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 --> ... research report "Pharmaceutical Packaging Equipment Market by Package Type ... Serialization), by Product Type (Tablet, Powder, Cream, Syrup, Aseptic ... MarketsandMarkets, studies the global market during the forecast period of ... at a CAGR of 6.9% during the forecast period ...
(Date:2/10/2016)... 2016 On Tuesday, February 9th, the ... with its Arthritis Advisory Committee to discuss ... & Johnson,s Remicade and most likely the ... U.S. The Biologics Prescribers Collaborative (BPC) along ... for Patient Access, American Association of Clinical ...
(Date:2/10/2016)... 10, 2016 --> ... Therapeutics and Companion Diagnostic Market to 2019 - ... Environment" research report indicates that the core personalized ... by 2020 growing at a CAGR of 8.74%. ... and targeted therapeutics and is dominated by oncology, ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... Gout is like no other ... that is often severe, with intense swelling and redness. It is triggered by the ... but older adults are the most susceptible, according to the February 2016 issue of ...
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... ... four time Emmy award winner and inspirational speaker Jan Fox will serve as ... by Speaking Boldly will provide participants with tools to more effectively communicate with ...
(Date:2/10/2016)... MN (PRWEB) , ... February 10, 2016 , ... ... that it will attend the Ohio Safety Congress and Expo event March 9-11, ... at the Greater Columbus Convention Center. , As the longest running and ...
(Date:2/10/2016)... ... February 10, 2016 , ... IDEX Health & Science, ... stainless steel (PLS) columns combine the strength of traditional stainless steel with the ... biological samples while operating at ultra-high pressures of 20,000 psi. The higher operating ...
(Date:2/10/2016)... ... February 10, 2016 , ... Workrite Ergonomics, who is ... has evolved from humble beginnings to being an internationally recognized leader in their industry. ... are today”, said Charlie Lawrence, President of Workrite. “Workrite recognized the importance of ...
Breaking Medicine News(10 mins):