Pacritinib Phase 3 Study Shows Positive Results In Patient Reported Outcomes Measuring Quality Of Life In Patients With Myelofibrosis






VIENNA, June 12, 2015 /PRNewswire/ — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) and Baxter International’s BioScience business (NYSE: BAX) today announced Brand-new patient-reported outcome (PRO) data for pacritinib – an investigational oral multikinase inhibitor along with specificity for JAK2 and FLT3 – from the Phase 3 PERSIST-1 study. As recently reported at the American Society of Clinical Oncology (ASCO) annual meeting, results prove to a substantial reduction in the Total Symptom Score (TSS) (the proportion of patients along with a 50 percent or higher reduction in TSS from baseline to Week 24), and in each specific common disease-related symptom, from baseline to Week 24, in patients treated along with pacritinib compared to ideal available therapy (exclusive of a JAK inhibitor) (BAT). These PROs, as well as others quality of life measures, will certainly be presented at the 20th Congress of European Hematology Association (EHA) by Adam Mead, M.D., Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, United Kingdom in an oral presentation on Sunday, June 14, 2015 at 12:15 CEST (abstract #LB2072). These data were likewise picked for inclusion in the official EHA Press Briefing which occurred today (Friday, June 12, 2015) at 08:30 CEST. As previously reported, the PERSIST-1 trial met its primary endpoint of spleen volume reduction of 35 percent or higher from baseline to Week 24 as measured by MRI/CT scan.

Myelofibrosis is a rare blood cancer associated along with significantly reasonable quality of life and shortened survival. As the disease progresses, the physique slows production of essential blood cells and within one year of diagnosis the incidence of disease-related thrombocytopenia (quite reasonable blood platelet counts), severe anemia, and red blood cell transfusion requirements boosts significantly. Among others complications, most patients along with myelofibrosis present along with enlarged spleens (splenomegaly), as well as lots of others potentially devastating physical symptoms such as abdominal discomfort, bone pain, feeling full after consuming little, severe itching, night sweats, and extreme fatigue.

“Patient-reported outcomes are an essential measure for understanding the potential benefit of a therapy on patients’ lives – particularly for a disease such as myelofibrosis where the symptoms have actually such a tremendous impact on the quality of patients’ day-to-day lives,” stated James A. Bianco, M.D., President and CEO of CTI BioPharma. “These Brand-new data from the PERSIST-1 study further support our belief, not only in the activity of pacritinib, however likewise the potential to positively impact patients’ day-to-day lives by relieving the symptoms that accompany myelofibrosis.” 

“The PERSIST-1 trial has actually continued to generate positive and essential findings for the hematology community,” said David Meek, Head of Oncology at Baxter BioScience. “We look forward to advancing the clinical trial program of pacritinib as we job to realize the full potential of this investigational compound to advice patients along with serious blood cancers, such as myelofibrosis.”

Study Details and Findings Presented at EHA
PERSIST-1 is a randomized (2:1), controlled Phase 3 registration-directed trial comparing the efficacy and safety of pacritinib to BAT – which included a range of currently utilized off-label treatments – in 327 patients along with myelofibrosis, regardless of the patients’ platelet counts. As previously reported at ASCO, the trial met its primary endpoint of spleen volume reduction (35 percent or higher reduction from baseline to Week 24 by MRI/CT scan) in the intent-to-treat (ITT) population; these results included patients along with severe or life-threatening thrombocytopenia. The study likewise measured patient-reported outcomes (PROs), the proportion of patients along with a 50 percent or higher reduction in TSS from baseline to Week 24, which have actually become essential for approval of Brand-new therapies and was one of the secondary endpoints of the study. As previously reported, patients treated along with pacritinib suffered higher improvement in their disease-related symptoms (ITT patient population: 24.5 percent of pacritinib-treated patients vs 6.5 percent of BAT-treated patients, p<0.0001; evaluable patient population: 40.9 percent of pacritinib-treated patients vs 9.9 percent of BAT-treated patients, p<0.0001).

