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Press Release

Incyte Reports First Quarter 2009 Financial Results and Provides Update on Drug Development Programs
Conference Call Scheduled Today at 8:30 a.m. ET

WILMINGTON, Del.--(BUSINESS WIRE)--May. 7, 2009-- Incyte Corporation (Nasdaq:INCY) today reported first quarter 2009 financial results and provided an update on its highest priority clinical programs.

“We continued to make good progress in our lead clinical programs during the first quarter. Thus, over the next few months we expect a number of key events, including the initiation of Phase III trials for INCB18424 in patients with myelofibrosis, the report of final results from the Phase IIb trial for topical INCB18424 in psoriasis, the start of a 6-month multiple-dose trial for INCB28050 in rheumatoid arthritis and the report of final results from our Phase IIb trial for INCB13739 in type 2 diabetes,” stated Paul A. Friedman, M.D., Incyte’s President and Chief Executive Officer.

Below is a summary of recent developments for our most advanced product candidates:

Janus Kinase (JAK) Inhibitor Program

INCB18424: (oral formulation) Myelofibrosis (MF), Polycythemia Vera (PV) and Essential Thrombocythemia (ET)

* Resubmitted the Special Protocol Assessment to the U.S. Food and Drug Administration (FDA) for treatment in MF. If the FDA agrees with our response we intend to begin our Phase III trials in the second quarter of the year.
* Submitted the Phase III clinical trial application to Ethics Committees and Competent Health Authorities in Europe. This trial is also expected to begin in the second quarter of the year.
* Recruitment of approximately 70 clinical sites in the U.S. and Canada, and an equal number in Europe, for the two Phase III registration trials.

INCB18424: (topical formulation) Psoriasis and Other Inflammatory Conditions of the Skin

* Completed enrollment of a three-month multiple-dose Phase IIb trial in patients with mild to moderate psoriasis. Results from this trial are expected in the summer of 2009.

INCB28050: JAK Inhibitor Compound for Rheumatoid Arthritis and Other Inflammatory Conditions

* Completed the required preclinical and clinical trials to support initiation of a double-blind placebo-controlled dose-ranging Phase II program in approximately 100 rheumatoid arthritis patients. This six-month Phase II trial is expected to include clinical sites in the U.S. and Europe and is scheduled to begin enrolling patients in the second quarter of the year.

11beta-HSD1 Inhibitor Program

INCB13739: Type 2 Diabetes

* Completed enrollment of a 3-month placebo-controlled, dose-ranging Phase IIb clinical trial in patients with type 2 diabetes to evaluate the safety and efficacy of once-daily INCB13739 when added to failing metformin monotherapy. Final results from this trial are expected in June 2009 and, if positive, our objective is to secure a partner for this program.

Sheddase Inhibitor Program

INCB7839: Breast Cancer

* Continued enrollment of a Phase II trial in combination with Herceptin(R) in breast cancer patients with final results expected in the second half of 2009.

First Quarter 2009 Financial Results

Cash Position

As of March 31, 2009, cash, short-term and long-term marketable securities totaled $175.6 million, compared to $217.8 million as of December 31, 2008. During the first quarter of 2009, the Company used $42.2 million in cash and marketable securities. Our previous guidance for cash use in 2009 of between $122 and $128 million remains unchanged.

Revenues

Total revenues for the quarter ended March 31, 2009 were $0.7 million as compared to $1.3 million for the same period in 2008.

Net Loss

The net loss for the quarter ended March 31, 2009 was $40.0 million, or $0.41 per share, as compared to $40.2 million, or $0.47 per share, for the same period in 2008. Included in the net loss for the quarter ended March 31, 2009 was $3.4 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $3.3 million for the same period in 2008.

Operating Expenses

Research and development expenses for the quarter ended March 31, 2009 were $29.6 million as compared to $33.0 million for the same period last year. Included in research and development expenses for the quarter ended March 31, 2009 was $2.5 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $2.4 million for the same period in 2008. The decrease in research and development expenses is due to prioritization of our pipeline to focus on products we believe have a greater likelihood of creating near-term value. We expect our research and development expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

Selling, general and administrative expenses for the quarter ended March 31, 2009 were $4.8 million as compared to $4.4 million for the same period last year. Increased selling, general and administrative expenses reflect our initial sales and marketing preparations for the potential commercialization of INCB18424 for myeloproliferative disorders. Also included in the selling, general and administrative expenses for each of the quarters ended March 31, 2009 and 2008 was $0.9 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options.

