•Envarsus® (LCP-Tacro) is Veloxis' lead product candidate for suppression of the immune response to prevent the rejection of transplanted organs (immunosuppression)
•Positive top-line results from a clinical phase III study in newly operated kidney transplanted patients (de novo) were announced June 2013
◦Envarsus®, once-daily, demonstrated non-inferiority to Prograf®, twice-daily, based on the composite endpoint of treatment failure at one year (Envarsus® 18.3%, Prograf® 19.6%)
◦Treatment failure rates through the first three months after transplant were 10.4% for Envarsus® and 14.2% for Prograf®
◦Similar incidence of adverse events and impact on laboratory results reported for Envarsus® and Prograf®
•Positive top-line results from clinical phase III study in stable kidney transplant patients were announced June 2011
•In April 2013, Veloxis submitted a marketing authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union
•In December 2013, the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® in the U.S.
•Envarsus® will be a branded primary immunosuppressant drug not automatically substitutable by generics
•In 2010, more than 50,000 organ transplants were conducted in the United States, Japan, the United Kingdom, France, Germany, Italy and Spain
Envarsus® XR Demonstrates Lower Treatment Failure Rate in African-Americans Compared to Twice-Daily Tacrolimus (Prograf®)
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Result seen across stable and de novo kidney transplant patients -
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Data to be presented at the World Transplant Congress -
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®). These study data will be presented at the World Transplant Congress (WTC), July 26 to 31, in San Francisco, in a presentation entitled “Lower Treatment Failures in Blacks and Older De Novo and Stable Kidney Transplant Recipients Treated with Envarsus XR Once-Daily MeltDose Tablets vs. Twice Daily Prograf Capsules”. The presentation will occur at 6:30 pm – 8:00 PM, Sunday, July 27th, 2014. There are several additional presentations on Envarsus XR at WTC in addition to the subgroup analysis on African-American patients, which are summarized below.
Key points:
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Problem: Managing immunosuppression of African-American kidney transplant recipients can be challenging, as are clinical outcomes for this demographic group
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Envarsus XR is an extended release formulation of tacrolimus being designed for once-daily dosing, flatter pharmacokinetics and greater bioavailability compared to twice-daily Prograf (tacrolimus). Data from two Phase III trials were pooled (Envarsus XR n=428; Prograf n=433) and several pre-specified subgroup analyses were conducted
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African-American subgroup demonstrated significantly less efficacy failure in favor of Envarsus XR (-13.82%, CI=-27.22%, -0.31%)
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A second subgroup, older patients greater than 65 years of age demonstrated a similar significant result. Other pre-specified subgroups trended toward improved efficacy with Envarsus XR
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Other presentations on Envarsus XR accepted for presentation:
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Abst.2160, 11:39 AM/ Wednesday, July 30th, 2014/Room 2005/2007.
Once-daily Envarsus Demonstrates Comparable Efficacy and Safety to Twice-Daily Prograf: A Phase 3 Study for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
L. Rostaing, K. Ciechanowski, S. Bunnapradist, H.T. Silva, J.M. Grinyo, K. Budde
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Abst. A208, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
Once-Daily MeltDose Tacrolimus (Envarsus) Offers Dosing Flexibility and Maintains Therapeutic Activity When Make-Up Dose is Taken Outside of Schedule
S. Gabardi, R. Nachtrieb, V. Nigro
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Abst.A212, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
Higher Initial Exposure of Envarsus Immediately Post Transplantation is Not Associated with Increased Risk of Delayed Graft Function in Kidney Transplant Patients Treated with Novel Once-daily MeltDose Tacrolimus (Envarsus) Vs. Twice-Daily Tacrolimus (Prograf): Results from A Phase 3, Double-Blind, Double- Dummy, Multi-Center, Randomized Trial
K. Budde, H.T. Silva, S.M. Steinberg, N. Kamar
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Abst.A210, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
Rapid Attainment of Tacrolimus Trough Levels Early Post-Transplant Reduces Risk of Treatment Failure in De Novo Kidney Transplant Patients: A Covariate Analysis of a Phase 3 Double-Blind Study
J.M. Grinyo, L. Rostaing, K. Budde, K. Ciechanowski, S. Bunnapradist, H.T. Silva
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Abst.A207, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
Higher Starting Dose and Rapid Attainment of Tacrolimus Blood Levels with Envarsus Vs. Prograf is Not Associated with Increased Toxicity: Exploratory Analysis of A Phase 3, Double-Blind, Double- Dummy, Multi-Center, Randomized, Prospective Study of Envarsus (Once-daily MeltDose Tacrolimus Tablets) Vs. Prograf (Twice-daily Tacrolimus Capsules)
H.T. Silva, S. Bunnapradist, S.M. Steinberg
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Abst. A2978, 6:30 pm – 8:00 PM/Sunday, July 27th, 2014/Exhibit Hall.
Two-Year Results of Envarsus (Once-daily MeltDose Tacrolimus Tablets) vs Prograf (Twice-daily Tacrolimus Capsules): A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study
L. Rostaing, K. Ciechanowski, S. Bunnapradist, H.T. Silva, J.M. Grinyo, K. Budde,
Quotes:
Suphamai Bunnapradist, M.D., professor of Medicine and Director of Kidney Transplant Research at the Ronald Reagan Medical Center and David Geffen School of Medicine at UCLA, California, USA., said, “The African-American kidney transplant population has been a particularly challenging one to manage and unfortunately we have not been able to bring clinical outcomes to the same level as other transplant patient groups. The results of this pooled analysis suggest that a once-daily formulation of tacrolimus with improved pharmacokinetics and better bioavailability may improve clinical outcomes in these patients. This would be the first important clinical advance for African-American transplant patients in many years. Additional studies with Envarsus XR are being conducted and planned in this population group and we look forward to gaining further understanding.”
