By John Miller
ZURICH (Reuters) – Fledgling Swiss biotech Idorsia has suffered delays in recruiting patients for a key trial of its experimental lucerastat drug but that will not damage its commercial prospects, founder Jean-Paul Clozel told Reuters on Tuesday.
Clozel – who owns 28% of Idorsia shares with his wife, Martine Clozel, the chief scientific officer – was speaking after the company reported third-quarter loss stabilized at 120 million Swiss francs ($121.4 million) amid spending on four late-stage drug programs.
Sluggish patient recruiting will push its lucerastat trial into 2021, Clozel said, adding the delay allows Idorsia to trim its 2019 overall spending forecasts to no more than 540 million francs on a GAAP basis, from 570 million previously.
Lucerastat – which is being developed to treat Fabry disease – has orphan drug designation in the United States and the European Union, granting it incentives like 10 years of market exclusivity should it win approval.
It is among four medicines in Phase III trials that Clozel hopes will help turn Idorsia into a “second Actelion”, the Swiss biotech company he sold to Johnson & Johnson in 2017 for $30 billion.
“It’s not like we are losing with lucerastat very precious years of marketing,” Clozel said in a telephone interview. “Orphan drugs are protected, and the protection starts when the product is on the market.”
Idorsia shares fell 3.3% by 1230 GMT but are up by nearly 47% this year.
Analysts from Bank Vontobel said “slight delays to the pipeline should not have any material effect as main product candidates are on track”.
Clozel said his top drug candidate, a medicine for insomnia tipped as a possible rival to Merck’s Belsomra, remains on track to be filed for U.S. approval in 2020 amid ongoing studies.
“The sleep drug has a huge potential, certainly the largest of the drugs in terms of market potential that we have in phase III,” Clozel said.
Idorsia had cash reserves of 875 million francs on Sept. 30, down from 1.2 billion at the start of year.
Clozel said he remains on the lookout for partners, among other financing options, to help him develop about a dozen drug projects underway at his laboratories in Allschwil, near Basel.
“Clearly, we will favor non-dilutive options,” he said. “It is true that we will need at one stage to find money to become, really, one of the two or three biggest biopharmaceutical companies in Europe. We are going very fast and of course we need to finance it.”
(Reporting by John Miller and Paul Arnold in Zurich, editing by Deepa Babington)