NEWS & COMMENTS

PROHOST    FILTER

                                                                     HALOZYME

                                                                  FIRST: THE NEWS

Halozyme Therapeutics (HTI) and Roche entered into an agreement to apply Halozyme's proprietary Enhanze™ Technology to Roche's biological therapeutic compounds. Enhanze Technology is Halozyme's proprietary drug delivery technology based on its recombinant human hyaluronidase (rHuPH20). rHuPH20 is an analogue of a human enzyme that temporarily clears space in the matrix of tissues such as skin. This clearing activity should allow rHuPH20 to improve drug delivery by enhancing the entry of therapeutic molecules through the subcutaneous space.

READ MORE: Halozyme and Roche Enter Agreement for the Application of Enhanze, A Novel Technology to Improve Drug Delivery

PROHOST COMMENTS:  After the announcement of this news, HTI price almost doubled. The reason? Informed investors took the agreement as a validation to this firm's technology, which increases the confidence in its approved products and pipeline products.

HALOZYME PROFILE

And Pipeline

   Halozyme Therapeutics develops and commercializes recombinant human enzymes for the drug delivery, palliative care, oncology and infertility markets. Halozyme has two FDA-approved products, Cumulase, for in vitro fertilization (IVF), and Hylenex, for drug and fluid infusion. In June 2005, the company transitioned from a development-stage organization to a commercial entity after the launch of its first product Cumulase Halozyme also has one product candidate, Chemophase, a chemoadjuvant for superficial bladder cancer, which is in clinical development. All other product candidates are in the research or pre-clinical stage. Its Enhanzed Products (agents for enhanced drug delivery) include HTI-101 and HTI-201 (inflammation, oncology), and HTI-401 (central nervous system trauma and wound healing).

Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20, an enzyme essential to preparation of oocytes (eggs) prior to IVF during the process of intracytoplasmic sperm injection (ICSI). The firm’s rHuPH20 replaces the bovine enzyme used for this important procedure. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to perform the ICSI procedure, injecting the sperm into the oocyte.

    The FDA considers hyaluronidase IVF products as medical devices subject to 510(k) approval and the Company filed its 510(k) application in September 2004 and received FDA clearance in April 2005. Halozyme launched Cumulase in the European Union and in the United States in June 2005.

Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other

injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. Hylenex was approved in December 2005. Hylenex facilitates subcutaneous delivery of fluids up to one liter without the need for intravenous access, a procedure known as advanced subcutaneous infusion (ASI).

ASI for fluid replacement in terminal patients may be achieved with limited or no need for nursing assistance.

INcreased Flow: During January 2006, Halozyme completed Utilizing Subcutaneously-Enabled Lactated Ringer's (INFUSE-LR) clinical trial study, designed to determine the subcutaneous (Sub-Q) infusion flow rate of Lactated Ringer's solution with and without Hylenex.

- To determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose.

- To assess safety and tolerability.

Results: There were no serious or severe adverse events (AE). Based on the AE profile, Hylenex was at least as well tolerated as placebo.

A natural extension of Hylenex may be applying this technology as a spreading factor for local anesthetics around the eye, to other areas of the body. For example, lidocaine and bupivacaine are administered for most minor surgical operations requiring local anesthesia and that the dispersion rates of these local anesthetics might be improved through a combination with Hylenex.

Chemophase: The is the firm's lead oncology product candidate. This product is a chemoadjuvant designed to  enhance the transport of chemotherapeutic agents to tumor tissue, increasing diffusion in tissues without affecting vascular permeability.

Indications: This product is designed for the treatment of patients with various solid malignant tumors. 

Rationale: Many solid tumor types (such as colon, breast, prostate) accumulate hyaluronic acid, creating a barrier to the penetration of current or future chemotherapeutics. Previous clinical trials of bovine (bull) PH20 in patients showed enhancing chemotherapy regimens using adjunctive systemic hyaluronidase in previously chemo-refractory patients.

     In June 2005, Halozyme submitted an investigational new drug application (IND) in order to begin clinical testing of its Chemophase product candidate in superficial bladder cancer. Authorization was granted for the initiation of clinical testing of Chemophase in August 2005. Patient enrollment started in October 2005. Enrollment in Chemophase Phase I clinical trials was completed in March 2006.

Enhanze Technology, a drug enhancement system using rHuPH20. This technology is Halozyme’s broad technology has been expected to bring partnerships with other pharmaceutical companies. It did (See agreement with Roche above)

      When co-formulated with other injectable drugs, Enhanze Technology may act as a molecular machete to facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin. Molecules as large as 200 nanometers may pass freely through the perforated extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform, which does not permanently alter the architecture of the skin. Halozyme is seeking partnerships with pharmaceutical companies that market drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology.

HTI-101, 201, and 401: These products are being investigated for potential use in oncology, inflammation, and central nervous system trauma and wound healing.

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