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Thursday, February 10, 2022

House Republicans, advocacy groups urge HHS to abandon curbed coverage of Biogen Aduhelm

 A group of House Republicans, led by Cathy McMorris Rodgers (R-Wash.), are urging Health and Human Services secretary Xavier Becerra to “abandon and re-propose” a measure that would restrict Medicare coverage of Biogen’s controversial Alzheimer’s disease drug Aduhelm.

Last month, the Centers for Medicare and Medicaid Services’ National Coverage Determination (NCD) proposed that anti-beta-amyloid drugs such as Aduhelm only be covered for patients enrolled in approved clinical studies. The proposal would severely limit the drug's uptake at a perilous time for Biogen, and so the company itself is advocating for broader coverage ahead of a final CMS decision expected in April.

Also Wednesday, Becerra heard from more than 50 patient advocacy groups who oppose the NCD. In their letter to the secretary, the organizations warned that the proposal would have implications beyond Alzheimer’s disease.

"This proposed CMS coverage plan raises concerns because it sets a precedent that could have far-ranging and damaging impacts on approval and access to new therapeutics across all disease areas,” the letter read.

Groups signing off on the letter went beyond those representing Alzheimer's disease patients. They include cancer, HIV/AIDS and muscular dystrophy advocacy organizations.    

Meanwhile, in the Republicans' letter to Becerra, Rodgers wrote that she was “shocked” to discover that the NDC “severely restricts coverage for a whole class of Alzheimer’s treatments,” including Aduhelm. 

“It also includes those with Down Syndrome from participating in covered trials, even though Alzheimer’s may affect greater than 90% of those with Down Syndrome over the age of 60. This is wrong,” wrote Rodgers, who is the Energy and Commerce Committee’s Republican leader.

By restricting Medicare coverage to those in clinical trials, the Republicans wrote, the government could “unnecessarily deny to patients and their families the hope of breakthrough AD treatments and further eroding Americans’ trust in their public health institutions.”

For its part, CMS contends that existing data on the drug is "insufficient to establish that the treatment is reasonable and necessary" under federal law. The agency is calling for limited coverage through clinical trials in a bid to learn more about its risks and benefits.

The CMS is hearing feedback on its initiative through Thursday. A final decision on coverage is expected in April.

https://www.fiercepharma.com/pharma/house-republicans-advocacy-groups-urge-hhs-to-abandon-a-measure-would-restrict-medicare

Astra bake-off cooks up a new inhaled Jak

 Astrazeneca today disclosed that it has canned AZD0449, an inhaled Jak in development for asthma – but the group has not given up on this mechanism, and is instead now prioritising a similarly acting project, AZD4604. Astra’s head of biopharmaceuticals R&D, Mene Pangalos, said there had been a “bake-off” between these two assets, and that AZD4604 had won out on measures including lung distribution and toxicology. The inhaled Jak pipeline is looking sparser than it once was, with Roche discontinuing RG6151 and Theravance “pausing” development of TD-8236. The latter group is still in the game with nezulcitinib, but it is unclear how much it can invest in this asset after two clinical disasters last year led to a cost-cutting drive. Nezulcitinib has already failed in Covid, but Theravance thinks it still has potential in acute lung injury and fibrotic disease; however, trials here have yet to begin. This leaves the private company Kinaset as Astrazeneca’s main competitor, with early results on its contender, KN-002, due soon. Kinaset says a pan-Jak strategy is required for inhaled assets, while with AZD4604 Astrazeneca is sticking to a selective approach.

Selected inhaled Jak inhibitors in development
ProjectCompanyMechanismIndication(s)Trial details/note
Nezulcitinib (TD-0903)TheravanceJak 1-3 & Tyk2 inhibitorAcute lung injury, fibrotic diseaseFailed ph2 in Covid-19
KN-002Kinaset (ex Vectura)Jak 1-3 & Tyk2 inhibitorAsthmaPh1 in healthy volunteers & pts, topline results due early 2022
AZD4604AstrazenecaJak 1 inhibitorAsthmaPh1 in healthy volunteers, ends Sep 2022
UnnamedTheravance"Pan-Jak inhibitor"AsthmaPreclinical; plans to progress to clinic via strategic partnership
Fallen by the wayside
AZD0449Astrazeneca/RigelJak 1 inhibitorAsthmaRemoved from ph1 2022
RG6151 (GCD-0214)RocheJak 1 inhibitorAsthmaRemoved from ph1 Apr 2021
TD-8236TheravanceJak 1-3 & Tyk2 inhibitorAsthmaFailed ph2 lung allergen challenge study in mild asthma; programmed "paused"
Source: Evaluate Pharma, clinicaltrials.gov & company presentations.

https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/astra-bake-cooks-new-inhaled-jak

AstraZeneca Swung to 4Q Loss Despite Revenue Rise; Expects $2.1 Billion Restructuring

 AstraZeneca PLC said Thursday that it swung to a fourth-quarter loss despite posting higher revenue as charges related to its acquisition of Alexion Pharmaceuticals weighed on earnings, and said it expects to incur in a $2.1 billion post-acquisition restructuring charge.

