San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO) to­day an­nounced the sub­mission of a New Drug Appli­ca­tion (NDA) to the Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharma­ceu­tical K.K. (Janssen) seek­ing ap­­prov­al of a new sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab, an in­tra­venous (IV) treat­ment approved for patients with mul­ti­ple myeloma.

"We are pleased to see this New Drug Appli­ca­tion sub­mission in Japan, which builds on Janssen's prior regu­la­tory sub­missions in the U.S. and EU that are cur­rent under re­view," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. "We are ex­cited that patients with mul­ti­ple myeloma in Japan may soon have a new thera­peutic op­tion that can be admin­istered with a shorter in­fusion time when com­pared with a multi-hour in­tra­venous in­fusion."

The NDA is sup­ported by pivotal data from the Phase 3 COLUMBA (MMY3012) study – a ran­dom­ized open label study – that in­cluded a non-inferiority comparison of dara­tu­mu­mab SC for­mu­la­tion versus dara­tu­mu­mab IV admin­istra­tion in patients with mul­ti­ple myeloma who had re­ceived at least three prior lines of ther­apy in­clud­ing a pro­te­a­some in­hib­i­tor (PI) and an immuno­modu­la­tory drug (IMiD), or whose dis­ease was re­frac­tory to both PI and IMiD. In addi­tion to non-inferiority, dara­tu­mu­mab SC showed a lower rate of in­fusion-related reac­tions. Data from the Phase 2 PLEIADES (MMY2040) study – a non-randomized open label study con­ducted in newly diag­nosed or re­lapsed or re­frac­tory mul­ti­ple myeloma patients – are also in­cluded in the NDA. The sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab is co-formulated with Halozyme's ENHANZE® drug de­livery tech­nology, based on recombinant human hyal­uron­i­dase PH20 (rHuPH20).

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, Inc. is a biopharma tech­nology plat­form com­pany that provides inno­va­tive and disruptive solu­tions with the goal of im­prov­ing patient ex­peri­ence and out­comes. Our pro­pri­e­tary enzyme rHuPH20 is used to facilitate the de­livery of injected drugs and fluids. We license our tech­nology to bio­pharma­ceu­tical com­pa­nies to col­lab­o­ratively de­vel­op prod­ucts that com­bine our ENHANZE® drug de­livery tech­nology with the col­lab­o­rators' pro­pri­e­tary com­pounds. Halozyme is headquartered in San Diego. For more in­for­ma­tion visit www.halozyme.com.

Halozyme 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, 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 the prod­uct de­vel­op­ment efforts of Halozyme's ENHANZE® part­ner. 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 in­clud­ing any poten­tial delays caused by the cur­rent COVID-19 global pan­dem­ic, 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.

Source: Halozyme Thera­peutics.