Novel cardioprotective agent to move forward in Phase III development

    NEW YORK, Aug. 20 /PRNewswire/ -- PeriCor Therapeutics announced today
that its licensing agreement for acadesine with Schering-Plough Corporation
has become effective. The agreement grants Schering-Plough exclusive
worldwide rights for the development and commercialization of PeriCor's
lead compound, acadesine. Financial terms of the transaction were not
disclosed.
    Acadesine is currently under evaluation in Phase III clinical
development as an intravenous infusion for the prevention of adverse
cardiovascular and cerebrovascular outcomes that occur as complications
associated with ischemia-reperfusion injury in patients undergoing coronary
artery bypass graft (CABG) surgery. Acadesine has been studied in
placebo-controlled trials that enrolled more than 4,000 patients.
Schering-Plough will conduct an additional randomized, placebo-controlled
Phase III trial needed for regulatory approval. An agent, such as
acadesine, that can be shown to reduce the surgical complications of
stroke, heart failure and death that can accompany CABG would not only make
an important contribution to patients' well-being, but would also be
anticipated to reduce health care costs dramatically.
    "Schering-Plough possesses the vital organizational and financial
resources to complete the clinical and regulatory processes required to
make this life-saving medicine available to cardiac surgeons and
anesthesiologists around the world," said Richard R. Stover, President and
Chief Executive Officer of PeriCor Therapeutics. Commenting further, Mr.
Stover said, "We are especially impressed with the caliber of
Schering-Plough's cardiovascular group in clinical development, medical,
and marketing activities and their unparalleled record of innovation in
this therapeutic area."
    Previous clinical experience with acadesine in placebo-controlled
studies in CABG surgery suggests that acadesine may have unique
cardioprotective activity. Last year, a landmark study of this novel
cardioprotective agent demonstrated the drug's ability to prolong long-term
survival in those patients who suffer heart attacks following heart bypass
surgery. Among patients who underwent CABG surgery and suffered
post-reperfusion myocardial infarction (MI), mortality after two years was
reduced by 77% with acadesine treatment. (p=0.006) (JACC 2006: 48:206-14).
The principal benefit, which was observed in the first 30 days following
MI, was sustained over the two-year period. The incidence of adverse events
was similar in the acadesine and placebo groups, with the exception of a
transient increase in serum uric acid among acadesine-treated patients and
a higher incidence of heart failure in placebo-treated patients.
    Adenosine-Mediated Cardioprotection
    Adenosine regulation by acadesine provides highly site- and
event-specific amplification of adenosine-mediated cardioprotection while
exhibiting a remarkable safety profile in more than 2,000 patients who have
received the drug in controlled clinical trials. Adenosine targets a
broad-spectrum of the pathophysiology of ischemia/reperfusion injury that
involves an even broader range of chemical mediators and cell types than
was recognized only ten years ago. Adenosine has been shown to be a
powerful mediator of ischemic preconditioning, the most potent approach to
reducing infarct size in ischemia/reperfusion injury in animal studies.
    "Acadesine represents the first of an entirely new class of
cardioprotective agents that harness and enhance the cardioprotective
activity of endogenous adenosine," said Robert L. Engler, M.D., one of the
original discoverers of the cardioprotective effects of adenosine
regulating agents (ARAs). "As such, we are optimistic that acadesine may
become the first clinically available 'preconditioning mimetic' agent." Mr.
Stover noted, "The closing of this licensing transaction will enable
PeriCor to move ahead to evaluate the life-saving potential of its
second-generation ARAs in an extended range of clinical settings where
patients may benefit from protection from ischemia/reperfusion injury.
    About PeriCor Therapeutics
    PeriCor Therapeutics, Inc. is a privately-held specialty
biopharmaceutical company focused on the development and commercialization
of a new class of medicines, adenosine regulating agents, to prevent the
perioperative complications of surgery and improve the treatment and
outcomes of acute cardiovascular care.

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