BioWorld International Correspondent
LifeCycle Pharma A/S gained FDA approval at the first time of asking for its formulation of fenofibrate, based on the company's proprietary MeltDose delivery technology, for treating hyperlipidemia and hypertriglyceridemia. The Hørsholm, Denmark-based firm now expects that its marketing partner, Atlanta-based Sciele Pharma Inc., will be able to move into a market launch before the end of this year.
The approval triggered a $4 million milestone payment to LifeCycle Pharma, in addition to an up-front payment of $5 million it received when the deal was signed earlier this year. It also could gain another $8 million in sales-related milestones, as well as tiered mid-teen to high-teen percentage royalties on sales.
LifeCycle Pharma had submitted an NDA under the FDA's 505(b)(2) procedure for previously approved compounds last October, and initially had anticipated a commercial launch of the product in early 2008. "For a small company like ours, that wants to be a specialty pharma company, to have got it approved the first time without any issues was a major surprise," CEO Flemming Ørnskov told BioWorld International.
"It's a milestone for LifeCycle Pharma, but it's also a milestone for Medicon Valley, as they call it here," he said, referring to the biotech cluster that encompasses the greater Copenhagen, Denmark region and the neighboring Skåne area of southwest Sweden. The approval, he said, is the first FDA approval to be gained by any emerging biotechnology firm from the region.
The compound is not a new molecular entity, but the approval represents a significant validation of LifeCycle Pharma's Meltdose technology, Ørnskov said, because the FDA had to get comfortable with it during the approval process. LifeCycle Pharma was spun out of Copenhagen-based H. Lundbeck A/S in 2002 with a nascent version of the technology, development of which it has completed. It improves bioavailability of compounds with poor solubility by incorporating them into a solid solution with the aid of a "melted vehicle," which is sprayed onto a carrier using a patented process.
LifeCycle Pharma has obtained approval for 120-mg and 40-mg doses of fenofibrate, both of which are below the approved doses of fenofibrate therapies from rival firms, such as Abbott Park, Ill.-based Abbott and Waltham, Mass.-based Oscient Pharmaceuticals Corp. Patients who take fenofibrate are typically on other drugs, particularly high-dose statins, so a low dose is preferable to minimize the potential for drug interactions, Ørnskov said.
Nevertheless, LifeCycle and Sciele have modest ambitions for the drug. "If this product can sell in the region of $75 million to $150 million that's a really good success for us," Ørnskov said. Abbott's TriCor dominates the U.S. fenofibrate market, with sales of $526 million for the first half of the year. Oscient's Antara attained $26.4 million during the same period.
Sciele already markets a fenofibrate, TriGlide, which it licensed from London-based SkyePharma plc, in a deal worth up to $50 million in regulatory and sales-based milestones, plus 25 percent of net sales. Sciele will effect a transition from that product to the LifeCycle Pharma formulation, Ørnskov said. "That will happen in a way that is totally sensitive to patients."
Following disclosure of the news Monday, the company's stock (Copenhagen:LCP) closed at DKK53.50 (US$9.76), up DKK3.50 from its previous close.