UK to lead G7 discussion on COVID economic recovery on February 12

 Britain will chair a meeting of finance chiefs from the Group of Seven rich nations on Feb. 12 to try to map a way out of the global economic crisis inflicted by COVID-19 and to find a solution to an international tax wrangle too.

British finance minister Rishi Sunak and Bank of England Governor Andrew Bailey will co-host an online meeting of their peers from the United States, Japan, Germany, France, Italy and Canada, as well as the European Central Bank, Britain’s finance ministry said.

“Recognising that a global crisis needs global solutions, the Chancellor will work with his counterparts to address the shared economic challenges facing our domestic and global economies, and seek to achieve a strong and sustainable economic recovery from coronavirus,” the ministry said.

The administration of new U.S. President Joe Biden has said it will work with other countries to secure an economic recovery and tackle difficult climate and international tax issues, a change in tone from former president Donald Trump.

Britain is chairing the G7 this year at a time when the global economy is still reeling from the impact of lockdowns, prompting governments to spend trillions of dollars to stave off the worst of the damage.

Vaccination programmes are now underway, raising the prospect of a recovery later this year. But the different pace of the rollouts is likely to mean some regions lag behind with the euro zone at particular risk of a slow recovery.

Climate change and biodiversity loss would be made a central priority ahead of the COP26 conference to be hosted by Britain in November, the British finance ministry said.

“This in addition to working closely to reach a global solution on tax challenges created by digitalisation on the economy, and supporting the global sustainable financing of COVID-19 vaccines, therapeutics and diagnostics,” it said.

Nearly 140 countries are negotiating the first update in a generation to rules for taxing cross-border commerce, reflecting the dominance of big digital companies like Google, Apple, Amazon and Facebook.

British Prime Minister Boris Johnson is due to host the first in-person summit of G7 leaders in nearly two years in June in a seaside village in Cornwall, western England, to discuss rebuilding from the pandemic and climate change.

https://www.reuters.com/article/us-health-coronavirus-britain-g7-exclusi/exclusive-uk-to-lead-g7-discussion-on-covid-economic-recovery-on-february-12-idUSKBN2A32L0

Novo’s Rybelsus launch defies Covid-19

 Launching a diabetes drug during a global pandemic sounds like a recipe for disaster. But Novo Nordisk has beaten 2020 forecasts for its oral GLP-1 agonist, Rybelsus, despite Covid-19: full-year product sales were DKK1.87bn ($303m), versus EvaluatePharma sellside consensus of $279m. And any fears that Rybelsus could cannibalise Novo’s older injectable GLP-1 Ozempic have also been allayed, as over 80% of Rybelsus prescriptions were for patients new to the GLP-1 class. However, things look set to remain tough: face-to-face promotion has been on hold since November, a situation that could continue for some time with ongoing lockdowns. The sellside sees Rybelsus as Novo’s second-biggest product in 2026, with sales of over $5bn; however, this figure will rocket if a long shot in Alzheimer’s pays off. One thing not likely to change is Novo’s focus on internally developed assets and early-stage deals, despite the imminent retirement of its chief scientific officer, Mads Krogsgaard Thomsen, announced today. The Danish group’s research and M&A strategy will remain the same, its chief executive, Lars Fruergaard Jørgensen, told a media call this morning, particularly as Mr Thomsen is being replaced by his “lieutenants”, Marcus Schindler and Martin Holst Lange.

https://www.evaluate.com/vantage/articles/news/snippets/novos-rybelsus-launch-defies-covid-19

Amgen slams the brakes on a clutch of cancer drugs

 Amgen is pausing and stopping a whole series of next-gen cancer assets as it tries to figure out the best way forward for its early oncology programs.

Buried in its annual financial results, released Tuesday night, is evidence the Big Pharma, which is hoping for success and approval with its closely watched KRAS hopeful sotorasib, is having a tougher time making its other next-gen assets work.

There is a slew of updates here: First up is AMG 701 (aka pavurutamab), a half-life extended BiTE molecule targeting B-cell maturation antigen for relapsed or refractory multiple myeloma, which saw new data published at the American Society of Hematology meeting late last year.

Amgen said it is now pausing enrollment in the ongoing phase 1 ”while we discuss protocol modifications to optimize safety monitoring and mitigation with the FDA,” but it “expects to resume patient enrollment” in the coming months.

Analysts at Jefferies said they believe this pause is due to “protocol modifications for safety mitigation (we think from cytokine release syndrome),” a common but potentially deadly side effect and one many companies have had to balance with efficacy from their immuno-oncology meds.

There’s a second pause for AMG 673, another half-life extended BiTE molecule targeting CD33, which is on a hiatus “while we gather further information on the CD33 program through progression of AMG 330.”

That drug is a bispecific antibody that works by targeting CD33, an antigen widely expressed on the surface of acute myeloid leukemia cells, and then using another antigen, CD3, on the surface of T cells, to enable the latter to target the former.

At the American Society of Clinical Oncology meeting last summer, Amgen presented phase 1 data from ‘330 in certain leukemias, but these disappointed some analysts with relatively low efficacy and high rates of cytokine release syndrome. A path forward for the drug could include different blood cancers and a combo approach.

