SMITHKLINE PAXIL HAS SWIFTEST RATE OF SALES, Rx GROWTH AMONG SSRIs, COMPANY TELLS ANALYSTS; HAVRIX INTERNET AD CAMPAIGN FOCUS EXPANDING TO GAY MEN

SmithKline Beecham's serotonin reuptake inhibitor Paxil is third in its class but growing most rapidly in the U.S. with a 39% jump in 1996, the company reported at a meeting with analysts in New York City on Feb. 18. Pfizer's Zoloft sales gained 27% while Lilly's Prozac grew 20%.

U.S. sales of the three SSRIs combined advanced 25.1% in 1996. Worldwide, the rate of growth was 23.1%. Paxil posted the swiftest growth on a worldwide basis as well, a 42% gain compared to Zoloft's 29% increase and Prozac's 14% growth. Paxil's total dollar volume still lags behind Zoloft and Prozac. Paxil posted U.S. sales of $680.2 mil. and broke past the billion dollar mark with $1.1 bil. in worldwide sales. Paxil added indications for panic disorder and obsessive compulsive disorder in May.

SB also calculated growth in total SSRI scripts in each month of 1996 versus 1995, showing that Paxil had the fastest rate of growth of the three. Paxil's growth in scripts was strongest in December, reaching almost 43%. In its smallest growth performance, the March script gain was still 24%, the company said. Zoloft Rx growth had peaks in January and July at about 33%, and a low of 10% in November. Prozac's monthly growth rate ranged from 5% to 20%, according to the SB data.

Paxil has supplanted the antibiotic Augmentin as SB's top product in the U.S. Augmentin's U.S. sales of $544.4 mil. were off 1%. Worldwide, Augmentin retains the top spot among SmithKline Beecham pharmaceuticals, with sales of $1.35 bil. for the year, up 4%. "In the U.S., fourth quarter sales grew 9%, helped by the earlier introduction of twice-a-day pediatric and adult formulations," SB said. U.S. sales in the last quarter totaled $190.3 mil.

SB highlighted Augmentin's pediatric use to the analysts as a growing market for the product. In September, Augmentin pediatric scripts advanced 3% in a market that was declining by 3%, the company reported. In October, Augmentin gained 16% and the market 11%; in November, Augmentin's 14% gain was twice the market's 7% growth; and, in December, the market produced a 7% growth rate while Augmentin scripts advanced 25%.

The anti-emetic Kytril almost equaled Paxil's sales growth with a 38% climb in the U.S. and a 31% gain worldwide. Kytril sales totaled $177.8 mil. in the U.S. and $316.7 mil. worldwide. U.S. growth was "driven by the launch of the oral formulation," SB said.

SmithKline's oncologic agent Hycamtin, approved in May 1996, generated sales of $23.5 mil. in the U.S. during 1996, according to IMS America data from pharmacies, hospitals, clinics and nursing homes.

A second camptothecin derivative approved during 1996 also appears to be off to a nice start, the IMS America data indicate. Pharmacia & Upjohn's Camptosar, approved in June, posted $22 mil. in sales for the year.

Generic competition continues to exert pressure on SB's acid suppressant cimetidine. Sales of the company's branded and generic cimetidine slipped 41% in the U.S. to $78 mil.; worldwide sales dropped 20% to $340.1 mil.

SmithKline highlighted its vaccines business to analysts throughout 1996. In the U.S., vaccines posted $288.6 mil. in sales, an increase of 2%. Worldwide vaccine sales grew 5% for a total of $996.8 mil. Infanrix sales approximately doubled between 1995 and 1996. In 1995, the acellular DTP vaccine contributed $25 mil. in sales. In 1996, that figure was $51.5 mil.

Sales of the hepatitis B vaccine Engerix-B were off 8% worldwide and 6% in the U.S., the company reported. Worldwide sales totaled $567.8 mil. Sales in the U.S. accounted for $216.8 mil. of the total. The company attributed Engerix-B's sales decline primarily to "exceptional 1995 sales of that product in France."

Sales of the hepatitis A vaccine Havrix climbed 45% in the U.S.; worldwide sales gained 29% to $259 mil. The company is in the process of expanding its direct- to-consumer promotions, which previously had a primary focus on international travelers, to gay men.

SB's "Boy Meets Boy" Havrix Web site debuted Jan. 28. The site opens with an on-line version of the company's direct-to-consumer print ads for the hepatitis A vaccine, beginning: "Boy meets boy. Boy gets hepatitis A. Oh Boy, should've got Havrix..."

