June 11, 2011 12:30 PM Eastern Daylight Time 

Results Presented at 16th Congress of the European Hematology Association

LONDON–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) announced today additional symptom improvement and quality of life (QoL) results from COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK inhibitor Treatment), a randomized, double-blinded, placebo-controlled Phase III trial of Incyte’s JAK1 and JAK2 inhibitor, ruxolitinib, in patients with myelofibrosis (MF). the data, being reported at the 16th EHA Congress today, demonstrated that treatment with ruxolitinib resulted in significant reductions in spleen volume and improvements in Total Symptom Score (TSS) while placebo-treated patients experienced progressive splenomegaly (enlarged spleen) and worsening of symptoms, complementing clinical results presented recently at the 2011 ASCO Annual Meeting.

“Quality of life in patients with myelofibrosis can be severely compromised by massive splenomegaly and debilitating symptoms, and it is highly gratifying to see profound symptomatic improvement resulting in improved quality of life in MF patients.”

the findings are being reported at the EHA Congress in Poster #0912: Results Using the Modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0) in COMFORT-I: a Randomized, Double-Blind, Phase III Trial of JAK1/2 Inhibitor Ruxolitinib vs. Placebo in Myelofibrosis.1 the presenting author is Ruben A. Mesa, M.D., Professor of Medicine, Chair, Division of Hematology & Medical Oncology, Mayo Clinic, Arizona. Dr. Mesa is a leading expert on the symptomatic burden of myelofibrosis and has been instrumental in developing tools, such as the modified MFSAF, for measuring these symptoms.

these data demonstrated that the primary endpoint of a 35% reduction in spleen volume was clearly associated with reduction of abdominal symptoms (abdominal discomfort, pain under the ribs and feeling of fullness (early satiety)) associated with an enlarged spleen. Importantly, many patients with less than 35% reduction in spleen volume also had meaningful improvement in abdominal symptoms. Patient benefit also was assessed using the Patient Global Impression of Change (PGIC), which measures patients’ global assessment of change in their condition on a 7-point scale ranging from “very much worse” to “very much improved.” while more than two-thirds of ruxolitinib-treated patients graded their disease as “much or very much improved” based on the PGIC, nearly three-quarters of placebo-treated patients reported “no change” or “worsening” on that scale.

in addition, of patients who had a 50% or greater reduction in TSS (a key secondary endpoint), nearly 90% rated their disease as “much or very much improved” based on the PGIC scale. Also, over 50% of patients with a 25% to 50% TSS improvement rated their disease as “much or very much improved,” indicating that a significant proportion of these ruxolitinib-treated patients also had meaningful improvement in their disease. associated with these improvements were improvements in almost all sub-scales of the European Organization for Research and Treatment of Cancer Quality-of-Life 30 Questionnaire (EORTC QLQ-C30), a standard and well-validated measure of quality of life in cancer patients. A copy of the poster presentation can be viewed by clicking on the following link: EHA 2011 Ruben Mesa Poster.

Richard Levy, M.D., Incyte’s Executive Vice President and Chief Drug Development and Medical Officer, stated, “Quality of life in patients with myelofibrosis can be severely compromised by massive splenomegaly and debilitating symptoms, and it is highly gratifying to see profound symptomatic improvement resulting in improved quality of life in MF patients.”

as expected based on the mechanism of action of ruxolitinib, the most common adverse events occurring more frequently on ruxolitinib treatment than on placebo were anemia and thrombocytopenia. Both were manageable as evidenced by the low discontinuation rate as a result of these events (1 patient for each event in each arm of the study). Thrombocytopenia was managed with dose modifications and anemia was generally managed with transfusion. the prevalence of grade 3 and 4 anemia in ruxolitinib patients diminished over time as did the need for transfusion. among the most frequently reported non-hematologic adverse events in ruxolitinib treated patients were dizziness, headache and bruising and were generally of low grade, and self limited with continued therapy.

About COMFORT-I

COMFORT-I is a randomized (1:1), double-blind, placebo-controlled Phase III study comparing the efficacy and safety of ruxolitinib to placebo in 309 patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) and involved over 80 clinical sites in the US, Canada and Australia.

the primary endpoint was the proportion of patients achieving a reduction in spleen volume of 35% or more from baseline to week 24 as measured by MRI (or CT scan in applicable patients). Key secondary endpoints included duration of maintenance of a 35% or greater reduction in spleen volume from baseline and the proportion of patients with 50% or more reduction in symptom improvement as measured by the MFSAF v2.0 electronic diary.

the study met its primary end-point and will be presented by Srdan Verstovsek, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, University of Texas – MD Anderson Cancer Center and Principal Investigator for COMFORT-I in the Presidential Symposium, one of the two plenary sessions at EHA, on June 11.

