Friday, August 31, 2012

TMC435 (Simeprevir)-Medivir CEO hopes hepatitis C drug candidate will multiply revenue

Medivir CEO hopes drug candidate simeprevir will multiply revenue
-- Partner Janssen will seek regulatory approval next year if trials succeed
-- Medivir plans to use simeprevir income for organic expansion, acquisitions
STOCKHOLM--Swedish biotech company Medivir AB (MVIR-B.SK) hopes soon to multiply its revenue through the planned launch of a Hepatitis C treatment, in an attempt to defy the setbacks that have recently plagued the sector.

Swedish biotech firms such as Karo Bio AB and BioInvent AB have suffered drug development failures this year, causing their shares to slump, whereas Medivir's have held up comparatively well as investors pin their hopes on the forthcoming simeprevir trial results. That said, the shares are down around 2% since the start of the year, underperforming a 6% rise in the wider Stockholm market.

"A successful launch would multiply Medivir's revenue," Chief Executive Maris Hartmanis said in a recent interview. "It would give extremely good opportunities to grow the company."

Simeprevir is undergoing late-stage clinical trials for Hepatitis C, a liver disease, with results due around the end of this year.

Medivir has outlicensed the drug to Johnson & Johnson /quotes/zigman/230812/quotes/nls/jnjJNJ+0.70%-controlled Janssen Pharmaceuticals, which aims to obtain regulatory approval in the U.S., Europe and Japan in the second quarter of next year, he added. The Swedish company aims to launch the drug itself in the Nordics and receive royalties on sales elsewhere.                           

"The [earlier] Phase II studies indicated good efficacy and there haven't been any unpleasant side effects so far," Mr. Hartmanis said.

Royalties in this type of license deals are typically around 8% to 10% of sales, Mr. Hartmanis said, but he declined to comment specifically on the deal with Janssen.

Drug companies have spent considerable efforts in recent years on developing Hepatitis C drugs that don't have side effects such as fever, anemia and hair loss, but with scant success.

Earlier this month, U.S. giant Bristol-Myers Squibb Co. /quotes/zigman/220498/quotes/nls/bmyBMY+0.65% cancelled development of a treatment candidate after tests revealed severe side effects. The U.S. Food & Drug Administration subsequently halted studies of a similar compound, developed by U.S.-based biotech firm Idenix /quotes/zigman/90571/quotes/nls/idixIDIX-1.72%.
Simeprevir will be one of the main treatment options if it reaches the market so it will become a main revenue source for Medivir, as the company looks for organic growth and complementary acquisitions within the infectious disease field, Mr. Hartmanis said, but he declined to give a specific peak sales estimate for the drug.
"One size doesn't fit all so there will be several new drugs for Hepatitis C, but simeprevir is likely to be a cornerstone in future treatment," he added.
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