The Anglo-Swedish pharma giant posted a net loss of $347 million for the last quarter of the year compared with a net profit of $1.01 billion the year prior. However, revenue rose to $12.01 billion from $7.41 billion as sales grew in most therapeutic areas.

Losses per share for the quarter were $0.22 compared with earnings per share of $0.78 the year prior.

The company posted earnings before interest, taxes, depreciation and amortization of $1.90 billion in the quarter, down from $2.28 billion as the Alexion acquisition negatively affected the metric with an unwind of inventory fair value uplift and restructuring charges.

Sales of the company's Covid-19 vaccine contributed $1.87 billion to revenue in the quarter, but it said that it expects sales of the shot to decline in 2022. Overall, total revenue from Covid-19 medicines is expected to decline by a low-to-mid 20s percentage in 2022, though the expected decline in vaccine sales should be offset by growth in sales of monoclonal-antibody combination Evusheld, AstraZeneca said. Gross profit margin from Covid-19 medicines is expected to be lower than company average. It added that the majority of vaccine revenue in 2022 is expected to come from initial contracts.

The company said in its third-quarter statement in November that it would start selling its Covid-19 jab at cost after pledging to make no profit from it.

AstraZeneca said it has initiated a "comprehensive review" in conjunction with the acquisition of Alexion, which it is aimed at integrating systems, structure and processes, and which it expects to complete by the end of 2025. The review is expected to produce $2.1 billion restructuring costs.

Revenue is seen increasing by a high-teens percentage in 2022, while core earnings per share are expected to rise in the mid-to-high 20s percentage, AstraZeneca said, adding that the growth rates include the full-year contribution of its Covid-19 vaccine, Vaxzeviria, in both 2021 and 2022.

Research-and-development costs and other operating expenses increased both during the fourth quarter and overall in 2021, as the company continued to invest in its coronavirus vaccine and in its Evusheld Covid-19 treatment. Other expenses included increased amortization of intangible assets related to the Alexion acquisition and heightened investment in oncology launches.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Swung-to-4Q-Loss-Despite-Revenue-Rise-Expects-2-1-Billion-Restructuring-Charge-Upda-37837411/

Data Suggest Vir-Glaxo Sotrovimab Retains Neutralizing Activity Against Omicron Subvariant BA.2

 Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that preclinical data suggest that sotrovimab, an investigational monoclonal antibody authorized for emergency use in the United States and developed in conjunction with GlaxoSmithKline, retains neutralizing activity against the BA.2 subvariant of Omicron. These pseudovirus results are being shared with government and regulatory authorities around the world and the Company expects to publish data on bioRxiv in the coming week, with live virus data to follow.

“Our view of the data is that they support the ongoing role of sotrovimab as a critical treatment in the fight against the continuously evolving SARS-CoV-2 virus,” said George Scangos, Vir’s chief executive officer. “We note recent conclusions from another lab, which state that no approved or authorized monoclonal antibodies for treatment retain activity against all subvariants of Omicron. We are therefore pleased to share that, based on our pseudovirus and extensive pharmacokinetic data, we believe that the 500 mg dose of sotrovimab is sufficient to retain activity against the BA.2 variant, just as it has against all other variants of concern and interest.”

https://finance.yahoo.com/news/data-suggest-sotrovimab-retains-neutralizing-062400073.html

Labcorp 2021 Fourth Quarter and Full-Year Results

 

  • Revenue: Q4 of $4.1 billion, versus $4.5 billion last year; Full year of $16.1 billion, versus $14.0 billion last year

  • Diluted EPS: Q4 of $5.75, versus $9.54 last year; Full year of $24.39, versus $15.88 last year

  • Adjusted EPS: Q4 of $6.77, versus $10.56 last year; Full year of $28.52, versus $23.94 last year

  • Free Cash Flow: Q4 of $548 million, versus $675 million last year; Full year of $2.6 billion, versus $1.8 billion last year

  • Strengthened leading oncology position by agreeing to acquire Personal Genome Diagnostics Inc.

