MNKD Licensed - United Therapeutics Corporation Reports

[yash]

finance.yahoo.com/news/united-therapeutics-corporation-reports-third-100000659.html


Third Quarter Highlights

Announced that our FREEDOM-EV study of Orenitram® met its primary endpoint.
Settled patent litigation with Watson Laboratories, Inc. (Watson), relating to Tyvaso®. Under the terms of the settlement, Watson is permitted to launch a generic version of Tyvaso in the U.S. beginning on January 1, 2026 (or earlier under certain circumstances).

Completed the acquisition of SteadyMed Ltd. and its drug product candidate Trevyent®, which is a development-stage drug-device combination product that combines SteadyMed's PatchPump® technology with treprostinil to treat pulmonary arterial hypertension (PAH). We anticipate resubmitting the Trevyent NDA to the FDA during the first half of 2019.

In-licensed MannKind Corp.'s Treprostinil Technosphere®, a phase III-ready development-stage drug-device combination product that combines MannKind's dry inhalation technology with treprostinil for the treatment of PAH.

In-licensed the U.S. and Canadian rights to Samumed LLC's SM04646, a phase I development-stage oral Wnt pathway inhibitor, to treat idiopathic pulmonary fibrosis.
Completed enrollment of the DISTINCT study of dinutuximab in patients with small cell lung cancer (n=472).

[yash]

Some people doubted whether UTC will mention about MNKD licensing or not.

[sportsrancho]

[lakers]

ir.unither.com/node/25031/html

10-Q For the quarterly period ended September 30, 2018

14. Subsequent Events


License and Collaboration Agreement with MannKind Corporation


In September 2018, we entered into a worldwide exclusive license and collaboration agreement with MannKind Corporation (MannKind) for the development and commercialization of a dry powder formulation of treprostinil called Treprostinil Technosphere®, which is a phase III-ready development-stage product currently being evaluated in clinical trials for the treatment of PAH. The agreement became effective on October 15, 2018, upon expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the agreement, we are responsible for global development, regulatory and commercial activities relating to Treprostinil Technosphere. We and MannKind will share responsibility for manufacturing clinical supplies and initial commercial supplies of Treprostinil Technosphere. We will manufacture long-term commercial supplies. Under the terms of the agreement, we paid MannKind $45.0 million following the effectiveness of the
agreement in October 2018, and we are required to make potential milestone payments of up to $50.0 million upon the achievement of specific development targets. MannKind is also entitled to receive low double-digit royalties on our net sales of the product. In addition, we have the option in our sole discretion to expand the license to include other active ingredients for the treatment of pulmonary hypertension. Each product added pursuant to the option would be subject to the payment to MannKind of up to $40.0 million in additional option exercise and development milestone payments, as well as a low double-digit royalty on our net sales of any such product.


We also entered into a research agreement for the conduct of research by MannKind for products outside the scope of the licensing and collaboration agreement. MannKind received an initial payment of $10.0 million in consideration for its performance under the research agreement. The $10.0 million payment is included within research and development costs on our consolidated statements of operations for the three and nine months ended September 30, 2018.

Treprostinil Technosphere incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. If the FDA approves Treprostinil Technosphere, we believe this new inhaled treprostinil therapy will provide substantial lifestyle benefits to PAH patients, as compared with Tyvaso therapy, because it will be : (1) less time consuming due to faster administration times and less required device maintenance as the device and drug will be provided in a pre-filled, single use disposable cassette eliminating the need for cleaning and filling; and (2) mobile and more convenient as the compact design of MannKind’s Dreamboat device and drug cassettes used with Treprostinil Technosphere can easily fit into the patient’s pocket and do not require electricity. Going forward, we plan to develop Bluetooth enhancements using MannKind’s Bluehale® technology. We also have the right to develop a single-use device based on MannKind’s Cricket® design. The Cricket device would come pre-loaded with treprostinil and would be discarded immediately after use. In contrast, we envision each Dreamboat device would be used for up to two weeks before it is replaced with a new device.

We enter into certain license agreements that generally prohibit our counterparties or their affiliates from taking necessary steps to acquire or merge with us, directly or indirectly throughout the term of these agreements, plus a specified period thereafter. We are also party to certain license agreements that restrict our ability to assign or transfer the rights licensed to us to third parties, including parties with whom we wish to merge, or those attempting to acquire us. These agreements often require that we obtain prior consent of the counterparties to these agreements if we contemplate a change of control. If these counterparties withhold consent, related agreements could be terminated and we would lose related license rights. For example, Lilly, Samumed, MannKind and Toray Industries, Inc. have the right to terminate our license agreements relating to Adcirca, SM04646, Treprostinil Technosphere and esuberaprost, respectively, in the event of certain change of control transactions. These restrictive change of control provisions could impede or prevent mergers or other transactions that could benefit our shareholders.