March 2007 Vol 7 No 3 www.drugdeliverytech.com IN THIS ISSUE INTERVIEW WITH DPT’S PRESIDENT MR. PAUL JOHNSON In Situ Gel Systems 30 Mitan Gokulgandhi, BPharm Dharmesh M. Modi, MPharm COX-II Microspheres 38 Lakshmi Sivasubramanian Madhumathi Seshadri Undermining CEO’s 82 John A. Bermingham FEATURING Parkinson’s Disease 59 Steven Damon Yogi R. Patel The science & business of specialty pharma, biotechnology, and drug delivery Specialty Pharma Indices 64 Dr. Barath Christopher Avani Amin, Josef Bossart, PhD Shankar Robinson, PhD Drug Delivery’s PhD Current Status of Clinical Trials Increasing New Ways to Non-Invasive In Asia 68 Importance to Partner With Insulin Delivery Ames Gross, MBA Big Pharma & the Federal Technologies Specialty Pharma Government Momoko Hirose March 2007 Vol 7 No 3 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. 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Drug Delivery Technology g o (ISSN 1537-2898) is published 10 times in 2007, January, February, March, April, May, June, July/August, September, l o October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ 07045. n h Subscription rates: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 for 1 year outside the United c e States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug T Delivery Technology LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. Single copies (prepaid) y r $15.00, US, Canada, and Mexico; $24.00 in all other countries. Add $5.00 per order for shipping and handling. e v i Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send l e address changes to Drug Delivery Technology, 219 Changebridge Road, Montville NJ 07045. All rights reserved under D the U.S., International and Pan-American Copyright Conventions. All rights reserved. No part of this publication may g u be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, r D or information storage and retrieval system, without written permission from the publisher. Authorization to photocopy 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 4 01923; phone: (978) 750-8400, fax: (978) 750-4470. 26 Drug Delivery’s Increasing Importance to Big Pharma & Specialty Pharma Frost & Sullivan Research Analyst Barath Shankar says the drug delivery market is likely to enable pharmaceutical companies to revive late-stage products by using drug delivery platforms and re- branding products. As a result, drug delivery companies are likely to remain the focus of attention of big pharma and specialty pharma as acquisition targets or licensing partners. 30 In Situ Gel Systems for Ocular Drug Delivery: A Review Mitan R. Gokulgandhi, Dharmesh M. Modi, and Jolly R. Parikh, PhD, explain in their research that to optimize topical ocular drug delivery systems, prolonged contact time with the cornea surface and “Drug Delivery companies are likely to better penetration through the cornea are necessary. enable pharmaceutical companies to revive late-stage products by using drug delivery 38 COX-II Inhibitor-Loaded Microspheres for Familial Adenomatous Polyposis: platforms and re-branding products. As a Characterization, In Vitro Release & Stability Studies result, Drug Delivery companies are likely to Madhumathi Seshadri and Lakshmi Sivasubramaniam remain the focus of attention of big pharma use three different polymers (ethyl cellulose, sodium carboxymethylcellulose, hydroxypropyl and specialty pharmaceutical companies as methyl cellulose) and various characterizations like acquisition targets or licensing partners.” drug content, microencapsulation efficiency, in vitro release studies, flow property, scanning electron 3 o microscopy, and stability studies to prove the best N 7 of the three polymers used. l o V 7 0 0 2 48 Current Status of Non-Invasive Insulin h c r A Delivery Technologies M y g Avani Amin, MPharm, PhD; Tejal Shah, MPharm; o l o n Jagruti Patel, MPharm, PhD; and Anuradha Gajjar, h c e T y MPharm, PhD; review the current status of the r e v i l various non-invasive technologies for insulin. e D g u r D p.26 6 59 Addressing Unmet Needs in Management of Parkinson’s Disease Mr. Steven Damon and Mr. Yogi R. Patel discuss the development of a transdermal skin patch to provide continuous delivery of apomorphine for the prevention of “off” periods and an improved option for the symptomatic management of Parkinson’s Disease. 