COMFORT-II, which was conducted by Novartis in the EU as part of the Incyte-Novartis worldwide collaboration and license agreement, is a randomized (2:1), open-label Phase III study of ruxolitinib versus best available therapy. COMFORT-II enrolled 219 patients with primary MF, PPV-MF or PET-MF in 56 study locations in Europe.

About Myelofibrosis (MF)

Myelofibrosis is a potentially life-threatening blood cancer characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms, such as fatigue, pruritus (severe itching), night sweats, bone pain and early satiety. MF is one of the Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs), which also include polycythemia vera and essential thrombocythemia.2 Aberrant activation of the Janus kinase (JAK) pathway, which regulates blood cell production, has been associated with the development of the MPNs, including MF.3

Myelofibrosis is associated with poor prognosis and often results in a shortened survival. Up to 20% of patients can experience transformation to fatal secondary acute myelogenous leukemia within 10 years of diagnosis. currently, there are limited treatment options and no FDA-approved medicines for MF; the only potential cure is allogeneic stem cell transplant, for which a very small proportion of patients qualify.2

About Ruxolitinib

Ruxolitinib is Incyte’s lead internally developed JAK1 and JAK2 inhibitor that entered clinical trials in may 2007 and showed clinical activity in a number of hematologic disorders. This agent recently completed a global Phase III program (COMFORT) in myelofibrosis, and the new Drug Application is currently under review by the US Food & Drug Administration. Ruxolitinib also is in a global Phase 3 registration study, RESPONSE,4 in advanced polycythemia vera, a related hematologic neoplasm, as well as Phase 2 studies in patients with other hematologic malignancies and solid tumors. Other clinical studies evaluating ruxolitinib in patients with lymphoma and pancreatic cancer are planned.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs for oncology and inflammation. For additional information on Incyte, visit the Company’s web site at incyte.com.

Forward-Looking Statements

except for the historical information contained herein, the matters set forth in this press release, including statements regarding the presentation of the COMFORT-I results at one of the two plenary sessions at EHA on June 11 and other clinical studies evaluating ruxolitinib in patients with lymphoma and pancreatic cancer being planned, 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 studies, unanticipated developments in the efficacy or safety of ruxolitinib, the possibility that the outcomes for each of the planned clinical studies for ruxolitinib may not be favorable, the possibility that regulatory authorities may require additional clinical studies in order to support registration of ruxolitinib in any particular indication, the possibility that there may be other interpretations of the data produced in one or more of Incyte’s clinical studies, the results of further research and development, 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, 2011. 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.

References

1. Mesa RA, Verstovsek S, et al. Results Using the Modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0) in COMFORT-I: a Randomized, Double-Blind, Phase III Trial of JAK1/2 Inhibitor Ruxolitinib vs. Placebo in Myelofibrosis. Abstract #0912. 16th Congress of the European Hematology Association.

2. the Leukemia & Lymphoma Society. Idiopathic Myelofibrosis. 2007. available at lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/mpd/pdf/idiopathicmyelofibrosis. Accessed may 2011.

3. Vannucchi AM, Guglielmelli P, Tefferi A. Advances in understanding and management of myeloproliferative neoplasms. CA Cancer J Clin. 2009;59:171-191.

4. National Institutes of Health. Study of Efficacy and Safety in Polycythemia Vera Subjects who are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets versus Best available Care: the RESPONSE Trial. available at clinicaltrials.gov/ct2/results?term=%22The+RESPONSE+Trial%22. Accessed may 2011.

Addition of boceprevir significantly increased treatment success in more patients and in a significantly shorter time period compared to standard treatment

MONTREAL, March 30 /CNW/ -Two Phase III studies (HCV RESPOND-2 and HCV SPRINT-2) are published in the March 31 edition of the New England Journal of Medicine (NEJM) demonstrating that addition of the investigational oral medication boceprevir to standard treatment significantly improved sustained virologic response (SVR) – the goal of treatment – in a significantly greater number of adult patients who failed previous treatment (treatment-failure) and in those who were new to treatment (treatment-naïve) for chronic hepatitis C virus (HCV) genotype 1, compared to standard therapy alone. Also, both studies investigated a new treatment strategy resulting in many patients being able to shorten the duration of therapy from the standard 48 weeks.1

"these results signal a truly important change in the treatment of hepatitis C genotype 1 infection, one of the most prevalent genotypes in Canada," said Dr. Marc Bilodeau, a Canadian investigator in the SPRINT-2 study and Associate Professor of Medicine at Université de Montréal. "the addition of boceprevir not only substantially increased the success rates, but also by using response-guided therapy – which indicates how individuals are responding to treatment – many patients taking the drugs for the first time saw their treatment times cut almost in half."

