September 4, 2018 / 6:04 AM / 2 months ago

Santhera lifts forecast amid cash burn, trial setbacks

ZURICH, Sept 4 (Reuters) - Santhera lifted its full-year 2018 sales forecast slightly but quickly drew down cash reserves in the first half, as the Swiss drugmaker continued efforts to make a success of its main drug despite regulatory and trial setbacks.

Santhera now expects 30-32 million Swiss francs ($33 million) in sales in 2018, up from the previous goal of 28-30 million, as sales of its Raxone treatment for rare Leber's hereditary optic neuropathy were stronger than expected.

Still, its first-half loss widened to 27.4 million francs from 21.7 million francs in the 2017 period, and the Pratteln-based company saw cash reserves fall to 34.8 million francs from 58.2 million on Dec. 31.

Santhera's efforts to expand Raxone's approval have been stymied: In March, a study of the drug against primary progressive multiple sclerosis showed no efficacy benefit, while a push to win European Medicines Agency backing in Duchenne muscular dystrophy (DMD) has so far also failed.

Santhera is trying to win a change of heart from regulators, hoping new data it plans to submit for Raxone in DMD will help support its case. Despite shrinking reserves, Chief Executive Thomas Meier said he still has enough money to pursue his strategy.

"These funds will allow the company to proceed with its clinical trial programme and regulatory filings as foreseen," Santhera said.

Santhera shares have plunged with the dour regulatory and trial news, falling about 85 percent since reaching nearly 140 francs in 2015. They are down 52 percent this year to 17.10 francs.

$1 = 0.9694 Swiss francs Reporting by John Miller

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