Fresh off reporting good news at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Halozyme Therapeutics Inc. segued into yet another global collaboration and license agreement – this time with Abbvie Inc. – that could add $1.193 billion to its coffers. The deal allows Abbvie, of North Chicago, to apply Halozyme's Enhanze delivery platform to up to nine of its compounds in return for $23 million up front to Halozyme and milestone payments totaling approximately $130 million for each collaboration target. Abbvie is fully funding the development and commercialization programs, with Halozyme also entitled to tiered mid-single-digit royalties on related product sales.

Halozyme's Enhanze platform is based on its recombinant human hyaluronidase enzyme (rHuPH20), which temporarily degrades hyaluronan (HA) – a sugar that can accumulate around cancer cells and inhibit other therapies – to aid in the dispersion and absorption of other injected therapeutic drugs. For Abbvie, the technology may allow for more rapid delivery of its injectable biologics through subcutaneous delivery.

In December 2014, Halozyme inked a similar deal with Janssen Biotech Inc., a unit of Johnson & Johnson, of New Brunswick, N.J., to develop and commercialize products for up to five targets by combining rHuPH20 with Janssen's compounds. In that agreement, Halozyme received $15 million up front and milestone-based payments of up to $566 million, plus royalties. (See BioWorld Today, Dec. 12, 2014.)

Halozyme also has an oncology focused partnership with Roche AG, of Basel, Switzerland, for up to eight targets – subcutaneous formulations of Herceptin (trastuzumab) and Mabthera (rituximab) from the deal have gained approval in the EU – and with New York-based Pfizer Inc. for up to six primary and specialty care targets. Its partnership on Hyqvia (immune globulin infusion 10 percent [human] with recombinant human hyaluronidase) with Deerfield, Ill.-based Baxter International Inc. led to U.S. and European approvals for that drug to treat primary immunodeficiency. (See BioWorld Today, Dec. 7, 2006, Sept. 11, 2007, Oct. 19, 2011, and Dec. 26, 2012.)

FDA approval of Hyqvia in July 2014 provided regulatory validation that prompted increased looks at the Enhanze platform, according to Helen Torley, who was named Halozyme's president and CEO last year after serving as executive vice president and chief commercial officer for Onyx Pharmaceuticals Inc., where she oversaw the company's collaboration with Bayer on Nexavar (sorafenib) and Stivarga (regorafenib) and the U.S. launch of Kyprolis (carfilzomib). Onyx was picked up by Amgen Inc. in August 2013 for $10.4 billion. (See BioWorld Today, Aug. 27, 2013.)

"Since the middle of last year, we definitely have seen a lot more interest from companies calling us to understand our platform better and see if it would make a difference for them," Torley told BioWorld Today. That was the time frame when Halozyme began engaging with Janssen, with Abbvie talks beginning shortly thereafter, she added.

"These things take some time to come together," Torley pointed out. Although the structure of each deal has essentially remained the same, "since our early deals we've been continually seeking to add incremental value," she said.

The significant step-up in the Abbvie deal terms wasn't lost on investors. Shares of San Diego-based Halozyme (NASDAQ:HALO) swelled Wednesday to a one-year high of $19.59. The stock closed at $19.57 for a gain of $1.58, or 8.8 percent.

"Coming less than six months after the last agreement with Janssen and less than a year after the U.S. approval of Hyqvia substantially de-risked the approach from a U.S. regulatory standpoint," J.P. Morgan analyst Jessica Frye wrote about the deal. "We view today's update as a clear positive. While these agreements are inherently long term in nature and thus represent less of a driver of the short-term valuation, we view them as both expanding and diversifying the ultimate value of the company."

SHORT-TERM DRIVER

Progress on Halozyme's internal asset, PEGPH20, which the company is evaluating in pancreatic and lung cancer, remains the key short-term share driver, Frye added. The pegylated formulation of the firm's recombinant human hyaluronidase, marketed as Hylenex, also temporarily breaks down HA but increases half-life and improves intravenous delivery.

Halozyme is winning hearts on that front, as well. A year ago, the company's shares were dented when the phase II trial testing PEGPH20 in pancreatic cancer was halted following an unexpected imbalance in thromboembolic event rate between treatment and control groups. (See BioWorld Today, April 7, 2014.)

At the time, analysts and investors worried about bigger, platform-related issues, but those concerns were largely laid to rest when the FDA green-lighted Halozyme to start a phase III program with PEGPH20 in metastatic pancreatic cancer. The FDA subsequently endorsed a trial design that could allow for approval based on either progression-free survival (PFS) or overall survival endpoints. (See BioWorld Today, April 9, 2015.)

At ASCO, Halozyme shared interim data from the ongoing second stage of its randomized phase II study showing that, when combined with Abraxane (nab-paclitaxel, Celgene Corp.) and gemcitabine, PEGPH20 more than doubled median PFS, to 9.2 months vs. 4.3 months, in patients with high levels of HA. (See BioWorld Today, June 2, 2015.)

The steady flow of partnerships allows Halozyme to continue funding PEGPH20's development and "to go broader and start testing other interesting tumors, as well," Torley said. Other than a small internal core team that provides "guidance and expertise" to partners on regulatory and manufacturing matters, the work and expense in applying Enhanze to each company's pipeline is borne entirely by partners.

"That is a very accretive model for us in terms of supporting multiple partnerships at minimal expense," Torley said.

Halozyme doesn't intend to rest on a handful of big pharma partners, she added.

"It remains our goal to sign more of these deals," Torley insisted. "Even though we've got these great partnerships, there are many targets out there in many areas where we believe our platform could help. I look at this as really just the beginning for our Enhanze platform."