Novo’s $3.3bn GalXC quest

 Novo Nordisk’s biggest ever acquisition is a platform play. Its $3.3bn cash bid for Dicerna nets the Danish group a portfolio of RNA interference assets, but more importantly the technology behind them, which ought to let it look beyond its metabolic juggernaut semaglutide. 

Novo and Dicerna are old friends, with a development deal concerning RNAi therapies using Dicerna’s proprietary GalXC technology in place since 2019. But much of Dicerna’s pipeline is entailed elsewhere, with the company collaborating with Roche, Lilly and Alexion, among others. It might, therefore, be unwise to rule out a counterbid. 

There is history here. Novo was pipped once before, its €2.6bn ($3.1bn) offer for Ablynx having been scotched by a €3.9bn counterbid from Sanofi in early 2018 (Sanofi's Ablynx buy leaves no doubt about its pipeline troubles, January 29, 2018). Novo’s unwillingness to overpay is well-known, and might make a white-knight move more likely. 

Rolling the dice

Still, at $38.25 per share Novo’s offer comes at a chunky 80% premium to Dicerna’s closing share price on Wednesday. In fact the bid is not far off from where Dicerna was trading before the nasty clinical miss with its primary hyperoxaluria candidate nedosiran (Dicerna can’t catch up with Alnylam, August 6, 2021). 

And Novo has been getting more aggressive of late. Last year it did two of its biggest deals to date, paying $2.1bn for Corvidia Therapeutics and $1.8bn for Emisphere, a departure from its track record of small transactions for early-stage companies.

Assuming it goes ahead without incident, the Dicerna deal will allow Novo to develop precision medicines for chronic diseases such as diabetes, obesity, cardiovascular disease and Nash, using the GalXC technology. Molecules developed using this technology have a proprietary N-acetyl-D-galactosamine-mediated structure of double-stranded RNA, and are designed to bind specifically to receptors on liver cells, allowing access to the RNAi machinery within. 

Novo also intends to look beyond the liver and cardiometabolic diseases, towards endocrine and bleeding disorders, with the Dicerna technology. This will rely on Dicerna’s next-gen GalXC-Plus platform, which uses alternative RNA structures and synthetic ligands to target other tissues. 

But this is likely still some way off, since the first project developed under the two groups’ 2019 collaboration has yet to reach the clinic. It is expected to reach this milestone next year. It is notable that many others working in the RNAi field are already pushing into later-stage trials in these cardiovascular and liver disease settings. 

Pushing ahead: selected RNAi-based projects in Novo's areas of interest
Product	Company	Mechanism of Action
ARO-APOC3	Arrowhead	ApoC 3 antisense, in phase 2 and 3 trials for dyslipidemia and familial chylomicronemia.
Pelacarsen	Novartis (from Ionis)	ApoA antisense; phase 3 trial in patients with established cardiovascular disease and elevated Lp(a) ongoing.
ARO-ANG3	Arrowhead	ANGPTL3 antisense; phase 2b ongoing
Vupanorsen	Pfizer (from Ionis)	ANGPTL3 antisense; phase 2b ongoing
AMG 890 (olpasiran)	Amgen (from Arrowhead)	ApoA RNAi therapeutic; phase 1 ongoing.
AZD8601	AstraZeneca (from Moderna)	VEGFA inhibitor; phase 1 in heart failure just completed.
ARO-HSD	Arrowhead	HSD 13 inhibitor; phase 1 trial ongoing in Nash.
JNJ-75220795	J&J (from Arrowhead)	Anti-PNPLA3 siRNA therapeutic, in phase 1 for fatty liver
Note: selected projects, list not exhaustive. Source: Evaluate Pharma, company statements.

There is one last aspect of today’s deal that is worth considering: the biodollar value of the deals with Dicerna’s other partners. Under the Lilly tie-up, Dicerna – and therefore presumably now Novo – could receive up to $350m per target in development, plus commercialisation milestones and tiered royalties. Three Lilly-partnered projects are in phase 1 at the moment, and two more are preclinical. 

The Roche deal, which concerns the phase 2-stage hep B candidate DCR-HBVS (RG6346), is even richer.  Roche could end up paying nearly $1.5bn in milestones, with royalties on top. If Novo is extremely fortunate and DCR-HBVS goes all the way, the Dicerna buy will be a positive bargain. 

https://www.evaluate.com/vantage/articles/news/deals/novos-33bn-galxc-quest

Cassava Starts 2nd Phase 3 Study of Simufilam for Treatment of Alzheimer’s

 Second Phase 3 Study is Designed to Evaluate Safety and Efficacy of Simufilam Over 78 Weeks in 1,000 Patients with Alzheimer’s Disease

Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, announced today it has initiated a second Phase 3 study of simufilam, the Company’s investigational drug for patients with Alzheimer’s disease. This second Phase 3 study is designed to evaluate the safety and efficacy of simufilam over 78 weeks in approximately 1,000 patients with Alzheimer’s disease across clinical sites in the U.S. and Canada.

