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HTL signs agreemeent with leading Italian pharmaceutical company

High Tech Lipids (HTL) signs Cooperation Agreement with Chiesi Group, a Major European Pharmaceutical Company

Chiesi has agreed to finance the development, regulatory procedure and introduction of HTL’s first product, an innovative lipid emulsion optimized for intravenous feeding of preterm neonates, into the market.


Misgav (Israel) and Parma (Italy) -- October 7, 2009 -- High Tech Lipids Ltd. (HTL) today announced that it has signed a cooperation agreement with Chiesi Farmaceutici S.p.A, the leading European pharmaceutical company in the field of products for premature infants. Chiesi is to fund and support HTL from the initial stages of clinical trials until the innovative lipid emulsion can be commercialized on a global basis following regulatory approval.

Although lipid emulsions are a vital component for human growth and bodily processes, several complications can arise from the infusion of existing lipid emulsions. Complications may include infection, raised blood fat levels and liver damage, which cause patients protracted suffering and a considerable increase in the need for clinical intervention. If lipids are not made available to patients requiring intravenous nutrition, this can result in even greater damage, such as impaired brain development and function, damage to the nervous, immune or blood coagulation systems, as well as to the heart, and the blood vessels  may impair the growth and development of premature and normal infants, to the point of death.

Total parenteral nutrition (TPN) -- the intravenous infusion of nutrients directly into the bloodstream -- is a life-saving therapy for patients who cannot be fed through the digestive system, especially premature babies. Ten to twelve percent of births in developed countries are premature and these babies cannot receive nutrition due to the incomplete development of their digestive system: they must therefore be fed intravenously. HTL has developed an innovative emulsion that is optimized for intravenous feeding. The emulsion is based on a new model of engineered triglycerides and a unique profile of fatty acids.

Dr. Bertold Fridlender, Chairman of the Board of HTL, noted that "the agreement with Chiesi is a great achievement for the company. On the one hand, it constitutes recognition and a vote of confidence from one of the leading firms in the field, and on the other, it is a commitment to finance all stages of the trials and marketing, firstly in the European market and later in the U.S. and the rest of the world." Dr. Ohad Karnieli, HTL’s Project Manager added, "We are currently making preparations to begin pre-clinical testing, which we are confident will soon achieve positive results."
Prof. Pierre Singer, a well-known expert in clinical nutrition and senior member of the scientific leadership of the company which has made a major contribution to HTL observes that "No lipid emulsion currently on the market addresses the complex needs of patients in general and of premature infants in particular."

"The agreement with HTL is a strategic choice for the development of our neonatology portfolio," stated Dr. Paolo Chiesi, Chiesi Group Vice President and R&D Director. "We are confident that, once fully developed and registered, this innovative lipid emulsion will significantly contribute to the improvement of clinical nutrition of preterm newborns. The deal with HTL confirms the Chiesi Group’s commitment to developing new therapeutic solutions for rare diseases." 


About HTL
HTL, which started with Misgav Venture Accelerator, has developed a new lipid molecule that is the most advanced solution to the problem of intravenous lipid infusions. It will prevent severe side effects and meet all of the premature infant’s nutritional needs. This breakthrough has been achieved as the result of a collaboration between HTL’s founders, Dr. Geila Rozen and Irit Shochat, together with Dr. Sobhi Basheer, an internationally renowned chemist specialising in enzymatic processing of lipids. This success was accomplished by uniquely combining two fields: clinical nutrition and enzymology.


About The Chiesi Group
The Chiesi Group is a research-focused international company developing added-value innovative pharmaceutical solutions to improve the quality of human life. Founded in Parma in 1935, Chiesi today operates globally through 23 direct affiliates, three manufacturing sites and four research laboratories (in Italy, France, the United Kingdom and the United States). The Group has over 3, 200 employees and invests about 15% of its turnover in Research and Development. Chiesi’s technologies and products are available in over 65 countries through a strategic alliance network of international pharmaceutical groups developed on both a global and local scale. The therapeutic focus is on respiratory diseases and special care.


About Misgav
The Misgav Venture Accelerator,  founded in 1992, specializes in medical instrumentation, pharmaceutical, and biotechnology companies. The Israeli Trendlines Group owns a controlling interest in the accelerator, which is managed by Steve Rhodes.

For further information, please contact:
High Tech Lipids Ltd.
www.HighTechLipids.com


Chiesi Farmaceutici S.p.A.
Massimo Zaninelli,
Corporate Communication
www.chiesigroup.com

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