FTC Targets ‘Junk’ Patents Including Novo’s Ozempic, GSK’s Trelegy Ellipta and Other Drugs

The U.S. Federal Trade Commission on Tuesday sent warning letters to 10 pharmaceutical companies, challenging patents for several drugs including Novo Nordisk’s blockbuster diabetes treatment Ozempic (semaglutide) and GSK’s asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol).

The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan  said in a statement.

“By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” Khan added.

In addition to Ozempic and Trelegy Ellipta, the FTC’s latest round of patent challenges also targets Novo’s Saxenda (liraglutide) and Victoza (liraglutide)—both indicated for type 2 diabetes—and Novartis’ inhaler products Seebri Breezhaler (glycopyrronium bromide) and Utibron Neohaler (indacaterol and glycopyrrolate), approved for chronic obstructive pulmonary disease.

The pharma companies now have 30 days to either withdraw or amend their disputed listings, or confirm “under penalty or perjury” that these patents indeed comply with the statutory and regulatory requirements.

A GSK spokesperson in a statement to Endpoints News said that the company is reviewing the FTC’s letter. GSK takes “the FTC’s views seriously; however, we will also do our own analysis as the law requires. Once complete, we will respond to the FDA and FTC.”

Meanwhile, a Boehringer Ingelheim spokesperson said that the pharma “has never wrongfully submitted patents for listing in the Orange Book.”

Tuesday’s warnings follow an initial salvo in November 2023, when the FTC challenged more than 100 patents by 10 pharma companies including AbbVie, AstraZeneca and subsidiaries of GSK and Teva Pharmaceuticals. At the time, the antitrust watchdog targeted a wide range of pharmaceutical products, including inhaler devices, multidose bottles and epinephrine autoinjectors.

Aside from the FTC, members of Congress have also started targeting the high cost of medication in the U.S., paying particular attention to Ozempic. Last week, Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, launched a probe into the ‘outrageously high prices’ of Ozempic, as well as its sister weight-loss therapy Wegovy (semaglutide).

Sanders in a letter to Novo CEO Lars Fruergaard Jørgensen asked for additional information regarding Ozempic and Wegovy, including revenue, prices paid by public and private payers, R&D spending and the pharma’s tactics to extend their exclusivity.

https://www.biospace.com/article/ftc-goes-after-junk-patents-targets-novo-s-ozempic-gsk-s-trelegy-ellipta-and-other-drugs/

Neurocrine Wins FDA Approval for ‘Sprinkle’ Formulation of Ingrezza for Huntington’s Disease

The FDA on Tuesday approved the use of a sprinkle capsule formulation of Neurocrine Biosciences’ Ingrezza (valbenazine) for the treatment of tardive dyskinesia and chorea in Huntington’s disease.

Like its original oral capsule version, Ingrezza’s sprinkle formulation comes in 40-mg, 60-mg and 80-mg doses but is designed to be opened and sprinkled on soft foods. This new route of administration provides a more convenient alternative for patients who have trouble swallowing whole capsules, according to Neurocrine’s announcement.

“We developed Ingrezza Sprinkle to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule,” Neurocrine CMO Eiry Roberts said in a statement. “We are pleased to offer the proven efficacy of Ingrezza in reducing uncontrollable movements in a new formulation.”

The label expansion was backed by chemistry, manufacturing and controls information, showing that Ingrezza’s sprinkle formulation was bioequivalent to its currently approved capsule version. Neurocrine also provided data demonstrating similar tolerability profiles for the two formulations.

Designed to be orally available, Ingrezza is a small molecule selective and reversible blocker of the vesicular monoamine transporter 2, which is involved in the uptake of monamines from the cell’s cytoplasm into its synaptic vesicle, where they are either stored or bound for release. The exact mechanism of action for Ingrezza is still unknown, according to its label.

Ingrezza was first approved in April 2017 for tardive dyskinesia, which is a motor condition characterized by uncontrollable repetitive movements of the trunk, limbs and face, and is often triggered as a side effect of antipsychotic treatments. The drug picked up another approval in August 2023 for chorea in Huntington’s disease.

