KENILWORTH, N.J., and EAST HANOVER, N.J., Nov. 1 /PRNewswire-FirstCall/ --
Schering-Plough Corporation (NYSE: SGP) and Novartis Pharmaceuticals
Corporation, an affiliate of Novartis AG (NYSE: NVS), today announced an
agreement giving Schering-Plough exclusive U.S. distribution and marketing
rights to Novartis' FORADIL(R) AEROLIZER(R) (formoterol fumarate inhalation
powder), a selective, long-acting beta2-agonist indicated for the maintenance
treatment of asthma and chronic obstructive pulmonary disease (COPD), and the
acute prevention of exercise-induced bronchospasm.
Under terms of the agreement, Novartis receives an upfront license payment
and could receive additional payments upon the achievement of certain
milestones. In addition, Schering-Plough will pay a royalty on its net sales
of FORADIL AEROLIZER. Specific financial terms of the agreement are not being
disclosed.
"Schering-Plough has a significant presence in the U.S. respiratory
market, based on leading products, an experienced sales force and a strong
relationship with physicians who prescribe our allergy and asthma
medications," said Richard W. Zahn, president of Schering Laboratories.
"FORADIL AEROLIZER promises to be an important addition to our respiratory
product line and reflects our continued commitment to this therapy area," he
said.
"Our strategy focuses our resources on key growth drivers, yet seeks to
maximize our return on our full portfolio of products," said Lawrence Perlow,
senior vice president for Novartis Pharmaceuticals Corporation.
"Schering-Plough is well positioned to establish FORADIL AEROLIZER with the
broader primary care community, a clear expansion from the specialty
communities in which we have been promoting FORADIL AEROLIZER. This allows us
to continue our strong growth emphasis on our major primary care products.
Novartis remains fully committed to bringing its other Respiratory Care
products through development to physicians and patients."
INDICATIONS
FORADIL AEROLIZER was approved in February 2001 by the U.S. Food and Drug
Administration (FDA) and is indicated for long-term, twice-daily
administration in the maintenance treatment of asthma and in the prevention of
bronchospasm in adults and children 5 years of age and older with reversible
obstructive airways disease, including patients with symptoms of nocturnal
asthma who require regular treatment with inhaled, short-acting,
beta2-agonists. It is not indicated for patients whose asthma can be managed
by occasional use of inhaled, short-acting, beta2-agonists. In September
2001, FORADIL AEROLIZER received an additional indication for the maintenance
treatment of bronchoconstriction in patients with COPD, including chronic
bronchitis and emphysema.
Additionally, FORADIL AEROLIZER is indicated for the acute prevention of
exercise-induced bronchospasm (EIB) in adults and children 12 years of age and
older, when administered on an occasional, as needed, basis.
FORADIL AEROLIZER can be used to treat asthma concomitantly with
short-acting beta2-agonists, inhaled or systemic corticosteroids, and
theophylline therapy. A satisfactory clinical response to FORADIL AEROLIZER
does not eliminate the need for continued treatment with an anti-inflammatory
agent.
DOSAGE AND ADMINISTRATION
The recommended dose for FORADIL for the maintenance treatment of asthma
in adults and children 5 years of age and older is the inhalation of the
contents of one 12 mcg FORADIL capsule every 12 hours using the AEROLIZER
Inhaler. For prevention of EIB in adults and adolescents 12 years of age or
older, the recommended dosage is the inhalation of the contents of one 12 mcg
FORADIL capsule at least 15 minutes before exercise administered on an
occasional, as-needed basis. For maintenance treatment of COPD the
recommended dosage is the inhalation of the contents of one 12 mcg FORADIL
capsule every 12 hours using the AEROLIZER inhaler. FORADIL capsules should
be administered only by the oral inhalation route and only using the AEROLIZER
inhaler. FORADIL capsules should not be ingested (i.e. swallowed) orally.
FORADIL capsules should always be stored in the blister, and only removed
IMMEDIATELY BEFORE USE.
