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To: Anthony Wong who wrote (463)	7/6/1998 1:50:00 PM
From: Anthony Wong	Respond to of 1722

Pfizer Faults Insurers on Viagra Monday July 6 1:12 PM EDT JOHN HENDREN AP Business Writer NEW YORK (AP) - Taking the offensive against insurers who say they won't cover Viagra due to safety concerns, Pfizer Inc. officials today called the decision ''irresponsible'' and said it promotes ''unnecessary fear.'' The company's unusual confrontation of insurers who hold the power to approve or disapprove its many drugs came after Prudential HealthCare and Humana Inc. refused to reimburse patients for the drug because they weren't sure it was safe. Some Wall Street analysts say the insurers appear to be using safety concerns as an excuse to avoid financial strain from the pricey $10-a-pill impotence treatment. ''Any challenges to the safety of Viagra are factually and medically incorrect,'' Pfizer spokeswoman Mariann Caprino said. ''It's irresponsible to raise the concerns of the general public over the safety of this drug ... and it's causing unnecessary fear.'' At least 16 Viagra patients have died since the drug came on the market in March. Pfizer and the Food and Drug Administration point out that users of the blockbuster impotence drug are mostly elderly and often have other health problems. Both maintain that there's no evidence any of the patients would have died if they took the drug as directed. Kaiser Permanente and other insurers have refused to cover Viagra because of the high cost. But Prudential and Humana say safety was their primary concern. The rate of serious problems in patients using Viagra is lower than the overall rate for the aging men using the drug, Ms. Caprino said. ''We had some concerns about the long-term safety effects of the drug,'' Humana spokeswoman Valerie Kennedy said. Neither company has contacted Pfizer to seek further safety information, Ms. Caprino said. ''We would certainly welcome an opportunity to meet with them and put these concerns to rest,'' she said. Insurers are using safety concerns to mask their real reason for denying the drug - its budget-busting price, said industry analyst Hemant K. Shah said. ''There's no question about it,'' said Shah, an independent drug industry analyst in Warren, N.J. ''It's very difficult to give other reasons (besides safety) because the consumer backlash could be quite significant.'' With the price of new drugs rising, insurers are drawing a line at covering what they deem to be ''lifestyle'' drugs, Shah said. For instance, if an employer pays an insurer $4,000 a year to cover a patient and the patient is taking two pricey drugs - such as Viagra and a cholesterol-lowerer such as Merck & Co.'s Zocor - the insurer could spend half that amount on drugs alone. ''You're going to see that more and more, with drugs being pushed off the reimbursement list, because managed care companies can't survive like that,'' Shah said. ''The cost has skyrocketed.'' Drug makers have raised demand for drugs through aggressive direct-to-consumer advertisements on television and in news magazines after the FDA made such pitches easier last year. Insurers had held drug costs below inflation levels until this year. But now prices have began to outpace inflation and some health care observers expect drug costs to jump 10 percent or more in 1999.

To: Anthony Wong who wrote (463)	7/6/1998 1:56:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 1722