  • Announced yesterday a comprehensive, long-term strategic agreement with Ascension; Arrangement includes acquisition of certain outreach laboratory assets with annual revenues of approximately $150 million and a purchase price of $400 million

  • Full-Year 2022 Guidance: Adjusted EPS of $17.25 to $21.25 and Free Cash Flow of $1.7 billion to $1.9 billion

  • Longer-Term Outlook (2022-2024): Base Business organic revenue compound annual growth of 4%-7% versus 2021; Base Business average annual margin expansion of 30 bps to 50 bps versus 2021; adjusted EPS compound annual growth of 11%-14% versus 2019

Wednesday, February 9, 2022

Georgia bill banning abortion pills by mail advances

 Georgia Republicans advanced a bill Wednesday that would ban the delivery of abortion pills by mail and require women to be examined by a physician in person before the pills are dispensed.

The state Senate’s health and human services committee voted 7-5 in favor of the legislation after an expedited hearing that drew abortion opponents and supporters. The bill would still need approval from the state Senate and House before it could become law.

More than a dozen other Republican-led states have passed measures limiting access to the pills, including outlawing delivery by mail. The conservative-majority U.S. Supreme Court recently signaled it was ready to make seismic changes to the nationwide right to abortion that has stood for nearly half a century. If the court overturns the landmark Roe v. Wade decision entirely, GOP-controlled states such as Georgia would be likely to severely restrict abortion access, potentially causing more women to seek out abortion pills by mail.

Proponents of the Georgia bill say drug-induced abortion can lead to complications, so physicians need to closely monitor patients. Critics say the procedure carries little risk, and the bill’s true aim is to impede access to abortions.

“In the name of safety, this bill sets out requirements for which there is no current medical justification,” said Dr. Melissa Kottke, a specialist in pregnancy and contraception at Emory University and the past president of the Georgia Obstetrical and Gynecological Society. “Indeed, it denies medical advancements, and ultimately this bill will put into law substandard medical care. It will do harm.”

Kottke and other speakers were cut off by committee chairman Ben Watson, who warned at one point that security was outside the hearing room.

The Georgia legislation responds to the U.S. Food and Drug Administration’s December decision that changed a federal rule that required women to pick up the medication in person. The federal government had already set aside the rule temporarily during the COVID-19 pandemic.

The in-person requirement had long been opposed by medical societies, including the American Medical Association, which say the restriction offers no clear benefit to patients.

Watson, a Republican from Savannah, said the Georgia bill was written narrowly and returned things to the way they were before the COVID-19 emergency.

“There is no bill that is ever perfect,” he said. He added, “But we don’t want to let the good get bogged down by the perfect.”

Republican Sen. Bruce Thompson, a co-sponsor of the legislation, said its aim was to keep women safe.

“This bill is simply intended to protect these women from the reckless actions of those mailing these drugs to women without ensuring she receives the proper and necessary care to ensure her health and safety, and that it’s not compromised,” he said.

Right now, abortion pills can be prescribed in Georgia 24 hours after a telephone consultation by a physician or someone working for the physician. Under the new bill, physicians would have to examine the patient in person and perform an ultrasound in advance. They would also be required to schedule a follow-up visit seven to 14 days after the drugs are administered.

The bill would also ban abortion pills from being provided at secondary schools, colleges and universities in the state.

https://apnews.com/article/abortion-health-business-georgia-9b38222cb7552dfa8965262e84401f34

Russian star practices despite report of positive drug test

 Kamila Valieva, the 15-year-old Russian superstar who was expected to deliver her nation its third straight Olympic gold medal in women’s figure skating, practiced as usual Thursday, hours after reports that she tested positive for a banned substance.

Valieva tested positive for a banned heart medication before the Beijing Games, the Russian newspaper RBC reported.

The sample was reportedly obtained before Valieva won the European championship last month in Estonia, a performance that solidified her status as the leader of Russia’s “quad squad” of elite women’s figure skaters.

It’s unclear if Russia is appealing or fighting the result. Her appearance at practice implies that the federation isn’t accepting any finding that would eliminate her.

“She is not suspended,” Russian figure skating federation spokeswoman Olga Ermolina said, with no further detail.

Valieva ran through her program and skated with teammate Alexandra Trusova while getting pointers from coach Eteri Tutberidze at the practice rink. Valieva flashed a smile to one of her coaches near the end of the roughly 30-minute session, and none of the skaters took questions from reporters.

When Valieva left the press conference area, she gave a gesture with a fist in the air. It appeared she responded to something inaudible asked by a journalist speaking to her in Russian.

A positive test could cost Russia the gold medal from the team competition and threaten Valieva’s chance to win the individual competition that starts Tuesday. She is the heavy favorite.

