WXPRESS. December An Integrated R&D Service Company

Transcription

1 WXPRESS December 2009 Shanghai Suzhou Tianjin Philadelphia St. Paul An Integrated R&D Service Company Atlanta In this edition: Holiday Greetings from Dr. Ge Li, Chairman and CEO, to Our Customers, Partners, and Friends Year-in-Review of WuXi AppTec Small Molecule Drug Discovery and Development Services: Medicinal Chemistry, Synthetic Chemistry, Discovery Biology, in vivo Pharmacology, DMPK, ADME, Bioanalytical Services, Process R&D, Formulation, Analytical R&D, Manufacturing, and Toxicology

2 WXpress December 2009 Page 2 Pharmaceutical discovery and development Services YEAR-IN-REVIEW Dear Customers, Collaborative Partners, and Friends, Happy Holidays! For more than nine years, WuXi AppTec's value proposition has been to provide high-quality R&D services to our customers in a cost-effective and efficient manner. Because of support from our customers, we have been able to achieve solid growth in our global business. On behalf of all WuXi AppTec employees, I want to thank our many loyal customers for your trust and ongoing support. We are continuing to expand our innovation-driven and fully integrated pharmaceutical, biotechnology and medical device R&D service platform. We extended our leadership position as a global R&D outsourcing company in China by adding operations in the United States in As one measure of our growth, the total number of WuXi AppTec employees is now over 4,000. We were recently named to the Deloitte Technology Fast 50 China list of rapidly growing Chinese companies for the fifth consecutive year, a Top Ten Chinese Outsourcing Enterprise by China's Ministry of Commerce, a Top Ten Employer for New College Graduates in Pharmaceutical Industry, and ranked 8th on the Fast Company world 50 Most Innovative Companies list. In 2008, we received the Frost & Sullivan Award for Best in Class Outsourced R&D in Pharmaceuticals and Biotechnology. In response to client demand, WuXi AppTec is actively growing its capabilities. We completed construction of a large-scale manufacturing facility in the Jinshan area of Shanghai, which we expect to be operational in 2010, quadrupling existing capacity. Our Suzhou safety evaluation facility, one of the largest such facilities in Asia, is now operational. Throughout the company, we will continue to build capabilities and capacity to provide you with more and better services in the coming years to assist you in improving the success of research and shortening the time of development. The focus at WuXi AppTec remains to strengthen our partnership with our global customers so we can help you achieve your strategic goal finding and bringing to market new life-saving and life-enhancing products more quickly and cost effectively. On behalf of WuXi 's management team, I wish you a joyous holiday season and a happy New Year! Ge Li, Ph.D. Chairman and Chief Executive Officer

3 WXpress December 2009 Page 3 A YEAR OF ACCOMPLISHMENTS February Deloitte Technology Fast 500 Asia Pacific 2008 List for the February Ranked #8 on "The World's Most Innovative Companies: March Bioanalytical Services Unit Passes FDA Inspection May Commercial Manufacturing Capabilities Expanded Fifth Consecutive Year The Fast Company 50" 2009 June Shanghai Facility Awarded AAALAC Accreditation July Opening of Suzhou Toxicology Facility, Asia s Largest Safety August Top Ten Employer for New College Graduates in November Deloitte Technology Fast 50 China 2009 List for the Fifth Evaluation Center Pharmaceutical Industry Consecutive Year Seven Customer Service Awards Received in 2009, including: Global Supplier Award Excellent Service Award Excellence Award Strategic Supplier in Discovery Award

4 WXpress December 2009 Page 4 DISCOVERY SERVICES Dr. Shu-Hui Chen, Chief Scientific Officer reflected on 2009 as a pivotal year for Wuxi AppTec: I would like to take this opportunity to thank all of our customers in 2009 for your support of WuXi AppTec in Despite challenging times for the industry, WuXi AppTec remained committed to providing the best-in-class outsourcing solutions and services to our customers in discovery services. WuXi AppTec made significant investments in biology and pharmacology in 2009 as key new service offerings to our customers and brought in outstanding leadership and talent to spearhead these growing areas. As in previous years, WuXi AppTec maintained the highest level of productivity in chemistry and thus the highest value for our customer s outsourcing needs. DMPK-ADME services continued to grow as the demands of our customers increased for effective and cost-efficient outsourcing. The bioanalytical unit achieved a significant milestone by passing an FDA audit without any major or minor issues. WuXi AppTec s commitment to the highest quality service for our customers will continue as we look forward to collaborating with you in Dr. Shu-Hui Chen Chief Scientific Officer

