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got them and sold at 7.07 today, I saw 10 easily with this. $15 sounds good...45 a stretch. I'll be watching. Any idea on when phase 3 news planned for?
a lot of mutual funds mgrs, me, you, surf, thats a crowd as far as Im concerned....shares double to 15 on release of final phase three data........45 on FDA approval...get yours now
Anyone watching this anymore??
Incyte Announces Positive Top-Line Phase IIb Results for Topical INCB18424 in Psoriasis
Press Release
Source: Incyte Corporation
On Monday September 21, 2009, 8:00 am EDT
Companies:Incyte Corporation
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis. These results were obtained from a multi-center three-month Phase IIb trial comparing three once-daily doses of topical INCB18424 to vehicle in 200 patients with mild-to-moderate psoriasis. In the trial patients treated with INCB18424 had a statistically significant improvement over placebo in the reduction in total lesion score (erythema + scaling + thickness), which was the primary efficacy endpoint of the trial. Statistical significance was also achieved for the secondary endpoints: the Physician Global Assessment score and the Psoriasis Area and Severity Index score. INCB18424 was well tolerated at all doses and no clinically significant effects were noted in hematology or other laboratory parameters.
Paul Friedman, M.D., Incyte's President and CEO, will review these top-line clinical trial results during his corporate presentation at 12:00 pm (ET) today at the 2009 UBS Global Life Sciences Conference.
Dr. Friedman stated, “Our JAK1/JAK2 inhibitor was designed to block signaling from multiple key cytokines implicated in psoriasis and it is gratifying to see that topical INCB18424 met the primary and secondary endpoints in this three-month Phase IIb trial. We believe the positive safety and efficacy results achieved with this new mechanism of action have the potential to differentiate topical INCB18424 from the topical corticosteroids and vitamin D analogues which are limited by their duration of use and/or their tolerability profile.”
Incyte intends to present full results from this Phase IIb trial at an appropriate future scientific meeting.
To access today’s presentation at the UBS conference, please go to www.incyte.com under Investor Relations, Events and Webcasts. Investors interested in listening to the live webcast should log on before the start time in order to download any software required. A replay of the presentation will also be available.
Incyte Reports Second Quarter 2009 Financial Results and Provides Update on Drug Development Programs
Conference Call Scheduled Today at 8:30 a.m. ET
Press Release
Source: Incyte Corporation
On Thursday July 30, 2009, 7:00 am EDT
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) today reported second quarter 2009 financial results and provided an update on its highest priority clinical programs.
"With the Phase III registration trials for our lead JAK1/JAK2 inhibitor, INCB18424, now underway in both the U.S. and Europe; the launch of a six-month Phase II trial for our second JAK1/JAK2 inhibitor, INCB28050, in rheumatoid arthritis; the release of positive Phase IIb results for our 11beta-HSD1 inhibitor for type 2 diabetes; and the expected release of Phase IIb results for topical INCB18424 in psoriasis later this summer, we have made substantial progress building our pipeline. I believe we are in a strong position to create and capture value from these programs both on our own and through strategic partnerships," 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, Polycythemia Vera and Essential Thrombocythemia
Agreement reached with the U.S. Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) for INCB18424 as a treatment in myelofibrosis (MF).
Announcement that the Phase III trial under the SPA, COMFORT-I, is expected to begin patient enrollment in August and involve 240 patients with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) and post essential thrombocythemia myelofibrosis (PET-MF). COMFORT-I is scheduled to include over 90 clinical sites in the U.S., Canada and Australia.
Initiation of a second Phase III trial, COMFORT-II, in Europe began enrolling patients in July and is expected to enroll 150 patients in approximately 70 clinical sites.
INCB18424: (topical formulation) Psoriasis and Other Inflammatory Conditions of the Skin
Completed a three-month multiple-dose Phase IIb trial in patients with mild to moderate psoriasis. Results from this trial are expected later this summer.
INCB28050: JAK Inhibitor Compound for Rheumatoid Arthritis and Other Inflammatory Conditions
Initiated a six-month double-blind placebo-controlled dose-ranging Phase II trial that is scheduled to include 100 patients with active rheumatoid arthritis who have had inadequate response to currently available disease modifying therapies.
11beta-HSD1 Inhibitor Program
INCB13739: Type 2 Diabetes
Presented clinical results at the American Diabetes Association 69th Scientific Sessions from a 3-month placebo-controlled, dose-ranging Phase IIb trial involving over 300 patients with type 2 diabetes which demonstrated that treatment with once-daily doses of INCB13739 significantly improved glycemic control, as measured by hemoglobin A1c, insulin sensitivity and total-cholesterol levels.
Sheddase Inhibitor Program
INCB7839: Breast Cancer
Continued enrollment of a Phase II trial in combination with Herceptin(R) in breast cancer patients. We expect to present results from this trial at the San Antonio Breast Cancer Symposium in December 2009.
Second Quarter 2009 Financial Results
Cash Position
As of June 30, 2009, cash, short-term and long-term marketable securities totaled $147.5 million, compared to $217.8 million as of December 31, 2008.
During the six months ended June 30, 2009, we used $70.3 million in cash and marketable securities. Cash use guidance of $122 to $128 million for 2009 remains unchanged.
Revenues
Total revenues for the quarter ended June 30, 2009 were $0.8 million as compared to $0.6 million for the same period in 2008. Total revenues for the six months ended June 30, 2009 were $1.5 million, as compared to $1.9 million for the same period in 2008.
Net Loss
The net loss for the quarter ended June 30, 2009 was $40.0 million, or $0.41 per share, as compared to $45.6 million, or $0.54 per share, for the same period in 2008.
The net loss for the six months ended June 30, 2009 was $80.1 million, or $0.82 per share, as compared to $85.7 million or $1.01 per share, for the same period in 2008.
Included in the net loss for the quarter and the six months ended June 30, 2009 were $2.5 million and $5.9 million, respectively, of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $3.9 million and $7.3 million, respectively, for the same periods in 2008.
Operating Expenses
Research and development expenses for the quarter ended June 30, 2009 were $29.0 million, as compared to $38.1 million for the same period last year. Research and development expenses for the six months ended June 30, 2009 were $58.6 million, as compared to $71.1 million for the same period last year. The decrease in research and development expenses was 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.
Included in research and development expenses for the quarter and the six months ended June 30, 2009 were $1.8 million and $4.2 million, respectively, of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $2.9 million and $5.3 million, respectively, for the same periods in 2008.
Selling, general and administrative expenses for the quarter and the six months ended June 30, 2009 were $4.1 million and $8.9 million, respectively, as compared to $4.1 million and $8.5 million, respectively, for the same periods in 2008. Increased selling, general and administrative expenses for the six months ended June 30, 2009 reflected our initial sales and marketing preparations for the potential commercialization of INCB18424 for myeloproliferative disorders. Also included in selling, general and administrative expenses for the quarter and the six months ended June 30, 2009 were $0.7 million and $1.7 million, respectively, of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $1.0 million and $2.0 million, respectively, for the same periods in 2008.
