Another one that we're unlikely to see go public...
Schering-Plough Announces Licensing of Acadesine, an Investigational Agent Being Studied for Prevention of Complications From Cardiac Surgery
prnews
Potentially Life-Saving Agent Strengthens Company's Cardiovascular Late-Stage Development Portfolio
KENILWORTH, N.J., July 19 /PRNewswire-FirstCall/ -- Schering-Plough
Corporation (NYSE: SGP) today announced the worldwide licensing of acadesine,
an investigational, potentially first-in-class adenosine regulating agent
(ARA), from PeriCor Therapeutics, Inc., a privately held, specialty
biopharmaceutical company. Acadesine is currently under evaluation in Phase
III clinical development as an intravenous infusion for the prevention of
ischemia-reperfusion injury, a complication of cardiac surgery in patients
undergoing coronary artery bypass graft (CABG) surgery using cardiopulmonary
bypass (a procedure that stops the heart and places the patient on a pump).
Financial terms of the transaction were not disclosed. The transaction is
expected to close in the third quarter subject to certain conditions to
closing.
Ischemia-reperfusion injury represents a serious and life-threatening
cardiac surgery complication in patients undergoing coronary artery bypass
surgery performed with cardiopulmonary bypass, and there are currently no
approved treatments. Although CABG surgical techniques have improved and
reduced procedural morbidity and mortality, complication rates resulting from
these procedures, such as ischemia-reperfusion injury, remain unacceptably
high. According to a national cardiac surgery database from the Society of
Thoracic Surgeons, there is a 30-day operative mortality and major
complication rate of 13.4 percent associated with the CABG procedure (Ann
Thorac Surg 2003;75:1856-1865).
"Acadesine represents an important strategic opportunity to expand and
strengthen our growing cardiovascular franchise," said Fred Hassan, chairman
and chief executive officer, Schering-Plough. "With the thrombin receptor
antagonist, TRA or SCH-530348, our novel investigational antiplatelet
medication in late-stage development; the Merck/Schering-Plough cholesterol-
lowering products VYTORIN and ZETIA; and INTEGRILIN, the leading GP IIb-IIIa
inhibitor, acadesine further demonstrates our long-term commitment to
developing treatments to address unmet needs in cardiac care."
CABG and Reperfusion Injury
CABG surgery is a recommended treatment for high-risk patients who have
coronary artery disease or previously experienced an ischemic event, such as a
myocardial infarction (heart attack) or unstable angina, according to the
guidelines of the American Heart Association and the American College of
Cardiology.
Ischemia-reperfusion injury refers to damage to tissue caused when blood
supply returns to the tissue after a period of ischemia. The absence of
oxygen and nutrients from blood creates a condition in which restoration of
circulation results in inflammation and oxidative damage rather than
restoration of normal function.
"There is a significant unmet medical need in preventing morbidity and
mortality from ischemia-reperfusion injury following CABG surgery," said Rick
Veltri, MD, Group Vice President, Global Clinical Development, Cardiovascular
and Metabolic Diseases, Schering-Plough Research Institute. "Acadesine has
the potential to reduce perioperative complications in this patient
population, as well as decrease the burden of costs on the healthcare system,"
he added.
Clinical Data for Acadesine
In a meta-analysis of five randomized trials of acadesine, there was a
statistically significant 26 percent reduction in composite events (cardiac
death, myocardial infarction, and stroke) in patients undergoing CABG (p=0.01)
(JAMA 1997; 277:325-332). Acadesine therapy was also shown to reduce the
severity of acute post-reperfusion MI, substantially reducing the risk of
dying over the 2 years after the infarction by 4.3-fold, from 27.8 percent in
the control group to 6.5 percent in the acadesine group (p=0.006) (JACC 2006;
48:206-14). The incidence of adverse events was similar in the acadesine and
placebo groups, with the exception of a transient increase in serum uric acid.
An additional randomized, placebo-controlled Phase III trial will further
evaluate acadesine in high-risk patients. High-risk patients are defined as
either females, or males with a previous history of CABG surgery or
cardiovascular events, such as heart attack or stroke. An agent that can be
shown to reduce surgical complications can potentially have a significant
impact on healthcare costs, since treated patients may be less likely to
experience subsequent death, heart attacks, or strokes. The total cost for
care of an average CABG patient in the US is approximately $60,000 per case
(Am J Manag Care. 2004; 10:S370-S376).
About Schering-Plough Corporation
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