TORONTO, April 3 /CNW/ - Transition Therapeutics Inc. ("Transition")
(TSX: TTH) announced today that the United States Food and Drug Administration
("FDA") has granted Fast Track designation to investigational drug candidate
AZD-103/ELND005, being developed in collaboration with Elan Corporation, plc.
("Elan") (NYSE: ELN) for the treatment of Alzheimer's disease. AZD-103/ELND005
is currently being evaluated in multiple Phase I clinical studies, and the
companies anticipate starting Phase II clinical studies around the end of
"The decision by the FDA is very encouraging news for Alzheimer's disease
patients and their families, and we believe it reflects the considerable
potential for AZD-103 in this area," said Dr. Tony Cruz, Chairman and Chief
Executive Officer of Transition. "Transition and Elan welcome this decision
and look forward to working with the FDA and the clinical community to make
continued progress on AZD-103/ELND005."
Under the FDA Modernization Act of 1997, Fast Track designation is
intended to facilitate the development and expedite the review of a drug or
biologic if it is intended for the treatment of a serious or life-threatening
condition, and it demonstrates the potential to address unmet medical needs
for such a condition.
Transition is a biopharmaceutical company, developing novel therapeutics
for disease indications with large markets. Transition's lead products include
AZD-103/ELND005 for the treatment of Alzheimer's disease and regenerative
therapies E1-I.N.T.(TM) and GLP1-I.N.T.(TM) for the treatment of diabetes.
Transition has an emerging pipeline of preclinical drug candidates developed
using its proprietary drug discovery engine. Transition's shares are listed on
the Toronto Stock Exchange under the symbol "TTH". For additional information
about the company, please visit www.transitiontherapeutics.com.
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For further information:
For further information: on Transition, visit
www.transitiontherapeutics.com or contact: Dr. Tony Cruz, Chief Executive
Officer, Transition Therapeutics Inc., Phone: (416) 260-7770, x.223,
email@example.com; Mr. Elie Farah, CFO and VP Corporate
Development, Transition Therapeutics Inc., Phone: (416) 260-7770, x.203,
firstname.lastname@example.org; For further information on Elan, visit