Strange message from FDA's Califf: Don't 'abandon Twitter' amid 'troubling times'

 FDA Commissioner Robert Califf, M.D., used to be a quiet, highly reserved figure on Twitter during his first tenure as the head of the agency. But the second time around, he’s fully embraced the social media platform, and is now imploring users to stay on the site.

Califf, who was FDA commish under President Barack Obama from February 2016 to January 2017 and now again under President Joe Biden from this February, said in a series of tweets that: “The easy thing to do would be to abandon using Twitter, but that’s not the right thing for us to do at this time.

“More than ever before, it’s important that FDA continues to use Twitter for good and do everything in our power to protect the public from potential harm.”

He said he understands, however, that these “are troubling times,” and that “the kind of divisive and hateful language that we’ve seen on Twitter in recent days is alarming. It’s entirely unacceptable, and I fear for the health of our fellow citizens targeted by these attacks.”

Califf added that: “I grew up in the segregated South, and our society is still struggling to progress past a part of the history that I experienced first-hand. There’s absolutely no place for racism or antisemitism in our society.”

Misinformation, notably medical misinformation, is something the FDA has been trying to defend against for years, and never more so than over the past two years amid COVID-19 and vaccines for the disease. Both have been the subject of misinformation on Twitter and other social media platforms.

Califf said he does truly "believe in the power of social media being used for good.” Because of that, he and the FDA “will continue to post accurate health information. We’ll continue to provide accurate info to inform decision-making.”

He ended on an almost poetic note: “I encourage you to use your voices to bring that light to the surface to drown out the darkness. Be a part of the solution.”

https://www.fiercepharma.com/marketing/fda-commish-califf-implores-dont-abandon-twitter-amid-troubling-times-platform

Lilly walks diabetes tightrope as Novo Nordisk shortages drive demand for Trulicity and Mounjaro

 Eli Lilly is in prime position with its new GIP/GLP-1 launch tirzepatide and its entrenched diabetes blockbuster Trulicity. Chalk it up to a temporary shortage of its chief rival Novo Nordisk’s competitor products Wegovy and Ozempic, which a Lilly exec said has helped spur “unprecedented demand” for the Indianapolis-based drugmaker’s incretin-based meds.

Still, the fact that so many patients are clamoring for Trulicity and tirzepatide—approved in Type 2 diabetes this summer as Mounjaro—could prove to be a double-edged sword for Lilly, whose executives on Tuesday warned of supply challenges ahead of a capacity-doubling manufacturing expansion planned for the end of 2023.

Trulicity and Mounjaro performed exceptionally well in the third quarter of 2022, bringing home $1.85 billion and $187.3 million in sales, with Mounjaro’s haul handily beating revenue estimates of $81 million.

Intense demand for the meds has been fueled, in part, by “limited availability of competitors’ GLP-1s,” Eli Lilly CFO Anat Ashkenazi said on the company’s third-quarter earnings call Tuesday.

Those would be Novo Nordisk’s respective rivals in weight loss and diabetes, Wegovy and Ozempic, which have been suffering from supply issues for the better part of a year.

Aside from Mounjaro’s recent Type 2 diabetes nod, the med is angling to compete with Novo’s Wegovy in obesity, where tirzepatide has snared an FDA Fast Track tag. Lilly’s current plan is to start a rolling submission in weight loss in 2022 and complete its filing shortly after phase 3 data from its SURMOUNT-2 trial rolls out around April of next year, the company said in a release.

But its rival’s supply woes have also challenged Lilly’s “ability to meet expanding demand [for Trulicity] in most international markets,” Ashkenazi explained.

In those places, the CFO says Lilly is “working hard to supply market demand” and will angle to “minimize” the impact on existing Trulicity patients. Part of that strategy revolves around pumping the brakes on new patient starts outside the U.S., Ashkenazi said.

Stateside, Trulicity prescription volume “remains robust,” though wholesalers may be hit by “intermittent restocking delays” of the drug as Lilly bolsters its incretin capacity, she added.

As for Mounjaro, “we intend to take actions designed to ensure access and supply for [Type 2 diabetes] patients,” Ashkenazi explained.

Without going into further detail, the CFO said those measures could “negatively impact prescription volumes but are not expected to impact net revenue.”

Michael Mason, EVP and president of Lilly Diabetes, added some additional color, noting that Lilly is “taking actions to maximize production supply for our current facilities while we ramp up our new manufacturing facilities.”

The patient response to Mounjaro has been overwhelmingly positive, the Lilly diabetes lead said, but he cautioned that the company finds itself in a “dynamic situation given the uncertainty of competitor GLP supply,” not to mention the fact that Mounjaro adherence, dose titration rates and more are still being ironed out in the wild.

“So given the dynamic nature of this, it’s reasonable to assume that weekly production forecasts [on Mounjaro] won’t perfectly align with demand each week,” he explained, cautioning this would “produce some intermittent delays in meeting wholesaler orders for some dosing strengths.”

