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Post by Deleted on Jan 18, 2023 19:42:54 GMT -5
Oddly I think it's good news for MNKD. Yes, the manufacturing revenue goes away, but there is no way UTHR would build their own manufacturing plant if DPI wasn't getting serious traction so there are the prospects for far greater royalties. I can't see them buying MNKD because in that case they would use or expand the existing facility. It's hard to tell, just more bread crumbs for us to speculate about. Danbury facility addition...
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Post by longliner on Jan 18, 2023 19:48:49 GMT -5
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Post by Deleted on Jan 18, 2023 20:37:44 GMT -5
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Post by Deleted on Jan 18, 2023 20:58:48 GMT -5
What does this have to do with Mannkind? If anything?🤣 Nothing, goodbye...
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Post by longliner on Jan 18, 2023 21:09:41 GMT -5
What does this have to do with Mannkind? If anything?🤣 Nothing, goodbye... I apologize for messing with you. Ashley may have institutional voting privileges! Anything she posts is certainly relevant to Mannkind. Thanks for giving her credit for the post, as I should have for Shadydep.
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Post by letitride on Jan 18, 2023 21:43:21 GMT -5
Given Martines foresight I would think Martine wants a second facility ready should there be problems at Danbury. Danbury is already expanding looks like Martine dosent think a 1 year supply is enough of a buffer in my opinion.
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Post by longliner on Jan 18, 2023 21:51:43 GMT -5
Given Martines foresight I would think Martine wants a second facility ready should there be problems at Danbury. Danbury is already expanding looks like Martine dosent think a 1 year supply is enough of a buffer in my opinion. Pretty awesome, isn't it? I'm guessing you'll be adding to that car collection.....soon.
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Post by stevil on Jan 18, 2023 21:57:14 GMT -5
Seems like UTHR is pretty confident they’ll expand the label and I imagine they don’t think MNKD will be able to keep up with future production once it does
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Post by akemp3000 on Jan 19, 2023 8:46:38 GMT -5
I believe Martine stated during the last conference call there will be a two-year inventory supply. If so, very good news for Mannkind now.
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Post by Clement on Jan 19, 2023 9:07:23 GMT -5
Seems like UTHR is pretty confident they’ll expand the label and I imagine they don’t think MNKD will be able to keep up with future production once it does I agree. The IPF indication will offer large numbers of possible patients if things go as hoped for the TETON study. It is possible that approval for this indication could happen in 2026. How long does it take to build a production facility from scatch and get it running? 2 or 3 years? Looks like good planning to me.
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Post by sayhey24 on Jan 19, 2023 9:12:21 GMT -5
A portion of a new UTHR job opening; How you’ll contribute The Principal Process Engineer (DPI) will provide process engineering expertise for new facility projects, with a core focus on Tyvaso DPI related projects. Responsibilities include serving as the project point person from conceptual plan, detailed design, and construction. Additional responsibilities include equipment/process feasibility assessments, throughput analysis, process specification, and constructability assessments. ... My note; Several folks noticed even though Martine acknowledged Mike as the CEO of the Company that Mfgs. Tyvaso DPI at the JPM conference, she didn't say the company name. Why would she want any other name affiliated with a technology UTHR would soon exclusively own? JMHO Oddly I think it's good news for MNKD. Yes, the manufacturing revenue goes away, but there is no way UTHR would build their own manufacturing plant if DPI wasn't getting serious traction so there are the prospects for far greater royalties. I can't see them buying MNKD because in that case they would use or expand the existing facility. What are the contractual obligations with the TS manufacturing process and patents? Did UTHR get all rights to manufacture when they signed the licensing deal?
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Post by peppy on Jan 19, 2023 9:16:35 GMT -5
Oddly I think it's good news for MNKD. Yes, the manufacturing revenue goes away, but there is no way UTHR would build their own manufacturing plant if DPI wasn't getting serious traction so there are the prospects for far greater royalties. I can't see them buying MNKD because in that case they would use or expand the existing facility. What are the contractual obligations with the TS manufacturing process and patents? Did UTHR get all rights to manufacture when they signed the licensing deal?No.
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Post by Clement on Jan 19, 2023 10:05:28 GMT -5
From 2018: "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. " investors.mannkindcorp.com/news-releases/news-release-details/united-therapeutics-and-mannkind-announce-collaborationIn 2021, there was a Collaboration and Services Agreement that modified this somewhat, giving MNKD extended manufacturing responsibilities and some security in the addition of manufacturing capacity. But the projected cash from this was "$399.2 million for future supply of Tyvaso DPI over the remaining term of the CSA." (That's from page 27 of the MNKD 10Q for Q3 2022. investors.mannkindcorp.com/node/18711/html#NOTES_TO_CONDENSED_CONSOLIDATED_FINANCIA ) The remaining term is until 2031. $399 million over nine years is small compared to my optimism for TDPI.
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Post by agedhippie on Jan 19, 2023 19:43:06 GMT -5
What are the contractual obligations with the TS manufacturing process and patents? Did UTHR get all rights to manufacture when they signed the licensing deal?No. Actually yes It's section 5.2 in the contract. Mannkind agree to help them set up manufacturing: 5.2c) ...The Manufacturing Information will be of sufficient detail to enable a reasonably experienced manufacturer to manufacture, assemble, test, operate, and service the Initial Product.
And agree that UTHR can buy the raw materials directly from the manufacturer to produce the drug: 5.2d) The Parties agree that United Therapeutics has the right under Section 2.2 to source all raw materials for the manufacture of Product from the suppliers of its choice...(Section 2.2 allows UTHR to grant sub-licenses. That allows UTHR to have someone else manufacture all or part of the drug. It's also multi-tiered so they can grant sub-licenses below the sub-licensee) It's worth remembering that the expectation back when this started was that beyond the initial batch UTHR would manufacture the drug and Mannkind would get a royalty. In the interval UTHR sub-contracted manufacture to Mannkind on a longer basis which made sense for UTHR because it reduced their risk if something went wrong - they didn't want to be landed with a manufacturing plant for a poorly selling drug. This is why I think it is good that they are starting to exercise their options - they are now convinced it will be successful to the point where it makes sense to incur the cost of a manufacturing plant.
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Post by letitride on Jan 19, 2023 21:36:00 GMT -5
Know matter how I slice it I like it!
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