UK Orders All Poultry And Captive Birds Indoors Amid "Largest Ever" Bird Flu Outbreak

 Authorities in the UK have ordered all captive birds and poultry to be kept indoors due to concerns over avian influenza.

The stepped-up measures from the UK's chief veterinary officer make the housing measures a legal requirement, and are accompanied by stringent biosecurity measures to protect flocks from disease, Sky News reports.

The rules come into force one minute past midnight on Monday, November 7th, giving owners one week to prepare.

It comes after the national risk of bird flu in wild birds was raised to 'very high', and the whole of Great Britain was made a bird flu prevention zone two weeks ago.

Chief veterinary officer Christine Middlemiss said: "We are now facing this year the largest ever outbreak of bird flu and are seeing rapid escalation in the number of cases on commercial farms and in backyard birds across England. -Sky News

"The risk of kept birds being exposed to disease has reached a point where it is now necessary for all birds to be housed until further notice," Middlemiss continued. "Scrupulous biosecurity and separating flocks in all ways from wild birds remain the best form of defence."

All bird owners must follow the rules, whether they keep 'a few, or thousands,' she added.

"This decision has not been taken lightly, but is the best way to protect your birds from this highly infectious disease."

The Department for the Environment and Rural Affairs reports that housing birds reduces the risk of infection.

That said, housing alone will not protect the birds, and keepers are instructed to implement enhanced biosecurity measures laid out earlier this month to prevent the disease from spreading. The measures include restricting access for non-essential people on site, and ensuring that workers change clothing and footwear before entering bird enclosures. Vehicles must also be disinfected regularly.

The UK Health Security Agency says the risk to public health remains unchanged.

https://www.zerohedge.com/commodities/uk-orders-all-poultry-and-captive-birds-indoors-amid-largest-ever-bird-flu-outbreak

Lilly says Mounjaro launch is “viral in nature”

 One of the highlights of Eli Lilly’s third-quarter results was the rapid uptake of new type 2 diabetes therapy Mounjaro, which added more than $97 million in US sales alone in what has been described as “viral” take-up by the drugmaker.

Lilly’s head of diabetes, Mike Mason, said on the company’s results call that the rollout of Mounjaro (tirzepatide) was “really unprecedented” for a new diabetes therapy in the US, and had been driven by “tremendous patient satisfaction and the visible results that people experience.”

Mounjaro was approved by the FDA in May, becoming the first combined GLP-1/GIP agonist to reach the market, but has also benefitted from supply constraints from Novo Nordisk’s GLP-1 agonist Ozempic (semaglutide), a key competitor.

Mason acknowledged that, noting that take-up is a “dynamic situation”, given the uncertainty of competitor supply, and data on titration rates and patients stopping or not adhering to therapy, are still not mature.

Nevertheless, Mounjaro arrived on the scene with clinical data showing that it was more effective than Ozempic at controlling blood sugar levels and achieving weight loss in adults with type 2 diabetes, although the comparison was made before Novo Nordisk launched a higher-strength version of its drug.

The launch of Mounjaro always raised the risk that it would cannibalise sales of Lilly’s own GLP-1 agonist Trulicity (dulaglutide), which is competing head-to-head with Ozempic in the market, but the company says there is little evidence of that so far.

Around 70% of new prescriptions for the drug are for patients who haven’t received this type of therapy in the past, with fewer than 10% switching from Trulicity, said Lilly’s chief financial officer Anat Ashkenazi on the call.

Now, Lilly’s focus is on international expansion – with approvals for diabetes in Europe and Japan already in the bag – and increasing manufacturing capacity for tirzepatide, as well as approval of the new drug as an obesity therapy.

The company plans to start a rolling application with the FDA for obesity later this year, based on the results of the SURMOUNT-1 trial, which will conclude shortly after the readout of SURMOUNT-2 around April 2023.

A third trial called SURMOUNT-MMO is looking at morbidity and mortality outcomes in obesity patients treated with the dual agonist, hoping to demonstrate that the weight loss achieved with the drug can reduce patients’ risk of complications such as major adverse cardiovascular events (MACE).