Interest Income (Expense)

Interest income for the quarter ended March 31, 2009 was $0.5 million as compared to $2.1 million for the same period last year. The decrease is due primarily to a lower average cash balance and a lower yield for the three months ended March 31, 2009 as compared to the corresponding period in 2008. Interest expense for the three months ended March 31, 2009 was $6.3 million as compared to $6.2 million for the comparable period last year. Included in interest expense for the three months ended March 31, 2009 and 2008 was a $2.3 million non-cash charge to amortize the original issue discount of the Company's 3 1/2% Convertible Senior Notes.

Conference Call Information

Incyte will hold its first quarter 2009 financial results conference call this morning at 8:30 a.m. ET Thursday, May 7, 2009. To access the conference call, please dial 877-407-8037 for domestic callers or 201-689-8037 for international callers. When prompted, provide the passcode, which is 320337.

If you are unable to participate, a replay of the conference call, when made available, will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and dial-in number for international callers is 201-612-7415. To access the replay you will need the conference account number 278 and the ID number 320337.

The conference call will also be webcast live on CCBN and can be accessed at www.incyte.com under Investor Relations, Events and Webcasts. When available, the conference call replay can also be accessed at www.incyte.com under Investor Relations, Events and Webcasts.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs to treat serious unmet medical needs. Incyte's pipeline includes multiple compounds in Phase II clinical trials for oncology, inflammation and diabetes. For additional information on Incyte, visit the Company's web site at www.incyte.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to the intention to initiate Phase III trials for INCB18424 in patients with myelofibrosis in the U.S, and Europe in the second quarter of the year, the expectation of final results from the Phase IIb trial for topical INCB18424 in psoriasis in the summer of 2009, the intention to begin enrolling patients in a six-month Phase II trial in the U.S. and Europe for INCB28050 in rheumatoid arthritis in the second quarter of the year, the expected completion and timing of results of the Phase II trials for our HSD1 inhibitor for type 2 diabetes and our sheddase inhibitor program for breast cancer, and financial guidance about expected cash use, are all forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development and clinical trials, the uncertainty of the regulatory approval processes, including uncertainty regarding the FDA’s response to the revised Special Protocol Assessment, results of further research and development, the impact of competition and of technological advances and the ability of Incyte to compete against parties with greater financial or other resources, Incyte's ability to enroll a sufficient number of patients for its clinical trials, and other risks detailed from time to time in Incyte's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2008. Financial guidance regarding cash use excludes any effects of strategic collaboration or capital market activities, including activities with respect to outstanding convertible notes. Incyte disclaims any intent or obligation to update these forward-looking statements.

INCYTE CORPORATION
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)

Three Months Ended

March 31,
2009 2008
Revenues:
Contract revenues $ — $ 587
License and royalty revenues 671 720

Total revenues 671 1,307

Costs and expenses:
Research and development 29,587 32,955
Selling, general and administrative 4,821 4,354
Other expenses 509 123

Total costs and expenses 34,917 37,432

Loss from operations (34,246 ) (36,125 )
Interest and other income, net 548 2,141
Interest expense (6,338 ) (6,173 )

Net loss $ (40,036 ) $ (40,157 )

Basic and diluted net loss per share $ (0.41 ) $ (0.47 )


Shares used in computing basic and diluted net loss per share
97,340 84,602


INCYTE CORPORATION
Condensed Consolidated Balance Sheet Data
(in thousands)

March 31,

2009
December 31,

2008

Cash, cash equivalents, and short-term and long-term marketable securities 175,627 217,783
Total assets 189,635 232,388
Convertible senior notes 133,263 130,969
Convertible subordinated notes 265,411 265,198
Total stockholders’ deficit (256,751 ) (220,750 )


Source: Incyte Corporation

Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications
302-498-6944


Heute 2,45 USD

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SL 2,46 USD !

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Incyte to Present at Goldman Sachs 30th Annual Global Healthcare Conference

WILMINGTON, Del.--(BUSINESS WIRE)--May. 26, 2009-- Incyte Corporation (Nasdaq:INCY) announced today it will participate in the Goldman Sachs 30th Annual Global Healthcare Conference on Tuesday, June 9, 2009 at 10:45 a.m. (Eastern Time). Presenting for Incyte Corporation will be Paul Friedman, M.D., president and chief executive officer.

The presentation will be webcast live and can be accessed at www.incyte.com under Investor Relations, Events and Webcasts. A replay of the presentation will be available for 180 days. Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs to treat serious unmet medical needs. Incyte's pipeline includes multiple compounds in Phase II clinical trials for oncology, inflammation and diabetes. For additional information on Incyte, visit the Company's web site at www.incyte.com.

