GSK Press Release
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Med-Instill Inc. and GlaxoSmithKline Biologicals Announce Long Term Deal on INTACT™
Med-Instill’s innovation eliminates preservatives – a key step in addressing flu vaccine shortage.
Stamford, CT – October 19, 2004 – Medical-Instill Inc. (Med-Instill), a leading provider of technologies for the contamination-free manufacturing and delivery of pharmaceutical, cosmetic and nutrition products, today announced a major agreement with GlaxoSmithKline Biologicals (GSK-Bio).
Under the agreement, Med-Instill grants exclusive rights to GSK-Bio, until 2021, covering the filling of sterile vials, pre-filled syringes, and cartridges or other similar devices in the field of vaccines and pharmaceutical injectables. Using this technology, closed vials are filled through a stopper with a needle and re-sealed with a laser. GSK-Bio intends to implement the technology in its own manufacturing and to offer it to the rest of the industry through its dedicated Belgian subsidiary Aseptic Technologies.
This manner of filling devices allows for the retention of sterility without introducing any preservatives into the process. Preservative-free sterilization during and after the filling process is not performed by any other company on a large scale today. By dramatically simplifying the sterile filling process this new approach provides higher safety levels at lower capital and operating costs.
“We are happy to solidify our relationship with Glaxo SmithKline as a partner in moving toward a new way of guaranteeing sterility in the filling of pharmaceutical and other products. We believe this transaction is proof of a paradigm shift away from current filling technologies and toward innovative, simple technologies with far reaching applications beyond pharmaceuticals. This is the beginning of a new standard for sterile injectables – one that we envision governments and regulatory agencies will quickly embrace,” said Dr. Daniel Py, MD, Sc.D, Chairman of Med-Instill.
“The closed and sterile INTACT™ vial is the only insulator necessary. The chemicals currently added to destroy potential germs, are replaced by a pure physical barrier that prevents contamination. This means higher patient safety levels, and compliance that has been engineered through a relatively simple process.”The technology licensed under the deal brings a new level of reliability, speed and efficiency to the filling of sterile injectables. It allows for easier storage, quicker filling and a faster turnaround from storage to syringe.
“One of the factors contributing to the current flu-vaccine shortage in the US is the inability of companies to guarantee a sterile environment for their injectables,” said Dr. Py. “Our “INTACT”™ process solves this problem by allowing manufacturers to have greater confidence in sterility, turnaround new vaccines quickly and respond to shortages without fear of contamination.”
This technology allows for production of a vaccine using a smaller space, in more mobile situations, that is quicker, easier and cheaper than traditional methods. With the need for large-scale vaccinations often coming in times of crisis or instability, this level of mobility and speed is invaluable.
The transaction includes the transfer of assets such as filling equipment, development results and rights under patents. GSK-Bio intends to implement the technology in its own manufacturing and to offer it to the rest of the industry through its dedicated Belgian subsidiary Aseptic Technologies. Med-Instill retains the rights to the technology in other fields such as for ophthalmic and topical pharmaceuticals and for the cosmetic and beverage industries.
“This unique new filling method will provide aseptically processed products with exceptionally high sterility assurance levels through very simple technologies. It will totally change the way terminally sterilized injectable products are manufactured in the pharmaceutical industry,” said Mr. Jean Stephenne, President of GSK-Bio
Med-Instill, advised by the New York office of Rothschild, and legal counsels Clifford Chance and McCarter & English LLP, remains actively involved in the development, production, and commercialization of drug delivery devices based on a proprietary, contamination free valve. The proceeds from the licensing agreement are expected to allow Med-Instill to dedicate greater resources to research and development and to look for expanded opportunities in the cosmetic and traditional fields.
Medical-Instill Technologies is a company dedicated to the invention, development and commercialization of technologies for the contamination free manufacturing and delivery of pharmaceutical, cosmetic and nutrition products. Med-Instill holds over 100 patents for the contamination free filling and multiple dose delivery for non-preserved products. In addition, Med-Instill’s devices are conceived for enhancing drug efficacy and reducing side effects through accurate, consumer friendly, metered dose delivery systems for topical applications on skin and mucous membranes. Med-Instill continues to pursue partnerships and licenses for the commercialization of their filling technology and delivery devices in specific fields.