New data presented at EHA, which included results from multiple PROs measurement tools, showed:

Myeloproliferative Neoplasm Symptom Assessment (MPN-SAF TSS and MPN-SAF TSS 2.0)
As quickly as using the MPN-SAF TSS and MPN-SAF TSS 2.0, each of the 6 common disease-related symptoms from the TSS results showed improvements in abdominal discomfort (46 percent improvement along with pacritinib vs no improvement along with BAT); bone pain (32 percent improvement along with pacritinib vs 8 percent improvement along with BAT); feeling of early fullness (45 percent improvement along with pacritinib vs 1 percent worsening along with BAT); itching (48.5 percent improvement along with pacritinib vs 10 percent improvement along with BAT); night sweats (69.5 percent improvement along with pacritinib vs no improvement along with BAT); and fatigue (27.5 percent improvement along with pacritinib vs 4 percent worsening along with BAT). MPN-SAF TSS and MPN-SAF TSS 2.0 are individual sets of questions patients answer day-to-day (via electronic diary) and which are based on a questionnaire originally created by Ruben A. Mesa, M.D., Deputy Director of the Mayo Clinic Cancer Focus in Scottsdale, Arizona, USA.

Patient Global Impression of Modification (PGIC)
Based on the PGIC assessment – which measures a patient’s assessment of overall health on a 7-point scale ranging from “quite much worse” to “quite much improved” – approximately 80 percent of evaluable patients treated along with pacritinib rated their condition as improved compared to approximately 20 percent along with BAT.

European Organization for Research and Treatment of Cancer Quality-of-Life 30 Questionnaire (EORTC QLQ-C30)
A higher improvement was likewise reported by evaluable patients treated along with pacritinib vs BAT across all components of the EORTC QLQ-C30 questionnaire, a well-validated measure of quality of life in cancer patients.

The most common edge events occurring along with pacritinib within 24 weeks, of any grade, were mild to moderate diarrhea (53.2 percent vs 12.3 percent along with BAT), nausea (26.8 percent vs 6.6 percent along with BAT), anemia (22.3 percent vs 19.8 percent along with BAT), thrombocytopenia (16.8 percent vs 13.2 percent along with BAT), and vomiting (15.9 percent vs 5.7 percent along with BAT). Of the patients treated along with pacritinib, 3 discontinued therapy and 13 patients needed dose interruption (standard one week) for diarrhea. Patients received a day-to-day full dose of pacritinib over the duration of treatment. Gastrointestinal symptoms typically lasted for approximately one week and few patients discontinued treatment as a result of adverse effects. There were no Grade 4 gastrointestinal events reported.

About Pacritinib
Pacritinib is an investigational oral multikinase inhibitor along with specificity for JAK2 and FLT3. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have actually been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia, and lymphoma.

About Myelofibrosis
Myelofibrosis is a serious and life-threatening chronic blood cancer caused by the accumulation of malignant bone marrow cells that causes an inflammatory response and scars the bone marrow. The replacement of bone marrow along with scar tissue limits its ability to develop red blood cells, prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue, and pain.  Myelofibrosis is a one of three main types of myeloproliferative neoplasms (MPN), which are a closely related group of hematological blood cancers.1 The estimated prevalence of MPNs suggest there are approximately 300,000 individuals living along with the disease in the U.S. of which myelofibrosis accounts for approximately 18,000 patients.2 In Europe, there is a wide variation of prevalence observed across data sources. Myelofibrosis has actually a median age of 64 at the time of diagnosis2 and is a progressive disease along with approximately 20 percent of patients eventually making acute myeloid leukemia.3 The median survival for high-risk patients is much less compared to one and a half years; median survival for myelofibrosis patients overall is approximately 6 years.4

About the PERSIST Phase 3 Development Program of Pacritinib
Pacritinib is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients along with myelofibrosis. PERSIST-1 is a randomized (2:1), open-label, multinational Phase 3 clinical trial comparing the efficacy and safety of pacritinib along with that of BAT, in 327 enrolled patients along with primary and secondary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-necessary thrombocythemia myelofibrosis (PET-MF), devoid of exclusion for reasonable platelet counts. PERSIST-2 is a randomized (2:1), open-label, multinational Phase 3 clinical trial evaluating pacritinib compared to BAT, including the approved JAK1/JAK2 inhibitor dosed according to product label for patients along with myelofibrosis whose platelet counts are much less compared to or equal to 100,000 per microliter. The trial is designed to enroll up to 300 patients in North America, Europe, Australia, New Zealand, and Russia.

