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FDA Grants Orphan Drug Status to Hydralazine, A Peripheral Vasodilator
This Orphan Drug designation has been granted for the treatment of severe intrapartum hypertension associated with severe pre-eclampsia and eclampsia of pregnancy, conditions which can result in maternal and fetal morbidity and mortality.
Hydralazine, an approved anti-hypertensive agent, is not currently indicated for severe pre-eclampsia or eclampsia, albeit an injectable form of the medication is used "off-label" in hospitals as the drug of choice in treating these conditions. ESP Pharma noted that the intravenous hydralazine in its development pipeline involves a new, more stable, and patentable formulation. The Company further noted that this development program is nearing completion of the necessary study for submission of a New Drug Application.
John T. Spitznagel, ESP Pharma's Chairman and CEO, said, "Today's announcement represents another important milestone for ESP with regard to demonstrating the Company's continued successful implementation of its Buy and Build, Search and Develop acquisition strategy."
"The success of the Buy and Build component of our business plan is readily measurable in terms of our rapid growth in sales and profitability," noted Mr. Spitznagel. ESP Pharma began operations in the second quarter of 2002 and completed 2003 with gross sales and EBITDA, respectively, at $69 million and $25 million compared to $16 million and $5 million achieved in the eight months ended December 31, 2002.
Additionally, ESP's flagship product Cardene(r) IV - the only intravenous calcium channel blocker approved in the U.S. for hypertension - had annualized sales of some $6 million when the Company acquired it in May 2002. Post-acquisition sales of this product reached the $30 million level during 2003, supported by the strengths of ESP's hospital sales force, which has tripled in size in the past 18 months to nearly 60 representatives, plus the Company's commitment to excellence in its medical education programs.
"Meanwhile, the success of the Search and Develop component our growth strategy is quickly evident from the fact that we initiated this stage of our business plan in late 2002, or less than 18 months ago," said Mr. Spitznagel. In that comparatively short time frame, ESP has established a product pipeline consisting of one Phase III compound and two other development drugs that are candidates for a 505(b)(2) New Drug Application. The latter two, including the new formulation of intravenous hydralazine, are licensed from Barbeau Pharma (www.BarbeauPharma.com).
Mr. Spitznagel concluded, "Moreover, the successful pursuit of orphan drug status for intravenous hydralazine also stands as testimony to our ability and that of our partner Barbeau, to navigate through the complexities of the regulatory system."
Source: ESP Pharma, Inc.