GAITHERSBURG, Md., Aug 31, 2005 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it has amended its U.S. co-promotion
agreement with Abbott for Synagis (palivizumab), MedImmune's first-generation
monoclonal antibody (MAb) against respiratory syncytial virus (RSV). Abbott
will continue to co-promote Synagis through June 30, 2006, at which time
MedImmune will take full responsibility for product sales in the United
States.
"MedImmune will take full responsibility for sales of Synagis in the
United States starting in the 2006-2007 RSV season," said David M. Mott,
MedImmune's president and chief executive officer. "We plan to expand our 300-
person pediatric sales organization by approximately 125 professionals in
advance of the 2006/2007 RSV season to replace Abbott's co-promotion efforts.
This expansion will provide us with strategic and operational advantages as we
prepare for the continued growth of the pediatric infectious disease component
of our business. Key opportunities in this area include the potential launch
of CAIV-T, our next generation intranasal influenza vaccine, in the fall of
2007; the potential fall 2008 launch of Numax(TM) (motavizumab), our next-
generation anti-RSV antibody; and the recently announced anti-staphylococcal
antibody program currently in Phase 2 development."
Mr. Mott added, "This transaction and the resulting elimination of the co-
promotion fees to Abbott should be substantially accretive to MedImmune's
earnings per share beginning in 2007. As such, we are increasing our 2007
earnings target to approximately $1.15 per share, excluding stock option
expense. Importantly, while we continue to be optimistic about the prospects
of Numax, we are now positioned to achieve our 2009 earnings per share goal of
$2.00, before stock option expense, whether we are selling Synagis, Numax or
both."
Under the terms of the amendment, MedImmune will continue to pay a portion
of U.S. sales of Synagis to Abbott through 2006. MedImmune will also make
additional payments to Abbott, including incentive payments based on the
achievement of certain U.S. sales levels of Synagis during the 2005-2006 RSV
season. If Numax is not approved for marketing in the United States by
September 1, 2008, MedImmune will make additional payments to Abbott based
upon sales of Synagis for up to two years. As previously stated, MedImmune
intends to market and sell Numax on its own in the United States.
Earlier this year, MedImmune and Abbott amended their ex-U.S. distribution
agreement, providing Abbott rights to distribute and market Numax upon
approval outside of the United States. Abbott's rights to distribute and
market Synagis and Numax, upon approval outside the United States, are
unaffected by the amendment to the U.S. co-promotion agreement for Synagis.
Updated Financial Guidance
MedImmune expects this transaction to reduce earnings-per-share in 2005
and 2006 by $0.10 to $0.11 each year, resulting in a new range for 2005 of
$0.24 to $0.30 and a preliminary range for 2006 of $0.40 to $0.50*, excluding
stock option expense. MedImmune expects this transaction to be substantially
beneficial following 2006, with accretion in 2007 of approximately $0.28 per
diluted share. As such, MedImmune is increasing its 2007 earnings-per-share
target to approximately $1.15, excluding stock option expense. MedImmune is
also now positioned to reach its previously stated 2009 goal of $2.00 in
earnings per share, excluding stock option expense, with or without the
introduction of Numax. MedImmune continues to be encouraged with the progress
in its Phase 3 program with Numax, and following this transaction, has more
strategic flexibility to position Numax in the market, if and when it is
approved for marketing. MedImmune is providing this update on its financial
guidance as a convenience to investors. Guidance and targets provided by the
company are projections and are based upon numerous assumptions, many of which
MedImmune cannot control and that may not develop as MedImmune expects. For a
discussion of the risks associated with these forward-looking statements, see
the Disclosure Notice below.
* This is the first time that MedImmune has provided a guidance range for
2006. The company anticipates that it will refine this guidance during
its fall budgeting cycle and provide investors with any appropriate
updates at the time it reports 2005 financial results in early 2006.
