Gary, I hear you: I've been here all along. We went from " rare eye effects " with Viagra FDA submission data to " a moderate percentage " according to the Amer Acad of Ophthal ": Message 4327441 Sounds almost like the one arm bandits in Las Vegas : the picture changes even as you look. Stay tuned...... Staid Wall Street Jour begins to sound an alarm.... Message 4335118
And, Merck will begin selling cholesterol pill Zocor " for pennies ( see last story below ). That will put pressure on PFE's Lipitor profit margins.
And,"the market is listening", PFE down today... It's been nice trading in PFE and Vivus last few days. I also took time off to go to TDFX and Newbridge Networks. I am out of PFE 4 days ago until picture becomes clearer. I will continue to tade Vivus.
My computer is coming next week. Best to you and all,
TA
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Dow Jones Newswires -- May 5, 1998
Vivus Shares Gain 10% As Doctors Warn Against Viagra
Dow Jones Newswires
NEW YORK -- A warning from eye doctors that Pfizer Inc.'s (PFE) Viagra may prove dangerous to some patients with eye problems is giving a boost to Vivus Inc. (VVUS), which has its own answer to male impotence.
The warning energized Vivus's Nasdaq shares, which were recently up 15/16, or 10.1%, to 10 3/16 on volume of 2.5 million shares.
When Pfizer's Viagra blasted onto the impotence treatment scene last month it quickly generated upward of 40,000 prescriptions a day. In contrast, Vivus' MUSE suppository treatment more quietly has been used to help men suffering from impotence.
But Monday the American Academy of Opthamology, the largest organization of eye doctors, said high doses of Viagra can cause some eye problems, including retinal dysfunction, light sensitivity and bluish-tinged vision.
The consortium urged patients with retina problems, including macular degeneration or retinitis pigmentosa, to use the lowest possible dosages of the drug.
According to PaineWebber analyst Charles Olsziewski, Vivus stands to benefit from potential problems with Viagra as impotent men look elsewhere for help.
"The product works very successfully," Olsziewski said, referring to Vivus' suppository. "And that is also true for patients who are not suited for the pill."
A Vivus representative wasn't immediately available for comment.
Pfizer shares were recently trading at 110, down 2 11/16, or 2.3%, on volume of 4.6 million shares.
-Nancy Beiles; 201-938-5393
============================================= Dow Jones Newswires -- May 5, 1998
Eye Doctors Say More Studies Needed On Viagra
Dow Jones Newswires
SAN FRANCISCO (AP)--The world's largest organization of eye doctors called for more studies into the newly approved impotence drug, Viagra, and said users with some types of eye problems should stay away from higher doses.
A moderate percentage of people taking Viagra have experienced temporary vision problems, and the American Academy of Ophthalmology, meeting her this week, urged that people take the effects seriously.
"FDA clinical trials show that taking the medication, especially at higher doses, can cause some retinal dysfunction and affect the way we see for a number of hours," association spokesman Dr. Michael F. Marmor said Monday.
Patients reported visual disturbances described as a bluish color tinge and light sensitivity.
"On the surface, seeing the world with a bluish tinge may just be annoying," Marmor said in a statement.
Marmor, a professor of ophthalmology at Stanford University, said a clinical study showed that electrical measures of retinal function dropped by 30% to 50% and lasted for at least five hours after taking a high dose of Viagra.
"We need to do some studies about the long-term effects of taking Viagra," he said.
He suggested that users with retina problems such as macular degeneration or retinitis pigmentosa to "stay at the lowest dose level possible." According to the FDA, the recommended dose level for most patients is 50 mg.
Dr. Ian Osterloh, a researcher for the drug's developer, Pfizer Inc. (PFE), seemed perplexed by Marmor's comments about the changes in retinal function.
"I suspect there must be a misunderstanding," he said today. "The drug has been studied extensively. We have done more studies than have been reported."
The American Academy of Ophthalmology has more than 23,000 members.
Pfizer representatives did not immediately return calls left on an answering machine today.
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The Wall Street Journal Interactive Edition -- May 4, 1998
Reality Check: Viagra Won't Help Everyone
By MARILYN CHASE
THE BUZZ OVER a blue diamond-shaped pill suggests that every man can be a tiger with Viagra in his tank. But a success rate of up to 80% means one in five men won't feel renewed by the new impotence treatment.
Amid the first flush of Viagra success stories, there are some failures and frustrations. A 60-year old Bay Area consultant, who underwent prostate cancer surgery seven years ago, finds Viagra's promise so far unfulfilled.
<Picture: [Go]>Pfizer Explores Faster-Acting Form for Viagra
"I tried it twice," he says. "Zero. The first time, I was stressed out. The second time, I was calmer but it still didn't work."
Prior to prostate cancer at age 53, he was very sexually active, "but surgery knocked that out." A patient partner made the tough times tolerable. "I've been happily married for 15 years," he says. "She's so supportive it's unbelievable."
