subcutaneous herceptin (vs intravenous) being developed

[Lani]

Subcutaneous Herceptin Meets Goals in Phase III Trial
The Pink Sheet Daily. 2011 Oct 19, L LaMotta

San Diego-based Halozyme Therapeutics, Inc. and partner Roche announced Oct. 18 that a subcutaneous version of the big pharma's cancer drug Herceptin (trastuzumab) performed similarly to the intravenous version of the biologic when given to early-stage breast cancer patients in a Phase III clinical trial.

The injectable version of the popular cancer drug uses Halozyme's Enhanze technology to break down a substance between the tissue layers of the skin, allowing large-molecule biologics to be administered safely. Enhanze uses recombinant human hyaluronidase (rHuPH20) to temporarily break down hyaluronic acid, a major tissue component in the skin. Whereas the IV formulation requires a 30-minute infusion, the "ready-to-use" version takes five minutes to inject, allowing patients to spend less time in the hospital setting.

Subcutaneous Herceptin would not require preparation and therefore could cut down on pharmacy time. Herceptin IV currently is delivered to pharmacies as a dry powder that has to be formulated the proper dose for each patient. Herceptin SC would be given in a standard 600 mg dose for all patients.

The Phase III trial, deemed HannaH, showed that women receiving the injectible version responded as well to the treatment as those given the IV formulation, with patients showing similar levels of Herceptin concentration in the blood. The subcutaneous formulation also showed no evidence of side effects beyond those typically seen with the IV version. The most common side effects were anemia and low white blood cell count, both normal for patients receiving chemotherapy plus Herceptin treatment.

Further data from the trial will be presented at the San Antonio Breast Cancer symposium in early December. The companies expect to file a hybrid application for approval in the EU, similar to that of an sBLA in the U.S., in 2012. Analysts expect Herceptin SC to be on the European market by 2013.

Halozyme CEO Greg Frost said in an interview that Roche's Genentech division will meet with FDA in coming months to determine if the HannaH data are sufficient for approval in the U.S. and to determine the proper regulatory path going forward. Roche may have to conduct further clinical trials to achieve U.S. approval.

Roche currently is conducting a bridge trial that compares the administration of Herceptin SC via an auto-injector that the pharma is developing compared with the subcutaneous injection being delivered manually.

Roche signed an agreement with Halozyme in December 2006 that would allow the Swiss pharma to use the Enhanze technology with its biologic medications in exchange for $20 million upfront and $111 million in development, regulatory, and sales milestones, as well as royalties.

The agreement applied to three predefined biologic targets, as well as 10 targets that were undetermined at the time. Roche selected a fourth target in December 2008 and a fifth in June 2009. It also has the right to select another eight potential targets that can be enhanced with the Halozyme technology. The biotech has received more than $32 million in milestone payments from Roche so far.

While Halozyme did not receive a milestone payment upon the completion of the HannaH trial, it does expect the next payment upon regulatory filing of the drug and then again once it has been commercialized.

Analysts estimate that Halozyme will receive a mid-single digit royalty on all Herceptin SC sales. The drug currently brings in more than $5 billion annually. Analysts believe that the approval of Herceptin SC would be further validation for the programs currently in Halozyme's pipeline and that use the Enhanze technology on the company's own products.

Roche also is developing cancer drug MabThera (rituximab) with the Enhanze technology for non-Hodgkin's lymphoma. Subcutaneous MabThera currently is in Phase III and could hit the market by 2014.

Halozyme has partnerships for its Enhanze technology with several other companies, including Baxter and ViroPharma, which Frost sees as "the first horizon for the company." Halozyme also is developing pipeline programs, including an insulin therapy, which use the Enhanze technology. The biotech uses the milestone money it gets from partnerships to fund these pipeline initiatives.

[NEDenise]

Lani,
Very interesting development! Thanks for sharing this with the rest of us!
Denise

[YellowTail]

Always nice to read about medical advancements, thanks for sharing !