BioWorld International Correspondent
When big pharma sneezes, biotech catches a cold. In this case, though, Danish biotechnology firm Zealand Pharmaceuticals A/S claims to have lined up a remedy, following a decision by the troubled pharmaceutical firm Elan Corp. plc to exit their joint venture Betacure, which had been developing a novel Type II diabetes therapeutic, ZP10.
The Glostrup-based company secured approximately €5 million from existing investors, and it is actively pursuing an alternative development route for ZP10, which completed a Phase I/IIa trial in September.
"We are looking for a partner. We want to outlicense the project completely," CEO Eva Steiness told BioWorld International.
"We do not expect to continue doing any development activities ourselves." With Elan out of the picture, it will, she said, be easier for Zealand to negotiate directly, rather than having to reach a three-way agreement.
The writing was on the wall for Betacure last year, when Dublin, Ireland-based Elan prioritized neurology, pain and autoimmune disease in its turnaround plan. (See BioWorld International, Aug. 7, 2002.)
"When we disclosed the joint venture, the idea was that Elan would be involved in the development, but then they changed their strategy," Steiness said. "They decided not to go into metabolic disease." Elan still has exposure to any potential upside associated with ZP10, as it holds close to 20 percent of Zealand's equity.
The compound, Zealand's lead molecule, is a modified version of exendin-4, a bioactive peptide produced by Heloderma lizard species that are native to several American states. Exendin-4 has similar properties to glucagon-like peptide-1 (GLP-1), a hormone involved in stimulating the release of insulin in the presence of glucose. Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, already are investigating the potential of a synthetic form of exendin-4, exenatide (formerly AC2993), in Type II diabetes. That program, which is now at the Phase III stage, is the subject of an agreement worth up to US$435 million to Amylin.
ZP10 was modified using Zealand's Structure Inducing Probe technology. That enhances peptide stability through the addition of a bound probe that induces a conformational change and thereby protects against enzymatic degradation in the gastrointestinal tract. It could have some advantages over exenidate, Steiness said. "Our therapeutic window is much bigger," she said. ZP10 can be administered at a level close to its maximum efficient dose before side effects such as nausea and vomiting develop, as compared with exenatide. "They are doing dose titrations. We do not expect that we will need [to do] dose titrations for our compound," she said.
BankInvest, of Copenhagen, Denmark, led the new financing round, which brings Zealand's total funding up to DKK232 million (€31 million) since late 1998. The new injection is sufficient to meet the company's needs, Steiness said, "because we are in a situation where we are going to make deals with this compound and maybe another one."