GILEAD SCIENCES / GILD - Infothread - 500 Beiträge pro Seite

[Thierri]

Dieser Thread exisitert zwar schon, allerdings nur im Auslandswerteforum, wo er meines Erachtens schlecht aufgehoben ist.








Analyst Firms Making Recommendations:


BANC OF AMERICA SECURITIES LLC. > *STRONG BUY*
BEAR STEARNS & CO > *BUY*
C.E. UNTERBERG, TOWBIN > *STRONG BUY*
CREDIT SUISSE FIRST BOSTON CORPORATION > *STRONG BUY*
FIRST UNION SECURITIES > *STRONG BUY*
J.P.MORGAN > *STRONG BUY*
LEHMAN BROTHERS > *STRONG BUY*
MERRILL LYNCH > *STRONG BUY*
MORGAN STANLEY, DEAN WITTER DISCOVER > *STRONG BUY*
NEEDHAM & COMPANY > *BUY*
PACIFIC GROWTH EQUITIES > *BUY*
PRUDENTIAL VECTOR HEALTH CARE GROUP > *BUY*
ROBERTSON STEPHENS > *BUY*
SG COWEN > *BUY*
STANDARD & POORS CORP > *HOLD*
STURZA`S MEDICAL INVESTMENT LETTER > *HOLD*
UBS WARBURG > *HOLD*


Die "Poduktpalette":




Tamiflu™ (oseltamivirphosphate) is the first
neuraminidase inhibitor in
capsule form for the
treatment of influenza A
and B in adults.

Description:
Tamiflu™ (oseltamivir phosphate) is the first flu pill
from a new class of drugs called neuraminidase
inhibitors that are designed to be active against all
common strains of the influenza virus.



Status:
In September 1996, Gilead and Hoffmann-La Roche
entered into a collaborative agreement to develop
and market therapies that treat and prevent viral
influenza. In 1999, as Gilead`s worldwide
development and marketing partner, Roche led the
final development of Tamiflu. Only 26 months after
the first patient was dosed in clinical trials in April
1999, Roche and Gilead announced the submission
of a New Drug Application to the U.S. Food and
Drug Administration (FDA) for the treatment of
influenza. Six months later, in October 1999, Gilead
and Roche announced that the FDA approved
Tamiflu for the treatment of influenza A and B in
adults. These accelerated efforts allowed Tamiflu to
reach the U.S. market in time for the 1999-2000 flu
season. In November 2000, Tamiflu was approved
for the prevention of naturally occurring influenza
A and B in adults and adolescents 13 years and
older. One month later, in December 2000, Roche
and Gilead announced that the FDA approved
Tamiflu for the treatment of acute illness due to
influenza A and B in children one year and older.
December 2000 also marked regulatory approval of
Tamiflu for the treatment of influenza A and B in
adults in Japan. In addition to the United States,
Tamiflu is available in 26 countries worldwide.

Today, Hoffmann-La Roche continues to spearhead
a label extension strategy.

How Tamiflu Works:
Tamiflu is designed to prevent all common strains of
the influenza virus from replicating. The replication
process is what contributes to the worsening of
symptoms in a person infected with the influenza
virus.

Understanding Influenza:
Influenza, or flu, is an acute respiratory infection
caused by a variety of influenza viruses. Flu
symptoms often include headache, chills and dry
cough, which are followed rapidly by body aches
and fever.
Each year, up to 40 million Americans develop the
flu, an average of about 150,000 are hospitalized
and 10,000 to 40,000 people die from influenza and
its complications. The use of current influenza
treatments has been limited due to a lack of activity
against all influenza strains, adverse side effects,
and rapid development of viral resistance. Influenza
costs the United States an annual $14.6 billion in
physician visits, lost productivity and lost wages.







Description:
AmBisome® (amphotericin B) liposome for injection is a liposomal
formulation of the antifungal drug amphotericin B for the
treatment of confirmed infections caused by various fungal
species or visceral leishmaniasis, a parasitic infection.
Additionally, AmBisome is used to treat patients who are
refractory to or intolerant of conventional amphotericin B
therapy. These infections can be life threatening, particularly in
patients who have depressed immune systems as a result of
aggressive chemotherapy regimens or HIV infection. AmBisome
remains effective in patients who have failed prior amphotericin
therapy or in those who have developed intolerance to the drug.

AmBisome is the first and only amphotericin B product cleared for
use by the U.S. Food and Drug Administration for empiric therapy
for presumed fungal infections in patients with low white blood
cell counts and who exhibit fever of unknown origin in the United
States. AmBisome has been cleared for this expanded indication
in 14 countries around the world.

AmBisome was originally approved in Europe in 1990, where it is
marketed by Gilead and its NeXstar subsidiaries. In 1997,
AmBisome was cleared for use in the United States, where Gilead
co-markets the drug with Fujisawa Healthcare, Inc. In Japan, the
drug will be marketed by Sumitomo Pharmaceuticals. AmBisome is
available in more than 42 countries worldwide.







Description:
DaunoXome® (daunorubicin citrate liposome
injection), a liposomal form of the anticancer
agent daunorubicin, is the only oncology
product to receive clearance as a first-line
chemotherapy agent for advanced
AIDS-related Kaposi’s sarcoma (KS).







VISTIDE® (cidofovir injection) is an antiviral
medication for the treatment of
cytomegalovirus (CMV) retinitis in patients
with AIDS. Gilead received marketing
clearance from the U.S. Food and Drug
Administration for VISTIDE in June of 1996 and
markets the drug in the United States. In May
1997, Gilead received final clearance from
European regulatory authorities to market
VISTIDE in all 15 countries of the European
Union. In countries outside of the United
States, VISTIDE is marketed by Gilead`s
partner, Pharmacia & Upjohn.



In der "Pipeline":





Description:
Tenofovir disoproxil fumarate (tenofovir DF),
formerly known as PMPA, is an investigational,
once-daily, orally administered, nucleotide reverse
transcriptase inhibitor being tested for the
treatment of HIV.

Status:
Gilead is currently enrolling patients in the first
Phase III clinical trial for tenofovir DF in the United
States, Europe and Australia.





Description:
Adefovir dipivoxil is an investigational once-daily,
orally administered nucleotide reverse transcriptase
inhibitor for the potential treatment of patients with
chronic hepatitis B virus (HBV) infection.

Status:
Adefovir dipivoxil for HBV is currently in Phase III
clinical trials in the United States, Canada, Europe,
Australia and Southeast Asia.





Description:
NX 211, an injectable liposomal formulation of the
proprietary anticancer drug lurtotecan, is currently
being developed under exclusive license from Glaxo
Wellcome.

Status:
Phase II trials of NX 211 have been initiated in the
United States, Canada and Europe in patients with
refractory or topotecan resistant ovarian cancer
and in patients with recurrent small cell lung cancer.
Phase I studies of NX 211 evaluated its safety and
efficacy in a variety of solid tumors and
hematological malignancies. In preclinical studies,
NX 211 has demonstrated a three-fold increase in
the therapeutic index as compared to the
nventional form of lurtotecan.



Bericht aus der Börse Online/ Weber`s Web:


DIE ZUKUNFT IST KERNGESUND



Analysten trauen der Firma für 2004 einen Gewinn von vier Dollar je Aktie oder mehr zu. Ende 2001 sollen das Anti-HIV-Mittel
Tenofovir und 2002 Adefovir, ein Mittel gegen chronische Hepatitis B, an den Markt kommen.