"Being able to shorten the length of treatment is extremely important given that one of the most challenging aspects of treating HCV is managing the debilitating side effects. because the side effects are so hard to take, unfortunately some patients stop their course of therapy," said Dr. mark Levstik, an investigator in the SPRINT-2 NEJM-published study and Assistant Professor, Department of Medicine, Division of Gastroenterology, University of Western Ontario.

Boceprevir, an investigational agent not currently available in Canada, belongs to a novel class of direct-acting antiviral agents – called HCV protease inhibitors – that reduce the amount of virus in the blood through inhibition of the function of a viral protein called 'protease' that HCV needs to replicate.2

An estimated 250,000 individuals in Canada are infected with HCV and there are 3,200 to 5,000 newly infected individuals each year.3  HCV damages the liver and may lead to serious complications, including death, when left untreated.4  it is the leading cause of liver transplants in Canada.5

"the use of a protease inhibitor to treat hepatitis C infection is an important advance in the management of the disease," said Dr. Alnoor Ramji, an investigator in both the SPRINT-2 and the RESPOND-2 published studies and a Clinical Assistant Professor at the University of British Columbia. "as a Canadian investigator, I am encouraged that the studies have been published in this prestigious medical journal. it reinforces the importance of our results."

Treatments Improve, Stigma Persists

Karen Stacey lived with the virus for many years before experiencing any symptoms. her diagnosis came slowly, and only after many tests and visits to multiple physicians.

"I remember constantly feeling dizzy and nauseous, and having a hard time with my memory," said Ms. Stacey. "When I was finally diagnosed with hepatitis C, I had this sinking feeling that people felt I deserved to get this disease. In the minds of many people, only drug addicts or alcoholics get this virus."

Past or current drug use accounts for more than 56 per cent of all hepatitis C infection in Canada.6 In addition, the virus may be contracted via use of unscreened blood or blood products in medical procedures, body piercing, mother-child transmission and accidental needle-sticking in medical settings. In Karen's case, she contracted the virus following a blood transfusion, which she required during a failed pregnancy in the 1970s.

"To help eliminate the terrible stigma I suffered following my diagnosis, I'm dedicated to educating Canadians about the disease," said Ms. Stacey. "the most frightening thing about the stigma is that it creates an enormous barrier for people infected with hepatitis C to get diagnosed and receive treatment that could cure their disease."

About HCV: a Silent Disease

Approximately one-in-three of those infected with HCV are not aware of their infection and it often goes undetected for many years until symptoms appear.7 Symptoms can include fever, fatigue, reduced appetite, stomach pain, dark urine, jaundice (yellowing of skin or eyes), nausea and vomiting, aching muscles and joints, and poor concentration.8 If left untreated, HCV may lead, in some patients, to liver fibrosis, cirrhosis, liver cancer and liver failure.9

About the Studies

The two studies (HCV RESPOND-2 and HCV SPRINT-2) each evaluated two new treatment strategies with boceprevir administered in combination with peginterferon alfa-2b and ribavirin (PR) to assess the ability of boceprevir to improve SVR rates – the goal of treatment – and potentially shorten overall treatment duration compared to the use of PR alone for 48 weeks, which is the current standard duration of therapy.

The HCV RESPOND-2 study examined the use of boceprevir in adult patients who previously failed to eradicate the virus with current standard therapy, including patients who had either relapsed after initially clearing the virus or were non-responders to prior treatment with PR. the HCV SPRINT-2 study examined the use of boceprevir in adult patients who were treatment-naïve (no prior treatment).

A total of 1,500 patients participated in the two studies, with nearly 10 per cent of patients (146) recruited at 15 Canadian investigation sites.  In each study, patients were randomized to one of three treatment arms:

• Response-guided therapy (RGT), in which total treatment duration was based on certain early response criteria. Treatment-failure patients with undetectable virus (HCV-RNA) at week eight were eligible to stop all treatment at 36 weeks. Treatment-naïve patients who had undetectable virus (HCV-RNA) during weeks eight through 24 were eligible to stop all treatment at 28 weeks.
• 48 weeks of treatment, in which patients received a four-week lead-in with PR followed by the addition of boceprevir for 44 weeks.
• Control, in which patients received PR for 48 weeks.

In the HCV RESPOND-2 study (treatment-failure patients), the addition of boceprevir in the RGT arm resulted in 59 per cent of patients eliminating the virus and 66 per cent in the 48-week treatment arm, compared to 21 per cent in the control group (p<0.0001).

In the HCV SPRINT-2 study (treatment-naïve patients), the addition of boceprevir in the RGT arm resulted in 63 per cent of patients eliminating the virus and 66 per cent for the 48 week treatment arm, compared to 38 per cent in the control group (p<0.0001).

