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Post by ptass on Nov 7, 2024 17:28:43 GMT -5
The Q3 call was the first time I heard another company was developing an inhaled version of nintedanib. Based on a Google search, the company is Avalyn pharma and they are about 1 year ahead of us (competed phase 1 in the fall of 2023). Hopefully Boehringer doesn't partner with them.
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Post by prcgorman2 on Nov 7, 2024 17:34:19 GMT -5
Hmm, I missed that. When did you hear that? Timestamp in the presentation please.
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Post by ptass on Nov 7, 2024 17:44:12 GMT -5
One of the analyst mentioned it during the Q&A and Mike expanded on it. He said he believes there is room for 2 companies. When the transcript is available, I want to confirm that Mike said they were going right to dry powder instead of a nebulizer. If this is true, maybe it's due to the competition.
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Post by Clement on Nov 7, 2024 20:47:25 GMT -5
Avalon -- pirfenidone
Mannkind -- nintedanib
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Post by peppy on Nov 7, 2024 21:03:07 GMT -5
Ofev (nintedanib) revenues $3.8 billion ....... if we can build a better mouse trap. FDA-approved Drugs for IPF Currently, two drugs are FDA-approved for treatment of idiopathic pulmonary fibrosis (IPF), which is the most common form of PF. These include nintedanib (Ofev®) and pirfenidone (Esbriet®). These medications are called anti-fibrotic agents, meaning that they have shown in clinical trials to slow down the rate of fibrosis or scarring in the lungs. These drugs are approved for patients with mild, moderate and severe IPF. OFEV® (nintedanib capsules), for oral use Gastrointestinal disorders: Diarrhea, nausea, and vomiting have occurred with OFEV. Treat patients at first signs with adequate hydration and antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue OFEV if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment. (5.3) Gastrointestinal perforation has been reported. Use OFEV with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue OFEV in patients who develop gastrointestinal perforation. Only use OFEV in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk. (5.7) content.boehringer-ingelheim.com/DAM/b5d67da8-329b-4fa4-a732-af1e011fc0a5/ofev-us-pi.pdf |
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Post by ptass on Nov 7, 2024 21:05:41 GMT -5
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Post by peppy on Nov 7, 2024 21:20:15 GMT -5
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Post by ptass on Nov 7, 2024 21:35:17 GMT -5
Yeah our product is likely superior. The FDKP and dreamboat combination has a lot of real world and long term data from afrezza and tyvaso. |
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Post by mcbone on Nov 7, 2024 21:43:41 GMT -5
Thanks for pointing that out. I was not aware that there was a possible competitive inhaled version for nintedanib. The Avalyn product is administered with a nebulizer. Tyvaso DPI is superior to and preferred by patients over the older nebulizer administrated Tyvaso and hopefully that is going to be the case for OFEV, also. |
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Post by prcgorman2 on Nov 7, 2024 22:09:18 GMT -5
Thanks ptass. I looked up the company. I see they prioritized their perfenidone product over nintedanib. Could be lots of reasons for that. They look to be a start-up so the other product might be free of IPR encumbrances or have other advantages for their business plan. Plenty of reasons to pursue a generic so I suppose we should expect competitors just like there were competitors for generic treprostinil (Tyvaso). |
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Post by brentie on Nov 8, 2024 7:07:32 GMT -5
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Post by ktim on Nov 8, 2024 8:39:25 GMT -5
Yeah our product is likely superior. The FDKP and dreamboat combination has a lot of real world and long term data from afrezza and tyvaso. The bit question is whether it is "superior" according to the trials and enough so that insurance is compelled to cover it. We all think Afrezza is superior, but what has that gotten MNKD. However, it is a good sized market so as long as we are non-inferior, some part of the market can be captured. |
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Post by prcgorman2 on Nov 8, 2024 9:14:39 GMT -5
Yeah our product is likely superior. The FDKP and dreamboat combination has a lot of real world and long term data from afrezza and tyvaso. The bit question is whether it is "superior" according to the trials and enough so that insurance is compelled to cover it. We all think Afrezza is superior, but what has that gotten MNKD. However, it is a good sized market so as long as we are non-inferior, some part of the market can be captured. They prioritized another drug over nintedanib for development, and it sounds like either inhalable nintedanib is vastly superior to oral Ofev. Ofev is currently approaching $4B and forecast to be over $7B in 2030. Neither company is likely to have a product before nintedanib compound patent expires in the 1st quarter of 2026. Once that patent expires and an inhalable version is available, there’s going to be lots of headroom for price and performance as compared to Ofev which dominates its marketspace. |
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Post by ptass on Nov 8, 2024 9:29:02 GMT -5
2026 is definitely going to be a banner year for MNKD.
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Post by thekid2499 on Nov 8, 2024 9:48:32 GMT -5
I found it interesting that there was a significant reduction in their sales force (40%). Was that a strategic decision or did they get rid of underperformers? It was unclear to me reading the transcript whether they are going to re-invest in new folks or stay with a smaller sales force.
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