LILLY GEMZAR SELLS $31.6 MIL. IN SIX MONTHS ON U.S. MARKET; PRINIVIL IS MERCK's "ACE" IN HOLE WITH 33% U.S. SALES JUMP; FOSAMAX SALES IN EXCESS OF $200 MIL. IN U.S.

Lilly's Gemzar generated $31.6 mil. in U.S. sales from its May launch for treatment of prostate cancer. Gemzar contributed worldwide sales of $61.9 mil. for 1996, of which $26.3 mil. was in the fourth quarter.

Lilly is seeking to add an indication for treatment of non-small cell lung cancer to Gemzar's U.S. labeling. In a Phase II study of Gemzar plus cisplatin, 54% of NSCLC patients had a partial or complete response. The study, published in the January issue of the Journal of Clinical Oncology, found a one-year survival probability of about 60%. Responders had a median survival time of 71 weeks, compared to 38.5 weeks for non-responders. A 2,500 patient Phase III trial evaluating Gemzar plus cisplatin versus three other treatment regimens is under way, sponsored by the Eastern Cooperative Oncology Group.

Lilly's new antipsychotic Zyprexa posted $86.9 mil. in sales in its first three months on the market. Lilly told analysts in December that Zyprexa had a 5% share of new antipsychotic prescriptions in the U.S. ("The Pink Sheet" Jan. 13, p. 12).

Lilly/Centocor's ReoPro had 1996 worldwide sales of $149 mil., boosted by fourth-quarter sales of $50.8 mil. Centocor reported that applications to FDA to expand labeling to include use in unstable angina and for all PTCA procedures, regardless of risk factor, "are expected to be made within four weeks."

Humalog generated $9 mil. in fourth quarter sales, roughly equal to sales for the third quarter, when Lilly launched the insulin analog.

Humalog has not yet become a significant contributor to Lilly's insulin line. Lilly's Humulin human insulin had $884 mil. in 1996 worldwide sales, up 11%. In the U.S., Humulin sales rose 7% to $563.5 mil. for the year.

Worldwide sales of Prozac grew 14% to $2.35 bil. in 1996. U.S. sales of the antidepressant were up 20% to $1.73 bil. for the year, "while international sales were essentially flat," Lilly reported. Fourth-quarter worldwide sales of $603 mil. represented 17% growth.

Lilly's 1996 net sales of $7.3 bil. worldwide grew 9% over 1995. Fourth-quarter sales were up 15% to $2.06 bil. U.S. sales for the quarter increased 24% over the fourth quarter of 1995, while international sales rose 2%. Lilly Chief Financial Officer Charles Golden told participants of a Jan. 27 teleconference that international sales had 11% volume growth, which was offset by unfavorable foreign exchange rates.

Lilly's gross margin declined, reflecting increased revenue from lower-margin PCS: the pharmacy benefits manager contributed fees of $372 mil. for the year, a 44% jump. Lilly's gross margin for the year was 71.2%, a dip of .9 percentage points; the fourth-quarter gross margin of 71.3% was down 1.2 percentage points.

Merck said its PBM subsidiary, Medco, saw its drug spend increase 39% to $9.1 bil. The volume of prescriptions handled by Medco rose 38% to over 235 mil., Merck added. The rate of growth in covered lives was less, a 5% increase to about 49 mil. lives.

Merck's worldwide annual sales grew 19% to total $19.83 bil. Foreign exchange rates reduced "12-month sales growth by one percentage point," Merck commented. The U.S. accounted for 70% of 1996 sales. Pretax income was up 16% to $5.54 bil. Growth "was reduced by the company's share of the increase in taxes related to the Astra Merck joint venture and the European vaccine joint venture with Pasteur Merieux," Merck said. "However, the reduction in pre-tax growth was offset by a corresponding reduction in the company's tax rate in 1996, resulting in no effect on net income growth."

