Shares of Halozyme Therapeutics Inc. jumped 18.6 percent Tuesday on news that its subcutaneous version of HER2-positive breast cancer drug Herceptin (trastuzumab) was comparable to the marketed intravenous infusion in a Phase III study, positioning the firm to seek approval in Europe next year.

The San Diego-based company's stock (NASDAQ:HALO) closed at $7.35, up $1.15.

Herceptin, developed by Genentech Inc., now part of Roche AG, has been a success for the Swiss big pharma firm – sales topped $6 billion in 2010 – but administration requires a 30-minute infusion.

Using its Enhanze technology, which is designed to facilitate the delivery of drugs and fluids injected into the skin or muscle, Halozyme's subcutaneous formulations pares that administration time down to about five minutes.

Roche licensed rights to Enhanze in 2006 and is applying the technology to some of its other blockbuster drugs as well, including MabThera/Rituxan (rituximab). Enhanze-improved MabThera is in testing in CD20-positive non-Hodgkin's lymphoma and in chronic lymphocytic leukemia. (See BioWorld Today, Dec. 7, 2006.)

Other collaborations for Halozyme followed. The biotech signed a deal in 2007 with Baxter International Inc. for a subcutaneous version of intravenous immune globulin product Gammagard.

That product, known as HyQ, previously met its endpoints in a Phase III trial in primary immunodeficiency disorders and is under FDA review. (See BioWorld Today, Sept. 11, 2007.)

Earlier this year, Halozyme inked deals to use Enhanze with ViroPharma Inc.'s hereditary angioedema drug Cinryze (C1 esterase inhibitor) and with Intrexon Corp.'s investigational recombinant human alpha 1-antitrypsin drug. (See BioWorld Today, May 12, 2011, and June 8, 2011.)

Full data from the HannaH trial testing subcutaneous Herceptin are expected at a scientific conference later this year.

The 596-patient study enrolled women with HER2-positive early breast cancer and was designed to compare Herceptin concentration in the blood, efficacy (as measured by pathologic complete response) and safety of the subcutaneous version compared to the I.V. version.

Secondary endpoints include event-free survival and overall survival and are ongoing. But those data are not needed for approval in the early, resectable breast cancer population, noted Jefferies analyst Eun K. Yang.

Roche plans to submit a European marketing authorization application (MAA) next year, which means subcutaneous Herceptin could be on the market in 2013.

In addition its partnered programs, Halozyme also is working on an internal pipeline. It recently began a Phase I/II study of HTI-501 (rHuCAT-L), a recombinant human proteinase, in women with moderate to severe edematous fibrosclerotic panniculopathy.

That drug also has applications in other dermatologic and aesthetic indications.