Interest Income (Expense)
Interest income for the quarter and the six months ended June 30, 2009 was $0.4 million and $0.9 million, respectively, as compared to $1.4 million and $3.5 million, respectively, for the same periods in 2008. The decrease was due to a lower average cash balance and a lower yield for the three and six months ended June 30, 2009 as compared to the corresponding periods in 2008. Included in interest and other income (expense), net for the three and six months ended June 30, 2009 was a $1.3 million non-cash charge recognized pursuant to the provisions of SFAS 115 and FASB Staff Position FAS 115-2 Recognition and Presentation of Other-Than-Temporary Impairments.
Interest expense for the quarter and the six months ended June 30, 2009 was $6.4 million and $12.7 million, respectively, as compared to $6.2 million and $12.4 million, respectively, for the same periods in 2008. Included in interest expense for the quarter and the six months ended June 30, 2009, was $2.3 million and $4.6 million, respectively, of non-cash charges to amortize the original issue discount of our 3 1/2% Convertible Senior Notes.
Conference Call Information
Incyte will hold its second quarter 2009 financial results conference call this morning at 8:30 a.m. ET Thursday, July 30, 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 328036.
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 328036.
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.
So... what price could we be looking at after the news tomorrow?
this one impresses me the most................
http://www.incyte.com/backgrounders/Incyte%2011betaHSD1%20Program%20Backgrounder.June%202008.pdf
4.60 premarket!
Incyte Reaches Agreement with FDA on a Special Protocol Assessment for INCB18424 in Myelofibrosis
COMFORT– I, a Pivotal Phase III Clinical Trial, to Begin in the United States, Canada and Australia
Press Release
Source: Incyte Corporation
On Tuesday July 21, 2009, 7:30 am EDT
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Companies: Incyte corporation
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase III trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). The SPA provides agreement that the study design and planned analysis of the Phase III trial adequately address objectives in support of a regulatory submission.
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INCY 3.99 0.00
COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment), is a double-blind, placebo-controlled Phase III trial comparing the efficacy and safety of INCB18424 to placebo in approximately 240 patients with PMF, PPV-MF or PET-MF. COMFORT-I is expected to begin in August. COMFORT-II, a second Phase III trial being conducted in Europe, began patient enrollment in July.
Paul A. Friedman, M.D., Incyte’s President and CEO, stated, “Finalization of the SPA is an important achievement and we look forward to initiating COMFORT-I as quickly as possible in over 90 clinical sites in the U.S., Canada and Australia. The primary endpoint of COMFORT-I is the proportion of patients achieving a 35% or greater reduction in spleen volume as compared to patients receiving placebo. Key secondary endpoints include measuring the duration of the 35% or greater reduction in spleen volume among the patients initially randomized to INCB18424, and the proportion of patients who achieve a 50% or greater reduction in symptoms as measured by a modified version of the Myelofibrosis Symptom Assessment Form.”
Richard Levy, M.D., Incyte’s Executive Vice President, Chief Drug Development and Medical Officer, stated, “Based on our current estimates for patient recruitment of COMFORT-I, and assuming that results from the trial are positive, we anticipate filing the New Drug Application for INCB18424’s use in MF in late 2010 or early 2011.”
Srdan Verstovsek, M.D., Ph.D., Associate Professor, Leukemia Department, Myeloproliferative Disorders Program Leader, University of Texas M.D. Anderson Cancer Center, and the principal investigator for COMFORT-I stated, “Initiation of the Phase III registration trials for INCB18424’s use in myelofibrosis marks an important step forward in developing a new effective treatment for this under-served disease. Importantly, the primary and secondary endpoints in COMFORT-I and COMFORT-II are clinically relevant features of the disease that both physicians and patients are currently unable to overcome. I am optimistic that over time, the results from the INCB18424 myelofibrosis Phase III program will lead to important insights regarding the disease itself and the long-term value of treatment with a JAK1/JAK2 inhibitor.”
COMFORT-I Trial
Overall Design: COMFORT-I (also referred to as INCB18424-351) is a randomized (1:1), double-blind Phase III study comparing the efficacy and safety of INCB18424 to placebo in approximately 240 patients with PMF, PPV-MF or PET-MF. To be eligible for the study, patients must have a palpated spleen length of 5 cm or greater and be classified as intermediate 2 or high risk according to the International Working Group (IWG) criteria (Cervantes et al, 2008).
Primary Efficacy Endpoint: Proportion of patients achieving ≥ 35% reduction in spleen volume from baseline to week 24 as measured by MRI (or CT scan in applicable subjects).
Key Secondary Efficacy Endpoints: Durability of a ≥ 35% reduction from baseline in spleen volume among patients initially randomized to receive INCB18424 and the proportion of patients achieving a ≥ 50% reduction in their total symptom score from baseline to week 24 as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.
Duration of Trial: The double-blind portion of COMFORT-I is 24 weeks. Data are scheduled to be analyzed when the last patient has completed 24 weeks of treatment with either INCB18424 or placebo and at least 50% of patients remaining in the study have completed 36 weeks of treatment.
COMFORT-I is scheduled to continue until either INCB18424 receives marketing approval or when the last randomized patient remaining in the study has completed week 144 (36 months).
Cross Over From Placebo to INCB18424: When the last randomized subject has received 24 weeks of treatment with placebo, and at least 50% of patients remaining in the study have completed 36 weeks of treatment, and the primary data analysis is complete, the study is scheduled to be unblinded, and eligible patients randomized to placebo will have the opportunity to cross over and begin receiving INCB18424 open label. If a patient treated with placebo meets certain pre-determined criteria, he or she may be eligible to cross over and receive treatment with INCB18424 prior to week 24.
About the Modified Myelofibrosis Symptom Assessment Form (MFSAF) Diary:
A modified Myelofibrosis Symptom Assessment Form diary will be used to measure symptoms in COMFORT-I. The MFSAF diary was developed from work conducted by Ruben Mesa, M.D., Professor of Medicine, Mayo Clinic Arizona, et al to measure quality of life and symptomatic response to treatment in myelofibrosis: (Leukemia Research, Volume 33, Issue 9, Pages 1199-1203).
Dr. Mesa stated, “Quality of life in patients with myelofibrosis is severely compromised by debilitating symptoms including fatigue, night sweats, fever, weight loss, pruritus, and symptoms from frequently massive hepatosplenomegaly. Using an international internet-based survey of 458 patients with MF, we created a 20-item instrument, Myelofibrosis Symptom Assessment Form, which measured the symptoms reported by greater than 10% of MF patients. The results we generated from the survey were highly correlated with other validated instruments in cancer patients and judged comprehensive and understandable by patients. It is very gratifying to see the modified MFSAF being used in the INCB18424 COMFORT-I Phase III program.”
COMFORT-II Trial
COMFORT-II (also referred to as INCB18424-352) is a second Phase III trial being conducted in Europe. It 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. COMFORT-II is expected to involve approximately 70 clinical sites in 10 European countries: Belgium, Austria, France, Italy, Germany, Sweden, the Netherlands, Spain, Switzerland and the U.K. 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. Enrollment in COMFORT II began in July of this year.
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. Final marketing approval depends on the results of efficacy, the adverse event profile and on an evaluation of the benefit/risk of treatment demonstrated in the Phase III trials. 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/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
About Incyte
Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs for oncology, inflammation and diabetes. Incyte’s most advanced compound, INCB18424, is in Phase III development for myelofibrosis. For additional information on Incyte, visit the Company's website 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, the expected number of clinical sites and patients for COMFORT-I 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, uncertainty regarding the timing of commencement of the COMFORT-I trial, 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.
