Here is what I had in my notes from the april 27th call.
Q: In our Feb 6th conference call you stated that Dr. Kelly had identified a company to do a pre-clinical study more analogous to the studies forming the basis of material licensing deals in NASH. Could you provide an update on that pre-clinical work?
A: It is going forward. It will be a few more weeks before they can announce the start of that pre-clinical study.
And from the May 26th call:
Q: NASH
A: Scott K. hired company to do special animal study. Results could lead to a licensing agreement.
P2 NASH could start.
Probably want to start this trial.
Plan: Uplist, hit primary endpoint on COVID, then start all the indications.
+++++
And here is some background research on NASH deals
NASH licensing deals
It causes fatty build-up and fibrosis in the liver, sometimes leading to cirrhosis and the need for a liver transplant, and so far has no approved treatments with some analysts predicting the market for NASH drugs could go from a standing start to more than $20bn in just a few years.
+++++++
Allergen
It subsequently made a bold entry into the non-alcoholic steatohepatitis
(NASH) market with the complementary acquisitions of US-based Tobira Therapeutics
(Deal no. 73620) and UK-based Akarna Therapeutics (Deal no. 73633). The key driver of
the Tobira deal, which is potentially worth up to US$1.7 B was the Phase III-ready asset
cenicriviroc, an immunomodulator and dual inhibitor of the CCR2 and CCR5 chemokine
receptors.
++++++
Novartis in nearly $1.6B deal to buy NASH-focused subsidiary of IFM Therapeutics
The deal includes a $310 million upfront payment plus milestones for three IFM Tre assets - one clinical drug for NASH and atherosclerosis and two preclinical molecules.
++++++
Investors in Ionis Pharmaceuticals are happy this morning after the California-based company announced it struck another licensing deal with AstraZeneca that has the potential to yield up to $330 million.
++++++
Yuhan will receive an upfront payment of $40 million, of which $10 million comes after a preclinical toxicity test. The company will also get the other $830 million in potential milestone payments upon achievement of drug development, approval, and sales. If the drug is commercialized, the company will receive additional royalties depending on net sales.
++++++
NGM Bio and Merck started working together in 2015, when the big pharma signed a $450m development deal with the biotech, including $200m in upfront fees and equity investment, to tap into its biologic drug discovery expertise. The lead NASH candidate at that time was NP 201, but seems to have been leapfrogged by NGM313, now renamed MK-3655.
Merck us paying $20m upfront for rights to NGM313 and follow-up compounds, with the deal following a phase 1b trial readout which showed that the antibody was able to reduce levels of fat in the liver and improve metabolic measures such as blood glucose control in obese NASH patients.
+++++
Under the terms of the licensing agreement, GENFIT will receive an upfront payment from Terns of $35 million and will be eligible to receive up to $193 million in potential clinical, regulatory and commercial milestone payments. Terns obtains the exclusive rights to develop, register and market elafibranor in mainland China, Hong Kong, Macau and Taiwan (“Greater China”) for both NASH and PBC. Upon commercial launch of elafibranor for the treatment of NASH in Greater China, GENFIT will be entitled to receive mid-teen percentage royalties from Terns based on sales in the territory.
Q: In our Feb 6th conference call you stated that Dr. Kelly had identified a company to do a pre-clinical study more analogous to the studies forming the basis of material licensing deals in NASH. Could you provide an update on that pre-clinical work?
A: It is going forward. It will be a few more weeks before they can announce the start of that pre-clinical study.
And from the May 26th call:
Q: NASH
A: Scott K. hired company to do special animal study. Results could lead to a licensing agreement.
P2 NASH could start.
Probably want to start this trial.
Plan: Uplist, hit primary endpoint on COVID, then start all the indications.
+++++
And here is some background research on NASH deals
NASH licensing deals
It causes fatty build-up and fibrosis in the liver, sometimes leading to cirrhosis and the need for a liver transplant, and so far has no approved treatments with some analysts predicting the market for NASH drugs could go from a standing start to more than $20bn in just a few years.
+++++++
Allergen
It subsequently made a bold entry into the non-alcoholic steatohepatitis
(NASH) market with the complementary acquisitions of US-based Tobira Therapeutics
(Deal no. 73620) and UK-based Akarna Therapeutics (Deal no. 73633). The key driver of
the Tobira deal, which is potentially worth up to US$1.7 B was the Phase III-ready asset
cenicriviroc, an immunomodulator and dual inhibitor of the CCR2 and CCR5 chemokine
receptors.
++++++
Novartis in nearly $1.6B deal to buy NASH-focused subsidiary of IFM Therapeutics
The deal includes a $310 million upfront payment plus milestones for three IFM Tre assets - one clinical drug for NASH and atherosclerosis and two preclinical molecules.
++++++
Investors in Ionis Pharmaceuticals are happy this morning after the California-based company announced it struck another licensing deal with AstraZeneca that has the potential to yield up to $330 million.
++++++
Yuhan will receive an upfront payment of $40 million, of which $10 million comes after a preclinical toxicity test. The company will also get the other $830 million in potential milestone payments upon achievement of drug development, approval, and sales. If the drug is commercialized, the company will receive additional royalties depending on net sales.
++++++
NGM Bio and Merck started working together in 2015, when the big pharma signed a $450m development deal with the biotech, including $200m in upfront fees and equity investment, to tap into its biologic drug discovery expertise. The lead NASH candidate at that time was NP 201, but seems to have been leapfrogged by NGM313, now renamed MK-3655.
Merck us paying $20m upfront for rights to NGM313 and follow-up compounds, with the deal following a phase 1b trial readout which showed that the antibody was able to reduce levels of fat in the liver and improve metabolic measures such as blood glucose control in obese NASH patients.
+++++
Under the terms of the licensing agreement, GENFIT will receive an upfront payment from Terns of $35 million and will be eligible to receive up to $193 million in potential clinical, regulatory and commercial milestone payments. Terns obtains the exclusive rights to develop, register and market elafibranor in mainland China, Hong Kong, Macau and Taiwan (“Greater China”) for both NASH and PBC. Upon commercial launch of elafibranor for the treatment of NASH in Greater China, GENFIT will be entitled to receive mid-teen percentage royalties from Terns based on sales in the territory.
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