5 WXpress December 2009 Page 5 INTEGRATED PROGRAMS Dr. Richard M. Soll Senior Vice President Integrated Services In today s world of drug discovery, achieving program milestones in the most cost-efficient manner is a key goal of pharmaceutical and biotech companies. WuXi AppTec s Integrated Services Offerings addresses this issue through effective outsourcing comments Richard M Soll, Senior Vice President of Integrated Services. At WuXi AppTec, we now bring together our people and capabilities, well grounded in the rich history of performance and deliverable to our customers, to advance whole programs from screening to candidate selection. Since its inception in 2008, more than 30 programs have been running at WuXi AppTec, deploying teams of medicinal chemists, biologist, DMPK-ADME, and pharmacology, to create leads and preclinical development candidates derived from hits or knowledge-based approaches. The multidisciplinary team approach at WuXi AppTec has advanced compounds from screening hits through the hit-to-lead process and into lead optimization campaigns in as little as 3 months. In 2009 the first preclinical development candidates will emerge from lead optimization efforts, some in as little as 18 months from their start. WuXi is committed to building and broadening our integrated service platform to meet the challenging needs of our customers through investment in scientific leadership and expertise, equipment, and infrastructure. Dr. Richard M. Soll, Senior Vice President of Integrated Services, lectures at a session of Drug Discovery Training Program (27 special topics in 2009). Mr. Yunfu Luo, Associate Director of Chemistry, was awarded the "Merck Special Achievement Award" in recognition of o u t s t a n d i n g leadership as well as synthetic and m e d i c i n a l chemistry skills in service to the M e r c k - W u X i collaboration. Proven Track Record of Senior Scientific Team 38 compounds into Pre-clinical Development 22 compounds into Phase I trials 12 compounds into Phase II trials 4 compounds into Phase III trials 1 compound to market Dr. Jian Li, Executive Director of Enabling Technologies and WuXi scientists during a drug design session in a 3-D graphics room.

6 WXpress December 2009 Page 6 CHEMISTRY Medicinal Chemistry This year was a year of accomplishment for medicinal chemistry, noted Tao Guo, Vice President of Medicinal Chemistry. WuXi AppTec s medicinal chemistry teams have been involved in more than 30 medicinal chemistry programs from big pharma, biotech, virtual companies and animal health across the globe in addition to the numerous relationships WuXi AppTec has in medicinal chemistry support. According to Tao, Many of the medicinal chemistry efforts started with weak compounds derived from screening hits or from literature compounds possessing some liabilities and it was the objective of the WuXi AppTec medicinal chemists to improve upon and optimize a number of properties including potency on target, selectivity vs off-targets, herg liabilities, and pharmacokinetic and ADME properties amongst many other considerations such that screening hits can evolve through the hit-to-lead process, advance through lead optimization and ultimately lead to a preclinical candidate. WuXi AppTec s medicinal chemists have now gained significant experiences in major target classes such as GPCRs, enzymes, and ion channels across major disease indications such that programs have reached program milestones in as little as 3 months. The impact of the WuXi medicinal chemistry course and medicinal chemistry lecture series in 2009 has been significant, noted Tao. In 2010 we look forward toward compounds advancing into preclinical development, and further serving our customers in their medicinal chemistry needs. Dr. Tao Guo was promoted t o V i c e P r e s i d e n t o f Medicinal Chemistr y in Over 19 years of experience in organic/ m e d i c i n a l c h e m i s t r y, f o r m e r l y D i r e c t o r o f Chemistry at Pharmacopeia. Synthetic Chemistry D r. R u j i a n M a, V i c e P r e s i d e n t o f S y n t h e t i c Chemistry. Over 16 years' ex p e r i e n c e i n o rg a n i c synthesis and in training new fellow scientists. Rujian Ma, Vice President of Synthetic Chemistry, notes that 2009 was another year of accomplishment. WuXi AppTec delivered more than 2,000,000 compounds over the past several years to its customers and grew production capabilities to 1,000,000 compounds/year, each individually synthesized and purified to high purity levels for library enrichment programs, focused screening and medicinal chemistry analoging.. More than 1500 novel drug-like templates are now commercially available from WuXi AppTec and can be purchased in commercial catalogs such as ACD and SciFinder for every medicinal chemist to use in their quest for drug candidate identification against major target classes including GPCRs, ion channels, kinase and other enzymes Further we have created a Center of Excellence in Synthetic Chemistry for providing the highest value and best service to our customers. For example, we now provide fluorinated templates as part of our template offerings.

