OSI Pharmaceutical - Sammeltread - 500 Beiträge pro Seite

[Plaste]

Da es einfacher ist, die News hier gemeinsam zu sammeln, fang ich mal damit an.

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May 11, 2004 04:30 PM US Eastern Timezone

OSI Pharmaceuticals Announces Second Quarter Financial Results; Conference Call and Webcast to Follow

MELVILLE, N.Y.--(BUSINESS WIRE)--May 11, 2004--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced its financial results for the Company`s second quarter ended March 31, 2004. The Company reported net losses for the second quarter and six month period of $49.7 million ($1.27 net loss per share) and $89.8 million ($2.31 net loss per share), respectively, compared to net losses of $27.2 million ($0.75 net loss per share) and $57.3 million ($1.57 net loss per share) for the second quarter and six month period, respectively, in the prior year.

A significant component of the Company`s spending over the last several years has been the clinical development program for the Company`s flagship product, Tarceva(TM). Subsequent to completion of the quarter, the Company announced a positive outcome in the pivotal Phase III study of Tarceva(TM) in lung cancer patients. Top-line results indicated that this Phase III study of Tarceva(TM) in previously treated patients with non-small cell lung cancer (NSCLC) met its primary endpoint of improving overall survival, with patients receiving Tarceva(TM) living longer than those in the placebo arm of the study. In addition, the trial also met secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate.

"We believe that this top-line data firmly anchors Tarceva(TM) as the flagship clinical product around which we can continue to build a premier biotechnology organization delivering sustained growth and value creation for our shareholders," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We look forward to working closely with the FDA to make this important new medicine available to cancer patients as soon as possible."

Revenues for the three and six months ended March 31, 2004 were $7.2 million and $18.6 million, respectively, compared to $7.6 million and $12.1 million for the respective prior year periods. Included in revenues for the current three and six month periods were sales commissions and product sales of $5.9 million and $16.1 million, respectively, compared to approximately $900,000 for the prior year periods. The change in the Company`s revenue mix from the prior year periods reflects the completion of its transition from a business centered on funded collaborative programs to one generating its own commercial revenue ahead of a projected launch of Tarceva(TM) in 2005.

Total operating expenses for the three and six months ended March 31, 2004 were $55.1 million and $105.0 million, respectively, compared to $35.1 million and $70.9 million, respectively, for the comparable prior year periods. The increases in the current year periods primarily related to an increase in selling, general and administrative costs, amortization of intangibles and cost of product sales. Included in cost of product sales for the current three and six month periods was a charge of $2.0 million related to certain excess inventory the Company acquired from Cell Pathways, Inc. in June 2003. As anticipated, the increase in SG&A cost was primarily related to (i) the expansion of the Company`s commercial and administrative operations, (ii) the Company`s share of increased marketing and commercialization costs relating to Tarceva(TM), and (iii) closing costs relating to the consolidation of the Company`s Pennsylvania facility, acquired in the Cell Pathways acquisition. Amortization expense also increased by $3.9 million and $8.7 million for the three and six month periods, respectively, relating to the acquisition of marketing rights for Novantrone(R) and Gelclair(R). OSI also saw an increase in Other Expenses associated with the interest on convertible notes the Company issued in September 2003 and a decrease in the rate of return on investments.

Portfolio Highlights for the Quarter

Tarceva(TM)

The top-line data for Tarceva(TM) in the BR.21 trial represented the first time a non-chemotherapy agent has demonstrated a survival benefit in NSCLC. It was also the first controlled clinical study of a HER1/EGFR-targeted agent to have shown an improvement in survival in any disease setting. In addition to the top-line data, OSI also announced that detailed results of this international Phase III trial will be presented at the upcoming 2004 Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, Louisiana from June 5 to 8.

OSI will work with the U.S. Food and Drug Administration (FDA) to complete the New Drug Application (NDA) for Tarceva(TM) during the summer of 2004 and the Company projects an approval (assuming a successful six-month priority review by the FDA) in the first quarter of calendar year (CY) 2005. In 2002, OSI was granted Fast Track status from the FDA for this NSCLC indication. As a result in January 2004, OSI initiated a "rolling" submission by submitting the completed pre-clinical and chemistry, manufacturing and controls (CMC) sections of the NDA to the FDA`s Division of Oncology Drugs.

In March 2004, OSI announced it had initiated a Phase II randomized study of monotherapy Tarceva(TM) versus standard chemotherapy of previously untreated NSCLC patients with a poor performance status. This study is designed to evaluate monotherapy Tarceva(TM) as a therapeutic option to standard chemotherapy treatment for this high-risk sub-population of NSCLC patients.

OSI-7904L

The Company also announced that the Phase II single-agent study of OSI-7904L in chemotherapy-naive gastric and gastroesophageal junction cancer patients has moved forward to its second stage. The study, having met the initial requirement of achieving at least three responses in the first 18 evaluable patients, will now enroll approximately 50 patients in Europe and the United States. The primary endpoint of this trial is response rate. This open-label, non-randomized study was initiated in October 2003.

OSI-7904L is a liposomal formulation of a potent thymidylate synthase (TS) inhibitor which is designed to improve activity by changing the drug exposure (pharmacokinetic) profile when compared to its non-liposomal formulation, thereby maintaining active concentrations of drug in the tumor for extended periods of time.

OSI-930

The Company has continued to advance OSI-930 through pre-clinical development (IND-track). OSI-930 is a co-inhibitor of the receptor-tyrosine kinases c-Kit and VEGFR and is designed to target proliferative and angiogenic signaling in selected tumors. It is the first de novo development candidate to arise from the Company`s research organization since its re-structuring to focus on oncology research in the fall of 2002.

OSI-461

In February 2004, OSI announced it has expanded an ongoing Phase I dose escalating and pharmacokinetic trial of OSI-461 in patients with advanced solid tumors. This study has been amended to allow the Company to explore the possibility that administering OSI-461 with food may increase drug exposure levels achievable in humans following oral dosing of OSI-461. Data from this study are expected in the fourth quarter of CY2004. OSI-461 is also currently being evaluated in a series of preliminary Phase II studies in chronic lymphocytic leukemia, renal cell carcinoma and prostate cancer. OSI-461 is designed to be a selective apoptotic anti-cancer drug and is part of the technology platform OSI acquired from Cell Pathways in 2003.