Links to third-party websites or pages are provided for convenience only. Each website is subject to its own terms of use, and we encourage you to consult these policy statements. Incyte has no control over third party sites and does not endorse or recommend these sites, and expressly disclaims any responsibility for the accuracy of content or opinions set forth in any third party website or your use of that information.
Contact:
Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications
302-498-6944
7:31AM Incyte reaches agreement with FDA on a Special Protocol Assessment for INCB18424 in myelofibrosis (INCY) 3.99 : Co announces that it has reached agreement with the FDA regarding a Special Protocol Assessment on the design of a pivotal Phase III trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The SPA provides agreement that the study design and planned analysis of the Phase III trial adequately address objectives in support of a regulatory submission.
looking pretty good...
turn is here perhaps....
added 3.26s today
INCY TA
A nice MA crossover awaits the PPS just below, and the downward pressure of an MA200 gained too quickly is taking us there.
Yep, Chart Needs to Resolve.
Was sure doing some strong hinting along those lines.
fringe
and sound close to a partnering deal for the diabetes drug....
thinking maybe it fills the gap tomorrow and i add more around 3.25
They Need Money to Retire Debt -e-
He Sounds Ready On Spleen Program
but the FDA isn't quite... leading a horse to water here. But he sure sounds confident in terms of the trials. CEO is convinced re: the efficacy of Study 251 study as reflecting forward into the probability of technical success on Phase III... 'this will be a successful drug'
'We will be first to the market and will be able to protect that position.'
fringe
Incyte Presents Results
... "of INCB13739 that show improvement in glycemic control, insulin sensitivity and total cholesterol in patients with with Type 2 diabetes (INCY) 3.84 : Co announces clinical results of its Phase IIb trial of INCB13739, an orally bioavailable inhibitor of the enzyme 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1), at ADA. 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."
Well, We Didn't Thank You
Still doing DD
Bad candle Friday- I wouldn't touch this stock based on TA.
CC Tomorrow
Webcast - Live
Incyte Corporation at Goldman Sachs Global Healthcare Conference
06/09/2009 at 10:45 a.m. ET
DD Update
From RTT News June 07.... http://www.rttnews.com/ArticleView.aspx?Id=971643
Shares of biotechnology company Incyte Corp. (INCY: News ) are well off their 52-week high of $10.42 set in August 2008, but have been on fire lately. Over the last two weeks, the stock has gained 37% and closed Friday at $3.84.
The company will be participating in the Goldman Sachs 30th Annual Global Healthcare Conference on Tuesday, June 9. Incyte has no products on the market and has no new drugs to be launched in the immediate future, but has an interesting product pipeline.
Incyte will be advancing its investigational drug, INCB18424, for myelofibrosis into phase III testing in the U.S. in August 2009. The U.S. phase III trial of INCB18424 dubbed COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) was originally scheduled to begin in the first-half of 2009, but has been delayed by two months to August as it took time to establish the appropriate primary endpoint to support approval of a new treatment for myelofibrosis. The phase III European trial, COMFORT-II, is scheduled to begin enrollment this month.
Myelofibrosis is a disorder in which fibrous tissue replaces the blood-producing cells in the bone marrow, resulting in abnormally shaped red blood cells, anemia, and an enlarged spleen. The disease usually affects people between the ages of 50 and 70. There is currently no known cure for myelofibrosis other than stem cell transplantation and there are no adequately effective therapies.
Some of the treatments that are currently used to delay or relieve symptoms are the combination of male sex hormones (androgens) and the corticosteroid prednisone, blood transfusions, erythropoietin (a synthetic version of the hormone produced by the body) or darbepoietin, and chemotherapy drug hydroxyurea or interferon-alpha. When the spleen becomes extremely large and painful, it is removed or treated with radiation therapy.
On May 29, the company revealed that the single primary endpoint for its late-stage trial of INCB18424 will be the proportion of treated patients achieving a 35% reduction in spleen volume compared to patients receiving placebo. The company anticipates filing a New Drug Application for INCB18424 for myelofibrosis in late 2010 or early 2011 assuming positive results are achieved.
Myelofibrosis is a rare disease and it affects less than 200,000 people in the U.S. at any given time. Last November, the FDA granted orphan drug designation for INCB18424 for the treatment of patients with myelofibrosis.
The Phase II trial results of INCB18424 have demonstrated unprecedented reductions in splenomegaly (enlargement of the spleen) which affects the majority of myelofibrosis patients and clinically meaningful improvements in the constitutional symptoms of the disease, including reductions in fatigue, night sweats, pruritus (itch), abdominal discomfort, poor appetite and cachexia (loss of body weight and muscle mass).
In addition to myelofibrosis, INCB18424 is also being evaluated in patients with mild to moderate psoriasis, polycythemia vera/essential thrombocythemia, rheumatoid arthritis, refractory prostate cancer, and multiple myeloma in a phase II setting.
Other active investigational drugs under phase II testing include INCB28050 for rheumatoid arthritis, INCB13739 for type 2 diabetes and INCB7839 for breast cancer.
On June 6, at the 69th Scientific Sessions of the American Diabetes Association being held in New Orleans, Incyte revealed phase IIb trial results of INCB13739, which demonstrated that treatment with once-daily doses of INCB13739 significantly improved glycemic control, as measured by hemoglobin A1c (HbA1c), insulin sensitivity and total-cholesterol levels.
INCB13739 is an orally bioavailable inhibitor of 11beta-hydroxysteroid dehydrogenase type 1, an enzyme that converts inactive cortisone into the potent biologically active hormone cortisol. Obesity and type 2 diabetes are metabolic problems caused by too much cortisol. By selectively inhibiting 11beta-HSD1 and reducing the level of cortisol in key metabolic tissues, INCB13739 has the potential to simultaneously target multiple cardiovascular risk factors in patients with type 2 diabetes.
According to Incyte, the current treatments for type 2 diabetes typically address individual components of the disease, and few therapies target the multiple risk factors that lead to the elevated cardiovascular risk associated with this condition.
Incyte had incurred losses from inception in 1991 through 1996 and in 1999 through 2008. As of March 31, 2009, the accumulated deficit totaled $1.2 billion.
The company's fiscal year ends on December 31. During the first-quarter ended March 31, 2009, Incyte incurred a net loss of $40.0 million or $0.41 per share compared to a net loss of $40.2 million or $0.47 per share in the year-ago quarter.
Revenue, which includes contract revenue and license & royalty revenue, decreased to $0.7 million in the first-quarter of fiscal 2009 from $1.3 million in the comparable quarter a year before. Incyte did not recognize any contract revenue during the recent first-quarter.
Over the next few months, Incyte is slated to report a number of key events that are likely to impact its stock price. The final results from the phase IIb trial for topical INCB18424 in psoriasis are anticipated in the summer of 2009, while results of the phase II trial evaluating INCB7839 for breast cancer are expected to be released in the second half of 2009.
