Kos Announces Completion of Patient Randomization for Jerini's Phase III Clinica
-- 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 thecompletion of patient randomization for Jerini AG's (FSE: JI4) secondof two pivotal Phase III clinical trials, FAST-2 (For AngioedemaSubcutaneous Treatment), of Icatibant for the treatment of hereditaryangioedema (HAE). FAST-2 is a multi-center, double-blind trial with atotal enrollment of 74 patients in ten European countries and Israel.On April 24, 2006, Jerini announced the completion of randomization inits FAST-1 trial, in which 56 patients were treated at clinical sitesin the United States, Canada, Australia, and Argentina. The studiesseek to determine efficacy for symptom relief, as well as safety andtolerability. To date, more than 260 open-label treatments have beenadministered in both Phase III trials.
Icatibant is a potent and specific peptidomimetic bradykinin B2receptor antagonist developed by Jerini AG. HAE is a rare geneticdisease that can be debilitating, painful and life-threatening and ischaracterized by recurrent local swelling at three main sites:subcutaneous tissue, the gastrointestinal tract, and the larynx. Thereare approximately 10,000 diagnosed HAE patients in the European Unionand the US, but the disease is believed to be significantly underdiagnosed. Experts estimate the HAE patient population could be ashigh as 75,000. Icatibant has been granted orphan drug status andfast-track designation by the US Food and Drug Administration (FDA).HAE is the first of several indications for which Icatibant offers apotential treatment. The partnership with Jerini outlines ongoing andpotential development in other forms of angioedema, asthma, and livercirrhosis.
"We are very pleased with Jerini's timely completion of patientrandomization for FAST-1 and FAST-2, placing us on track to reporttop-line data in the third quarter of this year, filing a marketingauthorization application by year-end 2006 and projected launch in2007," said Adrian Adams, President and CEO. "Icatibant is an excitingopportunity for Kos and is an excellent example of the continuedsuccess of our expanded business model. In particular it highlightsthe value of making measured investments to build our R&D pipelinethrough corporate development and licensing activities. The next fewyears represents a busy and very exciting time for Kos as far as newproduct introductions are concerned with the projected roll-out ofoptimized Niaspan(R) MF, the launch of Icatibant, and the introductionof Simcor(R) and Flutiform(TM)," Adams added.
Kos has exclusive development, marketing and distribution rightsfor Icatibant in North America. As a first-to-market therapy for HAE,Icatibant's subcutaneous administration and excellent safety profiledemonstrated in clinical studies to date offer key advantages topatients. In addition, Kos plans to market Icatibant in a pre-filledsyringe, enabling patients to self-administer the drug at the onset ofan attack. Kos will enter a potential $300 million market space inNorth America, with orphan drug status securing seven-year US marketexclusivity upon approval. To support the anticipated 2007 Icatibantlaunch, Kos has established a new, self-contained Allergy BusinessUnit that will encompass sales and marketing, medical education andcommercial services functions to drive the successful introduction ofIcatibant.
About Icatibant
Icatibant is a potent and specific peptidomimetic bradykinin B2receptor antagonist. It has exhibited a strong safety profile in over1,000 individuals. Icatibant is being tested in clinical trials fortreatment of hereditary angioedema and liver cirrhosis as well as inpreclinical models for severe burn injuries.
About Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE) is a debilitating and potentiallylife-threatening genetic disease affecting between 1:10,000 and1:50,000 individuals worldwide. The disease is characterized byunpredictable 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. Thedisease is caused by a genetic defect, passed from parent to child.(1)
About Kos Pharmaceuticals, Inc.
Kos Pharmaceuticals, Inc. is a fully integrated specialtypharmaceutical company engaged in developing, commercializing,manufacturing and marketing proprietary prescription products for thetreatment of chronic diseases with a particular focus on thecardiovascular, metabolic and respiratory disease areas. The Company'sprincipal product development strategy is to reformulate existingpharmaceutical products with large market potential to improve safety,efficacy, and patient compliance. Kos' strategy also includes makingmeasured investments in new chemical entity research through in-houseand sponsored research, scientific in-licensing and general corporatedevelopment activities. The Company currently markets Niaspan andAdvicor(R) for the treatment of cholesterol disorders, Azmacort(R) forthe treatment of asthma, Cardizem(R)LA for the treatment ofhypertension and angina, and Teveten(R) and Teveten(R)HCT for thetreatment of hypertension. Kos has a strong and growing research anddevelopment pipeline including proprietary drug delivery technologiesin solid-dose, inhalation and aerosol metered-dose deviceadministration to help fuel sustained, organic sales growth into thefuture.
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