Corporate Highlights for the Quarter

In April 2004, OSI announced that its Board of Directors approved an investment of up to an additional $40 million in its UK-based majority-owned diabetes and obesity subsidiary, Prosidion Limited. The first installment of $10 million was invested at a cost of $10 per share which gives OSI an 81% ownership position in the subsidiary (on a fully diluted shares outstanding basis). The investment was based on a pre-money valuation of Prosidion at $24 million. As an independent vehicle to pursue research in the diabetes and obesity areas, Prosidion has advanced small molecule drug candidates targeting glucokinase activation and glycogen phosphorylase inhibition to IND track status. These are scheduled to enter clinical trials in early 2005.

Conference Call

The Company will host a conference call reviewing the Company`s year-end financial results, product portfolio and business developments on May 12, 2004 at 10:00am (Eastern time). To access the live call or the seven-day archive via the Internet, log on to www.osip.com. Please connect to the Company`s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1-800-838-4403 (U.S.) or 1-973-317-5319 (international) to listen to the call. Telephone replay is available approximately two hours after the call through May 19, 2004. To access the replay, please call 1-800-428-6051 (U.S.) or 1-973-709-2089 (international). The conference ID number is 354696.

About OSI Pharmaceuticals

OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI`s most advanced drug candidate, Tarceva(TM), a small-molecule inhibitor of the HER1 gene, has successfully completed Phase III clinical trials for lung cancer and is subject to an ongoing rolling submission of an NDA. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair(R) for the relief of pain associated with oral mucositis.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others successful marketing of products, product pricing and third-party reimbursement, the completion of clinical trials, the FDA review process and other governmental regulation, OSI`s and its collaborators` abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, and other factors described in OSI Pharmaceuticals` filings with the Securities and Exchange Commission. Tarceva(TM), OSI-7904L, OSI-461 and OSI-930 are investigational compounds and have not yet been determined safe or efficacious in humans for their ultimate intended use.



Quelle: http://home.businesswire.com/portal/site/biospace/index.jsp?…

[Plaste]

WO hat ja heute auch was zu OSI zu vermelden:

OSI – ein „ASCO Effekt“ Profiteur?
Tarceva Fantasie überwiegt bereits Quartalsverlust

Einen deutlich höheren Verlust als von Wall Street Analysten prognostiziert, gleichzeitig aber auch ein größeres Minus als im Vorjahresquartal, musste OSI Pharmaceuticals für das zweite Quartal 2004 vorlegen. Damit verfehlte das New Yorker Unternehmen das vierte Quartal in Folge die Schätzungen der Analysten, die auf einen Verlust je Aktie von $1,03 gefasst waren, von OSI Pharmaceuticals aber mit einem Fehlbetrag von $49,7 Millionen oder $1,27 überrascht wurden.

In der entsprechenden Vorjahresperiode hatte OSI mit $27,2 Millionen oder 75 Cents pro Aktie noch einen deutlich geringeren Verlust ausgewiesen. Der Umsatz, den OSI nur über Kollaborationspartner erzielt, lag mit $7,2 Millionen in Q2 ebenfalls etwas geringer als noch in Q2 2003, wo OSI noch einen Umsatz von $7,6 Millionen ausweisen konnte.

Sicher sind diese Zahlen alles andere als erfreulich, doch für den Verlust im abgelaufenen Quartal hat OSI auf jeden Fall einen triftigen Grund und dieser heißt Tarceva und könnte bei OSI schon in absehbarer Zeit für eigene Produktumsätze sorgen. Obwohl OSI, wie gesagt, noch keine Einnahmen aus dem Verkauf eines Produktes besitzt, ist seine Marktkapitalisierung in den letzten Wochen bereits beträchtlich in die Höhe geschossen.

Die Aufmerksamkeit die OSI in den letzten Wochen zuteil wurde liegt wie gesagt an Tarceva, einem Medikament das eine große Hoffnung für die Therapie des fortgeschrittenen Lungenkarzinoms darstellt und gemeinsam mit solchen Größen wie Genentech und dem Schweizer Pharmagiganten Roche entwickelt wird. Roche und Genentech zählen zu den renommiertesten und auch erfolgreichsten Unternehmen weltweit wenn es um die erfolgreiche Entwicklung von Krebsmedikamenten geht, was mit Sicherheit für den Wirkstoffkandidaten von OSI spricht.

Tarceva heißt deshalb auch der Grund für die deutlich gestiegenen Verluste bei OSI im abgelaufenen Quartal. Auf Grund sehr ermutigender Studiendaten mit Tarceva hat man sich bei OSI, Genentech und Roche nämlich dazu entschlossen, den Hemmer des Wachstumsfaktor-Rezeptors EGF so schnell als möglich durch den Zulassungsprozess zu puschen. Dass Tarceva, das ja nachweislich das Überleben von Patienten verlängern soll, die Zulassung auch erhalten wird, davon sind die Partner überzeugt.

Aus diesem Grunde baut OSI nun bereits eine Vermarktungsstrategie und eine entsprechende Vertriebsschiene auf. Wie die jüngsten Zahlen von OSI zeigen, kostet dies eine ganze Stange Geld, die sich aber, im Falle eines Erfolges von Tarceva, mehrfach auszahlen wird.

Noch in diesem Sommer soll der Zulassungsantrag an die FDA ergehen, im besten Falle wird Tarceva dann bereits im ersten Quartal 2005 auf dem Markt kommen können. OSI CEO Colin Goddard gab während der Pressekonferenz an, die Arbeiten mit der FDA im Hinblick auf einen optimalen Zulassungsantrag würden bereits im Gange sein. Ob Anfang 2005 wirklich ein realistisches Ziel für die Vermarktung von Tarceva sein wird, das werden die Überlebensdaten, die Anfang Juni auf dem ASCO Meeting vorgestellt werden, zeigen.

Ob Tarceva zum gegenwärtigen Zeitpunkt den Kurs von $74 rechtfertigt bleibt dahingestellt. Sicher ist dagegen, dass die Investoren voll auf Tarceva setzen, weshalb auch der Aktienkurs von OSI nach Bekannt werden der Geschäftszahlen nicht abschmierte, sondern sogar erneut 2,8 Prozent zulegen konnte.


Simone A. Hörrlein
Staatl. gepr. LebChem (Univ.)
(Life Scientist)

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Pressroom

OSI Pharmaceuticals, Inc. (ticker: OSIP, exchange: NASDAQ) News Release - 17-May-2004
OSI Pharmaceuticals to Present at the Banc of America Securities Health Care Conference

MELVILLE, N.Y.--(BUSINESS WIRE)--May 17, 2004--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced that Dr. Colin Goddard, Chief Executive Officer of OSI Pharmaceuticals will present at the Banc of America Securities Healthcare Conference on Thursday, May 20, 2004 at 7:00PM eastern time. Dr. Goddard will provide an overview on the Company`s product portfolio and business developments.

