March 2008 Vol 8 No 3 www.drugdeliverytech.com IN THIS ISSUE INTERVIEW WITH SCOLR PHARMA’S PRESIDENT & CEO MR. DANIEL O. WILDS Excipient Quality & Sourcing 30 Chris Moreton, PhD Bill Webb Non-Invasive Insulin 43 Avani Amin, PhD Tejal Shah, MPharm Life-Cycle Management 52 Douglas Martin, MD Calculating Solubility 56 Hannah Batchelor, PhD Rachael Myatt FEATURING The science & business of specialty pharma, biotechnology, and drug delivery Improving Ms. Cindy H. Taneli Mr. Daniel Vaccines 74 Dubin Jouhikainen, Ruppar Ronald Ellis, PhD Analytical MD, PhD, MBA Hurdles in Oral Laboratories: Addressing the Product Trends, Analgesic Gap in Development & Medical the Need for Management & Breakthrough 77 Relationships Cancer Pain Continued Diversity Investment Udo Kiessling, MD, PhD March 2008 Vol 8 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 Malcolm A. Teasdale 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 o n (ISSN 1537-2898) is published 10 times in 2008, January, February, March, April, May, June, July/August, September, h c October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ 07045. e T Subscription rates: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 for 1 year outside the United y States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug r International - Ralph Vitaro • Tel: (973) 263-5476 e Delivery Technology LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. Single copies (prepaid) v i l $15.00, US, Canada, and Mexico; $24.00 in all other countries. Add $5.00 per order for shipping and handling. e [email protected] D Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send address g changes to Drug Delivery Technology, 219 Changebridge Road, Montville NJ 07045. All rights reserved under the US u r International and Pan-American Copyright Conventions. All rights reserved. No part of this publication may be D 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 items for internal or personal use, or the internal or personal use of specific clients, is granted by Drug Delivery 4 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. 34 The Management Buy-Out: What’s a Fair Price? Derrek G. Hennecke, MBA, continues with part 2 of his 7- part series chronicling the challenges, issues, and more importantly, the opportunities he faced throughout his Management Buy-Out. 38 Addressing the Analgesic Gap in Breakthrough Cancer Pain – A Drug Delivery Case Study Josef Bossart, PhD, and Taneli Jouhikainen, MD, PhD, review some of the thinking and strategies being implemented to fill or bridge the Analgesic Gap through the rational application of drug delivery technology. 43 Annual Update on Non-Invasive Insulin Delivery Technologies Avani Amin, MPharm, PhD; Tejal Shah, MPharm; Jagruti Patel, MPharm, PhD; and Anuradha Gajjar, MPharm, PhD; present an update on the progress of the non-invasive delivery technologies for insulin since last year’s update featured in the March 2007 issue of this publication. 50 Oral Drug Delivery: Hurdles in Oral Product Development & the Need for Continued Technology Investment Daniel Ruppar believes as biopharmaceutical and specialty pharma products expand the importance of revenue streams for companies in the future, continued investment in oral technologies to deliver these products to patients is expected to become increasingly important. 52 Life Cycle Management: Taking an “The obvious solution to bridging the Aggressive Approach Analgesic Gap is to deliver fentanyl Douglas Martin, MD, suggests taking an aggressive “strategic innovation” approach to leverage years of 3 o N over a much larger surface area. This research to identify molecular entities similar to an expiring 8 l blockbuster and erecting new exclusivity barriers for these o V concept is being developed with two follow-on drugs by targeting strategically chosen 8 0 0 indications. 2 newer approaches (delivery to the nasal h c r a M mucosa and to the lungs), both of 56 Measuring the Solubility of a Model Drug in y g o Drug-in-Adhesive Transdermal Patches to l o which have a large surface area and n h Validate a Theoretical Solubility Calculator c e T Rachael Myatt, Gbolahan Oladiran, and Hannah Batchelor, y like the oral mucosa, are rich in drug r e v PhD, provide research to validate the use of a theoretical i l e D permeable vasculature.” solubility calculator by comparing the solubility of sodium g u r D fluorescein, a model hydrophilic drug, in a range of DURO- p.38 TAK adhesives using Higuchi kinetics to measure the 6 experimental solubility. 60 SCOLR Pharma, Inc.: A Differentiated Oral Drug Delivery Company Drug Delivery Executive: Daniel O. Wilds, President and CEO of SCOLR, discusses how his company intends to “Pertinent questions the client should ask commercialize products independently and through third- the laboratory are: 1) Does the laboratory party alliances with pharmaceutical and other industry partners utilizing its unique CDT delivery platform. have detailed and current SOPs and an 66 Analytical Laboratories: Trends, effective quality group; 2) Has the Management & Relationships laboratory been successfully audited by Contributor Cindy H. Dubin recently asked several of the industry’s leading analytical laboratories about trends in the the FDA recently; 3) Does the laboratory sector, project management, and how Specialty Pharma have the instrumentation and the level of companies can best manage relationships with providers. expertise needed for the project; and 4) Is 74 NasVax: Improving Vaccines With a Unique Platform it possible to discuss data directly with Executive Summary: Dr. Ronald Ellis, Senior VP & CTO for the analysts working on your project?” NasVax, discusses how the company built up its management team, completed two private investment rounds, and had a successful IPO to become a publicly traded company on the Tel Aviv Stock Exchange. 77 The Challenges of Medical Diversity Udo Kiessling, MD, PhD, questions whether different therapeutic areas and various diseases require a specific approach in drug development, highlighting key differences among three major therapeutic areas with regard to success rates in clinical development. DEPARTMENTS Market News & Trends . .. 12 Business Development . .. 22 What is the Value of Your Company? 3 3 Combination Update . .. 26 o o N N 7 Understanding the Regulatory Environment 8 l l o o V for Combination Products in the World’s V 7 8 0 Leading Markets 0 0 0 2 2 h h c r Excipient Update . .. 30 c r a a M M Big Pharma & Suppliers Collaborate y y g g o o on Excipient Quality l l o o n n h h c c e e Technology Showcase . .. 64 T T y y r r e e v v i i Facts & Figures . 73 l l e e D D g g u u External Delivery . .. 82 r r D D SARs Analysis 8 p.66 9 Drug Delivery Technology April 2006 Vol 6 No 4 Dan Marino, MSc Executive Editorial Director Drug Delivery Technology Shaukat Ali, PhD, MSc John A. Bermingham Der-Yang Lee, PhD Technical Service Manager President & CEO Research Fellow, R&D BASF Pharma Solutions The Lang Companies Technology, R&D Labs McNeil Consumer Healthcare, Johnson & Johnson Sarath Chandar, MBA Derek G. Hennecke, MBA Gary W. Cleary, PhD, Vice President, Global President & CEO PharmD, MBA Marketing & Commercial Xcelience President & CTO Development Corium International SPI Pharma Ms. Debra Bingham James N. Czaban, JD John Fraher Partner Partner, FDA Department President, North America Valeo Partners WilmerHale Eurand Philip Green, PhD Keith Horspool, PhD Ali Rajabi-Siahboomi, Director of Business Director, Research PhD Development Formulations Global Technical Director, Modified Release Advanced Drug Delivery Pfizer Global Research & Technologies Development BD Colorcon David Monteith, PhD, MBA Uday B.