* DDT Nov-Dec 2006 Round 5 11/10/06 7:20 PM Page 2 November/December 2006 Vol 6 No 10 IN THIS ISSUE Corporate Profiles 16 Drug Delivery Technologies 73 Excipients, Polymers, Liposomes & Lipids 90 Contract Pharmaceutical & Biological Development Services 96 Machinery & Laboratory Equipment and Software 109 Technology Spotlight 114 The science & business of specialty pharma, biotechnology, and drug delivery www.drugdeliverytech.com * DDT Nov-Dec 2006 Round 5 11/10/06 7:22 PM Page 3 * DDT Nov-Dec 2006 Round 5 11/10/06 7:22 PM Page 4 * DDT Nov-Dec 2006 Round 5 11/10/06 7:22 PM Page 5 November/December 2006 Vol 6 No 10 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Fax: (703) 548-3733 E-mail: [email protected] E-mail: [email protected] West Coast Warren De Graff Western Regional Manager 818 5th Avenue, Suite 301 San Rafael, CA 94901 Tel: (415) 721-0644 Fax: (415) 721-0665 E-mail: [email protected] International Ralph Vitaro 219 Changebridge Road Vol 6 No 10 Montville, NJ 07045 Tel: (973) 299-1200 Fax: (973) 299-7937 E-mail: [email protected] Mailing List Rental Candy Brecht Tel: (703) 706-0383 Fax: (703) 549-6057 E-mail: [email protected] All editorial submissions are handled with reasonable care, but the publishers assume no responsibility for the safety November/December 2006 of artwork, photographs, or manuscripts. Every precaution is taken to ensure accuracy, but publishers cannot accept responsibility for the accuracy of information supplied herein or for any opinion expressed. Drug Delivery Technology (ISSN 1537-2898) is published 10 times in 2006, January, February, March, April, May, June, July/August, September, October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ 07045. Subscription rates: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 for 1 year outside the United States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug Delivery Technology LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. Single copies (prepaid) $15.00, US, Canada, and Mexico; $24.00 in all other countries. Add $5.00 per order for shipping and handling. Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send address changes to Drug Delivery Technology, 219 Changebridge Road, Montville NJ 07045. All rights reserved under the U.S., International and Pan-American Copyright Conventions. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without written permission from the publisher. Authorization to photocopy Drug Delivery Technology items for internal or personal use, or the internal or personal use of specific clients, is granted by Drug Delivery Technology LLC for libraries and other users registered with the Copywrite Clearance, 222 Rosewood Drive, Danvers, MA 01923; phone: (978) 750-8400, fax: (978) 750-4470. 4 * DDT Nov-Dec 2006 Round 5 11/10/06 7:22 PM Page 6 * DDT Nov-Dec 2006 Round 5 11/10/06 7:22 PM Page 7 Company Profiles 16 For each participating company, this section presents a special 2-page spread featuring core technologies, capabilities, products, and services as well as visuals and complete contact information. Featured companies include: 3M Drug Delivery Capsugel Hovione Systems Cardinal Health Huber Engineering ALZA Corporation Coating Place Iomed ASSA International Controlled Release Society Kurve Technologies BASF Degussa Lipocine Baxter BioPharma DPT Laboratories Loparex Inc. Solutions Drug Delivery Partnerships NOF Corporation BC Technology Eurand PharmaCircle Bespak ExcipientFest PharmaMed Device BD Filtertek Inc. RDD Europe BioScreen Testing Genzyme Pharmaceuticals Safety Syringes Service Glatt Pharmaceutical Services Scolr Pharma, Inc BioConvergence Halozyme Weiler Engineering Partnerships, Technologies & Pipeline Report 73 This Report, divided into four sections for Drug Delivery, Excipient, Contract Services, and Machinery & Laboratory Equipment & Software, provides a checklist of currently marketed technologies or services and Vol 6 No 10 their applications, pipeline/investigational technologies and their applications and stage of development, and partnerships. Technologies include: Oral Gene Therapy Rectal Inhalation Mucosal Vaginal Transdermal Capsules Colon November/December 2006 Parenteral Intranasal Liposomes Implants Polymers Lipids Nasal Biomaterials Devices Topical Proteins & Peptides