$LLY $NVO
Lilly has been reprimanded by the UK’s pharmaceutical marketing watchdog over a press release about orforglipron, now sold as Foundayo.
The PMCPA concluded that Lilly used “promotional and emotive” language when communicating Phase 3 results to the BBC before the drug had received marketing authorization.
The watchdog specifically highlighted language such as “transform obesity care,” finding that the overall press release went beyond factual, non-promotional communication of clinical trial data and amounted to pre-license promotion.
The PMCPA ruled that Lilly had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry.
Lilly appealed, arguing that the language had been taken out of context and was forward-looking rather than promotional, but the appeal was rejected.
Lilly says it accepts the decision and remains committed to complying with relevant regulations and the industry’s code of practice.
Link: https://t.co/JumASddDyQ
View original →Nanexa CEO David Westberg provided more details on the company’s new collaboration with $NVO , which could be worth up to around SEK 13B.
Nanexa has already developed one-month and three-month formulations of semaglutide using its PharmaShell technology.
“We have seen extremely good results with our formulations. We have seen that we can create very good release profiles, meaning an even distribution of the drug in the blood over time.”
The next step is to demonstrate in clinical trials that the technology works with whichever molecule Novo chooses to advance.
David Westberg also commented on why Novo, which already owns 14.1% of Nanexa, did not simply acquire the company.
“If we succeed with one or more, and I believe we will succeed with several of them, then perhaps when it comes to the royalty payments there could be a reason to buy the company instead.”
However, he stresses that no such discussions have taken place.
#stocks #Investing
View original →Former $NVO chairman Göran Ando describes the past few years at Novo as “frustrating,” but says he believes in CEO Mike Doustdar’s plan to turn the company around.
Göran Ando, who is now chairman of Nanexa and remains a Novo shareholder, says Mike Doustdar’s push toward a more consumer-focused organization, faster processes and quicker decision-making is the right direction.
“I am completely convinced that Novo will come out of this as an even stronger company than it is today.”
He says the turnaround will take time, but argues that periods of difficulty are normal in pharma and believes Novo has “the right recipe” to get through it.
Göran Ando also provided more context on Nanexa’s new €1.165B collaboration with Novo.
Nanexa’s PharmaShell technology could potentially enable monthly or even quarterly dosing of obesity medicines. Unlike approaches that require modifying the underlying molecule, Göran Ando says PharmaShell applies a coating directly to the individual drug particles, allowing the original molecule to be used.
Novo has worked with Nanexa since 2022, and Göran Ando suggests the technology could potentially allow a long-acting medicine to reach the market within four to five years rather than requiring the traditional seven to ten years of development.
“It would naturally be a huge advantage for patients.”
Link: https://t.co/6gVJwCmQtR
#stocks #Investing
View original →CNBC takes a closer look at the widening competition between $NVO and $LLY and what Novo is betting on to regain momentum.
Lilly currently holds the stronger position in the U.S. GLP-1 market. According to Lilly, it had around 61% of the market in Q2 versus roughly 39% for Novo. Among the 700,000 Medicare patients who have started GLP-1 treatment since obesity coverage began in July, Lilly says around 70% are using its drugs.
The battle is now moving increasingly toward pills. Novo had the first-mover advantage with the Wegovy pill, which has already reached 7 million U.S. prescriptions. But Lilly CEO Dave Ricks says Foundayo now accounts for around one-third of new oral GLP-1 patients and is gaining share week by week.
Novo CEO Mike Doustdar remains focused on the size of the overall opportunity rather than market share alone. Novo believes pills could represent as much as 50% of the global obesity market by 2030 and is preparing manufacturing capacity to serve 15 million oral obesity patients.
Beyond Wegovy, Novo is betting on a much broader pipeline. The company is targeting more than five potential multi-blockbuster launches by 2030 and DKK 150B in risk-adjusted pipeline sales by 2035.
That includes CagriSema, cagrilintide and several other next-generation treatments, while Novo also plans to expand further beyond obesity and diabetes.
The challenge is clear. Wegovy and Ozempic currently account for roughly two-thirds of Novo’s sales, while semaglutide patent protection runs until 2032 in key markets.
Novo therefore needs to defend its existing franchise against Lilly while simultaneously building the products that can eventually replace it.
As CNBC puts it, investors are no longer just looking for a promising pipeline. They want evidence that Novo can turn that pipeline into renewed growth while Lilly continues to gain ground.
