Alpha-Antitrypsin — Alpha Therapeutic Corporation

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  • Alpha-Antitrypsin Alpha Therapeutic CorporationAAT Alpha Therapeutic Corporation, Alpha-1 ProteinaseInhibitor Alpha Therapeutic Corporation, Alpha-1-Antitrypsin Alpha Therapeutic Corporation, Aralast, Respitin

    Adis Comments Alpha-antitrypsin [AAT, -1-antitrypsin, -1 proteinase inhibitor, Aralast,Respitin] is a serine protease inhibitor.1 It is being developed by Alpha Thera-peutic Corporation for the treatment of emphysema in patients with congenital-1 antitrypsin deficiency. The trade name for the product was originally to beRespitin, but has been changed to Aralast. Alpha-antitrypsin products are alsobeing produced by Aventis Behring (in collaboration with Nektar Therapeutics),Bayer, PPL Therapeutics and Protease Sciences (in collaboration with Arriva Phar-maceuticals).

    Company agreements

    Alpha Therapeutic Corporation is a subsidiary of Mitsubishi Pharma Corporation,and was formerly a subsidiary of Welfide Corporation. On 1 October 2001, WelfideCorporation merged with Mitsubishi-Tokyo Pharmaceuticals to form MitsubishiPharma Corporation, a subsidiary of Mitsubishi Chemical.

    Agreement with Baxter Healthcare Corporation: On 20 December 2002, BaxterHealthcare Corporation announced that it had entered into a definitive agreementto acquire certain assets from Alpha Therapeutic Corporation, including AlphaTherapeutics -1 antitrypsin product. The transaction is expected to close in thefirst half of 2003.[1] After the approval of Aralast in December 2002, BaxterHealthcare was appointed as the exclusive distributor of Aralast and will launchthe product on behalf of Alpha Therapeutic Corporation.

    Collaboration with Profile Therapeutics: In August 2002, Alpha TherapeuticCorporation signed a collaboration agreement with the UK company ProfileTherapeutics to develop an inhaled -antitrypsin product for the treatment ofhereditary emphysema.[2] The product will be an aerosolised solution delivereddirectly to the lung by means of Profiles AAD (Adaptive Aerosol Delivery)technology. AAD optimises the delivery of precise and reproducible doses ofdrug in response to a patients breathing pattern.

    Key development milestones

    An intravenous formulation of -antitrypsin was approved in the US on 23December 2002 for the treatment of patients with congenital -1 antitrypsindeficiency with clinically evident emphysema.[3]

    ADIS R&D PROFILE Drugs R&D 2003; 4 (2): 113-1141173-8804/03/0002-0113/$30.00/0 Adis International Limited. All rights reserved.

    1 This profile has been selected from R&D Insight, a pharmaceutical intelligence databaseproduced by Adis International Ltd.

  • Table I. Features and properties

    WHO ATC R07A (Other Respiratory System Products)

    EphMRA ATC R7 (Other Respiratory System Products)

    Originator company Alpha Therapeutic Corporation (USA)

    Highest development phase Registered

    Properties

    Mechanism of action Protease inhibitors

    Route of administration IV; Inhalation

    Profile

    Adverse Events

    In a bioequivalence study, 28 adult patients withserum 1-antitrypsin (AAT) levels of