NOVATO, Calif., Aug. 8, 2013 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today provided a launch update for PROCYSBI (cysteamine bitartrate) delayed-release capsules and financial results for its second quarter and six months ended June 30, 2013.
PROCYSBI Update and Operational Highlights
- On April 30, 2013, PROCYSBI received marketing approval from the U.S. Food and Drug Administration (FDA) for the management of nephropathic cystinosis in adults and children six years and older.
- Raptor launched the product during the week of June 17, 2013.
- The launch is on track to meet initial guidance of 125 patients on PROCYSBI by the end of 2013.
- As of June 30, 2013, there were 114 unique prescriptions submitted for PROCYSBI, 17 had received payor approval and 2 shipped, or were scheduled to be shipped to patients.
- During this initial stage of the PROCYSBI launch, Raptor is providing a one-time mid-quarter commercial update to provide investors additional visibility into the product's early progress.
- As of August 2, 2013, there were 154 prescriptions submitted, 75 had received payor approval and 49 shipped or were scheduled to be shipped to patients. The remaining prescriptions are in process of benefits adjudication.
- On July 15, 2013, Raptor received a positive opinion from the European Union (EU) Committee for Orphan Medicinal Products (COMP) recommending orphan drug exclusivity for PROCYSBI gastro-resistant hard capsules for the treatment of proven nephropathic cystinosis. Final adoption of the opinions on drug approval and orphan exclusivity is expected from the European Commission in the coming months.
- Interim results from a Phase 2/3 study of PROCYSBI (RP103) in Huntington's disease following the first 18 months of treatment are anticipated in the first quarter of 2014.
"We are thrilled to see the number of cystinosis patients that are aware of and gaining access to PROCYSBI so soon after its launch," said Christopher M. Starr, Ph.D., Raptor's chief executive officer. "These results speak to Raptor's early and successful collaboration with the cystinosis community that has resulted in being able to satisfy their long awaited anticipation for this new therapy."