Additional details are available at www.clinicaltrials.gov or www.PERSISTprogram.com.

CTI BioPharma and Baxter BioScience, which is expected to become Baxalta Incorporated in mid-2015, entered in to a global license agreement in November 2013 to produce and commercialize pacritinib. CTI BioPharma and Baxter will certainly jointly commercialize pacritinib in the U.S. while Baxter has actually exclusive commercialization rights for all indications outside the U.S.

About CTI BioPharma Corp.
CTI BioPharma Corp. (NASDAQ and MTA: CTIC) is a biopharmaceutical company focused on the acquisition, development, and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has actually a commercial presence in Europe and a late-stage development pipeline, including pacritinib, CTI BioPharma’s lead product candidate, which is currently being studied in a Phase 3 program for the treatment of patients along with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington, along with offices in London and Milan under the name CTI Life Sciences Limited. For additional article and to sign up for email alerts and grab RSS feeds, please visit www.ctibiopharma.com.

About Baxter Global Inc.
Baxter Global Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of individuals along with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and others chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to produce products that advance patient care worldwide.

Forward Looking Statements
This press release includes forward-looking statements related to pacritinib and related clinical trials conducted pursuant to a collaboration between Baxter Global Inc. and CTI BioPharma Corp., as well as statements concerning the planned separation of Baxter’s biopharmaceutical and medical products businesses, which are within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the issuers’ securities. Such statements include, however are not limited to, statements concerning expectations along with respect to the potential therapeutic utility of pacritinib, the ability of the PERSIST-1 and PERSIST-2 trials to support a potential regulatory submission, the anticipated completion of enrollment, the ability of pacritinib to meet unmet medical requires and future regulatory, development and commercialization plans. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and are based on assumptions Concerning lots of essential factors and article currently available to us to the extent we have actually thus far had an opportunity to evaluate such article in light of all surrounding facts, circumstances, guidance and analyses. A number of results and uncertainties could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and others requirements; clinical trial results; changes in laws and regulations; product quality, product efficacy, study protocol, data integrity or patient safety issues; product development risks; and others risks identified in each issuer’s most recent filings on Form 10-K and others Securities and Exchange Commission filings as well as the Form 10 filed by Baxalta Incorporated. Neither Baxter nor CTI BioPharma undertakes to update its forward-looking statements.

1. MPN Research Foundation website, www.mpnresearchfoundation.org.

2. Based on Mesa R, ASH 2012 poster.

3. Cervantes F, et al., Brand-new prognostic scoring system for primary myelofibrosis based on a study of the Global Working Group for Myelofibrosis Research and Treatment. Blood. 2009; 113:2895-2901.

4. Vannucchi, A. Management of Myelofibrosis. ASH Education Book. 2011; 1:222-230.

CTI BioPharma Contact:
Monique Greer
206-272-4343
mgreer@ctibiopharma.com

Baxter Investor Contact:
Mary Kay Ladone
224-948-3371

Baxter Media Contact:
Kellie Hotz
224-948-5353
media@baxter.com

 

SOURCE CTI BioPharma Corp.; Baxter

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Axovant Sciences Ltd. Announces Pricing of Initial Public Offering






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HAMILTON, Bermuda, June 10, 2015 /PRNewswire/ — Axovant Sciences Ltd. (NYSE: AXON), a clinical-phase biopharmaceutical company, today announced the pricing of its first public supplying of 21,000,000 common shares at a fee of $15.00 per share. The common shares of Axovant Sciences Ltd. have actually been approved for listing on the brand-new York Stock Exchange and are expected to start trading under the ticker symbol “AXON” on June 11, 2015. Every one of the common shares are being readily available by Axovant Sciences Ltd. In addition, Axovant Sciences Ltd. has actually granted the underwriters a 30-day option to get up to 3,150,000 extra common shares.

