Date: 2013-05-13
Type of information: Collaboration agreement
Compound: participation interest in potential future royalty payments related to four respiratory programs partnered with GSK: Relvar™ Ellipta™/Breo™ Ellipta™, Anoro™ Ellipta™, MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist) monotherapy (GSK961081, or MABA \'081), and vilanterol (VI) monotherapy
Company: Elan (Ireland) Theravance (USA)
Therapeutic area: Respiratory diseases
Type agreement: collaboration
Action mechanism:
Disease:
Details: Theravance and Elan have entered into a royalty participation agreement wherein Elan will purchase a participation interest in potential future royalty payments related to four respiratory programs partnered with GSK: Relvar™ Ellipta™/Breo™ Ellipta™, Anoro™ Ellipta™, MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist) monotherapy (GSK961081, or MABA \'081), and vilanterol (VI) monotherapy. Under the terms of the agreement, Elan will make a one-time cash payment of $1.0 billion to Theravance in exchange for a 21% participation interest in the potential future royalty payments from the four programs when, as and if received by Theravance .
RELVAR™ ELLIPTA™/BREO™ ELLIPTA™ (fluticasone furoate (FF)/vilanterol (VI)), ANORO™ ELLIPTA™ (umeclidinium bromide (UMEC)/VI) and VI monotherapy have been developed under the LABA collaboration with GSK. For RELVAR™ ELLIPTA™/BREO™ ELLIPTA™ and VI, Theravance is entitled to receive royalties from GSK of 15% of the first $3.0 billion of combined annual global net sales, and 5% of combined annual global net sales above $3.0 billion . If ANORO™ ELLIPTA™ is approved and commercialized, royalties on annual global net sales are upward tiering and range from the mid-single digits to 10%. The transaction does not include any royalty participation interest associated with UMEC/VI/FF, an investigational medicine also in development under the LABA collaboration with GSK.
MABA \'081 is an investigational medicine in development under the strategic alliance between Theravance and GSK. If MABA \'081 is successfully developed and commercialized as monotherapy, Theravance is entitled to receive royalties from GSK of between 10% and 20% of the first $3.5 billion of annual global net sales, and 7.5% of all annual global net sales above $3.5 billion . The transaction does not include any royalty participation interest associated with MABA \'081 in combination with any other therapeutically active component, including an inhaled corticosteroid, or any other MABA compound as monotherapy or in combination.
The transaction is not subject to any material conditions, other than approval by Elan\'s shareholders. Elan plans to promptly prepare the required documentation to enable a shareholder vote, which Elan has agreed to hold within 35 days. If approved by Elan\'s shareholders, the parties expect the transaction to be consummated by the end of June 2013 .
Financial terms: Under the terms of the agreement, Elan will make a one-time cash payment of $1.0 billion to Theravance in exchange for a 21% participation interest in the potential future royalty payments from the four programs when, as and if received by Theravance.
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