Approval breakthrough for IS Pharma
PHARMACEUTICAL group IS Pharma said today it had passed an “important milestone” as it seeks to gain US approval for one of its products.
Its Lucassin kidney failure treatment is now being considered for marketing approval by the US Food and Drug Administration (FDA). The drug has also been granted “priority review”, said the company.
After gaining this approval IS Pharma’s US licensee, Orphan Therapeutics, will transfer the North American rights to another company, Ikaria Holdings, which will then handle the manufacturing, distribution, marketing, sales, customer service and post-market development of Lucassin.
Chief executive Tim Wright, said: “We are pleased that Lucassin has been granted priority review by the FDA. This marks an important milestone towards obtaining marketing approval in the US where currently no drug is approved for the treatment of hepatorenal syndrome (HRS) Type 1.
“HRS Type 1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months.”
The Chester-based business develops, acquires and commercialises late stage pharmaceuticals and medical devices in the areas of critical care, oncology and neurology.
Earlier this month it said it had enjoyed a record year after reporting a 70% leap in profits.
Revenue at the group grew by 73% to 12.2m in the year to March while pre-tax profits rose 70% to £2m.
