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Tuesday, February 28, 2023

Big-sellers from Merck, Novo and Lilly likely to face Medicare price negotiations

 While new drug pricing laws won’t empower Medicare to haggle over prescription costs for another three years, the dimensions of the talks have started to take shape.

Between 2026 and 2028, Medicare could parley on pricing for some 38 Part D drugs and 2 Part B drugs under Democrats’ Inflation Reduction Act (IRA), according to a new report from the Journal of Managed Care & Specialty Pharmacy (JMCP). 

In 2026—the first year Medicare’s price negotiations are set to start under the IRA—the top drugs expected to fall victim to discussions include blood thinners Eliquis from Bristol Myers Squibb and Xarelto from Johnson & Johnson. Oral diabetes drugs such as Merck's Januvia and Boehringer Ingelheim and Eli Lilly's Jardiance may also face negotiations during the first year, the journal says.

Under the law, CMS will apply negotiated maximum fair prices for select small molecule drugs that have been on the market for at least 9 years and for biologics marketed for more than 13 years. Starting in 2026, the Centers for Medicare & Medicaid Services (CMS) will hash out prices on the 10 highest spend Part D drugs, followed by 15 part D drugs for 2027 and 15 drugs across Medicare's Part B and D programs in 2028.

Amgen's Enbrel is also expected to be subject to cost discussions in 2026, JMCP said, plus the inhalers Symbicort from AstraZeneca and Breo Ellipta from GSK.

Three cancer meds—AbbVie and J&J's Imbruvica, Pfizer's Ibrance and Astellas and Pfizer's Xtandi—form another trio likely to enter Medicare’s pricing crosshairs in 2026, according to the journal.

Together, those 10 drugs made up $33.7 billion, or 17%, of Part D gross spending in 2020, JMCP notes.

Part D drugs are dispensed at pharmacies, while Part B drugs are doled out at the doctor’s office, the journal points out.

In 2027, Medicare is poised to haggle over 4 inhalers, 3 diabetes drugs, 2 kinase inhibitors for cancer and the antipsychotic Invega Sustenna from J&J, according to the research. The 15 drugs on the 2027 bargaining table accounted for $16.4 billion (8.3%) in gross Part D spending in 2020.

Some big stars in the potential 2027 cohort include Novo Nordisk’s diabetes stalwart Ozempic, GSK’s Trelegy Ellipta and Incyte’s Jakafi.

Come 2028, meanwhile, Part B drugs become eligible for negotiation under the IRA, though the journal only projects two medicines in that category will be subject to cost discussions. Those are Merck’s immuno-oncology cash cow Keytruda, plus Bristol Myers Squibb’s cancer blockbuster Opdivo. JMCP reasons that most Part B drugs that could come up in cost talks will likely face biosimilar competition before 2028, potentially making the discussions a moot point.

Under IRA’s cost negotiation provisions, a drug loses eligibility for inclusion in pricing talks when a generic or biosimilar version has been approved and marketed for at least nine months ahead of the first of the year when negotiated prices would apply. Between 2026 and 2028, major players like Bristol's Revlimid and AbbVie's Humira will maintain discussion immunity.

IRA’s cost negotiation provisions represent the first significant movement in a long-running national debate over the high price of pharmaceuticals. While there are still several more years to go before Medicare can start the haggling process, the move is expected to make a real difference for patients on the negotiated drugs.

“Some Medicare patients will benefit substantially from negotiations on these drugs, as a reduction in the drug’s price will result in lower coinsurance and liability during the deductible phase,” JMCP argues in its report. The talks will specifically help patients with common diseases like diabetes, cancer, respiratory conditions, or cardiovascular disease. 

https://www.fiercepharma.com/pharma/keytruda-ozempic-and-trulicity-may-fall-victim-medicare-price-talks-humira-escapes-looming

Sarepta stock surges more than 10% as results top expectations, drug given priority review

 Sarepta Therapeutics Inc. (SRPT) shares rallied in the extended session Tuesday after the biotech drug maker topped Wall Street expectations, and said U.S. regulators granted a priority review status for its muscular dystrophy drug candidate SRP-9001. Sarepta shares rallied as much as 14% after hours, following a 3.3% rise in the regular session to close at $122.13. The company reported a fourth-quarter loss of $109.2 million, or $1.24 a share, compared with a loss of $122 million, or $1.42 a share, in the year-ago period. The adjusted loss, which excludes stock-based compensation expenses and other items, was 53 cents a share, compared with a loss of 77 cents a share in the year-ago period. Revenue rose to $258.4 million from $201.5 million in the year-ago quarter. Analysts surveyed by FactSet had forecast a loss of $1.47 a share on revenue of $250.4 million. The company also said the biologics license application for SRP-9001 was granted priority review by the Food and Drug Administration, with an expected decision by May 29.

https://www.morningstar.com/news/marketwatch/20230228521/sarepta-stock-surges-more-than-10-as-results-top-expectations-drug-given-priority-review

Reata gets FDA OK for Friedreich’s Ataxia treatment

FRIEDREICH’S ATAXIA IS AN ULTRA-RARE, PROGRESSIVE, NEUROMUSCULAR DISEASE THAT AFFECTS APPROXIMATELY 5,000 DIAGNOSED PATIENTS IN THE UNITED STATES

SKYCLARYS IS INDICATED FOR THE TREATMENT OF FRIEDREICH’S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER

RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER GRANTED

MANAGEMENT TO HOST CONFERENCE CALL TODAY, FEBRUARY 28, 2023, AT 6:00 PM ET

Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the U.S. Food and Drug Administration ("FDA") has approved SKYCLARYS™ (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With this approval, the FDA granted a rare pediatric disease priority review voucher.

