Connetics, Alza enter drug delivery collaboration

Connetics Corp. (Palo Alto, CA) has entered into an agreement with Alza Corp. (Mountain View, CA) to develop an advanced drug delivery system for Connetics' proprietary recombinant human relaxin drug candidate. The development work will focus on applying Alza's implantable drug delivery technology, or DUROS system, to expand delivery options for relaxin. The current delivery system for relaxin involves the use of an external infusion pump. Connetics believes that an improved, more convenient delivery system will be critical for commercialization and acceptance of relaxin to large patient populations. Under the agreement, Connetics will pay all development costs and make milestone payments and royalties to Alza based on the achievement of development milestones and the success of the relaxin product.

"As we expand our clinical development activities with relaxin into infertility and peripheral arterial disease, we are committed to developing additional drug delivery systems to help address the commercial needs for these markets," said Krisztina Zsebo, executive vice president, research and development at Connetics. "Working with Alza allows us to develop a product using an exciting delivery technology which could simplify relaxin administration."

Relaxin is a naturally occurring hormone with a broad spectrum of biological activities including the inhibition of fibrosis and the promotion of vasodilation and angiogenesis. Connetics is currently testing the recombinant human form of the hormone in a pivotal trial for the treatment of diffuse scleroderma. Results from this trial will be announced late in October 2000. Significant preclinical data exist suggesting relaxin's potential in treating vascular and fibrotic diseases. Based on these and other preclinical data, Connetics has begun a Phase I/II clinical trial to study relaxin as a treatment for infertility and expects to initiate clinical trials with relaxin for the treatment of peripheral arterial disease as well as certain cardiovascular diseases.

Alza's unique DUROS Osmotic Implant is a non-biodegradable and osmotically-driven technology that can be used to deliver small drugs, peptides, proteins, genes or other bioactive macromolecules for up to one year of continuous therapy. The implant is a small titanium alloy cylinder. Water enters into one end of the cylinder, driven by an osmotic gradient, through a semipermeable membrane and the drug is delivered from a port at the other end at a controlled rate appropriate to the specific therapeutic agent. The implant membrane can be engineered to permit a wide range of drug delivery rates and times. The lead product incorporating this technology, Viadur (DUROS leuprolide) implant, was approved by the FDA in March 2000 for the palliative treatment of prostate cancer.

For more information: Krisztina Zsebo, Connetics Corp., 3294 West Bayshore Rd., Palo Alto, CA 94303. Tel: 650-843-2800. Fax: 650-843-2899.

Edited by Angelo DePalma
Managing Editor, Pharmaceutical Online
adepalma@pharmaceuticalonline.com