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To: Anthony Wong who wrote (370)	6/19/1998 11:07:00 PM
From: Anthony Wong	Respond to of 1722

Viagra? No, vuka vuka! June 19, 1998 Web posted at: 3:13 p.m. EDT (1913 GMT) BULAWAYO, Zimbabwe (CNN) -- The wonders of Viagra delight couples around the globe, but ask men in Zimbabwe what they think of the impotency-fighting drug, and they tout an alternative remedy: vuka vuka. Every morning, men line up outside the Bulawayo home of a local healer George Moyo to get their daily dose of vuka vuka, a natural cure African healers have been dispensing for years. Does it work? Moyo says his 23 children are proof enough for him. Watch this report from CNN's Bob Coen and decide for yourself. cnn.com

To: Anthony Wong who wrote (370)	6/19/1998 11:20:00 PM
From: Anthony Wong	Respond to of 1722

FDA move on Pfizer's Zeldox raises red flags Friday June 19, 6:11 pm Eastern Time By Ransdell Pierson NEW YORK, June 19 (Reuters) - The U.S. Food and Drug Administration's ''non-approvable'' letter for Pfizer Inc's (PFE - news) candidate drug for schizophrenia, Zeldox, will likely delay its launch by at least six months and raises concern about the medication's future, analysts said. Pfizer said Friday afternoon it had received a non-approvable letter from the federal agency for Zeldox, an antipsychotic which some analysts had expected to be approved this month. Pfizer expected the drug garner annual sales of $200 million to $600 million within four years. Pfizer gave no explanation of what information the FDA might have requested or whether the agency had cited concerns about the safety or effectiveness of Zeldox also known as ziprasidone. But analysts said the wording of Pfizer's statement strongly hinted the agency was seeking another clinical trial of the drug. ''We believe that the additional studies and analyses suggested by the FDA can be undertaken in a relatively short period, and that we will be able to advance the application accordingly,'' Pfizer's research chief Dr. John Niblack said in the statement released mid-afternoon. ''We are obviously disappointed at this development, but remain confident of the safety and efficacy of Zeldox,'' Niblack said, referring to the FDA letter. Pfizer said it remained committed to launching the drug in the U.S. and abroad and planned to meet with the FDA to discuss related issues, ''including the possible submission of additional data, as suggested by the FDA,'' the Pfizer statement said. Pfizer spokesman Andrew McCormick later said the company, perhaps best known for its blockbuster impotence pill, Viagra, approved in March, would not comment further on the FDA letter. ''The non-approvable letter is a big shock, although it is still unclear exactly what it means,'' said New Jersey independent drug analyst Hemant Shah. Shah said the agency sends such letters sometimes for minor, technical problems with a drug approval application but sometimes to express potentially serious regulatory hurdles. ''The non-approvable letter means the data the FDA has now is not sufficient for Zeldox to be approved. And it sounds like the FDA wants another clinical trial,'' said Mario Corso, a Boston-based pharmaceuticals analyst for ABN-AMBRO Securities. ''A new trial would take up to a year,'' said Corso, who described1Zeldox as a ''fairly important drug'' in the New York-based company's pipeline. He said he had projected Zeldox sales of $60 million in 1998, rising to $600 million by 2001. Corso added Zeldox, if approved, would compete with Johnson & Johnson's (JNJ - news) Risperdal and with Eli Lilly's (LLY - news) Zyprexa, an antipsychotic with 1997 sales of $730 million. Hambrecht & Quist drug analyst Alex Zisson said he had projected Zeldox annual sales of $500 million three or four years after launch, far short of the $1 billion annual sales needed to qualify as a modern-day blockbuster drug. Zisson said if the FDA simply wanted a clarification of existing Zeldox data, which he called the ''best-case scenario,'' the drug could face a marketing delay of six to nine months. ''But if a new trial is needed, you're talking at least six months to run the trial and another six months for the FDA to approve the drug,'' he added. Pfizer in March won FDA approval for Viagra, the world's first impotence pill. It has been perhaps the fastest selling drug in history -- chalking up over two million prescriptions. Although 16 men have died after taking Viagra, the FDA and Pfizer said no deaths were linked directly to the drug. biz.yahoo.com

