PHILADELPHIA—It has been a big year for Halozyme Therapeutics, and 2019’s not over yet. The biotech inked its ninth licensing deal for its drug delivery platform with its first biotech partner, saw promising data from its partnership with Johnson & Johnson and, later this year, will report its own data for an in-house program in pancreatic cancer.
The San Diego-based biotech operates under a two-pillar strategy—its Enhanze tech brings in licensing dollars and, eventually, milestones and royalties that bankroll its clinical programs. Enhanze uses the enzyme hyaluronidase to break down hyaluronan, a natural sugar chain that forms a gel in the innermost layer of skin. This allows drugs that would otherwise require hourslong intravenous infusion to be injected just under the skin.
It’s teamed up with the likes of Roche, AbbVie and Eli Lilly in addition to Johnson & Johnson and has seen three partnered products approved. The latest was a subcutaneous form of Roche’s breast cancer med Herceptin, which can be given to a patient in two to five minutes rather than an infusion that can take up to 90 minutes.
Phase 3 data for the subcutaneous version of J&J’s multiple myeloma drug Darzalex showed an even more dramatic change. The study, presented Monday at the annual meeting of the American Society for Clinical Oncology, showed that patients receiving subcutaneous Darzalex saw benefits at similar rates to patients on the infused drug—41% versus 37%. The Enhanze-based form of the blockbuster could cut treatment time from seven to eight hours for an infusion to just five minutes.
Halozyme’s lead program is a treatment for pancreatic cancer combining PEGPH20, a PEGylated version of the company’s hyaluronidase enzyme, with Celgene’s Abraxane and the chemo drug gemcitabine. Halozyme expects to report data for a phase 3 study later this year.
It has a second program in the pipeline targeting adenosine, but has put it on the back burner to throw its weight behind PEGPH20, CEO Helen Torley told FierceBiotech.
“The team discovered and started work on PEG-ADA2 three years ago, but we’ve paused the spend on that as we await the results of PEGPH20. Upon success, we’d want to add [PEG-ADA2] to the portfolio,” Torley said. “It’s still preclinical, so the spend to get it to the clinic would be better spent to get something already in the clinic forward to approval.”
When asked whether she thought Halozyme’s clinical work could be overshadowed by the Enhanze franchise, Torley said she didn’t worry about being pigeonholed as a platform provider.
“Our strategy is that, upon success of PEGPH20, we would add it to the portfolio and really become an oncology company. We will be adding interesting novel pathways and developing additional products there, so we’re not worried about getting niched at all,” she said.
Keeping the two businesses together makes the most sense for now. They work better together than they would alone—the company has “synergies” across both businesses, Torley said—and the arrangement makes Halozyme less reliant on the capital markets to fund its drug development programs. But that doesn't mean it won’t split the units up further down the line. If PEGPH20 doesn’t deliver, Halozyme will shift to an Enhanze-only model to stay afloat.
That said, Halozyme is preparing for success. It’s planning a U.S. launch of the pancreatic cancer treatment and is investigating a launch in Europe as well.
“Finalizing all of that will depend on the final decision on the profile of the drug… Meanwhile, we are doing all of the pre-launch activities—making sure we understand pricing and reimbursement … and how to state the value proposition to support the price,” Torley said.
“We will be ready if we decide to do it,” she said.
Torley hasn’t been in a position to consider when to go public—Halozyme did so in 2004, 10 years before she took the helm. But, given the recent wave of biotech companies filing for IPOs at increasingly earlier stages—some with only preclinical data—she said, “it’s a mystery to me why people are going public.”
“A lot of the ones that went public early last year are well below their public price and that’s because it’s hard when a company is really early-stage to show the progress needed to support the price,” she said. "The ones I follow are all well underwater at this point in time, which will happen until their next clinical data.”
But, she conceded, it's a question of different perspectives and the economic environment.
“I would probably have been one of the ones that waited to have compelling clinical data. If you can find VC funding, there’s obviously plenty of funding available for companies,” she said.
“Some worry that the markets are closing. It is an open market at the moment, there is a willingness to invest. But they think about what might happen, for example, it could close soon.” Some biotechs are just looking to strike while the iron is hot.