Jefferies LLC, Evercore Group L.L.C. and RBC Capital Markets LLC are acting as joint book-operating managers for the offering. JMP Securities LLC is acting as lead manager, and Robert W. Baird & Co. Incorporated is acting as co-manager for the offering.

The supplying will certainly be gained just by means of a prospectus. As soon as available, copies of the last prospectus related to the supplying could be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 5twenty Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: Prospectus_Department@Jefferies.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (212) 653-9054 or email: ecm@evercore.com; or RBC Capital Markets, LLC, Attention: Prospectus Department, Brookfield Place, 200 Vesey Street 8th Floor, New York, NY 10281, telephone: (877) 822-4089, email: equityprospectus@rbccm.com.

A registration statement relating to these securities has actually been filed along with the Securities and Exchange Commission and was declared efficient on June 10, 2015. This press launch shall not constitute an supply to sell or the solicitation of an supply to get nor shall there be any kind of sale of these securities in any kind of point out or jurisdiction in which such offer, solicitation or sale would certainly be unlawful prior to registration or qualification under the securities laws of any kind of such point out or jurisdiction.

About Axovant
Axovant Sciences Ltd. is a clinical-phase biopharmaceutical business focused on the acquisition, progress and commercialization of novel therapeutics for the treatment of neurodegenerative disorders. Axovant intends to create a pipeline of product candidates to comprehensively manage the cognitive, behavioral and functional components of dementia, a condition characterized by substantial decline in psychological capacity and impaired day-to-day function. 

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CROMSOURCE lance le service de solutions de dotation en personnel TalentSource Life Sciences






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VÉRONE, Italie, June 9, 2015 /PRNewswire/ —

CROMSOURCE annonce ce jour le lancement de TalentSource Life Sciences, le nouveau nom et la nouvelle identité de marque de child program établi de programs de dotation en staff pour le secteur clinique des sciences de la vie. Ce changement de marque témoigne de l’engagement de TalentSource Life Sciences à recruter des specialists talentueux, capables d’apporter une supplement majeure dans le cadre de leurs responsabilités auprès des sociétés clientes. Le logo choisi réunit l’picture d’une silhouette aux bras étendus prête à aider et une double hélice stylisée, symbolisant la manière dont les recherches cliniques font partie intégrante de l’ADN de TalentSource Life Sciences.

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« L’inspire des cabinets de dotation généralistes sur notre secteur s’est accrue au cours des dernières années », a précisé Sabine Hutchison, dirigeante respectée du secteur, qui s’est récemment jointe à CROMSOURCE en qualité de conseillère chargée de la division TalentSource Life Sciences. « En revanche, nos clients apprécient notre soutien et les spécialistes compétents que nous leur fournissons, ainsi que les atouts d’un partenaire qui connaît vraiment leur secteur d’activité ».

« Après plus de twenty ans de réussites sous la bannière CROMSOURCE, il était temps de créer une nouvelle identité pour notre program de programs de dotation en staff », a expliqué Oriana Zerbini, PDG de CROMSOURCE. « À cet effet, nous tenions à mettre l’accent sur notre philosophie qui repose sur la souplesse avec laquelle nous proposons les specialists le mieux qualifiés du secteur qui peuvent compter sur le savoir-faire et le soutien de CROMSOURCE dans leur travail avec nos clients ».

À propos de CROMSOURCE : Fondé en 1994, CROMSOURCE est le premier prestataire indépendant de programs externalisés complets à l’échelle internationale pour les secteurs pharmaceutique, de la biotechnologie et des instruments médicaux. CROMSOURCE se spécialise dans le développement clinique et les programs de dotation en staff à travers l’Europe et l’Amérique du Nord.