Shares Outstanding5: 97.34M
Float: 93.21M
% Held by Insiders1: 12.44%
% Held by Institutions1: 86.90%
Shares Short (as of 12-May-09)3: 11.13M
http://finance.yahoo.com/q/ks?s=INCY
Incyte's Topical JAK Inhibitor Demonstrates Positive Proof-of-Concept Results in Patients with Mild to Moderate Psoriasis
Thursday September 18, 7:00 am ET
Results Presented Today at the 17th Congress of European Academy of Dermatology and Venereology
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) reported positive results from two 28-day Phase IIa clinical trials of topical INCB18424, a selective janus-associated kinase (JAK) inhibitor, in patients with mild to moderate psoriasis. Results from the first study (Study 201), a Phase IIa dose-escalation trial involving 28 patients, demonstrated that INCB18424 was well tolerated at all doses and significantly improved overall total lesion score and each component of the total lesion score (thickness, erythema and scaling) as compared to vehicle. In this trial, INCB18424 at 1.5% twice daily also showed improvements in total lesion scores that were similar to the currently approved therapies, Dovenex® and Diprolene®.
The second study (Study 202) is an ongoing open-label sub-total inunction 28-day Phase IIa trial designed to evaluate the safety and pharmacokinetics of INCB18424 at increasing coverage levels of total body surface area (BSA). Results from Study 202 demonstrated that INCB18424 was well tolerated in the first cohort of patients involving five subjects who applied the compound to not less than 2% or more than 7% of their BSA. Data from the first cohort of this trial also showed that INCB18424 improved lesion thickness, erythema and scaling, and reduced overall treated lesion area as compared to the overall untreated lesions.
Alice Gottlieb, M.D. Ph.D., Chair of Dermatology and Dermatologist-in-Chief at Tufts Medical Center and Harvey B. Ansell Professor of Dermatology at Tufts University School of Medicine and Senior Author stated, “In addition to the these encouraging safety and efficacy results seen with 28-days of treatment with INCB18424, transcriptional profiling data demonstrate that topical INCB18424 inhibits two key pathways, Th1 and Th17, that play important roles in the pathogenesis of psoriasis. Highly efficacious injectable anti-TNF agents inhibit many of the same pathways. While we lack long-term data, a topical JAK inhibitor may prove to be effective in patients with mild to moderate psoriasis.”
These findings were presented as a poster, “Initial Efficacy and Safety of Topical INCB018424 Cream, a Selective Janus Kinase 1&2 (JAK1&2) Inhibitor in Psoriasis”, at the 17th Congress of European Academy of Dermatology and Venereology currently being held in Paris.
To access a copy of the poster go to: http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-presentations
About the Phase IIa Clinical Trials
Study 201: A 28-day dose-escalating proof-of-concept trial designed to evaluate the preliminary efficacy, pharmacokinetics and safety of 0.5%, 1.0% and 1.5% once- or twice-daily topical formulations of INCB18424 versus vehicle or active comparators in patients with limited plaque psoriasis. Each cohort consisted of 5 or 6 subjects and each subject served as his or her own control with INCB18424 or vehicle applied to paired lesions separated by at least 15 cm in patients with active but stable plaque psoriasis.
Results from this study demonstrated that:
* the 1% once-daily dose and the 1.5% twice-daily dose decreased mean total lesion scores by 53% and 54%, respectively, compared with 32% and 27% reduction with vehicle treatment on day 28 (p≤ 0.05);
* improvements were seen in each component of total lesion scores (lesion thickness, erythema and scaling); and,
* mean total lesion scores for the 1.5% twice-daily dose of INCB18424 decreased on day 28 by 46% as compared to 40 % for Dovonex® and 58% as compared to 44% for Diprolene®AF.
INCB18424 was well tolerated at all doses; no significant adverse effects were noted and no laboratory or ECG abnormalities were seen.
Study 202: This is an ongoing 28-day open-label sub-total inunction study to evaluate the safety and pharmacokinetics of INCB18424 in patients who apply the compound to as much as 20% of their BSA. Results from the first cohort of patients using the 1.5% twice-daily dose over 2-7% of their BSA demonstrated that INCB18424 improved lesion thickness, erythema and scaling and also reduced the overall treated lesion area as compared to the overall untreated lesions. In this study, INCB18424 was well tolerated with no serious adverse effects observed. Additionally, transcriptional profiling data in these patients confirmed that topical INCB18424 treatment inhibits two pathways, Th1 and Th17, which are considered to be central drivers of psoriasis. These effects correlated with clinically relevant improvements in total lesion scores.
Current Status of Topical INCB18424
A three-month Phase IIb trial involving approximately 300 psoriasis patients with mild to moderate disease is scheduled to begin in October. The Phase IIb trial will evaluate three doses of topical INCB18424 applied once-daily as compared to vehicle. The primary endpoints for the trial include change in total lesion score (erythema + scaling + thickness) of all psoriatic lesions, and safety and tolerability as assessed by monitoring signs and symptoms and through collection of clinical laboratory and blood samples. Secondary endpoints include change in individual lesion scores (erythema, scaling, and thickness) of all psoriatic lesions, the mean change in Physicians Global Assessment (PGA) in INCB18424 treated subjects compared to placebo subjects, the percentage of subjects achieving clear (0) and almost clear (1) on PGA, the percentage of subjects achieving improvements in their Psoriasis Area Severity Index (PASI) (PASI 50, PASI 75 and PASI 90 improvement), and trough plasma concentrations of INCB18424 prior to application at steady state.
Ahead of the Bell: Citi rates Incyte 'Buy'
Wednesday August 27, 9:08 am ET
Analyst places 'Buy' rating on Incyte on potential sales for INCB18424 and solid pipeline
NEW YORK (AP) -- A Citi Investment Research analyst began coverage of Incyte Corp. with a "Buy" rating late Tuesday, predicting success for the drug developer's prospective myelofibrosis treatment and noting its deep slate of product candidates.
Lucy Lu set a share price target of $15 per share, a level Incyte stock has not reached since February 2002. The target implies upside of 56 percent from the stock's Tuesday closing price of $9.62.
Lu expects regulatory approval for Incyte's INCB18424 in 2011, and said it will be the first drug approved to treat myelofibrosis, a condition characterized by bone marrow failure and life-threatening enlargement of the spleen.
Lu predicted sales of the drug will reach $465 million by 2015. She estimated there are about 27,000 myelofibrosis patients in the U.S, and added that INCB18424 could be granted orphan drug status, giving Incyte a longer period of patent protection.
Other drug candidates for the Wilmington, Del.-based company include treatments for type 2 diabetes, cancer and HIV.
Incyte Biotech a Near-Term Hold
Friday August 1, 11:14 am ET
By Grant Zeng, CFA
The discontinuation of dexelvucitabine, the most advanced candidate for HIV/AIDS was a big setback for Incyte Corp. (NasdaqGM: INCY - News). However, we are pleased to see the progress in the company's other product candidates. In our opinion, these are valuable assets, which have the potential to drive growth forward at Incyte.
The company received a major boost recently with the announcement of a collaboration agreement with Pfizer (NYSE: PFE - News) on CCR2 antagonist program. We view this collaboration as a major positive for Incyte. Positive clinical development could validate the company's research approach and drive the shares higher thanks to Pfizer's marketing muscle.
