San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO), a bio­technology com­pany devel­op­ing novel on­col­ogy and drug-delivery ther­a­pies, to­day an­nounced that its col­lab­o­rator Janssen Biotech, Inc. (Janssen) has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion for the sub­cu­tane­ous de­livery of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma.

"Janssen's BLA sub­mission for sub­cu­tane­ous DAR­ZA­LEX® rep­re­sents an im­por­tant devel­op­ment for our ENHANZE® drug de­livery tech­nology business," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. "We are delighted that an ap­­prov­al of the sub­cu­tane­ous for­mu­la­tion may soon provide patients with mul­ti­ple myeloma a new thera­peutic op­tion that offers the poten­tial of DAR­ZA­LEX® with a shorter admin­istra­tion time."

Janssen's BLA sub­mission follows the an­nouncement of pos­i­tive re­­sults from its Phase 3 COLUMBA study, which in­ves­ti­gated sub­cu­tane­ously admin­istered DAR­ZA­LEX® in comparison to in­tra­venous DAR­ZA­LEX® in patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. Subcutaneous DAR­ZA­LEX®, using ENHANZE® drug de­livery tech­nology, was found to be non-inferior to in­tra­venous DAR­ZA­LEX® with regard to the co-primary end­points of over­all re­sponse rate and Maximum Ctrough con­cen­tra­tion on day 1 of the third treat­ment cycle.

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.

About Halozyme

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, 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, the prod­uct devel­op­ment and ap­­prov­al efforts of Halozyme's ENHANZE® part­ners and 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, and state­ments con­cern­ing cer­tain other poten­tial ben­e­fits of ENHANZE® in­clud­ing facilitating more rapid de­livery of injectable med­i­ca­tions through sub­cu­tane­ous de­livery. These for­ward-looking state­ments also in­clude state­ments re­gard­ing Halozyme's poten­tial receipt of pay­ments asso­ci­ated with future col­lab­o­rative target nominations, achieve­ment of cer­tain mile­stones, and royalties on sales of com­mer­cial­ized prod­ucts. These for­ward-looking state­ments in­volve­ risks 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 un­cer­tain­ties con­cern­ing whether col­lab­o­rative prod­ucts are ultimately devel­oped, approved or com­mer­cial­ized, unexpected ex­pen­di­tures and costs, unexpected re­­sults or delays in devel­op­ment and regu­la­tory re­view, unexpected regu­la­tory ap­­prov­al re­quire­ments, unexpected ad­verse events and competitive con­di­tions. These and other factors that may re­­sult in dif­fer­ences are discussed in greater detail in Halozyme's most recent Annual and Quar­ter­ly Reports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion. Except as re­quired by law, Halozyme under­takes no duty to up­date for­ward-looking state­ments to reflect events after the date of this re­lease.

DARZALEX® is a trade­mark of Janssen Pharmaceutica NV.

Source: Halozyme Thera­peutics.