Kos Announces Completion of Patient Randomization for Jerini's Phase III Clinical Trials of Icatibant for the Subcutaneous Trea
07 6์ 2006 - 10:42PM
Business Wire
Kos Pharmaceuticals, Inc. (Nasdaq:KOSP): -- Kos collaboration
partner, Jerini, on schedule to file US marketing authorization
application by year-end 2006 with projected launch in 2007 -- US
Food and Drug Administration has granted Icatibant fast track
designation and orphan drug status -- Icatibant is first-to-market
therapy in an under-diagnosed area of significant unmet need --
Jerini plans further clinical development of Icatibant for
additional indications of angioedema -- Kos responsible for
Icatibant's potential clinical development in asthma and liver
cirrhosis Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) announced today
the completion of patient randomization for Jerini AG's (FSE: JI4)
second of two pivotal Phase III clinical trials, FAST-2 (For
Angioedema Subcutaneous Treatment), of Icatibant for the treatment
of hereditary angioedema (HAE). FAST-2 is a multi-center,
double-blind trial with a total enrollment of 74 patients in ten
European countries and Israel. On April 24, 2006, Jerini announced
the completion of randomization in its FAST-1 trial, in which 56
patients were treated at clinical sites in the United States,
Canada, Australia, and Argentina. The studies seek to determine
efficacy for symptom relief, as well as safety and tolerability. To
date, more than 260 open-label treatments have been administered in
both Phase III trials. 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, but
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 US Food and Drug Administration
(FDA). HAE is the first of several indications for which Icatibant
offers a potential treatment. The partnership with Jerini outlines
ongoing and potential development in other forms of angioedema,
asthma, and liver cirrhosis. "We are very pleased with Jerini's
timely completion of patient randomization for FAST-1 and FAST-2,
placing us on track to report top-line data in the third quarter of
this year, filing a marketing authorization application by year-end
2006 and projected launch in 2007," said Adrian Adams, President
and CEO. "Icatibant is an exciting opportunity for Kos and is an
excellent example of the continued success of our expanded business
model. In particular it highlights the value of making measured
investments to build our R&D pipeline through corporate
development and licensing activities. The next few years represents
a busy and very exciting time for Kos as far as new product
introductions are concerned with the projected roll-out of
optimized Niaspan(R) MF, the launch of Icatibant, and the
introduction of Simcor(R) and Flutiform(TM)," Adams added. Kos has
exclusive development, marketing and distribution rights for
Icatibant in North America. As a first-to-market therapy for HAE,
Icatibant's subcutaneous administration and excellent safety
profile demonstrated in clinical studies to date offer key
advantages to patients. In addition, Kos plans to market Icatibant
in a pre-filled syringe, enabling patients to self-administer the
drug at the onset of an attack. Kos will enter 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 Icatibant launch, Kos has established a new,
self-contained Allergy Business Unit that will encompass sales and
marketing, medical education and commercial services functions to
drive the successful introduction of Icatibant. About Icatibant
Icatibant is a potent and specific peptidomimetic bradykinin B2
receptor antagonist. It has exhibited a strong safety profile in
over 1,000 individuals. Icatibant is being tested in clinical
trials for treatment of hereditary angioedema and liver cirrhosis
as well as in preclinical models for severe burn injuries. 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 often
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) 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 and Advicor(R)
for the treatment of cholesterol disorders, Azmacort(R) for the
treatment of asthma, Cardizem(R)LA for the treatment of
hypertension and angina, and Teveten(R) and Teveten(R)HCT for the
treatment of hypertension. 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 the timing of US and European
marketing authorization applications for Icatibant, the potential
for the patient population in the HAE indication being as high as
75,000, the number of indications for which Icatibant offers a
potential treatment, the timing of the release of top-line data
from the FAST-1 and FAST-2 clinical studies, the timing of new
product introductions to the market, including optimized Niaspan
MF, Icatibant, Simcor and Flutiform, 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, the protection afforded by the Company's
patents and those related to its acquired and licensed products,
including but not limited to Icatibant and Flutiform, the ability
to build awareness for the Company's products 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 in a timely manner
including optimized Niaspan MF, Icatibant, Simcor and Flutiform,
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 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 June 6, 2006 and the
Company undertakes no duty to update this information. (1) United
States Hereditary Angioedema Association. FAQs. Accessed June 1,
2006: http://www.hereditaryangioedema.com/pamphlet.html
Kos (NASDAQ:KOSP)
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