7 WXpress December 2009 Page 7 BIOLOGY Discovery Biology Discovery Biology grew to nearly 100 scientists and has established many first-in-china in This includes the creation of the first Center of Excellence for Ion Channel Screening, commitment to automation and robotics (the core built around the Labcyte 801 platform with the ECHO555 acoustic dispensing system), Cellomics Array Scan VT1, FLIPR fluorescence Imaging System,, and MesoScale Discovery Sector Imager 6000 ECL Analyzer, and Clone Pixfor amongst many others. Qiang Lu, Vice President of Discovery Biology and electrophysiology expert, comments: With the best-in-class biology capabilities in China, we now offer our customers a wealth of opportunity for biology screening to support many medicinal chemistry programs across numerous target classes and therapeutic indications, including virology, obesity, CNS disorders, CV, oncology, pain,and neurogeneration amongst others. Today we support protein crystallography at WuXi AppTec through protein generation and are running primary and secondary cell-free and cell-based screens for more than 20 medicinal chemistry programs with customers. Additionally, Qiang notes many thousands of compounds from customers have been screened at WuXi AppTec in 2009 for safety pharmacology against the herg channel for hit-to-lead and lead optimization programs. Our goal continues to focus on providing the best-in-class service in biology to our customers; through this commitment we will continue to seek the highest caliber of scientist and invest in important technologies as we continue to grow our biology service organization. Dr. Qiang Lu was promoted t o V i c e P r e s i d e n t o f Discovery Biology in He joined WuXi AppTec with 19 years of industry experience at Wyeth and Novartis. In Vivo Pharmacology Dr. Chi-Chung Chan joined WuXi AppTec in 2009 as Vice President of in vivo Pharmacology after a 26- year career with Merck Frosst in Canada. Expert in M e t a b o l i c D i s e a s e, C a r d i o v a s c u l a r, a n d Inflammation. Chi-Chung Chan joined WuXi AppTec as Vice President of Pharmacology in 2009 after more than 26 years of pharmacology expertise at Merck Frosst in Canada where he developed models and characterized compounds for programs in inflammation, CV and metabolic disorders, In 2009, the pharmacology services have established models for diabetes, obesity, oncology, CV and neurodegeneration and pain. Chi notes WuXi AppTec s customers have taken advantage of our pharmacology services and we now are screening compounds for efficacy and PK/PD relationships from our customer s discovery programs across many therapeutic indications. Our goal is to develop these models, working closely with our customers to design the most relevant pharmacology model and study protocol for their needs. In 2010 we will continue to grow our current service line and expand into inflammation.

8 WXpress December 2009 Page 8 DMPK & BIOANALYTICAL SERVICES DMPK - ADME DMPK-ADME is a key service for our customer base. In 2009 we added significant leadership and scientific depth to the team of more than 140 staff members in addition to the capital investment. Our staff conducted thousands of rodent, dog and non-primate studies in 2009, supported by more than 15 LC/MS/MS instruments., noted Angela Wong, Vice President of DMPK-ADME. The group characterized many thousands of compounds in ADME screens such as microsomal and hepatocyte stability, CYP inhibition for drug-drug interactions, plasma protein binding, caco-2 permeability, and potential for p- glycoprotein substrate in MDR1/MDCK cells and we conducted more than 25 metabolite ID studies. We have executed a multi-year contract with Pfizer where we routinely screen for Pfizer for ADME properties and we have become the PK-ADME screening center for another major pharma customer for all of their Chinese outsourcing relationships. Dr. Angela Wong, Vice President, DMPK - ADME. O v e r 2 0 y e a r s o f experience at SmithKline and Vitae Pharmaceuticals. Bio-Analytical Services (BAS) D r. J i n s o n g X i n g w a s promoted to Vice President of Bioanalytical Services in Formerly at BASF and Bristol-Myers Squibb. WuXi's Bioanalytical Services (BAS) was established in BAS provides Good Laboratory Practice (GLP)- compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy, and to m e a s u re b i o m a rk e r / b i o l o g i c s a n d a n t i b o dy immunogenicity using immunochemistry. In March 2009, the Bioanalytical Services (BAS) unit was inspected by the U.S. Food and Drug Administration (FDA) without the issuance of a Form 483, which is used to report any non- compliance issues after a site inspection. It represents our company's first audit by U.S. FDA and the first such audit of any bioanalytical laboratory in China. "As a GLPcompliant facility, BAS always treats quality and compliance as our highest priorities," commented Dr. Jinsong Xing, Vice President of BAS. "We maintain GLP readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data and closely monitors the facility for compliance on a daily basis."

