FOR IMMEDIATE RELEASE
–Innovative device/drug combination system for cold sores currently in Phase III trials–
ARLINGTON, VT, PHILADELPHIA, PA AND FRAMINGHAM, MA October 12, 2005 – Mack Molding Company and Transport Pharmaceuticals (Transport) announced today that they have entered into an agreement to provide development services for Transport’s proprietary device/drug combination system that will be used to treat cold sores (herpes labialis), currently in Phase III clinical trials. Working together, the two companies will finalize the product design for the device. The newly redesigned device will be tested in a skin irritation study in February 2006 and in a pivotal Phase III trial to be initiated in 2Q 2006.
“Aesthetics, ergonomics, additional product features, and designing for volume manufacturing will be key considerations during this phase,” notes Joan Magrath, Mack business unit director. Under the terms of the agreement, Mack will manufacture and test the device for clinical trials, as well as FDA submission. The company will also support a clinical trial evaluation process for disassembling and collecting data on returned product.
“We have unique areas of expertise in medical device manufacturing,” adds Magrath. “As a Class II combination product, this program is a perfect fit for us. This development agreement is the first step in what will become a full manufacturing partnership, where Mack is providing services in every phase, from product development, plastic molding and PCB manufacturing to final assembly, test and distribution.” Already FDA registered at its headquarters location, Mack is well versed in the strict regulatory environment that will be required for the manufacture of this product.
“This agreement marks a significant milestone for Transport and represents the tremendous progress made in advancing our product through early clinic development to its current state in a large phase III clinical trial,” notes Dennis I. Goldberg, Ph.D., president and COO of Transport Pharmaceuticals. “As we seek to plan our next trial, it was a strategic decision to join forces with a top-tier design firm such as Mack. After having signed a commercial partnership deal for this product and initiated our phase III trial, we tasked Mack with an aggressive timeline to redesign our device, and they moved quickly and effectively to meet the challenge. They will help design, develop, and manufacture our product through the final stages of development toward commercialization.
“Mack has moved very quickly to meet an aggressive plan to utilize the redesigned device in our next study. That parallels our other development activities and provides the final piece to our clinical and manufacturing programs,” Goldberg states.
About the product
Transport’s device delivers acyclovir, an approved cold sore treatment, directly to impacted skin at concentrations up to 40 times higher than conventional topical formulations. Because skin serves as a natural barrier for the body, it also restricts optimal dosage levels for current topical therapies and, thus, limits their effectiveness.
Transport’s product, however, uses a painless, low-voltage electrical charge to increase skin permeability and locally deliver medication through the skin. The product requires only one ten-minute application, compared with available treatments that require multiple applications each day for several days.
The company has developed a small, wireless computer-controlled electrode and medication applicator that will allow patients to self-administer topical drugs for a variety of dermatological diseases, with an initial focus on cold sores. The system consists of a reusable control unit and disposable, single-use medicated cartridges.
Transport has completed two double blind, placebo-controlled Phase II studies, which demonstrated that the therapy reduces healing time with a single treatment. The company initiated a Phase III study in May 2005 to further test the effectiveness and safety of the new treatment model. The clinical treatment phase of the study should be finished before the end of 2005.
Transport has also previously signed a license and collaboration agreement for this product providing the partner with exclusive rights to market and sell the product in Europe. Transport has recently secured $27 million in private financing, accelerating the programs’ development, and will be seeking a U.S. partner for this indication.
About Mack Molding
Mack Molding – a wholly owned subsidiary of the Mack Group corporation – is a leading custom plastics molder and supplier of contract manufacturing services. Mack specializes in plastics design, prototyping, molding, sheet metal fabrication, and medical device manufacturing. The company operates seven facilities throughout the eastern United States. Founded in 1920, Mack is a privately owned business that has earned a 5A1 D&B rating, the highest available. For further information, call 802-375-2511 or visit Mack on the web at www.mack.com.
About Transport Pharmaceuticals, Inc.
Transport Pharmaceuticals, Inc. is developing a proprietary electrokinetic drug delivery technology applicable to multiple dermatological diseases, with an initial focus on herpes labialis, or cold sores. The Company’s lead product enables the delivery of high doses of acyclovir, an approved cold sore treatment, directly to impacted skin areas, addressing a primary barrier to effective treatment of herpes labialis. The Company operates under the management of neXus therapeutics, inc., a biopharmaceutical management company that employs an “essential product development” paradigm to enhance the development process of early stage drugs and combination products. For more information, please visit www.transportpharma.com.