“Alzheimer’s disease isn’t going away anytime soon, and neither are we,” said Remi Barbier, President & CEO. “Developing a new drug solution for Alzheimer’s is a daunting task during the best of times. During these times of outlandish allegations made against us by short sellers, we stand committed to translate what we believe is a promising scientific breakthrough into a potentially meaningful treatment for people with Alzheimer’s disease. The rest is noise.”

Cassava Sciences’ Phase 3 program in Alzheimer’s is being conducted under Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration (FDA). The SPAs document that FDA has reviewed and agreed on the key design features of each Phase 3 study protocol.

Cassava Sciences is developing simufilam in accordance with high ethical standards and sound scientific principles. Cassava Sciences is committed to transparency and sharing information related to its Phase 3 program – for clinical protocol details, including patient eligibility, please visit: https://clinicaltrials.gov/ct2/results?cond=&term=simufilam&cntry=&state=&city=&dist=

https://finance.yahoo.com/news/cassava-sciences-initiates-second-phase-141500835.html

J&J sees potential for 14 new multibillion-dollar drugs by 2025

 Johnson & Johnson expects to file for approval of 14 new drugs by 2025, and has projected average peak sales of $4 billion a year for each, a top J&J scientist said ahead of a strategy review of the company's pharmaceuticals unit on Thursday.

Among the top pipeline assets, Mathai Mammen, global head of research for J&J's Janssen pharmaceutical division, pointed to a drug combination for non-small cell lung cancer, an anticoagulant it is developing with partner Bristol Myers Squibb and a vaccine for respiratory syncytial virus (RSV).

J&J said last week that it plans to spin off its consumer health division that sells Listerine and Band-Aid bandages in order to focus on pharmaceuticals and medical devices in the biggest shakeup in the U.S. company's 135-year history.

Mammen in an interview said he did not think the transaction would change much in terms of research and development spending.

"We're really happy and proud of the way R&D is functioning - the strategy we're using and the level of investments," he said.

J&J developed one of the three COVID-19 vaccines authorized in the United States, but its use in the country tailed off sharply after rare cases of blood clotting were linked to the shot.

Nonetheless, Mammen said J&J still expects to develop more vaccines using the same adenovirus vector technology.

"It induces not just antibodies that tend to be relatively short-lived, but also good, multiple kinds of T-cells... so you have that really long-lasting benefit," Mammen said.

Mammen said the company was "actively looking" at a lot of different technology platforms, including messenger RNA, the backbone of the COVID-19 vaccines from Moderna and Pfizer and partner BioNTech

"We have several technologies right now, and we'll look at expanding that out further," he said.

https://finance.yahoo.com/news/j-j-sees-potential-14-130959893.html

Teladoc Health : 2021 Investor Day Presentation

 

Our Vision for Whole-Person Care	Jason Gorevic
Commercial Strategy	Kelly Bliss
Delivering Whole-Person Care	Dan Trencher

Pulling It All Together:	Donna Boyer
The Integrated Experience
Product and Platform Enablement	Claus Jensen,
PhD

Q&A

BetterHelp's Playbook for Growth	Alon Matas
Winning With Consumers:	Stephany
The Forefront of Engagement	Verstraete
Financial Outlook	Mala Murthy
Closing Remarks and Q&A

Our Vision for

Whole-Person Care

Jason Gorevic

Chief Executive Officer

4

Member Story

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https://www.marketscreener.com/quote/stock/TELADOC-HEALTH-INC-22762533/news/Teladoc-Health-2021-Investor-Day-Presentation-37070918/

CVS to Close 300 Stores a Year for Next Three Years; Cuts Guidance

 CVS Health Corp. said it will close about 300 stores a year for the next three years, resulting in a cut to full year earnings forecast.

The changes will begin in the spring of 2022, CVS said.

In connection with the planned store closures, the company said it expects to record an impairment charge in the fourth quarter of 2021 of between $1 billion and $1.2 billion, or 56 cents to 67 cents a share of earnings. The charge is related to the write down of operating lease right-of-use assets and property and equipment.

Due to the planned store closures, the company cut its 2021 earnings guidance range to $5.46 to $5.67 a share, from $6.13 to $6.23. The impairment charges are excluded from the company's calculation of adjusted EPS and CVS said it expects the impact to adjusted EPS to be immaterial in 2021 and 2022, and modestly accretive in 2023 and thereafter.

