Nycomed and Forest Laboratories Holdings Limited, a wholly owned
subsidiary of Forest Laboratories, Inc. (NYSE: FRX), today
announced that they have entered into a definitive collaboration
and distribution agreement for Daxas® (roflumilast) in the United
States. Daxas® is a proprietary selective phosphodiesterase 4
(PDE4) enzyme inhibitor that has been developed by Nycomed for the
treatment of COPD (chronic obstructive pulmonary disease) and for
which Nycomed submitted an NDA with the FDA in July.
Under the terms of the agreement, Forest will make an upfront
payment to Nycomed of $100 million and will pay future, undisclosed
milestone payments. In addition, Nycomed will receive royalties
based on Daxas sales. Forest will assume responsibility for the US
regulatory approval and commercialization of Daxas in the United
States and the companies will collaborate on future development
programs.
Håkan Bj�rklund, Chief Executive Officer of Nycomed, said: “We
have received considerable interest in the marketing rights to
Daxas and we believe Forest Laboratories is the best possible
partner for Nycomed in the US. Forest Laboratories has a
significant US sales force, an increasing focus on respiratory
products and an unrivalled track record of partnering with European
companies to build hugely successful franchises. We believe their
absolute commitment to Daxas will help to bring this innovative new
therapy to as many patients in the United Sates as possible who
suffer from COPD, a disease which is predicted to become the
third-leading cause of death worldwide by 2030.”
Howard Solomon, Chairman and Chief Executive Officer of Forest,
said, "We are pleased to have entered into this collaboration with
Nycomed. Nycomed has demonstrated great dedication in bringing
Daxas to its current NDA stage of development and we are looking
forward to working with such a talented and committed group as we
consider ways to further develop and expand the use of Daxas. Daxas
represents the first in a new class of agents to treat COPD and
would be the first oral agent to be approved for this debilitating
disease. If approved, Daxas will give physicians and patients a
much needed new treatment option in a unique oral dosage form that
can augment the existing armamentarium of inhaled therapies.” In
addition Mr. Solomon commented that “oglemilast, our phase II PDE4
inhibitor licensed from Glenmark remains in active development for
both COPD and asthma and represents a potentially complementary
opportunity.”
In a recently completed Phase III pivotal program consisting of
two studies in a total of over 3,000 patients with COPD, Daxas
demonstrated statistically significant improvements compared to
placebo on the co-primary endpoints of moderate to severe
exacerbations and pre-bronchodilator FEV1 over a 12 month treatment
period in both studies. Daxas also demonstrated a statistically
significant improvement compared to placebo on the primary
endpoint, pre-bronchodilator FEV1, in two supportive studies over a
six month period when used in conjunction with commonly used
long-acting bronchodilators.
About Daxas®
Daxas is an orally administered phosphodiesterase 4 (PDE4)
enzyme inhibitor, targeting cells and mediators in the body
believed to be important in the COPD disease process. Daxas is
expected to act on an underlying mechanism of COPD and related
inflammatory diseases. If approved, Daxas, a once-a-day tablet,
will be the first drug in its class. It will also be the first oral
anti-inflammatory treatment for COPD patients. Current treatment
for COPD patients includes the use of inhaled bronchodilators and
inhaled corticosteroids.
Nycomed’s most recent and very extensive program for Daxas
included two international Phase III, 12-month trials, HERMES and
AURA, which included over 3,000 patients. The primary aim of both
studies was to investigate the effect of Daxas on exacerbation
rates and pulmonary function (pre-bronchodilator FEV1) in
predominantly severe and very severe COPD patients. Daxas (500 μg
roflumilast) was administered orally once daily for up to 52 weeks.
The randomized, double-blind, placebo-controlled studies were
conducted in a number of territories, including the US, Europe,
Canada, Australia, Russia, India and South Africa. Both HERMES and
AURA met their primary endpoint objectives.
Two additional supportive double-blind, placebo-controlled Phase
III studies, EOS and HELIOS, evaluated the efficacy of Daxas in
more than 1,500 patients, the majority with moderate COPD, when
used concomitantly with standard bronchodilator treatments for
COPD, i.e., tiotropium or salmeterol. The primary endpoint was the
mean change from baseline in pre-bronchodilator FEV1. Both EOS and
HELIOS demonstrated a statistically significant improvement in the
primary endpoint with Daxas given in combination with a long acting
bronchodilator compared to the same bronchodilator given alone.
Full data from all four studies are to be published in a leading
peer-reviewed journal later this year and will be presented at the
annual European Respiratory Society (ERS) Congress in Vienna,
Austria, in September.
Two earlier double-blind placebo-controlled Phase III studies in
COPD with Daxas demonstrated statistically significant effects on
FEV1 compared to placebo treatment and showed a positive trend with
respect to exacerbation improvement which was not statistically
significantly different than placebo.
Daxas is protected by a composition of matter patent through
January 27, 2015 and is eligible for patent term extension which
should provide an additional five years of exclusivity beyond the
life of the patent.
About COPD
COPD remains a significant area of unmet medical need. It is a
progressive and irreversible lung disease resulting in difficulty
in breathing. The disease is characterized by severe episodes of
worsening, called exacerbations. According to World Health
Organization (WHO) estimates, 80 million people have moderate to
severe COPD worldwide. More than 3 million people died of COPD in
2005, which corresponds to 5% of all deaths globally. The WHO
predicts that total deaths from COPD could increase by more than
30% in the next 10 years unless urgent action is taken to reduce
the underlying risk factors, especially smoking.
(see
http://www.who.int/respiratory/copd/burden/en/index.html)
About Nycomed
Nycomed is a privately owned global pharmaceutical company with
a differentiated portfolio focused on branded medicines in
gastroenterology, respiratory and inflammatory diseases, pain,
osteoporosis and tissue management. An extensive range of OTC
products completes the portfolio.
Its R&D is structured around partnerships and in-licensing
is a cornerstone of the company's growth strategy.
Nycomed employs 12,000 associates worldwide, and its products
are available in more than 100 countries. It has strong platforms
in Europe and in fast-growing markets such as Russia/CIS and Latin
America. While the US and Japan are commercialized through
best-in-class partners, Nycomed plans to further strengthen its own
position in key Asian markets.
Headquartered in Zurich, Switzerland, the company generated
total sales of €3.4 billion in 2008 and an adjusted EBITDA of €1.2
billion.
For more information visit www.nycomed.com.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical
company with a long track record of building partnerships and
developing and marketing products that make a positive difference
in people's lives. In addition to its well-established franchises
in therapeutic areas of the central nervous and cardiovascular
systems, Forest's current pipeline includes product candidates in
all stages of development and across a wide range of therapeutic
areas. The company is headquartered in New York, NY. To learn more
about Forest Laboratories, visit www.FRX.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Report on Form
10-Q, and any subsequent SEC filings.
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