However, without a foreseeable candidate on the market before 2011, the company is under further financing pressure for its ongoing operations. The company just announced a proposed 9 million share offering in July. We think Incyte may need to tap the capital market in 2009 again. Equity offering will dilute current share base. This potential dilution is an impediment on the path to positive earnings.
At the current share price, we see the risk/reward relatively balanced for investors in Incyte. Based on peer comparisons with other smaller genomic/pure discovery-based biotechnology companies, we believe that INCY shares are fairly valued at current levels. We rate the shares a Hold. Our $10 target price corresponds to a market capitalization of $847 million which we think is fair to Incyte.
Incyte Reports Progress in Multiple Clinical Programs; Announces Second Quarter Financial Results
Tuesday July 29, 4:16 pm ET
NOTE: Conference Call Now Scheduled for Tomorrow Morning, Wednesday, July 30 at 8:00 a.m. ET
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) today announced its second quarter 2008 financial results and reported continued progress in several lead clinical programs.
Paul Friedman, M.D., President and CEO of Incyte, stated, "During the second quarter, we presented clinical findings at several scientific conferences from our ongoing phase II trials demonstrating that our lead JAK inhibitor compound, INCB18424, was well tolerated and provided rapid and profound effects in patients with myelofibrosis and rheumatoid arthritis. Additionally, we continue to see encouraging efficacy results in psoriasis patients using the topical formulation of INCB18424.
We also presented clinical results from a 28-day Phase IIa trial with INCB13739 demonstrating that oral treatment with this 11beta-HSD1 inhibitor significantly improved insulin sensitivity and decreased plasma cholesterol levels in patients with type 2 diabetes. These results suggest that INCB13739 may be more effective in addressing a broad range of metabolic risk factors than existing diabetes therapies.
We expect to make substantial clinical progress this year and next, which will include results from ongoing Phase II trials with INCB18424 in myelofibrosis, polycythemia vera and essential thrombocythemia, rheumatoid arthritis and psoriasis, the ongoing Phase IIb trial for our HSD1-inhibitor and a Phase IIa trial with our HM74a agonist."
Below is a summary of recent clinical activities during the second quarter:
Janus Associated Kinase (JAK) Inhibitor Program
INCB18424: Myelofibrosis, a life-threatening myeloproliferative disease
-- Results from the ongoing Phase II trial were the subject of oral presentations at the American Society of Clinical Oncology meeting and the European Hematology Association meeting, June 2 and 14, 2008, respectively. These results demonstrated that INCB18424 provided:
-- unprecedented reductions in splenomegaly which affects the majority of myelofibrosis patients;
-- improvements in quality of life measures, including clinically meaningful reductions in fatigue, night sweats and pruritus; and
-- marked increases in appetite and weight gain which improves the cachexia seen in these patients
-- Reversible thrombocytopenia seen in this trial has been effectively managed by dose reduction and/or interruption of therapy.
-- Continued enrollment of patients in the Phase II trial to confirm an optimal dosing regimen and to select, in addition to spleen reduction, a co-primary endpoint to use in the myelofibrosis registration trials. Currently, over 100 myelofibrosis patients have been enrolled in the trial.
http://biz.yahoo.com/bw/080729/20080729006407.html?.v=1
Incyte to Report Second Quarter 2008 Financial Results and Provide Update on Drug Discovery & Development Programs on July 31
Tuesday July 22, 5:00 pm ET
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) announced today that it has scheduled its second quarter 2008 financial results conference call for 8:30 a.m. ET on Thursday, July 31, 2008. The schedules for the press release and conference call are as follows:
* Q2 2008 Press Release:
July 31, 2008 at 7:00 a.m. ET
* Q2 2008 Conference Call:
July 31, 2008 at 8:30 a.m. ET
* Domestic Dial In Number:
877-407-8037
* International Dial In Number:
201-689-8037
* Conference ID #
291287
If you are unable to participate, a replay of the conference call 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 291287.
The conference call will also be webcast live on CCBN and can 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 I and Phase II development for oncology, inflammation and diabetes. For additional information on Incyte, visit the Company's web site at www.incyte.com.
Contact:
Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate
Communications
302-498-6944
Source: Incyte Corporation
Incyte Getting Boost from Pfizer
Thursday July 10, 9:15 am ET
By Grant Zeng, CFA
The discontinuation of Incyte Corp's (NasdaqGM: INCY - News) dexelvucitabine, or DFC (formerly Reverset) in April 2006, the most advanced candidate for HIV/AIDS, was a big setback for the company. DFC had been the company's key growth driver. However, we are optimistic about Incyte's other programs.
The company received a major boost recently with the announcement of a collaboration agreement with Pfizer (NYSE: PFE - News) on CCR2 antagonist program. We maintain a Hold rating on Incyte shares.
The most advanced candidate in the CCR2 portfolio is INCB3284, which is an oral CCR2 antagonist for inflammatory disease. Incyte recently initiated a phase II trial with INCB3284 for Type II diabetes in obese insulin-resistant patients. The company expects to deliver top-line results from this trial soon. Another phase II trial on rheumatoid arthritis is currently ongoing, and we also expect to see top-line results from this trial soon.
Besides Type II diabetes and rheumatoid arthritis, INCB3284 may offer potential in multiple sclerosis, atherosclerosis, or chronic pain management. Pfizer will get exclusive worldwide rights to all potential indications other than multiple sclerosis and lupus nephritis for which Incyte will retain exclusive worldwide rights.
At the current share price, we see the risk/reward relatively balanced for investors in Incyte. We were encouraged to hear about the recent agreement with Pfizer and believe this agreement validates Incyte's development efforts. Based on peer comparisons with other smaller genomic/pure discovery-based biotechnology companies, we believe that INCY shares are fairly valued at current levels. Our $8.50 target price corresponds to a market capitalization of $720 million which we think is fair to Incyte.
Incyte shares jump on promising drug study results
Thursday June 12, 7:47 pm ET
Incyte shares rise as developing rheumatoid arthritis drug shows promising results in study
NEW YORK (AP) -- Shares of Incyte Corp. surged Thursday after the drug developer said its experimental rheumatoid arthritis drug proved safe and quickly prompted patient responses in a small, midstage study.
The stock jumped 54 cents, or 6.8 percent, to $8.48. Shares have traded between $4.75 and $12.83 over the last 52 weeks.
Earlier Thursday, the company said a 15-milligram, twice-daily dose of drug candidate INCB18424 invoked response rates of 17 percent to 75 percent from patients in a 16-person Phase IIa clinical trial. The response rates, spread throughout four treatment groups, compare favorably with current treatments on the market, the company said.
Incyte is studying three additional groups involving 32 patients receiving either 5-milligrams or 25 milligrams twice-daily, or 50 milligrams once daily.
"The rapid onset of activity of INCB18424, as early as one week after the start of therapy, as well as its apparent safety and oral availability, suggest that selective inhibition of JAK 1 and 2 could be an important advancement in the treatment of rheumatoid arthritis," said Dr. William V. Williams, Incyte's vice president of exploratory development, in a statement.
While analysts noted the positive data, several are awaiting for additional study results to make an assessment on the drug.
"While the data support additional study, the safety bar for rheumatoid arthritis is set very high (by competitors) and long-term safety data as well as a larger efficacy database are needed to draw meaningful conclusions," said Cowen and Co. analyst Rachel McMinn, in a note to investors.
