MannKind to Establish Boston-Area R&D Foothold

[hellodolly]

MannKind to Establish Boston-Area Research & Development Foothold and Expand Portfolio of Dry Powder Inhalation Technology in Transaction With Pulmatrix


5/29/24


Immediate opportunity to increase capacity for formulation and early asset development in upgraded Boston area R&D space

Non-cash deal includes royalty-free iSPERSE™ technology license in exchange for access to MannKind’s Cricket® inhaler

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has agreed to in-license iSPERSE™ technology from Pulmatrix for certain indications in exchange for an out-license of MannKind’s Cricket® inhaler to Pulmatrix for inhaled delivery of dihydroergotamine (DHE) for migraine treatment. The two companies also agreed that Pulmatrix will transfer its Bedford, Mass. R&D facility to MannKind, along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory in non-cash transaction.



“We are delighted to grow our Boston-area presence as we continue to progress our pipeline efforts, and in particular, our expanding orphan lung programs,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We have formulated two FDA-approved products utilizing our proven Technosphere® dry powder technology, and this agreement affords us access to another option for future development opportunities.”



“Our Technosphere technology, which is a unique carrier-based, dry powder inhalation platform used in tandem with our proprietary inhaler, provides deep and effective penetration of lung tissue that is well suited for many active ingredients,” said Dr. Burkhard Blank, Executive Vice President, Research & Development and Chief Medical Officer of MannKind Corporation. “However, for some drug candidates, such as Clofazimine, that may require a significantly higher drug payload, the iSPERSE formulation technology may be better suited for developing viable powders.”



The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and insulin, and non-exclusive use for endocrine diseases and interstitial lung diseases (ILD) including idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PFF) and other related lung diseases. In exchange, Pulmatrix will receive a royalty-free, exclusive license to MannKind’s single-use Cricket inhalation device for inhaled delivery of DHE in any formulation and non-exclusive use for neurological diseases.



MannKind expects to consolidate its Boston presence by transitioning its Marlborough staff into the newly renovated, fully outfitted R&D facility in Bedford. To maintain continuity of iSPERSE platform knowledge, MannKind plans to hire some members of current Pulmatrix R&D staff.



The agreement is anticipated to close in July 2024.

[uvula]

Here is my negative spin:
1. More mouths to feed.
2. The initial attempt to technospherize clofazimine failed because they couldn't deliver enough of the drug with the cricket inhaler.

[limo]

makes me think that when they've banged on about how "our particles fly" etc was all nonsense. 

[prcgorman2]

It is unlikely the FDA approved a Fast Track for a failed drug. They had talked about a follow-on for TS for clofazimine. Looks like they found a better option that’s cheap.

[porkini]

Link: investors.mannkindcorp.com/news-releases/news-release-details/mannkind-establish-boston-area-research-development-foothold-and

[limo]

the fast track with the FDA is for nebulised clofazimine

[cjm18]

The two companies also agreed that Pulmatrix will transfer its Bedford, Mass. R&D facility to MannKind, along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory in non-cash transaction.

Were they going bankrupt?

Pulmatrix Inc

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NASDAQ: PULM

Market cap of 7m.

[celo]

Until Mannkind gives some deeper understanding of the synergies of this acquisition, I do not like it. Mannkind needs to keep their eyes on the prize. They are adding unnecessary time and weight while trying to maintain profit and stay lean and mean. They keep acquiring either the business or employees from dying companies with products that are faltering. Please prove me wrong, mannkind.

[uvula]

Pulmatrix was financially okay but very small. They also had a partnership with Cipla.

www.prnewswire.com/news-releases/pulmatrix-announces-year-end-and-q4-2023-financial-results-and-provides-corporate-update-302101942.html

Update: I originally said Cipra instead of cipla.

[celo]

May 29, 2024 8:43:54 GMT -5 uvula said:

Pulmatrix was financially okay but very small. They also had a partnership with Cipra.

www.prnewswire.com/news-releases/pulmatrix-announces-year-end-and-q4-2023-financial-results-and-provides-corporate-update-302101942.html

The Cipra partnership maybe what Mannkind is after.  Maybe that allows them a foot in the door in India that seems to be continually delayed.  For Pulm, with single digit millions quarterly revenues, the Cipra agreement has not meant much for them.