ABOUT FORADIL AEROLIZER
FORADIL capsules are administered via the AEROLIZER Inhaler, a delivery
system that provides patients and caregivers dosing confirmation that the full
dose of medication has been taken. Many patients are concerned that they are
not able to confirm that they have taken the full dose of medication with
traditional metered-dose inhalers. In contrast, the AEROLIZER Inhaler emits a
whirring sound when it is activated and can be visually inspected to confirm
that a full dose has been dispensed. In addition, the AEROLIZER Inhaler
eliminates the need for hand-breath coordination associated with traditional
metered-dose inhalers.
Adverse reactions with FORADIL AEROLIZER are similar to other selective
beta2-agonists, and include: tachycardia, nervousness, tremor, muscle cramps,
nausea and insomnia. FORADIL AEROLIZER should not be used to treat acute
symptoms or used more than twice daily. Acute symptoms should be treated with
inhaled, short-acting beta2-agonists. FORADIL AEROLIZER should be used with
caution in patients with cardiovascular disorders. FORADIL AEROLIZER is not a
substitute for inhaled or oral corticosteroids and they should not be stopped
or reduced.
NOVARTIS DISCLOSURE NOTICE
This release contains certain "forward-looking statements," relating to
Novartis' business, which can be identified by the use of forward-looking
terminology such as "could," "promises," "confident," "will," "help" or
similar expressions, or by discussions of strategy, plans or intentions. Such
statements include descriptions of the potential benefit of FORADIL AEROLIZER
as evidenced by clinical trial results. Those statements reflect the current
views of the Company with respect to future events and are subject to certain
risks, uncertainties and assumptions. Many factors could cause the actual
results, performance or achievements of the Company to be materially different
from any future results, performances or achievements that may be expressed or
implied by such forward-looking statements.
There are no guarantees that the aforementioned licensing agreement will
result in increased sales for FORADIL AEROLIZER in any market. Any such sales
can be affected by, among other things, uncertainties relating to regulatory
actions, delays in or government regulation generally, competition in general,
loss of intellectual property rights and other risks and factors referred to
in the Company's current Form 20-F on file with the Securities and Exchange
Commission of the United States.
SCHERING-PLOUGH DISCLOSURE NOTICE
The information in this press release includes certain "forward-looking"
information relating to FORADIL AEROLIZER and its importance to
Schering-Plough. The reader of this release should understand that the extent
that FORADIL AEROLIZER will be prescribed will be determined by market forces,
and that the market viability of FORADIL AEROLIZER is subject to substantial
risks and uncertainties. In addition, the forward-looking statements may also
be adversely affected by general market and business factors, competitive
product development, product availability, the extent of market acceptance of
new products, current and future branded, generic or over-the-counter
competition, federal and state regulations and legislation, the regulatory
process for new products and indications, manufacturing issues, trade buying
patterns, patent positions, litigation and investigations. For further
details and a discussion of these and other risks and uncertainties, see
Schering-Plough's Securities and Exchange Commission filings, including its
2001 annual report on Form 10-K and subsequent quarterly reports on Form 10-Q
and current reports on Form 8-K.
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including respiratory disorders, central nervous
system disorders, organ transplantation, cardiovascular diseases,
dermatological diseases, cancer and arthritis. The company's mission is to
improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, N.J., Novartis Pharmaceuticals Corporation is an
affiliate of Novartis AG (NYSE: NVS), a world leader in healthcare with core
businesses in pharmaceuticals, consumer health, generics, eye care, and animal
health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion
(USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The
Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies employ about
74,000 people and operate in over 140 countries around the world.
Schering-Plough is a research-based company engaged in the discovery,
development, manufacturing and marketing of pharmaceutical products worldwide.
SOURCE Schering-Plough Corporation
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Related links:
http://www.schering-plough.com
CONTACT:
Harry Rohme of Novartis, +1-973-781-5151;
Media - Dana C. Bicsko, +1-908-298-7350, Investors - Geraldine U.
Foster, +1-908-298-7410, Lisa W. DeBerardine, +1-908-298-7437,
Janet M. Barth, +1-908-298-7417, all of Schering-Plough
Corporation
NOTE TO EDITORS: Schering-Plough press releases are available on
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