Gilead Sciences hat vor kurzem NeXstar Pharmaceuticals übernommen und somit seine Entwicklungskapazitäten ausgebaut. 2002
dürfte das Unternehmen in die Gewinnzone kommen und nach bisherigen Schätzungen 24 Cents pro Aktie verdienen. Das KGV
belaufe sich auf 150. Analysten trauen der Firma allerdings für 2004 einen Gewinn von vier Dollar je Aktie zu - oder sogar mehr. Das
Unternehmen erzielt bereits solide Umsätze: 196 Millionen US-Dollar im vergangenen Jahr. Es verfügt über eigene
Produktionskapazitäten und eine Vertreibsmannschaft in den USA und Europa. Der Konzern ist - zum Teil schon seit Jahren- mit
vier Produkten am Markt: AmBiosome gegen Pilzinfektionen, Vistide gegen Augenentzündungen, DaunoXome gegen
Karposisarkome sowie TamiFlu gegen Grippe, das gemeinsam mit Hoffmann-La Roche entwickelt wurde und vermarktet wird.
Für AmBiosome erwarten Experten durch Indikationserweiterung steigendes Wachstum. Ebenso bei dem 1999 eingeführten
TamiFlu: Das Grippemittel hält 58% Marktanteil in den USA. Es wird jetzt auch in Japan, wo alljährlich sechs bis zwölf Millionen
Menschen erkranken, von den Krankenkassen bezahlt. Durch die Anwendung dürfte sich die Anzahl der Krankheitstage um 30%
reduzieren.
Große Hoffnungen stezen Spezialisten auf zwei neue Produkte: Ende 2001 soll das Anti-HIV-Mittel Tenofovir auf den Markt
kommen. Es wirkt auch bereits gegen resistente Viren. Gileqad Sciences erwartet sich davon mehr Umsätze als vom bisherigen
Bestseller AmBiosome, der im vergangenen Jahr 142 Millionen Dollar brachte. 2002 will man mit Adefovir an den Markt, einem
Mittel gegen chronische Hepatitis B, an der weltweit 350 Millionen Menschen leiden. Mit den insgesamt sechs Produkten schätzt
der Konzern sein Umsatzpotential auf eine Milliarde Dollar.

Fazit: Auch in schwierigen Zeiten eignet sich die Aktie als Langfristinvestition.



Weitere Empfehlungen:


von Pitu 19.04.01 23:49:44

Bear Stearns stuft Gilead Sciences (GILD) mit BUY Rating und Kursziel 77 Dollar ein. Besonders vielversprechend beurteilt das
Investmenthaus das AIDS- Präparat Tenofovir, das die Virusvermehrung der infizierten Zellen zum Stillstand bringen soll.



Der Aktionär-online

Gilead Sciences klares Potenzial
Datum: 27.03.2001


Das kalifornische Unternehmen Gilead Sciences Inc. (WKN 885823) steht kurz davor, in
den Olymp der Blue Chips aufzusteigen, so die Analysten von Der Aktionär-online. Die
aktuelle Marktkapitalisierung von 3,4 Milliarden US-Dollar, so die einhellige Meinung
unter den Biotech-Analysten, entspreche in keiner Weise dem wirklichen Wert des
Unternehmens. Derzeit vermarkte Gilead Sciences vier Präparate: AmBisome, Tamiflu,
DaunoXome und VISTIDE. Umsatzstärkstes Produkte sei AmBisome, ein Medikament
zur Behandlung von lebensbedrohenden Pilzinfektionen, von denen unter anderem
Chemotherapie- und HIV-Patienten betroffen sein können. Pilzbefall drohe aber auch
allen Menschen, die, aus welchen speziellen Gründen auch immer, über eine
abgeschwächte Immunabwehr verfügen. So würden allein in den USA jedes Jahr rund
100.000 Fälle bekannt, bei denen es während eines Krankenhausaufenthalts zu einem
Pilzbefall komme. AmBisome sei das erste und einzige in den USA zugelassene
Produkt seiner Art. Weltweit werde AmBisome in 42 Ländern vertrieben und
erwirtschafte einen jährlichen Umsatz von rund 160 Millionen US-Dollar. Positiv
hervorheben wolle man ebenfalls das Produkt Tamiflu. Bei Tamiflu handele es sich um
ein Grippe-Präparat, dass sowohl zur schnelleren Genesung als auch zur Vorbeugung
verabreicht werde. Tamiflu hemme das Enzym Neuraminidase, das das Grippe-Virus
für seinen Angriff auf die Körperzellen benötige. Wenn Tamiflu kurz nach einer Infektion
verabreicht werde, verkürze es die durchschnittliche Krankheitsdauer um bis zu 40
Prozent. Zugleich könnten mit der Grippe-Infektion einhergehende Begleiterkrankungen
wie Bronchitis und Sinusitis (Nebenhöhlen) umgangen werden. Tamiflu sei bisher in
den USA und in Japan zugelassen, entsprechende Genehmigungsverfahren würden
derzeit aber auch bei der EU laufen. Das weltweite Umsatzpotenzial von Tamiflu sei nur
bedingt einzuschätzen, da der Einsatz des Medikaments vor allem vom alljährlichen
Verlauf der Grippe-Saison abhänge, somit also stärkeen Schwankungen ausgesetzt
sei. Bei veranschlage man bei Der Aktionär-online vorsichtig für Tamiflu einen
durchschnittlichen Umsatz von 250 Millionen US-Dollar und dürfe sich damit eher am
unteren Rand des Potenzials bewegen. Doch wie immer in der Geschichte liege die
Fantasie des Unternehmens in der Zukunft. Tenofovir und Adefovir seien die großen
Hoffnungsträger von Gilead Sciences. Von ihnen erwarte das Unternehmen den Sprung
in die aller erste Liga der Biotech-Garde. Tenofovir verspreche eine überaus einfache
und unkomplizierte Hilfe für HIV-Patienten, bei denen bisherige Medikamente zur
Eindämmung des AIDS-Virus entweder nicht helfen oder ihre Wirksamkeit nach
längerer Behandlung eingebüßt haben. Mit der Erstzulassung von Tenofovir in den USA
sei ab Mitte 2001 zu rechnen. Das jährliche Marktpotenzial für Tenofovir veranschlage
man in einem ersten Schritt auf 500 Millionen US-Dollar, die allerdings erst ab
frühestens 2002 in der Bilanz von Gilead voll zu Buche schlagen dürften. Der zweite
Hoffnungsträger Adefovir stelle eine neue Behandlungsform von Hepatitis B da, eine
Krankheit, an der weltweit 350 Millionen Menschen erkrankt seien. Vor allem in den
reichen Industrieländern dürfe Adefovir seine Kundschaft finden. Man schätze das
jährliche Marktpotenzial von Adefovir auf rund 500 Millionen US-Dollar; mit einer
Zulassung sei ab Mitte 2002 zu rechnen. Tenofovir und Adefovir würden also zusammen
voraussichtlich ab 2003/2004 einen zusätzlichen Umsatz von rund 1 Milliarde US-Dollar
für Gilead Sciences erwirtschaften. Im Hinblick auf die Produkte beziehungsweise die
Produktpipeline eröffne die aktuelle Börsenbewertung klares Potenzial nach oben. Der
geschätzte Jahresumsatz von 1,5 Milliarden US-Dollar ab 2003/2004 würde eine
aktuelle Marktkapitalisierung von 5 Milliarden US-Dollar rechtfertigen. Mit Tenofovir und
Adefovir habe Gilead Sciences in der Tat das Zeug dazu, zum Blue Chip in der
Biotechnologie zu avancieren.