With these two indications, Ingrezza became Neurocrine’s top-selling asset. In 2023, the drug brought in $1.84 billion, accounting for almost all of the biotech’s overall revenue of nearly $1.89 billion. For 2024, Neurocrine expects Ingrezza to generate between $2.1 billion and $2.2 billion in sales.

Despite strong sales for Neurocrine, Ingrezza’s original formulation posed difficulties for patients who had trouble swallowing whole capsules. In Tuesday’s announcement, the biotech revealed that a survey of Huntington’s disease patients with chorea, along with their caregivers, showed that 62% had difficulty swallowing due to their involuntary movements.

In a similar survey of tardive dyskinesia patients with moderate-to-severe involuntary movements, 37% of respondents said that they had problems eating and drinking due to their symptoms.

https://www.biospace.com/article/neurocrine-wins-fda-approval-for-sprinkle-formulation-of-ingrezza-for-huntington-s-disease/

Pfizer Boost FY24 Adj. EPS Outlook

 While reporting financial results for the first quarter, drug major Pfizer Inc. (PFE) raised its adjusted earnings guidance for the full-year 2024, while maintaining annual revenue outlook.

For fiscal 2024, the company now projects adjusted earnings in a range of $2.15 to $2.35 per share, up from the prior guidance range of $2.05 and $2.25 per share.

However, the company continues to project revenues between $58.5 billion and $61.5 billion, with revenues of about $5 billion for Comirnaty, about $3 billion for Paxlovid and about $3.1 billion from legacy Seagen.

https://www.rttnews.com/3443594/pfizer-boost-fy24-adj-eps-outlook-update.aspx

CVS Shares Dump On Earnings Miss, Outlook Slashed On Rising Medical Costs

 CVS Health shares plunged in the premarket trading session in New York after first-quarter revenue and adjusted earnings missed Wall Street's average expectations. The drugstore chain also slashed its full-year profit outlook, citing rising medical costs in its Medicare insurance unit. 

Here's what CVS reported for the first quarter compared with average Wall Street analysts' expectations tracked by Bloomberg:

• Adjusted EPS $1.31 vs. $2.20 y/y, estimate $1.69

• Comparable sales +5.3% vs. +11.6% y/y, estimate +3.95%

• Net revenue $88.44 billion, +3.7% y/y, estimate $89.33 billion

• Healthcare Benefits revenue $32.24 billion, +25% y/y, estimate $30.49 billion

• Health services revenue $40.29 billion, -9.7% y/y, estimate $40.64 billion

• Pharmacy network revenues $20.46 billion, -26% y/y, estimate $23.86 billion

• Mail & specialty revenue $17.26 billion, +6.9% y/y, estimate $14.6 billion 

• Total pharmacy claims processed 462.9 million, -21% y/y, estimate 467.83 million

• Pharmacy and consumer wellness revenue $28.73 billion, +2.9% y/y, estimate $28.29 billion

• Corporate & Other revenue $115 million, -39% y/y, estimate $113.3 million

• Adjusted operating income $2.96 billion, -32% y/y, estimate $3.58 billion

Adjusted earnings for the first quarter were $1.31 a share, well below the average estimate of $1.69 and $2.2 in the same period one year ago. Revenue of $88.4 billion missed estimates by nearly $1 billion but up 4% from the year-earlier period, driven mainly through its pharmacy business and insurance unit. 

Due to underwhelming first-quarter results, CVS lowered its earnings outlook for the full year to $7 per share from the previously announced $8.30. It also lowered its forecast for cash flow from operations by $1.5 billion to around $10.5 billion. 

Here's the full-year outlook:

• Revised GAAP diluted EPS guidance to at least $5.64 from at least $7.06 

• Revised Adjusted EPS guidance to at least $7.00 from at least $8.30

• Revised cash flow from operations guidance to at least $10.5 billion from at least $12.0 billion

The earnings report noted that rising medical costs were a significant factor in first-quarter results. CVS' Aetna division reported a 90.4% medical loss ratio, up from 84.6% a year earlier. A lower ratio indicates that the company received more premiums than it paid out in benefits, resulting in higher profitability. 