She reaffirmed a "Neutral" rating.
The drug, if approved, would eventually enter the market against Amgen Inc. and Wyeth's Enbrel, Johnson & Johnson's Remicade and Abbott Laboratories' Humira.
Meanwhile, Piper Jaffray analyst Thomas Wei reaffirmed a "Buy" rating, saying the safety profile of the developing drug, so far, suggests it is acceptable for rheumatoid arthritis patients.
Incyte shares rise on favorable pipeline outlook
Thursday May 15, 5:53 pm ET
Incyte shares rise as Wall Street anticipates favorable study data from several programs
NEW YORK (AP) -- Shares of drug developer Incyte Corp. rose Thursday as Wall Street maintained a favorable outlook on the company's rheumatoid arthritis and bone marrow disease drug candidate.
The stock rose 17 cents, or 1.7 percent, to $10.40. Shares have traded between $4.75 and $12.83 over the last 52 weeks.
The drug candidate, INCB18424, is currently in a midstage study for rheumatoid arthritis. In a presentation planned for June, the company will review data showing that four of six patients taking the drug showed improvement in signs and symptoms. The 28-day study also involves two patients on placebo.
The data are inline with Incyte's previous disclosures on the developing drug and support positive expectations, in light of the short treatment period, said Piper Jaffray analyst Thomas Wei, in a note to investors.
He reaffirmed a "Buy" rating with a $19 price target and expects positive data presented in both June and then during the fall at the American College of Rheumatology's meeting.
Meanwhile, Banc of America Securities analyst Katherine S. Kim reaffirmed a "Buy" rating with a $15 price target. She also expects rheumatoid arthritis data in June, along with positive data on the developing diabetes treatment INCB13739.
Other programs include INCB18424 in myelofibrosis, a bone marrow disease, which the company plans to move into midstage and late-stage studies during the fourth quarter.
"We believe that once the pivotal studies start, enrollment should be brisk, allowing for approval in 2010, Kim said, in a note to investors.
Meanwhile, study results from early and midstage studies on myelofibrosis will likely be presented at the upcoming American Society of Clinical Oncology's annual meeting in June.
Incyte Reports First Quarter Financial Results and Positive Clinical Progress in Multiple Programs
Wednesday April 30, 7:00 am ET
Conference Call and Webcast Scheduled for 8:30 a.m. ET Today
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) today reported first quarter 2008 financial results and reviewed recent clinical accomplishments in multiple programs.
Paul Friedman, M.D., Incyte’s President and CEO stated, “Our lead JAK inhibitor compound, INCB18424, which has already generated impressive proof-of-concept clinical results in myelofibrosis, rheumatoid arthritis and psoriasis and may also be of value in other oncological and inflammatory conditions, continued to make solid progress throughout the first quarter. As I’ve stated previously, the JAK inhibitor program is now our highest priority.”
Below is a summary of recent clinical activities and accomplishments:
JAK Inhibitor Program
INCB18424: Myelofibrosis
-- Confirmed that results from the Phase I/II trial will be the subject of an oral presentation by the principal investigator at the American Society of Clinical Oncology meeting on June 2, 2008 and the European Hematology Association (EHA) meeting on June 14, 2008
-- Conducted a successful first meeting with the FDA in which we reached agreement on the type of endpoints that will support approval in this indication and confirmed that we will not be required to demonstrate improved survival or normalization of cell counts in the blood or bone marrow
-- Expanded the ongoing Phase I/II trial which now includes over 60 patients with additional enrollment expected which will allow us to further refine the dosing regimen and assess a number of potential endpoints to use in the registration trials
INCB18424: Other Oncology Indications
--
Initiated two Phase IIa trials, one in multiple myeloma patients and a second in hormone-refractory prostate cancer patients
-- Confirmed that our abstract describing the preclinical effects of Incyte JAK inhibitors in multiple myeloma was accepted for oral presentation at EHA on June 15, 2008
INCB18424: Rheumatoid Arthritis
-- Completed the first cohort of patients in a 28-day placebo-controlled dose-escalation Phase IIa trial, in which 12 patients received 15 mg BID of INCB18424 and 4 received placebo
-- Initiated three additional cohorts to evaluate two twice-daily doses and one once-daily dose
-- Confirmed that results from the first cohort will be presented at the European League Against Rheumatism meeting on June 12, 2008
INCB18424: Psoriasis (topical formulation)
--
Completed the 28-day Phase IIa trial in mild-to-moderate psoriasis patients in which the compound was extremely well tolerated and provided comparable efficacy to the potent topical steroid, Diprolene(R)
-- Completed the first cohort in the 28-day sub-total inunction safety study in which the compound continued to show impressive efficacy and tolerability
-- Submitted results from the 28-day Phase IIa trial to the European Academy of Dermatology and Venereology meeting for presentation in September 2008
11beta-HSD1 Inhibitor Program
INCB13739: Type 2 Diabetes
-- Confirmed that results from the 28-day Phase IIa trial will be presented by the principal investigator at the American Diabetes Association meeting on June 9, 2008
-- Finalized the protocol for the three-month Phase IIb trial which is scheduled to initiate in May 2008
INCB20817: Type 2 Diabetes
-- Initiated Phase I trials
HM74a Agonist Program
INCB19602: Type 2 Diabetes
-- Completed Phase I trials in which the compound was well tolerated, lowered free fatty acids without rebound and did not produce the flushing seen with niacin and its derivatives
-- Results from the Phase I trials support the initiation of a 28-day Phase IIa trial in type 2 diabetics that is expected to provide top-line proof-of-concept data later this year or early next year
Sheddase Inhibitor Program
INCB7839: Breast Cancer
--
Initiated a Phase II trial in combination with Herceptin(R) with results expected later this year
CCR5 Antagonist Program
-- Announced that we would not advance the lead compound, INCB9471, into Phase IIb trials in treatment-experienced HIV patients and that we are seeking to out-license the program in order to focus on our higher priority programs
Financial Results
2008 Financial Guidance Update
http://biz.yahoo.com/bw/080430/20080430005319.html?.v=1
Sirtris Pharmaceuticals Picks Director
Tuesday March 25, 8:25 am ET
Sirtris Pharmaceuticals Appoints Incyte CEO Paul A. Friedman to Board of Directors
CAMBRIDGE, Mass. (AP) -- Biopharmaceutical company Sirtris Pharmaceuticals Inc. said Tuesday Paul A. Friedman has been appointed to its board of directors.
Friedman serves as the president and chief executive of drug developer Incyte Corp
Incyte to Report 2007 Financial Results and 2008 Financial Guidance and Provide Update on Drug Discovery & Development Programs on February 14
Tuesday February 5, 9:17 am ET
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY - News) announced today that it has scheduled its fourth quarter and year-end 2007 financial results conference call for 8:30 a.m. ET on Thursday, February 14, 2008. The schedules for the press release and conference call are as follows:
-- Q4 & YE 2007 Press Release: February 14, 2008 at 7:00 a.m. ET
-- Q4 & YE 2007 Conference Call: February 14, 2008 at 8:30 a.m. ET
-- Domestic Dial In Number: 877-407-8037
-- International Dial In Number: 201-689-8037
-- Conference ID # 273161
If you are unable to participate, a replay of the conference call 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 273161.