About Synagis
Synagis is indicated for the prevention of serious lower respiratory tract
disease caused by RSV in pediatric patients at high-risk of RSV disease, which
is prominent in the Northern Hemisphere during the winter months. Synagis is a
humanized MAb given by an intramuscular injection once a month during the RSV
season. Synagis was approved in 1998 by the U.S. Food and Drug Administration
(FDA); in 1999, by the European Medicines Evaluation Agency; and in 2002, by
the Japanese Ministry of Health, Labor and Welfare. In 2003, the FDA expanded
the U.S. label for Synagis for use in young children with hemodynamically
significant congenital heart disease at risk of RSV disease. To date, Synagis
has been approved in 62 countries, including the United States. Synagis has
been used in more than half a million babies since 1998. Adverse events with
Synagis may include upper respiratory tract infection, ear infection, fever,
runny nose, rash, diarrhea, cough, vomiting, gastrointestinal upset and
wheezing. Very rare cases of severe allergic reactions such as anaphylaxis
(less than 1 case per 100,000 patients) have been reported following re-
exposure to Synagis. Rare severe, acute hypersensitivity reactions have also
been reported on initial exposure or re-exposure to Synagis. Synagis should
not be used in patients with a history of a severe prior reaction to Synagis
or its components. For full prescribing information for Synagis, see the
company's website at http://www.medimmune.com/products/synagis/index.asp.
About Numax
Numax is an investigational humanized MAb in Phase 3 development to
evaluate its potential to prevent serious lower respiratory tract disease
caused by RSV in pediatric patients at high risk of RSV disease. Phase 1 and
Phase 2 studies have recently been reported showing that Numax appears to have
a similar safety and pharmacokinetic profile to Synagis in infants. By the end
of 2005, there will be three active late-stage clinical trials underway with
Numax involving more than 7,500 children worldwide. These include a pivotal
Phase 3 study initiated in November 2004 comparing the safety and efficacy of
Numax with Synagis in reducing serious RSV disease in high-risk infants; a
second Phase 3 study initiated in November 2004 to assess whether Numax can
reduce the incidence of RSV hospitalization in full-term Native American
infants; and a safety study planned to begin in late 2005 in children with
congenital heart disease.
About RSV
RSV is the most common respiratory infection in infancy or childhood.
Approximately one-half of all infants are infected with RSV during the first
year of life, and nearly all children have been infected at least once by the
time they reach their second birthday. Children born prematurely as well as
those with chronic lung disease or congenital heart disease are at highest
risk of severe disease and hospitalization due to RSV.
Conference Call & Webcast
MedImmune will hold a conference call with the financial community on
Wednesday, August 31, 2005 at 12:00 p.m. eastern time to discuss the impact of
the amended agreement with Abbott for the co-promotion of Synagis in the
United States. The live webcast and related information can be accessed by
going to the Investor Relations section of the MedImmune website at
http://www.medimmune.com. Following the webcast, an archived version of the
call will be available at the same address until September 7, 2005. An audio
replay of the webcast will be available beginning at 2:00 p.m. eastern time on
August 31, 2005 and ending at midnight September 7, 2005 by calling (888) 286-
8010. The passcode for the audio replay is 55928325
About MedImmune
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious diseases,
cancer and inflammatory diseases. With approximately 2,000 employees
worldwide, MedImmune is headquartered in Maryland. For more information, visit
http://www.medimmune.com.
This announcement contains forward-looking statements regarding
MedImmune's future financial performance and business prospects. Those
statements involve substantial risks and uncertainties, and are present in the
section captioned "Updated Financial Guidance," as well as other sections
containing words such as "anticipate," "believe," "estimate," "expect,"
"intend," "project" or other terms of similar meaning. Those statements
reflect management's current beliefs and are based on numerous assumptions,
which MedImmune cannot control and which may not develop as MedImmune expects
for reasons set forth in MedImmune's Annual Report on Form 10-K for the year
ended December 31, 2004, as amended, its quarterly reports on Form 10-Q for
each of the two quarters of 2005 for which such a report was filed, its
current reports on Form 8-K filed for events occurring in 2005 and other
public disclosures and filings with the U.S. Securities and Exchange
Commission. Consequently, actual results may differ materially from those
projected in the forward-looking statements.
MedImmune is developing Numax and other products described in this
announcement for potential future marketing and the overall success of these
development efforts is important for the company's long-term prospects. There
can be no assurance that such development efforts will succeed, that such
products will receive required regulatory clearance or that, even if such
regulatory clearance is received, such products will ultimately achieve
commercial success.
SOURCE MedImmune, Inc.
Media:
Jamie Lacey
+1-301-398-4035
Investors:
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+1-301-398-4086
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