The Web site allows users to enter the date of their first Havrix vaccination to receive an e-mail reminder of the booster dose. The site also provides answers to "frequently asked questions" about Havrix and hepatitis A. An answer about hepatitis A and HIV reports that a Phase II study of Havrix in HIV-positive patients is ongoing.

The "Boy Meets Boy" Web site offers links to the American Liver Foundation, the Centers for Disease Control & Prevention, the National Lesbian and Gay Health Association and Gay Men's Health Crisis. The site does not feature a link to SmithKline's corporate Web site or "HealthCast" site, which offers health care information without direct mention of particular products. "HealthCast" articles feature links to labeling for SB products in the therapeutic category.

The "HealthCast" site links to another product-specific Web site, SmithKline's "Cafe Herpe" about Famvir and genital herpes. The coffee-house themed site, created by Boston-based Bronner Slosburg Humphrey subsidiary Strategic Interactive Group, includes genital herpes information under the headings "the reading lounge" and "the buffet" (the "reading lounge" also offers images of paintings in SB's collection); Famvir information in "the espresso bar"; and, on "the terrace," links to other sites such as the Columbia Prebyterian Medical Center Net, the Mayo Health Oasis, the New England Journal of Medicine "Health News" site and Selective Beginnings, a "herpes dating service." Cafe Herpe has been contacted 70,000 times since its launch in December, SB said.

Famvir sales doubled in the U.S. in 1996, jumping 114% to $67.1 mil. Worldwide sales of $103 mil. represent 90% sales growth. Scott-Levin, which calculated Famvir's total 1996 scripts at 659,000, reported that the compound's 102.6% rate of Rx growth was the fifth fastest among branded products.

The "Cafe Herpe" site is part of a broader genital herpes awareness campaign being conducted by SmithKline. A print advertisement featuring "a young woman who has been scarred by the pain and isolation associated with genital herpes" debuted in city magazines in February and will appear in women's publications, including Cosmopolitan, Glamour, Ladies Home Journal, Working Woman and Elle, in early March. A toll-free hotline has been established and SB provided an unrestricted grant to the American Medical Women's Association that funded a "documentary-type" TV program. "The Facts, Future and Myths Surrounding Genital Herpes" aired on the Discovery Channel Jan. 30.

SB's U.S. pharmaceutical sales (excluding the effect of currency translation) gained 18% in 1996, reaching $3.68 bil. Worldwide pharmaceutical sales increased 14% to $7.42 bil.

"In North America, pharmaceutical sales excluding Diversified Pharmaceutical Services grew 14%," SB observed. Revenues for the pharmacy benefits manager climbed 37% to $719 mil. as the number of covered lives rose 27% to 33 mil. DPS managed a drug spend of $5.2 bil. in 1996, an increase of 60%.

"Margins were maintained at 24.8% even though research and development expenditure rose 19%," SB declared. SB's pharmaceutical R&D spend in 1996 totaled $1.09 bil.

Five compounds entered Phase III in 1996, SmithKline told analysts: the 5HT1 agonist SB220453 for migraine; the 5HT4 antagonist SB207266 for irritable bowel syndrome; keliximab, an anti-CD4 monoclonal antibody, for rheumatoid arthritis, asthma and psoriasis; the insulin sensitizer BRL49653 for diabetes; and the muscarinic M1 partial agonist Memric for Alzheimer's disease ("The Pink Sheet" Feb. 17, T&G-10).

SB maintains that it has shaved almost 1,000 days off of its average drug development time. The company said that it took an average of 2,500 days until submission of a regulatory application in the 1994-1996 time period. In 1993-1995, the average development cycle time was almost 3,500 days.

SmithKline has reached a tentative settlement with the HHS Office of the Inspector General over HHS' investigation "into the billing and marketing practices of the group's U.S. clinical laboratory business," SB disclosed. The company deposited $325 mil. into an escrow account related to the settlement.

"Despite a difficult business environment, performance improved as operating profit grew 7%," SB said. SB Clinical Labs recorded operating profit of $132.6 mil. in 1996 on sales of $1.31 bil. "Sales increased 2%, with volume up 7% and average prices down 5%," SB added. The business had margins of 10%. Clinical Labs has added a number of new accounts, the company told analysts, including the Premier hospitals, Cigna, Aetna, Humana CHAMPUS and Health Services Corporation of America.