Sepracor Reports That Schering-Plough Applies For Broader Clarinex(TM) Indication in United States For Treatment of Allergic Rhinitis

Broader Claim Covers Seasonal Allergic Rhinitis and Perennial Allergic

Rhinitis



Apr 16, 2001, 01:00 ET from Sepracor Inc.

    MARLBOROUGH, Mass., April 16 /PRNewswire/ --  Sepracor Inc. (Nasdaq:   SEPR)
 today reported that Schering-Plough Corporation (NYSE:   SGP) has submitted a
 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
 seeking to broaden the allergy indication for its nonsedating antihistamine,
 CLARINEX(TM) (desloratadine) 5 mg Tablets.  The proposed indication of
 allergic rhinitis would encompass both seasonal allergic rhinitis (SAR) and
 perennial allergic rhinitis (PAR).  The allergic rhinitis NDA is based on
 eight randomized, placebo-controlled studies evaluating 4,700 patients with
 either SAR or PAR.
     CLARINEX 5 mg Tablets has already received an "approvable" letter for the
 treatment of SAR.  The broader allergic rhinitis indication, when approved,
 would include both the SAR and PAR indications for the tablet formulation.
     Under draft guidance issued in April 2000, the FDA considers allergic
 rhinitis to encompass both SAR and PAR.  SAR is considered a response
 typically to outdoor allergens such as airborne pollens and molds that occur
 during specific and predictable times of the year in a given geographic
 region.  PAR has been defined as a response to indoor allergens such as dust
 mites and animal dander that are generally present throughout the year.
     CLARINEX Tablets received an FDA "approvable" letter for the treatment of
 SAR on Jan. 19, 2001.  A separate marketing application for CLARINEX Tablets
 is currently pending with the FDA for the treatment of chronic idiopathic
 urticaria (CIU), or hives of unknown cause.
     Schering-Plough has also submitted separate marketing applications to the
 FDA for CLARINEX(TM) RediTabs(R), a rapidly disintegrating tablet formulation;
 CLARINEX(TM) Syrup for use in patients as young as 2 years of age; and
 CLARINEX-D(TM) 12 Hour, a fixed combination of CLARINEX and a decongestant.
     In the European Union (EU), desloratadine 5 mg tablets was granted
 marketing authorization as a once-daily, nonsedating treatment of SAR in
 January 2001.
     Allergies affect an estimated 45 million Americans and can have a
 significant impact on everyday activities at work, school and leisure time.
 Allergies result in an estimated 6 million lost workdays and 2 million lost
 school days each year.  In addition, there is a growing body of evidence that
 points to an association between allergies and even more serious conditions
 such as asthma.
     Sepracor is a specialty pharmaceutical company that develops and
 commercializes potentially improved versions of widely-prescribed drugs.
 Referred to as Improved Chemical Entities ("ICE"), Sepracor's ICE(R)
 Pharmaceuticals are being developed and marketed as proprietary, single-isomer
 or active-metabolite versions of these leading drugs.  ICE Pharmaceuticals are
 designed to offer meaningful improvements in patient outcome through reduced
 side effects, increased therapeutic efficacy, improved dosage forms, and in
 some cases, the opportunity for additional indications.
     This news release contains forward-looking statements that involve risks
 and uncertainties, including statements with respect to the safety, efficacy
 and potential benefits of the Company's ICE Pharmaceuticals under development.
 Among the factors that could cause actual results to differ materially from
 those indicated by such forward-looking statements are: the submission of
 NDAs, acceptance of submitted NDAs for filing, and approval of NDAs; the
 results of the Company's clinical trials with respect to its products under
 development; the commercial success of Sepracor's products; the ability of the
 Company to attract and retain qualified personnel; the scope of the Company's
 patent protection with respect to such product candidates; the availability of
 sufficient funds to continue research and development efforts; and certain
 other factors that may affect future operating results and are detailed in the
 Company's periodic reports filed with the Securities and Exchange Commission.
     CLARINEX is a trademark and RediTabs(R) is a registered trademark of
 Schering Corp.  ICE is a registered trademark of Sepracor Inc.
     To receive a copy of this release or any recent release via fax,
 call Sepracor's automated news fax line at 1-800-758-5804 ext. 780960
 or visit the website at www.sepracor.com.
 