[mango]

May 29, 2024 8:00:30 GMT -5 uvula said:

Here is my negative spin:
1. More mouths to feed.
2. The initial attempt to technospherize clofazimine failed because they couldn't deliver enough of the drug with the cricket inhaler.

1. Typically when a company expands, it has to feed more mouths. Just how it works. I take it you’d rather MannKind remain small. I don’t, and thank goodness MannKind doesn’t either!

2. MannKind has never said that. Will you please provide the source for your information? MannKind is using a nebulized formulation of clofazimine that has been fast tracked by FDA. Mike has mentioned the R&D team tinkering with a Technosphere version, but has never once mentioned Cricket that I am aware of. In fact, we never use the Cricket, only the Dreamboat. Cricket is meant to be a one time single use device. Dreamboat is reusable and totally different design. We’re out licensing something we don’t even utilize.

I believe this was a great deal and look forward to seeing what happens with this. If MannKind, who is an expert in dry powder formulation and drug delivery, believes this is a good powder to acquire for future drug development, then I’ll take their word for it.

[Clement]

Thanks, Mango. I choose to adjust my attitude.
Mannkind can continue to promote the idea that Mannkind is expert in formulation and delivery of inhaled pharmaceuticals. Mannkind can now address a large range of molecule size and drug payload.

[hellodolly]

May 29, 2024 9:04:40 GMT -5 mango said:

May 29, 2024 8:00:30 GMT -5 uvula said:

Here is my negative spin:
1. More mouths to feed.
2. The initial attempt to technospherize clofazimine failed because they couldn't deliver enough of the drug with the cricket inhaler.

1. Typically when a company expands, it has to feed more mouths. Just how it works. I take it you’d rather MannKind remain small. I don’t, and thank goodness MannKind doesn’t either!

2. MannKind has never said that. Will you please provide the source for your information? MannKind is using a nebulized formulation of clofazimine that has been fast tracked by FDA. Mike has mentioned the R&D team tinkering with a Technosphere version, but has never once mentioned Cricket that I am aware of. In fact, we never use the Cricket, only the Dreamboat. Cricket is meant to be a one time single use device. Dreamboat is reusable and totally different design. We’re out licensing something we don’t even utilize.

I believe this was a great deal and look forward to seeing what happens with this. If MannKind, who is an expert in dry powder formulation and drug delivery, believes this is a good powder to acquire for future drug development, then I’ll take their word for it.

Both reasonable and sensible.  This was a net-net zero transaction upfront and nothing like the V-Go acquisition in terms of initial outlay of CAPEX. We took on a small piece of their hub in Boston, a biotech haven and research gold mine, plus we've added another DPI Formulation technology product to the pipeline.  Now we have two options, Technosphere and iSPERSE, for the inhaled drug space.  This fits into MNKDs overall mission as a lung delivery platform that they're gaining recognition for with not only DPI formulations but with other inhaled drugs such as nebulizer versions, too. 

[uvula]

mango:2. MannKind has never said that. Will you please provide the source for your information?

This is directly in the mnkd press release:

"However, for some drug candidates, such as Clofazimine, that may require a significantly higher drug payload, the iSPERSE formulation technology may be better suited for developing viable powders.”

Also, I was sloppy in my wording. I should have said dreamboat instead of cricket.

[porkini]

May 29, 2024 9:55:11 GMT -5 uvula said:

mango:2. MannKind has never said that. Will you please provide the source for your information?

This is directly in the mnkd press release:

"However, for some drug candidates, such as Clofazimine, that may require a significantly higher drug payload, the iSPERSE formulation technology may be better suited for developing viable powders.”

Also, I was sloppy in my wording. I should have said dreamboat instead of cricket.

Should have also said "Cipla" in your other post.

"Cipra" appears to be something much different www.cipra.org/en/cipra/about