Kos Announces Positive Overall Results for Two Phase III Trials of Icatibant for the Treatment of Hereditary Angioedema
22 9์ 2006 - 5:41AM
Business Wire
Kos Pharmaceuticals, Inc. (Nasdaq:KOSP): -- Efficacy data for
FAST-2 meets primary endpoint, FAST-1 and FAST-2 combined analysis
demonstrates a reduction in time to onset of symptom relief --
Patients receiving Icatibant reported a median time to onset of
symptom relief of 2.5 hours in FAST-1 (versus 4.6 hours with
placebo) and 2 hours in FAST-2 (versus 12 hours with comparator) --
Initial submission of a New Drug Application (NDA) with the US Food
and Drug Administration (FDA) expected by year-end 2006, with
potential launch in 2007 -- Kos collaboration partner Jerini plans
to seek expedited review by FDA Kos Pharmaceuticals, Inc.
(Nasdaq:KOSP) announced today preliminary results from two pivotal
Jerini AG (FSE: JI4) Phase III Icatibant clinical trials, FAST-1
and FAST-2 (For Angioedema Subcutaneous Treatment), for the
subcutaneous treatment of hereditary angioedema (HAE), a
debilitating and potentially life-threatening genetic disease. The
primary study endpoint was met in FAST-2; and while it was not met
in FAST-1, combined analysis of both studies showed a significant
reduction in time to onset of symptom relief for patients receiving
Icatibant versus those receiving placebo or comparator as measured
by a visual analog scale (VAS). Initial application for regulatory
approval with the FDA is anticipated in December 2006 and Jerini
plans to seek an expedited review by the FDA. Patients receiving
Icatibant reported a median time to onset of symptom relief of 2.5
hours in FAST-1 as compared to a median time of 4.6 hours for those
receiving placebo. A median time of 2 hours was reported by
patients receiving Icatibant in FAST-2, as compared to 12 hours by
those receiving the comparator, tranexamic acid. A total of 56
patients participated in FAST-1, a double-blind, placebo-controlled
study conducted in the United States, Canada, Australia and
Argentina. The FAST-2 trial treated a total of 74 patients at
clinical sites in 10 European countries and in Israel in a
double-blind study against the comparator, tranexamic acid. An
aggregate of 231 open-label treatments were administered in both
trials. The median time to first improvement, as reported by
patients receiving Icatibant in the FAST-1 and FAST-2 studies, was
consistent with Jerini's Phase II study results. "The strength and
consistency of these trial results demonstrate Icatibant's
potential as a safe, effective and much needed therapy for
hereditary angioedema," said Adrian Adams, President and CEO, Kos
Pharmaceuticals. "We are pleased that, based on these results,
Jerini will seek expedited reviews by the FDA and the European
Medicine Evaluation Agency, keeping Icatibant on track for a
potential 2007 launch. Icatibant is an exciting near-term
opportunity for Kos, and is an excellent example of the continued
success of our expanded specialty pharmaceutical business model
that enhances our growing R&D pipeline through sound and
synergistic corporate development and licensing activities." The
primary endpoint of FAST-2, as measured by a VAS, was met with a
median time to onset of symptom relief of 2 hours for Icatibant
versus 12 hours for tranexamic acid (p less than 0.001). Secondary
endpoints entered in the analysis also showed statistically
significant differences in favor of Icatibant. Time to onset of
relief of key symptoms, as measured by a preset reduction in the
VAS, was highly significant for skin swelling (p less than 0.001);
skin pain (p=0.002), and abdominal pain (p=0.028). Median time to
first improvement of symptoms as reported by patients was 0.8 hours
for Icatibant versus 7.9 hours for tranexamic acid (p less than
0.001). Icatibant also showed an excellent safety profile. In
FAST-1, the primary endpoint in median time to onset of symptom
relief was 2.5 hours for Icatibant versus 4.6 hours for placebo.
Although relevant clinically, this difference did not reach
statistical significance (p=0.131) due to an unexpectedly high
response to placebo in patients with abdominal pain as analyzed by
the VAS. In two subgroup analyses, the primary endpoint was met
(p=0.025 and p=0.024), and further analyses are ongoing. Time to
onset of relief of key symptoms, as measured by VAS, showed a
statistically significant reduction for skin swelling (p=0.032) and
skin pain (p=0.007), and a strong trend for reduction in abdominal
pain (p=0.056). Median time to first improvement of symptoms, as
reported by patients, was 0.8 hours for Icatibant versus 16.9 hours
for placebo (p less than 0.001). Also in this study, Icatibant
showed an excellent safety profile. For the treatment of
life-threatening laryngeal attacks, Icatibant showed a significant
and clinically relevant reduction in time to symptom relief. A
total of 11 laryngeal attacks were treated in the FAST-1 and FAST-2
trial controlled phase, with patients reporting a median time of 1
hour (FAST-2) and 0.6 hours (FAST-1) to symptom relief. Time to
symptom relief as assessed by the physician was 0.7 hours (FAST-2)
and 0.8 hours (FAST-1). An additional 19 laryngeal attacks were
also successfully treated in the Open Label Extension phase of the
trials. Further response of Icatibant efficacy was demonstrated in
the combined analysis of FAST-1 and FAST-2, with data meeting both
the primary endpoint and all secondary endpoints entered into the
analysis. Icatibant has shown an excellent safety profile in
previous and ongoing trials sponsored by Jerini and Sanofi-Aventis,
and has been administered to date in over 1300 subjects. The safety
profile was confirmed in the FAST-1 and the FAST-2 studies. No
drug-related, serious adverse events occurred. The most frequent
adverse events were injection site reactions such as erythema,
swelling, and occasional itching and pain. These symptoms were
transient and resolved spontaneously. Icatibant is a potent and
specific peptidomimetic bradykinin B2 receptor antagonist developed
by Jerini AG. HAE is a rare genetic disease that can be
debilitating, painful and life-threatening and is characterized by
recurrent local swelling at three main sites: subcutaneous tissue,
the gastrointestinal tract, and the larynx. There are approximately
10,000 diagnosed HAE patients in the European Union and the US;
however, the disease is believed to be significantly under
diagnosed. Experts estimate the HAE patient population could be as
high as 75,000. Icatibant has been granted orphan drug status and
fast-track designation by the FDA. HAE is the first of several
indications for which Icatibant offers a potential treatment and
the partnership with Jerini allows for ongoing potential clinical
development in other forms of angioedema, asthma, and liver
cirrhosis. Kos has exclusive development, marketing and
distribution rights for Icatibant in North America. As a potential
first-to-market therapy for HAE, Icatibant subcutaneous
administration and excellent safety profile demonstrated in
clinical studies to date, offer key advantages to patients. Kos
anticipates Icatibant entering a potential $300 million market
space in North America, with orphan drug status securing seven-year
US market exclusivity upon approval. To support the anticipated
2007 launch, Kos has established a new, self-contained Allergy
Business Unit that will encompass sales and marketing, medical
education and commercial services functions. About Icatibant
Icatibant, a synthetic peptidomimetic, works by blocking the B2
receptor as an antagonist to the peptide-hormone bradykinin.
