Myogen has licensed commercialization rights for ambrisentan, a selective endothelin receptor antagonist (ERA) currently in phase III development, to GlaxoSmithKline in all territories outside of the US. Filing for marketing approval in the US and Europe is expected later this year.
Simultaneously, GSK and Myogen have entered into a distribution agreement whereby Myogen will be responsible for the marketing and distribution of GSK’s Flolan (epoprostenol sodium), which is used in the treatment of pulmonary arterial hypertension (PAH), in the US.
Under the terms of the ambrisentan license agreement, Myogen will receive an upfront payment of $20 million and, subject to the achievement of specific milestones, will be eligible to receive up to an additional $80 million in milestone payments. In addition, Myogen will also receive stepped royalties on product sales with an estimated average royalty in the mid-20% range.
Myogen will be responsible for the continued clinical development of ambrisentan and GlaxoSmithKline will be responsible for all regulatory and commercial expenses in its licensed territories.
Under the terms of the Flolan distribution agreement, Myogen will build a commercial support team and field sales organization beginning in the second quarter of 2006 dedicated to the marketing and distribution of Flolan in the US.
The distribution agreement is a three-year agreement with an option to renew upon mutual consent.
“We are pleased to be in this alliance with Myogen and view this collaboration as a continuation of our corporate pipeline expansion,” said Andrew Witty, president of Pharma Europe for GSK. “Myogen’s innovative approach to collaboration on ambrisentan has provided both companies with a potentially rewarding opportunity by giving GlaxoSmithKline access to a product candidate in an indication we know very well. At the same time, Myogen will be able to establish a commercial presence in the PAH market in the US.”
In a separate announcement, Myogen reported a net loss of $63 million, or $1.68 per share, for the year ended December 31, 2005, compared to a net loss of $57.7 million, or $2 per share, the previous year.