The FDA has already awarded fast-track status to tirzepatide in obesity, which it will compete with Novo Nordisk’s fast-growing Wegovy brand of semaglutide.

Assuming all goes to Lilly’s plan, analysts at EvaluatePharma have previously predicted that sales of tirzepatide could break the $1 billion barrier as early as 2024, and the $3 billion threshold two years later.

Along with $97 million in US sales, Lilly also claimed $86 million in Mounjaro revenue related to a sales collaboration agreement with Mitsubishi Tanabe for the right to sell and distribute Mounjaro in Japan.

https://pharmaphorum.com/news/lilly-says-mounjaro-launch-is-viral-in-nature/

Arcturus, CSL to Develop and Commercialize Self-amplifying mRNA Vaccines

 

• Arcturus to receive upfront payment of $200 million and more than $4 billion in potential development and commercial milestones

• 40% profit sharing for COVID-19 vaccines, up to double digit royalties for influenza, pandemic preparedness and three additional respiratory infectious disease vaccines

• Combines Arcturus’ self-amplifying mRNA vaccine technologies with CSL’s world-leading capabilities as a commercial scale manufacturer and global distributor of influenza and pandemic vaccines

https://finance.yahoo.com/news/arcturus-announces-collaboration-csl-develop-220500213.html

Novo Nordisk sees faster profit growth on demand for diabetes drug

 Danish drugmaker Novo Nordisk raised its full-year earnings outlook on strong sales of diabetes treatment Ozempic, also reporting a better-than-expected profit.

In a statement on Wednesday, it predicted 2022 operating profit growth at constant exchange rates of 13-16%, up from a previous target range of 11-15%.

Nine-month operating profit rose 28% to 57.7 billion Danish crowns ($7.66 billion), above the 56.8 billion forecast by analysts, according to Refinitiv data.

It reiterated that it expects to make all doses of weight-loss drug Wegovy, a future growth driver, available in the United States towards the end of 2022, as it seeks to overcome production problems.

It belongs to a drug class known as GLP-1 analogues such as Ozempic.

"The growth is driven by increasing demand for GLP-1-based diabetes treatments, especially Ozempic," CEO Lars Fruergaard Jorgensen said.

Analysts have speculated that Ozempic demand is partly driven by prescriptions to patients who seek to lose weight, which is outside of its approved indication.

In obesity, much of the company's growth aspirations are riding on weekly injection Wegovy, which was shown to help patients lose about 12% of their body weight. It won U.S. approval in June 2021 as an obesity drug.

But a contractor filling syringes for injection pens for the U.S. market ran into production problems last December, which has left Novo scrambling to reorganise the launch.

Novo faces keen competition from Eli Lilly, whose monthly injection Mounjaro won U.S. approval for type 2 diabetes in May and it is under fast-track review as a potential weight-loss drug.

https://finance.yahoo.com/news/novo-nordisk-sees-faster-profit-071827368.html

New GSK shines brighter with another forecast upgrade

 GSK beat third-quarter earnings forecasts on Wednesday and raised its 2022 estimate for the second time in four months, continuing its strong start as a standalone prescription medicine business since spinning off its consumer health brands.

After years of underperformance relative to its peers and missing on the lucrative market for the first set of COVID-19 vaccines, GSK has delivered a string of strong results, with the latest led by its blockbuster shingles vaccine Shingrix.

Shingrix generated quarterly sales of 760 million pounds ($873 million), compared with the GSK-compiled analyst consensus forecast for 685 million pounds.

Although demand for the vaccine suffered as adult immunisations took a hit during the first pandemic years, sales have rebounded as COVID pressures have eased.

The British drugmaker now expects 2022 sales to rise between 8% and 10% and adjusted operating profit to increase by 15% to 17%, excluding any contributions from its COVID-19 solutions business. It is the second hike to the company’s initial full-year forecasts issued in February.

GSK’s robust results, coupled with positive pipeline developments, provide some encouragement on the underlying business performance, Citi analysts wrote in a note.

On Wednesday, GSK said it had secured priority regulatory review in the United States for its RSV vaccine, with a decision expected by early May.

GSK is among a handful of drugmakers racing to develop a vaccine for the respiratory virus, which causes thousands of hospitalisations and deaths each year.