The source of the medical cost spike is a surge in Medicare Advantage patients returning to hospitals and doctor offices for procedures that were delayed during the Covid pandemic. Some of these non-essential medical surgeries include joint and hip replacements. 

The earnings report spooked investors. Shares are down 13% in premarket trading. 

If the losses hold, this will be the largest intraday drop for CVS in years...

And shares are touching Covid lows. 

"The current environment does not diminish our opportunities, enthusiasm, or the long-term earnings power of our company. We are confident we have a pathway to address our near-term Medicare Advantage challenges," CEO Karen Lynch said in the press release. 

Lynch continued: "We remain committed to our strategy and believe that we have the right assets in place to deliver value to our customers, members, patients, and shareholders."

https://www.zerohedge.com/markets/cvs-shares-dump-earnings-miss-outlook-slashed-rising-medical-costs

GSK raises full-year profit forecast, says first-half will see stronger sales

 GSK raised its full-year profit forecast on Wednesday and said its sales would be higher in the first six months of the year than the second half on the back of strong demand for its common respiratory virus and shingles vaccines.

The London-listed drugmaker said it now expects a rise of 8% to 10% in annual adjusted earnings per share, up from the 6%-9% growth previously forecast. It also expects its 2024 sales to rise in the upper end of its 5% to 7% forecast range.

CEO Emma Walmsley's strategy has been centred around sharpening GSK's focus on vaccines and infectious diseases, and shifting its HIV focus to long-acting treatment and prevention therapies. The strategy has paid off as the company gears up for 12 new launches from 2025.

The British drugmaker reported a profit of 43.1 pence per share on sales of 7.36 billion pounds ($9.18 billion) for the first quarter, above analysts' average expectations of a 37.3 pence profit on sales of 7.07 billion pounds, according to a company-compiled consensus.

https://finance.yahoo.com/news/gsk-raises-full-profit-forecast-060741180.html

In Israel, Blinken set to push Netanyahu for sustained aid into Gaza

 U.S. Secretary of State Antony Blinken on Wednesday kicked off a series of meetings with Israeli leaders discussing how to get more humanitarian aid into Gaza while at the same time repeatedly urged Palestinian militant Hamas to accept a deal offer that will release hostages and achieve a ceasefire.

Following visits to Riyadh and Amman earlier this week, the top U.S. diplomat is now in Israel for the final stop of his wider Middle East tour.

It is Blinken's seventh visit to the region which was plunged into conflict on Oct. 7 when Hamas attacked Israel.

Blinken's top priority in Israel will be to push the Israeli government to take a set of specific steps so that improvements in the humanitarian aid flow into the densely populated enclave.

"Even as we're working with relentless determination to get the ceasefire that brings the hostages home, we also have to be focused on people in Gaza for suffering in this crossfire of Hamas' making," Blinken said in remarks at the start of his meeting with Israeli President Isaac Herzog in Tel Aviv.

"Focused on getting them the assistance they need, the food, and medicine, the water or shelter is also very much on our minds," Blinken said.

Hamas killed 1,200 people and abducting 250 others in its Oct. 7 assault on Israel, according to Israeli tallies.

In response, Israel has launched a relentless assault on Gaza, killing more than 34,000 Palestinians, local health authorities say, in a bombardment that has reduced the enclave to a wasteland. More than one million people face famine after six months of war, the United Nations has said.

Blinken's check-in with Netanyahu on aid will take place about a month after U.S. President Joe Biden issued a stark warning to Netanyahu, saying Washington's policy could shift if Israel fails to take steps to address civilian harm, humanitarian suffering, and the safety of aid workers.

Biden has threatened to condition support for Israel's offensive in Gaza on it taking concrete steps to protect aid workers and civilians, seeking for the first time to leverage U.S. aid to influence Israeli military behavior.

U.N. Secretary-General Antonio Guterres said on Tuesday there had been incremental progress toward averting "an entirely preventable, human-made famine" in the northern Gaza Strip, but called on Israel to do more.

