BRISTOL-MYERS SQUIBB GLUCOPHAGE 1996 SALES TARGET IS $200 MIL., COMPANY TELLS ANALYSTS; COST-CUTTING MOVES ARE PROJECTED TO SAVE $1.1 BIL. TO $1.5 BIL. BY 1998

Bristol-Myers Squibb's Glucophage (metformin) could reach 1996 sales of $200 mil., the company told securities analysts Dec. 11.

Bristol expects the oral antidiabetic to register $70 mil. in sales in 1995, its first year on the market. Since its April launch, Glucophage has captured approximately a 17% share of the weekly prescriptions in the Type II diabetes market, ahead of Pfizer's Glucotrol XL (about 13%), Pharmacia & Upjohn's Glynase Prestab (about 8%), Hoechst Marion Roussel's Diabeta (6%) and Pharmacia & Upjohn's Micronase (also 6%). Metformin is licensed from Lipha.

Bristol's HMG-CoA reductase inhibitor Pravachol (pravastatin) is on track for 1995 sales in excess of $700 mil., the company said. In 1996, the drug should top the $1 bil. mark.

The company sees a large opportunity for the cholesterol-lowering agent based on the West of Scotland study, which showed that Pravachol reduces the risk of heart attack by 31% and reduces the risk of death by 22%. The WOS study was published in the New England Journal of Medicine in November, and Bristol is seeking expanded Pravachol labeling based on the results ("The Pink Sheet" Nov. 20, T&G-15).

At a Dec. 12 meeting with securities analysts, Merck maintained that the WOS results will benefit its market-leading HMG-CoA reductase inhibitors Mevacor and Zocor. Human Health-U.S./Canada President David Anstice declared that the study "has finished for all time" the argument over whether cholesterol-lowering drugs produce a mortality benefit. He maintained that Merck's" 4S "study of Zocor showed an even stronger effect, and that Zocor is a more potent agent without a significant price differential. He also reported that Merck is studying higher doses of Zocor.

Bristol expects to lose $300 mil. in Capoten (captopril) sales with the advent of generic competition in the U.S. in 1996, the company indicated.

Worldwide Capoten sales will reach $1.5 bil. in 1995, Bristol said, with 60% coming from international markets. The company has a 1996 sales target of $1.2 bil., which suggests that Bristol expects to lose at least half of the U.S. market when generics become available in February. Bristol likely will launch the first outside generic version through Apothecon; the company already has presumably given up some share of Capoten sales to Geneva as part of a settlement keeping that company's generic product off the market until February ("The Pink Sheet" Dec. 4, T&G-5).

Bristol's second ACE inhibitor, Monopril (fosinopril), should replace a portion of the lost Capoten revenues in 1996, the firm indicated. Monopril is tracking for $190 mil. in 1995 sales and has a target of $275 mil. in 1996, the company told the analysts.

In the oncology sector, Taxol (paclitaxel) is on pace for $560 mil. in 1995 sales with $750 mil. projected for 1996. Paraplatin (carboplatin) will tally $300 mil. in 1995 with an expected $325 mil. in 1996, Bristol reported. Both agents are expected to benefit from combination studies in non-small-cell lung cancer and other indications.

Bristol's Cefzil (cefprozil) became the number one prescribed oral cephalosporin brand in the U.S. in October, the company said. Cefzil is targeted for $210 mil. in 1995 sales and $250 mil. in 1996. Maxipime (cefipime), which is pending approval in the U.S., will generate $30 mil. in 1995 sales and is expected to jump to $100 mil. with new launches in 1996, Bristol said. The two AIDS therapies Videx (didanosine) and Zerit (stavudine) will combine for $110 mil. in 1995 sales and are projected to grow to $150 mil. in 1996.

The anxiolytic BuSpar (buspirone) will tally $300 mil. in sales in 1995, Bristol said. Next year the company forecasts growth to $325 mil.; direct-to-consumer ads are planned for the product. Bristol's recent antidepressant introduction, Serzone (nefazadone), is on track for $55 mil. in 1995 sales, projected to more than double to $125 mil. in 1996. Stadol NS (butorphanol) sales will reach $100 mil. this year, and the anti-psoriasis agent Dovonex (calcipotriene) will reach $65 mil., the company said.

Phase III research projects highlighted during the meeting include the angiotensin II inhibitor irbesartan, the platelet aggregation inhibitor clopidogrel, the migraine treatment avitriptan and the oral anticancer agent UFT.

Irbesartan is under study for hypertension, heart failure and diabetic nephropathy, Bristol said. "Early experience" with the drug "suggests potential for greater antihypertensive activity" than seen with Merck's AII inhibitor Cozaar (losartan), Bristol maintained. Regulatory filings are scheduled for the third quarter of 1996.

Clopidogrel is under development for prevention of ischemic events via an agreement with Sanofi. Bristol's focus in development is that the drug must demonstrate once-daily efficacy superior to aspirin. The company plans regulatory filings in early 1997.

Avitriptan is an oral 5HT1-like receptor antagonist that Bristol claims will show a more rapid response and less rebound headache than is seen with Glaxo's Imitrex (sumatriptan). The company anticipates a first quarter 1997 filing for the drug. UFT is an oral combination of ftorafur and uracil licensed from Taiho with regulatory filings planned for mid-1996 in 40 international markets. The company has predicted a 1998 U.S. NDA filing ("The Pink Sheet" May 15, T&G-7).

Bristol-Myers Squibb expects its productivity initiatives to produce $1.1 bil. to $1.5 bil. in pretax savings through 1998, the company told the analysts. The cost-cutting move will involve "associated future restructuring charges," including a 1995 year-end pretax restructuring charge of $250 mil. to $300 mil.

The productivity programs are being implemented now, following what Bristol called a "major" planning and diagnostics effort in 1994 examining all four of the company's businesses: pharmaceuticals, consumer products, nutritionals and medical devices. The review followed a 1994 restructuring that resulted in a staff downsizing by 5,000, with the pharmaceutical sales and marketing staffs bearing the brunt of the reductions.

The initiatives will "sharpen purchasing strategies, stimulate cross-divisional shares of services, boost manufacturing and asset utilization," including shutting down some facilities, "and improve our cost structures, among other things," Bristol-Myers Squibb said. The benefits will be used for internal growth projects, to "lessen the dilutive effect of potential acquisitions" and support earnings performance.

The pretax charge to earnings for 1995 is in addition to a likely charge relating to breast implant litigation. In October, an "opt-out" order was signed by a federal court judge, freeing 440,000 plaintiffs who registered for a failed $4.23 bil. "global" class action settlement to pursue individual claims against Bristol and the other defendants.

Merck is also in the process of less dramatic efficiency moves. The company announced plans in 1994 to produce manufacturing savings of $200 mil. to $250 mil. in 1995-96, and savings in SG&A expenses of $50 mil. to $100 mil. in the same period. Chairman Raymond Gilmartin reported Dec. 12 that "we will achieve our interim targets in 1995 and are on track to fully achieve these goals in 1996."

Cost-cutting moves within the pharmaceutical industry do carry risks, particularly in the manufacturing sector. American Home Products ran into numerous recalls of OTC products as it moved its Hammonton, N.J. plant off-line, and more recently the company has received warning letters pertaining to its injectables manufacturing ("The Pink Sheet" Dec. 11, T&G-4). Merck issued recalls on three products manufactured in West Point, Penn. during September and October ("The Pink Sheet" Dec. 11, T&G-6). Merck disputes the inference that those recalls were related to its manufacturing rationalization moves.