The presentation will be webcast live and may be accessed by visiting OSI`s website at www.osip.com. A replay of the webcast will also be available on the Company`s website until Thursday, June 3, 2004.

About OSI Pharmaceuticals

OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI`s most advanced drug candidate, Tarceva(TM), a small-molecule inhibitor of the HER1 gene, is currently in Phase III clinical trials for lung and pancreatic cancers. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair(R) for the relief of pain associated with oral mucositis.

CONTACT: OSI Pharmaceuticals, Inc.
Kathy Galante
Director
Investor & Public Relations
631-962-2000
or
Burns McClellan (representing OSI)
Kathy Jones, Ph.D. (media)
Jonathan M. Nugent (investors)
212-213-0006

SOURCE: OSI Pharmaceuticals

[Plaste]

Hallo Leute,
hier nun mal etwas zum nachdenken bzw. diskutieren.
Das OSIP in den letzten Wochen einer der unangefochtenen Highflyer im Biotechsektor war, kann man wohl nicht bestreiten.
Ich habe mir lange Zeit darüber Gedanken gemacht, wie eine Bank of America und eine Lehmann Brothers auf ein Kusziel von ca 120,- USD kommt.
Evtl. hab ich ja die Begründung gefunden!:
Wer sich die Prudukte der Phase III von OSIP anschaut, findet Tarceva und Aptosyn. Die letzten Kurssprünge wurde wie jeder weiß von Tarceva ausgelöst. Aber von Aptosyn spricht bis heute kein Mensch. Obwohl ja dort demnächst, bzw auf Sicht von 12 Monaten, auch was kommen müsst, oder?!

Hier eine kleine Studie aus dem Jahr 2003 (glaube ich zumindestens), die bei Biotech-World auf der Homepage zu finden ist. Sie handelt von Cell Pathways (welche ja von OSIP übernommen wurden) und u.a. Aptosyn:

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Cell Pathways, Inc (CPI) wurde in 1990 in Horsham, PA gegründet. Ziel war es, neuartige Produkte zur Behandlung von Krebskrankheiten in frühen und fortgeschrittenen Stadien zu erzeugen und zu vermarkten. Die Drug-Targets liegen hierbei im Apoptose-Zyklus wobei die Apoptose selektiv im neoplasmatischen Gewebe induziert wird. Die gesunden Zellen bleiben also im Gegensatz zur herkömmlichen Chemotherapie weitgehend unberührt. Das Unternehmen greift auf die eigene „SAANDs“-Technologie (Selective Apoptotic Antineoplastic Drugs Technology“) zurück. Zwei Präparate, Aptosyn (Exisulnid) und CP-461, befinden sich in klinischen Testphasen. CPI vermarktet noch keine eigenen Produkte, das Unternehmen hat sich neben Forschung v.a. auf Ausbau der Anlagen, Rekrutierung von Personal und Kapitalgewinnung konzentriert.

Clinicals:
Der Vorteil der SAANDs liegt lt. CPI darin, dass sie Apoptose selektiv in neoplasmatischen Zellen, also in Zellen mit verminderter Apoptoserate, bewirken. Ansatzpunkt (Target) ist hierbei das Enzym cGMP-Phosphodiesterase (cGMP-PDE), dass cGMP in GMP umwandelt. Das cGMP ist an der Apoptoseinduktion beteiligt, liegt aber in neoplasmatischen Zellen (Krebszellen) aufgrund einer hohen cGMP-PDE-Konzentration hauptsächlich als inaktives GMP vor. Die SAANDs setzen hier an und wirken als c-GMP-PDE-Inhibitoren, erhöhen also die Konzentration des cGMP, dass nun weitere Stoffe aktiviert, die schliesslich zur Bildung der Caspasen führt. Durch nachfolgende Kaskadenreaktionen wird die Apoptose aktiviert.
Die selektive Wirkungsweise der SAANDs konnte in vorklinischen Studien bewiesen werden.
Aptosyn ist das erste Präparat auf SAANDs-Basis, dass CPI in klinischen Phasen testete. Seit 1993 laufen klinische Testreihen, um die Effektivität von Aptosyn in Verbindung mit herkömmlicher Chemotherapie u.a. gegen Lungen-, Brust- und Prostatakrebs zu testen (es laufen auch Phase II Tests, bei denen tägliche Aptosyn-Gabe ohne andere Präparate gegen Prostatakrebs eingesetzt wird).
Eine 1999 gestellte „New Drug Application“ (NDA) für Aptosyn zur Behandlung von FAP (familial adenomatous polyposis) wurde von der FDA aufgrund unvollständiger Daten abgelehnt und sorgte für erhebliche Kursstürze. Obgleich die FAP-Testreihen weitergeführt werden, konzentriert man sich nun verstärkt auf den Einsatz von Aptosyn gegen fortgeschrittene Krebserkrankungen.

Seit Anfang des Jahres laufen zwei Phase III Studien von Aptosyn in Verbindung mit dem von Aventis hergestellten Präparat Taxotere (zur Behandlung von NSCLC).

Ende 1998/Anfang 1999 begann CPI sein zweites Präparat, CP-461, in klinischen Phasen zu testen. Im Ggst. zu Aptosyn setzt man hier v.a. auf den Einzeleinsatz des Präparats ohne zusätzliche Chemotherapie. CP-461 soll auch zur Behandlung von CML (Chronisch Myeloischer Leukämie) verwendet werden.
Es ist nicht abzusehen, ob und wann das erste Medikament seine Zulassung erhalten wird. Selbst wenn die klinischen Testphasen erfolgreich verlaufen sollten, wäre mit einer Zulassung frühestens in 12-18 Monaten zu rechnen. Besonderes Augemerk sollte der Anleger auf die Zulassung von CP-461 richten.
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Hier noch eine kurze Empfehlung, die ich hier aus "Sammelleidenschaft" rein Stelle.

