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Tuesday, April 16, 2024

Sandoz’s Biosimilar Skyrockets After CVS Removes AbbVie’s Humira from Formularies

 Prescriptions for biosimilar versions of AbbVie’s Humira (adalimumab) have spiked to 36% after leading pharmacy benefit manager CVS Caremark removed the branded reference product from its major national commercial formularies, according to STAT News.

Citing a note to investors by analyst firm Evercore ISI, STAT reported that in the week ending April 5, there were almost 8,300 new prescriptions for Sandoz’s Hyrimoz (adalimumab-adaz), up from approximately 640 in the week ending March 29. Hyrimoz accounted for 93% of the growth of biosimilars, which previously only captured around 5% of the market share.

CVS Caremark in January 2024 announced that it would be taking Humira off its major national commercial formularies and that it would instead favor biosimilars for reimbursement. The changes took effect on April 1.

Humira can still be accessed through CVS’ Choice and Standard Opt Out commercial formularies, which are mostly used by employers, unions and health plans.

Launched in July 2023, Hyrimoz is a citrate-free and high-concentration biosimilar version of Humira, making its onset of effect more rapid and its injections less painful than other copycat competitors, according to Sandoz. Hyrimoz’s formulation also reduces the injection formulation by 50% and could lead to fewer injections in some patients.

Unlike other biosimilars such as Boehringer Ingelheim’s Cyltezo, Hyrimoz has not yet won the FDA’s interchangeability designation, meaning it cannot be substituted for the branded reference product without consulting the prescriber.

In August 2023, CVS Health launched a new, wholly owned subsidiary called Cordavis to co-develop and commercialize biosimilar products in the U.S. At the time, the consumer healthcare giant said that its goal was to boost access to medicines and drive down prices by developing a robust portfolio of biosimilars that could foster more competition in the market.

Cordavis’ first product is Hyrimoz, which it sells in partnership with Sandoz, at an 80% discount to Humira.

Several other Humira biosimilars have already hit the U.S. market, including Amgen’s Amjevita, Celltrion’s Yuflyma, Organon and Samsung Bioepis’ Hadlima and Alvotech and Teva’s Simlandi, which also has a citrate-free and high-concentration formulation and also has the FDA’s interchangeability designation.

However, according to Evercore ISI, these products together account for around half of the new prescriptions written for biosimilars. Hyrimoz has captured the other half.

Still, even with discounts that reach as high as 86%, Humira biosimilars are finding it difficult to take market share away from AbbVie’s blockbuster, according to a report last week from Samsung Bioepis which found that these biosimilars have secured only 4% of the market share.

https://www.biospace.com/article/sandoz-s-biosimilar-skyrockets-after-cvs-removes-abbvie-s-humira-from-formularies/

J&J Narrowly Misses Q1 Revenue on Lower-Than-Expected Stelara Sales

 Johnson & Johnson reported first-quarter 2024 earnings on Tuesday, posting a 2.3% increase in sales buoyed by the strong performance of its oncology and immunology businesses. However, sales of its blockbuster psoriasis drug Stelara were lower than expected by Wall Street analysts and causing J&J to miss Q1 revenue estimates.

J&J’s revenue for the quarter came in at $21.38 billion versus an expectation of $21.4 billion. Sales of the pharma’s blockbuster immunotherapy Stelara (ustekinumab) has stagnated at $2.45 billion, held back by what J&J in its investor presentation called an “unfavorable patient mix.” Analysts expected Stelara to make $2.6 billion in the quarter, according to Reuters.

Stelara is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines and is indicated for various immune-mediated conditions such as Crohn’s disease, ulcerative colitis and plaque psoriasis. The therapy made nearly $10.9 billion in 2023, but also had to contend with the expiration of one of its key patents.

Trying to keep its hold on the market, J&J has struck a series of deals that would keep biosimilars off the U.S. market until 2025.

However, on the positive side of the ledger in the first quarter, J&J brought in nearly $21.4 billion, up from almost $20.9 billion during the same period in 2023. The company’s Innovative Medicine division—which is responsible for developing its pharmaceutical products across its priority therapeutic areas—accounted for approximately 65% of its revenue, while its MedTech unit contributed the remaining 35%.