68 Conducting Clinical Trials in Asia Mr. Ames Gross and Ms. Momoko Hirose explain that with steadily increasing drug development costs and significant time spent on clinical trials, outsourcing clinical trials in Asia has rapidly become an appealing option for many firms. 77 R&D Takes Center Stage at DPT Executive Summary: Paul Johnson, President of DPT, tells Specialty Pharma why his company is turning its attention to R&D while still maintaining its focus on dosage forms, as well as its desire to remain privately held. DEPARTMENTS Market News & Trends . .. 12 3 o Business Development . .. 20 N 7 l New Ways to Partner With the Federal o V 7 Government: Insights From King 0 0 2 Pharmaceuticals h c r a M Technology Showcase . .. 56 y g o l o n h Facts & Figures . .. 64 c e T y r e External Delivery . .. 82 v i l e D On Guard….or is it En Guard? g u r D 8 9 Drug Delivery Technology April 2006 Vol 6 No 4 Dan Marino, MSc Executive Editorial Director Drug Delivery Technology Jack Aurora, PhD John A. Bermingham Matthew D. Burke, PhD Senior Director, R&D President & CEO Investigator, Perrigo Company The Lang Companies Pharmaceutical Development 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 Marc J. Kirchmeier, PhD James N. Czaban, JD John Fraher Associate Director, Partner, FDA Department President, North America Pharmaceutical R&D WilmerHale Eurand Biologicals & Vaccines Merck Research Laboratories Philip Green, PhD Keith Horspool, PhD Ravi Kiron, PhD, MBA President Director of Business Director, Research Development Formulations R&K Consulting Advanced Drug Delivery Pfizer Global Research & BD Development David Monteith, PhD, MBA Uday B. Kompella, PhD James W. McGinity, PhD Senior Director, Drug Associate Professor of Professor of Pharmaceutics Delivery & Life Cycle Pharmaceutics University of Texas at Austin Development University of Nebraska Schering-Plough Medical Center Nasser Nyamweya, PhD Kinam Park, PhD Philip L. Smith, PhD Technical Service Manager President Investment Manager Degussa Akina, Inc S.R. One, Limited, GlaxoSmithKline 3 o N 7 l o V 7 0 Ronald L. Smith, PhD Cornell Stamoran Tom Tice, PhD 0 2 Director of Exploratory VP, Strategy & Business Executive Vice President h Biopharmaceutics & c Process and Chief Scientific Officer r a Drug Delivery M Cardinal Health, PTS Brookwood y Bristol-Myers Squibb Pharmaceuticals g o l Research Institute o n h c e T y r e v James Vaughan Howard S. Wachtler Henry Y. Wu, PhD, MS i l e General Manager President & CEO Director D g 3M Drug Delivery u Actinium Merck Research r D Systems Pharmaceuticals Laboratories 10 BDSI Announces FDA Acceptance of Bioral® Amphotericin IND: First IND for Cochleate Drug Delivery Technology ioDelivery Sciences International, Inc. recently reported the filing and drugs, such as Amphotericin B, which are currently available only by Bacceptance by the US FDA of BDSI’s first IND for the company’s Bioral injection, into patient friendly, orally available products. Cochleates are made cochleate drug delivery technology. The lead Bioral product for which the of naturally occurring substances and are designed to encapsulate, protect, IND was filed is an enchocleated version of Amphotericin B (CAMB), a and deliver certain drug molecules that are either broken down by potent, broadly active antifungicidal agent for treating infections, such as gastrointestinal enzymes and acids, or cannot be absorbed through the esophageal candidiasis, an infection prevalent in HIV patients and many gastrointestinal tract. patients who are receiving cancer chemotherapy. “CAMB consistently showed significant efficacy against systemic fungal In addition to the treatment of such infections as esophageal candidiasis, infections and substantial safety levels throughout the preclinical development Amphotericin B is also an important drug for treating Leishmaniasis, a period using animal models,” stated Dr.