04.05.2004 09:27 (GLOBAL BIOTECH INVESTING)

OSI Pharmaceuticals verkaufen

Die Experten vom Börsenbrief "Global Biotech Investing" raten den Anlegern bei OSI Pharmaceuticals (ISIN US6710401034/ WKN 873205) zu Gewinnmitnahmen. OSI arbeite derzeit mit dem Pharmariesen Roche an einem Lungenkrebsmedikament. Das Präparat mit dem Namen Tarceva habe in Phase III-Testreihen anscheinend glänzende Ergebnisse erzielt. Der Markt habe auf diese Meldung positiv reagiert. So sei der Kurs der OSI-Titel um 131,99% auf 91,10 USD nach oben geschossen. Von den Wertpapierexperten habe der Titel vor geraumer Zeit eine Kaufempfehlung erhalten, wobei das Kursziel gerade mal bei 20 USD gelegen habe. Die kompletten Daten von Tarceva würden erste Anfang Juni, im Rahmen des ASCO-Meetings, verkündet. Die Wertpapierspezialisten würden jedenfalls einen weiteren Durchbruch in der Krebsforschung erwarten und mit einer Marktzulassung von Tarceva rechnen. Branchenexperten seien der Ansicht, dass das Präparat im Jahr 2010 Umsätze von mindestens 1,6 Mrd. USD erzielen könne. Zudem befinde sich der Wirkstoff derzeit in klinischen Testphasen der Stufe I und II, bezüglich der Anwendung in weiteren Bereichen. Nach dem jüngsten Kursprung erscheine das Papier ambitioniert bewertet. Das US-Investmenthaus Lazard erwarte nun im Jahr 2008 einen Gewinn je Aktie von 2,52 USD, womit der Wert dann mit einem KGV von 24 bewertet würde. Die Experten vom "Global Biotech Investing" empfehlen beim Titel von OSI Pharmaceuticals Gewinne mitzunehmen und die Position bis auf einen kleinen Rest glattzustellen.
Quelle: AKTIENCHECK.DE

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June 02, 2004 10:00 AM US Eastern Timezone

OSI Pharmaceuticals to Provide a Summary on Data Presented at the American Society of Clinical Oncology

MELVILLE, N.Y.--(BUSINESS WIRE)--June 2, 2004--OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) today announced it will host a live webcast to provide a summary on data which will be presented during the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA. The webcast will be hosted by Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals, and will begin at 8:30AM Eastern Time on Tuesday, June 8, 2004.

To access the webcast live via the internet, please log onto www.osip.com approximately 15 minutes before the start of the event to allow for any software downloads that may be necessary. Following the webcast, an archive will be available at the same address for seven days.

About OSI Pharmaceuticals

OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI`s most advanced drug candidate, Tarceva(TM), a small-molecule inhibitor of the HER1 gene, has successfully completed Phase III clinical trials for lung cancer and is subject to an ongoing rolling submission of an NDA. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair(R) for the relief of pain associated with oral mucositis.

[Plaste]

http://home.businesswire.com/portal/site/biospace/index.jsp?…

June 04, 2004 07:30 AM US Eastern Timezone

OSI Pharmaceuticals Announces Appointment of Herbert Michael Pinedo to Its Board

MELVILLE, N.Y.--(BUSINESS WIRE)--June 4, 2004--OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) today announced the appointment of Herbert Michael "Bob" Pinedo, M.D., Ph.D., to the Company`s Board of Directors. Dr. Pinedo has over thirty years of extensive oncology experience in medical practice and research and he continues to be a thought leader to both the medical and research communities. Dr. Pinedo is currently Professor of Medical Oncology, and Director of the VUMC-Cancer Center-Amsterdam. Dr. Pinedo assumes the position vacated by Mr. John H. French II who retired from the Board of Directors in March of this year.

"We are delighted to welcome Bob to our Board of Directors," stated Robert A. Ingram, Chairman of OSI Pharmaceuticals. "Bob`s global stature, experience and reputation in oncology make him an ideal addition to our Board."

"I am excited to be joining the OSI board at this point in its history," said Dr. Pinedo. "Dr. Goddard and his management team have built a strong foundation for the continued growth of its oncology franchise around Tarceva and I look forward to working with my board colleagues in support of the next phase of the company`s development."

Dr. Pinedo`s work focuses on translational research, in particular, drug resistance, angiogenesis and immunology. He is a member of the British Royal Society of Medicine and The Royal Dutch Academy of Science and Arts, where he is Chairman of the Board of the Medical Division. Dr. Pinedo founded the New Drug Development Office (NDDO) - Oncology, which coordinates early clinical trials with anticancer agents internationally. He was the first President of the Federation of European Cancer Societies (FECS), and Past President to the European Society of Medical Oncology (ESMO). Dr. Pinedo is the co-founder of the Annals of Oncology and The Oncologist and is the Co-Editor of Current Opinion in Anticancer Drugs. He serves on numerous editorial boards including Clinical Cancer Research, and Journal of Clinical Oncology. Dr. Pinedo has authored more than 600 peer-reviewed international publications and more than 120 chapters, invited papers or proceedings.

Dr. Pinedo has received many international awards including the prestigious Josef Steiner award and has been decorated by H.M. Queen Beatrice of the Netherlands with the prestigious Knight of the Order of the Netherlands Lion.

About OSI Pharmaceuticals

OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI`s most advanced drug candidate, Tarceva(TM), a small-molecule inhibitor of the HER1 gene, has successfully completed Phase III clinical trials for lung cancer and is subject to an ongoing rolling submission of an NDA. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair(R) for the relief of pain associated with oral mucositis.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, successful marketing of products, product pricing and third-party reimbursement, the completion of clinical trials, the FDA review process and other governmental regulation, OSI`s and its collaborators` abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, and other factors described in OSI Pharmaceuticals` filings with the Securities and Exchange Commission.

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Kaum ist die "Krebskonferenz" vorbei, die erste Empfehlung:

NEW YORK, June 7 (New Ratings) - Analyst Akhtar Samad of Bear Stearns reiterates his "outperform" rating on OSI Pharmaceuticals (OSIP.NAS).

In a research note published this morning, the analyst mentions that the company and its partners, DNA and Roche, released preliminary data for Tarceva`s Phase III Trial in-line with expectations. Tarceva`s results exhibited substantial benefits as compared to Iressa, the analyst adds. Bear Stearns expects the NDA filing for Tarceva to be announced this summer.

[Plaste]

Aus dem OSIP Pressroom:

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OSI Pharmaceuticals, Inc. (ticker: OSIP, exchange: NASDAQ) News Release - 5-Jun-2004
Phase III Study of Tarceva in Relapsed Non-Small Cell Lung Cancer Shows Significant Improvement in Survival

Only HER1/EGFR-Inhibitor to Show Survival Benefit in Lung Cancer

NEW ORLEANS--(BUSINESS WIRE)--June 5, 2004--OSI Pharmaceuticals, Inc. (Nasdaq: OSIP), Genentech, Inc. (NYSE: DNA), and Roche (SWX Zurich) today announced that the pivotal Phase III trial of Tarceva(TM) (erlotinib HCl) in advanced non-small cell lung cancer (NSCLC) demonstrated a 42.5 percent improvement in median survival and a 41 percent improvement in one-year survival rates compared to placebo. The results were featured in an American Society of Clinical Oncology (ASCO) press briefing during the 40th Annual ASCO meeting in New Orleans, La. More detailed presentations of the data will be made to meeting attendees on Monday, June 7th.