Quelle: AktienCheck




Der Aktionär

Gilead Sciences mit Potenzial
Datum: 06.03.2001


Die Analysten des Börsenmagazins „Der Aktionär“ berichten, dass Tenofovir und
Adefovir die großen Hoffnungsträger von Gilead Sciences (WKN 885823) sind. Tenofovir
biete eine überaus einfache und unkomplizierte Hilfe für HIV-Patienten, bei denen
bisherige Medikamente zur Eindämmung des AIDS-Virus entweder nicht helfen würden
oder ihre Wirksamkeit nach längerer Behandlung eingebüßt hätten. Mit der Zulassung
von Tenofovir in den USA sei ab Mitte 2001 zu rechnen. Das jährliche Marktpotenzial für
das Medikament veranschlage man in einem ersten Schritt auf 500 Millionen US-Dollar,
die allerdings erst ab frühestens 2002 in der Bilanz voll zu Buche schlagen dürften. Der
zweite Hoffnungsträger Adefovir stelle eine neue Behandlungsform von Hepatitis B dar,
einer Krankheit, an der weltweit 350 Millionen Menschen erkrankt seien. Vor allem in
den reichen Industrieländern dürfte Adefovir seine Kundschaft finden. Man schätze
dessen jährliches Marktpotenzial ebenfalls auf rund 500 Millionen US-Dollar; mit einer
Zulassung sei ab Mitte 2002 zu rechnen. Tenofovir und Adefovir würden zusammen
voraussichtlich ab 2003/2004 einen zusätzlichen Umsatz von rund 1 Milliarde US-
Börsenbewertung klares Potenzial nach oben. Der geschätzte Jahresumsatz von 1,5
Milliarden US-Dollar ab 2003/2004 würde eine aktuelle Marktkapitalisierung von 5
Milliarden US-Dollar rechtfertigen. Mit Tenofovir und Adefovir habe Gilead Sciences in
der Tat das Zeug dazu, zum Blue-Chip in der Biotech-Branche zu avancieren.



Quelle: AktienCheck



Prudential Securities

Gilead Sciences Kursziel 100 USD
Datum: 22.02.2001


Die Analysten von Prudential Securities halten Kurse von 100 USD bei der Aktie von
Gilead Sciences (WKN 885823, GILD) für realistisch. Neben dem Kursziel von 100 USD
erteile man dem US-Titel das Höchstprädikat „Strong Buy“. Das Unternehmen habe
zuvor Ergebnisse des Medikamentes Tenofovir im der klinischen Testphase III
veröffentlicht. Statistisch habe das Medikament mit einem Wert von –0,61 Viren in der
Probe reduziert. Das Placebo habe einen Wert von –0,03. Diese Ergebnisse dürften die
Beantragung der Produkteinführung bei der Gesundheitsbehörde nach sich ziehen. Im
Jahr 2002 könnte das Medikament dann bereits eingesetzt werden.



Quelle: AktienCheck




CE Unterberg Towbin

Gilead Sciences Kursiel 90 USD
Datum: 21.02.2001


CE Unterberg Towbin beurteilt die Aktie von Gilead Sciences (WKN 885823) positiv. Man
halte für den Titel ein Kursziel von 90 USD. Gleichzeitig stufe man die Aktie von „neutral“
auf „kaufen“ herauf. Reagiert habe man, nachdem die Gesellschaft positive
Testergebnisse des Medikamentes Tenofovir veröffentlicht habe. Das Medikament
befinde sich derzeit in der letzten Testphase (Phase III) vor Markteinführung. Das
Medikament dürfte nach Markteinführung einen bedeutenden Anteil am Therapiemarkt
halten. Insbesondere bei der Erstbehandlung der Patienten komme dieses Produkt
zum Einsatz.



Morgan Stanley Dean Witter

Gilead Sciences "Strong Buy"
Datum: 09.02.2001


Die Analysten des Investmenthauses Morgan Stanley Dean Witter sehen in der Aktie
des Biotechnologieunternehmens Gilead Sciences (WKN 885823) ein
aussichtsreiches Investment. Das Unternehmen sei erfolgreich auf dem Gebiet der
Erforschung von Infektionskrankheiten und onkologischen Erkrankungen tätig. Gilead
Sciences verfüge bereits über vier vermarktete Medikamente, und es würden zwei
weitere sehr erfolgsversprechende Medikamente in den kommenden zwei Jahren
zugelassen werden. Dazu zähle Tenofovir, zur Bekämpfung der HIV-Infektion und
Adefovir, was bei der Hepatitis B Erkrankung eingesetzt werden könne. Die Ergebnisse
der klinischen Studien seien im Hinblick auf beide Medikamente sehr positiv und man
rechne mit einem beschleunigten Zulassungsverfahren durch die FDA für Tenofovir, so
dass das Medikament noch vor dem erwarteten Termin in 2002 zugelassen werden
könnte. Das Medikament Tamiflu sei kürzlich von der FDA auch zur prophylaktischen
Behandlung von Erwachsenen und Jugendlichen, die älter als 13 Jahre alt seien, und
zur Behandlung von Kindern zugelassen worden. Damit habe Tamiflu das
Konkurrenzprodukt von GlaxoSmithKline Relenza deutlich auf den zweiten Platz
verwiesen. Die Analysten würden davon ausgehen, dass Gilead Sciences durch die
neuen Produkte Ende 2002 die profitable Grenze erreichen werde und würden mit
einem Gewinn pro Aktie von –0.98 USD für das Jahr 2000 und einem Gewinn pro Aktie
von -1.01 USD für das Jahr 2001 rechnen.

[2002 soll der Gewin bei 0,07 $ liegen, in 2004 bereits um oder über 4 $]



Quelle: AktienCheck







Generiert Kaufsignal beim Durchbrechen der Marke von 37,38 $. Doppel-Boden-Formation. Anstieg über 46,55 $ möglich. RSI zwar
überkauft, aber nur geringes Rückschlagspotenzial.


Puh, das wars fürs erste!


Hier noch die Homepage selbst:

http://www.gilead.com



Gruß Thierri

[Thierri]

Gilead übertrifft Analystenerwartungen

Gilead übertrifft klar die Erwartungen der Analysten. Statt eines Verlustes von 29 bis 45 Cents je Aktie steht tatsächlich nur ein Verlust von 23 US-Cents an. Für das Jahr 2002 rechnet man bereits mit ersten Gewinnen. Diese sollen aktuell bei etwa 7 Cents je Aktie liegen. Es würde aber nicht verwundern, wenn Gilead auch dieses gesteckte Ziel mindestens erfüllen kann.


Gilead Sciences Announces First Quarter 2001
Financial Results

Total Revenues Increased 21 Percent Over First Quarter 2000

FOSTER CITY, Calif.--(BUSINESS WIRE)--April 26, 2001--Gilead Sciences, Inc. (Nasdaq: GILD - news) announced
today its results of operations for the first quarter ended March 31, 2001. For the first quarter, Gilead recorded revenues from
net product sales of $45.1 million, royalty revenues of $6.2 million and contract revenues of $6.6 million. Total revenues for the
first quarter ended March 31, 2001 were $57.8 million, which represents a 21 percent increase over the same quarter in 2000.
For the first quarter of 2000, total revenues of $47.7 million included net product sales of $36.3 million, royalty revenues of
$8.0 million and contract revenues of $3.3 million.

The net loss for the first quarter 2001, including the cumulative effect of a change in accounting principle related to the
company`s adoption of Statement of Financial Accounting Standards Nos. 133 and 138, was $21.7 million, or $0.23 per
share. This compares to a net loss in the first quarter 2000 of $16.9 million, or $0.19 per share, including the cumulative effect
of the adoption of Staff Accounting Bulletin 101 in the first quarter 2000 of $0.15 per share. Excluding the effects of the
changes in accounting principles, the net loss for the first quarter 2001 would have been $22.8 million, or $0.24 per share,
compared to a net loss of $3.3 million, or $0.04 per share, for the same period last year.

Net revenues from product sales were primarily derived from sales of AmBisome® (amphotericin B) liposome for injection,
accounting for 93 percent of product sales for the first quarter of 2001. AmBisome sales for the first quarter of 2001 were
$41.9 million, an increase of 21 percent compared to the first quarter of 2000. Excluding the impact of the decline in foreign
currencies relative to the U.S. Dollar, AmBisome sales grew 29 percent for the first quarter of 2001 over the comparable
quarter of 2000. In addition, Gilead recorded product sales of $2.1 million and $1.0 million from the sale of VISTIDE®
(cidofovir injection) and DaunoXome® (daunorubicin citrate liposome injection), respectively, during the first quarter of 2001.

