|
|
Post by neil36 on Jun 10, 2021 5:26:42 GMT -5
|
|
|
|
Post by neil36 on Jun 10, 2021 5:27:49 GMT -5
WESTLAKE VILLAGE, Calif. and SAN DIEGO, June 10, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) and Thirona Bio, Inc. today announced that they have entered into a transaction that is intended to advance the development of a novel compound with potential for multiple indications. FBM5712 is a novel small molecule inhibitor of the ALK-5 kinase (the transforming growth factor-β (TGF-β) receptor kinase), which is being developed by Thirona as a topical product intended to prevent and/or reduce skin fibrosis. “TGF-β is also implicated in lung fibrotic diseases and ALK-5 has been validated as a potential target for idiopathic pulmonary fibrosis,” said Thomas Hofmann, M.D., Ph.D., Chief Scientific Officer of MannKind Corporation. Under the terms of the collaboration agreement, the companies will evaluate the therapeutic potential of Thirona’s locally acting TGF-β inhibitor for the treatment of pulmonary fibrosis. MannKind will formulate FBM5712 as a dry powder formulation. If initial studies are promising, MannKind can exercise certain rights to seek a full license to the compound for clinical development and commercialization for the treatment of fibrotic pulmonary diseases. In addition to the collaboration agreement, the companies entered into a convertible promissory note purchase agreement to support Thirona’s Series A financing. “This collaboration with MannKind gives Thirona the opportunity to potentially expand the development of FBM5712 into fibrotic lung diseases with a new formulation,” said Dr. Gordon Foulkes, Thirona Bio’s Founder and Chief Executive Officer. “We remain focused on the dermatological applications of this drug – targeting scleroderma, keloid scars and certain cancers – and now look forward to exploring lung indications with the experienced MannKind team.” “We recently announced our goal of launching a new product from our pipeline every year between 2025 and 2030,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We are excited by the opportunity to evaluate FBM5712 and to assess its potential to support our pipeline ambitions.” About Thirona Bio Thirona Bio is focused on the development of drugs for fibrotic diseases. Target indications include scleroderma, keloid scars and certain cancers where there are no effective therapies. The Company’s unique approach uses a potent, topically applied drug to inhibit TGF-β “locally”, thereby minimizing the potential risk of systemic exposure. The Company is headquartered in San Diego, California. More information can be found at www.thirona.bio.com. |
|
|
|
Post by mango on Jun 10, 2021 6:13:24 GMT -5
Exciting news 🥋☕️🤙
🥭 MannKind will conduct formulation and preclinical studies of a new chemical entity owned by Thirona
🥭 MannKind purchased a convertible note issued by Thirona
🥭 The transaction is intended to advance the development of a novel compound with potential for multiple indications
🥭 FBM5712 is a novel small molecule inhibitor of the ALK-5 kinase (the transforming growth factor-β (TGF-β) receptor kinase), which is being developed by Thirona as a topical product intended to prevent and/or reduce skin fibrosis. “TGF-β is also implicated in lung fibrotic diseases and ALK-5 has been validated as a potential target for idiopathic pulmonary fibrosis,” said Thomas Hofmann, M.D., Ph.D., Chief Scientific Officer of MannKind Corporation
🥭 MannKind will formulate FBM5712 as a dry powder formulation. If initial studies are promising, MannKind can exercise certain rights to seek a full license to the compound for clinical development and commercialization for the treatment of fibrotic pulmonary diseases
🥭 “We recently announced our goal of launching a new product from our pipeline every year between 2025 and 2030,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We are excited by the opportunity to evaluate FBM5712 and to assess its potential to support our pipeline ambitions.”
|
|
|
|
Post by peppy on Jun 10, 2021 6:15:53 GMT -5
What does this mean? "In addition to the collaboration agreement, the companies entered into a convertible promissory note purchase agreement to support Thirona’s Series A financing."
|
|
|
|
Post by mango on Jun 10, 2021 6:33:50 GMT -5
|
|
|
|
Post by kc on Jun 10, 2021 7:02:34 GMT -5
It sounds like MannKind is investing in this other company. That’s a interesting move for the company. Again there are things happening behind the scene that none of us know. I just wonder how that is tied into United therapeutics.
