Santhera May Market Muscular Dystrophy Drug on its Own in U.S.

Santhera Pharmaceuticals Holding AG may market a drug for a degenerative muscular disease on its own in the U.S. to secure a bigger share of revenue and longer patent protection.

The Swiss drug developer had been seeking a partner to promote Catena, a medicine for Duchenne muscular dystrophy, since May last year. Instead, Santhera may raise capital in the second half of the year to do the work itself in the U.S., Chief Executive Officer Thomas Meier said at a biotech industry meeting in Basel.

U.S. investors have encouraged Santhera to take that step, which would enable the company to keep its patent until 2027, Meier said. The drug won fast-track designation last week from the U.S. Food and Drug Administration, a status intended to speed the review of potential drugs for serious unmet needs.

“We would need access to 20-30 hospitals in order to launch an orphan drug product in the U.S.,” Meier said, a fraction of the approximately 200 treatment centers in the country that treat the rare disease. Santhera is already working with a non-profit group to identify which hospitals to target.

Armed with data from a late-stage trial that showed Catena delayed the loss of respiratory function in people with the condition, Santhera is preparing an application for U.S. approval and plans to meet with the FDA in coming weeks to discuss the drug.

Positive regulatory action related to Duchenne muscular dystrophy, or approval of the drug for a vision-loss condition, would probably make Santhera a takeover target, according to Simos Simeonidis, an analyst at RBC Capital Markets. For muscular dystrophy, the drug may generate about $535 million in peak sales in 2025 in the U.S. and Europe, he said.

Duchenne muscular dystrophy is a genetic disease that leads to muscle degeneration and premature death due to cardio-respiratory failure. Santhera is also developing the medicine as a treatment for Leber’s hereditary optic neuropathy, an inherited condition that causes vision loss. Catena is known as Raxone in Europe.

Santhera fell as much as 9.4 percent earlier today, the most in six months, after reporting that its net loss widened in 2014 to 7.5 million francs ($7.7 million). The stock has risen 28-fold in the last 12 months, the biggest gain among the 206 companies in the Swiss Performance Index. The shares were down 2.7 percent at 104 francs as of 3:01 p.m. in Zurich.

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