Danish therapeutic peptide specialist Zealand Pharmaceuticals A/S licensed its candidate Type II diabetes treatment ZP10 to Aventis SA in a deal worth up to US$100 million in milestones plus additional royalties on product sales.
The agreement, which includes an up-front payment of US$10 million, assigns global ZP10 rights to Aventis.
The Strasbourg, France-based pharmaceutical firm will take on responsibility for clinical development, regulatory approval, manufacturing, marketing and sales of the product.
This transaction represents Zealand's second deal with a major pharmaceutical firm this year. In May, it entered a co-development pact potentially worth US$50 million with Madison, N.J.-based Wyeth based on its gap junction modulator ZP123, which is in preclinical development as a potential treatment for arrhythmias and other cardiovascular diseases. (See BioWorld International, May 7, 2003.)
ZP10 previously was the subject of a joint venture, Betacure, between Glostrup-based Zealand and Dublin, Ireland-based Elan Corp. plc. The latter company formally pulled out of that initiative in the spring, although it retains an equity stake in Zealand of close to 20 percent. (See BioWorld International, April 2, 2003.)
Zealand had started to look for an alternative partner the previous summer, CEO Eva Steiness told BioWorld International. Interest in the compound was high, she said, but the company went with Aventis because of its extensive GP sales force and its existing position in diabetes. "They are very strong in diabetes and they will be very strong with their pipeline."
ZP10, which is undergoing a Phase IIa trial, is an analogue of exendin-4, a peptide produced by Heloderma lizard species that has similar properties to the glucagon-like peptide-1 (GLP-1) hormone. It binds to GLP-1 receptors in pancreatic beta cells and stimulates insulin release in the presence of high levels of blood glucose. It also suppresses production of glucagon, a hormone that causes the liver to release stored sugar into the bloodstream, thereby reducing the risk of hypoglycemia.
Zealand has not yet published its data, but ZP10 has exhibited efficacy in patients, Steiness said. "From that study we have seen a broad therapeutic window, broader than competitors', and we have an indication of the optimal dose."
ZP10 has been modified by the addition of an amino acid group that was derived from the company's Structure Inducing Probe peptide-modification technology, which, Steiness said, appears to improve both the kinetics and the distribution of the drug. "You can't prevent degradation of peptides but you can control the half-life in a given enzymatic environment."
Zealand has one other compound in the clinic, ZP120, which is in development for treating acute heart failure patients suffering from severe shortness of breath due to excessive accumulation of water in the body. A subcutaneous version of the treatment has completed a Phase I trial, but the company now is developing a formulation for delivery via intravenous infusion. That would offer better therapeutic control, Steiness said, as subcutaneous absorption rates tend to differ in heart failure patients due to edema. The intravenous version of ZP120 should be ready to enter clinical trials during the first half of next year, she said.
Zealand has raised €31 million in venture capital funding since its establishment in late 1998. The latest cash injection notwithstanding, it plans to seek another R25 million in the fall. "We are ambitious. We have a pipeline which is very interesting. We would like to bring new compounds into clinical development," Steiness said.