|
|
|
|
Post by boca1girl on Jun 10, 2021 7:06:47 GMT -5
What does this mean? "In addition to the collaboration agreement, the companies entered into a convertible promissory note purchase agreement to support Thirona’s Series A financing." When will Mnkd disclose how much $$ and what the terms are for this note purchase? |
|
|
|
Post by jlaw277 on Jun 10, 2021 7:13:51 GMT -5
What does this mean? "In addition to the collaboration agreement, the companies entered into a convertible promissory note purchase agreement to support Thirona’s Series A financing." It means that they are essentially loaning the company money with the option to convert to equity in Thirona at some pre-agreed price. What we don't know is how much was lent, what recourse if any does the note come with (meaning if the amount isn't repaid and MNKD doesn't want to convert), how long the term is and what the convert price is and at what premium to today's valuation. |
|
|
|
Post by akemp3000 on Jun 10, 2021 7:15:53 GMT -5
Prior knowledge of this forthcoming Thirona agreement likely contributed, at least in small part, to the recent MNKD fund raising. Expansion of the pipeline is exactly what Castagna has been discussing and driving. The first significant revenue looks like it will come from UTHR later this year but there's now quite a lot of additional potential revenue sources that should eventually come in; Afrezza growth, international and pediatrics, RLS (two molecules) and several other relationships that are now in the works.
A few years ago, optimistic phrases were thrown around such as "embarrassment of riches", "next generation drug delivery system", "global drug company" etc. Detractors laughed this off and even suggested MNKD should go ahead and sell out at a loss. IMO, it now seems other drug companies are waking up to the efficacy and superiority of Mannkind's drug delivery system. It's looking more and more like this is the beginning of TS become an influential presence in the industry. It could be that those optimistic phrases that were discounted previously are beginning to move forward. It's still a long way to go but looking better and better. GLTA
|
|
|
|
Post by mango on Jun 10, 2021 7:35:05 GMT -5
This deal is for a NCE (new chemical entity). This will take several years to traverse from concept to launch, but the good news is is that we are actively developing this for preclinical studies as we speak.
Furthermore, upon approval of this NCE we will receive 12 years combined exclusivity (5 years for the NCE exclusivity + 7 years marketing exclusivity for the rare disease/condition designation).
This is nothing different than us going forward with a NCE that we found through our own drug discovery process, expect here, we are paying someone else for their efforts for the NCE. Nice!
|
|
|
|
Post by peppy on Jun 10, 2021 7:43:10 GMT -5
What does this mean? "In addition to the collaboration agreement, the companies entered into a convertible promissory note purchase agreement to support Thirona’s Series A financing." When will Mnkd disclose how much $$ and what the terms are for this note purchase? Thirona Bio Looks like they are private. |
|
|
|
Post by markado on Jun 10, 2021 7:43:33 GMT -5
It sounds like MannKind is investing in this other company. That’s a interesting move for the company. Again there are things happening behind the scene that none of us know. I just wonder how that is tied into United therapeutics. This definitely seems more like a UT play or at minimum influenced by UT play. At < 20,000 to 60,000 PF patients per year in the US, would this qualify for Orphan Drug Status? Adding Cystic Fibrosis in (other indication), could this earn a priority review voucher? All longer term plays, but with real bottom line economic gains, but not just from the drug and scripts, itself. |
|
|
|
Post by mango on Jun 10, 2021 8:30:56 GMT -5
It sounds like MannKind is investing in this other company. That’s a interesting move for the company. Again there are things happening behind the scene that none of us know. I just wonder how that is tied into United therapeutics. This definitely seems more like a UT play or at minimum influenced by UT play. At < 20,000 to 60,000 PF patients per year in the US, would this qualify for Orphan Drug Status? Adding Cystic Fibrosis in (other indication), could this earn a priority review voucher? All longer term plays, but with real bottom line economic gains, but not just from the drug and scripts, itself. Under 200K is considered orphan, so yes. Also, with this being a NCE + orphan designation that would equate to a combined total of 12 years exclusivity (5 for being a NCE and 7 for it being orphan). |
|
|
|
Post by qwertqwert on Jun 10, 2021 8:33:37 GMT -5
When will Mnkd disclose how much $$ and what the terms are for this note purchase? Thirona Bio Looks like they are private. The thing that stuck out for me was all the Pfizer experience in their (co-founders) bios. |
|
|
|
Post by neil36 on Jun 10, 2021 8:33:53 GMT -5
It looks like Dr. J. Gordon Foulkes, CEO of Thirona Bio, was previously CEO of Excaliard, which was purchased by Pfizer in December 2011.
There are two female directors listed on the Thirona Bio website. Kay Chandler negotiated the sale of Excaliard to Pfizer.
Nancy Hutson was previously a Senior Vice President for Pfizer and oversaw their largest R&D facility. She is also on the board for Endo International. She was previously on the board for PhaseBio and Cubist, which were both sold to Merck ($8.4 billion and $480m respectively).
|
|