Contact :
Margherita Mosconi
CROM

SOURCE
Téléphone : +39-045-8222811
Fax : +39-045-8222812
(Siège européen)
Via Giorgio De Sandre, 3
37135 Vérone, Italie

Lilly’s Basal Insulin Peglispro Shows Superiority to Insulin Glargine in Reducing HbA1c in People with Type 2 Diabetes






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INDIANAPOLIS, June 6, 2015 /PRNewswire/ — Eli Lilly and Company’s (NYSE: LLY) basal insulin peglispro (BIL) consistently demonstrated superior hemoglobin A1c (HbA1c) reduction in people along with type 2 diabetes compared to insulin glargine across three Phase III trials. The results were presented today at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston.1,2,3

The trials compared BIL and insulin glargine in three common type 2 patient populations: those not previously using insulin (IMAGINE-2), those using basal insulin along with mealtime insulin (IMAGINE-4) and those currently using a basal insulin (IMAGINE-5).

“BIL is the initial and only basal insulin to consistently demonstrate superior glycemic benefits along along with a reduction in nocturnal hypoglycemia and a weight advantage compared to insulin glargine in Phase III clinical studies,” said Melanie Davies, M.D., professor of diabetes medicine, University of Leicester, United Kingdom. “Further innovation in basal insulin treatments is necessary as lots of people currently being treated do not reach glycemic targets and experience nocturnal hypoglycemia or weight gain.”

Additional data from IMAGINE-2, IMAGINE-4 and IMAGINE-five showed that a lot more patients taking BIL consistently met the ADA’s recommended HbA1c target of much less compared to 7 percent.4 A higher percentage of BIL-treated patients additionally reported much less nocturnal hypoglycemia compared to those on insulin glargine. Rates of total and severe hypoglycemia did not differ significantly between treatment groups. Patients taking BIL went through much less weight gain compared to patients taking insulin glargine in IMAGINE-2 and IMAGINE-4.

In all three clinical trials, patients taking BIL had an increase in the liver enzyme ALT (alanine aminotransferase), and triglyceride levels were better compared to in patients treated along with insulin glargine.1,2,3  Liver fat content was better after treatment along with BIL compared to insulin glargine in subsets of patients studied from IMAGINE-2 and IMAGINE-5. 

“BIL is mechanistically different from current basal insulins. It has actually a hepato-preferential action, driven by its low effect on peripheral tissues,” said David Kendall, M.D., vice president, Medical Affairs, Lilly Diabetes. “Exactly what we’ve seen from the Phase III trials are unprecedented results in the basal insulin space: superior glycemic control along with much less nocturnal hypoglycemia and low weight gain, all of which are necessary to physicians and patients. We’re pleased to share these Phase III results along with the scientific community this week. ”

BIL Type 2 Clinical Data
In all three type 2 diabetes trials, BIL showed consistent superiority in reducing HbA1c levels from baseline to the primary endpoint compared to insulin glargine:1,2,3,5

  • IMAGINE-2 (reductions of 1.6 percent vs. 1.3 percent at 52 weeks)1
  • IMAGINE-4 (reductions of 1.7 percent vs. 1.five percent at 26 weeks)2
  • IMAGINE-five (reductions of 0.82 percent vs. 0.29 percent at 26 weeks).3

More patients taking BIL reached the ADA’s recommended target HbA1c of much less compared to 7 percent compared to insulin glargine at the primary endpoint:

  • IMAGINE-2: 58 percent vs. 43 percent at 52 weeks1
  • IMAGINE-4: 63 percent vs. 53 percent at 26 weeks2
  • IMAGINE-5: 73 percent vs. 52 percent at 26 weeks3

In another Phase III trial (IMAGINE-6), patients taking BIL went through higher reductions in HbA1c compared to those taking Neutral Protamine Hagedorn (NPH) insulin (1.7 percent vs. 1.4 percent). a lot more BIL patients additionally reached the ADA’s recommended target of much less compared to 7 percent (63.1 percent vs. 43.4 percent).5 A higher percentage of BIL-treated patients additionally reported much less nocturnal hypoglycemia compared to those on NPH.

