Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ORPHAN EXCLUSIVITY CHANGES TO ALLOW MARKETING OF FISON’s PENTAMIDINE URGED BY FIVE SENATE APPROPRIATIONS COMMITTEE MEMBERS IN LETTER TO SULLIVAN

Executive Summary

Changes in the Orphan Drug Act to allow approval of Fisons' aerosol pentamidine, Pneumopent, is supported by five senators on the Appropriations/Labor and HHS Subcommittee in a May 3 letter to HHS Secretary Sullivan. The five senators -- Bumpers (D-Ark.), Inouye (D-Hawaii), Burdick (D-N.D.), Adams (D-Wash.), and Hatfield (R-Ore.) -- asked Sullivan "whether the Administration will support an amendment to the Orphan Drug Act to permit the marketing of the Sloan-Kettering/Fisons regimen of pentamidine." If the White House does not plan to endorse a change in the Orphan Drug Act, the senators requested that Sullivan explain the Administration's "rationale for declining to extend support" to their proposal "as soon as possible." The letter was sparked in part by the development of Rep. Waxman's (D-Calif.) bill to amend the Orphan Drug Act. Waxman's bill would effectively allow FDA to approve Fisons' product. The Administration has been opposed to changing the marketing exclusivity of the Orphan Drug Act. As members of the HHS appropriations subcommittee, the senators have been involved in finding supplemental funding to help AIDS patients defray the cost of treatments. Fisons' product is potentially a more cost-effective treatment for Pneumocystis carinii pneumonia. An identical Senate counterpart to the Waxman bill has been introduced by Sen. Metzenbaum (D-Ohio). The senators explained that their interest in Pneumopent was due to the lower cost of the regimen vis-a-vis Lyphomed's product, Nebupent. An NDA for Pneumopent has been blocked since last spring by FDA's approval of Lyphomed's product as an orphan drug, which bestowed seven years of marketing exclusivity to Nebupent under the marketing incentives of the Orphan Drug Act. "In the case of aerosol pentamidine," the senators wrote, "there is evidence that a nebulizing regimen developed at Memorial Sloan-Kettering Cancer Center and tested by the Fisons Corp. offers tangible advantages over the product currently on the market in terms of enhanced patient convenience and cost-effectiveness." The senators said it had been reported to them that the Fisons Pneumopent regimen, "because of the efficiency of the device it employs, can result in savings of 50% or more on drug costs alone." The senators also suggested that the nebulizer used in the Fisons' regimen, which is portable, "could achieve additional savings for the Medicare and Medicaid programs by avoiding the charges for administration in hospitals, clinics, or physicians offices or through home health agencies, which are associated with the more cumbersome existing regimen." While declaring their support for the Orphan Drug Act, the five senators noted that the act "does not seem to address circumstances in which different devices may be used in combination with the same drug...[or] deal with situations in which more than one company devotes substantial resources to development of an orphan drug product only to find the investment wasted because of the vagaries of the approval process." In addition, the letter suggests that Memorial Sloan-Kettering began development of the Fisons product before Lyphomed. Sen. Pryor (D-Ark.) floated a proposal to change the Orphan Drug Act late last year that was specifically directed at eliminating the obstacles to Fisons' marketing of its pentamidine product. That suggestion never materialized in the form of legislation, possibly due to the opposition expressed by the National Organization for Rare Disorders to the Pryor proposal.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1135424

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel