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Wednesday, November 8, 2023

Lexicon Financial Results and Business Update

 

  • Commercial launch of INPEFA® (sotagliflozin) as a differentiated, new treatment option for heart failure patients shows meaningful progress in Q3 with increasing demand across the cardiology community
  • Significant formulary inclusions effective in Q4 opening the opportunity for further commercial acceleration into 2024 and beyond
  • LX9211 moving into late-stage development for the treatment of diabetic peripheral neuropathic pain
  • Conference Call and Webcast at 8:00 am Eastern Time
Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-317-6003 and the conference ID for all callers is 2598226. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

China health sector sees better sentiment from anti-graft drive - execs

 Business activities in China's healthcare sector are returning from a sudden near freeze that began in July when Beijing kicked off a year-long anti-corruption campaign, two foreign industry executives said.

The campaign targets the bribing of doctors in drug and medical equipment sales and marks a sharp escalation of an anti-corruption drive in the sector that started years ago. The latest campaign has sent a chill through the sector, pummeling healthcare stocks and prompting some firms to cancel IPOs.

"We see a recovery in terms of engagements ... we see an improvement in that area," Zafer Unluer, China president of U.S. healthcare company Organon, told Reuters on the sidelines of an industry event in Shanghai.

"It is still as not high as before, but we see a bit of a balancing act."

The anti-graft drive initially caused huge business disruptions and many multinational pharmaceutical firms lost engagement with hospitals, executives said.

"We've seen some disruption in the ability of our medical representatives to visit hospitals, in our ability to implement some medical application activities," Larry Merizalde, China CEO of South African drugmaker Aspen, told Reuters.

Barclays said in a recent note that AstraZeneca was also "facing challenges from the healthcare anti-corruption investigations in China, reducing AZN's access to physicians in the region as well as having some negative impact on prescription volumes".

A spokesperson for AstraZeneca declined to comment as the company reports quarterly results later on Thursday.

The two executives said the overall mood, however, had improved over the past two months following communications such as a National Health Commission Q&A and a presentation from a government official.

"Over the last month, since the latest announcements from the government to clarify the objectives of this anti-corruption policy, we see that overall activities are coming back to normal," Merizalde said.

China is one of the biggest healthcare markets for global healthcare companies but their business sentiment has turned fragile this year due to factors including the anti-graft drive.

https://www.marketscreener.com/quote/stock/CHINA-HEALTH-GROUP-LIMITE-6170590/news/China-health-sector-sees-better-sentiment-from-anti-graft-drive-execs-45281882/

AstraZeneca hikes annual profit outlook

 Drugmaker AstraZeneca raised its annual core profit outlook on Thursday, buoyed by strong demand for its oncology and rare blood disorder drugs.

The London-listed company now expects core earnings per share to increase by a low double-digit to low-teens percentage for the year, compared with an earlier forecast of high single-digit to low double-digit percentage growth.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-hikes-annual-profit-outlook-45281914/

Merck KGaA Q3 earnings down 20% on weak biotech, electronics demand

 Germany's diversified group Merck KGaA reported a 20% decline in quarterly operating profit on weak demand for specialty materials that are used to make biotech drugs and semiconductors.

Earnings before interest, taxes, depreciation and amortisation (EBITDA), adjusted for one-offs, fell to 1.45 billion euros ($1.55 billion) in the third quarter, slightly ahead of an average analyst estimate of 1.39 billion posted on the company's website.

Last month, Merck raised the prospect of returning to revenue growth next year, recovering from a slump in demand for its specialty materials to produce biotech drugs and semiconductors.

https://www.marketscreener.com/quote/stock/MERCK-KGAA-436395/news/Merck-KGaA-Q3-earnings-down-20-on-weak-biotech-electronics-demand-45281128/

HUTCHMED: Takeda. FDA Approval of FRUZAQLA™ (fruquintinib) for Colorectal Cancer

 — FRUZAQLA is the first targeted therapy approved in the U.S. for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in more than a decade —

— U.S. approval of FRUZAQLA triggers first milestone payment from Takeda of US$35 million and royalties on net sales —

https://www.biospace.com/article/releases/hutchmed-announces-that-takeda-receives-u-s-fda-approval-of-fruzaqla-fruquintinib-for-previously-treated-metastatic-colorectal-cancer/

Haley, Christie open to raising Social Security retirement age

 At debate, candidates dodge specifics but say younger people may need to face a higher retirement age

Social Security's pending insolvency grabbed attention at the Republican presidential debate Wednesday night, with some candidates saying they would be willing to raise the full retirement age for young people just starting out.

"We have to raise the retirement age," said former New Jersey Gov. Chris Christie. "I have a son who's in the audience tonight, who's 30 years old. If he can't adjust to a few years increase in Social Security retirement age over the next 40 years, I got bigger problems with him than his Social Security payments."

Nikki Haley, the former South Carolina governor, said promises to current older adults must be kept, but young people just starting out should see higher retirement ages.

"What we need to do is keep our promises, those that have been promised should keep it," Haley said. "But for like, my kids in their 20s, you go and you say 'We're going to change the rules.' You change the retirement age for them."

Currently, the full retirement age is 67 for those born in 1960 or later.

Read: Social Security is now projected to be unable to pay full benefits a year earlier than expected

Haley declined to cite a specific age that retirement should be raised to, but said it should reflect longer life expectancy.

Sen. Tim Scott, however, said he would protect Social Security for older adults and not raise the retirement age.

"Let me just say to my mama and every other mama or grandfather receiving Social Security: As president of the United States, I will protect your Social Security."

Florida Gov. Ron DeSantis said he'd protect Social Security for seniors.

"I know a few people on Social Security and ... my grandmother lived until 91 and Social Security was her sole source of income. And that's true for a lot of seniors throughout this country," DeSantis said. "So I'd say to seniors in America: Promise made, promise kept."When pressed whether he would raise the retirement age, he said: "So it's one thing to peg it on life expectancy, but we have had a significant decline in life expectancy in this country, and that is the fact."

https://www.morningstar.com/news/marketwatch/202311081093/haley-christie-open-to-raising-social-security-retirement-age

Widower Sues Hospital for Withholding Ivermectin, Claims Wrongful Death

 The family of a woman who died after a hospital refused to treat her with ivermectin for Covid-19 has filed a wrongful death lawsuit.

Scott Mantel, whose wife Deborah Bucko died at Mount Sinai Hospital on May 16, 2021 from complications related to Covid-19, filed the lawsuit in September. He contends that the hospital refused to administer ivermectin, which was prescribed by her doctor. Mantell claims that the refusal contributed to her death.

According to the lawsuit, Mantel "researched possible alternative treatments, and he read several news stories about patients with severe COVID-19 illness who had been treated successfully with ivermectin."

Despite her condition initially improving after she received the drug under a court order, the hospital's subsequent decision to stop the treatment led to a rapid decline in her health, according to the complaint.

"While she was being treated with the ivermectin and immediately afterwards, Ms. Bucko’s respiratory and cardiovascular functions showed significant improvement and she required significantly less oxygen, vasopressors, and ventilator support, which was clearly demonstrated in her medical records," reads the suit. "As a result of the ivermectin, Ms. Bucko was on her way to recovery."

Mantel’s lawsuit seeks not only compensation for himself and his two children but also punitive damages against the hospital. The claim is that Mount Sinai's withholding of ivermectin after it had been prescribed constituted a breach of standard medical care, the Epoch Times reports.

Mantel's lawyer, Steven Warshawsky, says that the hospital's refusal to comply with the court-ordered treatment, particularly given the patient’s initial improvement, was against the patient's best interests and the integrity of the doctor-patient relationship.

"Early on during the pandemic there were a lot of early legal actions seeking court orders requiring hospitals and doctors to treat patients with ivermectin, but here you have a situation where orders were issued and the hospital did not fully comply with them despite [the] patient showing progress of ivermectin," he said.

The controversy around the use of ivermectin as a treatment for COVID-19 has been a contentious issue within the medical community. Despite this, a lawyer for the FDA confirmed to the U.S. Court of Appeals for the 5th Circuit in August 2023 that doctors are legally permitted to prescribe ivermectin for the treatment of COVID-19.

"FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID," said Ashley Cheung Honold, a Department of Justice lawyer representing the Food and Drug Administration (FDA), in a statement to the US Court of Appeals for the 5th Circuit.

Dr. Mary Talley Bowden, who supports the use of ivermectin, has criticized pharmacists who refuse to fill such prescriptions, arguing that this oversteps their authority and impacts patient care.

"This needs to come to an end. In telling my patients what medicines they can and cannot have access to, we effectively have a large group of pharmacists practicing medicine without a license," Bowden said on Friday. "They have no accountability for this yet they are allowed to dictate patient care."

"I see it every single day. Enough is enough," she continued.

The outcome of Mantel’s lawsuit could have implications for future cases where there is a conflict between hospital policies and the treatments doctors wish to prescribe. Warshawsky hopes that a favorable ruling will set a precedent affirming the right of physicians to administer treatments they deem necessary, without undue interference from hospital administration. The hospital is expected to respond to the motion later this month.

"I am hoping to not only get a good result for Deborah and her family but certainly to lay a precedent which is that physicians cannot withhold life-saving treatments from their patients, not only in the case of ivermectin, but also with other medications that might not be standard protocol for hospitals," said Warshowsky.

https://www.zerohedge.com/medical/enough-enough-widower-sues-hospital-withholding-ivermectin-claims-wrongful-death