For the first quarter of 2001, royalty and contract revenues resulting from collaborations with corporate partners totaled $12.8
million. These revenues include contract revenues for research and development projects, royalties on sales of AmBisome in the
United States by Gilead`s co-promotion partner Fujisawa Healthcare, royalties on sales of Tamiflu(TM) (oseltamivir phosphate)
by Hoffmann-La Roche and royalties on product sales of VISTIDE outside the United States by Pharmacia Corporation.

Research and development expenses for the first quarter of 2001 were $51.1 million, compared to $26.2 million for the same
quarter in 2000. The substantially higher spending during the first quarter of 2001 was attributable in part to the recognition of
$10.6 million of a $13 million up-front payment to Cubist Pharmaceuticals related to the European licensing agreement for
daptomycin signed in January. In addition, Gilead`s expenses associated with the Phase III clinical programs for tenofovir
disoproxil fumarate (tenofovir DF) for HIV and adefovir dipivoxil for hepatitis B virus (HBV) increased significantly during the
quarter, including the initiation of an early access program and clinical supply costs for tenofovir DF. Selling, general and
administrative expenses for the three months ended March 31, 2001, were $21.9 million, compared to $18.0 million for the
same quarter of 2000.

Net interest income for the first quarter 2001 was $3.8 million, compared to $2.4 million for the same quarter in 2000.

The company also reported equity in the loss of its unconsolidated affiliate of $0.4 million and $0.9 million for the first quarter
ended March 31, 2001 and 2000, respectively. The losses are derived from Gilead`s 49 percent interest in Proligo L.L.C., a
manufacturing joint venture between Gilead and SKW Americas, Inc.

As of March 31, 2001, the company had cash, cash equivalents and marketable securities of $483.8 million, compared to
$512.9 million at December 31, 2000.

``During the past quarter, we made significant strides in our three therapeutic areas -- anti-infectives, antivirals and oncology,``
said John C. Martin, Ph.D., President and Chief Executive Officer, Gilead Sciences. ``Importantly, the strong positive results
from our Phase III study of tenofovir have enabled us to initiate expanded access programs and prepare our regulatory
packages for marketing approval. We intend to submit our New Drug Application to the U.S. Food and Drug Administration
and our Marketing Authorisation Application to the European Medicines Evaluation Agency for tenofovir DF in May.``

Products and Pipeline Highlights
Tamiflu(TM) (oseltamivir phosphate) for Influenza

In the first quarter of 2001, Roche made Tamiflu available to pharmacies and hospitals in Japan for the treatment of influenza A
and B in adults. Additionally, Roche submitted its application to European authorities for approval of Tamiflu for the treatment
of influenza A and B in adults and children and the prevention of influenza A and B in adolescents and adults.

Also in February, the Journal of the American Medical Association published a study in which Tamiflu was shown to be
effective in protecting individuals from influenza infection when in contact with someone already infected with the disease. The
study results demonstrate that Tamiflu, when taken once daily for seven days, can significantly reduce the rate of influenza
infection in individuals exposed to the virus in settings such as households and universities. In the studies, Tamiflu was generally
well tolerated, with the adverse events qualitatively similar to those seen in previous treatment studies, despite the longer
duration of treatment, and no clinically relevant differences in safety profile were seen in the elderly patients compared to the
younger population.

Tamiflu continues to be the only antiviral neuraminidase inhibitor approved in the United States for the prevention of influenza in
adults and the treatment of flu, in pill or liquid form, in adults and children one year and older. Although the incidence of flu was
relatively light during this past season, Tamiflu was once again the number one prescribed neuraminidase inhibitor, with
approximately 90 percent of the market in the United States.
Tenofovir DF for HIV

In February, Gilead unblinded 24-week data from Study 907, a 48-week Phase III intensification trial evaluating the safety and
efficacy of tenofovir DF versus placebo in 552 treatment-experienced patients. Patients were randomized (2:1) to receive
tenofovir DF (one 300 mg tablet, dosed once daily) or placebo in addition to their existing antiretroviral therapy. After 24
weeks of dosing, patients assigned to tenofovir DF or placebo were allowed to receive tenofovir DF for the remainder of the
48-week study period. The study achieved its primary efficacy endpoint demonstrating that tenofovir DF was associated with a
statistically significant HIV RNA decrease in mean DAVG24 of 0.61 log10 copies/mL compared to a decrease of 0.03 log10
copies/mL in the placebo group (p (less than) 0.0001). Drug discontinuation at 24 weeks was six percent in both the placebo
and tenofovir DF arms of the study. Additionally, through 24-weeks, the incidence of grade 3 and 4 laboratory abnormalities
and clinical adverse events was similar between both arms. This multi-center study is ongoing at sites in Australia, Europe and
North America. Gilead expects to present these 24-week data in detail at scientific conferences later this year.

In January, enrollment was completed with 601 treatment-naive patients in Study 903, a randomized, double-blind,
multi-center, active-controlled trial. This 48-week Phase III trial is designed to compare the safety and tolerability of two
treatment regimens -- tenofovir DF, efavirenz and lamivudine (3TC) versus stavudine (d4T), efavirenz and lamivudine.

Additionally in January, Gilead initiated early access programs for tenofovir DF. Programs currently are registering physicians
and enrolling patients in the United States, France and the United Kingdom, and will open in Germany, Italy, Spain and Canada
as regulatory approvals are obtained. This program will make tenofovir DF available in these countries to patients with
advanced HIV disease and limited treatment options.
Cidecin(TM) (daptomycin for injection)

Gilead Sciences and Cubist Pharmaceuticals signed a licensing agreement in January giving Gilead the exclusive
commercialization rights to Cidecin(TM) (daptomycin for injection) and an oral formulation of daptomycin in the European
Union and Switzerland. In exchange for the exclusive rights, Gilead paid a $13 million up-front licensing fee and will pay
milestones as clinical and regulatory milestones are achieved as well as a fixed royalty on future net sales.

In March, Cubist Pharmaceuticals announced preliminary results from Study 9901, its first pivotal Phase III clinical trial
assessing the safety and efficacy of Cidecin in the treatment of complicated skin and soft tissue infection resulting from
Gram-positive bacteria. Study 9901 was an international, multi-center, randomized, double blinded study in 562 patients, aged
18-85 years. Cubist indicated that the primary endpoint of demonstrating equivalency to comparator agents was achieved as
per the protocol previously reviewed by the U.S. Food & Drug Administration. In April, these data were presented in detail at
the 11th European Congress of Clinical Microbiology and Infectious Diseases in Istanbul, Turkey. In addition, Cubist presented
safety data demonstrating that the incidence of total adverse events was similar in both arms of the trial.

Corporate Activities

In January, Gilead announced the appointment of James M. Denny to the position of Chairman of the Board of Directors. Mr.
Denny has been a member of the Gilead Board since January 1996 and served as Chairman of the Audit Committee. Mr.
Denny replaced Donald H. Rumsfeld, who resigned from the Board to serve the Bush Administration as Secretary of Defense.
Last week, Gilead announced the appointment of Cordell W. Hull to the Board of Directors and as Chairman of the Audit
Committee. He is the co-founder, Chairman and CEO of InfrastructureWorld, Inc., a business-to-business portal for the global
infrastructure community. Mr. Hull also serves as a Director of Darby Overseas Investments, Ltd., Bechtel Group, Inc.,
Bechtel Enterprises and the Fremont Group.

On February 2, 2001, stockholders approved an increase in the number of authorized shares of common stock from 100
million to 500 million, allowing Gilead to complete a two-for-one stock split in the form of a stock dividend. As a result of the
split, the number of outstanding shares of Gilead`s Common Stock increased to approximately 94 million.