Study authors reported that nearly half of all patients in the RGT arms of both studies met the early response criteria, meaning that they received a shorter total duration of therapy. In the HCV RESPOND-2 study, 46 per cent of patients met the early response criteria, and were able to stop all treatment at 36 weeks (12 weeks shorter than current standard therapy). In the HCV SPRINT-2 study,  44 per cent of patients met the early response criteria and were able to stop all treatment at 28 weeks (20 weeks shorter than current standard therapy).

In the HCV RESPOND-2 study, the most commonly reported side effects were fatigue, headache, nausea, chills and influenza-like illness. serious adverse events were reported in 10 per cent of patients in the RGT arm of the study, 14 per cent of patients in the 48-week treatment arm and in five per cent of patients in the control group. Discontinuation of treatment due to adverse events over the total course of the study was eight per cent in the RGT arm, 12 per cent for the 48-week treatment arm and three per cent for control.

Tolerability profile in treatment-failure patients

The five most common treatment-related adverse events in the HCV RESPOND-2 study reported for patients receiving boceprevir in RGT, boceprevir in a 48-week treatment regimen and control, respectively, were: fatigue, headache, nausea, anemia and chills.  serious adverse events were reported in 10, 14 and five per cent of patients in the study arms, respectively.  There was one death in the study, a suicide in the group receiving boceprevir in RGT, which occurred 18 weeks after the end of the study treatment and was considered to be unrelated to the study treatment.

Treatment discontinuations due to adverse events over the total course of all treatment were eight per cent and 12 per cent for patients receiving boceprevir in RGT and boceprevir in a 48-week treatment regimen, respectively, compared to two per cent for control. Treatment discontinuations due to anemia were 0 per cent and three per cent for the treatment groups receiving boceprevir, respectively, compared to 0 per cent for control.

Tolerability profile in treatment-naïve patients

The five most common treatment-related adverse events in the HCV SPRINT-2 study reported for patients receiving boceprevir in RGT, boceprevir in a 48-week treatment regimen and control, respectively, were: fatigue, headache, nausea, anemia and dysgeusia (bad taste). serious adverse events were reported in 11, 12 and nine per cent of patients in the study arms, respectively. There were six deaths during the study: four patients in the control group died, as did two patients in the boceprevir groups. two suicides (one patient in the control group and one patient receiving boceprevir in RGT) were judged to have possibly been related to peginterferon.  no other deaths were considered to be drug-related.

Treatment discontinuations due to adverse events over the total course of all treatment were 12 per cent and 16 per cent for patients receiving boceprevir in RGT and boceprevir in a 48-week treatment regimen, respectively, compared to 16 per cent for control.  Treatment discontinuations due to anemia were two per cent for each of the treatment groups receiving boceprevir compared to one per cent for control.

The HCV RESPOND-2 and HCV SPRINT-2 studies each employed futility or "stopping" rules, whereby patients in any treatment arm who had detectable virus at week 12 in the HCV RESPOND-2 study or at week 24 in the HCV SPRINT-2 study were considered treatment failures and discontinued all treatment.   the stopping rules allowed study patients who did not respond to treatment to have therapy stopped early, thereby avoiding unnecessary treatment.

Boceprevir is an investigational medication and not currently available in Canada.

Merck's global commitment to advancing hepatitis therapy

Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis.  Extensive research efforts are underway to develop differentiated oral therapies that bring innovation to viral hepatitis care.

About Merck

Today's Merck is a global healthcare leader working to help the world be well.  Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit merck.ca.

Forward-Looking Statement

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. such statements may include, but are not limited to, statements about the benefits of the merger between Merck and    Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2009 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (sec.gov).

1 Merck news release: In Pivotal Phase III Studies, Merck's Investigational Medicine Boceprevir helped Majority of Patients with Chronic Hepatitis C Genotype 1 Infection Achieve Sustained Virologic Response, the Primary Endpoint of the Studies. Available at:  merck.com/newsroom/news-release-archive/research-and-development/2010_0804.html. March 15, 2011.2  Ibid .3  Canadian Institutes of Health Research. About the Hep C Research Initiative. cihr-irsc.gc.ca/e/38855.html. Accessed March 23, 2011.4  Public Health Agency of Canada. phac-aspc.gc.ca/hepc/pubs/multiling-hepc/index-eng.php. Accessed March 23, 2011.5  Canadian Liver Foundation. liver.ca/Liver_Disease/. Accessed March 23, 2011.6  Sherman M, Shafran S, Burak K, et al. Management of Chronic Hepatitis C: Consensus Guidelines. Can J Gastroenterol (2007).7  Public Health Agency of Canada.phac-aspc.gc.ca/hepc/pubs/ihp-ips/index-eng.php. Accessed March 21, 2011.8  Health Canada. hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/hepc-eng.php. Accessed March 23, 2011.9  Public Health Agency of Canada. phac-aspc.gc.ca/hepc/pubs/multiling-hepc/index-eng.php. Accessed March 18, 2011.

