There are now four pivotal trials under way that involve Inhale Therapeutic System Inc.'s PEGylation technology, the fourth coming as Pharmacia Corp. bumped CDP 870 in a Phase III rheumatoid arthritis trial.
Earlier this month, Inhale partner F. Hoffmann-La Roche Ltd., of Basel Switzerland, reported it had gained approval for combination therapy with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) for the treatment of adults with chronic hepatitis C who have compensated liver disease and who have not previously been treated with interferon alpha.
Those developments, said Rob Chess, chairman of San Carlos, Calif.-based Inhale, add to his idea that Inhale's PEGylation platform is "a very established, commercially viable" technology.
"The nice thing for us is that with the combination with the [Pegasys] announcement, we now have six products using our technology that are approved in the U.S. or Europe and another four in pivotal trials," he told BioWorld Today.
The PEGylation technology chemically attaches polyethylene glycol polymer chains to drugs. The attached chains increase the size of drug substances, which can include proteins, peptides, antibodies and some small molecules. Generally, the smaller a drug, the faster a patient's body clears it from the bloodstream, making a PEGylated drug potentially beneficial in several ways.
"What [PEGylation] does is it increases the circulating half-life in the bloodstream," Chess said. "That oftentimes increases the efficacy and safety of the drug itself." It also can mean fewer injections for the patient, he added.
CDP 870 is a humanized PEGylated antibody fragment targeting TNF-alpha. The product is being developed by Peapack, N.J.-based Pharmacia and Celltech Group plc, of Slough, UK, in a deal valued at as much as $230 million to Celltech. The companies formed the alliance in March 2001. (See BioWorld Today, March 6, 2001.)
Also in pivotal trials is its SprayGel adhesion barrier system for the prevention of postsurgical adhesions, partnered with Confluent Surgical; Macugen for age-related macular degeneration, partnered with Eyetech Pharmaceuticals Inc.; and Exubera, an inhaled insulin product partnered with Pfizer Inc., of New York.
Last week Inhale reported it was cutting 75 employees and shifting its focus in order to save itself $8 million in 2003. But with $314 million in cash, cash equivalents and short-term investments as of Sept. 30., and no shortage of partners, Inhale said the move was done "when the company's business is extremely strong." (See BioWorld Today, Dec. 13, 2002.)
"It was done to allow us to focus on increasing our number of proprietary programs," Chess said. "We want to apply our technology broadly ourselves. That's one application. Secondly, we will be increasing our PEGylation manufacturing capacity. Third, we'll be scaling up [our] next-generation pulmonary platform and supercritical fluid processing platform."
Inhale posted a net loss in the third quarter of $26.5 million, or 48 cents per share, but it brought in $23.2 million in revenue, mainly due to increased funding of partnered products. Applying its technology to everything from diabetes to Crohn's disease, Inhale is "still a partnering company," Chess said, although it plans to hold onto programs until "Phase I or Phase II, generally."
The initiation of the fourth pivotal trial, he said, "gives us one of the broadest pipelines in the drug delivery field."