InfiMed Therapeutics to Collaborate with Nikken Chemicals Co. Ltd. on Controlled-Release Growth Hormone Drug in Japan Market

Agreement validates InfiMed's breakthrough technology platform for

controlled-release of protein- and peptide-based drugs



"We strongly believe this partnership will result in a more powerful protein

drug that requires fewer injections, thus ensuring better patient compliance

and, ultimately, a leading share of the market for human growth hormone."

Stephen C. Rowe, CEO

InfiMed Therapeutics, Inc.



Apr 19, 2001, 01:00 ET from InfiMed Therapeutics Inc.

    CAMBRIDGE, Mass., and TOKYO, April 19 /PRNewswire/ -- InfiMed Therapeutics
 Inc., an emerging specialty pharmaceuticals company, and Nikken Chemicals Co.
 Ltd., which actively researches and develops innovative new drugs in Japan,
 announced today that the two companies are collaborating on development of
 InfiMed Therapeutics' drug Infitropin CR(TM), a novel controlled-release human
 growth hormone (hGH) used in the treatment of children with growth failure due
 to insufficient secretion of endogenous growth hormone and Turner Syndrome.
     Financial terms of the agreement were not disclosed.
     "Japan represents the largest market segment opportunity for a controlled-
 release formulation of Infitropin CR(TM), a market that exceeds $1.5 billion
 annually worldwide," said Stephen C. Rowe, president and chief executive
 officer of privately held InfiMed Therapeutics.  "As a result of this
 collaboration with Nikken, we hope that human clinical trials begin in Japan
 with our controlled-release hGH drug Infitropin CR by the end of this year,"
 added Rowe.  "We are confident that at least equal efficacy will be
 demonstrated with our controlled-release formulation, compared to the gold
 standard of daily injections.  When this happens, our broad platform
 technology for delivery of protein drugs will be validated."
     "Nikken is proud to be partnering with InfiMed Therapeutics," added
 Kazuhide Shimano, Nikken's chief executive officer.  "Given our mission to
 discover new drugs that improve the standard of medical treatment for our
 children and our citizens, we are looking forward to developing and
 commercializing InfiMed's superior, controlled-release formulation of a very
 important drug, human growth hormone. Nikken has had a long and successful
 history marketing human growth hormone in Japan and looks forward to the
 opportunity to significantly expand its share of the Japanese hGH market with
 Infitropin CR(TM)."
     The controlled-release formulation of Infitropin CR(TM) will be based on
 InfiMed's patented breakthrough IFE(TM) (Improved Formulation Entity) platform
 for sustained-release of protein and peptide drugs, which involves trapping
 the molecules of a protein or peptide drug in a matrix of polyethylene glycol
 (PEG)-based hydrogel, a concept akin to trapping live fish within a 3-D
 fishing net.  The hydrogel microspheres can be administered as intramuscular,
 or subcutaneous, injections or administered in a pulmonary dosage formulation.
     Controlled release of the drug is predicated on degradation of the
 hydrogel in the body - the timing of which can be strictly "programmed in" by
 altering the characteristics of the hydrogel so that specific drug levels can
 be sustained for weeks, even months.
     In vitro and in vivo preclinical testing with human growth hormone (hGH)
 and erythropoietin (EPO) protein drugs incorporated within InfiMed's IFE(TM)
 system has demonstrated several critically important features and benefits:
 (1) virtually no initial 'burst' of drug-release upon administration,
 important for safety and efficacy, and for minimizing wasteage of expensive
 protein/peptide drug; (2) a smooth profile of drug release, sustained over
 periods of one week to several months, important for efficacy and minimizing
 side effects; and, (3) ability to load relatively large amounts of drug into
 microparticles that makes it possible to use smaller needles and smaller
 injection volumes.
     InfiMed holds the exclusive worldwide rights for systemic drug delivery to
 IFE(TM) technology, which was invented by Jeffrey A. Hubbell, Ph.D., while at
 the University of Texas (Austin) and is protected by several issued University
 of Texas patents.
 
     Nikken Chemicals Co., Ltd., headquartered in Tokyo, Japan, discovers,
 develops, manufactures and markets a broad range of innovative pharmaceutical
 products.
 
     InfiMed is a specialty-pharmaceuticals company developing proprietary
 polyethylene glycol (PEG)-based hydrogels as a broad technology platform for
 the sustained delivery of protein and peptide drugs.  Drugs suitable for
 delivery utilizing InfiMed's technology include erythropoietin, interferon,
 growth hormone, Factor VIII, insulin (pulmonary), LHRH (prostate cancer) and
 other products that have current annual worldwide markets in the hundreds of
 millions to several billions of dollars.
 