Forest Labs' Celexa Could Push Stock Higher After Gain in Year Bloomberg News July 6, 1998, 11:44 a.m. ET Forest Labs' Celexa Could Push Stock Higher After Gain in Year New York, July 6 (Bloomberg) -- Forest Laboratories Inc. shares have risen 41 percent this year and could rise more if the company gets the expected U.S. approval for its Celexa, a drug to challenge Prozac, the world's best-selling antidepressant. The stock of the New York-based company has risen 61 percent in the past year, closing at 34 13/16 Thursday, in anticipation of Forest Labs getting approval for Celexa. The stock hit a 52- week high of 40 1/2 on April 1. Warner-Lambert Co., one of the biggest U.S. drugmakers, will help sell the drug in the U.S. The antidepressant, known chemically as citalopram, is already sold in Europe by the Danish drugmaker H. Lundbeck A/S, which developed it. Celexa, which may get approval as early as this month, faces competition from other drugs in its class, including Pfizer Inc.'s Zoloft and SmithKline Beecham Plc's Paxil as well as Eli Lilly & Co.'s Prozac. ''If citalopram is half as successful in the U.S. as it is in Europe, then the stock is going to go up a lot,'' said Charles Engelberg, an analyst with AmeriCal Securities who has a ''buy'' rating on Forest Labs. Citalopram is the best-selling drug in its class in Denmark, where it was introduced eight years ago, and outsells Prozac more than three to one. It is a top-seller in at least seven European countries and has a 10 percent share of the antidepressant market in Europe, said Ken Goodman, Forest Labs chief financial officer. It is the No. 1 selling drug of any kind in Finland and Austria. Sales of antidepressants in the U.S. are expected to rise to $7 billion annually by 2002 from $5 billion today. Depression affects almost 18 million people in the U.S., according to the National Institute for Mental Health. Nearly two-thirds of those affected don't seek treatment. Side Effects ''This drug singlehandedly has the potential to double or triple the revenue base of Forest Labs,'' said Ron Nordman, an investor with Deerfield Management, which owned 1.2 million of the company's shares in March, according to regulatory filings. Nordman said one of the main benefits of Celexa is that unlike many other antidepressants in its class, it doesn't react negatively with a large number of drugs. This makes it an ideal drug for elderly people who are often on several medications at once. The U.S. Food and Drug Administration in May found the drug, known chemically as citalopram, to be ''approvable.'' Forest Labs hopes to get final approval in July and begin selling the drug in August, said company spokesman John Eggers. Others are skeptical about Celexa's prospects in the U.S. market, saying it's coming too late to the party. ''It's going to be in the group of also-rans, along with Bristol-Myers Squibb's Serzone and American Home Products' Effexor,'' said James Keeney, an analyst with ABN Amro Inc. ''I don't see that Celexa has the horsepower to become a market- leading product.'' Alex Zisson, analyst with Hambrecht & Quist, said expectations are ratcheted very high. ''If Celexa gets off to a very strong start, the stock is probably fine, but if anything short of a strong launch happens, there's a fair amount of room for expectations to be lowered,'' said Zisson, who has a ''neutral'' rating on the stock's forecasting earnings of 7 cents a share for the June quarter, compared to the 13-cent average estimate. Depression has been linked to low levels of the chemical messenger, serotonin, in the brain. Like Prozac, Paxil and Zoloft, Celexa works by preventing the brain's nerve cells from reabsorbing serotonin and so bathing the brain in the chemical. The group, known as selective serotonin reuptake inhibitors, or SSRIs, make up 56 percent of the U.S. market for antidepressants. Whatever the prospects for Celexa, Forest Labs has its share of problems, too. The company got a warning letter in April from the U.S. Food and Drug Administration after its drug-manufacturing plant in Cincinnati, Ohio, showed quality control problems. The FDA's concerns included follow-up testing and documentation over batches of a thyroid drug that had to be recalled because they didn't meet consistency requirements. The FDA also found that water used to manufacture the thyroid pill may have been contaminated by microbacteria. The company has taken corrective action in response to the FDA letter, said spokesman Eggers. Forest Labs is currently one of 22 defendants in a case pending in federal court in Chicago by pharmacies alleging drug- price fixing, the company said in a regulatory filing. The case is scheduled for trial in September. The company is also involved in lawsuits in 12 states and the District of Columbia that includes cases brought by retail pharmacists and consumers. ''Forest has taken a firm stand that we are not settling on any of these suits,'' said CFO Goodman. Forest Labs got the license to market citalopram in March 1996. Warner Lambert agreed this March to co-market the drug. According to Lundbeck, Pfizer originally had the license to market citalopram in the U.S. The New York company terminated the accord, though, as it developed its own antidepressant, Zoloft, said Kerstin Fredricson Overo, medical marketing director at Lundbeck. Pfizer declined to comment. Forest develops, makes and sells name-brand and generic prescription and nonprescription drugs. The company sells its products to wholesalers, chain drugstores and generic distributors. --Michelle Cortez in Ithaca, New York (607) 272-1174 and Evan