If approved, the shots are expected to generate billions in sales for their makers, given the complex molecular structure of the virus and safety concerns have stymied protracted efforts to develop a vaccine.

GSK shares hit a 2-1/2 month high of 1,470.2 pence in early trade and were last up 1% at 1,461.3 pence.

ZANTAC

Having survived a revolt by activist investors Elliott and Bluebell last year, GSK’s prospects since splitting off its consumer arm earlier this year have been boosted by clinical trial success and acquisitions, though concerns around U.S. litigation over heartburn drug Zantac have spooked investors.

GSK said it had incurred a charge of 45 million pounds in the third quarter, primarily reflecting provisions for increased legal fees related Zantac. Thousands of cases have been filed in the United States against a variety of drugmakers over allegations the compound contains a probable carcinogen. Originally marketed by a forerunner of GSK, Zantac has been sold by companies including Pfizer (NYSE:), Boehringer Ingelheim and Sanofi (NASDAQ:), as well as many generic drugmakers. Shareholders fear a worst-case scenario where costs run into billions of dollars, as happened in cases involving Merck & Co’s painkiller Vioxx and Bayer (OTC:)’s glyphosate-based weedkiller.

GSK reported a third-quarter adjusted profit of 46.9 pence per share on sales of about 7.83 billion pounds, topping analysts’ forecasts for 40.1 pence and 7.32 billion pounds. 

https://thespidernews.com/stock-market/new-gsk-shines-brighter-with-another-forecast-upgrade-by-reuters/

Central Banks Ease off on Rate Hike Push in October

  The pace and scale of rate hikes delivered by central banks around the globe in October slowed down dramatically following September's historic peak.

Central banks overseeing four of the 10 most heavily traded currencies delivered 200 basis points of rate hikes between them last month, while the remaining ones held rates. Policy makers at the European Central Bank, the Reserve Bank of Australia, the Reserve Bank of New Zealand and the Bank of Canada raised lending rates.

By comparison, eight of the same 10 central banks raised rates by a combined total of 550 bps in September, the fastest pace of tightening in at least two decades.

The latest moves have brought total rate hikes in 2022 from G10 central banks to 2,050 bps.

"The pace of central bank tightening has likely peaked," said Marko Kolanovic at JPMorgan in a note to clients.

"More dovish rhetoric from the ECB, BoC, Fed and RBA recently indicate the pace of central bank tightening is likely to slow in the coming months, though it is early to assess whether this means a lower terminal rate."

(G10 interest rates https://graphics.reuters.com/GLOBAL-MARKETS/mypmomxdjpr/G10CENOCT22.gif)

Markets had recently taken heart from indications that rate hikes from major central banks - especially the U.S. Federal Reserve - were slowing down.

However, any optimism on that front might be premature, said Jean Boivin, head of the BlackRock Investment Institute.

"We see central banks on a path to overtighten policy," said Boivin on Monday in a weekly outlook note from the world's largest asset manager.

"We think the Fed, like other developed market central banks, will only stop when the severe damage from rate hikes is clearer. Rates have already hit levels that may trigger recessions, in our view."

Policy makers and analysts have warned of a rising risk of recession, especially in Europe.

Data from emerging market central banks painted a similar picture. Five out of 18 central banks delivered 325 bps of rate hikes in October - less than half of September's tally and well below the monthly tally of 800-plus basis points in both June and July.

Indonesia, South Korea, Israel, Colombia and Chile all raised interest rates with the hiking cycle also nearing its end though there are some differences in near-term trajectories. While policy makers in Chile indicated that no more rate hikes were in the offing for now, Israel's central bank said it saw rates rising to levels above current levels.

Meanwhile outlier Turkey, where President Tayyip Erdogan is pushing for lower interest rates, delivered a bigger-than-expected 150 bps benchmark cut despite inflation at above 80%.

"The extent of the cost-of-living pressures are highly de-synchronised across the EM complex, with clear winners and losers," said Ehsan Khoman at MUFG.