      Contacts:
      Jennifer Briggs
      Account Executive
      Ronald Trahan Associates Inc.
      508-647-9782, ext. 17
 
      Stephen C. Rowe
      Chief Executive Officer
      InfiMed Therapeutics Inc.
      617-497-8303
 
 

SOURCE InfiMed Therapeutics Inc.
    CAMBRIDGE, Mass., and TOKYO, April 19 /PRNewswire/ -- InfiMed Therapeutics
 Inc., an emerging specialty pharmaceuticals company, and Nikken Chemicals Co.
 Ltd., which actively researches and develops innovative new drugs in Japan,
 announced today that the two companies are collaborating on development of
 InfiMed Therapeutics' drug Infitropin CR(TM), a novel controlled-release human
 growth hormone (hGH) used in the treatment of children with growth failure due
 to insufficient secretion of endogenous growth hormone and Turner Syndrome.
     Financial terms of the agreement were not disclosed.
     "Japan represents the largest market segment opportunity for a controlled-
 release formulation of Infitropin CR(TM), a market that exceeds $1.5 billion
 annually worldwide," said Stephen C. Rowe, president and chief executive
 officer of privately held InfiMed Therapeutics.  "As a result of this
 collaboration with Nikken, we hope that human clinical trials begin in Japan
 with our controlled-release hGH drug Infitropin CR by the end of this year,"
 added Rowe.  "We are confident that at least equal efficacy will be
 demonstrated with our controlled-release formulation, compared to the gold
 standard of daily injections.  When this happens, our broad platform
 technology for delivery of protein drugs will be validated."
     "Nikken is proud to be partnering with InfiMed Therapeutics," added
 Kazuhide Shimano, Nikken's chief executive officer.  "Given our mission to
 discover new drugs that improve the standard of medical treatment for our
 children and our citizens, we are looking forward to developing and
 commercializing InfiMed's superior, controlled-release formulation of a very
 important drug, human growth hormone. Nikken has had a long and successful
 history marketing human growth hormone in Japan and looks forward to the
 opportunity to significantly expand its share of the Japanese hGH market with
 Infitropin CR(TM)."
     The controlled-release formulation of Infitropin CR(TM) will be based on
 InfiMed's patented breakthrough IFE(TM) (Improved Formulation Entity) platform
 for sustained-release of protein and peptide drugs, which involves trapping
 the molecules of a protein or peptide drug in a matrix of polyethylene glycol
 (PEG)-based hydrogel, a concept akin to trapping live fish within a 3-D
 fishing net.  The hydrogel microspheres can be administered as intramuscular,
 or subcutaneous, injections or administered in a pulmonary dosage formulation.
     Controlled release of the drug is predicated on degradation of the
 hydrogel in the body - the timing of which can be strictly "programmed in" by
 altering the characteristics of the hydrogel so that specific drug levels can
 be sustained for weeks, even months.
     In vitro and in vivo preclinical testing with human growth hormone (hGH)
 and erythropoietin (EPO) protein drugs incorporated within InfiMed's IFE(TM)
 system has demonstrated several critically important features and benefits:
 (1) virtually no initial 'burst' of drug-release upon administration,
 important for safety and efficacy, and for minimizing wasteage of expensive
 protein/peptide drug; (2) a smooth profile of drug release, sustained over
 periods of one week to several months, important for efficacy and minimizing
 side effects; and, (3) ability to load relatively large amounts of drug into
 microparticles that makes it possible to use smaller needles and smaller
 injection volumes.
     InfiMed holds the exclusive worldwide rights for systemic drug delivery to
 IFE(TM) technology, which was invented by Jeffrey A. Hubbell, Ph.D., while at
 the University of Texas (Austin) and is protected by several issued University
 of Texas patents.
 
     Nikken Chemicals Co., Ltd., headquartered in Tokyo, Japan, discovers,
 develops, manufactures and markets a broad range of innovative pharmaceutical
 products.
 
     InfiMed is a specialty-pharmaceuticals company developing proprietary
 polyethylene glycol (PEG)-based hydrogels as a broad technology platform for
 the sustained delivery of protein and peptide drugs.  Drugs suitable for
 delivery utilizing InfiMed's technology include erythropoietin, interferon,
 growth hormone, Factor VIII, insulin (pulmonary), LHRH (prostate cancer) and
 other products that have current annual worldwide markets in the hundreds of
 millions to several billions of dollars.
 
      Contacts:
      Jennifer Briggs
      Account Executive
      Ronald Trahan Associates Inc.
      508-647-9782, ext. 17
 
      Stephen C. Rowe
      Chief Executive Officer
      InfiMed Therapeutics Inc.
      617-497-8303
 
 SOURCE  InfiMed Therapeutics Inc.