Source: Incyte Corporation

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Incyte Provides Update on Special Protocol Assessment for INCB18424 as a New Treatment for Myelofibrosis

Announces Plan to Initiate a Phase III Registration Trial in Europe in June

WILMINGTON, Del.--(BUSINESS WIRE)--May. 28, 2009-- Incyte Corporation (Nasdaq:INCY) announced today that based on recent input from the U.S. Food and Drug Administration (FDA) regarding Incyte’s request for a Special Protocol Assessment (SPA) for INCB18424 for patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF), it is clear that the most appropriate single primary endpoint for Incyte’s U.S. Phase III trial is the proportion of treated patients achieving a 35% reduction in spleen volume as compared to patients receiving placebo.

Paul A. Friedman, M.D., President and CEO of Incyte, stated, “Because INCB18424 is a first-in-class compound and there has never been a registration trial for this disease conducted in the U.S., it has taken a couple of iterations on the SPA request to establish that reduction in spleen volume is the most appropriate primary endpoint to support approval of a new treatment for myelofibrosis.”

Dr. Friedman added, “Although resubmitting our request will cause a modest delay in starting the Phase III study, we still anticipate completion of the study in a time frame that will allow for filing a New Drug Application in late 2010 or early 2011 assuming positive results are achieved. This time frame is consistent with prior guidance provided.”

Based on the aforementioned interaction with the FDA, Incyte expects to begin enrollment of COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) in August 2009.

The Phase III European trial, COMFORT-II, is scheduled to begin enrollment in June 2009. COMFORT-II is an open-label study designed to evaluate the efficacy, safety and tolerability of INCB18424 as compared to the best-available therapy in 150 patients with PMF, PPV-MF or PET-MF. This trial is expected to involve approximately 70 clinical sites in 10 European countries and has been designed based on scientific advice from the European Medicines Agency. The primary efficacy endpoint in COMFORT–II is the proportion of patients achieving at least 35% reduction in spleen volume from baseline to week 48.

About Myelofibrosis

Myelofibrosis is a serious neoplastic condition for which there are no approved therapies in the U.S. It is characterized by varying degrees of bone marrow failure, splenic enlargement and debilitating constitutional symptoms resulting in a significant loss in quality of life and reduced life-span. Myelofibrosis is part of a related group of hematological neoplasms called myeloproliferative disorders that includes myelofibrosis, polycythemia vera and essential thrombocythemia. Approximately 10 to 20% of patients with polycythemia vera and essential thrombocythemia progress to myelofibrosis. Myelofibrosis can also develop without a prior history of polycythemia vera and essential thrombocythemia.

About Special Protocol Assessments

The SPA is a process that allows for official FDA evaluation of the clinical protocols of a Phase III clinical trial intended to form the primary basis for an efficacy claim and provides trial sponsors with a binding written agreement that the design and analysis of the trial are adequate to support a marketing application submission if the trial is performed according to the SPA. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit http://www.fda.gov/cder/guidance/3764fnl.htm.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs to treat serious unmet medical needs. Incyte's pipeline includes multiple compounds in Phase II clinical trials for oncology, inflammation and diabetes. For additional information on Incyte, visit the Company's web site at www.incyte.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to the anticipated completion of the Phase III clinical trial in patients with myelofibrosis and timing of filing of a New Drug Application for INCB18424 assuming positive results are received, the expected times to begin enrollment of patients in COMFORT-I and COMFORT-II, and the expected number of clinical sites and countries for COMFORT-II, are all forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk and uncertainty associated with drug development and clinical trials, the uncertainty of the regulatory approval processes, including uncertainty regarding the nature and timing of the FDA’s response to Incyte's revised request for SPA and the timing of submission of Incyte's revised request, uncertainty regarding the timing of commencement of the COMFORT-I trial based in part on uncertainty regarding the timing and nature of the FDA's response to Incyte's revised request for SPA, Incyte's ability to enroll a sufficient number of patients for the COMFORT-I and COMFORT-II clinical trials in a timely manner or at all, unanticipated developments in the efficacy or safety of INCB18424, and other risks detailed from time to time in Incyte's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2009. Incyte disclaims any intent or obligation to update these forward-looking statements.

