Under the terms of the agreement Animas has acquired an exclusive worldwide license to make, use, and sell products utilizing the intellectual property portfolio owned by Debiotech relating to micro-pumps and micro-needles for use related to insulin administration and in vivo glucose sensing.
Animas is to pay Debiotech $12 million (€9.4 million) in cash and will issue 400,000 restricted shares in common stock to the Swiss company. In addition, Animas will pay Debiotech a license fee up to $2.0 million upon receipt of the requisite deliverables for 510(k) approval from the FDA for the micro-pump.
Debiotech is to receive royalties on sales of products resulting from these agreements. A large portion of the upfront license fee will be taken as an operating charge in the fourth quarter of 2004.
The agreement is not expected to have any material impact on the Company's anticipated net revenues or net income in 2005 and 2006.
Alan How, business development manager of Debiotech told In-Pharmatechnologist.com: "The primary objective of this agreement was the development of an insulin pump based on the MEMS technology. This approach allows a higher accuracy of insulin to be administered, which as a result requires less insulin. The primary advantage is that control of blood sugar level becomes a lot more accurate."
MEMS technology uses fabrication techniques similar to those used in the semi-conductor industry. The micro-fluidics technology makes pump therapy attractive to a greater number of people with diabetes as it allows for the development of much smaller insulin pumps. The micro-needle technology offers the possibility of reducing pain and inflammatory response associated with infusion needles and may additionally be useful for the sensing of glucose
An insulin pump based on the MEMS technology allows a higher accuracy of insulin to be administered, which as a result requires less insulin. The primary advantage is that control of blood sugar level becomes a lot more accurate. Compared to existing technology performance this technology is a major improvement. In addition, the MEMS technology is to form a basis for Debiotech's ultimate goal to produce the world's first artificial pancreas.
Patrick Paul, vice president of research and development for Animas commented: "We believe this acquisition strengthens our intellectual property position in our existing primary markets."
The medical device industry is currently in the midst of a growth splurge with a significant trend seemingly emerging where collaborations within the pharmaceutical industry and medical device industry are emphasising the administration of the drug.
How commented that in working on the administration of the drug, its effectiveness can be improved, which meant the chemistry of the drug could be left alone.
The collaboration represents a major step in Debiotech's continuous growth through global presence in the medical device arena with leading partners in the industry. Indeed, the deal with Animas could be seen as not only representing future developments in the diabetes field but in the dialysis, diagnostics and imaging device field also.
In July of this year, Debiotech announced a license agreement with Delphi Medical Systems, which included rights to manufacture and market Debiotech's ambulatory intravenous (IV) pump, its associated disposables and accessories.
Likewise in May, Debiotech announced a strategic alliance with Baxter Healthcare to develop renal therapy systems and technologies. The initial agreement was to focus on the development and marketing of next-generation dialysis systems intended to treat end-stage renal disease (ESRD) patients.
How said: "We hope that this collaboration with Animas is one of many. The MEMS technology is cutting edge and its potential cannot be realised without additional partnerships and input from other companies."