The conference call will also be webcast live on CCBN and can be accessed at www.incyte.com under Investor Relations, Events and Webcasts.
About Incyte
Incyte is a Wilmington, Delaware based drug discovery and development company with a growing pipeline of oral compounds to treat oncology, inflammation, diabetes and HIV. For additional information on Incyte visit the Company’s web site at www.incyte.com.
Contact:
Incyte Corporation
Pamela M. Murphy
Vice President
Investor Relations & Corporate Communications
(302) 498-6944
UPDATE 1-Incyte up 20 pct on early arthritis, diabetes data:
http://www.reuters.com/article/marketsNews/idUKN0852581120080108?rpc=44
Data Presented At The American Society Of Hematology 49th Meeting Demonstrate That Incyte's Novel JAK Inhibitor, INCB18424, Provides Rapid and Profound Clinical Benefits in Myelofibrosis Patients
Monday December 10, 3:00 pm ET
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY - News) announced today the presentation of interim Phase I/II results of INCB18424, its orally available janus-associated kinase (JAK) inhibitor in patients with myelofibrosis (MF). MF is a serious neoplastic condition with a survival rate of 3 to 7 years that is characterized by varying degrees of bone marrow failure, life-threatening splenic enlargement, and marked constitutional symptoms, resulting in a significant loss in quality of life.
Results presented at the American Society of Hematology 49th Meeting, involving 11 patients treated with INCB18424, demonstrate that:
-- A profound and rapid reduction in splenomegaly, regardless of the presence of the JAK mutation, has been seen in all patients
-- Mean reduction in spleen size reached 52% and 86% at months one and three, respectively, with similar responses at the two dose levels studied
-- All six patients treated for three months or longer achieved clinical improvement as per the International Working Group (IWG) consensus criteria for treatment response in myelofibrosis
-- All patients achieved significant improvements in quality of life
-- INCB18424 was well tolerated at clinically effective doses with no off-target toxicities; no patients discontinued from study
-- Of two transfusion-dependent patients treated for three to five months, one has become transfusion-independent
Thirty-two patients are currently enrolled in this ongoing Phase I/II study: eleven from the initial dose-escalation phase involving two doses of INCB18424 (25 mg BID and 50 mg BID), and an additional 21 patients in the expanded cohort arm, which is designed to further evaluate INCB18424 at the maximum tolerated dose (MTD), 25 mg BID.
http://biz.yahoo.com/bw/071210/20071210006022.html?.v=1
Baker Brothers Life Sciences Capital, LLC can't buy enough of INCY, new 52 week high today:
http://www.form4oracle.com/company?cik=0000879169&ticker=incy
Improving Chaikin Money Flow (INCY)
Stocks in a New Uptrend (Aroon) (INCY)
Incyte Reviews Positive Proof-of-Concept Clinical Results Achieved During the Third Quarter; Cites Continued Progress in Multiple Drug Development Programs; Announces Third Quarter Financial Results
Incyte Corporation (Nasdaq:INCY) today reviewed its drug discovery and development programs and reported third quarter 2007 financial results.
Paul A. Friedman, M.D., President and CEO of Incyte, stated, "We made significant progress during the third quarter and have now demonstrated clinical proof-of-concept in four of our wholly owned, internally developed programs: our CCR5 antagonist for HIV, our JAK inhibitor for myelofibrosis and psoriasis, and our 11beta-HSD1 inhibitor for type 2 diabetes.”
“Over the next six to twelve months, we have the potential to further strengthen the pipeline as we progress multiple compounds into Phase IIb trials and generate additional proof-of-concept data from compounds already in clinical development as well as from several new programs.”
Below is a summary of recent progress and expected upcoming milestones, by program:
Janus-Associated Kinase (JAK) Inhibitor Program
For INCB18424, Incyte’s lead JAK inhibitor in Phase II development for several indications, including myelofibrosis (MF), psoriasis and rheumatoid arthritis (RA), we have:
-- Reported positive top-line results from the first six MF patients in an ongoing dose-escalation Phase Ib/IIa trial with orally administered INCB18424
-- Additional results from this trial will be presented at the upcoming American Society of Hematology meeting during the "Myeloproliferative Syndromes Therapy" session on Monday, December 10
-- Provided the compound continues to be well tolerated and demonstrates comparable efficacy in additional patients, we intend to begin discussions with the Food and Drug Administration (FDA) to define the potential registration pathway for INCB18424 as a treatment for MF
-- Reported positive results from a recently completed 28-day Phase IIa dose-escalation trial with topical INCB18424, involving 18 mild-to-moderate psoriasis patients
-- Completed a Phase I single- and multiple-dose trial in healthy volunteers using the oral formulation of INCB18424
-- Initiated a 28-day placebo-controlled Phase IIa dose-escalation trial with oral INCB18424 in RA patients who are not well-controlled on methotrexate therapy, with results expected in the first half of 2008
-- Initiated several required safety studies with both oral and topical formulations to support longer-term Phase II trials
-- Provided the compound continues to be well tolerated in these studies, we expect to begin a one-month Phase IIa trial in psoriasis using the oral formulation in the first half of 2008 and a three-month Phase IIb trial in psoriasis using the topical formulation in the second half of 2008
11beta-HSD1 Inhibitor Program
For INCB13739, Incyte’s lead 11beta-HSD1 inhibitor in Phase II development for type 2 diabetes, we have:
-- Reported positive interim results from the ongoing 28-day Phase IIa placebo-controlled clinical trial in type 2 diabetes. In the 20 patients included in this interim analysis, we demonstrated positive effects on fasting plasma glucose and on dyslipidemia, including reduction of LDL, total cholesterol and triglycerides, as well as modest increases in HDL
-- A three-month Phase IIb trial in type 2 diabetes is scheduled to begin in the first half of 2008, provided full results from the ongoing trial are comparable to the interim data
-- Full results from the Phase IIa trial are expected in the first half of 2008
-- For INCB20817, the follow on 11beta-HSD1 compound, the Investigational New Drug Application (IND) has been accepted and Phase I trials are expected to begin in the first quarter of 2008
CCR5 Inhibitor Program
For INCB9471, Incyte’s lead CCR5 antagonist in Phase II development for HIV, we are:
-- Conducting several required drug interaction studies and completing longer-term safety studies to support initiation of two Phase IIb trials in treatment-experienced HIV patients beginning in the first half of 2008
Sheddase Inhibitor Program
For INCB7839, Incyte’s lead sheddase inhibitor in Phase II development for cancer:
-- We initiated the first of two Phase II trials in breast cancer patients, with results expected in the second half of 2008 and early 2009
-- We will present results from the Phase Ib/IIa clinical trial in poster form at the San Antonio Breast Cancer Meeting in December
CCR2 Inhibitor Program
INCB8696, Incyte’s lead CCR2 antagonist for multiple sclerosis, recently entered Phase I development, with results expected in the first half of 2008.
Discovery Programs
Lead compounds have been advanced from three new programs, one for metabolic disease, which is currently in Phase I development, and two for oncology, which are expected to begin clinical development in 2008.