"Tarceva(TM) is the first and only epidermal growth factor receptor (EGFR) inhibitor and the first targeted non-chemotherapy agent to demonstrate an improvement in overall survival and exhibit symptom related benefits in a large randomized study in lung cancer patients," stated Dr. Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We believe that the association of these benefits with a favorable safety profile will provide an important potential treatment option for lung cancer patients."

"These results represent an important medical advance in the treatment of advanced lung cancer patients," stated Study Chair, Frances A. Shepherd, M.D., FRCPC, Scott Taylor Chair in Lung Cancer Research at the Princess Margaret Hospital, Professor of Medicine at the University of Toronto. "The outcome of the study is particularly noteworthy considering the broad spectrum of advanced lung cancer patients enrolled in the study. The observations concerning symptoms are also particularly meaningful to these patients."

The study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen`s University, Ontario in collaboration with OSI Pharmaceuticals.

Study Results

This trial of Tarceva(TM) met the pre-determined primary study endpoint of improvement in overall survival and demonstrated significant effects in all secondary endpoints including time to symptom deterioration, progression-free survival and response rate. A total of 731 patients were enrolled in BR.21, a randomized, international, double-blind controlled study comparing the use of 150mg/day Tarceva(TM) versus placebo for the treatment of patients with advanced NSCLC following failure of first or second-line chemotherapy. The study randomized patients with a 2:1 ratio in favor of Tarceva(TM) to receive either Tarceva(TM) or placebo.

Patients receiving Tarceva(TM) had a median survival of 6.7 months compared to 4.7 months in patients who received placebo (a 42.5 percent improvement). A hazard ratio of 0.72 and a p-value of 0.001 were determined for comparisons of overall survival (a hazard ratio (HR) of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). In addition, 31 percent of patients receiving Tarceva(TM) in the study were alive at one year versus 22 percent in the placebo arm (a 41 percent improvement). Statistically significant improvements in time to symptom deterioration were observed for key lung cancer symptoms of cough, pain, and dyspnea. The objective response rate in patients treated with Tarceva(TM) was 9 percent versus less than 1 percent in the placebo arm.

Approximately 50 percent of the patients in the study had previously received one prior regimen while the remainder had received two prior regimens. In addition, the study enrolled a relatively large proportion of patients with poor performance status (PS2: 25% and PS3: 9%). Despite these unfavorable pre-treatment characteristics, treatment benefit was documented in the majority of patients.

"This trial is important because a survival treatment benefit was achieved among a broad group of patients who were not selected for factors such as EGFR status, gender, smoking history or type of non-small cell lung cancer," said Hal Barron, M.D., Genentech`s senior vice president, development and chief medical officer. "We are grateful to the hundreds of patients and their families around the world who volunteered for this study and contributed to this landmark research."

OSI will work with the U.S. Food and Drug Administration to complete the New Drug Application (NDA) for Tarceva(TM) during the summer of 2004.

Safety

The safety profile observed for Tarceva(TM) in the study was consistent with observations made in prior Tarceva(TM) studies. Seventy-six percent of patients receiving Tarceva(TM) exhibited rash (versus 17 percent in the placebo group) and 55 percent of patients receiving Tarceva(TM) experienced diarrhea (versus 19 percent for placebo). Most of these were mild or moderate. Dose reductions occurred for rash and diarrhea only in the Tarceva(TM) arm, 12 percent and five percent respectively. In this large placebo-controlled study, severe pulmonary events including potential cases of interstitial lung events were rare and generally equally distributed between treatment arms.

About Tarceva(TM)

Tarceva(TM) is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in many cancers. HER1, also known as EGFR, is a key component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva(TM) is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Results of a Phase III trial of Tarceva(TM) in pancreatic cancer are expected in the second half of 2004. Early-stage trials of Tarceva(TM) are being conducted in other solid tumors, such as ovarian, colorectal, head and neck, kidney, brain and gastrointestinal cancers.

About Non-Small Cell Lung Cancer

According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. It is estimated that more than 173,000 people will be diagnosed with lung cancer in the United States in 2004. According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the United States, and is responsible for nearly 30 percent of cancer deaths in the country. NSCLC is the most common form of the disease and accounts for almost 80 percent of all lung cancer.

About the Companies

OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development, and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality of life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI`s most advanced drug candidate, Tarceva(TM), a small-molecule inhibitor of the HER1 gene, has successfully completed Phase III clinical trials for lung cancer and is subject to an ongoing rolling submission of an NDA. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair(R) for the relief of pain associated with oral mucositis. For additional information about the company, please visit http://www.osip.com.

Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients` lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is leading clinical development programs for Rituxan(R) (Rituximab), Herceptin(R) (Trastuzumab), and Avastin(tm) (bevacizumab) and markets all three products in the United States either alone (Avastin, which it recently launched in the United States, and Herceptin) or with Biogen Idec Inc. (Rituxan). Genentech has licensed Rituxan, Herceptin and Avastin to Roche for sale by the Roche Group outside of the United States.

The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e. programmed cell death), the HER pathway and B-cell biology. Potential oncology therapies directed at the HER pathway include Tarceva(tm) (erlotinib) and a therapeutic antibody currently in Phase II trials. Also in early development are a small molecule directed at the hedgehog pathway, a therapy targeting apoptosis and a humanized anti-CD20 antibody for hematology/oncology indications.

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Eighteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 13 biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

Roche in Oncology

Within the last five years the Roche Group has become the world`s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit: Herceptin, MabThera, Xeloda and Avastin (launched by Genentech in the US recently), which treat a range of malignancies such as breast cancer, non-Hodgkin`s lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi`s sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. Roche`s cancer medicines generated sales of more than 6 billion Swiss francs in 2003.

In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer.

Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

The statements made in this press release relating to the expected timeframes for NDA filing and for data availability from the Phase III trial in pancreatic cancer are forward-looking and actual results could differ materially. Among other things, the timeframes could be affected by safety or efficacy concerns, manufacturing issues, additional time requirements to achieve study endpoints or for data analysis or NDA preparation, discussions with the FDA, the need for additional clinical studies, or FDA actions or delays.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others successful marketing of products, product pricing and third-party reimbursement, the completion of clinical trials, the FDA review process and other governmental regulation, OSI`s and its collaborators` abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, and other factors described in OSI`s filings with the Securities and Exchange Commission. Tarceva(TM) is an investigational compound and has not yet been determined safe or efficacious in humans for its ultimate intended use.