Conference Call

Gilead will host a conference call today, April 26, 2001, at 4:30 p.m. ET. The dial-in number for the call is 888-937-3116
domestic; 212-346-7495 international. The replay of this call will be available from 7:00 p.m. April 26, 2001, until 7:00 p.m.
on April 29, 2001. The dial-in number for the replay is 800-633-8284 domestic, 858-812-6440 international; the password is
18466849. Gilead also will be webcasting the conference call; this feature will be available on our website at www.gilead.com.
The information provided on the teleconference and on the webcast is only accurate at the time of the call, and Gilead will take
no responsibility for providing updated information.

About Gilead

Gilead Sciences, Inc., 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. Gilead 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;
Cambridge, UK, and Dublin, Ireland, and sales and marketing organizations in the United States, Europe and Australia.

Forward-looking Statements

Statements included in this press release that are not historical in nature are ``forward-looking statements`` within the meaning of
the Private Securities Litigation Reform Act of 1995. These statements include those regarding Gilead`s future financial results,
including: revenues, research and development expenses, selling, general and administrative expenses, the efficacy of any
marketed or pipeline development products, the ability to file for or obtain marketing approval for Gilead`s pipeline
development products, or the competitive positioning of its marketed or pipeline development products. Gilead cautions
readers that forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ
materially. These risks and uncertainties include those that can cause fluctuations in our financial results, such as our ability and
the ability of our partners to successfully market our products and maintain revenue growth; our ability to control the timing and
amount of spending in our research and clinical programs; fluctuations in foreign currency against the U.S. dollar; our ability to
achieve and the timing of milestones, as well as risk and uncertainties that affect our future prospects such as the risk that we
may not continue to observe the safety, tolerability and efficacy data for our products and product candidates that we are
observing today; other risks relating to the regulatory approval of our products and product candidates; and other risks
identified from time to time in the company`s reports filed with the U.S. Securities and Exchange Commission. The company
directs readers to its Annual Report on Form 10-K, for the year ended December 31, 2000, filed in March 2001, and its 2000
Quarterly Reports on Form 10-Q filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private
Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company`s Web site at www.gilead.com or call the Gilead Corporate
Communications Department at 1-800-GILEAD-5 (1-800-445-3235).

GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)

Three months ended
March 31,
--------
2001 2000
-------- --------
(unaudited)

Revenues:
Product sales, net $ 45,064 $ 36,340
Royalty revenue, net 6,182 8,042
Contract revenue 6,437 840
Contract revenue - SAB 101 153 2,490
-------- --------
Net revenues 57,836 47,712

Cost of goods sold 10,581 7,947
-------- --------
Gross profit 47,255 39,765

Operating expenses:
Research and development 51,146 26,246
Selling, general and administrative 21,911 17,970
-------- --------
Total operating expenses 73,057 44,216
-------- --------
Loss from operations (25,802) (4,451)

Interest income 7,383 3,945
Interest expense (3,533) (1,537)
-------- --------

Loss before provision for income
taxes, equity in loss of
unconsolidated affiliate and
cumulative effect of change in
accounting principle (21,952) (2,043)

Provision for income taxes 470 307
Equity in loss of
unconsolidated affiliate 390 921
-------- --------
Loss before cumulative
effect of change
in accounting principle (22,812) (3,271)

Cumulative effect of change
in accounting principle (note 1) 1,089 (13,670)
-------- --------
Net loss $(21,723) $(16,941)
======== ========
Basic and diluted amounts
per common share: (note 2)
Loss before cumulative
effect of change in
accounting principle $ (0.24) $ (0.04)
Cumulative effect of change
in accounting principle 0.01 (0.15)
-------- --------
Net loss $ (0.23) $ (0.19)
======== ========
Common shares used in the
calculation of basic and diluted
amounts per share (note 2) 94,349 88,680
======== ========

Notes:
(1) Gilead adopted Statement of Financial Accounting Standards No. 133
(SFAS 133) Accounting for Derivative Instruments and Hedging
Activities effective January 1, 2001 and also the SEC`s Staff
Accounting Bulletin No. 101 (SAB 101) Revenue Recognition in
Financial Statements effective January 1, 2000. These changes were
accounted for as the cumulative effect of a change in accounting
principle.

(2) The net loss per share and number of shares used in the per
share calculation for all periods presented reflect the two-for-one
stock split effective February 22, 2001.

(3) Certain prior period amounts have been reclassified to conform to
the current presentation.


CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

March 31, December 31,
2001 2000
-------- --------
(unaudited) (note 1)
Assets

Cash, cash equivalents
and marketable securities $483,810 $512,878
Other current assets 86,568 80,920
-------- --------
Total current assets 570,378 593,798
Property, plant and
equipment, net 54,975 55,174
Other noncurrent assets 32,192 29,127
-------- --------
$657,545 $678,099
======== ========
Liabilities and stockholders` equity

Current liabilities $ 55,202 $ 58,238
Long-term obligations 268,003 268,737
Stockholders` equity 334,340 351,124
-------- --------
$657,545 $678,099
======== ========
Notes:
(1) Derived from audited financial statements at that date.



Contact:

Gilead Sciences
Sharon Surrey-Barbari, 650/522-5798
Susan Hubbard, 650/522-5715

[Pitu]

Gilead files for fast-track review of HIV drug

FOSTER CITY, Calif., May 1 (Reuters) - Gilead Sciences Inc. (NasdaqNM:GILD - news) said on Monday it submitted an application to the U.S. Food and Drug Administration (FDA) for an experimental drug called tenofovir that could inhibit the growth of HIV, the virus that causes AIDS.

Gilead said it expects FDA review and action within six month on the marketing application for its experimental reverse transcriptase inhibitor in development for the treatment of HIV infection. The company also said it plans to submit an application for regulatory approval in the European Union in the near future.

Tenofovir, a once-daily drug, works by blocking an enzyme necessary for HIV, the virus that causes AIDS, to replicate.



Gilead Sciences Submits New Drug Application To U.S. FDA For Tenofovir DF For the Treatment of HIV Infection

FOSTER CITY, Calif.--(BW HealthWire)--May 1, 2001--Gilead Sciences, Inc. (Nasdaq:GILD - news) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of tenofovir disoproxil fumarate (tenofovir DF), an investigational reverse transcriptase inhibitor in development for the treatment of human immunodeficiency virus (HIV) infection. Gilead anticipates FDA review and action within six months of this submission. The company also plans to submit its application for regulatory approval in the European Union in the near future.

Tenofovir DF is dosed as a single 300 mg tablet taken once daily and works by blocking reverse transcriptase, an enzyme crucial to the replication of HIV. Tenofovir DF is an investigational compound and has not yet been determined safe or efficacious in humans for its ultimate intended use.

``Gilead has a heritage of developing products to treat challenging human diseases,`` said John C. Martin, Ph.D., President and Chief Executive Officer, Gilead Sciences. ``Based on data from our pivotal studies, we believe that tenofovir DF has the potential to be an important new option for the treatment of HIV, and we are pleased to have reached this significant milestone in the development of the product.``

New Treatment Options Needed

There are approximately 36 million people in the world living with HIV. Nine hundred thousand live in the United States alone, and 540,000 live in Western Europe. In the United States, 350,000 patients currently receive anti-HIV treatment regimens and an estimated 15,000 new patients begin treatment each year. As the HIV patient population grows and these patients live longer, the need for long-term disease management - achieved through safe, potent and convenient regimens - has intensified.

Early Access Program Initiated

In January, Gilead announced the initiation of an expanded access program to provide tenofovir DF to people with advanced HIV infection. Regulatory review has been concluded and programs are open for registration in the United States, France, Spain and the United Kingdom. Gilead expects to initiate early access programs in Germany, Italy, Canada and other countries as regulatory approvals are obtained.

For more information regarding the tenofovir DF early access program or to request registration materials, physicians in the United States may call 1-800-GILEAD-5 and those within Europe may call 33-1-44-90-34-46.

