Exclusive license agreement for Treprostinil Technosphere®; $95 million in upfront and milestone
payments
Research agreement for additional products for additional $10 million
SILVER SPRING, Md. and WESTLAKE VILLAGE, Calif., Sept. 04, 2018 (GLOBE NEWSWIRE) -- United Therapeutics
Corporation (Nasdaq: UTHR) and MannKind Corporation (Nasdaq: MNKD) today 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 million and
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.”
Conference Call
MannKind will host a conference call today at 4:00 p.m. Eastern Time. To listen to the conference call webcast
live via the Internet, visit the Company's website at www.mannkindcorp.com and click on the link in the Webcasts section of News & Events. To
participate in the live call by telephone, please dial (800) 289-0438 toll-free or (323) 794-2423 toll/international and use the
conference passcode: 6006518.
A telephone replay of the call will be accessible for approximately 14 days following completion of the call by
dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 6006518. A replay will
also be available on MannKind's website for 14 days.
About MannKind Corporation
MannKind Corporation (NASDAQ: MNKD) focuses on the development and commercialization of inhaled therapeutic
products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently
commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled
rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is
headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The
Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
About United Therapeutics
United Therapeutics is a biotechnology company focused on the development and commercialization of innovative
products to address the unmet medical needs of patients with chronic and life-threatening conditions. [uthr-g]
Forward-looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include
projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations
with respect to future financial results, events, operations, services, product development and potential, and statements regarding
future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”,
“intends”, “estimates”, “plans” and similar expressions. Although United Therapeutics’ and MannKind’s management teams believe that
the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally
beyond the control of United Therapeutics and MannKind, that could cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including
post marketing, decisions by regulatory authorities, such as the FDA, regarding whether and when to approve any drug or device
application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that
could affect the availability or commercial potential of such product candidates, the absence of any guarantee that the product
candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as
well as those discussed or identified in the public filings with the Securities and Exchange Commission made by United Therapeutics
and MannKind, including those risks and uncertainties listed in United Therapeutics’ and MannKind’s annual reports on Form 10-K for
the year ended December 31, 2017, and listed or described in subsequent reports filed by United Therapeutics and MannKind with the
Securities and Exchange Commission. We are providing this information as of September 4, 2018, and neither United Therapeutics nor
MannKind undertake any obligation to update or revise the information contained in this press release whether as a result of new
information, future events or any other reason.
REMODULIN and TYVASO are registered trademarks of Untied Therapeutics Corporation. REMUNITY is a trademark of
United Therapeutics Corporation. TREVYENT is a registered trademark of SteadyMed Therapeutics, Inc. DREAMBOAT, AFREZZA, BLUHALE,
CRICKET and TECHNOSPHERE are registered trademarks of MannKind Corporation.
Contacts:
United Therapeutics
James Edgemond
Phone: (301) 608-9292
E-mail: jedgemond@unither.com
MannKind Corporation
Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com