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OSI Pharmaceuticals, Inc. (ticker: OSIP, exchange: NASDAQ) News Release - 5-Jun-2004
Early Clinical Data Evaluating the Combination of Avastin and Tarceva Yield Initial Promising Results in Several Cancers

- Researchers Present Phase I/II Data Showing Improved Progression-Free Survival in Patients With Metastatic Kidney Cancer and Relapsed Non-Small CellLung Cancer -

NEW ORLEANS, June 5 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA) and OSI Pharmaceuticals (Nasdaq: OSIP) today announced results from Phase I/II clinical studies examining the combination of Avastin(TM) (bevacizumab) and the investigational small molecule Tarceva(TM) (erlotinib HCl) in the treatment of metastatic renal cell carcinoma (kidney cancer) and relapsed non-small cell lung cancer (NSCLC). These trials are important because patients received no chemotherapy and instead were treated with a combination of two therapies targeted at two distinct avenues of growth in cancer: angiogenesis and EGFR signaling. The results were presented at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO).

Avastin is a therapeutic antibody designed to inhibit angiogenesis, the process by which new blood vessels develop, which is necessary to support tumor growth and metastasis. Avastin is currently approved in the United States for use in combination with intravenous 5-Fluorouracil (5-FU)-based chemotherapy as a treatment for first-line metastatic colorectal cancer. Tarceva, an investigational therapy, is an oral, once-a-day, small molecule designed to target the human epidermal growth factor receptor 1 (HER1/EGFR) pathway, which is one of the factors critical to cell growth in many cancers.

"As cancer patients lives longer, quality of life and avoiding toxic side effects become more important," said Gwen Fyfe, M.D., Genentech`s vice president, Clinical Hematology/Oncology. "Evaluating the combination of Avastin and Tarceva in certain cancers is representative of our strategy to inhibit tumor growth by simultaneously targeting different cancer pathways. We are encouraged by the response and progression-free survival data observed in these studies of patients with advanced kidney and lung cancers and believe these data support future evaluation of this combination in multiple tumor types."

In addition to the combination studies in recurrent NSCLC and metastatic kidney cancer, preliminary data from studies evaluating the combination of Avastin plus Tarceva in metastatic breast cancer and recurrent and/or metastatic head and neck cancer will be presented at this year`s ASCO meeting.

Phase II Study of Tarceva and Avastin in Metastatic Renal Cell Carcinoma (Abstract #4502)

This single-arm Phase II study, presented by John Hainsworth, M.D., of the Sarah Cannon Cancer Center in Nashville, Tenn., focused on preliminary results from 62 patients with metastatic renal cell carcinoma (kidney cancer) treated with a combination of Avastin and the investigational drug Tarceva. Results of this study will be highlighted by ASCO in a "Targeted Therapies" press conference at 9:00 a.m. CDT on Sunday, June 6. These results add to the data generated by the Phase II study of single-agent Avastin in metastatic renal cell carcinoma, which were presented at the 2002 ASCO meeting and published in the New England Journal of Medicine in 2003.

At the time of analysis, 62 patients had been enrolled in the study and 58 were evaluable for response. The authors reported that at eight weeks, 21 percent of patients (12/58) experienced an objective response (defined as a 50 percent or greater decrease in the size of a tumor) to the combined therapy and 66 percent (38/58) experienced a minor response or disease stabilization. At six months, 67 percent of the evaluable patients (39/58) had progression-free survival and after one year, 50 percent of patients (29/58) had progression-free survival. Overall survival after six months was 92 percent and after one year was 81 percent.

The Grade 3 or 4 adverse events observed in the study included hypertension (8 percent, 5/58), diarrhea (10 percent, 6/58), rash (13 percent, 8/58), nausea/vomiting (10 percent, 6/58), bleeding (5 percent, 3/58), pruritus (3 percent, 2/58), proteinuria (3 percent, 2/58), neuropathy (3 percent, 2/58) and edema (2 percent, 1/58).

Phase I/II Study of Avastin and Tarceva in Recurrent Non-Small Cell Lung Cancer (Abstract #2000)

Alan Sandler, M.D., of Vanderbilt-Ingram Cancer Center, reported on results from a multicenter Phase I/II study designed to evaluate the combination of Avastin and Tarceva in the treatment of recurrent non-small cell lung cancer (NSCLC) patients.

To date, 40 patients have been enrolled in the trial. At the time of analysis, median survival was 12.6 months, median progression-free survival was 7 months and the estimated one-year survival was 54 percent. Partial responses were observed in 20 percent of patients (8/40) and an additional 65 percent of patients (26/40) achieved stable disease in the study. The most frequent adverse events reported were mild-to-moderate rash (93 percent, 37/40), diarrhea (78 percent, 31/40) and proteinuria (18 percent, 7/40).

Traditionally patients with relapsed NSCLC are treated with chemotherapy, which may be very poorly tolerated by some advanced patients. If randomized, Phase III trials of Avastin plus Tarceva show clinical benefit, this combination could provide an important treatment option that does not include chemotherapy.

About Avastin

Avastin is a therapeutic antibody designed to inhibit VEGF, a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By binding to VEGF, Avastin is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis. Avastin received approval by the U.S. Food and Drug Administration (FDA) on February 26, 2004, to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for first-line metastatic colorectal cancer. For full prescribing information, Boxed Warnings on Avastin and information about angiogenesis, visit www.gene.com. For more information about Avastin, visit www.avastin.com.

Earlier this year, the National Comprehensive Cancer Network (NCCN), an alliance of 19 of the world`s leading cancer centers, updated their Colorectal Clinical Practice Guidelines and added Avastin in combination with 5-Fluorouracil-based regimens -- including those using oxaliplatin or irinotecan -- to its list of treatment options for first-line advanced colon or rectal cancer.

Based on data showing that VEGF plays a broad role in a range of cancers, Genentech is pursuing a late-stage clinical development program with Avastin evaluating its potential use in various cancers, including renal cell (kidney), breast and non-small cell lung cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in prostate, ovarian and several other types of solid tumor cancers as well as in hematologic malignancies and melanoma.

