BioWorld Today Contributing Writer

When serial entrepreneur Reginald Hardy formed Concordia Pharmaceuticals Inc. in 2003, it was to answer the question, "Can we use our relationships to build a pharmaceutical company?" Seven years later, the answer is clear: affirmative.

Having recently licensed its first-in-class Phase II cancer drug, salirasib, to Japan's Ono Pharmaceutical Co Ltd., the Fott Lauderdale, Fla.-based company continues to do business on a virtual basis, building value on its relationships, headed by a four-man team with more than 100 years of combined experience in the pharmaceutical industry.

The management team, comprised of Hardy, Marc Watson, Victor Bauer and Hubert Huckel, quickly identified a ras inhibitor discovered by Yoel Kloog at Tel Aviv University, and made arrangements to develop the compound as a cancer drug.

The focus of Concordia has always been to move salirasib into Phase II studies, as quickly and efficiently as possible, and find a partner," Hardy told BioWorld Today.

The ras family of genes were the first identified oncogenes, so named because it was first found in rat sarcoma in the 1960s. However, efforts to develop cancer therapeutics by targeting ras protein have not been very successful thus far. (See BioWorld Today, June 2, 2009.)

Salirasib is the very first ras inhibitor to be developed for cancer therapy. The U.S. Adopted Names Council's (USAN) created a new name stem, "rasib" for Concordia in 2006 to reflect that fact.

In 2009, Concordia reported encouraging interim data from Phase I and II trials of patients with advanced pancreatic cancer and advanced non-small-cell lung cancer (NSCLC). Salirasib improved one-year survival in patients with advanced pancreatic cancer, and in a separate Phase II study in NSCLC, 38 percent of the treatment-naive salirasib group had stable disease following treatment.

In August, salirasib completed Phase I trials for pancreatic cancer at Johns Hopkins University and Phase II trials for NSCLC at Memorial Sloan-Kettering Cancer Center.

On Sept. 1, Ono signed an agreement with Concordia to develop and commercialize salirasib in Japan for all indications. (See BioWorld Today, Sept. 2, 2010.) That was a planned development in Concordia's overall business strategy.

Concordia sought a Japanese partner because even though the population is smaller, Japan has about the same number of pancreatic cancer cases – around 28,000 per year – as the U.S.

"We saw Japan as a very good opportunity for us. Ono is an ideal partner for us because of their experience in the oncology market and the development of first-in-class products," Hardy noted.

Through the deal, salirasib becomes part of Ono's growing pipeline of cancer drugs. Earlier this year, Ono licensed regional development and commercialization rights to a Phase IIb multiple myeloma drug, carfilzomib, from Onyx Pharmaceuticals Inc.

Concordia will receive an up-front payment from Ono, with additional milestone payments possible in the future based on clinical and regulatory progress. Concordia will also receive royalties on the sale of salirasib in Japan. The financial details were not released; Hardy said that Concordia has been funded privately from the start.

"Right now we're not looking for any additional financing. . . . We're talking with companies interested in acquiring global rights outside of Japan for salirasib," he noted.

In spite of the fact that pancreatic cancer is a notoriously aggressive cancer, often discovered in its advanced stages, few treatments have been found. Gemcitabine, marketed as Gemzar by Eli Lilly and Co., is the front-line therapy with annual sales of more than $500 million per year.

Median survival for patients with pancreatic cancer on gemcitabine is 6.2 months, with 19 percent survival at one year.

"We see this drug as being used in combination with gemcitabine or other therapies in the treatment of pancreatic cancer," Hardy said.

Regarding future business and exit strategies, Concordia's plans are as simple and laser-focused as its start-up strategy. "The exit is pretty well defined," he added. The company will seek additional regional partners like Ono, as well as an additional global partner to shepherd salirasib through Phase III trials and registration studies.

What's next after Concordia for serial entrepreneur Hardy? "We'll start something else."