ThromboGenics NV is seeking a partnership for an experimental blood thinner with an upfront cash payment large enough to help fund the introduction of eye treatment microplasmin, the company’s most advanced product.
ThromboGenics, based in Leuven, Belgium, is in talks with large pharmaceutical companies and is looking for a “front- loaded” deal for the anti-clot drug, TB-402, Chief Executive Officer Patrik De Haes said. TB-402 is in the second of three stages of testing normally required to get regulatory approval.
The company aims to find a partner for TB-402 by the first half of next year, De Haes said. That would help fund the company’s planned release and additional study of microplasmin, which treats patients with a retinal disorder that can lead to blindness. ThromboGenics plans to file microplasmin for U.S. and European regulatory approval in mid-2011 and expects to begin selling the medicine in 2012, he said.
“We only partner a drug when we can no longer do it ourselves,” De Haes said in an interview in London yesterday. "We’re going to be pragmatic on how we structure that deal. We’d be open to co-development. We’d take what money we get and put it back in.’’
The blood thinner, for the prevention of clots after hip and knee surgery, beat Sanofi-Aventis SA’s Lovenox in a study released in July. TB-402 would also compete against drugs including Bayer AG’s Xarelto, which is approved in Europe. The market for new blood thinners including Xarelto may surpass 10 billion euros ($14 billion) a year, and Xarelto sales may peak at more than 2 billion euros, Bayer Chief Executive Officer Marijn Dekkers estimated in a Bloomberg Television interview on Oct. 28.
"It’s a very competitive environment," De Haes said.
A licensing agreement between Merck & Co. and Portola Pharmaceuticals Inc. last year was a “heck of a deal” and “reasonable,” according to De Haes. Merck, based in Whitehouse Station, New Jersey, paid Portola an upfront fee of $50 million with a potential $420 million if the product reaches milestones. Merck would also pay royalties on sales of the drug. Portola, which is closely held, is based in South San Francisco, California.
If winning regulatory approval of microplasmin takes longer than planned, ThromboGenic’s cash situation would be “a bit tight,” De Haes said. “We spend about 3 million euros a month.”
ThromboGenic’s cash and cash investments declined to 59.1 million euros from 61.2 million euros at the end of June, the company said in a statement today.
“We wouldn’t have to go to the market if we got a partner” on TB-402, though “it wouldn’t be a problem if we had to” raise more money from investors, he said.
ThromboGenics plans to market microplasmin without a partner. De Haes said the company plans to hire 25 sales representatives in the U.S. and 25 in Europe if regulators approve microplasmin for treatment of vitreomacular adhesion, a disorder which plays a role in diseases affecting the back of the eye. The condition is linked to a poor prognosis in diabetic retinopathy, which causes 12,000 to 24,000 new cases of blindness in the U.S. each year, according to the American Diabetes Association.
The condition was resolved in 25 percent of 245 patients treated with an injection of microplasmin in a study, compared with 6 percent of 81 who received a placebo injection, the company said Sept. 1. The study was the second of two in the third and final stage of tests normally required for drug approval in the U.S. The company plans to study microplasmin in other eye diseases once it has more money, De Haes said.
ThromboGenics isn’t looking to be acquired, said De Haes. “It’s up to the shareholders to decide,” he said.
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