|
|
Post by sportsrancho on Feb 27, 2019 8:21:48 GMT -5
|
|
|
|
Post by therealisaching on Feb 27, 2019 8:46:10 GMT -5
Recent Highlights Closed license agreement with MannKind for Treprostinil Technosphere® |
|
|
|
Post by therealisaching on Feb 27, 2019 8:48:28 GMT -5
From the UT 10k
Treprostinil Technosphere
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 for the treatment of PAH. The agreement became effective on October 15, 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 to administer and easier to maintain 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. 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.
Under our agreement with MannKind, we are responsible for global development, regulatory and commercial activities related to Treprostinil Technosphere. We plan to commence a clinical study (called BREEZE) during the first half of 2019 to evaluate the safety of switching PAH patients from Tyvaso to Treprostinil Technosphere, as well as a pharmacokinetic study in healthy volunteers. The FDA has indicated that these two studies, if successful, will be the only clinical studies necessary to support FDA approval. 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 to MannKind 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. We will pay MannKind up to $40 million in additional option exercise and development milestone payments for each product (if any) added to the license pursuant to this option, as well as a low double-digit royalty on our net sales of any such product.
We also entered into a research agreement with MannKind under which MannKind will conduct research related to products outside the scope of the licensing and collaboration agreement. We paid MannKind $10.0 million in consideration for its performance under the research agreement.
|
|
|
|
Post by therealisaching on Feb 27, 2019 8:54:30 GMT -5
This isnt new news but from their 10k:
Low double-digit royalties on net product sales of Treprostinil Technosphere and up to $50.0 million in developmental milestone payments
Tyvaso accounted for $415MM in 2018 sales. If Trepostinil Technoshphere is approved $40+MM/year in royalty revenue to MNKD
|
|
|
|
Post by kite on Feb 27, 2019 9:01:07 GMT -5
Should there be a shout box for this earnings call?
|
|
|
|
Post by liane on Feb 27, 2019 9:03:06 GMT -5
When is the cc?
|
|
|
|
Post by kite on Feb 27, 2019 9:03:31 GMT -5
It's just starting right now |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Feb 27, 2019 9:03:42 GMT -5
|
|
|
|
Post by liane on Feb 27, 2019 9:09:39 GMT -5
OK - It's open now. Let me know when the cc is over as I am not monitoring it.
|
|
|
|
Post by therealisaching on Feb 27, 2019 9:33:44 GMT -5
Liane,
I think you can close. Not really any discussion on MNKD other than including it in a recap of deals they made.
|
|
|
|
Post by sportsrancho on Feb 27, 2019 9:38:30 GMT -5
|
|
|
|
Post by kite on Feb 27, 2019 9:41:15 GMT -5
|
|
|
|
Post by therealisaching on Feb 27, 2019 9:42:57 GMT -5
I was referring to UTHR call. Mike's call in your link is now available on replay. Listening now |
|
|
|
Post by celo on Feb 27, 2019 9:51:43 GMT -5
UTHR timeline for trep:
Early 2019 a couple studies for safety. How long will those studies take? Anyone have a timeline for FDA approval? United is full steam ahead. Revenue stream from trep could be available as soon second half of 2020?
If United switched over all their patients to trep from tyvaso then MNKD is good as gold. Half their annual expenses would be covered by royalties alone and they would be doing nothing.
|
|
|
|
Post by wyattdog on Feb 27, 2019 9:56:40 GMT -5
'afrezza is Seabiscuit" like that quote
|
|