To: Anthony Wong who wrote (370)	6/19/1998 11:28:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Merck says Astra deal ups earnings without risk Friday June 19, 7:48 pm Eastern Time By Ransdell Pierson NEW YORK, June 19 (Reuters) - Merck & Co. Inc. (MRK - news) said Friday the restructuring of its joint venture with Swedish drug group Astra AB (ASTRa.ST) will enhance earnings because Merck will share in the revenues but not the costs of Astra's U.S. product sales. At a briefing, Merck Chief Financial Officer Judy Lewent said the New Jersey-based company will get a percentage of Astra's U.S. revenues based on the product and the level of sales. The exact percentage was not disclosed. Astra said the restructuring would dilute its earnings by nil to five percent in 1998 and 1999, and be accretive to earnings by more than five percent starting in 2000. In the restructuring, the operations of the joint venture, Astra Merck Inc., will be combined with Astra USA Inc. unit in a new limited partnership, named Astra Pharmaceuticals LP. Astra will have management control as the general partner in the new limited partnership. Merck will receive revenue for at least 10 years based on sales of current products in the Astra Merck portfolio and those now in its development pipeline as well as certain Astra USA products. ''The restructuring allows Merck to participate in Astra's sales growth without having to contribute toward Astra's expenses -- including research and development, sales and marketing and advertising,'' Lewent told Reuters. ''So we ride with the successful products without having any downside risk from expenses,'' said Lewent, who declined to speculate just how accretive earnings from the deal would be for Merck. Astra will have the right to buy out Merck's interest in the drugs in the years 2008, 2012 or 2016, except Merck's interest in the ulcer drug Prilosec and perprazole -- another ulcer drug now in Phase III clinical trials. That interest will continue until 2017 if the ulcer drugs' combined sales stay above a specified level. The cash buyout will be based on a multiple of the prior three-year average of pre-tax income received by Merck for all products except Prilosec and perprazole, but will be no less than $4.4 billion in 2008. Prilosec, sold under the brand name Losec outside the United States, was the world's biggest-selling drug in 1997 with global sales of over $4 billion. It accounted for over 90 percent of Astra Merck's 1997 sales of $2.3 billion, making Prilosec the crown jewel of the joint venture. Astra has called perprazole a ''better'' drug which it plans to launch before Prilosec's expected U.S. patent expiration in 2001. Astra will also grant Merck a 40-year, $1.4 billion cash loan at the closing of the restructuring scheduled for July 1. Lewent said she is still comfortable with analysts' estimates that Merck will earn $4.28 to $4.39 a share for 1998 on a diluted basis. She said the loan from Astra carries a coupon rate of 6 percent and is ''not a primary driver'' in Merck's projected accretive benefit from the deal. Carl-Gustaf Johansson, executive vice president of Astra AG, will become chief executive of Astra Pharmaceuticals LP. He said Friday the U.S. operation will be his parent company's largest unit, representing 40 percent of total worldwide Astra AG sales. ''I think that will rise to 50 percent within two years because the U.S. is such a fast-growing market,'' he told Reuters after a New York meeting with analysts. Johansson said he began negotiating the deal announced Friday in 1996 with Merck's Lewent, adding he had wanted to buy out Merck's interest ''as soon as possible'' but would have to wait years longer under terms of the restructuring. Johansson, however, called the arrangement a ''win-win'' deal for both companies. He said the Astra U.S. unit now has ''management freedom'' and a sales force of 2,200 eager to flex its ''marketing muscle.'' Steve Lisi, a New York drug analyst for Mehta Partners, said while the deal was ''fair'' for both companies, it was particularly auspicious for Merck. ''It gives Merck access to almost all Astra products and to everything that is developed in Astra's pipeline by that time, which could prove to be enormous cash flow if the pipeline proves robust,'' Lisi said. He added Merck had hedged its bets well by also ensuring that it receives a multibillion dollar payoff when the partnership is dissolved years down the road. ((New York Newsdesk 212 859-1736). biz.yahoo.com