CVS affirmed its full-year 2021 adjusted EPS guidance range of $7.90 to $8 and confirmed it expects full-year cash flow from operations in range of $13 billion to $13.5 billion.

The health care services company said it has been evaluating changes in population, consumer buying patterns and future health needs to "ensure it has the right kinds of stores in the right locations for consumers and for the business."

As part of the company's strategic review of its retail business, CVS Health said it will also create new store formats to drive higher engagement with consumers. Three models will include sites dedicated to offering primary care services, an enhanced version of its "HealthHUB" locations with products and services for everyday health and wellness needs, and traditional CVS Pharmacy stores that provide prescription services and health, wellness, personal care and other retail offerings.

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/CVS-to-Close-300-Stores-a-Year-for-Next-Three-Years-Cuts-Guidance-37070866/

Jobless claims near pre-pandemic level as labor market recovers

 The number of Americans filing new claims for unemployment benefits fell close to pre-pandemic levels last week as the labor market recovery continues, though a shortage of workers remains an obstacle to faster job growth.

The weekly unemployment claims report from the Labor Department on Thursday, the most timely data on the economy's health, also showed jobless benefit rolls declining to a 20-month low in early November. The economy is regaining momentum following a lull over the summer as a wave of COVID-19 infections driven by the Delta variant battered the nation.

"Demand for labor is very strong and workers are in short supply, so layoffs are very low right now," said Gus Faucher, chief economist at PNC Financial in Pittsburgh, Pennsylvania.

Initial claims for state unemployment benefits slipped 1,000 to a seasonally adjusted 268,000 for the week ended Nov. 13, the Labor Department said on Thursday. That was the lowest level since the start of the coronavirus pandemic in the United States more than 20 months ago.

Economists polled by Reuters had forecast 260,000 applications in the latest week. The smaller decline was because the model that the government uses to strip out seasonal fluctuations from the data was less generous last week.

Unadjusted claims dropped 18,183 to 238,850 last week. The decrease was led by Kentucky, likely due to automobile workers returning to factories after temporary layoffs as motor vehicle manufacturers deal with a global semiconductor shortage. There were also big declines in Michigan, Tennessee and Ohio, which have a strong presence of auto manufacturers.

The decreases offset a surge in filings in California.

The seventh straight weekly decline in claims left them just above the 256,000 level in mid-March 2020, and in a range that is associated with a healthy labor market. Claims have declined from a record high of 6.149 million in early April 2020.

The continued improvement is consistent with other data that have suggested an acceleration in economic activity early in the fourth quarter after gross domestic product increased at its slowest pace in more than a year in the July-September period.

Retail sales surged in October and production at factories also rebounded sharply.

U.S. stocks opened higher. The dollar fell against a basket of currencies. U.S. Treasury prices were lower.

WORKER SHORTAGE

The claims report showed the number of people continuing to receive benefits after an initial week of aid dropped 129,000 to 2.080 million in the week ended Nov. 6. That was also the lowest level since the middle of March in 2020.

A total 3.185 million people were collecting unemployment checks under all programs the week ended Oct. 30. Shrinking unemployment rolls raise hopes that more people will return to the labor force soon. Millions of unemployed Americans remain at home even after the expiration of generous federal government-funded benefits and the reopening of schools for in-person learning.

The claims data covered the period during which the government surveyed business establishments for the nonfarm payrolls component of November's employment report.

Claims have dropped since mid-October, which would suggest stronger employment growth this month. But there is an acute shortage of workers, with 10.4 million job openings as of the end of September.

"There is some uncertainty as a key to monthly job growth is labor supply and the Delta variant," said Ryan Sweet, a senior economist at Moody's Analytics in West Chester, Pennsylvania. "The good news is that the Delta variant's impact on the labor market in November will be less than that seen during the teeth of the recent wave."

The economy created 531,000 jobs in October. Employment growth has averaged 582,000 jobs per month this year and the labor force is down 3 million from its pre-pandemic level.

https://money.usnews.com/investing/news/articles/2021-11-18/u-s-weekly-jobless-claims-edge-down-as-labor-market-recovers

Longeveron Gets Rare Pediatric Disease Tag for Life-Threatening Infant Heart Condition Med

 Phase 2 clinical trial underway for Hypoplastic Left Heart Syndrome, which affects approximately 1,000 babies per year

Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect in infants. Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently being evaluated in a Phase 2 trial.

https://finance.yahoo.com/news/u-food-drug-administration-approves-130000821.html