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Post by peppy on Jul 11, 2019 19:53:48 GMT -5
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-expands-commercial-scale-manufacturing-capabilitiesMannKind Expands Commercial Scale Manufacturing Capabilities for High-Potency MoleculesWESTLAKE VILLAGE, Calif., July 11, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation(Nasdaq:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced that it has completed construction of a new high-potency manufacturing suite in its Danbury Connecticut facility. This expansion provides the Company with the capability to produce dry powder formulations of highly potent active ingredients, such as epinephrine, on a commercial scale, in alignment with MannKind's strategic partnerships. The new suite will house bulk powder formulation and fill/pack operations for high-potency powders and adds to MannKind's extensive commercial manufacturing capability, which includes inhalation devices, large-scale compounding, particle formation, tangential flow filtration, cryogranulation, and high capacity (300 kg/day) lyophilization. “This expansion will allow us to utilize more fully the capacity of our world class, FDA-approved manufacturing facility for dry powder inhalation products. We are also pursuing opportunities to utilize our lyophilization capacity to fulfill the needs of our industry and drug development partners," stated Joe Kocinsky, Chief Technology Officer of MannKind. Does this tie in to their next milestone in any way with UTHR? I thought I heard Mike say something about them having to accomplish this in order to take their next step??? " United Therapeutics was one of the molecules that we announced last year with Treprostinil. We continue to have a very strong partnership and move together as we think about BluHale connected care and manufacturing facility capabilities. The next milestones related to United Therapeutics are things that we control." "I'm very proud to announce that during Q2 we started to build out the factory to make high-potency molecules, which establishes a new capability within MannKind. Additionally, BluHale continues to help integrate our platform with other pipeline molecules and Afrezza, as we think about how to get into connected care in the future." "The first milestone from United Therapeutics was paid. We expect the second milestone in the second half of 2019, of $12.5 million as we complete the build-out of our factory." "From our perspective, we receive our GMP certificate from our factory, which enables us to ship product to Brazil. And we've done shipping stability studies to know that it will be safe and consistent throughout the transportation process. We have additional pursuit of more international agreements and we continue to complete formulation work for an unnamed compound for United Therapeutics. So overall, when we think about the future, we continue to see Technosphere platform in the pipeline, as I'll give you some updates during Q2, to focus the pipeline on things that we believe will make a difference in patients."
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Post by thekid2499 on Jul 11, 2019 20:00:43 GMT -5
Just those 3 extra words: "such as epinephrine". As an example of a dry powder formulation, it is one that most readers would be familiar with. They could have listed something more exotic, such as Treprostinil, but a lot of retail investor readers (especially those not currently invested in Mannkind, i.e. potential investors) may not be so familiar with that. Even some analysts, I suppose. Also, whether Mannkind has any real intention to do Epi or not, mentioning it still excites its devoted retail fan base. And, of course, it could signal that Mannkind is serious about doing Epi. I think it's fair to say, without knowing more, that the PR wasn't as clear as it could be. It raises unanswered questions. Something here just doesn't seem right. If there were a deal then they would have announced the deal and then followed up with a PR stating the manufacturing expansion. To those who are excited about this, I get that you want to see expansion of Technosphere but based on this PR I would be wary, I would be very wary. The milestone payment for the 2H of the year for TreT is tied to the buildout of the manufacturing facility. This means that things are progressing the way they should and MNKD is on track to get the milestone payment. There is nothing to be wary about with respect to this announcement, other than your post.
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Post by falconquest on Jul 11, 2019 20:31:25 GMT -5
Something here just doesn't seem right. If there were a deal then they would have announced the deal and then followed up with a PR stating the manufacturing expansion. To those who are excited about this, I get that you want to see expansion of Technosphere but based on this PR I would be wary, I would be very wary. The milestone payment for the 2H of the year for TreT is tied to the buildout of the manufacturing facility. This means that things are progressing the way they should and MNKD is on track to get the milestone payment. There is nothing to be wary about with respect to this announcement, other than your post. We will know in the fullness of time.
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Post by rtmd on Jul 11, 2019 21:07:53 GMT -5
Does this tie in to their next milestone in any way with UTHR? I thought I heard Mike say something about them having to accomplish this in order to take their next step??? " United Therapeutics was one of the molecules that we announced last year with Treprostinil. We continue to have a very strong partnership and move together as we think about BluHale connected care and manufacturing facility capabilities. The next milestones related to United Therapeutics are things that we control." "I'm very proud to announce that during Q2 we started to build out the factory to make high-potency molecules, which establishes a new capability within MannKind. Additionally, BluHale continues to help integrate our platform with other pipeline molecules and Afrezza, as we think about how to get into connected care in the future." "The first milestone from United Therapeutics was paid. We expect the second milestone in the second half of 2019, of $12.5 million as we complete the build-out of our factory." "From our perspective, we receive our GMP certificate from our factory, which enables us to ship product to Brazil. And we've done shipping stability studies to know that it will be safe and consistent throughout the transportation process. We have additional pursuit of more international agreements and we continue to complete formulation work for an unnamed compound for United Therapeutics. So overall, when we think about the future, we continue to see Technosphere platform in the pipeline, as I'll give you some updates during Q2, to focus the pipeline on things that we believe will make a difference in patients." Okay, "we continue to complete formulation work for an unnamed compound for United Therapeutics," so why is this compound "unnamed"? When can we finally expect a name?
