BioWorld International Correspondent

LifeCycle Pharma A/S aims to gain a significant slice of the $1 billion U.S. fenofibrate market through a newly struck partnership with Sciele Pharma Inc., which has licensed U.S., Canadian and Mexican rights to its lead compound, LCP-FenoChol.

LifeCycle is receiving an up-front payment of $5 million and would receive a further $12 million in regulatory and commercial milestones. The deal is skewed toward an expectation of commercial success. LifeCycle would receive tiered mid-teen to high-teen percentage royalties on eventual product sales.

"We are kind of aligning our interests with theirs," LifeCycle CEO Flemming Ornskov told BioWorld International. Negotiating larger milestone payments could take resources away from a successful product launch. Hørsholm, Denmark-based LifeCycle would prefer to see Atlanta-based Sciele spend the cash on marketing and on Phase IV trials, once the product gains approval for managing high cholesterol and high triglyceride levels.

"It's with the FDA and could be approved later this year," he said. The company filed a new drug application under the 505(b)(2) procedure last October. That approval pathway allows the FDA to use data in the scientific literature or data used in earlier drug reviews.

If it gains approval, LifeCycle Pharma claims LCP-FenoChol would be the lowest-approved dose of fenofibrate on the market. Tricor, marketed by Abbott Park, Ill.-based Abbott Laboratories, which has about 95 percent market share, is available in 145 mg and 48 mg doses. Antara, which is marketed by Waltham, Mass.-based Oscient Pharmaceuticals Corp., is sold in 130 mg and 43 mg doses. LCP-FenoChol, which is based in LifeCycle Pharma's MeltDose delivery technology, would be available in 120 mg and 40 mg doses.

Many patients using fenofibrates also are on statins and are diabetic as well. Therefore, the current trend in the market is, Ornskov said, toward lower doses to minimize potential drug interactions. "We had a lot of interested parties wanting to acquire this product," he said.

Sciele already has a fenofibrate - Triglide - in its portfolio of cardiovascular drugs. "They wanted to get a new and improved product in the same category," Ornskov said. Although their existing product is "suboptimal," the company still gained about 2 percent of the market. "We really like their aggression and skills," he said. Moreover, the company will have sufficient muscle to make headway in the market. "Today they have 455 reps, and they keep adding," he said.

The Sciele deal is unconnected with a previous accord LifeCycle Pharma entered with Sandoz, the generics arm of Basel, Switzerland-based Novartis AG, to develop and market a generic version of Tricor. That program is at an earlier stage of development, Ornskov said, and the U.S. fenofibrate market has yet to undergo any significant degree of genericization. "This, like any other market, will always live with the threat of genericization."

LifeCycle Pharma, which was spun out of Copenhagen, Denmark-based H. Lundbeck A/S in 2002, is focusing its drug development efforts on the U.S. The company netted about DKK500 million (US$91.5 million) from an IPO on the Copenhagen Stock Exchange in the fall and is developing a pipeline of new versions of approved cardiovascular drugs. Behind LCP-FenoChol is CP-AtorFen, a fixed-dose combination therapy incorporating atorvastatin and low-dose fenofibrate. That will enter a Phase II clinical trial soon.

The company also is developing a pipeline of products for managing organ transplant rejection, which it plans to commercialize itself. A Phase II clinical trial of a once-daily tablet version of tacrolimus will commence shortly.

Investors reacted positively to news of the Sciele deal Tuesday. By late afternoon, LifeCycle Pharma shares were changing hands at DKK58.50, up more than 8 percent on the previous day's close of DKK54.

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