In total, emerging market central banks have raised interest rates by a total 6,765 bps year-to-date, more than double the 2,745 bps for the whole of 2021, calculations show.

https://money.usnews.com/investing/news/articles/2022-11-02/central-banks-ease-off-on-rate-hike-push-in-october

String of gene therapy deals spurs cautious optimism on Wall Street

 Despite safety concerns and pushback from drug regulators, gene therapy continues to be an area of interest to biopharmaceutical dealmakers, as shown by a recent spate of activity.

In mid-October, Akouos, a Boston-based developer of gene therapies for hearing loss, agreed to be bought by Eli Lilly in a deal that could be worth north of $600 million. Less than a week later, on Oct. 23, Applied Genetic Technologies Corp. said it would be taken private through an acquisition by the life sciences investing company Syncona.

And the following day, the Japan-based pharmaceutical firm Astellas Pharma announced a $50 million investment in Taysha Gene Therapies, which is advancing treatments for rare neurological disorders.

To some on Wall Street, these deals are a positive sign for an area of drug research that drove immense excitement several years ago, but has since weathered setbacks. Safety scares like those seen in clinical trials run by Pfizer, UniQure, Bluebird bio and others drew scrutiny from the Food and Drug Administration, which last year held a special meeting to discuss the risks of gene therapy.

Safety hasn’t been the only issue, either. In recent years, experimental treatments from Biogen, Sarepta Therapeutics and Amicus Therapeutics came up short in key trials testing their effectiveness. And for Editas Medicine, positive, albeit early, results from a study of its CRISPR-based gene editing therapy were met with disappointment from some investors, with company shares subsequently sliding in value.

To Dae Gon Ha, an analyst at the investment firm Stifel, the fresh string of deals could be seen as a “boon” for gene therapies targeting rare diseases. “We agree that an onslaught of [mergers and acquisitions] in such a short period can add a much-needed sentiment shift to a sector that’s been in investors’ penalty box for much of 2022,” he wrote in an Oct. 25 note to clients.

However, Ha also wrote that these deals don’t necessarily mean the gene therapy space is “out of the woods yet.”

For example, Ha noted how these deals are “noticeably smaller” in value — both in comparison to the gene therapy acquisitions seen a few years ago, like that of AveXis and Spark Therapeutics, and to other, more recent ones targeting different drugmaking technologies.

Several factors may have influenced these lower deal values. A record amount of funding flowed into gene therapy research over the last few years, leading to the creation of more companies, many of which are still relatively small. Akouos, for instance, was founded in 2016, and by the end of this February had just over 100 employees.

But with greater competition, and amid a historic downturn in the biotechnology stock market, money has been harder to come by, forcing a number of companies to cut costs and trim their workforces. As a result, some gene therapy developers could be more willing to consider cheaper offers.

The investment firm Cantor Fitzgerald reviewed five gene therapy acquisitions, including Lilly’s planned purchase of Akouos, and found the more recent ones have taken longer to agree upon final costs. Cantor analyst Kristen Kluska wrote that her team suspects “most of this is driven by recent weakened market conditions.”

Given the setbacks experienced by the gene therapy field, the newer deals may also suggest buyers are more interested in programs that are “de-risked” to some degree. In the case of Akouos, the FDA in September cleared the company to begin human testing of its most advanced therapy — a milestone that regulatory filings show prompted Lilly to renew acquisitions talks.

Akouos also had a narrow focus, which has been true of other gene therapy acquisitions. Nightstar Therapeutics, purchased by Biogen for roughly $800 million, was developing treatments specifically for eye diseases, while Audentes Therapeutics and Prevail Therapeutics, bought respectively by Astellas and Lilly, centered their research around neurological conditions.

In spite of the caveats, the three deals from the past month could at least signal a growing comfort from buyers and investors “in the risk/reward profile of gene therapy, companies’ compelling valuation, or both,” according to Ha.

“In sum, the recent transactions and announcements are undoubtedly encouraging for the sector,” Ha wrote, “but the acquirer’s selectivity of assets, capital commitment, and what the acquirer ultimately brings to the table buffer greater enthusiasm, in our view.”

https://www.biopharmadive.com/news/gene-therapy-deals-acquisitions-akouos-agtc-taysha/635523/