U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem
October 23 2006 - 8:00AM
PR Newswire (US)
LOUISVILLE, Colo. and NEW YORK, Oct. 23 /PRNewswire-FirstCall/ --
Replidyne, Inc. (NASDAQ:RDYN) and Forest Laboratories, Inc.
(NYSE:FRX), reported today the U.S. Food and Drug Administration
(FDA) has issued a non- approvable letter for Replidyne's new drug
application (NDA) for faropenem medoxomil, a novel oral, community
antibiotic. Replidyne submitted the NDA in December 2005 for four
adult indications: acute bacterial sinusitis (ABS),
community-acquired pneumonia (CAP), acute exacerbation of chronic
bronchitis (AECB) and uncomplicated skin and skin structure
infections (SSSI). The NDA as filed was based on the results of
eleven Phase III clinical trials for these indications and a safety
data base of more than 5,000 patients treated with faropenem.
According to the non-approvable letter, the FDA recommends further
clinical studies for all indications. For ABS and AECB, superiority
studies may be needed and for CAP, studies requiring additional
microbiologic evaluation. In its letter the FDA did not raise any
safety concerns or chemistry, manufacturing or controls (CMC)
issues related to the product. Replidyne and Forest intend to
discuss the clinical plans with the FDA including the number of
trials needed for each indication, and expect that a minimum of two
years will be required for completion of the clinical studies.
Historically the FDA has not required superiority design studies
such as placebo-controlled studies for approval for antibiotics,
but the Companies believe that recent public FDA deliberations over
the need for placebo- controlled studies for antibiotics were a
factor in its decision. Further, recent FDA statements have
reflected a preference for superiority studies in ABS. "Based on
the filing packages we included in our NDA submission, particularly
for ABS and CAP, we are disappointed that the FDA is requiring
additional clinical trials," said Kenneth J. Collins, President and
Chief Executive Officer of Replidyne. "However, we believe that at
the doses studied faropenem has a clearly demonstrated favorable
safety profile. Replidyne is in a strong financial position to
continue the development of faropenem with our partner Forest and
to advance our promising pipeline." Howard Solomon, Chairman and
Chief Executive Officer of Forest, stated, "It is our intention to
work together with Replidyne to conduct the additional clinical
trials required to obtain FDA approval for at least two respiratory
indications in order to launch faropenem. Upon approval, faropenem
will be a valuable additional pipeline product for us." Forest and
Replidyne announced their collaboration and commercialization
agreement on February 13, 2006 and will discuss the agreement based
on the FDA decision. Replidyne will hold a conference call at 8:30
AM EDT on Monday, October 23, to discuss the FDA's response. To
access the call, please dial 800-591- 6945 (domestic) or +1
617-614-4911 (international) five minutes prior to the start time,
and provide the access code 57552349. A replay of the call will be
available from 6 PM ET on October 23, 2006 until October 30, 2006
at midnight. To access the replay, please call 888- 286-8010
(domestic) or +1 617-801-6888 (international) and reference access
code 85816020. About Faropenem Medoxomil Faropenem medoxomil is an
investigational compound being developed for oral treatment of
community-acquired respiratory infections and uncomplicated skin
and skin structure infections. Community antibiotics are generally
used to treat infections acquired in the community rather than a
hospital setting. Faropenem is a member of the penem subclass
within the beta-lactam class of antibiotics. Beta-lactams are
generally characterized by their favorable safety and tolerability
profiles, as well as their broad spectrum of activity, and as a
result are often used as first line therapy in many respiratory and
skin infections in adult and pediatric patients. About Replidyne,
Inc. Replidyne is a biopharmaceutical company focused on
discovering, developing, in-licensing and commercializing
innovative anti-infective products. Replidyne's lead product,
faropenem medoxomil, is a novel oral, community antibiotic that is
expected to be appropriate for use as a first- line antibiotic for
treatment of respiratory and skin infections in adult and pediatric
patients. In February 2006, Replidyne entered into a partnership
agreement with Forest Laboratories to develop and commercialize
faropenem medoxomil in the US. An IND for Replidyne's second drug
candidate, REP8839, was submitted to the FDA in May 2006. REP8839
is a topical anti-infective product under development for the
treatment of skin and wound infections, and the prevention of S.
aureus infections, including multiple antibiotic- resistant S.
aureus (MRSA) infections, in hospital settings. Replidyne is also
pursuing the development of other novel anti-infective products
based on its in-house discovery research. About Forest Laboratories
and Its Products Forest Laboratories ( http://www.frx.com/ ) is a
US-based pharmaceutical company dedicated to identifying,
developing, and delivering products that make a positive difference
in peoples' lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major
depressive disorder and for generalized anxiety disorder;
Namenda(R) (memantine HCl), an N-methyl- D-aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil),
an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan
medoxomil- hydrochlorothiazide), an angiotensin receptor blocker
and diuretic combination product, each indicated for the treatment
of hypertension; and Campral(R)* (acamprosate calcium), indicated
in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation. *Benicar is a registered
trademark of Sankyo Pharma, Inc., and Campral is a registered
trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany. Except for the historical information contained
herein, this release contains "forward-looking statements" within
the meaning of the Private Securities Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, 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 the Companies' SEC
reports, including the Forest Laboratories, Inc.'s Annual Report on
Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q
for the period ended June 30, 2006 and Replidyne, Inc.'s Prospectus
on Form S-1 and on Form 10-Q for the period ended June 30, 2006.
DATASOURCE: Replidyne, Inc.; Forest Laboratories, Inc. CONTACT:
Mark L. Smith, CFO, +1-303-996-5503, , or Sabrina B. Oei, Dir,
Investor & Public Relations, +1-303-996-5535, , both of
Replidyne, Inc.; or Charles E. Triano, VP - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, Web site:
http://www.replidyne.com/ http://www.frx.com/
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