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[kmu]

NASDAQ HALT GILD.O NEWS PENDING LAST 63 3/16

GILD an Nasdaq ausgesetzt aufgrund folgender Meldung. (Handel in D wahrscheinlich auch)

Monday November 1 12:13 AM ET
Gilead To Argue For HIV Drug Approval Monday
By Lisa Richwine

WASHINGTON (Reuters) - Gilead Sciences Inc (Nasdaq:GILD - news)., a biotech firm that co-developed a just-approved flu pill, is set to argue its case Monday for a new drug that could beat back HIV in patients resistant to other treatments.

Gilead officials and researchers will present data to a Food and Drug Administration advisory panel to show the drug, adefovir dipivoxil, suppressed the virus that causes AIDS in patients who had stopped responding to multi-drug cocktails.

The drug regimens have achieved great success in keeping HIV levels at bay. But doctors now find a growing number of patients become at least partially resistant to one or more of the drugs after taking them for several months, or failing to take them properly.

Adefovir, as part of a multi-drug treatment, could provide an option for patients who now have no other choices, drug industry analysts said.

``In terms of an unmet medical need, I think it`s very important,`` said Prudential Securities analyst Caroline Copithorne. ``... The big benefit is that it works in patients where other medications don`t.``

Analysts` estimates for adefovir`s peak sales ranged from $100 million and $200 million, which would be important for Forest Hills, Calif.-based Gilead, a company that has yet to turn a profit. Gilead also sells two drugs for AIDS complications and an anti-fungal drug and will gain revenue from sales of Tamiflu, a flu pill approved this week that was co-developed with Hoffman-LaRoche Inc. .

But first Gilead will have to overcome concerns about adefovir`s potential to harm the kidneys, a topic expected to dominate the panel meeting, analysts said.

``The challenge this drug has is the kidney toxicity,`` said PaineWebber analyst Elise Wang, adding that the side effect could limit the population of patients who could take adefovir.

The issue slowed Gilead`s clinical trials, prompting investigators to lower the adefovir dose. But studies showed kidney problems were less severe at the lower dose, developed slowly and could be reversed, Gilead officials say. Doctors also can spot kidney changes early with monthly monitoring.

``The good news is it appears to be completely reversible in all the patients,`` said ING Barings analyst Jonas Alsenas.

The FDA usually follows its panels` advice.

If approved, adefovir would be the first of a new type of anti-HIV drugs called nucleotides to hit the market. The drug prevents HIV from replicating by priming cells to stop infection. It is given in a single oral capsule daily.

Adefovir, to be sold under the brand name Preveon, could be eclipsed in a few years by another Gilead drug, a nucleotide called tenofovir that has shown no serious side effects in tests so far, analysts said. Tenofovir is currently in Phase II studies.

[Awester]

Geht es jetzt nach oben oder nach unten?
Kann mich mal jemand aufklären?

[kmu]

November 01, 1999 19:57

Gilead Sciences Announces Results of FDA Advisory Panel On Anti-HIV Agent, Adefovir Dipivoxil 60 mg
Jump to first matched term

GAITHERSBURG, Md.--(BUSINESS WIRE)--Nov. 1, 1999--Gilead Sciences today presented evidence to the U.S. Food and Drug Administration`s (FDA) Antiviral Drugs Advisory Committee on the safety and efficacy of adefovir dipivoxil 60 mg for patients infected with HIV.

Following the company`s presentation, the Committee recommended that the FDA not approve adefovir dipivoxil 60 mg based on the currently available data. Gilead Sciences will be meeting with the FDA staff to further discuss the Committee`s views.

"We are obviously disappointed with the Committee`s decision. However, we plan to work closely with the FDA to resolve the outstanding issues and respond to the questions they have raised," said John C. Martin, Ph.D., Chairman and Chief Executive Officer of Gilead Sciences.

Gilead filed its New Drug Application for adefovir dipivoxil in June 1999. While under review, Gilead has made adefovir dipivoxil available in the United States and Canada to patients in need through an Expanded Access Program, free of charge.

Gilead also is seeking approval to market adefovir dipivoxil for the treatment of HIV infection in Europe and in October 1999 filed a marketing application through the centralized procedure of the European Medicines Agency. Earlier this year, Gilead began making the drug available in France to patients with HIV infection through an Expanded Access Program. The program will begin in additional countries throughout the European Union as regulatory approvals are obtained.

In addition to adefovir dipivoxil, Gilead has other product candidates in human testing for the potential treatment of viral diseases caused by the human immunodeficiency virus (HIV), chronic hepatitis B, bacterial infections and cancer.

Gilead Sciences, headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. The Company discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA, Boulder, CO, San Dimas, CA, and Cambridge, UK, and sales and marketing organizations in the United States, Europe and Australia. Gilead common stock is traded on The Nasdaq Stock Market under the symbol GILD.


CONTACT: Gilead Sciences
Susan Hubbard, Investors
650/522-5715
or
Sheryl Meredith, Media
650/522-5505

[Jockey]

klar das in den letzten tagen runter ging, aber so schreibt hicks:
"
Gilead Sciences is one for one with the FDA. After receiving FDA approval for
its flu pill, Tamiflu, the FDA rejected the company`s HIV agent. Although there
will be some selling based on this news, I expect the stock to recover. The reason
being is that the HIV drug addressed only a very small market, whereas the flu pill
has the potential to be a cash cow.

I still rate Gilead Sciences (GILD - NASDAQ) a strong buy under $60.
"

also locker bleiben

[kmu]

Monday November 8, 2:00 am Eastern Time
Company Press Release
SOURCE: Hoffman La-Roche Inc.

