WINRHO SD NOW AVAILABLE THROUGHOUT THE UNITED STATES.ROCKVILLE, Md.--(HealthWire)--May 24, 1995--Univax Biologics, Inc. (Nasdaq: UNVX) today announced the first sales of WinRho SD [Rho (D) Immune Globulin Immune globulin Serum containing antibodies against a specific infection. Mentioned in: Maternal to Fetal Infections Intravenous (Human)] to five regional distributors across the United States. The distributors, in turn, are shipping product to hospitals and other institutional customers. "We are very happy that WinRho SD will now be available to doctors and their patients," said Thomas P. Stagnaro, Univax President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "People with AIDS The People With AIDS (PWA) Self-Empowerment Movement was a movement of those diagnosed with AIDS and grew out of San Francisco. The PWA Self-Empowerment Movement believes that those diagnosed as having AIDS should "take charge of their own life, illness, and care, and to minimize and others who suffer from Immune Thrombocytopenic Purpura immune thrombocytopenic purpura n. See idiopathic thrombocytopenic purpura. immune thrombocytopenic purpura Idiopathic thrombocytopenic purpura, see there , or ITP ITP - Intent to Package , will benefit from this new safe, effective and convenient treatment option. WinRho SD will also provide an extra measure of safety for women whose pregnancies are complicated by Rh incompatibility Rh incompatibility, n a condition in which two groups of blood cells are antigentically different because of the presence of Rh factor in one group and the absence of the Rh factor in the other. See also Rh factor. ." WinRho SD is indicated for the treatment of children with chronic and acute ITP, adults with chronic ITP and children and adults with ITP secondary to infection with the human immunodeficiency virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. (HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. ). ITP is a disease in which the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. attacks and destroys blood platelets, an essential element of the blood clotting blood clotting, process by which the blood coagulates to form solid masses, or clots. In minor injuries, small oval bodies called platelets, or thrombocytes, tend to collect and form plugs in blood vessel openings. process. ITP can therefore lead to uncontrolled bleeding episodes. WinRho SD has been shown in clinical trials to raise platelet levels in all target ITP patient groups. Platelet counts usually rise within one to two days and peak within seven to fourteen days after treatment. Although the duration of response can vary, platelet levels remain elevated for approximately 30 days. "The combination of excellent response rates and convenient administration in only three to five minutes at a lower cost than competitive therapies will benefit those who need treatment," noted Samuel Shakespeare, Univax Vice President of Sales. Each year, approximately 50,000 people in the U.S. suffer from ITP as a complication of HIV infection, while another 18,000 manifest the disease as a primary condition. WinRho SD may also be prescribed for the suppression of Rho (D) isoimmunization, which occurs principally when a woman with an Rh negative blood type becomes pregnant with a Rho (D) positive fetus. The woman's immune system recognizes the fetal blood cells blood cells, n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes). blood cells See erythrocyte and leukocyte. Platelets are classed separately. as foreign and develops antibodies that can be life threatening to the unborn baby and to any subsequent Rho (D) positive fetuses. Rh isoimmunization can be suppressed by treating the mother with an Rho (D) Immune Globulin product, such as WinRho SD, which reduces the toxic reaction. Each year, approximately 500,000 American women are treated for Rh incompatibility. WinRho SD is the first intramuscular/intravenous, virally inactivated inactivated rendered inactive; the activity is destroyed. inactivated viruses treated so that they are no longer able to produce evidence of growth or damaging effect on tissue. Rho (D) Immune Globulin to be made available for prescription in the United States. WinRho SD is manufactured using solvent/detergent (SD) viral inactivation inactivation /in·ac·ti·va·tion/ (in-ak?ti-va´shun) the destruction of biological activity, as of a virus, by the action of heat or other agent. step that provides an added level of safety through inactivation of lipid enveloped en·vel·op tr.v. en·vel·oped, en·vel·op·ing, en·vel·ops 1. To enclose or encase completely with or as if with a covering: "Accompanying the darkness, a stillness envelops the city" viruses such as hepatitis B, hepatitis C and HIV. "Because of the SD process, WinRho SD offers an extra measure of safety that is not provided by other Rho (D) immunoglobulin products," noted Scott Harkonen, M.D., Univax Vice President of Medical and Regulatory Affairs. "This is a milestone for Univax," commented Mr. Stagnaro. "We have been working toward the day when this company will join the elite among biotechnology firms that have generated significant revenues from product sales. Today's shipments are another step toward realizing that corporate goal." The price for a 300ug vial of WinRho SD will be approximately $85. WinRho SD is manufactured by Rh Pharmaceuticals Inc. of Winnipeg, Canada and is marketed, sold and distributed in the U.S exclusively by Univax under a licensing agreement. WinRho has been available in Canada since 1980 and the solvent/detergent virally inactivated formulation of the product has been marketed there since 1993. WinRho SD received U.S. marketing clearance in March 1995. Univax Biologics, founded in 1988, is a biopharmaceutical company engaged in the development of products that prevent and treat infectious diseases and related complications through activation and targeting of the human immune system. The Company's product pipeline includes vaccines for long-term protection and specific polyclonal antibodies (such as WinRho SD) for immediate, short-term protection and therapeutic intervention. In addition to WinRho SD, the Company has eight products in development, three of which are in human clinical trials. See Editor's Notes Editor's Notes: For more information, contact Univax directly or one of the following distributors for information. A copy of the package insert for WinRho SD(TM) is available from Univax Customer Service (tel: 1-800-4-WINRHO; fax: 301-770-3097). WinRho SD(TM) Distributors Northeast Mid-west (North) National Hospital Specialties Provider's Choice 2000, Inc. 104 Johnson Avenue 5693 West Howard Street Hackensack, NJ Niles, IL 60714 1-800-344-6087 1-800-851-0509 1-201-488-1174 1-708-647-5934 1-201-488-0983 (fax) 1-708-647-8898 (fax) Southeast Mid-west (South) Health Coalition Paragon Scientific Corp. 4906 SW 72nd Avenue 301 Lavaca, Suite 102 Miami, FL 33155 Austin, TX 78701 1-800-456-7283 1-800-887-3377 1-305-662-2988 1-512-476-3330 1-305-667-5389 (fax) 1-512-476-3303 (fax) West Coast Williams Medical Company 1150 South Las Brisas Place Placentia, CA 92670 1-800-252-8646 1-714-961-8956 (fax) CONTACT: Cabot R. Caskie Vice President, Chief Financial Officer 301/770-3099 |
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