9 WXpress December 2009 Page 9 DEVELOPMENT SERVICES Dr. Suhan Tang Chief Manufacturing Officer Manufacturing services reached new heights in 2009 notes Suhan Tang, Chief Manufacturing Officer. I wish to thank all of customers who have chosen WuXi AppTec for their manufacturing needs. Having completed more than 182 plant production projects, 45 APIs for clinical studies in US and Europe, and multi-metric ton deliverables of GMP material, 2009 also witnessed strategic cgmp manufacturing partnerships with a number of customers in addition to completion of the commercial scale cgmp facility in Jinshan. With over 230 process chemists under the leadership of Minzhang Chen and nearly 1/3 million liter overall capabilities, WuXi AppTec is now well poised for increasing GMP API and advanced intermediate production from toxicology studies through to commercialization. WuXi is uniquely positioned for chiral resolution at the multi-kilogram scale with extensive GMP-chiral SFC capabilities. WuXi AppTec s pharmaceutical development group, under Deepak Hegde s and Eugene Gong s leadership, has brought in numerous clients for clinical trial drug production through phase II as well as stability studies. In addition, pharmaceutical development capabilities have been expanded with spray drying capabilities and an enlarged drug product production footprint to meet the needs of our customers. To meet these expanded capabilities the manufacturing group bolstered its technical and scientific leadership with highly experienced managers. In 2010 we are committed to being our customers strategic partner of choice. Process R&D Formulation Analytical R&D Manufacturing Dr. Mingzhang Chen Executive Director Mingzhang joined WuXi w i t h 1 3 Y e a r s experience in Process R & D a n d A P I Manufacturing. Formerly Director of Technical Operations at Vertex. Dr. Deepak Hedge Vice President O v e r 1 4 y e a r s e x p e r i e n c e i n f o r m u l a t i o n d e v e l o p m e n t a n d technical transfers at R h o n e P o u l e n c, Novartis, and USV. Dr. Eugene Gong Executive Director Over 15 years product development experience at Forest Laboratories, Boehringer Ingelheim, and Wyeth. Dr. Wei-Min Chang VP and General Manager of STA O v e r 2 4 y e a r s e x p e r i e n c e a t Eastbound Synopharma (HK), Taiwan Biotech Co., and Eli Lilly.

10 W X p r e s s D e c e m b e r P a g e 10 T OX I C O L O G Y S E R VI C E S Greetings! Founded in October 2006, the Safety Evaluation Center is located on a Grand Opening of S u z h o u Tox i c o l o g y Center, Asia s largest safety evaluation center a c re c a m p u s i n Suzhou, China, approximately 60 miles west of Shanghai. It is the Edward Hu Chief Operating Officer largest toxicology facility in Asia with a total area of 30,000 m2 of which 17,000 m2 is dedicated to the vivarium. This Center is equipped with world-class laboratory equipment and instruments. Our technical staff are well trained and under the leadership of experienced Dr. Brian Xu was a p p o i n t e d a s Vi c e President of Toxicology and Head of Safety Evaluation Center. He joined WuXi with over 10 years of experience at Merck, Roche, and Schering-Plough. senior members who received their training overseas. We offer customer focused toxicology testing services WuXi s Suzhou Safety Evaluation Center including General Toxicology, Safety Pharmacology, Genetic Toxicology, and Immunolog y; and we offer an interdisciplinary approach to preclinical safety testing. We have initiated non-glp studies as well as clientsponsored GLP validation studies, both of which are intended to develop our capability to conduct GLP studies. Staff Training on GLP Genotoxicology Assays We remain on target with our previous timetable to offer GLP toxicology services by mid-2010.

11 W X p r e s s D e c e m b e r P a g e 11 SC IE NTI F I C A F F A IR S Professor Paul Bartlett University of California, Berkeley Dr. Ge Li, Chairman and CEO, introduces Professor K.C. Nicolaou of The Scripps Research Institute, as a speaker of the 2009 WuXi Distinguished Lecture Series. World-Class Lecture Series 2009 Professor Stephen Buchwald Massachusetts Institute of Technology Dr. Steve Djuric Abbott Laboratories Dr. David Perry Pfizer Inc. Professor James Leighton Columbia University W u X i A p p Te c establishes Award of Excellence in Teaching and Research to the College of Chemistry and Molecular Engineering at Peking University. Professor Masakatsu Shibasaki University of Tokyo

12 WXpress December 2009 Page 12 OUR PLACE In 2009 WuXi AppTec was selected as a Top Ten Employer for New College Graduates in Pharmaceutical Industry in

13 WXPRESS December 2009 Contact Us WEBSITE: Hui Cai, PhD, MBA Vice President, Business Development Phone: Phone: China Steven Hutchins Vice President, Corporate Development Phone: (O) Phone: (M) Glenn Killingworth Key Account Manager Phone: +44 (0) (O) Phone: + 44 (0) (M) [email protected] Lulu Tang Associate Director, Customer Service Phone: Phone: [email protected] Shanghai Suzhou Tianjin Philadelphia St. Paul Atlanta