Healthcare Industry News:  hereditary angioedema 

Biopharmaceuticals

 News Release - June 7, 2006

Kos Announces Completion of Patient Randomization for Jerini's Phase III Clinical Trials of Icatibant for the Subcutaneous Treatment of Hereditary Angioedema

  • 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


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® MF, the launch of Icatibant, and the introduction of Simcor® 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® for the treatment of cholesterol disorders, Azmacort® for the treatment of asthma, Cardizem®LA for the treatment of hypertension and angina, and Teveten® and Teveten®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


Source: Kos Pharmaceuticals

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