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Post by sportsrancho on Jul 11, 2019 21:23:46 GMT -5
Spencer told everybody what the name of the unnamed molecule was. Unfortunately I can’t remember the name. It has the same compound in it that Cialis does but would not be used in the same way.
As far as Epi goes your throat doesn’t close up for 20 minutes, there’s plenty of time to inhale. Why would you need to carry a pen also? Those pens expire in 18 months, people have to pay $1200 every 18 months to carry them. And with the Epi inhaler you can do it at the first sign of something, doesn’t matter if you’re wrong or not it will not hurt you in the least. People are hesitant to take the shot because they’re not sure.
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Post by gamblerjag on Jul 11, 2019 21:40:08 GMT -5
Step by step in a very deliberative (slow) manner this company is putting the building blocks together. Getting its financial house in order and extending the runway for miles remains a must. At what point does a board of directors of a pharma company, aside from UTHR recognize the potential of this company that we all see and partner/invest in this proven technosphere platform and the success of its inhaled insulin among patients. Perhaps today's news as suggested will create a line at the door, I hope. . Agree that’s why I don’t believe for a second the board in anyway is trying to get rid of Mike c and we do not have all the information and for reasons that someday we will be glad they did not release and jeopardize stockholders. I know it’s difficult when we’re at $1.10 however sometimes you got a look at the bigger picture. The progress they have made is nothing short of remarkable just don’t let PPS Convince you otherwise
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Post by sportsrancho on Jul 11, 2019 21:44:41 GMT -5
Huh?
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Post by mnkdfann on Jul 11, 2019 21:46:56 GMT -5
Spencer told everybody what the name of the unnamed molecule was. Unfortunately I can’t remember the name. It has the same compound in it that Cialis does but would not be used in the same way. "United Therapeutics bought exclusive rights to commercialize Adcirca (tadalafil) for the treatment of PAH in the United States from Eli Lilly LLY in November 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction." finance.yahoo.com/news/united-therapeutics-uthr-down-despite-132601369.html
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Post by prcgorman2 on Jul 11, 2019 21:48:20 GMT -5
I think he’s saying MNKD is well managed and under valued.
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Post by sportsrancho on Jul 11, 2019 21:50:10 GMT -5
I think he’s saying MNKD is well managed and under valued. Yes he edited his post after I said that so just forget it:-)
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Post by sportsrancho on Jul 11, 2019 21:51:29 GMT -5
Spencer told everybody what the name of the unnamed molecule was. Unfortunately I can’t remember the name. It has the same compound in it that Cialis does but would not be used in the same way. "United Therapeutics bought exclusive rights to commercialize Adcirca (tadalafil) for the treatment of PAH in the United States from Eli Lilly LLY in November 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction." finance.yahoo.com/news/united-therapeutics-uthr-down-despite-132601369.html Yes that’s it thank you.
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Post by mnkdfann on Jul 11, 2019 21:54:37 GMT -5
As far as Epi goes your throat doesn’t close up for 20 minutes, there’s plenty of time to inhale. Why would you need to carry a pen also? Those pens expire in 18 months, people have to pay $1200 every 18 months to carry them. And with the Epi inhaler you can do it at the first sign of something, doesn’t matter if you’re wrong or not it will not hurt you in the least. People are hesitant to take the shot because they’re not sure. According to various expert opinions I've seen, like those at the Mayo clinic, wheezing and gasping can start within seconds to a few minutes for some people. Your throat may not be closed, but it may already be too hard for you to inhale (properly and successfully) a powder medication at that point. Heck, we all know that some people with unrestricted throats and perfect breathing have had difficulty inhaling Afrezza properly for their first attempts, and we've all heard of people who stopped using Afrezza because it didn't work (likely because they did not inhale properly).
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Post by sportsrancho on Jul 11, 2019 21:57:47 GMT -5
Very possible, I’ve just had a lot of personal experience with people that have had it happen..my ex-husband, a roommate, the wife of a friend. Of course statistically that’s not saying much it’s just my own experience.
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Post by peppy on Jul 11, 2019 22:05:46 GMT -5
Spencer told everybody what the name of the unnamed molecule was. Unfortunately I can’t remember the name. It has the same compound in it that Cialis does but would not be used in the same way. As far as Epi goes your throat doesn’t close up for 20 minutes, there’s plenty of time to inhale. Why would you need to carry a pen also? Those pens expire in 18 months, people have to pay $1200 every 18 months to carry them. And with the Epi inhaler you can do it at the first sign of something, doesn’t matter if you’re wrong or not it will not hurt you in the least. People are hesitant to take the shot because they’re not sure. Tadalafil Brand name: Cialis remember tada? Mike did say the undisclosed molecule had consumer demand.
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Post by rtmd on Jul 11, 2019 22:09:06 GMT -5
Very possible, I’ve just had a lot of personal experience with people that have had it happen..my ex-husband, a roommate, the wife of a friend. Of course statistically that’s not saying much it’s just my own experience. I think a bigger problem would be getting docs to prescribe it. How do you explain to a malpractice jury that you prescribed an inhaled drug to treat an ailment whose hallmarks are airway constriction and difficulty breathing?
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