Source: Incyte Corporation

Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations/Corporate Communications
302-498-6944

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FOR IMMEDIATE RELEASE
Pamela M. Murphy
Vice President, Investor Relations/Corporate Communications
302/498-6944
Results Presented at the ADA 69th Scientific Sessions Demonstrate that INCB13739,
Incyte’s Oral 11beta-HSD1 Inhibitor, Significantly Improves Glycemic Control,
Insulin Sensitivity and Total Cholesterol in Patients with Type 2 Diabetes
A Live Webcast & Conference Call to Discuss These Results Are Scheduled for
Sunday, June 7, 2009, 5:00 p.m. ET / 4:00 p.m. CT
New Orleans, LA and Wilmington, DE – June 6, 2009 – Incyte Corporation
(Nasdaq:INCY) announced today clinical results of its Phase IIb trial of INCB13739, an
orally bioavailable inhibitor of the enzyme 11beta-hydroxysteroid dehydrogenase type 1
(11beta-HSD1), at the American Diabetes Association 69th Scientific Sessions being held
in New Orleans.
Results from this double-blind, placebo-controlled Phase IIb trial involving over 300
patients with type 2 diabetes showed that treatment with once-daily doses of INCB13739
significantly improved glycemic control, as measured by hemoglobin A1c (HbA1c), insulin
sensitivity and total-cholesterol levels. These results will be described by the principal
investigator for the trial, Julio Rosenstock, M.D., of the Dallas Diabetes and Endocrine
Center at Medical City and Clinical Professor of Medicine at University of Texas
Southwestern Medical School, on Sunday from noon to 2 p.m. CT during a late breaker
poster session entitled, “Clinical Therapeutics/New Technology - Pharmacologic
Treatment of Diabetes or its Complications.” The poster is currently available at:
http://phx.corporateir.net/External.File?item=UGFyZW50SUQ9Nz…
1
Dr. Rosenstock stated, “Agents targeting novel mechanisms to combat cardio-metabolic
disease in patients with type 2 diabetes are clearly needed as this population continues to
rapidly expand in the coming decades. INCB13739 has provided the first proof-of-concept
for the potential therapeutic utility of 11beta-HSD1 inhibition in type 2 diabetes by
demonstrating improvements on glycemic control and indirect measurements of insulin
sensitivity. Further studies are warranted to better characterize this new and interesting
class of drugs.”
Summary of Phase IIb Results

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heute 3,4 USD

verkauft

[Rainbowfu]

Der Verkauf war ein Fehler, denn jetzt nimmt die Aktie wirklich Fahrt auf.....aber Fehler kommen immer wieder vor....

[Rainbowfu]

Ich werde bei 10 USD verkaufen

[Rainbowfu]

ne kleine Verschnaufpause

[Rainbowfu]

die Richtung wird bleiben, denn die Firma ist top

[Rainbowfu]

eine kleine Konso, nachgekauft und weiter gehts....

[pedestrian]

Antwort auf Beitrag Nr.: 37.635.383 von Rainbowfu am 23.07.09 20:19:52

incyte kursziel 7 euro.

[pedestrian]

Antwort auf Beitrag Nr.: 37.666.834 von pedestrian am 29.07.09 09:05:00

incyte rückt vor.

Incyte and the FDA have agreed on a special protocol assessment (SPA) for a Phase III trial of the company’s myelofibrosis treatment candidate. The company expects to file an NDA in late 2010 or early 2011 seeking to use INCB18424 to treat myelofibrosis, a bone marrow disorder, it says in a statement. The trial is expected to begin in August. There are no therapies approved to treat myelofibrosis in the U.S., Incyte says.

[aktianer]

Antwort auf Beitrag Nr.: 37.621.297 von Rainbowfu am 22.07.09 11:51:47

sieht so aus, als könnten wir noch 2009 die 10 $-Marke brechen!

[moneyhouse]

Da müssen doch heute ganz fröhliche Gesichter hier sein....

News:

Analystenmeinung

Novartis schließt Lizenzabkommen mit Incyte
BASEL (Dow Jones)--Das schweizerische Pharmaunternehmen Novartis hat mit dem US-Pharmaunternehmen Incyte ein Lizenzabkommen abgeschlossen. Wie Novartis am Mittwoch mitteilte, wird der Konzern aus Basel zwei hämatologisch-onkologische Produkte von Incyte lizensieren.

Die Novartis AG werde sofort 150 Mio USD an Incyte zahlen. Hinzu kommt eine erste Meilensteinzahlung von 60 Mio USD für eine Myelofibrose-Therapie, die seit Juli in einer europäischen Phase-III-Studie untersucht wird. Diese Meilensteinzahlung wird ebenfalls sofort fällig.

Sollten alle für die Laufzeit des Abkommens vereinbarten Meilensteine erreicht werden, würde Novartis insgesamt 1,1 Mrd USD an Incyte zahlen. Vereinbart ist Entwicklung von Therapien zur Behandlung von Myelofibrose sowie weiterer Krebsarten.


1 Mrd USD ....

Das klingt nach Weihnachten !!!

Denke mal ne ganz heisse Story, wir werden
bald alte Hoch´s wieder vorfinden.

Na denn, fröhliche Weihnachten