CORRECTED - Halozyme: subcutaneous Herceptin trial met goals
* Halozyme patents valid through at least 2024By Deena BeasleyOct 18 (Reuters) - Halozyme Therapeutics , which
specializes in reformulating drug products available only as
infusions, said a pivotal trial of subcutaneous Herceptin, the
cancer drug sold by Roche , met its goals.The under-the-skin injections offer a faster, more
convenient way to administer the drug, according to Halozyme
Chief Executive Officer Gregory Frost. Herceptin had 2010
global sales of $6.8 billion.In addition, Halozyme’s enzyme technology is patented
globally until 2024, with formulation patents extending beyond
that, he said.The Phase 3 Roche trial, involving patients with a specific
type of breast cancer, showed that women receiving the
subcutaneous injection responded to the drug as well as women
treated with intravenous Herceptin, Halozyme said on Monday.No new safety signals were observed, with the most common
side effects being infections and anemia, the company said.Frost said Roche plans to file next year for European
regulatory approval of subcutaneous ready-to-use Herceptin,
which takes about five minutes to administer, compared with at
least 30 minutes for the intravenous infusion.Halozyme said the new formulation may also reduce pharmacy
time since no preparation is needed.Roche is expected to present full details of the trial at
an upcoming medical conference.Halozyme said it is “comfortable” with Wall Street
estimates of a mid-single-digit royalty from Roche on sales of
subcutaneous Herceptin. It also earns milestone payments from
the development deal.Roche is also conducting pivotal trials of subcutaneous
Halozyme-engineered Rituxan, also known as MabThera, in
patients with non-Hodgkin’s lymphoma and chronic lymphocytic
leukemia.Both Herceptin and Rituxan are monoclonal antibodies that
require such large-volume doses that they cannot currently be
given subcutaneously.