TUEBINGEN, Germany, April 11, 2011 /PRNewswire/ — immaticsbiotechnologies GmbH, a clinical-stage biopharmaceutical company developingadvanced therapeutic vaccines that are active against cancer, today announcedthat Pfizer has agreed to support its pivotal Phase III trial (IMPRINT =IMA901 Multi-Peptide vaccine Randomized INTernational study) with IMA901, itstherapeutic cancer vaccine for advanced renal cell carcinoma.

The pivotal Phase III study will evaluate as the primary endpoint theoverall survival of advanced renal cell carcinoma patients treated withIMA901 in combination with Pfizer's Sutent(R) (sunitinib malate) versusSutent(R) alone. The study is expected to enroll approximately 330 patientsacross Europe and in the US.

Pfizer will support the trial by supplying Sutent(R) for all the patientsenrolled in the pivotal study. The first patients are expected to starttreatment in April 2011.

Paul Higham, CEO of immatics, said: "We are extremely pleased that Pfizerhas committed to supporting our pivotal Phase III trial with IMA901 with thesupply of Sutent. Their decision reflects the growing interest in IMA901 andits potential to be an important breakthrough in the treatment of renal cellcarcinoma patients."

IMA901 has generated encouraging overall survival data, which comparefavorably with historical comparisons of currently available treatments, in aPhase II trial in advanced renal cell carcinoma patients. Importantly, thePhase II study also showed an association between survival and the patient'simmune response to IMA901, as well as confirming the favorable safety profileobserved in an earlier Phase I study.

"Pfizer is pleased to provide Sutent to support immatic's clinicaldevelopment program in advanced renal cell carcinoma patients," said CraigEagle, Vice President of Strategic Alliances and Partnerships for PfizerOncology. "This collaboration underscores Pfizer's ongoing commitment to thediscovery, investigation and development of innovative treatment options toimprove the outlook for cancer patients worldwide."

for more information on SUTENT and Pfizer please visitpfizer.com.

about IMA901

IMA901 is a therapeutic cancer vaccine comprising 10 tumor-associatedpeptides (TUMAPs) that are frequently found to be over-expressed in themajority of patients suffering from renal cell carcinoma. as with allimmatics' vaccines, IMA901 has been designed to elicit a strong, clinicallyrelevant immune response to a specific tumor type. The TUMAPs were selectedfrom over 2,000 peptides identified via immatics' unique XPRESIDENT(TM)platform. TUMAPs included in IMA901 are from targets with vital functions forthe tumor, for example invasion, neo-angiogenesis.

about SUTENT((R)) (sunitinib malate)

SUTENT is an oral multi-kinase inhibitor approved for the treatment ofadvanced/metastatic renal cell carcinoma (RCC), unresectable and/ormetastatic malignant gastrointestinal stromal tumor (GIST) after failure ofimatinib mesilate treatment due to resistance or intolerance.

In Europe, SUTENT is also indicated for the treatment of unresectable ormetastatic, well-differentiated pancreatic neuroendocrine tumours withdisease progression in adults. Experience with SUTENT as first-line treatmentis limited.

SUTENT works by blocking multiple molecular targets implicated in thegrowth, proliferation and spread of cancer. Two important SUTENT targets,vascular endothelial growth factor receptor (VEGFR) and platelet-derivedgrowth factor receptor (PDGFR), are expressed by many types of solid tumorsand are thought to play a crucial role in angiogenesis, the process by whichtumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENTalso inhibits other targets important to tumor growth, including KIT, FLT3and RET.

important SUTENT((R)) (sunitinib malate) Safety Information

Hepatotoxicity has been observed in clinical trials and post-marketingexperience. Cases of hepatic failure, some with a fatal outcome, wereobserved in <1% of solid tumor patients treated with SUTENT. it isrecommended to monitor liver function tests before initiation of treatment,during each cycle of treatment, and as clinically indicated. if signs orsymptoms of hepatic failure are present, sunitinib should be discontinued andappropriate supportive care should be provided.

Women of child bearing age who are (or become) pregnant during therapyshould be informed of the potential for fetal harm while on SUTENT.

Decreases in left ventricular ejection fraction (LVEF) to below the lowerlimit of normal (LLN) have been observed. Patients with concomitant cardiacconditions should be carefully monitored for clinical signs and symptoms ofcongestive heart failure. Patients should be monitored for hypertension andtreated as needed with standard antihypertensive therapy. Complete bloodcounts (CBCs) with platelet count and serum chemistries should be performedat the beginning of each treatment cycle for patients receiving treatmentwith SUTENT.