Link: https://t.co/XPyUXF98GX
View original →CNBC takes a closer look at the widening competition between $NVO and $LLY and what Novo is betting on to regain momentum.
Lilly currently holds the stronger position in the U.S. GLP-1 market. According to Lilly, it had around 61% of the market in Q2 versus roughly 39% for Novo. Among the 700,000 Medicare patients who have started GLP-1 treatment since obesity coverage began in July, Lilly says around 70% are using its drugs.
The battle is now moving increasingly toward pills. Novo had the first-mover advantage with the Wegovy pill, which has already reached 7 million U.S. prescriptions. But Lilly CEO Dave Ricks says Foundayo now accounts for around one-third of new oral GLP-1 patients and is gaining share week by week.
Novo CEO Mike Doustdar remains focused on the size of the overall opportunity rather than market share alone. Novo believes pills could represent as much as 50% of the global obesity market by 2030 and is preparing manufacturing capacity to serve 15 million oral obesity patients.
Beyond Wegovy, Novo is betting on a much broader pipeline. The company is targeting more than five potential multi-blockbuster launches by 2030 and DKK 150B in risk-adjusted pipeline sales by 2035.
That includes CagriSema, cagrilintide and several other next-generation treatments, while Novo also plans to expand further beyond obesity and diabetes.
The challenge is clear. Wegovy and Ozempic currently account for roughly two-thirds of Novo’s sales, while semaglutide patent protection runs until 2032 in key markets.
Novo therefore needs to defend its existing franchise against Lilly while simultaneously building the products that can eventually replace it.
As CNBC puts it, investors are no longer just looking for a promising pipeline. They want evidence that Novo can turn that pipeline into renewed growth while Lilly continues to gain ground.
Link: https://t.co/XPyUXF98GX
View original →$LLY $NVO
Eli Lilly has received U.S. approval for its once-weekly basal insulin Onswik for the treatment of type 2 diabetes.
Lilly plans to launch Onswik KwikPen in the U.S. in the coming months.
The approval brings new competition to Novo Nordisk, which launched its own once-weekly insulin Awiqli in the U.S. earlier this year.
Onswik has already been approved in Europe, Japan and Mexico.
View original →$LLY $NVO
Eli Lilly has received U.S. approval for its once-weekly basal insulin Onswik for the treatment of type 2 diabetes.
Lilly plans to launch Onswik KwikPen in the U.S. in the coming months.
The approval brings new competition to Novo Nordisk, which launched its own once-weekly insulin Awiqli in the U.S. earlier this year.
Onswik has already been approved in Europe, Japan and Mexico.
View original →$NVO ’s new deal with Sweden’s Nanexa could be an early sign of the company looking more actively outside its own pipeline for future growth.
Jyske Bank analyst Henrik Hallengren Laustsen says the agreement shows Novo’s willingness to pursue partnerships involving external technologies, something management also emphasized at its recent Capital Markets Day.
While the deal could potentially be worth up to DKK 8.7B, he believes it is likely a relatively small agreement from Novo’s perspective.
Still, he notes that it could become significant depending on how the partnership develops.
#stocks #Investing
View original →Danish asset manager ArthaScope has bought more $NVO shares following the recent weakness.
Investment strategist Lars Hytting says the firm sold its position in ISS to finance the purchase, buying Novo shares at around DKK 249.
“Perhaps we are beginning to identify a bottom,” Lars Hytting said.
#stocks #Investing
View original →Nordnet’s Per Hansen argues that $NVO ’s Capital Markets Day failed to convince skeptical investors in the short term, despite management laying out some ambitious long-term targets.
Among the key messages from Mike Doustdar and the team:
• Around 130 clinical trials supporting the pipeline
• A target of moving 15 projects into the pipeline annually
• One new mega-blockbuster launch per year over the next five years
• New products targeted to generate DKK 150B in risk-adjusted sales by 2035
• Novo expects pills could represent around 50% of the obesity market by 2030
• Management continues to see significant potential in CagriSema
But Per Hansen highlights something he believes is missing: insider buying.
He says he has not seen any significant individual share purchases by Novo’s management team this year.
Novo itself is currently repurchasing more than 1 million shares per week, but Per Hansen argues that management buying shares with their own money would send a stronger signal that they personally believe in the long-term investment case.
Link: https://t.co/X19yPawYTh
#stocks #Investing
View original →