Reata’s management will host a conference call on February 28, 2023, at 6:00 pm ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using access code 827526. The webcast link is https://events.q4inc.com/attendee/939887927.

https://finance.yahoo.com/news/reata-pharmaceuticals-announces-fda-approval-222500644.html

Drone crashes in failed attack southeast of Moscow, regional governor says

 A drone crashed near a natural gas distribution station southeast of Moscow on Tuesday in an apparent failed attack 110 km (68 miles) from the centre of the Russian capital, the regional governor said.

Andrei Vorobyov reported the incident near the town of Kolomna shortly after the Defence Ministry accused Ukraine of attempting two drone strikes in southern Russia overnight.

Ukraine does not publicly claim responsibility for attacks inside Russia. If it was behind the Kolomna incident, it would be its closest attempted drone strike to the Russian capital since Russia invaded Ukraine just over a year ago.

Postings on Russian social media showed the grey metal wreckage of a drone lying in a snowdrift by the edge of a wood said to be near Kolomna. Reuters could not immediately verify the images.

Vorobyov said the drone appeared to have been intended to strike a "civil infrastructure facility" but there was no damage. He said the FSB security agency was dealing with the situation and there was no danger to residents.

Earlier, the Defence Ministry accused Ukraine of launching attack drones towards civil infrastructure targets in the southern regions of Krasnodar and Adygea.

It said its anti-drone defence systems had caused the drones to veer off course and miss their targets.

"Both drones lost control and deviated from their flight paths. One fell into a field, the other, deviating from its trajectory, did not harm the intended target," it said.

There was no immediate comment from Ukrainian authorities.

Russian state news agencies had earlier reported a fire at an oil depot in the Krasnodar region, around 240 km (150 miles) southeast of the Crimean peninsula, after a drone was spotted flying overhead.

The main civilian airport of Russia's second city, St Petersburg, suspended all flights for an hour on Tuesday morning for what the Defence Ministry said were exercises involving fighter jets in Russia's western air space.

FDA panel votes for Pfizer's RSV vaccine

 A panel of outside advisers to the U.S. Food and Drug Administration (FDA) on Tuesday recommended Pfizer Inc's respiratory syncytial virus (RSV) vaccine, paving the way for one of the first approved RSV shots in the United States for older adults.

The FDA advisory committee voted 7 to 4 in favor of the drug, saying data from the clinical study conducted by the company established that the treatment was effective and safe in preventing the lower respiratory tract disease caused by RSV in 60 years and older

https://finance.yahoo.com/news/u-fda-panel-votes-pfizers-210636909.html

Novavax raises doubts about its ability to remain in business

 COVID-19 vaccine maker Novavax Inc on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign.

The company said there is significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance GAVI. But its cash flow forecast indicates it has sufficient capital to fund operations over the next year.

The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. Analysts had expected sales of $383 million, according to Refinitiv data.

Novavax shares fell over 20% in after-the bell trading.

"If we execute on our operating plan, we'll be in a very strong position not only at the end of this year, but going into next year," Novavax's new Chief Executive John Jacobs, who joined the company in late January, said in an interview. Novavax had $1.33 billion of cash on hand at the end of 2022.

However, Jacobs cautioned that there are risks in the near term to that operating plan, including the fact that protein-based vaccines like Novavax's take longer to produce than their messenger RNA-based competitors.

Companies will need to change their vaccine each year to match circulating strains as required by regulatory agencies, including the U.S. Food and Drug Administration.

"We don't know what the strain selection is yet from FDA. We don't know what global health authorities may want from a regulatory standpoint on how the new vaccine needs to look," Jacobs said. "The sooner we know that the more clarity we have on our path forward."

The CEO said the company has been spending at a "hot rate," and plans to cut back, likely including job cuts.

"We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said.

Air Force Relieves Six Leaders At Nuclear Base Over "Loss Of Confidence"

 Six leaders, including two commanders and four of their subordinates, at Minot Air Force Base, North Dakota, were abruptly relieved of their duties "due to a loss of confidence," the US Air Force wrote in a press release Monday.  

Maj. Gen. Andrew J. Gebara, commander of the 8th Air Force, relieved Col. Gregory Mayer of the 5th Mission Support Group and Maj. Jonathan Welch of the 5th Logistics Readiness Squadron from their leadership positions at Minot AFB "due to a loss of confidence in their ability to complete their assigned duties." 

"These personnel actions were necessary to maintain the very high standards we demand of those units entrusted with supporting our Nation's nuclear mission," said Gebara.

Also, four subordinate leaders assigned to Minot AFB were relieved of their duties. 

"Eighth Force continues to safeguard global combat power and conduct around-the-clock strategic deterrence operations in a safe, secure and effective manner.

"Our mission is foundational to our Nation's defense, and we remain committed to the success of that no-fail mission," Gebara said.

Minot AFB is home to the 5th Bomb Wing, which falls under the 8th Air Force. The wing flies nuclear-capable Boeing B-52 Stratofortress bombers. The air base also has a missile wing that operates intercontinental ballistic missiles. 

Gebara did not explain what caused the loss in confidence among Minot AFB commanders entrusted with the nation's nuclear bombers and ICBMs. 

https://www.zerohedge.com/military/air-force-relieves-six-leaders-nuclear-base-over-loss-confidence