The most common adverse reactions in GIST, RCC and pancreatic NETclinical trials were diarrhea, fatigue, asthenia, nausea,mucositis/stomatitis, anorexia, vomiting, neutropenia, hypertension,dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skindiscoloration, hair color changes, altered taste and bleeding. for moreinformation on SUTENT and Pfizer Oncology, including full prescribinginformation for SUTENT (sunitinib malate), please visit pfizer.com.

about immatics

immatics biotechnologies is a clinical-stage biopharmaceutical companydeveloping rationally designed therapeutic vaccines that are active againstcancer. immatics' lead product, IMA901, has completed a successful phase IItrial in renal cell carcinoma. immatics' pipeline also includes IMA910, inphase II for colorectal cancer, and IMA950 which is in phase I for glioma.

immatics' XPRESIDENT(TM) technology platform rapidly generates definedtherapeutic cancer vaccines, based on multiple tumor-associated peptides(TUMAPs), that have the ability to specifically stimulate the immune systemagainst cancer cells. these vaccines – comprising multiple peptides confirmedto be naturally presented by real tumor tissue – offer the prospect ofgreater effectiveness than existing cancer vaccine approaches. immatics'products are 'drug like' with stable, off-the-shelf formulations and robusteasily scalable manufacturing.

immatics is based in Tuebingen and Munich, Germany. for additional information on immatics please visit immatics.com or contact: Paul Higham, CEO Katrin Eckert, Assistant to the Management immatics biotechnologies GmbH Phone: +49-7071-5397-110 E-mail: David Dible / Chris Gardner / Sita Shah Citigate Dewe Rogerson Phone: +44-207-638-9571 E-mail: david.dible@citigatedr.co.uk

CAMBRIDGE, Mass. (TheStreet) –Vertex Pharmaceuticals(VRTX) released clinical trial results Wednesday demonstrating that an experimental drug VX-770 significantly improved lung function by more than 10% and provided other clinical benefits in adults with a specific form of cystic fibrosis. the results from the phase III study represent a potential scientific breakthrough because VX-770, if eventually approved, would be the first and only drug to repair the underlying genetic cause of cystic fibrosis rather than merely treating the symptoms of the disease. Vertex shares were up 20% to $45.90 in Wednesday pre-market trading. VX-770 corrects a genetic mutation found only in approximately 4% to 7% of the 70,000 cystic fibrosis patients worldwide. the number of cystic fibrosis patients who stand to benefit from VX-770 may be small, but the results from the study are so strong and clinically meaningful that Vertex stands to generate peak annual sales from VX-770 in the range of $400 million to $600 million if the drug is priced comparable to other expensive treatments for rare, genetic disorders. Vertex said Wednesday that it plans to seek regulatory approval for VX-770 in the second half of the year. Results from the phase III study known as STRIVE reported by Vertex showed that treatment with VX-770 through 24 weeks resulted in a mean absolute improvement in lung function of 10.6% compared to placebo. This clinical benefit in favor of VX-770 — the primary endpoint of the STRIVE study — was highly statistically significant and was even sustained through 48 weeks of treatment. the STRIVE study enrolled 161 patients aged 12 and older. to put the 10.6% absolute improvement in lung function in perspective, Vertex designed the phase III study with the intent that a 4.5% improvement would be enough to yield positive results. Wall Street’s professional biotech investors, as a group, were expecting positive results from the VX-770 study but just barely. In a survey of investors conducted by ISI Group biotech analyst mark Schoenebaum released Tuesday, 87% of respondents believed VX-770 would improve lung function by 5% or less over placebo. just 6% of the investors in Schoenebaum’s poll believed VX-770 could improve lung function by 10% or more.

HATFIELD, England, January 25, 2011 /PRNewswire/ — Eisai announced today that it will submit Marketing Authorization Applications in the United States and the European Union for the investigational compound perampanel (E2007) based on the results of three Phase III pivotal studies. Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial seizures in patients with epilepsy. Partial seizures involve epileptic activity in just a part of the brain and the symptoms experienced depend on which area of the brain is affected.

the clinical development plan for perampanel consisted of three global Phase III studies: Studies 306, 305 and 304 in which a total of 1,490 patients participated. the key goal of Study 306 was to identify the minimal effective dose and included four treatment arms (placebo, 2mg, 4mg, and 8mg). Studies 304 and 305 included three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range.

the studies were similar in design: global, randomized, double-blind, placebo-controlled, dose-escalation, parallel-group studies. the primary and secondary endpoints were the same in all the studies: standard median percent seizure reduction, 50% responder rate, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.

each of the studies showed consistent results in the efficacy and tolerability of perampanel given as an adjunctive therapy in patients with partial seizures.

