Re: Today's stream - link
in response to
by
posted on
Nov 20, 2020 01:13AM
Rocketman2- my 9/10 post was just a summary of the terms on the poster and the narrative which is in the link library -
Here is an excerpt re: the deal
Near Term Development Points • The US FDA and Resverlogix have now confirmed the final BETonMACE2 clinical plans. – Filing of a New Drug Application (NDA) with the FDA is possible following unequivocal efficacy at an interim analysis of BETonMACE2 - 2023 – All or most BETonMACE2 patients to receive top standard of care, including SGLT2 inhibitors – BETonMACE2 to increase enrichment of chronic kidney disease (CKD) patients – Based on existing results, the FDA encouraged the evaluation of a non-alcoholic fatty liver disease (NAFLD) subgroup as well as related exploratory endpoints • Development, Option 1, Resverlogix will now finalize it’s ongoing negotiations with Major Pharmaceutical companies to determine a suitable partner for co-developing apabetalone. Codevelopment discussions include the following: ▪ Resverlogix will receive a significant upfront payment H2, 2020. ▪ The Phase 3b clinical trial will be funded by the partnering company - $120 to $150 MM USD. ▪ Our new partner can supply their SGLT2 diabetes drug as the co-medication. Thus providing the pharma partner with valuable marketing material and the ability to launch a fixed dose combination product with patent coverage until 2040. ▪ The deal will also include substantial milestone and royalty payments with an M&A right of first refusal option. • Option 2, Resverlogix can finance the Phase 3b trial internally through the sale of 50% of the future royalty stream currently owned by Zenith Capital. Funds would be used to finance BETonMACE2. • Option 3, Resverlogix can finance and launch the Phase 3b trial with internal insider investors.
I also posted the following on 9/9/20
Some food for thought to pass the time until a deal is announced:
The 6/22/20 news release indicating FDA agreement for key aspects of the apabetalone registration enabling study put RVX-208 in the spotlight for a partnership with BP.
" In total, approximately 25% of BETonMACE patients were on new oral anti-diabetic treatments that included SGLT2 and DPP4 inhibitors. In combination with apabetalone, primary MACE was reduced by 57% and by 63% when hospitalization for congestive heart failure was included. We believe the efficacy and safety demonstrated with this combination approach will greatly assist in our strategic partnership discussions and significantly improves our intellectual property and commercial runway position. In short, we can demonstrate efficacy, safety and we believe we now have a clear path to commercialization."
Also, a Chinese connection may be good -
"Building upon previous predictions from 2019, we also expect to see China continuing their growth as a key player within the pharmaceutical industry in the coming decade, partially driven by reformed priority review and approval process that allows domestic drug developers to compete with multinational counterparts. With these changes we expect a more levelled global playing field in the world of biopharma deals, with an increase in both frequency and size of deals that involve Chinese companies."
https://mscnordics.com/largest-biotech-and-pharma-deals-2019-recap-2020-outlook/
Table 2. Top 10 partnership deals (Pharma and biotech)
Licensee (Licensor) | Deal value (deal breakdown) | Asset of interest; latest development stage at deal signing; indication | Date | Source |
Amgen (Celgene) | $13.4 billion (complete asset acquisition) | Otezla® (apremilast); marketed; inflammatory diseases | Completed: Nov 21, 2019 | Link |
AstraZeneca (Daiichi Sankyo) | $6.9 billion ($1.35 billion upfront, $3.8 billion in regulatory and milestone payments, and $1.75 billion in sales-related milestone payments) | DS-8201 (trastuzumab deruxtecan); phase 3; HER2-expressing breast and gastric cancers | Announced: Mar 28, 2019 | Link |
Gilead (Galapagos) | $5.4 billion ($4.0 billion upfront, $1.1 equity investment, and $0.3 billion in milestone payments) | GLPG1690 and filgotinib; phase 3 and pending approval; idiopathic pulmonary fibrosis and rheumatoid arthritis | Completed: Jul 14, 2019 | Link |
Novartis (Takeda) | $5.3 billion ($3.4 billion upfront, $1.9 in milestone payments) | Xiidra® (lifitegrast ophthalmic solution); marketed; dry eye disease | Completed: Jul 1, 2019 | Link |
GlaxoSmithKline (Merck KGaA) | $4.2 billion ($0.3 billion upfront, $0.6 billion in development milestone payments and $3.3 billion in commercial milestone payments) | M7824 (bintrafusp alfa); phase 2; PD-L1 expressing advanced non-small cell lung cancer | Announced: Feb 5, 2019 | Link |
Nanjing Chia Tai Tianqing Pharmaceutical Company NJCTTQ (Abpro) | $4 billion ($60 million in near-term R&D funding, plus potential milestones payments and royalties) | DiversImmune and Multimab (platform); preclinical; immuno-oncology candidates in ophthalmology and autoimmunity | Announced: Feb 28, 2019 | Link |
Undisclosed (WuXi Biologics) | $3 billion | Manufacturing contract for the undisclosed party’s vaccine product | Announced: May 20, 2019 | Link |
Gilead Sciences (Nurix Therapeutics) | $2.3 billion ($45 million upfront, up to $2.3 billion in milestone payments) | Targeted protein degradation drugs; oncology and other challenging diseases | Announced: Jun 19, 2019 | Link |
Swedish Orphan Biovitrum AB Sobi (AstraZeneca) | $2.3 billion ($1.5 billion upfront, $20 million in cash per year for three years, $0.47 billion in sales milestone payments, $0.29 billion in regulatory submission and development milestone payments) | U.S. rights to Synagis® (palivizumab); marketed; prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) | Completed: Jan 24, 2019 | Link |
Genentech (Skyhawk) | $2 billion (undisclosed upfront and up to $2 billion in milestone payments and royalties) | SkySTAR™ technology platform (small molecules that modulate RNA splicing); oncology and neurological diseases | Announced: Jul 16, 2019 | Link |
My bet is that a US BP with an anti-diabetic therapy on the market partners with Resverlogix in a deal similar to those listed above to improve their therapy, save lives, and protect and prolong their revenue stream.
jmo
Or, we could still be drifting west on that slow boat to China
DM said we would see RVX share price increase to June 2019 levels in just a short while - still waiting - painfully - I had forgotten about those September posts until responding to your post - seems like an eternity since 9/10/20 - had a mild case of Covid 19 - been quarentined for the last 3 weeks - my business partner and 2 college age grandkids have had the virus - no casualties - everyone is now healthy - thank God!
Come on DM - get this deal done
Chicagoest