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ASTRA CUTS FOSCAVIR PRICE FOR AIDS PATIENTS IN FEDERALLY FUNDED PROGRAMS

 ASTRA CUTS FOSCAVIR PRICE FOR AIDS PATIENTS
 IN FEDERALLY FUNDED PROGRAMS


Additional Commitments to AIDS Community Include New Research Funds,
 Model HIV Eye Health Program
 WESTBOROUGH, Mass., May 14 /PRNewswire/ -- Astra Pharmaceutical Products, Inc., developers of the drug Foscavir (foscarnet sodium) Injection, announced today that it has reduced the cost of the drug for AIDS patients who are treated in federally funded health centers. Foscavir is a treatment for cytomegalovirus (CMV) retinitis, an opportunistic eye infection that occurs in 20 percent of AIDS patients and often leads to blindness.
 "Our price reduction, combined with existing programs to make Foscavir available free to patients who cannot otherwise pay for it, further underscores Astra's commitment to help those AIDS patients with CMV retinitis whose financial need is the greatest," said Stefan Solvell, Astra senior vice president of finance and administration.
 The Astra Discount Drug Program, which began on May 1, offers a 15 percent discount on all of the company's drugs, including Foscavir, to the more than 1,600 Community Health Centers, Migrant Health Centers, Ryan White AIDS Treatment Centers and McKinney Act Homeless Centers, which receive grant funding from the U.S. Public Health Service.
 The discount will reduce the cost of Foscavir by more than $10 per day over the course of a 93-day treatment cycle for those who receive the drug at PHS-funded centers. Staff of PHS-funded centers wishing more information on the Astra Discount Drug Program may call toll free 800-685-ASTR (2787), Monday through Friday, 9 a.m. to 5 p.m. (Eastern Time).
 The Astra Discount Drug Program also includes Foscavir purchased by State AIDS Drug Reimbursement Programs under the Ryan White Act.
 Astra Expands Commitments to AIDS Community
 Details of the new price discount on Foscavir and other Astra drugs were among a number of subjects discussed in recent meetings between Astra and AIDS patient advocates in San Francisco, Los Angeles, Washington, New York and Boston.
 Astra summarized its presentation to these groups in a May 11, 1992, open letter that outlines the company's AIDS treatment and research programs and announces "Foscavir's Six-Point Commitment to the AIDS Community."
 This commitment includes steps to:
 1. Reduce the price of Foscavir to those patients who have the
 greatest financial need.
 2. Expand access to Foscavir for all patients, including free
 drugs to those who cannot pay for it.
 3. Improve eye health services for persons with AIDS/HIV.
 4. Provide new funds for AIDS research.
 5. Expedite the development of oral Foscavir.
 6. Involve the AIDS community actively in future discussions
 about access to Foscavir and Astra's continuing support to
 AIDS programs.
 "Astra is dedicated to furthering each of these objectives through concrete action," Solvell said. "We welcome feedback from the AIDS community and look forward to working with them to improve treatment and ultimately, to prevent AIDS-related infections."
 F.A.I.R. Program Provides Free Drug
 In addition to reducing the cost of Foscavir to PHS grantees, Astra is expanding the scope of the Foscavir Assistance and Information on Reimbursement (F.A.I.R.) program, which has been available since Foscavir was introduced in September 1991.
 Effective immediately, F.A.I.R. will provide free drugs to patients while coverage decisions from private or government payers are pending. Also, eligibility for the free drug program has been expanded from 50 states and the District of Columbia to include Puerto Rico.
 The F.A.I.R. toll-free hotline, 800-488-FAIR (3247), was established to respond to inquiries from doctors seeking information on reimbursement for their patients and to provide a safety net to uninsured patients, so that Foscavir therapy is not interrupted due to inability to pay. So far, every patient whose doctor has requested free drugs through F.A.I.R. has received it.
 Astra Forms Advisory Board, Initiates Eye Health Programs
 To further extend Astra's work with the AIDS community and maintain open channels of communication, Astra also has announced the establishment of a Community Advisory Board, which will consist of AIDS treaters and patient advocates.
