LAVAL, Quebec, June 1, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) ("Valeant" or the "Company") today announced the acceptance of five PROVENGE® (sipuleucel-T) scientific abstracts and one abstract regarding results from the Phase II study of DN24-02 at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO), which will take place June 3-7 in Chicago. The accepted abstracts include three poster presentations and one poster discussion. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer (more details below).
"We are proud to have the opportunity to present at the world's largest and most prestigious oncology meeting," stated Joseph C. Papa, chairman and chief executive officer. "Driving innovation is a key pillar of Valeant's strategy, and our team at our Dendreon business looks forward to sharing its promising research, which underscores our commitment to improving outcomes for patients."
"Extending survival for prostate cancer patients is at the heart of our development efforts, and we are excited with the potential that PROVENGE is showing across these studies," said James Caggiano, senior vice president and general manager of Dendreon.
Of note, the Company will present "Characteristics and Anticancer Interventions in African-American and Caucasian Patients Treated with sipuleucel-T: Real-World Experience from the PROCEED Registry." The research shows that African-American patients presented with higher baseline prostate-specific antigen and shorter prostate-specific antigen doubling time than Caucasian patients, but were less likely to have primary Gleason score 5. Despite the higher baseline prostate-specific antigens in African-American patients, which has been a predictor of worse clinical outcomes historically, Caucasian and African-American patients had similar time to anticancer interventions after sipuleucel-T. Additional follow-up will assess potential overall survival differences in these two patient groups.
For more information on ASCO's 2016 meeting, please visit http://iplanner.asco.org/am2016/#/.
On February 23, 2015, Valeant acquired the worldwide rights to PROVENGE, as well as certain other assets, from Dendreon Corporation.
PROVENGE® (sipuleucel-T)
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache and headache. Acute infusion reactions may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events, syncope, hypotension, hypertension and tachycardia. Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion. Cerebrovascular events and cardiovascular disorders have been reported following infusion of PROVENGE.
Please see the full Prescribing Information at www.valeant.com for more information.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
About ASCO
ASCO promotes and provides for lifelong learning for oncology professionals; cancer research; an improved environment for oncology practice; access to quality cancer care; a global network of oncology expertise; and educated and informed patients with cancer. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation, which funds groundbreaking research and programs that make a tangible difference in the lives of people with cancer. For further information, visit http://www.asco.org/.
Forward-looking Statements
This press release may contain forward-looking statements, including, but not limited to, expectations with respect to Valeant's' development efforts and the potential that PROVENGE is showing in clinical studies. Forward-looking statements may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.
Contact Information:
Laurie W. Little
laurie.little@valeant.com
or
Elif McDonald
elif.mcdonald@valeant.com
514-856-3855
877-281-6642 (toll free)
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
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SOURCE Valeant Pharmaceuticals International, Inc.