SAN DIEGO Halozyme Therapeutics Inc, which specializes in reformulating drug products available only as infusions, expects to have key results this fall from trials of its "ultrafast" insulin formulations.
Results from the mid-stage studies will dictate how the San Diego-based company moves ahead in the space, Chief Executive Officer Gregory Frost told Reuters in an interview.
"We are going to make a data-driven decision," he said, explaining that Halozyme is weighing whether to license its technology to makers of existing insulins, partner with makers of diabetes drugs who do not currently have an insulin product, market its own product with insulin pumps or all of the above.
The company presented at the annual meeting of the American Diabetes Association here results from a Phase 1 trial of its recombinant human hyaluronidase (rHuPH20) combined with the active ingredient of Novolog, an insulin sold by Novo Nordisk.
The product, called Aspart-PH20, was shown to reduce the variability of insulin absorption and limit changes in post-meal glucose levels compared to Novolog alone in patients with Type 1 diabetes using insulin pumps.
Halozyme is testing its enzyme with several different insulins.
People with Type 1 diabetes must have insulin delivered by injection or a pump in order to survive. Some people with advanced Type 2 diabetes also need insulin to regulate blood sugar levels.
"The problem is ... once the insulin gets under the skin things don't always work the same way," Frost said, explaining the rationale behind Halozyme's product, which is designed to open part of the matrix under the skin, allowing for more consistent insulin absorption.
CANCER AND CELLULITE
Halozyme expects the launch next year of a monthly subcutaneous version of Baxter International's immunoglobulin product for patients with primary immunodeficiency.
Other partnerships include a deal with Roche to develop versions of breast cancer drug Herceptin and lymphoma drug Rituxan that can be delivered subcutaneously, rather than by time-consuming intravenous infusions.
If approved by regulators, the new versions would also push patent expirations on the antibody-based drugs out to between 2027 and 2030, Frost said.
He said subcutaneous Herceptin is expected to reach the market in 2013, followed by Rituxan, also known as Mabthera, in 2014.
Halozyme would receive royalties on the two drugs, which currently have combined annual sales near $11 billion.
The company also has an internal drug development pipeline, and expects to launch a mid-stage trial later this year of an enzyme designed to break down the stroma that surrounds pancreatic cancer tumors, with the goal of allowing chemotherapy to get into the tumor.
Also later this year, Halozyme expects to have top-line results from a Phase 1 trial of HTI-501, an injected enzyme designed to reduce cellulite.
Shares of the company, which closed at $6.55 on Friday, have fallen more than 17 percent so far this year.
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