Based upon these study results, Eisai intends to submit regulatory applications simultaneously in the U.S. and EU during the first quarter of our Fiscal Year 2011.

the development of perampanel is an example of Eisai´s human health care corporate mission. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families.

about Perampanel

Eisai is currently developing perampanel for the potential treatment of partial seizures in patients with epilepsy. Perampanel is a highly selective, non-competitive AMPA (a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated broad-spectrum anti-seizure effects in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterized by excess neuroexcitatory signalling including epilepsy, neurodegenerative disorders, movement disorders, pain and psychiatric disorders.

if approved, perampanel will be the first product in this class.

about Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 8 in 1,000 people in Europe(i). there is an estimated 2.4 million people living with epilepsy in Europe(ii) and estimated 50 million people worldwide.(iii)

Epilepsy is a chronic disorder of the brain that affects people of all ages. it is characterized by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.

about Eisai Europe in Epilepsy

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. the development of anti-epileptic drugs (AEDs) is a major strategic area for Eisai in the European market.

in Europe, Eisai currently has three marketed treatments including:

– Zonegran(R) (zonisamide) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation – Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalization – Inovelon(R) (rufinamide) for the treatment of seizures associated with Lennox-Gastaut Syndrome

about Eisai

Eisai is one of the world´s leading research-based pharmaceutical companies that has defined its corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides, ” which we call human health care (hhc). Eisai concentrates its research activities in three key areas

– Integrative Neuroscience including: Epilepsy, Alzheimer´s disease, multiple sclerosis, neuropathic pain and depression – Integrative Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief and nausea – Vascular/Immunological Reaction including: acute coronary syndrome, atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis and Crohn´s disease

with operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employ more than 11,000 people worldwide.

in Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Hungary, and Slovakia.

for further information please visit our web site eisai.co.jp

(i) Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 – 2233

(ii) Forsgren L, Beghi E, Oun A, Sillanpaa M. the epidemiology of epilepsy in Europe – a systematic review. Eur J Neurol. 2005 Apr;12(4):245-53

(iii) Epilepsy Society UK: epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow Last accessed Dec 2010

Eisai Europe Limited

NDA filing planned in second half of 2011 following completion of extended use study

Conference call to begin at 4:30 p.m. Eastern time today

SAN DIEGO–(BUSINESS WIRE)–Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo (p=0.0047) in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. this second budesonide MMX Phase III clinical study was conducted in Europe in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals.

“we plan to submit a new Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study.”

“Positive top-line results from the European Phase III study are consistent with those from the U.S. Phase III study that we announced in late September. both studies indicate that the higher, 9 mg dosage strength of budesonide MMX was statistically superior to placebo for the induction of remission of mild or moderate active ulcerative colitis,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We plan to submit a new Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study.”

as specified in the statistical analysis plans that were submitted to the FDA for both Phase III studies, a p-value of 0.025 was required to achieve statistical significance for the comparison of each budesonide MMX dosage strength (9 mg and 6 mg) with placebo.

The intent-to-treat (ITT) population was pre-defined in the statistical analysis plan as all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, Good Clinical Practice (GCP) violations or major entry criteria violations.

Based on the preliminary analysis, the remission rates for the four treatment groups in the ITT population are summarized in the table below (the p-values correspond to the statistical comparison of remission rates in the three active treatment groups with placebo):

Treatment Arm

Number of Patients

Patients in Remission (%)

p-value

Budesonide MMX 9 mg   109   19 (17.4%)   0.0047* Budesonide MMX 6 mg   109   9 ( 8.3%)   Entocort®EC (budesonide) reference arm(a)   103   13 (12.6%)   Placebo   89   4 ( 4.5%)      

*Statistically significant vs placebo at p=0.025

**Statistically significant vs placebo at p=0.05

(a)Not powered to show a statistical difference between budesonide MMX treatment arms and Entocort EC

please refer to Santarus’ Current Report on Form 8-K filed today with the Securities and Exchange Commission for additional information on the European budesonide MMX Phase III clinical study results.

Safety

The top-line study results indicate that budesonide MMX 9 mg and 6 mg were generally well tolerated and the frequency of treatment related adverse events was similar across all treatment groups.

Budesonide MMX Phase III Study Design

Budesonide MMX was evaluated for the treatment of mild or moderate active ulcerative colitis in two Phase III clinical studies, both of which are intended to support U.S. regulatory submission. The primary endpoint was the achievement of clinical remission, defined as a UCDAI score ? 1 after eight weeks of treatment with a score of 0 for rectal bleeding and stool frequency, and ? 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (an indicator of mucosal inflammation).