 The Community Advisory Board will meet several times yearly to review Astra's patient support initiatives, including F.A.I.R. and the Astra Discount Drug Program, and help ensure that these programs are effectively managed and fully responsive to the changing needs of the community. In addition, the board will have responsibility for selecting recipients for future community research grants sponsored by Astra.
 In support of Astra's commitment to improve eye health services for persons with AIDS/HIV, Astra also is providing a major grant to create a "Model Eye Health Center Development Program" in cooperation with the Whitman-Walker Clinic in Washington.
 Costs of Foscavir Research Explained
 Also discussed in Astra's meetings with AIDS patient advocates was the relationship between Foscavir research and development costs and the drug's price. The company had noted on previous occasions that, while U.S. government-funded research was of great assistance in preparing the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), the actual amount of government funds was modest in comparison with Astra's $100 million outlay over a period of more than 12 years prior to U.S. marketing approval.
 In a recent letter to Sen. David Pryor (D-Ark.), U.S. Secretary of Health and Human Services Louis W. Sullivan confirmed that the U.S. government did not incur substantial costs for the development of Foscavir.
 The letter, dated April 10, states: "The majority of studies supported by NIH on foscarnet were not related to the new drug application (NDA) submitted to the FDA by Astra Pharmaceuticals, Inc., for the approval of foscarnet (trade name Foscavir) in 1991."
 According to Sullivan, the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) incurred an estimated $3.05 million in costs as part of the Foscavir NDA, a small figure in comparison to Astra's estimated $100 million costs for developing Foscavir.
 Foscavir Pricing
 Astra also had disclosed that it determined the price of Foscavir based on the projected overall need for CMV retinitis therapy and the existence of a competing CMV retinitis product.
 According to the Centers for Disease Control, 60,000 Americans were living with AIDS when Foscavir was approved. Of this population, about 20 percent are likely to contract CMV retinitis, indicating an annual patient population of about 12,000.
 Given Foscavir's initial labeling and the existence of a competing product, the company estimated that no more than 4,000 to 5,000 patients would be prescribed Foscavir each year, with an average length of therapy of six months, as observed in clinical trials. Based on this data, a wholesale price of $58.62 per day was set for daily maintenance therapy of Foscavir in order to achieve an annual maximum sales of $50 million.
 This projected level of sales, Astra has explained, would pay for the development of Foscavir up to its approval and cover all costs of manufacturing, physician education, and free or discounted drug programs for patients through the product's patent expiration in 1997. In addition, sales revenues from Foscavir for CMV retinitis are also needed to fund research for new indications for Foscavir, development of an oral dosage form, and to conduct FDA-mandated safety studies and studies in special populations. Also, Astra has made available detailed price comparisons showing that the U.S. price for Foscavir is generally comparable to its price in other countries in which it is approved.
 During the recent meetings with AIDS patient advocates, the company also released audited sales data for Foscavir from October 1991 to March 1992. "Sales to date suggest our first year's revenue from Foscavir will be less than $50 million," Solvell said.
 "We will, however, continue to report on sales regularly to the AIDS community and remain committed to our long-standing pledge to review prices at any time that the number of patients on Foscavir exceeds our original projection. In the meantime, we will continue to search for innovative ways to expand access to Foscavir for patients with the greatest financial need," Solvell added.
 Astra Pharmaceutical Products, Inc., based in Westborough, is the U.S. subsidiary of AB Astra, the Swedish pharmaceutical company.
 -0- 5/14/92
 /CONTACT: Stefan Solvell, 508-366-1100, or Ken Rabin, 202-944-5135, both for Astra Pharmaceutical Products/ CO: Astra Pharmaceutical Products, Inc. ST: Massachusetts IN: MTC SU:


MH -- DC024 -- 0402 05/14/92 16:13 EDT
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Date:May 14, 1992
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