Navigation Links
WuXi PharmaTech to Partner with Pharmacyclics
Date:11/15/2013

SHANGHAI, Nov. 15, 2013 /PRNewswire/ -- WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announced that its wholly owned subsidiary Shanghai SynTheAll (STA) Pharmaceutical Co., Ltd., has entered into a supply arrangement with Pharmacyclics, Inc. (Nasdaq: PCYC). This follows a successful multiple-year development and clinical manufacturing partnership that supported Pharmacyclics with the expedited New Drug Application submission and final approval by the U.S. Food & Drug Administration (FDA).  After an expedited review by the FDA, IMBRUVICA received approval on November 13, 2013, for treatment of patients with mantle cell lymphoma who have received at least one prior therapy.  This indication is based on overall response rate.  An improvement in survival or disease-related symptoms has not been established.  In the GMP pre-approval inspection of WuXi's manufacturing facilities in August, no Form 483 observations were issued by the FDA. 

IMBRUVICA is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton's tyrosine kinase (BTK).  BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells.  IMBRUVICA blocks signals that tell malignant B cells to grow and divide uncontrollably.  IMBRUVICA has been granted three Breakthrough Therapy Designations by the FDA, a first for an oncology drug.  These designations are intended to expedite the development and review of drugs for serious or life-threatening conditions.  To date, nine Phase III clinical trials have been initiated with IMBRUVICA and 37 clinical trials are currently registered on www.clinicaltrials.gov.

"It is important that we work with a development partner with expertise in both clinical and commercial supply, as well as U.S. and worldwide GMP regulations, to ensure reliable quality supply to patients," commented Heow Tan, Chief of Technical Operations at Pharmacyclics.  "STA's extensive experience will help us meet the demands of clinical and commercial supply for IMBRUVICA."

"We are very pleased and honored that Pharmacyclics has selected STA, WuXi's small-molecule development and manufacturing business unit, as a key partner for this supply," said Dr. Ge Li, Chairman and CEO of WuXi.  "WuXi is determined to help our partners introduce innovative breakthrough drugs like IMBRUVICA to benefit patients around the world."

About WuXi PharmaTech

WuXi PharmaTech is a leading pharmaceutical, biotechnology and medical device R&D outsourcing company, with operations in China and the United States.  As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical, biotechnology and medical device companies with a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process.  WuXi PharmaTech's services are designed to help its global partners in shortening the cycle and lowering the cost of drug and medical device R&D.  The operating subsidiaries of WuXi PharmaTech are known as WuXi AppTec.

For more information, please contact:

Ronald Aldridge
Director of Investor Relations
+1 201-585-2048
ron_aldridge@wuxiapptec.com 

Aaron Shi
Associate Director of Corporate Communications
+86-21-5046-4362
aaron_shi@wuxiapptec.com


'/>"/>
SOURCE WuXi PharmaTech (Cayman) Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. WuXi PharmaTech Announces Third-Quarter 2013 Results
2. WuXi PharmaTech Announces Licensing Agreement for Patient-Derived Xenograft Models with Mayo Clinics Center for Individualized Medicine
3. Zacks.com featured expert Kevin Matras highlights: Core Laboratories NV, Invesco Ltd., Medtronic, Inc., Willbros Group Inc. and WuXi PharmaTech Inc.
4. WuXi PharmaTech Schedules First-Quarter 2013 Earnings Release
5. Breckenridge announces agreement with Aptalis Pharmatech to market Propranolol Hydrochloride Extended-Release Capsules
6. WuXi PharmaTech Receives Letter from AAALAC Commending Animal Care at Suzhou Toxicology Facility as "Exemplary"
7. WuXi PharmaTech Announces Fourth-Quarter and Full-Year 2012 Results, Share Repurchase Program
8. WuXi PharmaTech and Open Monoclonal Technology Expand Human Antibody Development and Commercial Opportunities for Asian Regional and Global Pharmaceutical Companies
9. WuXi PharmaTech Schedules Fourth-Quarter 2012 Earnings Release
10. WuXi PharmaTech Presents the 2012 Life Science and Chemistry Awards
11. WuXi PharmaTech Announces Shareholder Resolutions Adopted at 2012 Annual General Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... , February 10, 2016 --> --> ... Japan .  --> Japan .  --> A ... With submission, Shire continues to strengthen ... With submission, Shire continues to strengthen its presence ... submission, Shire continues to strengthen its presence ...
(Date:2/10/2016)... SEATTLE , Feb. 10, 2016  Resolve ... potentially transformative new approaches to the treatment of ... completion of a multiple ascending dose study in ... lead compound RSLV-132. --> ... double-blind, placebo-controlled multiple ascending dose study of RSLV-132 ...
(Date:2/10/2016)... YORK , Feb. 10, 2016 Immune ... biopharmaceutical company, announced today that it has filed a ... Leukemia and other cancers. --> ... treating cancer by administration of Ceplene (histamine dihydrochloride) in ... provides methods of predicting the efficacy of Ceplene and ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... Ongoing news of the ravages ... Association™ (ALCA) to conduct a survey that takes a closer look at cases of ... the prevalence and causes of TBI among the aging population, and identifies the challenges ...
(Date:2/10/2016)... ... February 10, 2016 , ... United Benefit Advisors (UBA), the ... addition to its growing list of Partner Firms. S.S. Nesbitt is headquartered ... to Huntsville and in between. , Harnessing the experience and insights of the ...
(Date:2/10/2016)... , ... February 10, 2016 , ... AxoGen, Inc. (NASDAQ: ... report results for the fourth quarter and full year ended December 31, 2015 on ... conference call and webcast for the investment community following the release at 4:30 PM ...
(Date:2/10/2016)... ... ... AHRA: The Association for Medical Imaging Management announced today ... as keynote speaker at the organization’s 2016 Spring Conference. Fox’s topic, Lead with ... with their own organizational staff and leadership. , “I am so excited ...
(Date:2/10/2016)... ... February 10, 2016 , ... For additional information contact ... , Pioneering book "Better with Age: The Ultimate Guide to Brain Training" by award-winning ... improve memory. The book’s publication date is March 16, 2016. A free review ...
Breaking Medicine News(10 mins):