SAN DIEGO, Oct. 30, 2018 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that it has licensed its ENHANZE® drug-delivery technology to Roche for exclusive development of a new undisclosed clinical stage therapeutic target, with an option to select two additional targets within four years.
Under terms of the agreement, Halozyme will receive an upfront fee of $25 million with the potential to earn additional payments of up to $160 million to $165 million per target subject to achievement of specified development, regulatory and sales-based milestones. Additionally, Halozyme will receive a nomination fee for each of the two additional new target nominations. Halozyme will also receive mid-single digit royalties on sales of commercialized products. The company expects to recognize the initial $25 million payment in the fourth quarter of 2018.
"I am delighted to announce another further expansion of our long-term relationship with Roche, covering the selection of these three new targets," said Dr. Helen Torley, president and CEO. This agreement is a strong illustration of our strategy to unlock and grow ENHANZE value through supporting partners in advancing more promising targets into the clinic through the expansion of existing agreements and the addition of new ones."
The Halozyme/Roche relationship dates back to the original global collaboration and licensing agreement for the ENHANZE technology signed in 2006. Under this agreement, Roche developed Rituxan® SC ex-U.S., Rituxan Hycela® in the U.S., Herceptin® SC ex-U.S., is awaiting an FDA action date in 2019 for Herceptin SC in the U.S., and is conducting a Phase 3 study for the fixed dose combination of Perjeta®/Herceptin SC. In addition, Roche is in Phase 1 testing with an undisclosed target. More recently, in 2017, the relationship expanded to include the right to evaluate an additional target with ENHANZE.
The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan -- a glycosaminoglycan or chain of natural sugars in the body -- to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous delivery.
About ENHANZE® Technology Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for the treatment of several cancers and has the potential to be used in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb and Alexion for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved, and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.
Contacts: Robert H. Uhl Managing Director Westwicke Partners, LLC 858-356-5932 [email protected]