The first shipments of aid directly from Jordan to northern Gaza's newly opened Erez crossing will leave on Tuesday, goods are also arriving via the port of Ashdod, and a new maritime corridor will be ready in about a week, Blinken said.

https://www.marketscreener.com/quote/currency/EURO-ISRAELI-NEW-SHEKEL-E-60037304/news/In-Israel-Blinken-set-to-push-Netanyahu-for-sustained-aid-into-Gaza-46589352/

Musk disbands Tesla EV charging team, leaving customers in the dark

 Elon Musk's abrupt decision to lay off employees who ran Tesla's electric vehicle charging business blindsided automakers gearing up to equip new EVs for customers to use the Tesla Supercharger network, industry officials and analysts said on Tuesday.

For now, General Motors, Ford and other automakers which struck deals last year to give customers access to the network said they are not changing their plans.

Tesla's decision to open its network to rival EV manufacturers was hailed by U.S. President Joe Biden, and opened the door for Tesla to get federal subsidies to expand the reach of its North American Charging Standard (NACS) system.

Musk's decision, as reported by The Information, to dismiss the head of the business, Rebecca Tinucci, and most or all of the staff that operated and maintained the system left officials at automakers and Tesla suppliers uncertain about the future.

Tesla did not immediately respond to requests for comment.

"As contractors for the Supercharger network, my team woke up to a sharp kick in the pants this morning," said Andres Pinter, co-CEO of Bullet EV Charging Solutions, a supplier to the Supercharger network.

"Tesla has already been awarded money under the federal government's NEVI program," Pinter said, referring to the National Electric Vehicle Infrastructure formula program to provide funding to states to deploy EV charging networks.

"There's no way Mr. Musk would walk away from effectively free money. It may be possible Mr. Musk will reconstitute the EV charger team in bigger, badder, more Muskian way."

GM and Ford, in separate statements, said they are not changing plans to equip their EVs with connectors that will allow drivers of Chevrolet, Cadillac or Ford brand EVs to recharge at Tesla stations.

"We have nothing new to announce regarding our plans," GM said. "We are continuing to monitor the situation regarding changes to the Supercharger team and the potential impacts with no further comments or updates at this time."

'NOTHING IS OFF THE TABLE'

Some industry executives and analysts said Musk could have disbanded the existing Supercharger organization to build a leaner and less expensive team to run the operations.

However, Musk made clear in a call with analysts earlier this month that he is focused on opportunities in artificial intelligence, robotics and autonomous robotaxis.

"In this layoff, nothing is off the table," Wedbush Securities analyst Dan Ives said. "Musk is trying to send a signal internally that the difficulty that Tesla is going through, they're going to have to make tough decisions. It shows there is serious cost focus."

Tesla last week reported lower first-quarter profits and its first quarterly revenue decline since 2021. Even after a surge over the past week, Tesla shares are down 22% for the year.

With sales of Tesla's EVs falling and profit margins under increasing pressure, Musk could be cutting Supercharger network spending to conserve cash for other projects with more growth potential, analysts said.

"Tesla is looking to right size its (capital spending) and operating expenses over the next couple of years as the company is in a slower growth phase," Morningstar analyst Seth Goldstein said.

More traditional automakers might hang on to a business that promised steady revenue and near-continuous data exchanges with customers, analysts said. But Musk could take a Silicon Valley entrepreneur's view that charging is a legacy business that could be streamlined or even divested.

"My guess is that now that the industry has adopted the NACS standard, he views Supercharging less as a strategic moat and more as a cost center," said KC Boyce, a vice president at data analytics firm Escalent.

The Tesla Supercharger network could have significant value if Musk wanted to sell it, analysts said. Rival U.S. charging networks have struggled with reliability problems and do not have the scale or prime locations Tesla has locked in.

Seven large automakers, including Mercedes, GM, Stellantis, Honda, BMW and Hyundai-Kia last year formed a joint venture called Ionna to develop a fast-charging network to compete with the Tesla Supercharger network.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/Musk-disbands-Tesla-EV-charging-team-leaving-customers-in-the-dark-46586515/