TransTech Pharma Inc. reacquired all rights to a glucokinase activator program that it had partnered with Novo Nordisk A/S more than five years ago, increasing an already healthy pipeline in the area of diabetes.

TransTech, of High Point, N.C., acquired small-molecule clinical and preclinical compounds, as well as intellectual property surrounding the technology through an exclusive license with Novo, which last month said it was shifting its focus to development of protein-based drugs. Novo is entitled to an up-front payment along with potential milestone and royalty payments in the deal.

"To get this program back is a dream come true," Adnan Mjalli, founder, chairman and CEO of privately held TransTech, told BioWorld Today. "We've wanted to have this program for a long time. We're thrilled."

Mjalli would not discuss specifics of the deal or the status of the development programs, other than to say they include preclinical and clinical compounds But he did say the license gives TransTech "a very dominant position" in the area of glucokinase activators.

"GK activation, we believe, is a key switch to the cause of diabetes, as well as the prevention of diabetes," he said. "Some initial data we have seen showed you can normalize glucose levels without having the side effects [of hypoglycemia] associated with antidiabetic agents.

"We do not effect the activation in the pancreas or in the beta cells," he continued. "These molecules have a very unique profile."

The small-molecule compounds and accompanying intellectual property were developed under the deal with Novo, of Bagsvaerd, Denmark, that began in August 2001, TransTech's first significant collaboration - but certainly not its last. The deal called for TransTech to apply its TTP Translational Technology to the discovery of small-molecule therapeutics against Novo targets.

"We're getting the whole program," Mjalli said, adding that there was a lot of interest from others, "which made it difficult for a small company to compete with the big boys." He said a deciding factor at Novo could have been the progress that has been made, the capabilities TransTech brought to the program and the "competitive" financial terms.

"This gives us full domination of the concept, not just the molecules but the field itself," he said. "It's going to be quite difficult for people to get into this area without coming to TransTech for a license."

The deal with Novo adds to three internally developed, small-molecule programs in the diabetes/obesity area that TransTech plans to move into the clinic in the near term, along with a fourth expected to begin clinical testing in six months to a year.

The nearer-term programs include an inhibitor of protein tyrosine phosphatase-1B, or PTP1b, a target that mediates insulin resistance; an obesity-targeting inhibitor of AgRP, a ligand of the melanocortin 4 receptor; and an agonist of the glucagon-like peptide-1 receptor, or GLP-1R, in diabetes. The fourth program targets AMP-activated protein kinase, a target in metabolic disorders. TransTech also has programs in others areas, and plans to move an oncology candidate into the clinic in the next few months, too.

A blockbuster out-licensing deal with Pfizer Inc., of New York, last year is providing TransTech the resources to fund its up-and-coming pipeline. Pfizer got rights to compounds targeting the receptor for advanced glycation endproducts (RAGE), which includes a Phase II-stage small molecule (TTP488) against Alzheimer's disease and diabetic nephropathy.

TransTech, which has raised more than $100 million in venture financing, was entitled to up to $155 million in up-front and near-term milestone payments from that deal, as well as up to $18 million in research funding. (See BioWorld Today, Sept. 19, 2006.)

Specific and additional terms of that deal were not disclosed, but Mjalli said it was one of the biggest ever in the industry, and provided TransTech cash for the next five or six years. "I don't have to raise any more money," he said.

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