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MERCK WILL FILE NDA FOR TIMOPTIC-XE ONCE-A-DAY GLAUCOMA TREATMENT BY YEAR-END; FOSAMAX FRACTURE-PREVENTION FOUR-YEAR STUDY UNDER WAY, ANALYSTS TOLD

Executive Summary

Merck plans to file an NDA for Timoptic-XE, a once-daily formulation of its ophthalmic beta-blocker timolol, before year- end, Merck Chairman Roy Vagelos, MD, reported Nov. 5. Speaking at the company's annual autumn meeting at the New York Society of Security Analysts, Vagelos noted that Timoptic-XE with Gelrite (a polymer to extend the drug's contact with the eye) should give Merck an additional 10 years of patent protection when the once-daily formulation gets FDA approval. The patent for Timoptic (timolol), the company's first major treatment for glaucoma, expires in March 1997. Timoptic will be the next major Merck product to lose its patent protection. The new formulation could effectively hold Merck's position in the glaucoma market. Merck plans to file another NDA in the glaucoma treatment area in 1993, Vagelos said, for Trusopt (dorzolamide HCl, formerly MK- 507), "the first topical carbonic anhydrase inhibitor for the treatment of glaucoma." Trusopt is said by the company to be free of the systemic side effects associated with oral carbonic anhydrase inhibitors and would be an alternative to pilocarpine for glaucoma patients. The glaucoma treatments are one of four therapeutic areas of focus for Merck in diseases that disproportionately affect the elderly. Vagelos also named benign prostatic hyperplasia, osteoporosis and cardiovascular disease as geriatric therapeutic areas. The company's BPH drug Proscar (finasteride) was "the hot topic of the day" for the Merck chairman, who responded with vigor to an editorial on Proscar by Paul Lange, MD, in the Oct. 22 New England Journal of Medicine. Vagelos refuted Lange's suggestion that the standard surgical procedure for BPH, transurethral resection of prostate, or TURP, is "quicker, more effective, less costly and safe" in comparison to Proscar, giving a graphic description of TURP and showing the audience slides of the instrument used in the surgery. Vagelos criticized Lange's failure to discuss the complications associated with TURP and emphasized that the real market for Proscar is among the "watchful waiters" who would otherwise do nothing until the condition progresses and invasive procedures are required. Lange's editorial suggests that Proscar might "help a little in a small number of men with moderate-to- severe [BPH] symptoms who are not in serious trouble" ("The Pink Sheet" Oct. 26, T&G-5). The Agency for Health Care Policy & Research, the outcomes arm of HHS, is developing a treatment guideline for BPH which may go a long way towards resolving the surgery versus drug debate. Calling Proscar "a new medical paradigm," Vagelos reviewed the company's education efforts through a BPH awareness direct-to- consumer ad campaign for Proscar that broke Nov. 2. The campaign is targeted at reaching the estimated 10 mil. U.S. men with "bothersome BPH symptoms," Vagelos said. The Merck chief also sketched the company's continuing research efforts into the benefits of Proscar and noted that the National Cancer Institute "is planning a seven-year cancer prevention study in about 15,000 men beginning next year." A long- term, large-scale cancer prevention study by NCI had been planned to start up this autumn ("The Pink Sheet" Feb. 10, p. 11). The timetable for Merck's osteoporosis drug Fosamax (alendronate) appears to have been revised. Vagelos said the first registration for the drug will be in Italy in "early 1993" and an NDA filing is planned "for the first half of 1995." At last year's presentation to analysts, Vagelos projected a late 1993-early 1994 filing date for Fosamax, first for treatment of osteoporosis and later for prevention of the bone disease. He suggested that an NDA filing could be delayed if there were questions about fracture- prevention endpoints. Merck initiated a four-year study of 6,000 women earlier this year "to evaluate Fosamax in preventing bone fractures." An additional 3,000 women are a part of Phase III osteoporosis treatment and prevention trials. In the cardiovascular area, Vagelos said Merck is making "significant progress" with its lead angiotensin II receptor antagonist losarten and expects to file an NDA for the oral drug for hypertension in the second half of 1993. The drug is being co- developed at DuPont-Merck. Losarten may avoid the dry cough side effect seen with ACE inhibitors as well as the ankle edema, headache and tachycardia sometimes caused by calcium channel blockers, Vagelos said. The company continues to focus on expanding indications for existing drugs. Vagelos reminded the audience that Vasotec (enalapril) became the first ACE inhibitor to receive a supplemental NDA, in April of this year, covering new labeling for its ability to increase survival rates in patients with symptomatic heart failure ("The Pink Sheet" April 13, In Brief). In July, Merck submitted an additional filing for the prevention of heart failure in asymptomatic patients with cardiac dysfunction, Vagelos reported. Merck also has filed for new Mevacor (lovastatin) labeling indicating the drug can slow the progression and increase regression of arterial blockage. Vagelos also commented on the status of Merck products for schizophrenia (Roxiam), asthma (the leukotriene inhibitor MK-591) and vaccines for chicken pox and hepatitis A (Varivax and Vaqta, respectively). Roxiam (remoxipride), a lipophilic dopamine D-2 receptor antagonist from Astra, has completed Phase III trials that have shown the drug to have "a better side effect profile than other drugs currently on the market" for schizophrenia, Vagelos said. Merck expects to file an NDA for acute and chronic schizophrenia next year. The company's lead oral leukotriene inhibitor for asthma MK- 591 should begin Phase III clinicals trials in the first half of 1993, Vagelos said. Phase IIb trials are currently under way. A once-daily 250 mg dose of the drug "reduced the level of leukotrienes by more than 90% for 24 hours as reflected in the leukotrienes that are excreted in the urine," Vagelos reported. Discussing Merck's vaccine program, Vagelos said the company will "seek" PLAs for its Varivax vaccine for chicken pox "this year" and for its Vaqta hepatitis A vaccine "next year." He also indicated plans to combine Varivax with Merck's MMR (measles- mumps-rubella) vaccine in the future. Asked during Q&A how Merck's Aviva (linopirdine) compares to other Alzheimer drugs, Vagelos responded: "The early look at the data suggests that it's not working, so it probably is similar to the other Alzheimer drugs." Avia has been in Phase III trials ("The Pink Sheet" March 2, T&G-16). By the end of this year, Vagelos said Merck will have signed contracts with providers for "over 75%" of the managed care market and will have agreements with hospital group purchasing associations representing over 90% of the hospital beds in the U.S. He noted that Merck is implementing new computerized order, delivery and packaging systems for its contracts with the Department of Veterans Affairs and military hospitals. The Merck Chairman and CEO also took the time to respond to rumors that his name is on the short-list for HHS secretary in the Clinton Administration. "I have not been invited by the Clinton Administration" to take the post, he said, responding to an audience question. "If invited, I would tell them I have a very good job."
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