Hepatic (liver) safety findings:

  • In integrated analyses of type 2 diabetes clinical trials compared to glargine, a lot more patients taking BIL had a mean increase from baseline in the liver enzyme ALT at 52 weeks (mean difference between treatment groups: 7.4 IU/L). Additionally, a higher proportion of BIL patients had ALT levels higher compared to or equal to three times the upper limit of the normal range (ALT≥3X ULN) compared to insulin glargine (2.03 percent vs. 0.62 percent). No cases of severe drug-induced liver injury (Hy’s Law) occurred in these studies.

    • IMAGINE-2 :

      • ALT modification from baseline at 52 weeks: 4.1 IU/L vs. -2.0 IU/L
      • ALT ≥3X ULN: 2.3 percent vs. 0.6 percent1
    • IMAGINE-4:
      • ALT modification from baseline at 26 weeks: 7.6 IU/L vs. -0.6 IU/L
      • ALT ≥3X ULN: 1.9 percent vs. 0.9 percent2
    • IMAGINE-5:
      • ALT modification from baseline at 52 weeks: 8.3 IU/L vs. 0.4 IU/L
      • ALT ≥3X ULN: 2.3 percent vs. 0.0 percent3
  • In IMAGINE-6, a lot more patients taking BIL had a mean increase from baseline in the liver enzyme ALT at 52 weeks (mean difference between treatment groups: 7.4 IU/L). However, the proportion of BIL patients that had ALT levels higher compared to or equal to three times the upper limit of the normal range (ALT≥3X ULN) was similar to patients treated along with NPH insulin.
  • In IMAGINE-2 and IMAGINE-5, liver fat was measured using magnetic resonance imaging (MRI) in a subset of patients. Results showed:
    • In IMAGINE-2, liver fat did not modification from baseline in patients treated along with BIL, while patients taking insulin glargine went through a decrease in liver fat from 12.7 percent at baseline to 10.0 percent at 52 weeks. The mean difference between treatment groups at 52 weeks was 2.6 percent.1
    • In IMAGINE-5, patients taking BIL went through an increase in liver fat from 10.4 percent at baseline to 14.8 percent at 52 weeks, while liver fat did not modification significantly in patients taking insulin glargine. The mean difference between treatment groups at 52 weeks was 5.3 percent.3 

Non-hepatic safety findings:

  • In IMAGINE-2, IMAGINE-4 and IMAGINE-five trials, triglycerides were better in patients treated along with BIL compared to insulin glargine. Rates of major edge cardiac events MACE+ (cardiovascular death, non-fatal stroke, non-fatal MI and hospitalization as a result of unstable angina) were similar between patients treated along with BIL and insulin glargine.1,2,3
  • An analysis across all trials – including type 1—showed that the rates of major edge cardiovascular events among patients taking BIL and those taking insulin glargine or NPH insulin were similar, along with an observed hazard ratio below 1 and the upper limit of the 9five percent assurance interval below 1.4.
  • Injection site reactions were a lot more common along with BIL compared to insulin glargine.1,2,3

About the Studies
IMAGINE-2
IMAGINE-2 is a Phase III, randomized, 52-week, double-blind, treat-to-target study of BIL (n=1,003) compared to insulin glargine (n=535) in insulin-naïve patients along with type 2 diabetes. Patients in both groups had a baseline HbA1c of 8.five percent. Insulin therapy was taken alone or on a background of oral antihyperglycemic medication.1

IMAGINE-4
IMAGINE-4 is a Phase III, randomized, 26-week, double-blind, treat-to-target study designed to compare BIL (n=691; baseline HbA1c: 8.4 percent) to insulin glargine (n=678; baseline HbA1c: 8.five percent) in combination along with mealtime insulin in patients along with type 2 diabetes.2

IMAGINE-5
IMAGINE-five is a Phase III, 52-week, open-label, randomized, treat-to-target study designed to evaluate BIL (n=307) compared to insulin glargine (n=159) in patients along with type 2 diabetes already taking a basal insulin. Patients in both groups had a baseline HbA1c of 7.4 percent. Insulin was administered alone or in combination along with oral antihyperglycemic medications.3

