March 12, 2014
Sinclair IS Pharma plc, the international speciality pharmaceutical company, announces that the US FDA has granted orphan drug designation for Flammacerium® (sterile cream containing 1% silver sulphadiazine and 2.2% cerium nitrate) for the treatment of patients with severe dermal burns. The annual incidence of severe dermal burns in the US is within the threshold of 200,000 patients required for the granting of orphan drug designation which provides seven year marketing exclusivity following approval.
Whilst Flammacerium® may be used in all cases of severe burns, it has a unique role to play in cases where surgical excision and grafting are contraindicated or where facilities are unavailable or overwhelmed, as in the case of a mass casualty event. Flammacerium® was granted an emergency IND and was provided to and used by the US emergency services at the time of the 9/11 atrocity.
Flammacerium® must now be subject to the FDA regulatory process to gain marketing approval in the USA. While the expected time to filing for this approval remains uncertain and is dependent on the regulatory requirements to be finally determined, US approval would be expected to provide material upside to Sinclair’s earnings in future.
Chris Spooner Sinclair IS Pharma plc CEO commented: “Today’s announcement offers a major opportunity for Sinclair to launch a product into the US for a niche yet therapeutically important indication in patients who are severely burned. This is a high value specialist market in the US requiring a small dedicated sales and distribution team. With Flammacerium®already approved in various European markets and currently subject to a multi-country review for additional European approvals, there already exists a considerable body of safety and efficacy data. Sinclair is optimistic to receive US approval in due course and potentially within an accelerated timeframe from regulatory filing”
See the press release here.