Merck's cardiovascular line featured two products with worldwide sales exceeding $2 bil.: the HMG-CoA reductase inhibitor Zocor ($2.8 bil. worldwide) and the ACE inhibitor Vasotec ($2.54 bil.). Zocor is "now the leading HMG-CoA reductase inhibitor," Merck maintained. Combined with Mevacor, Merck holds "over 40% of the worldwide cholesterol-lowering market," the company said. Merck sees the potential for the market to grow: "less than 30% of patients with coronary disease currently receive cholesterol-lowering therapy."

In the U.S., Zocor sales jumped 76% to $1.31 bil. for the year, as Merck continues to profit from the 4S study. Worldwide volume was up 43%. Mevacor sales dipped 2% for the year in the U.S. to $985 mil.; worldwide annual sales of $1.26 bil. were flat.

Vasotec is "the leading branded ACE inhibitor in the worldwide cardiovascular market," Merck said. Sales grew 6% worldwide, while Vasotec's $1.08 bil. in U.S. sales were up 5%. Merck's other ACE inhibitor, Prinivil, saw swifter growth, as U.S. sales jumped 33% to $385 mil. and worldwide sales gained 29% to $485 mil. The ACE inhibitor category appears to be doing well despite the recent patent expiration for Bristol's Capoten: Warner-Lambert's ACE, Accupril, posted worldwide sales of $406 mil. for the year for a 30% gain.

Merck's newest antihypertensive offering, the angiotensin-II receptor antagonist losartan line (Cozaar and Hyzaar), had $189 mil. in U.S. sales in the first full year on the market. Worldwide sales totaled $339 mil. Novartis received FDA approval in late December for a second angiotensin-II receptor antagonist, Diovan; the company maintained that "initial sales...reflect a high degree of market acceptance." The calcium channel blocker Plendil, sold by the Astra Merck joint venture, grew 25% to $75 mil. for the year.

Merck is looking to a new indication for its alpha blocker finasteride (Proscar) to spur U.S. sales, which were flat at $170 mil. The company filed an NDA Dec. 20 for a lower dose of finasteride to treat male pattern baldness under the brand name Propecia. Worldwide sales of Proscar gained 11% to $450 mil.

Merck's H2 antagonist Pepcid broke the billion dollar sales barrier with $1.03 bil. in annual sales worldwide, a 14% rise. U.S. sales gained 21% to $855 mil. Lilly's H2 entrant, Axid, had a flat year in the U.S., producing $409.2 mil. in sales. Worldwide, Axid's sales dipped 3% to $531 mil. That category is facing the loss of patent protection for Glaxo's Zantac in July.

Astra Merck's acid suppressant offering, the proton pump inhibitor Prilosec, continued dynamic growth. Prilosec sales reached $1.71 bil. in the U.S., a 40% gain over 1995.

Merck's osteoporosis agent Fosamax posted U.S. sales of $206 mil. in 1996, the lion's share of the $282 mil. worldwide total.

"More than 1.3 mil. patients worldwide have received a prescription for Fosamax," Merck said. An FDA advisory committee will address expansion of the indication to prevention of post-menopausal osteoporosis Feb. 20 ("The Pink Sheet" Jan. 6, In Brief).

Another newer product, the chicken pox vaccine Varivax, contributed $107 mil. in 1996 U.S. sales, up 39%. Merck noted that 4.8 mil. doses have been distributed through the federal Vaccines for Children program, which Merck began to supply with the chicken pox vaccine in June. The recently approved hepatitis A vaccine Vaqta had U.S. sales of $5 mil.

Merck's protease inhibitor Crixivan generated $127 mil. in domestic sales after its March approval. Worldwide Crixivan sales were $188 mil.

Trusopt "is now the most widely prescribed anti-glaucoma medicine in the U.S.," Merck said. U.S. sales in 1996, its first full year on the market, reached $127 mil. as worldwide sales were $171 mil. The Timoptic line dropped 14% domestically to $155 mil. and 7% worldwide to $405 mil.