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:2/24/2017)... and Markets has announced the addition of the "Dry eye Drugs ... ... Drugs Price Analysis and Strategies - 2016, provides drug pricing data and ... following questions: What are the key drugs ... in the Global Dry eye market? What are the ...
(Date:2/24/2017)... CHAPEL HILL, N.C. , Feb. 24, 2017 ... sector are exploring ways to increase their self-service ... as Health Care Providers (HCPs). New ... that many pharma organizations have developed self-service website ... questions electronically.  This is just one of many ...
(Date:2/24/2017)... 2017 Report analyzes the worldwide markets for Endodontic ... for the US, Canada , ... Asia-Pacific , Latin America , and ... the period 2015 through 2022. Also, a six-year historic analysis ... derived from primary and secondary research. Company profiles are primarily ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... 2017 , ... Dr. Ronald E. Hawkins, vice president for ... Peter A. Bell, DO, MBA, HPF, FACOEP-dist., FACEP, as the new dean of ... Bell comes to Liberty from the Ohio University Heritage College of Osteopathic Medicine ...
(Date:2/24/2017)... ... February 24, 2017 , ... In the Health Care IT campaign, Robert ... because it’s not if you will be attacked, but when.” However, he and many ... digital health care. , Improvements in auditing and monitoring have taken security in health ...
(Date:2/24/2017)... ... , ... Healthcare Associates of McKinney announced today that they have ... State Highway 121, Suite 210, McKinney, Texas 75070. It is in the heart ... the practice has grown, the need for more space has been paramount. This ...
(Date:2/24/2017)... ... February 24, 2017 , ... With ProGlass Prism users ... X . Users have total control over position, rotation, distortion, edge softness, edge blur, ... Final Cut Pro X. , With ProGlass Prism users are given the tools ...
(Date:2/24/2017)... ... February 24, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... present generation. Yisrayl makes an astounding statement when he says that the entire ... the Bible details the current times so plainly that anyone should be able to ...
Breaking Medicine News(10 mins):