Halozyme Announces HALO-301 Phase 3 Study Fails To Meet Primary Endpoint

- Development of PEGPH20 to be Discontinued Immediately -

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Nov 04, 2019, 07:00 ET

SAN DIEGO, Nov. 4, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the HALO-301 Phase 3 clinical study evaluating investigational new drug PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreas cancer failed to reach the primary endpoint of overall survival.

The treatment arm of PEGPH20 in combination with gemcitabine and nab-paclitaxel (ABRAXANE^®) failed to demonstrate an improvement in median overall survival compared to gemcitabine and nab-paclitaxel alone (11.2 months compared to 11.5 months, HR=1.00, p=0.9692). While there was a higher response rate in the PEGPH20 treatment arm, this did not translate into an improvement in duration of response, Progression Free Survival or Overall Survival.

"Patients in both treatment arms of the HALO-301 trial surpassed the published median overall survival rates from the pivotal registration study of ABRAXANE^®plus gemcitabine as first-line therapy for metastatic pancreas cancer, published in 2013. Based on the lack of benefit over standard-of-care in this study, which performed well versus published data, we will be discontinuing PEGPH20 clinical development," said Dr. Helen Torley, president and CEO of Halozyme. "This well-designed and well-executed study did not have the outcome that we or the study participants wanted or expected. I would like to extend a heartfelt thank you to all those who supported and who made this study possible, including the patients who were enrolled, their families, our investigators, their staff, our investors and all of the dedicated Halozyme employees."

Halozyme intends to halt development activities for PEGPH20 and implement an organizational restructuring to focus its operations solely on its ENHANZE^® drug delivery technology.

Further details regarding the organizational restructuring and other strategic actions to position Halozyme for the future can be found in a separate press release issued today.

Conference Call and Webcast Information
Halozyme will webcast a conference call today at 8:30 a.m. ET / 5:30 a.m. PT to discuss its plans to focus strategy on its ENHANZE^® drug delivery technology. Dr. Helen Torley, president and chief executive officer, will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a replay will be available following the close of the call. To access the webcast, please visit www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 824-0907 (domestic callers) or (647) 689-5655 (international callers) using passcode 3069304. A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 3069304.

About Halozyme
Halozyme Therapeutics is a biotechnology that has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx 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 Company's plans to implement an organizational restructuring and to focus its operations solely on its ENHANZE^® drug delivery technology. Forward-looking statements regarding the Company's ENHANZE^® drug delivery technology may include 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 delays or results of the Company's organizational restructuring, 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 recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
[email protected]

SOURCE Halozyme Therapeutics, Inc.