Ocular Drug Delivery Technology Transmucosal Controlled Release Excipients 6 * DDT Nov-Dec 2006 Round 5 11/10/06 7:22 PM Page 8 * DDT Nov-Dec 2006 Round 5 11/10/06 7:23 PM Page 9 Drug Delivery Spotlight 114 To complement the Company Profiles and Special Report, this section examines innovative and emerging technologies, services, and devices, featuring dynamic 4-color visuals and contact information. Vol 6 No 10 November/December 2006 Drug Delivery Technology 8 * DDT Nov-Dec 2006 Round 5 11/10/06 7:23 PM Page 10 * DDT Nov-Dec 2006 Round 5 11/10/06 7:23 PM Page 11 Dan Marino, MSc Executive Editorial Director Drug Delivery Technology Jack Aurora, PhD John A. Bermingham Matthew D. Burke, PhD Director, Pharmaceutical President & CEO Investigator, Research & Development Ampad, LLC Pharmaceutical Development Pharmascience, Inc GlaxoSmithKline Sarath Chandar, MBA Mahesh Chaubal, Gary W. Cleary, PhD, Vice President, Global PhD, MS PharmD, MBA Marketing & Commercial Associate Director President & CTO Development Baxter Healthcare Corium International SPI Pharma Sonya Summerour James N. Czaban, JD John Fraher Clemmons, PhD, MBA, MS Attorney at Law President, North America Director, Business Heller Ehrman White & Eurand Development McAuliff, LLPP MediVas, LLC Philip Green, PhD Keith Horspool, PhD Ravi Kiron, PhD, MBA Executive Director, New Director of Business Director, Research Technology Assessment & Development Formulations Planning Advanced Drug Delivery Pfizer Global Research & ALZA Corporation BD Development David C. Klonoff, MD, FACP Uday B. Kompella, PhD James W. McGinity, PhD Clinical Professor of Associate Professor of Professor of Pharmaceutics Medicine - UC San Francisco Pharmaceutics University of Texas at Austin Medical Director University of Nebraska Mills-Peninsula Diabetes Medical Center Research Institute Nasser Nyamweya, PhD Kinam Park, PhD Philip L. Smith, PhD Technical Service Manager President Investment Manager Vol 6 No 10 6 No Vol Degussa Akina, Inc S.R. One, Limited, GlaxoSmithKline Ronald L. Smith, PhD Cornell Stamoran Tom Tice, PhD Director of Exploratory VP, Strategy & Business Executive Vice President Biopharmaceutics & Process and Chief Scientific Officer November/December 2006 November/December Drug Delivery Cardinal Health, PTS Brookwood Bristol-Myers Squibb Pharmaceuticals Research Institute James Vaughan Howard S. Wachtler Henry Y. Wu, PhD, MS General Manager President & CEO Associate Director 3M Drug Delivery Actinium Merck Research Drug Delivery Technology Drug Delivery Technology Systems Pharmaceuticals Laboratories 10 * DDT Nov-Dec 2006 Round 5 11/10/06 7:23 PM Page 12 * DDT Nov-Dec 2006 FINAL 11/14/06 12:58 PM Page 13 Tris Pharma Unveils Expansion of State-of-the-Art Research Facility ris Pharma, a privately owned specialty Tpharmaceutical company, recently unveiled a new state-of-the-art research and manufacturing facility at a South Brunswick, New Jersey, campus. These expanded capabilities are a result of the company’s success with its innovative drug delivery technologies. This 30,000-square-foot expansion adds a state- of-the-art, FDA-compliant cGMP facility and marks the transition of Tris Pharma to a technology firm that has all the capabilities, including manufacturing, in one facility. The company can provide its partners clinical supplies, submission batches, eCTD filing, and medium- scale commercial production of tablets, capsules, liquid suspensions, and oral solutions, and packaging for the finished products. “This facility enhances our manufacturing capabilities and also enables us to continue to invest in our drug development,” said Ketan Mehta, CEO and Founder of Tris Pharma. “This is the final piece of the puzzle for our first phase of growth and keeps our operations scalable to keep pace with several more deals and new technologies in the pipeline.” Tris Pharma envisioned a cutting-edge manufacturing facility and set out to build it. Rather than rely on outside contractors, the company hired top experts in the field to design and build the plant from scratch. The result is 15 cGMP suites that are completely flexible, with end-to-end in-built utilities and features that streamline the drug production process. The new facility also expands the company’s current capabilities by including