Navigation Links
WuXi PharmaTech to Partner with Pharmacyclics

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

"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 

Aaron Shi
Associate Director of Corporate Communications

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. 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:
(Date:10/12/2015)... Given the intricacy of the anatomy and physiology of ... drug effectively to a specific ocular site. Several barriers have ... include dilution of a drug by tears, clearance of a ... issues with respect to the cornea, sclera and choroid. Approximately ... due to the aforementioned barriers. --> Given ...
(Date:10/12/2015)... and CRANBURY, N.J. , ... Arroyo LLP announces that a securities fraud ... Court for the District of New Jersey.  The complaint ... (NASDAQGM: FOLD) violated the Securities Exchange Act of 1934 ... making materially false and misleading statements about Amicus Therapeutics, ...
(Date:10/12/2015)...  Millions of smokers worldwide have used vaping to ... An April 2015 study released by a ... cigarettes to be up to 95 percent less harmful ... after the technology was first introduced the potentially harmful ... --> --> Palm Beach Vapors, ...
Breaking Medicine Technology:
(Date:10/13/2015)... ... October 13, 2015 , ... ... Debbie Vereb has been named the organization’s Executive Vice President of Operations, and ... hired to key leadership roles in the company. , Debbie Vereb’s appointment to ...
(Date:10/13/2015)... ... 13, 2015 , ... Curly Hair Solutions® is thrilled to ... an exhibition featuring the newest products and services to hit the market for ... more excited to unveil their recent partnership with Trade Secrets, a leading Canadian ...
(Date:10/13/2015)... , ... October 13, 2015 ... ... LLC presented results from GyencoloGeneTM, the world’s first commercially-available next-generation sequencing laboratory ... FIGO World Congress of Gynecology and Obstetrics in Vancouver, BC, Canada. ...
(Date:10/13/2015)... NY (PRWEB) , ... October 13, 2015 , ... ... her award winning programs Elder Care Doula Training and End of Life ... elderly in a holistic model, physically, spiritually and emotionally. Based on her ...
(Date:10/12/2015)... ... October 13, 2015 , ... Career Step, ... the release of its new Professional Medical Coding and Billing with Applied PCS ... ICD-10-CM and ICD-10-PCS code sets, earn the Certified Professional Coder (CPC) and Certified ...
Breaking Medicine News(10 mins):