Each clinical study was a multicenter, randomized, double-blind, double-dummy, placebo-controlled four-arm study.

• Study CB-01-02/02 was conducted in Europe and compared budesonide MMX 9 mg or 6 mg dosed once daily to placebo. a reference arm using three Entocort EC 3 mg capsules for a total of 9 mg dosed once daily was also included.
• Study CB-01-02/01 was conducted in the U.S. and India and compared budesonide MMX 9 mg or 6 mg dosed once daily to placebo. a reference arm using two Asacol® (mesalamine) 400 mg delayed-release tablets dosed three times a day for a total of 2400 mg daily was also included.

The Phase III clinical studies were powered to show a statistical difference between the two budesonide MMX treatment arms and placebo. The reference arms using Entocort EC in the European study and Asacol in the U.S. study were not powered to show statistical differences versus budesonide MMX.

Extended use Study Ongoing Through Second Quarter 2011

as previously reported, the FDA requested that the results from an additional 12-month extended use study be included in the Phase III clinical program to support a U.S. regulatory submission. this study is designed to:

• Evaluate the long-term safety and tolerability of budesonide MMX 6 mg, and
• Collect data on the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo.

a total of 123 patients from the Phase III clinical studies in the U.S., India and Europe were enrolled in this double-blind, placebo-controlled extended use study, which is scheduled to be completed in the second quarter of 2011.

Achievement of Clinical Milestone

Based on the results of the U.S. and European Phase III clinical studies, Cosmo is entitled to receive a $3.0 million milestone payment, payable in cash or through issuance of shares of Santarus’ common stock, at Cosmo’s option, subject to certain limitations.

Conference Call

Santarus has scheduled an investor conference call at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) today, November 8, 2010 to discuss this announcement and the company’s third quarter 2010 financial results. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. a telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 17860587. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company’s website at santarus.com and a recording of the call will be available on the company’s website for 14 days following the completion of the call.

About Budesonide MMX

Budesonide MMX is an investigational drug that is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes Cosmo’s proprietary MMX® multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids.

About Ulcerative Colitis

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. it is believed that as many as 1.2 million people in the U.S. have IBD.

Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to aminosalicylate (5-ASA) drugs. Patients refractive to treatment with 5-ASA drugs typically receive a course of an oral, systemically absorbed corticosteroid, the success of which may be limited by significant side effects. for moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. if the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company expects to commercially launch CYCLOSET in November 2010.

Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: budesonide MMX® for induction of remission of active ulcerative colitis, rifamycin SV MMX® for treatment of travelers’ diarrhea and RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema. in addition, Santarus plans to initiate a Phase I clinical study in the first half of 2011 with SAN-300, its anti-VLA-1 antibody, which the company expects to investigate for the treatment of rheumatoid arthritis. More information about Santarus is available on the company’s website at santarus.com.

Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. these forward-looking statements include statements regarding the timing of the completion of the extended use study and the U.S. NDA submission for budesonide MMX. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus’ ability to successfully develop its budesonide MMX and other product candidates in a timely manner or at all (including timely and successful completion of the budesonide MMX extended use study); whether Santarus is able to obtain regulatory approval for budesonide MMX and its other product candidates in a timely manner or at all, including whether the FDA agrees with the statistical analysis plan for the budesonide MMX Phase III studies, the clinical interpretation of the results and the conduct of the studies; risks associated with the collaboration with Cosmo relating to the MMX product candidates, including the potential for termination of the collaboration; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus® is a registered trademark of Santarus, Inc. MMX® is a registered trademark of Cosmo Technologies Limited. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a registered trademark of VeroScience LLC. RHUCIN® is a registered trademark of Pharming Group NV. Any other trademarks in this press release are the property of their respective owners.

Posted on 09/08/2010 in Pharmaceutical Company Product News

Shire has published data from a phase IIIb study of its attention deficit hyperactivity disorder (ADHD) drug Vyvanse, demonstrating its efficacy among adult patients.Results published in the medical journal Behavioral and Brain Functions showed that patients using the once-daily Vyvanse Capsule CII treatment benefited from improved attention spans between two and 14 hours after administering.it has previously been proven to offer similar benefits among children aged between six and 12 in previous clinical studies.Dr Matthew Brams, study author and clinical assistant professor of psychiatry at Baylor College of Medicine, said this illustrates the drug’s benefits for ADHD sufferers wishing to manage their symptoms during a working day.He added: “Because ADHD symptoms may extend into the evening for many adults, the availability of treatments that provide symptom improvement throughout the day is important.”Earlier this month, the company published phase III trial data for the hereditary angioedema Firazyr, illustrating its efficacy when compared to placebo.

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