Washington Editor

Inhale Therapeutic Systems Inc. said Tuesday that it recently signed three collaboration deals for use of its PEG injectable technology, and a fourth using its pulmonary technology.

In a conference call with investors and analysts, company officials, who were disclosing the deals for the first time, would not release details about financial aspects of the agreements, but did say all include typical up-front, milestone, royalty and manufacturing payments.

Rob Chess, company chairman, later told BioWorld Today that past PEGylation deals have generated royalty and manufacturing payments for Inhale in the mid-single digits.

Of Tuesday’s deals, he said, “I think this shows that biotechnology and pharmaceutical companies are really recognizing the value of our breakthrough technologies to enhance the performance of their drugs.”

The newest companies to sign on are Pharmacia Corp., of Peapack, N.J.; 3-Dimensional Pharmaceuticals Inc., of Yardley, Pa.; Eyetech Pharmaceuticals Inc., of New York; and Unimed Pharmaceuticals Inc., of Chicago.

The first three companies will use the PEGylated technology, while Unimed will work with Inhale to develop a metered-dose inhaler (aerosolized version) of dronabinol (synthetic delat-9-tetrahydrocannabinol, or THC) for numerous indications.

Inhale, of San Carlos, Calif., acquired the PEG technology last year when it purchased Shearwater Corp., of Huntsville, Ala., for $191 million. (See BioWorld Today, May 23, 2001.)

PEG technology entails the attachment of polyethylene glycol polymer chains to a range of therapeutics. PEGylated drugs are designed to increase circulation time, improve drug solubility and stability, and reduce immunogenicity.

“Our strategy at Inhale is to focus on breakthrough delivery platforms with broad applications and to build a leading position in these fields,” Chess said in the conference call. “We believe that strategy is paying off and that is evidenced by the actions of our partners who are signing up to work with us at an unprecedented pace. We expect this pace to continue through 2002.”

The agreements with Pharmacia and Eyetech also generate payments for Enzon Inc., of Piscataway, N.J., based on a strategic alliance under which Enzon granted Inhale the exclusive right to grant sublicenses to Enzon’s PEG technology. (See BioWorld Today, Jan. 9, 2002.)

Pharmacia will use PEGylation technology to advance its studies of CDP870 in both rheumatoid arthritis and Crohn’s disease. The company licensed CDP870 last year from Celltech Group plc, of Slough, UK.

Ajit Gill, Inhale’s president and CEO, said Inhale will receive milestones, royalties and PEG manufacturing revenues if the product is commercialized. The agreement calls for Pharmacia to manage further clinical development and market the product for rheumatoid arthritis.

CDP870 is a humanized antibody fragment that binds with high affinity to tumor necrosis factor-alpha, a key mediator responsible for the inflammation of RA.

In Phase II RA studies, a 400-mg dose of CDP870 showed efficacy, Gill said.

“The efficacy data from Phase II trials was very encouraging, with 72 percent of patients responding to the therapy,” Gill said. “Pharmacia licensed the product from Celltech and gave them up-front payments totaling $50 million and will make additional payments up to $250 million based on the achievement of certain milestones and sales. We expect to see Phase III trials in RA later this year.”

In Crohn’s disease, the Phase II trial is ongoing.

Eyetech Pharmaceuticals, a privately held company, intends to use the PEG technology with its lead product, EYE001, for the treatment of age-related macular degeneration. The product currently is in Phase II/III pivotal clinical trials.

Inhale is scheduled to receive milestone payments, royalties and exclusive manufacturing rights for the PEGylated derivative.

Gill said macular degeneration is caused by abnormal blood vessel growth and leakage that could lead to vision loss.

3-Dimensional Pharmaceuticals signed on to use PEG technology for its synthetic thrombopoietin mimetic compound (3DP-3534) currently in preclinical development for the prevention and treatment of low blood platelet count.

Inhale will supply the technology enabling 3DP to synthesize 3DP-3534, which is a PEGylated peptide. 3DP will pay Inhale an up-front fee, milestone payments, manufacturing fees and royalties on product sales.

“3DP-3534 initially will be tested in clinical studies to see if it can reduce the severity of thrombocytopenia following certain types of chemotherapy,” Gill said. “By reducing the risks of side effects of chemotherapy, 3DP-3534 would contribute to an improved quality of life for cancer patients. We believe this will enter the clinic in 2003.”

Unimed Pharmaceuticals is a wholly owned subsidiary of Solvay Pharmaceuticals Inc. Dronabinol is the active ingredient in Unimed’s Marinol.

In the U.S., Marinol is approved for anorexia associated with weight loss in patients with AIDS and for the treatment of refractory nausea and vomiting associated with cancer chemotherapy.

The terms give Inhale responsibility for development of the formulation, as well as clinical and commercial manufacturing of the drug formulation and inhaler combination.

Unimed will be responsible for clinical development and worldwide commercialization of the system.

Meanwhile, Inhale will receive research and development funding, milestone payments as the program progresses through further clinical testing, and royalty payments and manufacturing revenues upon commercialization.

Inhale’s stock (NASDAQ:INHL) closed Tuesday at $13.60, up $1, or 7.9 percent.