Bradykinin has been shown to be elevated in HAE patients and
responsible for edema formation during HAE attacks. Icatibant has
been granted orphan drug status for the treatment of angioedema by
the FDA and the European Medicines Agency, potentially securing,
upon approval, market exclusivity for seven and ten years,
respectively. In addition, the FDA has granted fast-track
designation to Icatibant in the indication HAE. Icatibant's
subcutaneous administration, along with its excellent safety
profile demonstrated in clinical studies to date and
one-year-stability at room temperature, all offer key benefits to
HAE patients. About Hereditary Angioedema (HAE) Hereditary
Angioedema (HAE) is a debilitating and potentially life-threatening
genetic disease affecting between 1:10,000 and 1:50,000 individuals
worldwide. The disease is characterized by unpredictable episodes
of edema and swelling of the hands, feet, face, larynx and abdomen.
Swelling of the larynx can result in suffocation. In addition,
patients sometimes have bouts of excruciating abdominal pain,
nausea, and vomiting that is caused by intestinal wall swelling.
The disease is caused by a genetic defect, passed from parent to
child.(1) (1)United States Hereditary Angioedema Association. FAQs.
Accessed June 1, 2006:
http://www.hereditaryangioedema.com/pamphlet.html About Kos
Pharmaceuticals, Inc. Kos Pharmaceuticals, Inc. is a fully
integrated specialty pharmaceutical company engaged in developing,
commercializing, manufacturing and marketing proprietary
prescription products for the treatment of chronic diseases with a
particular focus on the cardiovascular, metabolic and respiratory
disease areas. The Company's principal product development strategy
is to reformulate existing pharmaceutical products with large
market potential to improve safety, efficacy, and patient
compliance. Kos' strategy also includes making measured investments
in new chemical entity research through in-house and sponsored
research, scientific in-licensing and general corporate development
activities. The Company currently markets Niaspan(R), Advicor(R),
Azmacort(R), Cardizem(R)LA, Teveten(R) and Teveten(R)HCT. Kos has a
strong and growing research and development pipeline including
proprietary drug delivery technologies in solid-dose, inhalation
and aerosol metered-dose device administration to help fuel
sustained, organic sales growth into the future. Certain statements
in this press release, including statements relating to application
for expedited review by the FDA and European Medicine Evaluation
Agency, the potential for the patient population in the HAE
therapeutic area being as high as 75,000, the number of indications
for which Icatibant offers a potential treatment, the submission of
the NDA for Icatibant to the FDA in 2006, and the potential
introduction of Icatibant to the market in 2007, the potential for
the HAE market space in North America to reach $300 million, the
Company's strong and growing research and development pipeline and
future sales growth are forward-looking and are subject to risks
and uncertainties which may cause actual results to differ
materially from those projected in a forward-looking statement.
These risks and uncertainties include market acceptance of
Icatibant, the protection afforded by the Company's patents and
those related to its acquired and licensed products, the ability to
build awareness for the Company's products, including Icatibant,
within the medical community, the continuing growth of the
cardiovascular, respiratory and allergy markets, the Company's
ability to increase the size of its sales force and to attract and
retain sales professionals, the Company's and its licensors'
ability to achieve regulatory approvals for products under
development, including Icatibant, and to successfully launch such
products in a timely manner, the ability of third party suppliers
to the Company continuing to be able to perform their supply
obligations, the Company's ability to entered into additional new
business development opportunities, the progress of the Company's
research and development pipeline, the effect of conditions in the
pharmaceutical industry and the economy in general, as well as
certain other risks. A more detailed discussion of risks attendant
to the forward-looking statements included in this press release
are set forth in the "Forward-Looking Information: Certain
Cautionary Statements" section of the Company's Annual Report on
Form 10-K/A for the year ended December 31, 2005, filed with the
Securities and Exchange Commission, and in other reports filed with
the SEC. All information in this press release is as of September
21, 2006 and the Company undertakes no duty to update this
information.
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