[Thierri]

Wonderful

[Pitu]

Der Biotech-Index verliert bis dato 2,5 %, Gilead hält sich aber (noch) über der wichtigen 50 USD-Marke.

[Thierri]

@Pitu...Yep, Gilead hält sich wirklich außerordentlich gut. Ich hatte eigentlich schon letzte Woche mit leichten Gewinnmitnahmen gerechnet, aber Gilead ist anscheinend in festen Händen. Besser kanns eigentlich nicht laufen!

Hier noch die neueste Meldung:


New Analyst Award Scorecard for Gilead Sciences Inc - BulldogResearch.com

---> http://biz.yahoo.com/bdr/ca/g/gild.html


Gruß Thierri

[Thierri]

Sehr gute Neuigkeiten:

Seit dem 31.03.01 ist Gilead Sciences neben dem Pictet Biotech Funds auch im DIT Biotechnologie Fonds [WKN 848186] enthalten. Die Position wird mit 3,47 % gehalten, was einem absolutem Betrag von 92.054.257,9 € entspricht. Gesamtvermögen des DIT Biotechnologie Fonds ist 2.652.083.170 EUR.


http://www.dit.de/fondspalette/detailinfo_848186.html


Nicht schlecht für den Anfang.


Gruß Thierri

[Thierri]

An dieser Stelle noch besten Dank an BoerseAugsburg!!!

[Pitu]

Gilead Sciences Submits Marketing Authorisation Application to European Regulatory Authorities for Tenofovir DF for the Treatment of HIV Infection

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 4, 2001--Gilead Sciences, Inc. (Nasdaq:GILD - news) today announced that it has submitted a Marketing Authorisation Application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) seeking approval of tenofovir disoproxil fumarate (tenofovir DF) for the treatment of human immunodeficiency virus (HIV) infection. Gilead submitted a New Drug Application (NDA) for tenofovir DF for the treatment of HIV infection to the U.S. Food and Drug Administration (FDA) on May 1, 2001.

Tenofovir DF is dosed as a single 300 mg tablet taken once daily and works by blocking reverse transcriptase, an enzyme crucial to the replication of HIV. As an investigational compound, tenofovir DF has not yet been determined safe or efficacious in humans for its ultimate intended use.

The MAA will be reviewed under the centralized licensing procedure, which, when finalized, provides one marketing authorization valid in all 15 member states of the European Community. Review of the application will be coordinated by the EMEA. The French authorities will act as rapporteur and the Spanish authorities will act as co-rapporteur for the procedure.

``This European regulatory filing represents another important step toward our goal of providing tenofovir DF to patients and physicians in an accelerated manner,`` said John C. Martin, Ph.D., President and Chief Executive Officer, Gilead Sciences. ``The submission of the NDA and MAA within three days of each other marks an impressive accomplishment and is reflective of the hard work of the Gilead team.``

``There are increasing needs across Europe for treatments to combat HIV infection, particularly for individuals who have failed other therapy. Based on data from clinical studies of tenofovir DF, this compound holds the potential to address the needs of patients at various stages of their HIV disease,`` said Brian Gazzard, M.D., Chelsea and Westminster Hospital and Clinical Research Director, Imperial College, London.

Early Access Program Initiated

In January, Gilead announced the initiation of an expanded access program to provide tenofovir DF to people with advanced HIV infection. Regulatory review has been concluded and programs are open for registration in the United States, France, Spain and the United Kingdom. Gilead expects to initiate early access programs in Germany, Italy, Canada and other countries as local regulatory approvals are obtained.

For more information regarding the tenofovir DF early access program or to request registration materials, physicians in the United States may call 1-800-GILEAD-5 and those within Europe may call 33-1-44-90-34-46.

[Thierri]

Die positiven Nachrichten nehmen einfach kein Ende. Hervorragend!!!

Dank Dir, Pitu!!!

Euch allen ein schönes Wochenende!!


Gruß, Thierri

[Thierri]

Ich habe mir mal die Mühe gemacht, ein paar Fonds, die Gilead Sciences als Top-Holding halten, herauszusuchen:

-DIT Bitechnologie # 848186

-Pictet Global Sector Funds Biotech P # 988562

-Oyster Biotechnology B (USD) # 926295

-Oyster Biotechnology A (EUR) # 937700

-Zürich Invest Bio Science # 849048

-SEB Invest Concept Biotechnology # 542164



T.

[Thierri]

CBS Market Watch

Friday, May 4 2001


Biotech stocks bounce back

By Ted Griffith, CBS.MarketWatch.com
Last Update: 4:24 PM ET May 4, 2001





NEW YORK (CBS.MW) - After falling sharply in early trading, biotech
stocks bounced back with the broader stock market indexes and
closed higher Friday.





In the biotech sector, shares of Gilead Sciences
(GILD: news, msgs, alerts) gained $2.73, or 5.7
percent, to $50.54. Gilead said Friday it applied
for European regulatory clearance to sell a
treatment for HIV, the virus that causes AIDS. On
Tuesday, Foster City, Calif.-based Gilead applied
for clearance to sell the HIV drug, tenofovir DF, in
the United States.

Analyst Geoffrey Harris at UBS Warburg said
tenofovir has the potential to generate annual sales of more than $100 million,
which could make Gilead profitable in 2002. In a note to clients, Harris said he
was raising his price target on Gilead stock to $60 from $50.



Notice: Gilead Sciences made sales of 196 Million $ in 2000.

Gruß T.

[Pitu]

GILEAD SCIENCES INC (GILD)
Quarterly Report (SEC form 10-Q)

http://biz.yahoo.com/e/010514/gild.html

[Thierri]

Sieht Gut aus!

Danke, Pitu!

Nur schade, daß leichte Gewinnmitnahmen eingesetzt haben, die Gilead auf ~ 47 $ gebracht haben. War aber eigentlich auch überfällig nach den "rasanten" Anstieg von ~ 30 auf über 50 $.


Gruß Thierri

[Pitu]

Amex Biotech Index Up More Than 8 Percent

LOS ANGELES (Reuters) - Investor optimism, touched off by the Federal Reserve (news - web sites)`s day-earlier half-point interest rate cut, swept through the biotechnology and pharmaceutical sectors on Wednesday.

The Amex Biotechnology Index (^BTK - news) was up 43.19, or 8.17 percent, at 571.53 in late trading, while the Amex Pharmaceutical Index (^DRG - news) was up 3.29 percent at 409.51.

``I don`t think there is any specific reason for the rally in the sector. The whole market is up because of the rate cut and sentiment that the economy may be turning around,`` one biotech analyst said.

The Dow Jones Industrial average was up 2.3 percent at 11,121.71, while the Nasdaq Composite was up over 3 percent at 2129.71.

Shares of big biotechnology companies such as Genentech Inc. (NYSE: DNA - news) and Amgen Inc. (NasdaqNM: AMGN - news), which last week presented strong clinical trial results on a range of drugs for cancer patients, moved higher. Amgen`s shares were up $4.07, or nearly 7 percent, at $64.59 on Nasdaq, while Genentech was up $2.90, or more than 6 percent, at $48.90 on the New York Stock Exchange (news - web sites).

But it has been the smaller biotech companies that are furthest along in the laborious process of bringing drugs from the concept to the commercial stage that have gained the most ground on Tuesday.

Shares of Gilead Sciences Inc. (NasdaqNM: GILD - news) rose $6.59, or more than 14 percent, at $53.11 on Nasdaq.

``Gilead`s drug application has already been filed. People are just starting to realize it will probably be approved by the end of the year,`` an analyst said.

The company filed with the U.S. Food and Drug Administration (news - web sites) earlier this month for clearance to sell Tenofovir DF for the treatment of HIV (news - web sites) infection.

Shares of Immunex Inc. (NasdaqNM:IMNX - news), maker of popular rheumatoid arthritis drug Enbrel, rose $1.45, or more than 9 percent, to $16.54.

