Valeant to submit epilepsy treatment to FDA for review
ALISO VIEJO, Calif. A specialty pharmaceutical company announced an update on its new drug application for an epilepsy treatment.
Valeant Pharmaceuticals International and its collaborative partner, GlaxoSmithKline, said that its investigational drug retigabine, will be submitted to the Food and Drug Administration for review Oct. 23.
Valeant met with the FDA in August to discuss the technical aspects for the new drug application.
Retigabine is an adjunctive treatment for treating adult epilepsy patients with partial-onset seizures.
Valeant also announced that three retigabine modified release technologies will be assessed in a Phase 1 clinical study commencing this month. The purpose of the study is to evaluate these candidate formulations to identify a lead MR compound that will be advanced in further research intended to support a product with either a once- or twice-daily dosing regimen.
“We are pleased with the outcome of the meeting with FDA and the progress we have made,” stated J. Michael Pearson, Valeant chairman and CEO. “We are confident in our dossier and we are diligently working to finalize the regulatory submissions which are based on positive results from two large Phase 3 trials. In addition, we are excited to have reached a key milestone in the MR development program. With three potential MR technologies under evaluation, we will soon be in a position to determine which MR formulation we intend to pursue as a once- or twice-a-day option for patients continuing to suffer from epilepsy seizures.”
Baucus bill cuts OTCs from FSAs
WASHINGTON While the recently released healthcare reform Baucus bill may be a mixed bag for the business of pharmacy, the bill is not necessarily good for purveyors of over-the-counter medicines, which make up the largest chunk of front-end drug store sales.
The America’s Health Future Act of 2009 sponsored by U.S. Senate Finance Committee chairman Max Baucus, D-Mont., includes in the draft the Senate’s version of a proposal already passed by a U.S. House of Representatives committee to restrict eligibility of OTCs for reimbursement under certain savings plans, such as flexible spending accounts, that allow certain healthcare expenditures to be made with tax-exempt dollars.
“While the Senate Finance Committee had previously circulated the bill containing provisions affecting OTC medicines, this was the first time the committee released information about the costs associated with the initiative,” the Consumer Healthcare Products Association stated in a Friday e-newsletter.
Under the proposed bill, OTC medicines would no longer qualify for FSA reimbursement without a doctor’s prescription. The U.S. Joint Committee on Taxation scored this provision as saving the government $2.3 billion over five years and $5.4 billion over 10 years, which is indicative of how much these tax savings are utilized by consumers.
The House version of the OTCs provision would completely eliminate eligibility for OTCs under these types of accounts. That provision scored as saving $8.2 billion over 10 years.
“CHPA continues to be a strong advocate for favorable tax treatment for OTC medicines,” the association stated. “The association is actively lobbying both the House and the Senate to remove or modify the OTC provisions. Coalition letters opposing the OTC language were organized by CHPA and sent to Congress earlier this week.”
Rite Aid executive shifted to new post
CAMP HILL, Pa. Rite Aid Corp. on Friday named Ernie Richardsen, a 17-year pharmacy industry veteran, to the post of group VP pharmaceutical purchasing and clinical services.
In his new position, Richardsen, 41, a licensed pharmacist, is responsible for pharmaceutical purchasing and purchasing strategy, patient compliance initiatives, pharmacy program development, in-store clinics and retail pricing. He reports to John Standley, president and COO of Rite Aid.
“[Richardsen] is a seasoned pharmacy executive with broad business experience,” Standley stated. “He’s made valuable contributions to Rite Aid since joining our company with the acquisition of Brooks/Eckerd, and we look forward to continuing to benefit from his talent and expertise as he takes on his new responsibilities.”
Richardsen most recently served as Rite Aid ‘s VP pharmacy programs and clinical services.
Prior to joining Rite Aid, Richardsen served as VP pharmacy category management for the former Brooks/Eckerd drug chain where he oversaw all aspects of pharmaceutical purchasing, including brand, generic and diagnostic product procurement; reverse logistics and patient compliance programs.
Richardsen is a graduate of The Ohio State University College of Pharmacy. He received his master’s degree in business administration from Waynesburg University in Pennsylvania.
He replaces David Vucurevich, who has left Rite Aid to pursue a new opportunity in the pharmaceutical industry.