MannKind Corporation, based in Westlake Village, California, and United Therapeutics, located in Silver Spring, Maryland, signed a worldwide exclusive license and collaboration deal to develop and commercialize a dry powder formulation of treprostinil.
MannKind Corporation, based in Westlake Village, California, and United Therapeutics, located in Silver Spring, Maryland, signed a worldwide exclusive license and collaboration deal to develop and commercialize a dry powder formulation of treprostinil. The product is being studied in clinical trials to treat pulmonary arterial hypertension (PAH).
Under the terms of the deal, United Therapeutics will handle global development, regulatory and commercial activities. MannKind will manufacture clinical supplies and initial commercial supplies at its manufacturing plant in Danbury, Connecticut. Long-term commercial supplies will be manufactured by United Therapeutics.
United Therapeutics is paying MannKind an upfront payment of $45 million and potential milestone payments of up to $50 million. MannKind is also eligible for low double-digit royalties on net sales. Also, MannKind granted United Therapeutics an option to expand the license to include active ingredients for the treatment of pulmonary hypertension. Each product optioned is subject to the payment to MannKind of up to $40 million in additional milestone payments and double-digit royalties.
The two companies also inked a research deal by MannKind on behalf of United Therapeutics for products outside the scope of this deal. Under this additional research deal, MannKind receives an immediate payment of $10 million.
“We are excited to partner with United Therapeutics, a company that shares our passionate focus on changing patients’ lives,” stated Michael Castagna, MannKind’s chief executive officer. “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.”
MannKind stock roared by 59 percent in premarket trading at the news.
This is particularly good news for MannKind, which was a company many expected to go out of business before 2020. Back in 2014, it received approval for an inhaled form of insulin, Afrezza. Because most people with diabetes are on injections or insulin pumps, Afrezza seemed like a product that had a built-in market all primed and ready. Many analysts projected a blockbuster, especially after MannKind signed a big sales and marketing deal with Paris-based Sanofi.
By January 2016, Afrezza was fizzling and Sanofi backed out of the partnership. The big problem was insurance companies. Insurance companies typically classify drugs in four tiers, 1 through 4. Tier 1 drugs are generally low-priced generic drugs. Tier 2 is typically a preferred brand name prescription drug. Tiers 3 and 4 are usually higher-cost prescription medications, and drugs that are considered effective, but not necessarily the best choice for the majority of patients.
Despite a lot of lobbying on the party of MannKind and Sanofi, most insurers placed Afrezza as Tier 3, rather than Tier 2. For consumers, that meant they usually pay a higher co-pay in addition to other potential restrictions.
MannKind was trying to go it alone. It had problems using a contract sales team. Meanwhile, the company was running out of money. In order to avoid being delisted, it had made a reverse stock split.
Of today’s deal, Martine Rothblatt, chairman and chief executive officer of United Therapeutics stated, “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. 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.”