Shares of major drugmakers Pfizer Inc. (NYSE:PFE - news) and Merck & Co. (NYSE:MRK - news) also gained ground after new federal guidelines were issued calling for higher use of cholesterol-lowering drugs made by the two companies.

Shares of Pfizer, which makes Lipitor (news - web sites), rose more than 4 percent to $44.70, while shares of Merck, which makes Zocor, were up more than 3 percent at $78.22. Both stocks trade on the New York Stock Exchange.

[Pitu]

Gilead Sciences Presents Data Characterizing Resistance Profile of Tenofovir DF, Investigational Agent for the Treatment of HIV

Data Presented at 5th International Workshop on HIV Drug Resistance and Treatment Strategies

SCOTTSDALE, Ariz.--(BUSINESS WIRE)--June 5, 2001--Gilead Sciences, Inc. (Nasdaq:GILD - news) today presented in vitro data further characterizing the resistance profile of tenofovir disoproxil fumarate (tenofovir DF), the company`s investigational agent in development for the potential treatment of HIV infection. The resistance profile of tenofovir was studied using phenotypic analyses of nearly 5,000 clinically-derived HIV samples from predominantly treatment-experienced patients, which were provided and analyzed by Tibotec-Virco. The results of the in vitro analyses indicate that reduced susceptibility to tenofovir is infrequent and is not closely correlated with cross-resistance to commercially-available drugs from the nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) classes.

Scientists at Gilead and Tibotec-Virco, a biotechnology company that markets genotypic, phenotypic and VirtualPhenotype(TM) resistance testing services, collaborated on this study. The data will be described today in an oral presentation by Michael Miller, Ph.D., Director, Clinical Virology, Gilead Sciences at the 5th International Workshop on HIV Drug Resistance and Treatment Strategies in Scottsdale, Arizona.

Results of this study indicate that over 88 percent of the samples were fully susceptible to tenofovir and were within the normal three-fold range. Decreases in tenofovir susceptibility were infrequent, with seven percent of samples having between a three- and five-fold decrease, four percent of samples having greater than a five-fold decrease and only one percent having greater than a ten-fold decrease. In contrast, 40 percent, 17 percent and 49 percent of these samples had greater than ten-fold reduced susceptibility (resistance) to 3TC, AZT or at least one NNRTI, respectively.

Study Design

In order to determine the normal range of tenofovir susceptibility (or the biological cut-off), researchers first screened 1,000 samples from HIV treatment-naive patients using the Virco Antivirogram(TM) assay. More than 97.5 percent of the samples (those falling within two standard deviations) had tenofovir susceptibility less than three-fold above the wild-type control. Therefore, a biological cut-off for tenofovir was set at three-fold for the Antivirogram.

Following the determination of the biological cut-off for tenofovir, Tibotec-Virco screened nearly 5,000 HIV samples derived from predominantly treatment-experienced outpatients to determine the cross-resistance profile of tenofovir and a panel of commercially available HIV drugs. Tibotec-Virco services are utilized by physicians to assist them in selecting HIV treatment regimens for patients who are failing, changing or initiating therapy. Reflecting the treatment-experienced nature of this patient population, the panel of samples showed a broad range of resistance to the commercially available HIV drugs. Specifically, 69 percent had a greater than ten-fold decrease in susceptibility to drugs from at least one antiretroviral drug class, 43 percent to drugs from two classes and 16 percent to drugs from all three classes. In contrast, only one percent of samples had a ten-fold or greater decrease in susceptibility to tenofovir. The three classes of approved HIV antiretroviral agents are nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs).

``It is becoming increasingly important to fully understand the potential patterns of cross-resistance between the classes of commercially available drugs and those in development,`` said John C. Martin, Ph.D., President and CEO, Gilead Sciences. ``These in vitro data are encouraging in that reduced susceptibility to tenofovir was infrequent. As we have recently completed our regulatory filings for tenofovir DF in both the U.S. and Europe, Gilead is making significant progress towards providing a novel treatment option to treatment-naive patients and to the growing number of patients who are infected with resistant HIV virus.``

Additional Resistance Data

In two additional presentations at the 5th International Workshop on HIV Drug Resistance and Treatment Strategies, Gilead researchers presented data describing the unique structural and enzymological features of tenofovir that may help to explain the compound`s favorable resistance profile. One study, which analyzed the crystal structure of HIV-1 reverse transcriptase bound to tenofovir, revealed that the unique acyclic chemical structure of tenofovir might contribute to the infrequency of cross-resitance and resistance development. The other study compared the removal of nucleosides (zidovudine, stavudine, zalcitabine, didanosine and lamivudine) versus nucleotides (tenofovir) using the ATP-dependent chain-terminator removal mechanism. The results demonstrate that chain-terminator removal occurs more readily with nucleosides than nucleotides and may contribute to the higher-level of resistance associated with nucleosides. The interaction of the acyclic structure of tenofovir combined with a unique resistance to chain-terminator removal may help explain why resistance to tenofovir is infrequent and slow to occur in vitro.

About Tenofovir DF

Tenofovir DF is dosed as a single 300 mg tablet taken once daily and works by blocking reverse transcriptase, an enzyme crucial to the replication of HIV. In May 2001, Gilead submitted a New Drug Application for tenofovir DF to the U.S. Food and Drug Administration and a Marketing Authorisation Application to the European Agency for the Evaluation of Medicinal Products. As an investigational compound, tenofovir DF has not yet been determined safe or efficacious in humans for its ultimate intended use.

Tenofovir DF Phase III Program

Gilead currently is evaluating tenofovir DF in two Phase III clinical trials. The first of these, Study 907, is an intensification of therapy study of tenofovir DF in 552 antiretroviral treatment-experience patients and is ongoing at sites in the United States, Europe and Australia. Twenty-four week data from this 48-week study were announced in February 2001, and Gilead expects to present these data at a scientific conference later this year.

Gilead initiated a second Phase III trial, Study 903, to evaluate tenofovir DF as a potential therapy for treatment-naive patients with HIV infection. This 48-week trial is designed to compare a treatment regimen of tenofovir DF, lamivudine (3TC) and efavirenz to a treatment regimen of stavudine (d4T), lamivudine and efavirenz in a blinded fashion in patients in the United States, Europe and South America who have not previously received antiretroviral treatment. Enrollment in Study 903 was completed in January 2001 at 601 patients.

Expanded Access Program Initiated

In January, Gilead announced the initiation of an expanded access program to provide tenofovir DF to people with advanced HIV infection. Programs are open for registration in the United States, France, Spain and the United Kingdom. Gilead expects to initiate expanded access programs in Germany, Italy, Canada and other countries as local regulatory approvals are obtained.

For more information regarding the tenofovir DF early access program or to request registration materials, physicians in the United States may call 1-800-GILEAD-5 and those within Europe may call 33-1-44-90-34-46.

[Pitu]

Gilead Is Worth the Wait

By Nadine Wong
Special to TheStreet.com
Originally posted at 2:20 PM ET 6/6/01 on RealMoney.com

If you were lucky enough to have bought Gilead Sciences (GILD:Nasdaq - news) right after its stock split in late February and held onto it, you`d have a 75% gain now. What`s the force driving this rise, and more important, will the momentum continue?

Two factors helped Gilead Sciences. First, the company submitted a new drug application to the Food and Drug Administration for marketing approval for tenofovir DF, an HIV treatment. Gilead anticipates FDA review and approval within six months, which puts the announcement at about the end of this year. Gilead also plans to submit its tenofovir application for regulatory approval in the European Union in the near future.

Tenofovir demonstrated significant effectiveness in a Phase III trial among HIV patients who had developed resistance to their current medications. Because of the rise of resistant strains of the HIV virus and tenofovir`s activity against resistant strains, the drug has the potential to become important for patients who have been heavily treated.

Second, Gilead signed an exclusive license with Cubist Pharmaceuticals in January to market cidecin in Europe. Cidecin is in a new class of drugs called lipopeptides and is being developed in intravenous and oral formulations to treat serious bacterial infections.