Shots of a drug called alprostadil restored his basic function, but "it isn't as comfortable as a normal sexual experience," he says. "It just doesn't seem natural."
Now, contemplating doubling his dose to 100 from 50 milligrams, his treatment is a work-in-progress.
Disappointment also followed a one-month regimen by a retired retailer in San Francisco. After more than a dozen doses, satisfaction eludes him. An hour after taking the pills, he felt a fleeting response, "but then -- nil."
"I should be able to perform," he insists. "I didn't have any trouble when I was 50 or 60." Describing himself as "a young 70," he hones his physique with a rigorous cross-training program.
In his seventh decade, however, he developed diabetes, which can bring atherosclerosis and nerve damage, leading to impotence. Although some diabetics find relief with Viagra, the retailer so far has relied on a vacuum pump to induce an erection.
HIS WIFE of 46 years sees the parade of Viagra hype passing her husband by. "It gives you the idea that it's going to help everybody. That's not true," she adds.
Unwilling to settle for snuggles, the retailer is already discussing with his urologist future treatment options in the new-drug pipeline such as Vasomax.
Who should and shouldn't use Viagra? In San Francisco, urologists Larry Werboff and Ira Sharlip say they're queried by soccer moms at games, friends at parties and neighbors at the supermarket.
Patients likely to get a good response on Viagra are men with "psychogenic impotence" and performance anxiety. Some men who suffer nerve damage from spinal cord injury, diabetes, prostate disease or multiple sclerosis may also find relief.
Less likely to benefit: men with atherosclerosis. Clogged vessels block the drug's power to increase blood flow.
Viagra, the urologists stress, is for men with serious "erectile dysfunction," rooted in physical or psychological disorders. Some normally potent men seek the drug for enhancement or recreational use, but "it doesn't make a man into a superman," says Dr. Sharlip. Nor does it work as an aphrodisiac or libido-booster for people lacking desire.
Who should avoid it? Men with heart disease taking nitrate drugs such as nitroglycerin for angina, due to lowering of blood pressure and cardiac risk. These drugs, sold under a dozen trade names, include Transderm-Nitro, Nitro-Dur, Nitro-Bid, and Nitrolingual, Dr. Werboff says.
Antibiotics and antifungal drugs -- such as erythromycin, keoconazole and itraconazole -- alter metabolism, raising blood levels of Viagra and potential risk too.
ANYONE INTERESTED in Viagra should get a medical evaluation, including a review of all their current medications. Hundreds of drugs, from antacids to antidepressants and antihistamines, can depress sexual function. Switching drugs or doses might be all it takes to solve an impotence problem, sparing the need for Pfizer's expensive pill.
Still, many -- perhaps most -- are benefiting. Among the successful: a 47-year-old Delta Airlines pilot. Recently divorced, he had been having sexual troubles for about three years. Dr. Sharlip prescribed Viagra and it worked "fabulously well."
So well, in fact, a dilemma arises. His new girlfriend is unaware his ardor is getting a pharmaceutical boost. "With all the publicity, I'm sure I'm going to be asked," he says. But until asked, he's staying silent.
Another success: a 39-year-old San Francisco banker, whose fear of failure made him avoid intimacy with his mate.
"I had withdrawn like an aging rock star who won't perform because he fears criticism," he says. Counseling didn't help; the prescription did.
"It worked in one hour. It felt natural," he says. And there were encores "all night long." Though he suffered a "Viagra hangover" (morning-after headaches), it's been worth it, he believes. "It's going to save a lot of relationships," he predicts, though he warns it won't aid spontaneous trysts.
"Viagra isn't something you take and go for a jog, hoping to get lucky," he says. "You have to have it on you, like a condom in your wallet. It would be like a Woody Allen movie if you lost it."
Age is not necessarily an impediment, says Dr. Sharlip. One 86-year-old man took Viagra and faxed back ratings of his per-dose virility: "50 milligrams give me 70%, and 100 milligrams give me 95%. Where can I get the other 5%?"
The doctor said, "Live with it." =========================================================================== The Wall Street Journal Interactive Edition -- May 4, 1998
Pfizer Explores Faster-Acting Form For Its New Impotency Drug Viagra
By ANDREA PETERSEN Staff Reporter of THE WALL STREET JOURNAL
Viagra, Pfizer Inc.'s hot-selling new prescription drug for impotence, may take on a new form to correct one of its biggest drawbacks: Men must swallow the pill a full hour before they have sex.
The effort could make Viagra, now the first potency pill, the first potency wafer, able to dissolve easily in the mouth in seconds.
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<Picture: [Go]>A Reality Check:
Viagra Won't Help Absolutely Everyone
Pfizer has signed a deal with R.P. Scherer Corp. to develop a delivery form that could be a faster-acting version of the blockbuster drug. Scherer's Zydis is a thin-wafer "delivery system" that, if it is proven to work well, could let patients take Viagra only minutes before sex.