 

SOURCE Sepracor Inc.
    MARLBOROUGH, Mass., April 16 /PRNewswire/ --  Sepracor Inc. (Nasdaq:   SEPR)
 today reported that Schering-Plough Corporation (NYSE:   SGP) has submitted a
 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
 seeking to broaden the allergy indication for its nonsedating antihistamine,
 CLARINEX(TM) (desloratadine) 5 mg Tablets.  The proposed indication of
 allergic rhinitis would encompass both seasonal allergic rhinitis (SAR) and
 perennial allergic rhinitis (PAR).  The allergic rhinitis NDA is based on
 eight randomized, placebo-controlled studies evaluating 4,700 patients with
 either SAR or PAR.
     CLARINEX 5 mg Tablets has already received an "approvable" letter for the
 treatment of SAR.  The broader allergic rhinitis indication, when approved,
 would include both the SAR and PAR indications for the tablet formulation.
     Under draft guidance issued in April 2000, the FDA considers allergic
 rhinitis to encompass both SAR and PAR.  SAR is considered a response
 typically to outdoor allergens such as airborne pollens and molds that occur
 during specific and predictable times of the year in a given geographic
 region.  PAR has been defined as a response to indoor allergens such as dust
 mites and animal dander that are generally present throughout the year.
     CLARINEX Tablets received an FDA "approvable" letter for the treatment of
 SAR on Jan. 19, 2001.  A separate marketing application for CLARINEX Tablets
 is currently pending with the FDA for the treatment of chronic idiopathic
 urticaria (CIU), or hives of unknown cause.
     Schering-Plough has also submitted separate marketing applications to the
 FDA for CLARINEX(TM) RediTabs(R), a rapidly disintegrating tablet formulation;
 CLARINEX(TM) Syrup for use in patients as young as 2 years of age; and
 CLARINEX-D(TM) 12 Hour, a fixed combination of CLARINEX and a decongestant.
     In the European Union (EU), desloratadine 5 mg tablets was granted
 marketing authorization as a once-daily, nonsedating treatment of SAR in
 January 2001.
     Allergies affect an estimated 45 million Americans and can have a
 significant impact on everyday activities at work, school and leisure time.
 Allergies result in an estimated 6 million lost workdays and 2 million lost
 school days each year.  In addition, there is a growing body of evidence that
 points to an association between allergies and even more serious conditions
 such as asthma.
     Sepracor is a specialty pharmaceutical company that develops and
 commercializes potentially improved versions of widely-prescribed drugs.
 Referred to as Improved Chemical Entities ("ICE"), Sepracor's ICE(R)
 Pharmaceuticals are being developed and marketed as proprietary, single-isomer
 or active-metabolite versions of these leading drugs.  ICE Pharmaceuticals are
 designed to offer meaningful improvements in patient outcome through reduced
 side effects, increased therapeutic efficacy, improved dosage forms, and in
 some cases, the opportunity for additional indications.
     This news release contains forward-looking statements that involve risks
 and uncertainties, including statements with respect to the safety, efficacy
 and potential benefits of the Company's ICE Pharmaceuticals under development.
 Among the factors that could cause actual results to differ materially from
 those indicated by such forward-looking statements are: the submission of
 NDAs, acceptance of submitted NDAs for filing, and approval of NDAs; the
 results of the Company's clinical trials with respect to its products under
 development; the commercial success of Sepracor's products; the ability of the
 Company to attract and retain qualified personnel; the scope of the Company's
 patent protection with respect to such product candidates; the availability of
 sufficient funds to continue research and development efforts; and certain
 other factors that may affect future operating results and are detailed in the
 Company's periodic reports filed with the Securities and Exchange Commission.
     CLARINEX is a trademark and RediTabs(R) is a registered trademark of
 Schering Corp.  ICE is a registered trademark of Sepracor Inc.
     To receive a copy of this release or any recent release via fax,
 call Sepracor's automated news fax line at 1-800-758-5804 ext. 780960
 or visit the website at www.sepracor.com.
 
 SOURCE  Sepracor Inc.

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