Larry,
Well here's why it's been making new highs:
News Alert from PR Newswire
Headline: Alexion Pharmaceuticals and Procter & Gamble Pharmaceuticals Enter
Drug Development Collaboration for Acute Cardiovascular Indications
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NEW HAVEN, Conn., Jan. 26 /PRNewswire/ -- Alexion Pharmaceuticals, Inc.
(NASDAQ:ALXN) and Procter & Gamble Pharmaceuticals (NYSE:PG) today announced
that the two companies have entered into a collaboration to develop and
commercialize Alexion's lead C5 complement inhibitor drug candidate,
5G1.1-SC,
currently in Phase IIb clinical trials for patients undergoing
cardiopulmonary
bypass (CPB) during coronary artery bypass graft (CABG) surgery. Under the
terms of the collaboration agreement, development efforts will concurrently
assess 5G1.1-SC in the settings of CABG, angioplasty and other acute
cardiovascular indications, such as myocardial infarction and unstable
angina,
as well as other applications. Procter & Gamble will receive worldwide
development and marketing rights. In return, Alexion will receive up to
$95 million in total payments, which may include up to $39 million in
pre-commercialization milestone payments. In addition, Alexion retains the
right for commercial manufacturing as well as co-promotion rights in the
U.S.
Leonard Bell, M.D., President and Chief Executive Officer of Alexion,
stated, "We believe that Alexion's collaboration with P&G is the most
comprehensive effort to date in the area of complement inhibition for acute
cardiovascular disease." Dr. Bell continued, "Within the next 12 months,
the
collaborative team expects to undertake advanced clinical development in
over
one thousand cardiopulmonary bypass patients and heart attack patients.
This
will provide Alexion with the opportunity to substantially accelerate the
rate
of clinical development with the objective of commercializing our product at
the earliest possible timepoint. Further, coming on the heels of P&G's
successful NDA submission for Azimilide, a pioneering anti-arrhythmic
cardiovascular drug, we believe that this collaboration is ideally timed to
benefit from an established network of clinical development professionals
who
are experienced in cardiovascular trials."
"As evidenced by this collaboration, P&G Pharmaceuticals is committed to
further developing its cardiac pipeline," said Mark A. Collar, head of
Procter
& Gamble Pharmaceuticals. "In addition to a substantial in house cardiac
R&D
program, we are working to supplement this effort with a few highly
promising
external relationships with innovative biotech companies like Alexion
Pharmaceuticals which have promising technologies with breakthrough
potential.
Further, this new opportunity in the cardiac area works well with our effort
on Azimilide -- an investigational anti-arrhythmic drug currently being
reviewed by the FDA."
Results from Phase I/II and Phase IIa CPB studies completed by Alexion
last year showed that 5G1.1-SC significantly reduces cardiac damage, new
cognitive (brain) deficits, and blood loss in patients undergoing CABG
surgery
during CPB. Alexion also recently completed dosing of 5G1.1-SC in a Phase I
study which was designed to support the CABG studies as well as an
anticipated
heart attack trial. Alexion's preclinical surrogates for 5G1.1-SC were
demonstrated to substantially reduce the myocardial infarction resulting
from
coronary ischemia in a variety of different experimental models of heart
attack and angioplasty published in the June 9, 1998 issue of the American
Heart Association's journal Circulation.
According to the most recent statistics available from the American
Heart
Association, approximately 1,000,000 patients suffer a heart attack, about
400,000 patients undergo angioplasty procedures, and approximately 500,000
CPB
procedures are performed in the U.S. each year. Further, according to the
same AHA statistics, in excess of $20 billion is spent annually on CABG
surgery and CABG-related medical care in the U.S. alone.
Alexion's class of C5 complement inhibitors are specific and potent
recombinant drugs which are designed to intervene in the complement cascade
by
preserving the normal disease-preventing functions of complement proteins
while generally inhibiting the disease-causing actions. The company's lead
C5
Inhibitor product, 5G1.1-SC, is a novel, bacterially produced, humanized
single chain antibody, specifically designed to rapidly penetrate tissue and
limit inflammation.
Procter & Gamble Pharmaceuticals is a part of Procter & Gamble Company,
a
$38 billion dollar leader in the development, manufacturing and marketing of
consumer goods. In prescription medicines, P&GP is focusing on
cardiovascular
and musculoskeletal health as well as anti-infective therapies. In the
cardiovascular area, P&G submitted a new drug application for azimilide with
the U.S. Food and Drug Administration in December 1998. Azimilide is an
investigational anti-arrhythmic drug. P&GP is seeking an indication for the
maintenance of sinus heart rhythm by prolonging the arrhythmia-free period
in
patients with atrial fibrillation, atrial flutter or paroxysmal
supraventricular tachhycardias (PSVT) various forms of irregular heartbeat.
Alexion Pharmaceuticals, Inc. was founded in 1992 and is engaged in the
development of selective immunotherapeutic drugs that generally are designed
to inhibit the disease-causing segments of the immune system while
preserving
the disease-preventing aspects of the immune system. The company is
developing three technology platforms: C5 complement Inhibitors and Apogen
T-Cell Therapeutics, which together target severe cardiovascular and
autoimmune disorders; and xenografts for organ transplantation.
This news release contains forward-looking statements. Such statements
are subject to certain factors which may cause Alexion's plans to differ or
results to vary from those expected including unexpected pre-clinical or
clinical results, the need for additional research and testing, delays in
manufacturing, access to capital and funding, delays and adverse changes in
development of commercial relationships and a variety of risks set forth
from
time to time in Alexion's filings with the Securities and Exchange
Commission,
including but not limited to the risks discussed in Alexion's Annual Report
on
Form 1O-K for the year ended July 31, 1998. Alexion undertakes no
obligation
to publicly release results of any of these forward-looking statements which
may be made to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events.
SOURCE Alexion Pharmaceuticals, Inc.
-0- 01/26/99
/CONTACT: Leonard Bell, M.D., President and CEO of Alexion
Pharmaceuticals, Inc., 203-776-1790; or Media - Lisa Burns or Justin
Jackson,
both of Burns McClellan, 212-213-0006, or Investors - Rhonda Chiger of
Thomson
Investor Relations, 212-440-9037, all for Alexion Pharmaceuticals, Inc.; or
Jim Martis, Investor Relations, 513-983-9974, or Terry Loftus, Public
Affairs,
513-945-8055, both of Procter & Gamble Pharmaceuticals/
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