Avastin Safety Profile

The addition of Avastin to chemotherapy is generally well tolerated. In Genentech-sponsored studies, the most serious adverse events associated with Avastin were infrequent, and included gastrointestinal perforation, wound healing complications, hemorrhage, hypertensive crisis, nephrotic syndrome, and congestive heart failure. The most common Grade 3-4 adverse events (occurring in greater than 2 percent of patients in the Avastin arm, compared to the control group) were asthenia, pain, hypertension, diarrhea and leukopenia. The most common adverse events (occurring in greater than 2 percent of patients in the Avastin arm, compared to the control group) of any severity were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

About Tarceva

Tarceva is an investigational small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in many cancers. HER1, also known as EGFR, is potentially a key component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. The Tarceva pivotal trial was a randomized Phase III study that assessed Tarceva as a single agent in patients with stage III/IV refractory NSCLC and showed an improvement in survival compared to placebo. Results of a Phase III trial of Tarceva in pancreatic cancer are expected in the second half of 2004. Early-stage trials of Tarceva are being conducted in other solid tumors, such as ovarian, colorectal, head and neck, kidney, brain and gastrointestinal cancers. Tarceva is being developed by a global alliance of Genentech, OSI Pharmaceuticals and Roche.

A preliminary analysis of data from the Tarceva pivotal trial showed that the toxicities reported were as expected in patients receiving Tarceva compared to those receiving placebo. In line with previous clinical studies, events that occurred more often with patients treated with Tarceva included mainly mild to moderate diarrhea and rash.

About Genentech

Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients` lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is leading clinical development programs for Rituxan(R) (Rituximab), Herceptin(R) (Trastuzumab), and Avastin(TM) (bevacizumab) and markets all three products in the United States either alone (Avastin, which it recently launched in the United States, and Herceptin) or with Biogen Idec Inc. (Rituxan). Genentech has licensed Rituxan, Herceptin and Avastin to Roche for sale by the Roche Group outside of the United States.

The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e. programmed cell death), the HER pathway and B-cell biology. Potential oncology therapies directed at the HER pathway include Tarceva(TM) (erlotinib) and a therapeutic antibody currently in Phase II trials. Also in early development are a small molecule directed at the hedgehog pathway, a therapy targeting apoptosis and a humanized anti-CD20 antibody for hematology/oncology indications.

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Eighteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 13 biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com .

About OSI Pharmaceuticals

OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development, and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality of life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair(R) for the relief of pain associated with oral mucositis. For additional information about OSI, please visit http://www.osip.com .

For full Avastin prescribing information, including Boxed Warnings, please call 650-225-7739 or visit http://www.gene.com .

The statement made in this press release relating to the expected time frame for data availability from the Tarceva Phase III trial in pancreatic cancer is forward-looking and actual results could differ materially. Among other things, the time frame could be affected by unexpected safety issues, the length of time to achieve study endpoints, additional time requirements for data analysis or discussions with the FDA.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others successful marketing of products, product pricing and third-party reimbursement, the completion of clinical trials, the FDA review process and other governmental regulation, OSI`s and its collaborators` abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, and other factors described in OSI`s filings with the Securities and Exchange Commission. Tarceva(TM) is an investigational compound and has not yet been determined safe or efficacious in humans for its ultimate intended use.

[Plaste]

OSI Pharmaceuticals upgraded to "buy"

Monday, June 07, 2004 12:22:45 PM ET
Merrill Lynch

NEW YORK, June 7 (New Ratings) - Analysts at Merrill Lynch upgrade OSI Pharmaceuticals (OSIP.NAS) from "neutral" to "buy."

[Plaste]

09.06.2004
OSI Pharmaceuticals neutral
IRG Research

Rating-Update:

Die Analysten von IRG Research stufen die Aktien von OSI Pharmaceuticals (ISIN US6710401034/ WKN 873205) von "sell" auf "neutral" hoch.

[Plaste]

Genentech, Inc. (DNA) And OSI Pharmaceuticals (OSIP) Release: Early Clinical Data Evaluating The Combination Of Avastin And Tarceva Yield Initial Promising Results In Several Cancers

NEW ORLEANS, June 5 /PRNewswire-FirstCall/ -- Genentech, Inc. and OSI Pharmaceuticals today announced results from Phase I/II clinical studies examining the combination of Avastin(TM) (bevacizumab) and the investigational small molecule Tarceva(TM) (erlotinib HCl) in the treatment of metastatic renal cell carcinoma (kidney cancer) and relapsed non-small cell lung cancer (NSCLC). These trials are important because patients received no chemotherapy and instead were treated with a combination of two therapies targeted at two distinct avenues of growth in cancer: angiogenesis and EGFR signaling. The results were presented at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO).

Avastin is a therapeutic antibody designed to inhibit angiogenesis, the process by which new blood vessels develop, which is necessary to support tumor growth and metastasis. Avastin is currently approved in the United States for use in combination with intravenous 5-Fluorouracil (5-FU)-based chemotherapy as a treatment for first-line metastatic colorectal cancer. Tarceva, an investigational therapy, is an oral, once-a-day, small molecule designed to target the human epidermal growth factor receptor 1 (HER1/EGFR) pathway, which is one of the factors critical to cell growth in many cancers.

"As cancer patients lives longer, quality of life and avoiding toxic side effects become more important," said Gwen Fyfe, M.D., Genentech`s vice president, Clinical Hematology/Oncology. "Evaluating the combination of Avastin and Tarceva in certain cancers is representative of our strategy to inhibit tumor growth by simultaneously targeting different cancer pathways. We are encouraged by the response and progression-free survival data observed in these studies of patients with advanced kidney and lung cancers and believe these data support future evaluation of this combination in multiple tumor types."

In addition to the combination studies in recurrent NSCLC and metastatic kidney cancer, preliminary data from studies evaluating the combination of Avastin plus Tarceva in metastatic breast cancer and recurrent and/or metastatic head and neck cancer will be presented at this year`s ASCO meeting.

Phase II Study of Tarceva and Avastin in Metastatic Renal Cell Carcinoma (Abstract #4502)

This single-arm Phase II study, presented by John Hainsworth, M.D., of the Sarah Cannon Cancer Center in Nashville, Tenn., focused on preliminary results from 62 patients with metastatic renal cell carcinoma (kidney cancer) treated with a combination of Avastin and the investigational drug Tarceva. Results of this study will be highlighted by ASCO in a "Targeted Therapies" press conference at 9:00 a.m. CDT on Sunday, June 6. These results add to the data generated by the Phase II study of single-agent Avastin in metastatic renal cell carcinoma, which were presented at the 2002 ASCO meeting and published in the New England Journal of Medicine in 2003.