The typically tight-lipped Russian team was even more guarded during the men’s free skate, where Mark Kondratiuk simply said, “No comment,” to a series of questions about the squad and whether he thought Valieva’s case would be resolved. The 18-year-old Kondratiuk performed both men’s programs during the team competition and stands to lose his gold medal.

The drug detected, trimetazidine, is a metabolic agent that helps prevent angina attacks and treats vertigo, according to the European Union’s medicines agency. It is banned by the World Anti-Doping Agency because it can help endurance and increase blood flow efficiency.

The most famous case of trimetazidine in sports doping involved Chinese star swimmer Sun Yang. The three-time Olympic champion served a three-month ban in 2014. Russian bobsledder Nadezhda Sergeeva tested positive for trimetazidine at the 2018 Pyeongchang Olympics. She was disqualified from the two-woman bobsled event and served an eight-month ban.

It is unclear whether Valieva applied for a therapeutic use exemption or has a history of heart problems.

Russian athletes are in Beijing competing as the “Russian Olympic Committee” (ROC), after the country was banned because of a massive state-sponsored doping scheme at the 2014 Sochi Olympics.

The International Olympic Committee and Switzerland-based International Testing Agency, which oversees the Olympic drug testing program, have declined to comment on the case.

On Thursday, IOC spokesman Mark Adams said it would not be appropriate to talk of an ongoing legal case or “all sorts of speculation that I have also seen overnight.”

The case is more complicated because minors have protection within the World Anti-Doping Code from being identified.

“Obviously everyone has been worried, waiting for a decision,” said Morisi Kvitelashvili of Georgia, who trains with Valieva in Moscow, adding he is in contact with her but doesn’t know details of case. “Her condition is good, and it seems like everything is fine.”

The uncertainty in Valieva’s case contrasts with swift action taken by the ITA against an Iranian skier at the Beijing Games. Hossein Saveh Shemshaki gave a sample Monday that tested positive for an anabolic steroid and was provisionally suspended late Wednesday.

The International Skating Union can also take out athletes with interim bans if they test positive at its events, or in samples it gets before Jan. 27, when the ITA took over the Olympic anti-doping program. The ISU also has not commented.

The first indication of a problem with the results of the three-day team competition — which concluded Monday with Russia winning gold, the U.S. silver and Japan bronze — came when the medal ceremony was postponed indefinitely.

Adams said Wednesday “legal consultation” was required between Olympic officials and the ISU, and acknowledged “we have athletes that have won medals involved.”

If the Russian team is disqualified, the U.S. team would be elevated to the gold medal for the first time in the event. Japan would be awarded silver and fourth-place finisher Canada would receive the bronze.

If any athlete and team is disqualified or had results nullified, an appeal is likely, which could further delay the medals presentation. The Court of Arbitration for Sport has set up an office in Beijing to hear urgent cases.

Reporters asked the Kremlin about the potential doping issue late Wednesday.

“Let’s, for the sake of understanding, wait for some explanations either from our sports officials or from the IOC,” Kremlin spokesman Dmitry Peskov said.

While the Russian team dominated the competition, Valieva was the star. Along with winning the short program and free skate, she became the first woman to land a quadruple jump in Olympic competition.

Many of the skaters that took part in the team competition, including American star Nathan Chen and Russian’s Mark Kondratiuk, are due to leave Beijing shortly after competing Thursday. They would miss any medal ceremony held later.

“Everyone is doing absolutely everything that the situation can be resolved as soon as possible,” Adams said, though he cautioned “as you know, legal issues can sometimes drag on.”

Traditional doping is uncommon in figure skating because additional muscle mass is generally a negative. But many skaters have been caught over the years trying to control their weight with diuretics, which are banned for their ability to mask steroid use, and other medications that could give them the slightest edge.

Russian skaters in particular have a history of positive results dating to 2000, when decorated pairs skater Elena Berezhnaya was stripped of a gold medal from the European championships for testing positive for pseudoephedrine.

Three years ago, pairs skater Alexandra Koshevaya was given a two-year ban after testing positive for torasemide, which she claimed to have used for a foot injury. Later that year, ice dancer Anastasia Shakun was given a one-year suspension for taking furosemide after she claimed a pharmacy suggested it for swelling in her eye.

In July 2020, Maria Sotskova was dealt a 10-year ban just months after announcing her retirement for allegedly forging a medical certificate to explain a doping violation. Sotskova finished eighth at the 2018 Olympics in Pyeongchang.

https://apnews.com/article/winter-olympics-figure-skating-kamila-valieva-sports-health-9002d0f02a95f3561b07c0326445fb69