Halozyme Therapeutics, Inc., a biopharmaceutical company, engages in making molecules into medicines for patients in need. The company’s research focuses primarily on human enzymes that alter the extracellular matrix. The extracellular matrix is a complex matrix of proteins and carbohydrates surrounding the cell that provides structural support in tissues and orchestrates many important biological activities, including cell migration, signaling and survival. The company’s proprietary enzymes can be used to facilitate the delivery of injected drugs and fluids. The company’s proprietary pipeline consists of multiple clinical stage products in diabetes, oncology and dermatology. Strategy Key aspects of the company’s strategy include gaining approval for and launch its proprietary product candidates; maximizing royalty revenue from existing collaborations; and expanding and deepen collaborations. Product and Product Candidates The company has one marketed proprietary product and multiple proprietary product candidates targeting various indications in various stages of development. Proprietary Pipeline Hylenex Recombinant (hyaluronidase human injection) Hylenex recombinant is a formulation of rHuPH20 that has received the U.S. Food and Drug Administration (FDA) approval to facilitate subcutaneous fluid administration for achieving hydration, to increase the dispersion and absorption of other injected drugs and, in subcutaneous urography, to improve resorption of radiopaque agents. The company is continuing to assess its commercial and strategic options for the product to address additional uses, such as in connection with insulin pumps under Ultrafast Insulin Program. The majority of its approved product and product candidates are based on rHuPH20, its patented recombinant human hyaluronidase enzyme. rHuPH20 temporarily breaks down hyaluronic acid (HA) - a naturally occurring substance that is a major component of the extracellular matrix in tissues throughout the body, such as skin and cartilage. Ultrafast Insulin Program The company’s most advanced proprietary program combines rHuPH20 with prandial (mealtime) insulin intended for the diabetes market. The company is viewing two distinct opportunities to enter the prandial insulin market: The first opportunity (what it refers to as the Continuous Subcutaneous Insulin Injection (CSII) market) is to pre-treat the insulin infusion site with Hylenex recombinant at the time of infusion site change (once every 3 days). The second opportunity (what it refers to as the Multiple Daily Injection (MDI) market) is to combine rHuPH20 with an FDA approved rapid acting analog insulin, such as insulin lispro (Humalog) (Lispro-PH20), insulin aspart (Novolog) (Aspart-PH20) and insulin glulisine (Apidra) (Glulisine-PH20), (each such combination, analog-PH20), to accelerate their action. PEGPH20 The company is developing PEGPH20, a new molecular entity, as a candidate for the systemic treatment of tumors that accumulate HA. In 2013, the company presented the results from a Phase 1b clinical study of PEGPH20 in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer (Phase 1b PEGPH20 Clinical Study). In 2013, the company initiated a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer. HTI-501 HTI-501, an engineered drug formulation variant of cathepsin L (a lysosomal proteinase), that acts by degrading collagen, is the company’s primary conditionally-active biologic. The company is exploring HTI-501 as an approach to the treatment of edematous fibrosclerotic panniculopathy, also known as cellulite. Collaborations The company has collaborations with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc. (Roche), Pfizer Inc. (Pfizer), Baxter Healthcare Corporation (Baxter) and Intrexon Corporation (Intrexon), with two products approved for marketing in Europe, one product candidate, which has been submitted for regulatory approval in the U.S., one product candidate which has been submitted for regulatory a
halozyme therapeutics inc
(HALO:Consolidated Issue Listed on NASDAQ Global Select )
11388 Sorrento Valley Road
San Diego, CA 92121
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