Several upcoming catalysts in play for Halozyme Therapeutics Print E-mail
By Brian Wilson   
Monday, 10 October 2011 06:36
FDA CalendarHalozyme Therapeutics (Nasdaq:HALO) is one to watch as the company is targets a substantial improvement in the growing diabetic market space, plus multiple clinical data milestones in the near future.

Halozyme is developing a hyaluronidase enzyme named PH20 to be used with insulin injections for a more rapid effect with greater consistency in treatment of diabetes.  The company has already put the new enzyme through Phase I studies, where healthy subjects injected with PH20 were shown to have favorable results – the subjects’ reaction closely mimicked the body’s natural release of insulin.

In 2009 the company released the data from its first Phase II study, which was performed to evaluate the enzyme’s effects in patients with type 1 diabetes. The study ultimately confirmed the results that were found in the Phase I trials – PH20 accelerated insulin absorption to more closely mimic the body’s natural reaction. By making the body’s reaction to medical insulin faster and more efficient, PH20 helps improve the patient’s overall reaction to diabetic treatment through better glycemic control and less weight gain.

Another phase II study was performed after to demonstrate the reduction in peak and total hyperglycemic excursion when combining PH20, lispro and the standard insulin treatment. This further proved the enzyme’s beneficial effects in glycemic control. This most recent clinical trial has finished in September of 2011, and the results are now available internally in the company. The release of this information is expected in the near future, and could be a driver in shares of HALO.

In addtion, a look at the BioMedReports FDA Calendar and World Regulatory Catalyst Tracker shows several more upcoming milestones for the stock- including as many as three more this quarter.

One of these milestone catalysts involves pivotal Phase III trial results for Roche Holdings' (RHHBY) Herceptin(R) as indicated for Her2-Positive Breast Cancer.  

Why is this important to HALO? Because the company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin(R) and MabThera(R), and with Baxter BioScience to apply Enhanze technology to immunoglobulin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. See theses press releases below:

We note that Halozyme reminded their own shareholders of the fact that Roche completed patient enrollment of its Phase 3 registration study for Herceptin(R) SC in December for the treatment of HER2-positive breast cancer and has stated it expects to have results from this study by the end of 2011.  At the end of September Roche reported positive data from a mid-stage trial on trastuzumab emtansine (T-DM1) in treatment-naïve patients with HER2-positive metastatic breast cancer. The phase II trial (TDM4450g) compared trastuzumab emtansine with the combination of Herceptin (trastuzumab) and chemotherapy (docetaxel).

In addition, in February 2011, Roche began patient dosing of the Phase 3 MabThera(R) SC  clinical trial in patients with follicular non-Hodgkin's lymphoma. Roche has stated it expects to file for the approval of Herceptin SC and MabThera SC in the EU during 2012.

HTI-501 is a first-in-class injectable recombinant human enzyme that has been shown preclinically to locally break down the collagen fibrils that can cause disfiguring scars, contractures and cellulite. If this unique mechanism of action is successfully recapitulated in the clinic, HTI-501 could represent another potential blockbuster opportunity for the company. HTI-501 will undergo ex-U.S. first-in-human safety and proof of mechanism studies in aesthetic medicine, with clinical data anticipated in late 2011 or early 2012.

Stated Gregory I. Frost, Ph.D.,
Halozyme's president and CEO. "Halozyme's research pipeline is positioned to achieve value inflection points this year including the results of three Ultrafast Insulin studies and the start of additional clinical trials for PEGPH20 in pancreatic cancer and for HTI-501 to assess its potential utility in cellulite. Our alliance partners should also demonstrate substantial progress in 2011 for products that utilize our technology as Baxter has stated it expects to file a BLA for HyQ (immunoglobulin subcutaneous) and Roche has stated it plans to announce top line data from the pivotal Phase 3 trial for subcutaneous Herceptin(R)."

Disclosure: None

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