Roche Announces New Data on Recently Approved Tamiflu(TM), First Pill to Treat The Most Common Strains of Influenza (A & B)

1998-1999 Flu Season Data Supports Benefits of Tamiflu(TM) (oseltamivir phosphate) for the Treatment and Prevention of Influenza
NUTLEY, N.J., Nov. 8 /PRNewswire/ -- Hoffmann-La Roche Inc. and Gilead Sciences, Inc. (Nasdaq: GILD - news) announced today results of 1998-1999 flu season clinical trial data on Roche`s Tamiflu(TM) (oseltamivir phosphate), the first oral neuraminidase inhibitor in pill form. Tamiflu was approved by the U.S. Food and Drug Administration (FDA) on October 27, 1999 for the treatment of influenza A & B, which includes the most common strains of influenza. These results, presented at a gathering of clinical trial investigators, focus on a recently concluded treatment study involving pediatric patients. In addition, preliminary data from an ongoing Tamiflu treatment study involving elderly patients were announced, as well as results from two prophylaxis studies, in an elderly and family setting.

The FDA approved Tamiflu for the treatment of uncomplicated acute illness due to influenza infection in adults who have been symptomatic for no more than two days. The recommended oral dose of Tamiflu is 75 mg twice daily for five days.

``The 1998-1999 flu season data reinforces the benefits that we have seen in previous clinical trials of Tamiflu,`` said Dr. Dominick Iacuzio, Medical Director, Hoffmann-La Roche. ``The exciting findings of these studies show promise for future additional uses of the medication.``

1998-1999 Flu Season

Treatment Studies

A treatment study (n=695) in pediatrics, 1-12 years of age, showed the drug met the primary clinical endpoints of the study and results indicated statistically significant differences between active and placebo arms. The primary clinical endpoints included duration of influenza illness and time to return to normal health and activity. Tamiflu, administered in an oral suspension formulation, showed a 37% reduction in the duration of influenza and allowed patients to return to normal health and activity 40% faster than patients taking placebo. An additional finding was that the incidence of acute otitis media was significantly reduced, by 43%, in patients treated with Tamiflu. Tamiflu, which is not indicated for the treatment of influenza in children, was well tolerated in this study. Mild vomiting ( 14.3% vs. 8.5% in the placebo group) and diarrhea (8.8% vs. 10.5% in the placebo group) were the most common adverse events.

A preliminary analysis of safety data from ongoing treatment studies involving elderly patients (65 years of age or older) was also announced. Results indicated no overall difference in safety and tolerability in clinical trials between the elderly patients and younger adults, and no dose adjustments are required when treating these patients.

A preliminary analysis of data from ongoing treatment studies in high-risk patients also showed similar safety results. The most frequently reported adverse events in both these studies were nausea and vomiting and, to a lesser extent, bronchitis, insomnia, and vertigo. These studies are ongoing and efficacy data will be analyzed upon completion of the trials.

Prophylaxis Studies

Two prophylaxis studies, one with a long-term dosing regimen and the other with a short-term dosing regimen, show that Tamiflu was statistically significant in preventing influenza illness. In a prevention study (n=548) investigating the use of once daily Tamiflu for six weeks, the medication was shown to provide a 92% protection rate among a frail, elderly population in a residential home care setting. A six-week course of Tamiflu was well tolerated among this population, where the mean age was 81 years old. The incidence of reported adverse events was similar in both study groups, with upper gastrointestinal events reported by 15 subjects on placebo (5.5%) and 17 subjects on Tamiflu (6.1%).

The other study, a post-exposure prophylaxis trial investigating the use of Tamiflu once daily for seven days, enrolled 377 households affected by at least one index case with respiratory illness. Post-exposure prophylaxis, 75 mg once daily for seven days, protected close contacts of influenza-infected patients against influenza by 92%, and interrupted influenza transmission within households by 89%. Tamiflu was well tolerated with transient nausea being the most commonly reported event, with low incidence in both groups (Tamiflu 5.5% vs placebo 2.6%).

Use of Tamiflu should not affect the evaluation of patients for annual influenza vaccination, in accordance with the Centers for Disease Control (CDC) guidelines.

About Tamiflu

Tamiflu is a systemic treatment for the most common strains of influenza (A & B). The medication targets one of the two major surface structures of the influenza virus, the neuraminidase protein. The neuraminidase site is virtually the same in all common strains of influenza. If neuaraminidase is inhibited, the virus is not able to infect new cells. Tamiflu will be available throughout the U.S. in time for the arrival of this year`s flu season.

About Hoffmann-La Roche and Gilead Sciences

Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets numerous important prescription drugs that improve, prolong and save the lives of patients with serious illnesses. Among the company`s areas of therapeutic interest are: Virology, including HIV/AIDS and hepatitis C; Infectious Diseases, including influenza; Cardiology; Neurology; Oncology; Transplantation; Dermatology; and Metabolic Diseases, including obesity and diabetes.

The Company provides a wide range of medications in the United States through its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J., both companies are members of the Basel, Switzerland-based Roche Group, a global leader in health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. For more information on Roche Pharmaceuticals in the United States, visit the company`s web site at: http://www.rocheusa.com .

Gilead Sciences, headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. The Company discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA, Boulder, CO, San Dimas, CA, and Cambridge, UK, and sales and marketing organizations in the United States, Europe and Australia. For more information about Gilead, visit the company`s Web site at www.gilead.com .

SOURCE: Hoffman La-Roche Inc.