William Polvino, M.D., president and chief executive officer of Veloxis said, “We are developing Envarsus XR to improve the care and quality of life of organ transplant patients. Results to date have shown that Envarsus XR, based on our proprietary MeltDose formulation technology, improves the pharmacokinetic profile of tacrolimus enabling once-daily dosing and more stable and steady blood levels. The results presented at the World Transplant Congress suggest that this profile may translate into differential clinical results compared to other formulations of tacrolimus. Envarsus XR is now under regulatory review in the U.S. and we look forward to bringing this potentially important new medicine to patients.”
For Investor and media contact:
John Weinberg, M.D. Johnny Stilou
EVP & COO EVP & CFO
Phone: +1 908 304 3389 Phone: + 45 21 227 227
Email: jdw@veloxis.com Email: jst@veloxis.com
About Envarsus® XR and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus XR (tacrolimus extended-release tablets), known as Envarsus® in the EU, is an investigational new drug that is being developed as a once daily tablet version of tacrolimus for prophylaxis of organ transplant rejection.
About Veloxis Pharmaceuticals
Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company’s lead product candidate is Envarsus® XR for immunosuppression, specifically organ transplantation. Veloxis’ unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low scale up costs. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Salix, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.
HORSHOLM, Denmark, July 28, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
Key points:
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The EMA marketing authorization is based on review of the favorable results of the Envarsus® Phase III 3001 study in stable kidney transplant patients and 3002 study in de novo kidney transplant recipients as well as data from an extensive Phase I and II clinical program, which included both kidney and liver transplant patients.
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Studies 3001 and 3002 demonstrated that Envarsus® dosed once-daily was not inferior to the current leading transplant drug, Prograf® (tacrolimus), dosed twice-daily. The Phase I pharmacokinetic and Phase II efficacy data that was submitted in the MAA enabled extrapolation into the broader populations of both kidney and liver transplant recipients.
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The marketing authorization includes both the de novo transplant and "switch" settings, as well as for treatment of rejection episodes resistant to treatment with other immunosuppressive products in adult patients.
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There are approximately 20,000 kidney transplants performed each year in the EU and approximately 7,000 liver transplants.
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Chiesi Farmaceutici S.p.A., through an exclusive license and distribution agreement with Veloxis, will hold the Marketing Authorization and commercialize Envarsus® in the European Union.
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Veloxis' New Drug Application (NDA) for Envarsus® XR for the prevention of organ rejection in kidney transplant patients is under regulatory review by the U.S. FDA and has a PDUFA action date of October 30, 2014. Veloxis does not expect to receive the additional liver indication in the U.S.
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Envarsus® XR received Orphan Drug Designation by the U.S. FDA for prophylaxis of organ rejection in patients receiving allogeneic kidney transplants.
The content of this release will have no influence on Veloxis' financial guidance for 2014 which was provided on 5 March 2014.
Quotes:
Professor Lionel Rostaing, Toulouse University Hospital, France said, "We are very pleased to have a new treatment option available for our transplant patients. Patients must receive immunosuppression as lifelong therapy and Envarsus represents a new once-daily treatment option that may allow patients to more consistently maintain their prescribed treatment regimen."
William Polvino, chief executive officer of Veloxis said, "This approval enables our partner, Chiesi, to offer a novel alternative therapy to kidney and liver transplant patients in the European Union. It further validates our clinical development plan and our underlying MeltDose technology. We now look forward to the initial launch of Envarsus in EU markets starting late this year."
Paolo Chiesi, Corporate R&D Head and Vice President of Chiesi Farmaceutici said, "Chiesi is delighted to have been part of the team which achieved this successful product approval in Europe. As marketing authorization holder we are fully committed to execute both the commercialization and roll out of an important program of further clinical studies for this innovative product. We believe Envarsus will be a valuable therapeutic for a broad population of transplant recipients, and its inclusion in the Chiesi portfolio provides an excellent strategic fit for the business as we expand our activities in the area of specialty care."
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For Investor and media contact:
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John Weinberg, M.D.
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Johnny Stilou
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EVP & COO
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EVP & CFO
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Phone: +1 908 304 3389
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Phone: + 45 21 227 227
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Email: jdw@veloxis.com
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Email: jst@veloxis.com
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About Envarsus® XR and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus (tacrolimus prolonged release tablets) has received marketing authorization in the EU for prophylaxis of organ rejection in kidney and liver transplant recipients. In the US Envarsus, known as Envarsus XR (tacrolimus extended-release tablets), is an investigational new drug under FDA review that is being developed as a once daily tablet version of tacrolimus for prophylaxis of kidney transplant rejection. Envarsus XR has received orphan drug designation in the US. Upon approval, Veloxis plans to commercialize Envarsus XR in the US through its own sales force and in the EU through its partnership with Chiesi Farmaceutici S.p.A.
About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is Envarsus® XR for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low scale up costs. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Salix, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.
For further information, please visit www.veloxis.com.
About Chiesi Farmaceutici
Chiesi Farmaceutici is a research-focused international group, with more than 75 years of experience headquartered in Parma (Italy). Chiesi researches, develops and commercializes innovative pharmaceutical solutions in the respiratory therapeutics, specialist medicine and rare diseases areas. In 2013, Chiesi achieved sales of over 1.2 billion Euros, constituting double digit growth over 2012. Its R&D centers in Parma (Italy), Paris (France), Rockville (USA), Chippenham (UK) and the R&D team of the newly-acquired Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. The Chiesi Group employs approximately 3900 people, 480 of which are dedicated to R&D activities.
For more information, please visit www.chiesi.com.
SOURCE Veloxis Pharmaceuticals A/S
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