IMAGINE-6
IMAGINE-6 is a Phase III, 26-week, open-label, treat-to-target, randomized study designed to determine if BIL (n=428) was non-inferior to NPH insulin (n=213) in reducing HbA1c once added to pre-study oral agents. Patients in both groups had a baseline HbA1c of 8.five percent. Insulin was administered alone or in combination along with oral antihyperglycemic medications.5

About Basal Insulin Peglispro
Basal insulin peglispro (BIL), which was discovered and created in Lilly Research Laboratories, is currently in Phase III clinical trials and is being studied as a once-day-to-day basal insulin treatment for type 1 and type 2 diabetes. BIL is a hepato-preferential basal insulin. Its activity profile is derived from its low effect in peripheral tissue, making it a lot more similar to endogenous insulin compared to others exogenous insulins along with a conventional activity profile.   

In the clinical trial program to date, consisting of a lot more compared to 6,000 patients, approximately 3,900 patients have actually been treated along with BIL. In the core Phase III clinical trial program – consisting of seven IMAGINE trials in patients along with type 1 and type 2 diabetes – superiority in HbA1c for BIL was seen in 5 trials conducted versus insulin glargine. 

About Diabetes
Approximately 29 million Americans6 and an estimated 387 million people global have actually type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 9five percent of all diabetes cases.  Diabetes is a chronic disease that occurs once the physique either does not properly produce, or use, the hormone insulin.7

About Lilly Diabetes
Lilly has actually been a global leader in diabetes care since 1923, once we introduced the world’s initial commercial insulin. Today we are building upon this heritage by working to meet the diverse calls for of people along with diabetes and those that care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to offer real solutions—from medicines to support programs and more—we strive to make life much better for all those affected by diabetes around the world. For a lot more information, visit www.lillydiabetes.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring along with discovery to make life much better for people around the world. We were founded a lot more compared to a century ago by a man committed to developing high-quality medicines that meet real needs, and today we stay true to that mission in all our work. Across the globe, Lilly employees job to find and bring life-changing medicines to those that need them, improve the understanding and management of disease, and provide spine to communities through philanthropy and volunteerism. To learn a lot more Concerning Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

P-LLY

 

This press release contains forward-looking statements Concerning an investigational compound basal insulin peglispro, which is currently in development for the treatment of diabetes. It reflects Lilly’s current beliefs; however, as along with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no make sure that future study results and patient experience will certainly be consistent along with study findings to date or that basal insulin peglispro will certainly receive called for regulatory approvals or prove to be commercially successful. For further discussion of these and others risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed along with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

                         

1 Davies M, Russell-Jones D, Selam J, et al. Basal Insulin Peglispro (BIL) is Superior to Insulin Glargine (GL) in Reducing HbA1c at 52 Wks in Insulin-Naïve T2D Patients (Pts) Treated along with Oral Antihyperglycemic Medications (OAMs): IMAGINE 2. Abstract 93-OR. Presented at 75th American Diabetes Association (ADA) Scientific Sessions; 3 Buse J, Rodbard H, Serrano C, et al. Superior HbA1c Reduction along with Basal Insulin Peglispro (BIL) vs Insulin Glargine (GL) Alone or along with Oral Antihyperglycemic Medications (OAMs) in T2D Patients (Pts) Previously Treated along with Basal Insulin: IMAGINE 5. Abstract 984-P. Presented at 75th American Diabetes Association (ADA) Scientific Sessions; 5 Grunberger G, Chen L, Rodriguez Á, et al. Basal Insulin Peglispro (BIL) Provides Clinically and Significantly much better HbA1c Control along with much less Nocturnal Hypoglycemia compared to NPH once Used in Combination along with Oral Agents in Insulin-Naïve T2D Patients (Pts): IMAGINE 6. Abstract 1004-P. Presented at 75th American Diabetes Association (ADA) Scientific Sessions; 7 Global Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: Global Diabetes Federation, 2014. http://www.idf.org/diabetesatlas/update-2014.

Refer to: Candace Johnson, johnson_candace_a@lilly.com, (317) 755-9143

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