At the time of analysis, 62 patients had been enrolled in the study and 58 were evaluable for response. The authors reported that at eight weeks, 21 percent of patients (12/58) experienced an objective response (defined as a 50 percent or greater decrease in the size of a tumor) to the combined therapy and 66 percent (38/58) experienced a minor response or disease stabilization. At six months, 67 percent of the evaluable patients (39/58) had progression-free survival and after one year, 50 percent of patients (29/58) had progression-free survival. Overall survival after six months was 92 percent and after one year was 81 percent.

The Grade 3 or 4 adverse events observed in the study included hypertension (8 percent, 5/58), diarrhea (10 percent, 6/58), rash (13 percent, 8/58), nausea/vomiting (10 percent, 6/58), bleeding (5 percent, 3/58), pruritus (3 percent, 2/58), proteinuria (3 percent, 2/58), neuropathy (3 percent, 2/58) and edema (2 percent, 1/58).

Phase I/II Study of Avastin and Tarceva in Recurrent Non-Small Cell Lung Cancer (Abstract #2000)

Alan Sandler, M.D., of Vanderbilt-Ingram Cancer Center, reported on results from a multicenter Phase I/II study designed to evaluate the combination of Avastin and Tarceva in the treatment of recurrent non-small cell lung cancer (NSCLC) patients.

To date, 40 patients have been enrolled in the trial. At the time of analysis, median survival was 12.6 months, median progression-free survival was 7 months and the estimated one-year survival was 54 percent. Partial responses were observed in 20 percent of patients (8/40) and an additional 65 percent of patients (26/40) achieved stable disease in the study. The most frequent adverse events reported were mild-to-moderate rash (93 percent, 37/40), diarrhea (78 percent, 31/40) and proteinuria (18 percent, 7/40).

Traditionally patients with relapsed NSCLC are treated with chemotherapy, which may be very poorly tolerated by some advanced patients. If randomized, Phase III trials of Avastin plus Tarceva show clinical benefit, this combination could provide an important treatment option that does not include chemotherapy.

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June 08, 2004 07:21 PM US Eastern Timezone

OSI Pharmaceuticals Summarizes Survival Benefits in Key Patient Subsets from The BR.21 Study

MELVILLE, N.Y.--(BUSINESS WIRE)--June 8, 2004--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today a summary of data presented earlier at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO) summarizing the treatment benefit observed in various subsets of patients treated with the investigational drug Tarceva(TM) (erlotinib HCl) in the BR.21 study. The study, presented on Monday, June 7, was a Phase III trial of Tarceva(TM) versus placebo in second and third-line patients with relapsed non-small cell lung cancer.

"The results of the BR.21 trial were noteworthy in that they demonstrated a survival benefit in essentially all subsets of lung cancer patients that we examined," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "Previous research on other EGFR inhibitors had suggested that any Tarceva(TM) benefit may have been restricted to certain subsets of patients. We believe that the observation of an improvement in survival in subsets including smokers and patients with squamous cell carcinoma is of particular interest to the lung cancer community."

The BR.21 trial of Tarceva(TM) met the pre-determined primary study endpoint of improvement in overall survival and demonstrated significant effects in all secondary endpoints including time to symptom deterioration, progression-free survival and response rate.

Patients receiving Tarceva(TM) had a median survival of 6.7 months compared to 4.7 months in patients who received placebo (a 42.5 percent improvement). A hazard ratio of 0.72 and a p-value of 0.001 were determined for comparison of overall survival (a hazard ratio (HR) of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). In addition, 31 percent of patients receiving Tarceva(TM) in the study were alive at one year versus 22 percent in the placebo arm (a 41 percent improvement).

As would be expected from historical data on the relative prognosis for survival in different subsets of lung cancer patients, patients treated with Tarceva(TM) who were female, had tumors with adenocarcinoma histology or were never smokers lived longer than patients treated with Tarceva(TM) who were male, had tumors with squamous cell carcinoma histology or were smokers, respectively. However, importantly, Tarceva(TM) improved survival in essentially all subsets of patients in the study including males, patients with squamous cell carcinoma and smokers. Data summarizing the broad-based treatment benefit that was observed in key subsets of patients in the BR.21 study is summarized in the table below.


Median Survival in Months Hazard Ratio

Tarceva(TM) Placebo
----------------------------------------------------------------------
Never Smokers 12.2 5.6 0.42
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Current or Former Smokers 5.5 4.6 0.87
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Adenocarcinoma 7.8 5.4 0.71
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Squamous Cell Carcinoma 5.6 3.6 0.67
----------------------------------------------------------------------
Female 8.4 6.2 0.80
----------------------------------------------------------------------
Male 5.7 4.5 0.76
----------------------------------------------------------------------

Note: OSI Pharmaceuticals, Inc. statistical analysis of data from the BR.21 trial

A total of 731 patients were enrolled in BR.21, a randomized, international, double-blinded controlled study comparing the use of 150mg/day Tarceva(TM) versus placebo for the treatment of patients with advanced NSCLC following failure of first or second-line chemotherapy. The study randomized patients with a 2:1 ratio in favor of Tarceva(TM) to receive either Tarceva(TM) or placebo.

Safety

The safety profile observed for Tarceva(TM) in the study was consistent with observations made in prior Tarceva(TM) studies. Seventy-six percent of patients receiving Tarceva(TM) exhibited rash (versus 17 percent in the placebo group) and 55 percent of patients receiving Tarceva(TM) experienced diarrhea (versus 19 percent for placebo). Most of these were mild or moderate. Dose reductions occurred for rash and diarrhea only in the Tarceva(TM) arm, 12 percent and five percent respectively. In this large, placebo-controlled study, severe pulmonary events including potential cases of interstitial lung events were rare and generally equally distributed between treatment arms.

About Tarceva(TM)

Tarceva(TM), an investigational small molecule, is designed to block tumor cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor thereby blocking the HER1/EGFR signaling pathway inside the cell. Tarceva(TM) is currently being evaluated in an extensive clinical development program together with the Company`s alliance partners at Genentech and Roche. The study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen`s University in collaboration with OSI Pharmaceuticals.

About OSI Pharmaceuticals

OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI`s most advanced drug candidate, Tarceva(TM), a small-molecule inhibitor of the HER1 gene, has successfully completed Phase III clinical trials for lung cancer and is subject to an ongoing rolling submission of an NDA. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair(R) for the relief of pain associated with oral mucositis.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, OSI`s and its collaborators` abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, and other factors described in OSI Pharmaceuticals` filings with the Securities and Exchange Commission. Tarceva(TM) is an investigational compound and has not yet been determined safe or efficacious in humans for its ultimate intended use.