In its largest financing to date, Eximias Pharmaceutical Corp. raised $63.5 million to carry its flagship product Thymitaq through Phase III liver cancer trials and to the market.
For Eximias - a company with only 20 employees and, up until now, only one product in the pipeline - it's no small matter.
"We've got blue-chip investors rallying behind little Eximias, and this has been a four-year fight to find something for patients with unresectable liver cancer," said Elizabeth Corsi, president and CEO of Berwyn, Pa.-based Eximias. "We're very excited."
Thymitaq has potential to become a blockbuster product as the first treatment approved for unresectable liver cancer, according to some reports.
Not only will the funds from this Series D financing take Thymitaq through a Phase III program to an estimated mid-2005 new drug application filing and potential launch, it also will help Eximias build a pipeline of other late-stage products, including an oral version of Thymitaq and an in-licensed oncology and infectious disease compound.
"This is the largest financing for us," said Fred Powell, chief financial officer at Eximias, who said the company has raised about $94 million to date. "I think it's a very significant milestone in the company. Up until this point we had been operating with a very shoestring budget to complete the clinical trials that we have."
Focused mainly on Thymitaq, Eximias now is building a pipeline that includes Orataq for oncology and Macrotac for oncology and infectious diseases. Orataq is the oral version of Thymitaq and might be studied for indications outside liver cancer. Macrotac was licensed from Emeryville, Calif.-based Chiron Corp. in January 2001. Chiron covered earlier clinical trials, and now Eximias plans to begin Phase III trials of Macrotac for undetermined oncology and infectious disease indications. (See BioWorld Today, Feb. 2, 2001.)
"We want to build the front end of the portfolio so we have revenues to sustain the business," Corsi told BioWorld Today.
Conducted in North America and certain European and South African countries, the Thymitaq trial has enrolled 350 of the 446 patients needed. Powell said enrollment should be completed by the fourth quarter.
In addition to U.S. marketing approval, the company plans to seek approval in Europe and Asia.
Thymitaq has been the subject of 22 completed clinical trials in indications such as pancreatic cancer and head and neck cancer. In a Phase II trial, it demonstrated a 32 percent response rate in head and neck cancer patients. It also has shown it can be orally and intravenously absorbed. Most cancer drugs are not absorbed orally, Corsi said.
The NDA filing will seek approval of Thymitaq as a first-line intravenous therapy for unresectable liver cancer. Other cancer indications could follow, she said.
Eximias licensed Thymitaq, a thymidylate-synthase inhibitor, from Agouron Pharmaceuticals Inc., of La Jolla, Calif., in 1998, while Agouron transformed itself from an oncology company to an HIV company.
"It was the right decision for Agouron at the time, and it was our good fortune that they made that decision," Corsi said.
Corsi said the company plans to build its own U.S. sales force and to partner Thymitaq and any other products in markets outside the U.S. Corsi said that almost 70 percent of U.S. cancer cases are concentrated in 17 states, making the market a manageable size for a small company. The company also expects eventually to go public.
"Obviously we're taking a look at the public markets," Corsi said, "and I don't think we've made a decision as to whether or not we'll file this year. It will depend on market conditions and then what happens with the Phase III trials."
Corsi compared the Thymitaq story to the Gemzar story of 1996. Gemzar hit the market as the first treatment of pancreatic cancer, much like Thymitaq would be the first unresectable liver cancer product.
Gemzar, marketed by Indianapolis-based Eli Lilly and Co., earned $1.2 billion in worldwide sales last year, Corsi said.
Founded in 1997, Eximias completed a $23.5 million Series C financing in 2000, when the company was called Zarix Inc. The company changed its name in July 2002 to reflect strategy and management changes. (See BioWorld Today, Oct. 5, 2000.)
Cross Atlantic Partners, of New York, and Quaker BioVentures, of Philadelphia, co-led the oversubscribed Series D round. New investors include New Enterprise Associates, OrbiMed Advisors, Birchmere Ventures, Easton Hunt Capital Partners, Cross Atlantic Capital Partners, Pacific Rim Ventures and Emerging Technology Partners. All Series C institutional investors also participated.
As part of the financing, Eximias appointed to its board John Cassis, of Cross Atlantic Partners; Brenda Gavin, of Quaker BioVentures; Michael Sheffery, of OrbiMed Advisors; and M. James Barrett, of New Enterprise Associates.
Ferghana Securities, of New York, served as placement agent and financial adviser for the transaction.