If this happens as the company ramps up its supply chain, Lilly will “work hard to avoid or minimize any short-term impact for people living with Type 2 diabetes,” Mason added.

To compensate for high demand on Trulicity and Mounjaro—and to steal market share while Novo’s shortage rolls on—Lilly has plans to build “substantial” additional manufacturing capacity for its injectable incretin meds in 2023, Ashkenazi added on the call.

Alongside a site at North Carolina’s Research Triangle Park, Lilly expects “additional actions and extensions in other sites” to double the company’s incretin production capacity at the end of next year, she said.

The executive comments came as Lilly logged a 7% revenue increase at constant currencies to nearly $7 billion for the quarter. While Trulicity, Mounjaro, and the rest of Lilly’s new launch roster is largely soaring, the company’s momentum was eclipsed by a cut to Lilly’s overall revenue projection for the year. Aside from pressures piled on by a stronger U.S. dollar, the Indianapolis-based drugmaker is grappling with lower insulin prices, plus generic competition on its cancer med Alimta.

Trulicity and Mounjaro aside, Lilly’s arsenal of growth products—which also consists of Verzenio, Jardiance, Taltz, Emgality, Retevmo, Cyramza, Tyvyt and Olumiant—grew 19%, forming a whopping 70% Lilly’s revenue for the period after subtracting its COVID-19 antibodies from the mix. Lilly’s COVID meds chipped in $386.6 million for the period.

Even still, Lilly is tempering its sales expectations for the remainder of 2022. The company revised its revenue guidance for the year to a range from $28.5 billion to $29 billion. The company had previously expected to generate sales between $28.8 billion and $29.3 billion.

https://www.fiercepharma.com/manufacturing/eli-lilly-performs-injectable-incretin-tightrope-walk-novo-nordisk-shortages-drive

GSK looming Zantac lawsuits raise M&A doubts

 In GSK’s first quarter after the Haleon consumer health spinoff, shingles vaccine Shingrix put up another record show. But while a cloud of Zantac lawsuits gathers over the company, CEO Emma Walmsley is maintaining GSK’s focus on the fundamental business.

Shingrix has completely recovered from a pandemic-related slowdown. In the third quarter, sales of the shot hit a new record, reaching £760 million ($874 million). The number beat the second quarter haul of £731 million and came 11% above Wall Street’s expectations.

A mix of factors contributed to Shingrix’s stellar performance, GSK said. These include a post-pandemic rebound, launches in new territories, increased demand in the U.S., favorable pricing and GSK’s commercial push outside the U.S., the company said.

Thanks to the strong sales, Walmsley, during a Wednesday call with reporters, reiterated GSK’s ambition to double Shingrix’s annual sales by 2026 versus 2020’s level.

Meanwhile, GSK recently offered new 10-year data for Shingrix, showing an efficacy above 80% during a follow-up period ranging between six and 10 years after immunization. The data set “a new gold standard of protection for shingles that is going to be very difficult for competitors to beat,” Walmsley said.

Overall, GSK’s third-quarter sales jumped 13% at constant currencies to £6.9 billion. Besides Shingrix, the company’s HIV franchise also notably contributed to the growth.

But as Walmsley touted GSK’s strong momentum and confidence in its ability to deliver growth after the consumer split, the growing Zantac product liability claims are weighing on the British pharma’s stock performance.

GSK currently counts about 77,000 claims spanning more than 4,000 cases across federal and state courts that allege the company’s Zantac caused cancer, CFO Iain Mackay told reporters during Wednesday’s press briefing. In preparation for the legal battle, GSK took a charge of £45 million in the third quarter, which Mackay said primarily reflects legal fees related to Zantac but not any approach toward a potential settlement.

GSK is still very early in the Zantac litigation; the majority of the cases haven’t even been vetted, Mackay said. In August, the plaintiff in the first Zantac trial moved for voluntary dismissal in an early win for GSK.

Now, GSK expects the first trial to start on Feb. 13, 2023, in California. The case will provide some insight for both the plaintiffs and GSK moving forward.

On the federal front, the claims are going through what’s known as Daubert hearings in front of District Judge Robin Rosenberg in Florida. The judge is deciding what expert evidence can be admitted into trial.

“The scientific consensus on this question is extremely clear,” Walmsley said during the press briefing. “And if you look at all of the research we’ve done over the last three years, the position of the FDA, the EMA 12 epidemiological studies that have been run, there is no reliable evidence of any causation between ranitidine and cancer, and so we will be vigorously defending our position on this.”

But as Wolfe Research analyst Tim Anderson suggested during a separate earnings call with investors, the uncertainty around the Zantac lawsuits means GSK might have to reserve money to resolve the legal liabilities. That could mean a temporary hold on dealmaking, especially mergers and acquisitions, Anderson argued.

For her part, Walmsley said GSK’s capital allocation strategy remains unchanged.

“I want to be absolutely, categorically clear,” Walmsley said during the investor call, “we will, as always planned, continue to pursue business development with agility, ambition and appropriate aggression and due discipline from a financial point of view. There is absolutely no change in our intention there.”