Two other programs have been hit with stoppages: AMG 596, another BiTE molecule but one targeting EGFR variant III for glioblastoma, a deadly form of brain cancer, has been halted “as we prioritize our portfolio.”

And finally, a phase 1 test of its oral MCL-1 inhibitor AMG 397 was paused “with focus shifting to the intravenous MCL-1 inhibitor AMG 176,” which is currently in phase 1 for blood cancers.

https://www.fiercebiotech.com/biotech/amgen-slams-brakes-a-clutch-cancer-drugs-as-reality-bites

Biogen tosses out Parkinson's hopeful cinpanemab

 As Biogen hopes and prays for a (now delayed) FDA approval of its controversial Alzheimer’s disease hopeful aducanumab, a key, closely watched pipeline asset has failed and been tossed out.

Buried in its annual results (PDF) published Wednesday morning, Biogen said the phase 2 study of BIIB054 (cinpanemab) in Parkinson’s disease “did not achieve proof-of-concept” and missed its primary and secondary endpoints

Biogen said it has now discontinued development of the drug and “will apply learnings to future efforts in Parkinson’s disease.”

As part of that cull, the pharma took a GAAP impairment charge of around $75 million during the fourth quarter.

Cinpanemab, which works as an anti-alpha synuclein (syn) monoclonal antibody, was being studied in the midstage SPARK study, with its primary endpoint being MDS-UPDRS total score, a measure of impairment and disability, versus a dummy treatment.

It was looking to rival Roche and Prothena’s syn drug prasinezumab, although this too has been beset by setbacks as it recently failed to beat placebo on MDS-UPDRS total score, although it saw enough to continue on with development. This follows a string of experimental drug failures over the years in Parkinson's R&D.

The drug had been a key weapon in Biogen’s arsenal but now hits the scrap heap at a time when its full-year guidance rests, literally, on the approval of aducanumab, which was rejected by the FDA’s expert panel late last year.

https://www.fiercebiotech.com/biotech/biogen-tosses-out-parkinson-s-hopeful-cinpanemab-pays-75m-for-its-syn

Healthcare services platform Signify Health sets terms for $423 million IPO

 Signify Health, which provides a value-based billing platform for in-home and bundled health services, announced terms for its IPO on Wednesday.

The Norwalk, CT-based company plans to raise $423 million by offering 23.5 million shares at a price range of $17 to $19. At the midpoint of the proposed range, Signify Health would command a fully diluted market value of $4.1 billion.

Signify Health is a leading healthcare platform that leverages analytics, technology, and nationwide healthcare provider networks to create and power value-based payment programs. Its customers include health plans, governments, employers, health systems, and physician groups. Its episode payment platform managed $6.1 billion of spend under the Medicare Bundled Payment for Care Improvement Advanced (BPCI-A) program in 2019, and the BPCI-A episodes it managed initiated in the 4Q19 resulted in approximately 15% greater discharges home from acute-care facilities and approximately 10% lower readmissions. Its mobile network of providers entered over 1 million unique homes to evaluate individuals in Medicare Advantage and other managed care plans in 2019.

Signify Health was founded in 2017 and booked $550 million in revenue for the 12 months ended September 30, 2020. It plans to list on the NYSE under the symbol SGFY. Goldman Sachs, J.P. Morgan, Barclays, Deutsche Bank, BofA Securities, UBS Investment Bank, Baird, Piper Sandler and William Blair are the joint bookrunners on the deal. It is expected to price during the week of February 8, 2021.

Relevant Profile: SGFY

https://www.renaissancecapital.com/IPO-Center/News/76042/Healthcare-services-platform-Signify-Health-sets-terms-for-$423-million-IPO#:~:text=Signify%20Health%2C%20which%20provides%20a,range%20of%20%2417%20to%20%2419.

Voyager cut to Neutral by BTIG

 From Buy.

https://finviz.com/quote.ashx?t=VYGR

TYME Granted U.S. Patent Claims Covering Use of TYME-19 to Treat COVID-19

 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced that it has received notification that the United States Patent and Trademark Office has granted additional patent claims related to the Company’s metabolomic technology platform. The patent, U.S. Patent No. 10,905,698, is directed to methods for treating COVID-19.

Unlike immune therapies that depend upon the structure of the external virus coat of COVID-19 where the therapy directs its attack, we believe TYME-19 is agnostic to this structure and any mutations to the viral coat. Like other TYME agents, TYME-19 affects cellular metabolism. It constrains viral replication after a virus has inserted its genetic blueprint into an infected cell by inhibiting the ability of the virus to use the cells synthetic apparatus to make viral proteins and lipids. As a result, we believe that TYME-19 diminishes the ability of COVID-19 to hijack an infected cell. TYME intends to initiate the appropriate clinical trials to substantiate the safety and efficacy of TYME-19.

TYME-19 is an investigational compound that is not approved in the U.S. for any disease indication.

https://finance.yahoo.com/news/tyme-granted-u-patent-claims-130000101.html