BURROUGHS WELLCOME ESTIMATES 3 MIL-PLUS UNTAPPED MARKET FOR OTC ZOVIRAX

BURROUGHS WELLCOME ESTIMATES 3 MIL-PLUS UNTAPPED MARKET FOR OTC ZOVIRAX as a treatment for recurrent genital herpes in a May 10 presentation to securities analysts in Baltimore sponsored by Alex. Brown. Burroughs Wellcome VP-Corporate Affairs Larry Wheeler noted that "less than half of the treatable patients, or as many as 3 or 4 mil. individuals...are not currently receiving therapy."

"Over 30 mil. people in the U.S. are infected with the virus that causes genital herpes," Wheeler said. He pointed out that the Centers for Disease Control and Prevention "[estimates] that 500,000 new patients" contract genital herpes each year. "While it is estimated that 7 mil. of these individuals have treatable disease, less than half receive Zovirax," he noted.

"Our challenge and indeed our opportunity," Wheeler said, "is to educate those individuals who are not currently receiving therapy." The company has notified FDA that it is considering the establishment of an OTC Zovirax patient assistance program for the financially disadvantaged ("The Tan Sheet" April 11, p. 1).

Wheeler characterized the Zovirax (acyclovir) Rx-to-OTC switch as "Wellcome's greatest opportunity for the near-term." He said the company believes that "OTC availability...provided with the advertising directly [to consumers]...will result in substantially increased demand for the product." As a prescription product, Zovirax reached $1.1 bil. in worldwide sales last year.

FDA's Nonprescription Drugs and Antiviral Drugs Advisory Committees are expected to review Burroughs Wellcome's Rx-to-OTC switch NDA for Zovirax at a July 28 meeting. The two committees will also meet on May 19 for an FDA public meeting on the switch ("The Tan Sheet" May 9, p. 7).

Several key physician groups including the American College of Obstetricians and Gynecologists and the Society of Infectious Diseases have come out in opposition to the Zovirax switch.

The two groups join the American Academy of Dermatology and the American Academy of Pediatrics, which have submitted comments to FDA recommending that Zovirax remain available only in prescription form due to the potential for misdiagnosis, misdosage, overuse and development of viral resistance ("The Tan Sheet" May 9, p. 7). In addition, while not openly opposing the switch, the American Medical Association has submitted comments to FDA voicing its concerns about the OTC availability of acyclovir.

The Association of Reproductive Health Professionals, however, has come out in favor of the Rx-to-OTC switch of Zovirax. In a summary of testimony submitted to FDA on May 2, the group declared that "the potential impact of Zovirax as an over-the-counter medication for recurrent genital herpes is significant for both the individual and public health." The group said it "believes that consumers can be educated to recognize the signs and symptoms of recurrent genital herpes and to take appropriate action" but that "public awareness and patient education must accompany" the switch "to empower consumers who avoid treatment because of the stigma and costs associated with recurrent" sexually transmitted diseases. Nonprescription Drugs Advisory Committee member Elizabeth Connell, MD, is on the association's board of directors.

Also in support of OTC Zovirax, the American Social Health Association commented to FDA that it "supports the concept of increasing access for diagnosed patients." ASHA President Peggy Clarke said the association is in favor of the switch because OTC availability would increase access to the drug, reduce the inconvenience of getting the drug, decrease the delay and, therefore, the time of discomfort before getting the drug and reduce the cost involved in obtaining the treatment by eliminating the need for a doctor's appointment.

Clarke emphasized, however, that a "responsible marketing and education" campaign would be crucial if the product were to be switched in order to communicate the appropriate uses of Zovirax and to increase the public's awareness of the broader health issues concerning sexually transmitted diseases.

In "conditional support" of the switch, the National Association of People with AIDS pointed out that "patients successfully treated for genital herpes will be less likely to acquire or transmit HIV." In addition, the group told FDA that a switch will help patients with genital herpes recurrences to "acquire the meditation easier and start getting relief of symptoms quicker" and "will hopefully save the patient money and economize the pharmacist's time."

However, the National Association of People with AIDS expressed "serious concerns" about patient education issues and the possibility that OTC status might "automatically translate into an out-of-pocket expense" for patients dependent on insurance or Medicaid. "If acyclovir becomes more readily available, but the OTC price places it out of reach for people in need, then the people depending on this and other pharmaceuticals will not benefit," the association said.

FDA also has received comments supporting the switch from the American Medical Women's Association and the National Association of Nurse Practitioners ("The Tan Sheet" May 9, p. 9).