Financial Overview and Results
Cash Position
As of September 30, 2007, cash, short-term and long-term marketable securities totaled $265.9 million, compared to $329.8 million as of December 31, 2006. During the nine months ended September 30, 2007, Incyte used $66.9 million in cash and marketable securities, excluding a $3 million milestone payment received from Incyte's collaborative research and license agreement with Pfizer.
Incyte’s cash use guidance remains unchanged and is expected to be in the range of $88 to $95 million for 2007. This cash use excludes the in-license or purchase of products, any milestones from Incyte’s collaboration with Pfizer and the proceeds from the sale of the convertible subordinated note to Pfizer discussed below.
Revenues
Total revenues for the quarter ended September 30, 2007 were $6.7 million as compared to $7.3 million for the same period in 2006. Revenues for the nine months ended September 30, 2007 were $24.7 million, as compared to $20.6 million for the same period in 2006. The increase was primarily the result of the $3 million milestone payment received from Pfizer in the second quarter of 2007. In October 2007, Incyte received $10 million from the sale of a convertible subordinated note to Pfizer. The note was issued for the filing and acceptance of an IND for INCB8696, Incyte’s lead CCR2 antagonist, in connection with the collaborative research and license agreement between Incyte and Pfizer effective in January 2006. The note bears no interest and is due in 2014. The additional consideration provided to Incyte associated with the interest-free nature of the note will be recorded as revenue primarily in the fourth quarter of 2007. As a result, Incyte is increasing its 2007 revenue guidance from a range of $29 to $31 million to a range of $32 to $34 million.
Net Loss
The net loss for the quarter ended September 30, 2007 was $24.5 million, or $0.29 per share, as compared to $15.8 million, or $0.19 per share, for the same period in 2006.
The net loss for the nine months ended September 30, 2007 was $65.1 million or $0.77 per share, as compared to $53.7 million or $0.64 per share, for the same period in 2006, which included a $5.5 million gain from the sale of a portion of a strategic investment, a $1.3 million charge for the write-down of a strategic investment, and a $3.4 million charge related to the settlement of litigation.
The increase in net loss for both the three and nine months ended September 30, 2007 is primarily due to higher clinical development expenses as Incyte’s pipeline continues to expand and advance.
Included in the net loss for the quarter and the nine months ended September 30, 2007 was $2.6 million and $7.4 million, respectively, of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $2.1 million and $6.6 million, respectively, for the same periods in 2006.
Operating Expenses
Research and development expenses for the quarter ended September 30, 2007 were $25.0 million as compared to $19.6 million for the same period last year. Research and development expenses for the nine months ended September 30, 2007 were $72.3 million, as compared to $64.0 million for the same period last year. As a result of the growth and steady advancement of our clinical pipeline we are increasing our 2007 research and development expense guidance from $88 to $95 million to a range of $98 to $100 million. We expect research and development expenses to vary from quarter to quarter, primarily due to our clinical development activities.
Included in the research and development expenses for the quarter and the nine months ended September 30, 2007 was $1.8 million and $5.1 million, respectively, of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $1.4 million and $4.2 million, respectively, for the same periods in 2006.
Selling, general and administrative expenses for the quarter and the nine months ended September 30, 2007 were $3.6 million and $10.8 million, respectively, as compared to $3.5 million and $10.8 million, respectively, for the same periods in 2006.
Included in the selling, general and administrative expenses for the quarter and the nine months ended September 30, 2007 was $0.8 million and $2.3 million, respectively, of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $0.7 million and $2.4 million, respectively, for the same periods in 2006.
Interest Income (Expense)
Interest income for the quarter and the nine months ended September 30, 2007 was $2.9 million and $10.7 million, respectively, as compared to $4.0 million and $11.3 million, respectively, for the same periods in 2006.
Interest expense for the quarter and the nine months ended September 30, 2007 was $6.0 million and $17.9 million, respectively, as compared to $4.1 million and $11.8 million, respectively, for the same periods in 2006. Included in interest expense for the quarter and the nine months ended September 30, 2007 was $2.1 million and $6.1 million, respectively, of non-cash charges to amortize the original issue discount of our 31/2% Convertible Senior Notes.
Conference Call Information
Incyte will hold its third quarter 2007 conference call at 8:30 a.m. Eastern Time today, November 1, 2007. 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 258134.
If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for domestic callers is 877-660-6853 and the 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 258134.
The conference call will also be webcast live on CCBN and can 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 I and Phase II development for HIV, diabetes, oncology and inflammation. 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 strengthening the pipeline by progressing multiple compounds into Phase IIb trials and generating additional proof-of-concept data, the effects of emerging data on those plans, expectations regarding the presentation of results and intention to begin discussions with the FDA regarding the registration pathway of INCB18424 as a treatment for MF, the potential benefits from and initiation of a 28-day Phase IIa trial in RA with INCB18424, and expectations regarding the initiation of a one-month and three-month trial in psoriasis with oral and topical INCB18424, respectively, or the potential benefits from and initiation of a three-month Phase IIb trial for INCB13739 in type 2 diabetes and timing of expected results from the Phase IIa trial for INCB13739, expectations regarding the timing of Phase I trials for the follow-on HSD1 compound INCB20817, expectations regarding the initiation of Phase II trials for INCB7839 in breast cancer and the timing and presentation of expected results from the Phase I/IIa trial for INCB7839, expectations regarding the initiation of two Phase IIb studies of INCB9471 in treatment-experienced HIV patients, expectations regarding the timing of expected results from a Phase I trial of INCB8696 as a treatment for multiple sclerosis, expectations regarding the advancement of lead compounds from three additional discovery programs into clinical development and trials, and financial guidance about expected cash use, research and development expenses, and revenue, 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, 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. 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
September 30,
Nine Months Ended
September 30,
2007 2006 2007 2006
Revenues:
Contract revenues $ 5,909 $ 6,249 $ 20,916 $ 18,069
License and royalty revenues 781 1,019 3,772 2,518
Total revenues 6,690 7,268 24,688 20,587
Costs and expenses:
Research and development 25,044 19,558 72,251 64,037
Selling, general and administrative 3,587 3,454 10,814 10,750
Other expenses (566) 13 (532) 3,105
Total costs and expenses 28,065 23,025 82,533 77,892
Loss from operations (21,375) (15,757) (57,845) (57,305)
Interest and other income, net 2,883 3,996 10,663 15,470
Interest expense (6,002) (4,077) (17,898) (11,828)
Net loss
$ (24,494) $ (15,838) $
(65,080)
$ (53,663)
Basic and diluted net loss per share $ (0.29) $ (0.19) $ (0.77) $ (0.64)
Shares used in computing basic and diluted
net loss per share
84,213 83,852 84,111 83,755
INCYTE CORPORATION
Condensed Consolidated Balance Sheet Data
(in thousands)
September 30,
December 31,
2007
2006
Cash, cash equivalents, and short-term and long-term marketable securities
$ 265,861 $ 329,810
Total assets 282,683 353,603
Convertible senior notes 120,076 113,981
Convertible subordinated notes 257,427 257,122
Total stockholders’ deficit (141,473) (84,908)
Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations
& Corporate Communications
302-498-6944
Source: Business Wire (November 1, 2007 - 7:03 AM EDT)
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