Pfizer says it is doing biochemical research on Zydis and will proceed with human clinical trials if it can. But the company adds that any new form is still years away. Scherer wouldn't comment on the deal, and neither company would disclose details.
Rumors that Troy, Mich.-based Scherer might get a seat on the Viagra bandwagon had fueled a 10% rise in its stock price in the past two weeks. On Friday, Scherer closed up again at $73.5625, rising 56.25 cents, in New York Stock Exchange composite trading. Pfizer closed at $112.375, down $1.4375, also in composite trading.
"Zydis generally can push a drug into the bloodstream much faster than when you swallow a pill," said Alex Zisson, a drug analyst at Hambrecht & Quist. "Efficacy might begin in 15 minutes rather than 60," and a glass of water wouldn't be necessary. In pill form, patients must swallow Viagra an hour before sex to give the drug time to be absorbed in the digestive system.
Pfizer says it is too early to tell how much more quickly a Zydis-enhanced Viagra would work.
"We're looking at different attributes we may add to improve compliance or to make it more patient- and physician-friendly," says Pfizer spokesman Andy McCormick.
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biz.yahoo.com
Friday May 1, 1:32 pm Eastern Time
Merck offers hospitals Zocor for pennies
By Ransdell Pierson
NEW YORK, May 1 (Reuters) - Merck & Co said Friday it was offering to sell hundreds of U.S. hospitals Zocor for pennies a day, a sharp discount to the anti-cholesterol drug's normal wholesale price which ranges from $1.88-$3.40 a daily tablet.
When asked by Reuters to confirm reports that Merck was offering Zocor to hundreds of hospitals at ''pennies a day,'' Merck spokesman John Bloomfield replied, ''That's not inaccurate.'' He declined to be more specific.
He said he could not immediately verify other details of the hospital pricing deal, which were provided to Reuters by ABN-AMBRO analyst James Keeney.
Bloomfield subsequently confirmed Merck began contracting with hospitals in April for cut-rate Zocor prices. In return, he said the hospitals were required to make sure about 70 percent of the statin drugs they prescribe are either Zocor or Mevacor, an older Merck statin.
Bloomfield said the logic of the deal is to help promote wider use of statins, which he said are only used by 30 percent of patients treated for serious heart problems.
A statin is a class of cholesterol lowering drug. Statins are favored by physicians over older drugs because of their potency.
Zocor has been losing ground since early 1997 to Warner-Lambert Co's (WLA - news) potent drug Lipitor, a newer and more potent member of the same ''statin'' class of cholesterol-lowering drugs.
ABN-AMRO's Keeney said Merck had pitched the Zocor prices to about 1200 hospitals.
Bloomfield declined to specify the number. But he added, ''We are targeting major acute care centers that have the highest number of heart patients.''
But Keeney said marketing sources had informed him Merck was offering hospitals discount Zocor prices in a ''tie-in'' with two other Merck products, its ulcer drug Pepcid and antibiotic Primaxin. When questioned again, he said he was not yet able to determine exactly what the tie-in is.
But Bloomfield said the special Zocor pricing was an independent offer.
''This program is not tied to any other product,'' he said, adding it was similar to another Merck program that has offered hospitals significant discounts for Pepcid.
He declined to comment on whether the Pepcid discounts were as steep as the Zocor pricing now being offered to hospitals.
When asked if the Zocor program was a move to stabilize Zocor market share from Lipitor's advance, Bloomfield declined to comment. ''It's a highly competitive marketplace,'' he added.
At Merck's annual shareholders meeting on Tuesday, Merck research chief Dr. Edward Scolnick expressed concern that Lipitor -- launched by Warner Lambert in early 1997 -- had bypassed Zocor to become the nation's best-selling anti-cholesterol drug.
Keeney said latest industry data show Lipitor has a 31.95 percent U.S. market share of all cholesterol-lowering drugs, based on new prescriptions, while Zocor has 24.85.
He said Zocor held over a 33 percent share before Lipitor was introduced.
Keeney said he approved of Merck's Zocor program. ''It signals a new competitiveness on the part of the company,'' he said.
''It represents a departure in Merck's marketing policies. The logic is to increase volume within prestigious acute-care institutions where opinion-molding prescribers are,'' Keeney added.
Drug analyst Alex Zisson of Hambrecht & Quist said, ''Wow'' when informed about the pricing program. He called it a ''slash and burn marketing method to get as much market share as you can regardless of profits'' for the drug at the hospitals. ''I can't remember a drug company ever having as steep a discount as this,'' Zisson said. Zisson noted the majority of prescriptions for drugs are written outside of hospitals, in doctor's offices, adding that if the hospital program increases Zocor's market share by two points or more, ''It will probably be worth it.''
TA |