get vaccines by Sanofi ($SNY) and Takeda Pharmaceutical to the market also gather steam.
Singapore's National Medical Research Council awarded a grant to the Singapore General Hospital for studies on the antiviral celgosivir and disease-modifying modipafant into Phase II clinical trials next March, Healio said, citing a press release.
Celgosivir is an alpha glucosidase inhibitor and modipafant and platelet-activating factor receptor antagonist, Healio said, adding that the work will be carried out by a company called 60 Degrees Pharmaceuticals along with hospital clinicians to evaluate safety and efficacy.
A Phase Ib trial of celgosivir with results published in the Lancet in August 2014 showed that although the drug was generally safe and well tolerated, Healio said, it did not appear to reduce viral load or fever burden in dengue patients.
The release noted that U.S. FDA-approved vaccines or antiviral drugs do not exist for dengue and treatment is limited to supportive and symptomatic care.
In June, Takeda Pharmaceutical moved to consolidate its Vaccine Business Unit into hubs to allow sharper focus on a complex set of vaccine programs covering norovirus, dengue and seasonal influenza in an increasingly competitive global horse race.
For Takeda, a key will be the success, or lack thereof, of Sanofi's rollout plans at the public-health level for a dengue vaccine that has a high-stakes manufacturing and approval strategy as early as this year.
In a second-quarter earnings call, Sanofi CEO Olivier Brandicourt was upbeat on the launch of a dengue vaccine this year, expecting the first license to be granted before the end of 2015, though Olivier Charmeil, executive vice president for vaccines, said it was a "little bit too premature" to discuss plans for the ramp up.
"As we speak we have filed in 7 countries. We will have filed in 20 countries by the end of the year that represent roughly half of the worldwide population at risk of dengue," he said, adding that the ramp-up for 2016 and 2017 onwards will be "very much dependent on the objective country-by-country in terms of getting the impact of dengue reduction."
In April, Takeda said it was eyeing Phase III for its own dengue vaccine candidate. The company has also hinted it is open to acquisitions in India and elsewhere in the vaccines business.