|Oncobiologics CEO Pankaj Mohan|
Four years ago, Pankaj Mohan set out to build an independent biosimilars developer, confident that by the time he was ready for a Phase III study of a lead knockoff, the FDA would have completed building the regulatory bridge needed for an approval in the U.S. and investors would be ready to put up the $70 million to $90 million needed to get through late-stage development to a new drug application.
Today, his company, Oncobiologics, is taking the next big step into late-stage work after raising $31 million from some prominent investors willing to back him at a critical point.
"$31 million breaks the sound barrier for me," says Mohan. And he's relying on the sonic boom of this round to set the stage for another big fundraising in the very near future.
"This gets our story out there," says Mohan. That story is centered on a small, independent outfit based in Cranbury, NJ, that has been growing development and manufacturing expertise side by side. A few regional licensing deals are in place, with more planned for ex-U.S. markets as Oncobiologics pushes ahead with plans to take on the U.S.
New investor Perceptive Advisors led the round. Participating new investors included Cormorant Global Healthcare Master Fund, Longwood Capital Partners, and venBio Select Fund. Other investors included Proximare Lifesciences Fund, OSSB Pharma Fund and MIH Fund.
The next step is centered on taking the biotech's lead biosimilar for Humira into a Phase III trial.
Mohan freely concedes that $31 million won't pay for the study. And while he's keeping his cards close to his vest for now, he says significantly more money should follow in a matter of months. ("We're keeping all options open," he says, when asked about the chance of floating an IPO.) His staff has grown to about 90 now, he says, with plans to double that by the end of next year as he adds another 100,000 square feet of space to the 50,000 square feet he's in now.
Oncobiologics is coming into the last turn on the track as a mix of small and huge enterprises have been making rapid progress in bringing a wave of biosimilars to the U.S. Mohan insists, though, that Oncobiologics has a competitive advantage--even compared to the major league players like Sandoz, under the Novartis ($NVS) wing, Biogen ($BIIB), Amgen ($AMGN) and others.
Mohan and his team all have Big Pharma backgrounds, he says, and they believe the key is getting the CMC/manufacturing side of the business done right for their monoclonal antibodies. After Humira, where he'll face plenty of competition, Oncobiologics is in Phase I for a copycat of Avastin, followed by 5 preclinical programs for Herceptin, Prolia, Erbitux, Actemra and Simponi.
The current timeline brings his Humira rival to regulators in time for a 2018 launch, though the CEO believes he might just be able to shave that down to 2017, not long after the loss of patent protection.