Cidecin has demonstrated an ability to rapidly kill virtually all gram-positive bacteria (a type of common bacteria), including those resistant to current therapies. Cubist is expected to file a new drug application in mid-2002 to expand the drug`s labeling to include other disease types including complicated skin and soft tissue infections, hospital-contracted pneumonia and complicated urinary tract infections. U.S. approval could come as early as mid-2003, with European approval in 2004. Cidecin has the potential for sales of up to $200 million.

So far, it appears Cidecin is on track for development. Recently, Cubist announced the first milestone in its collaboration with Gilead Sciences. Gilead is rendering to Cubist a milestone payment for the clinical development of Cidecin. On the completion of Study 9901, Cubist`s pivotal Phase III trial examining the safety and efficacy of Cidecin, Gilead has agreed to pay Cubist $1.25 million for meeting the primary endpoint of the clinical trial. The primary endpoint is Cidecin`s ability to reduce the number of bacteria in an infection. In addition, depending upon meeting certain clinical and regulatory milestones, Cubist can receive additional payments of up to $31 million. If Cidecin is approved, Cubist will receive a fixed royalty on net sales from Gilead Sciences.

Gilead Sciences is not projected to make a profit this year, nor in 2002. The story will probably change in 2003. The revenue from products such as AmBisome for severe fungal infections, tenofovir for HIV infection, adefovir for hepatitis B and Cidecin for bacterial infections should boost the company to profitability, which analysts project in 2003.

The time it will take Gilead to become profitable is undoubtedly one reason Prudential Securities analyst John Sonnier downgraded Gilead to hold from strong buy. Sonnier said Gilead`s stock price has nearly reached his price target of $55. One factor behind the downgrade could be decreased sales of Tamiflu, Gilead`s drug for influenza that it is co-marketing with Roche. Gilead expects royalties for Tamiflu to be lowered, due to the mild 2000-2001 flu season. As a result, lowered sales have more than likely been factored into Gilead Sciences` share price by Wall Street.

Among analysts, earnings models, evaluations and projections will vary. But Gilead`s outlook looks rosy over the long term. Wall Street likely favors Gilead because it has a good marriage between science and business. You can`t have one without the other. If the science is lousy, no amount of business will allow a company to be successful, and vice versa.

Nonetheless, Wall Street can be fickle, and at Gilead`s current valuation levels, there could be profit-taking. However, that could offer newcomers an opportunity to invest. The company has my vote.

[RandomGambler1]

The time it will take Gilead to become profitable is undoubtedly one reason Prudential Securities analyst John Sonnier downgraded Gilead to hold from strong buy. Sonnier said Gilead`s stock price has nearly reached his price target of $55. One factor behind the downgrade could be decreased sales of Tamiflu, Gilead`s drug for influenza that it is co-marketing with Roche. Gilead expects royalties for Tamiflu to be lowered, due to the mild 2000-2001 flu season. As a result, lowered sales have more than likely been factored into Gilead Sciences` share price by Wall Street.

Die Zeit, um Gilead profitabel werden zu lassen, ist unzweifelhaft ein Grund warum Prudential Securities Analyst John Sonnier Gilead von `unbedingt kaufen` auf `halten` abgestuft hat.
Sonnier sagte, daß Gilead sein Aktien Kursziel von 55$ beinahe erreicht hat. Ein Argument hinter dieser Abstufung könnten verminderte Verkäufe von Tamiflu sein - Gileads Grippe Arzneimittel, welches in Zusammenarbeit mit Roche vermarktet wird.
Für Tamiflu erwartet Gilead niedrigere Lizenzgebühren, aufgrund der leichten 2000/2001 Grippeperiode. Als Ergebnis davon werden die verminderten Verkäufe sehr wahrscheinlich mitbestimmend für die Gilead Sciences Aktienkurse an der Wall Streeet sein.

So, hab` ich mal übersetzt. Dann sieht es eben erst längerfristig wirklich rosig aus - und das heißt 2-3 Jahre!
Und 2Jahre wird der Kurs nie und nimmer wie an einer Schnur gezogen diese Steigung (Y:X) beibehalten. Deshalb habe ich mich Sonnier angeschlossen und erstmal verkauft.

mfg RG1

[Thierri]

Ich werde keine Aktie aus meinem Depot verkaufen, sondern bei niedrigeren Kursen eher meinen Barbestand angreifen und nachkaufen. Ich habe mich von Anfang an dazu entschlossen, Gilead langfristig zu halten, was in meinem Fall heißt: Mindestens bis 2004.

Natürlich werde ich darauf achten, daß mein eingesetztes Kapital nicht angegriffen wird. Bei einem Kurszuwachs von über 75% seit Kauf bereitet mir das allerdings keine schlaflosen Nächte.


Gruß Thierri

[Pitu]

Gilead Sciences Initiates Phase I Study in China of Adefovir Dipivoxil,
Investigational Compound for the Treatment of Chronic Hepatitis B Infection

FOSTER CITY, Calif.--(BW HealthWire)--June 11, 2001--Gilead Sciences, Inc. (Nasdaq:GILD - news) today announced that it has initiated Phase I trials of adefovir dipivoxil for the treatment of chronic hepatitis B (HBV) infection in China. Gilead is currently evaluating adefovir dipivoxil in Phase III clinical studies in North America, Europe, Asia and Australia.

``Of the nearly 400 million patients who suffer from chronic HBV infection, more than 100 million live in China,`` said John C. Martin, Ph.D., President and Chief Executive Officer, Gilead Sciences. ``We are working rapidly to advance the clinical development of adefovir dipivoxil in this important market. We believe the compound has the potential to address the unmet medical need of many patients with chronic HBV infection.``

Phase I Program in China

Gilead was granted Class 1 designation for adefovir dipivoxil in December 1999 by the People`s Republic of China State Drug Administration (SDA). In December 2000, Gilead received approval from the SDA to initiate clinical trials in China. To meet the requirements stipulated by the SDA, for drug registration in China, clinical trials must be conducted in China within the Chinese population. In addition, Phase I studies are required regardless of existing data from later-stage clinical studies conducted in other parts of the world.

The adefovir dipivoxil clinical program in China will be initiated with three separate Phase I trials (Studies 487, 488 and 489) that will be conducted in sequential order. After the completion of Phase I studies, a final report reviewing the safety and pharmacokinetic (PK) profile of the drug will be submitted to the SDA. The Class 1 designation of adefovir dipivoxil allows for an expedited review of these data. After the SDA`s review and subject to its approval, a single Phase II/III study will be initiated.

Adefovir Dipivoxil Global Phase III Program

Outside of China, two pivotal Phase III trials currently are underway to evaluate adefovir dipivoxil monotherapy as a potential treatment for chronic HBV infection. Study 437, initiated in March 1999 in Australia, Europe, North America and Southeast Asia, is a randomized, double-blind, placebo-controlled trial which is evaluating the safety and efficacy of adefovir dipivoxil at two active doses (10 mg and 30 mg) given once daily in hepatitis B ``e`` antigen positive patients. Enrollment in this trial was completed in March 2000 with 515 patients. Study 438, initiated in January 2000, is a randomized, double-blind, placebo-controlled trial which is evaluating adefovir dipivoxil 10 mg for the treatment of hepatitis B ``e`` antigen negative patients (precore mutant HBV infection). This trial is being conducted in Australia, Canada, France, Greece, Israel, Italy and Southeast Asia. Enrollment was completed in June 2000 with 185 patients.

Gilead anticipates the release or presentation of data from the 48-week analyses of these studies during the second half of 2001 and potential U.S. and European regulatory filings during the first half of 2002.

Patients and physicians who would like more information about adefovir dipivoxil may contact Gilead Sciences Medical Information at 1-800-GILEAD-5 (1-800-445-3235) or 1-650-574-3000 from outside the United States.

[Thierri]