New Strength 200-mg Once Daily Videx(r) Tablet Receives First Approval In France

NEW STRENGTH 200-MG ONCE DAILY VIDEX(R) TABLET RECEIVES FIRST APPROVAL IN FRANCE First Once Daily Nucleoside Analogue Now Available in Easier, More Convenient Dose That Cuts Pill Burden London, October 1 (PRN) - Bristol-Myers Squibb announced today that the French Health Authorities have approved a new strength 200-mg tablet for once daily VIDEX (R) (ddI, didanosine) for the treatment of HIV. VIDEX is the first and only nucleoside reverse transcriptase inhibitor (NRTI) approved for once daily dosing. The new strength tablet of VIDEX will cut daily pill burden by as much as fifty percent for some patients -- from as many as four tablets a day to two tablets a day. ''The 200-mg tablet is a meaningful improvement upon the convenience and simplicity that once daily VIDEX already offers HIV patients,'' says Professor Jacques Reynes, MD, PhD, Hopital Gui De Chauliac, University Montpellier Hospital, France. ''VIDEX continues to be a potent cornerstone of HIV therapy and now once daily dosing coupled with the reduced pill burden will help patients adhere to their anti-HIV regimens.'' After nearly seven years on the market, VIDEX(R) (ddi, didanosine) remains one of the most effective and durable antiretroviral therapies due to its superior potency and excellent resistance profile. VIDEX has been extensively studied in different populations of HIV-infected patients throughout the world and in ''HIV cocktail'' combinations with many approved antiretrovirals, including Bristol-Myers Squibb's ZERIT(R) (d4T, stavudine), also known as d4T, as well as with experimental drugs. When combined with other antiretrovirals, VIDEX(R) reduces viral load and increases CD4 cell count, the key indicators of efficacy in fighting HIV. ''Adherence is a daily challenge for patients taking antiretroviral therapy,'' says Steve Schnittman, MD, Group Director of Antiviral Clinical Research, Bristol-Myers Squibb. ''Changes like once daily dosing of VIDEX(R) with the 200-mg tablet, however, respond directly to the urgent call by patients and clinicians to constantly improve potent and proven anti-HIV agents.'' Today's antiretroviral drug regimens can be complicated and require careful long-term management. Some ''HIV cocktails'' combine as many as four or more drugs. In many cases, each drug has very specific dosing requirements and some carry pill burdens of as many as sixteen tablets a day. Incomplete adherence can lead to the emergence of resistance and drug failure. Therapies that minimize pill burden and that can be taken once a day will help patients comply with complex regimens whether they are starting therapy or making changes to their regimens. Today's announcement closely follows the June announcement by Bristol-Myers Squibb that the 15 Member States of the European Union had reached a mutual recognition agreement on the once daily dosing variation of VIDEX. The most recent approval is based upon the health authorities being satisfied with the manufacturing process of the 200-mg tablet. VIDEX has been developed by Bristol-Myers Squibb since 1988. VIDEX received marketing clearance in the European Union in 1991 for the treatment of HIV/AIDS and is marketed by Bristol-Myers Squibb in over 70 countries around the world. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal business are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular and metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin products. For full prescribing information on ZERIT(R) (d4T, stavudine) and VIDEX(R) (ddI, didanosine), please contact Annie Simond at +33-14090-6566 or Patricia Doykos Duquette at +1 609-897-3077. UNS Contact: Annie Simond, tel Paris +33-14090-6566, annie.simond@bms.com, or Patricia Doykos Duquette, International Public Affairs, tel New Jersey +1 609 897 3077, patricia.duquette@bms.com, both of Bristol-Myers Squibb ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1999/10/01/19991001BIT00150/bit0001.doc http://www.bit.se/bitonline/1999/10/01/19991001BIT00150/bit0002.pdf