In two small transactions, GSK recently bought Sierra Oncology for $1.9 billion to gain FDA review-ready myelofibrosis candidate momelotinib, and it also acquired Affinivax for $2.1 billion upfront, hoping the latter’s multiple antigen-presenting system could yield a challenger to Pfizer’s blockbuster Prevnar franchise of pneumococcal vaccines.

https://www.fiercepharma.com/pharma/gsks-shingrix-rebound-rolls-record-sales-looming-zantac-lawsuits-raise-ma-doubt

Tandem Diabetes cuts guidance

 2022 Annual Guidance Update

"In this highly variable environment, we are factoring greater caution into our guidance to re-baseline expectations for the next few quarters," said Leigh Vosseller, executive vice president and chief financial officer. "The timing of our potential new product introductions next year adds increased complexity to the current market dynamics, so we feel it’s prudent for our guidance to reflect more moderate growth in periods between new product launches."

For the year ending December 31, 2022, the Company is updating its financial guidance as follows:

• Non-GAAP sales* are estimated to be in the range of $800 million to $805 million, which represents an annual sales growth of 14 percent to 15 percent compared to 2021. The Company’s prior sales guidance for 2022 was estimated to be in the range of $835 million to $845 million.

  • Sales inside the United States of approximately $592 million to $595 million, compared to the prior guidance of $620 million to $625 million.

  • Sales outside the United States of approximately $208 million to $210 million, compared to the prior guidance of $215 million to $220 million.

• Non-GAAP gross margin* is estimated to be approximately 52 percent, compared to the prior guidance of 52 percent to 53 percent.

• Adjusted EBITDA margin* is estimated to be approximately 7 percent to 8 percent of sales, compared to the prior guidance of 11 percent of sales.

• Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $100 million, an increase from the Company’s prior guidance. This includes:

• Approximately $85 million non-cash, stock-based compensation expense.

• Approximately $15 million depreciation and amortization expense.

• https://finance.yahoo.com/news/tandem-diabetes-care-announces-third-200500570.html

Ultragenyx earnings and corporate update

 Third quarter 2022 total revenue of $90.7 million and Crysvita® revenue in Ultragenyx territories1 of $64.5 million

Reaffirm 2022 Crysvita revenue in Ultragenyx territories guidance of $250 million to $260 million and Dojolvi revenue of $55 million to $65 million

Enrollment completion of DTX401 Phase 3, UX143 Phase 2, and GTX-102 dose escalation cohorts anticipated around the end of the year

https://finance.yahoo.com/news/ultragenyx-reports-third-quarter-2022-200500018.html

Sonnet BioTherapeutics Highlights Safety Profile For Lead Cancer Candidate

 

• Sonnet BioTherapeutics Holdings Inc 
  SONN-0.98%+ Free Alerts
   says that the safety of SON-1010 dosing in several cohorts has been formally reviewed in both Phase 1 trials.
• The adverse events have generally been mild/moderate, transient in nature, and have all been tolerable. In addition, they have been less numerous and less intense with subsequent doses. 
• There was minimal/no signal for IL-1β, IL-6, IL-8, or TNFα and no indication of cytokine release syndrome (CRS). IL-10 was also induced at a low level, as expected. 
• Five of the six patients had stable disease at the first follow-up scan, with one patient progressing who is now off study. Investors are may be reacting to this.
• As of the most recent scan, 2 of the five stable disease patients remain stable, while the others had tumor growth that may represent tumor inflammation or unconfirmed progression. 
• One endometrial stromal sarcoma patient progressing at study entry has evidence of improvement after six months on SON-1010 with smaller tumors and complete resolution of ascites.

https://www.benzinga.com/general/biotech/22/11/29524835/sonnet-biotherapeutics-highlights-safety-profile-for-lead-cancer-candidate

U.S. Physical Therapy guides to low end of outlook range

 Management’s Comments

Chris Reading, Chief Executive Officer, said, "While our third quarter results were impacted by higher labor and other inflation-driven costs, volumes have remained solid, and I am encouraged by some early progress with respect to payer contract negotiations. On the development front, we are very excited to continue to add exceptional practices to our partner-centric portfolio of companies. Our industrial injury prevention business has almost doubled from the same period a year ago and our organic growth in that business has been considerable this year as well."

Carey Hendrickson, Chief Financial Officer, said, "The cost mitigation efforts we began early in the third quarter are ongoing; however, we expect elevated costs to continue to impact our near-term results. With solid volumes and rates, we expect our full year results to be within our previous guidance ranges for Operating Results and Adjusted EBITDA, but most likely on the low end of our ranges."

As previously disclosed, the Company’s guidance range for Adjusted EBITDA for the full year of 2022 is a range of $73.5 million to $75.4 million and for Operating Results is a range of $34.4 million to $35.8 million, or $2.65 to $2.75 per share.

https://finance.yahoo.com/news/u-physical-therapy-reports-third-200500665.html