Smart companies are cautious about fiddling with successful products. So I was intrigued to learn that Roche was reformulating its blockbuster breast cancer drug trastuzumab to include an enzyme from San Diego-based Halozyme Therapeutics (NASDAQ: [[ticker:HALO]]). Last week I caught up with Halozyme CFO Kurt Gustafson, who offered some insight into why companies like Roche are interested in the product.
First some background: Halozyme’s enzyme is a genetically-engineered copy of human hyaluronidase, which breaks down a gel-like substance found in cartilage and skin. This activity can speed the absorption of injectible drugs into the bloodstream or the lymph system.
Hyaluronidase from cattle or sheep has been used for decades to speed the absorption of anesthetics during cataract surgery. Roche is using Halozyme’s human hyaluronidase to develop an injectible form of trastuzumab, which is currently available only as an intravenous drug that takes about an hour to administer, often in a hospital.
Roche has solid business reasons for wanting to modify trastuzumab, which had global sales of nearly $5 billion in 2009. Gustafson explained that trastuzumab may soon face competition from generic knockoffs, particularly in Europe. (Currently, there is no clear path to approval for biologic generics in the U.S.) By offering trastuzumab shots that patients can use at home, Roche can eliminate the cost of administering the drug in a hospital infusion ward. This will help Roche compete against intravenous generic drugs, which carry added infusion costs.
The reformulated drug is in late-stage trials that Roche expects to complete by the end of this year.
This deal is part of Halozyme’s broader strategy for the enzyme, dubbed PH20. “We are leveraging PH20 in two ways,” Gustafson told me. “First we are licensing it to others to use with their drugs. And second, we are taking it and combining it with other drugs that have lost patents or might be losing their exclusivity.”
This allows Halozyme to make a new