By Lisa Seachrist
Having operated solely on equity financing for five and a half years, Trimeris Inc. signed its first corporate partnership that, all told, could be worth in excess of $88 million.
Durham, N.C.-based Trimeris partnered with Basel, Switzerland-based Roche Holdings Ltd. to develop the novel anti-HIV fusion inhibitors, T-20 and T-1249. The companies will co-develop the products in the U.S. and Canada, while Roche will develop the drugs in the rest of the world.
"Roche is a leader in drug development, which is very important," said Michael Rechny, architect of the deal and vice president of corporate development at Trimeris. "And, a timely introduction of a whole new class of anti-retroviral agents fits with their corporate profile. They will help us speed the timely development of T-20 and T-1249."
Under the terms of the deal, Roche will pay Trimeris $10 million up front and up to an additional $78 million in developmental, regulatory and commercial milestone payments for T-20 and T-1249. In the U.S. and Canada the companies are 50-50 partners, sharing the costs of development and splitting any future profits.
"We will be deeply involved in the marketing strategy and education of physicians and communication with patient groups," Rechny said. "But, it makes sense for us to let Roche do what Roche does best and use their existing sales force."
Roche will retain the rights to develop and market T-20 and T-1249 in the rest of the world and will fund all of those activities. Trimeris will receive undisclosed, but "very good," royalties on overseas sales, said Matthew Megaro, president and CEO of Trimeris.
Both T-20 and T-1249 are peptide drugs that work against HIV by keeping the virus from attaching to cells rather than by targeting already infected cells. T-20, Trimeris' lead drug candidate, has demonstrated in clinical trials the ability to inhibit the fusion of HIV to uninfected cells. It is in a Phase II clinical study, which is scheduled for an interim analysis during the third quarter of this year.
The second-generation anti-HIV fusion inhibitor, T-1249, is in a Phase I/II trial. Preclinical testing of the drug has shown that virus resistant to T-20 is susceptible to T-1249. In addition, neither T-20 nor T-1249 has shown drug-drug interactions that are the hallmark of other HIV therapies.
Both of the drugs require patients to give themselves subcutaneous injections, similar to insulin injections that diabetics administer to themselves. T-20 currently is given two times a day. The company is conducting a dosing study to determine the appropriate dose for T-1249. However, the two companies may investigate other formulations that could result in less frequent needle sticks.
"Roche offers expertise in developing new formulations, leaving that possibility open to us," Rechny said.
Roche also offers expertise in manufacturing scale-up. Trimeris managed a manufacturing breakthrough when the company developed a means to produce kilogram quantities of the two synthetic peptides. However, Megaro noted the company will need to produce metric tons of the drugs.
"We've created a process that is scaleable," Rechny said. "Roche brings a lot of expertise both internally and with third-party contractors to reach our goal."
Megaro mused that the process may allow active peptide drugs, which were orphaned because of production issues, a possible avenue to further clinical development. However, he also noted the primary responsibility of the company would be to see T-20 and T-1249 through clinical development.
Trimeris' stock (NASDAQ:TRMS) closed Monday at $18, down 50 cents per share.