United Therapeutics and MannKind Announce Collaboration for Pulmonary Hypertension Products

United Therapeutics Corporation and MannKind Corporation announced that they have entered into a worldwide exclusive licensing and collaboration agreement for the development and commercialization of a dry powder formulation of treprostinil, an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension.

Under the agreement, United Therapeutics will be responsible for global development, regulatory and commercial activities.  MannKind will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Danbury, Connecticut. Long-term commercial supplies will be manufactured by United Therapeutics.

Under the terms of the agreement, MannKind Corporation will receive an upfront payment of $45 millionand potential milestone payments of up to $50 million, dependent upon the achievement of specific development targets.  MannKind will also be entitled to receive low double-digit royalties on net sales of the product.  In addition, MannKind granted United Therapeutics an option to expand the license to include other active ingredients for the treatment of pulmonary hypertension.  Each optioned product would be subject to the payment to MannKind of up to $40 million in additional option exercise and development milestone payments as well as a low double-digit royalty on net sales of any such product.

The effectiveness of the licensing and collaboration agreement is conditioned on expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

The parties also entered into a research agreement for the conduct of research by MannKind on behalf of United Therapeutics for products outside the scope of the licensing and collaboration agreement.  MannKind will receive an immediate payment of $10 million in consideration for its performance under the research agreement.

“We are excited to partner with United Therapeutics, a company that shares our passionate focus on changing patients’ lives,” stated Michael Castagna, Pharm.D., Chief Executive Officer of MannKind. “We are pleased with this new opportunity to demonstrate the value of our drug and device combination platform for delivering therapeutic products.  We believe this collaboration will have the potential to significantly improve the lives of people living with pulmonary arterial hypertension.”

“On the very same day 21 years ago, we enabled the development of treprostinil into a practical treatment thanks to an invention of the late Al Mann – the discrete, ambulatory, programmable, parenteral infusion pump called the MiniMed 407c,” said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics.  “By marrying our molecule and MiniMed’s device, Remodulin was born. As we now move into the second generation of United Therapeutics products, we are proud to once again team with Al Mann’s brilliance, this time with his Dreamboat, Bluhale and Cricket devices for inhalation.  I believe these revolutionary new inhalation devices will accomplish for Tyvaso what our recently-approved Implantable System for Remodulin, pending RemUnity™ system and recently-acquired Trevyent product represent for Remodulin – a further step toward a next generation of treprostinil drug-device systems that enhance options for patients, their families and their prescribers.”