J&J’s cancer franchise delivered strong results for the company, bringing in more than $4.8 billion in revenue in the first quarter, according to an investor presentation. Darzalex (daratumumab), an anti-CD38 therapy indicated for multiple myeloma, is the pharma’s top oncology asset, generating $2.69 billion in the most recent quarter or approximately 19% growth, according to Reuters.

Darzalex was first approved in November 2015 for heavily pre-treated or double refractory multiple myeloma. In 2023, the Darzalex brand grew by more than 22% and brought in over more than $9.7 billion.

Carvykti (ciltacabtagene autoleucel), J&J’s Legend Biotech-partnered CAR-T therapy for relapsed or refractory multiple myeloma, was also a top-performing asset in the first quarter, making around $157 million in the first quarter, according to Reuters. Earlier this month, the FDA approved the use of Carvykti for use in an earlier-line setting.

J&J’s immunology franchise was its second strongest Innovative Medicine unit, securing nearly $4.25 billion in revenue.

The company’s first-quarter performance “reflects our sharpened focus and progress in our portfolio and pipeline,” J&J CEO Joaquin Duato said in a statement. “Our impact across the full spectrum of healthcare is unique in our industry, and the milestones achieved this quarter reinforce our position as an innovation powerhouse.”

Looking forward to the rest of the year, J&J has narrowed its 2024 guidance. The pharma now expects to make $88 billion to $88.4 billion in sales, a more precise range as compared with its prior forecast of $87.8 billion to $88.6 billion.

Among the pharma’s upcoming milestones are the potential U.S. approvals for Rybrevant (lazertinib) in non-small cell lung cancer and a regulatory filing for Tremfya (guselkumab) for Crohn’s disease, pediatric psoriasis and pediatric juvenile psoriatic arthritis.

https://www.biospace.com/article/j-and-j-misses-q1-revenue-on-lower-than-expected-stelara-sales/

Hims & Hers cut to Hold from Buy by Jefferies

 Target to $15 from $17

https://finviz.com/quote.ashx?t=HIMS&ty=c&ta=1&p=d

Why Is Palisade Bio (PALI) Stock Up

 

  • Palisade Bio (PALI) stock is up alongside new drug data.
  • The company saw positive performance from PALI-2108 as an ulcerative colitis treatment.

Palisade Bio (NASDAQ:PALI) stock is climbing higher on Tuesday after the clinical-stage biopharmaceutical company revealed additional data for its ulcerative colitis (UC) treatment.

The big news here is Palisade Bio completing its analysis of ex-vivo bioactivation of PALI-2108. That includes the successful conversion of PALI-2108 into its active PDE4 inhibitor form.

Palisade Bio notes that PALI-2108 was able to do this in stool samples of both healthy patients and those with UC. It did so at a mean rate of 90.1% with conversion “increasing over time.”


https://investorplace.com/2024/04/why-is-palisade-bio-pali-stock-up-57-today/

AbbVie, Medincell to Develop Next-gen Long-acting Injectable Therapies

 Medincell will receive an upfront payment of $35 million and is eligible for up to $1.9 billion in potential development and commercial milestones, plus royalties on worldwide sales.

Medincell and AbbVie will co-develop, and AbbVie will commercialize up to six cutting-edge long-acting injectables (LAI).

The first LAI program candidate has been selected and formulation activities are underway.

This pivotal alliance leverages Medincell's commercial-stage LAI technology and development know-how, and AbbVie's extensive clinical development and commercialization expertise, to deliver innovative therapeutic solutions to patients globally.

https://www.businesswire.com/news/home/20240415101781/en/Medincell-Enters-Into-Strategic-Co-development-and-Licensing-Agreement-with-AbbVie-to-Develop-Next-generation-Long-acting-Injectable-Therapies

JAGX stock is up on a new license agreement

 

  • Jaguar Health (JAGX) stock is rising higher on a new license agreement.
  • The company acquired the U.S. license for “chemo mouth” treatment Gelclair.
  • This treatment is already approved by the FDA.

Jaguar Health (NASDAQ:JAGX) stock is rocketing higher on Tuesday after the pharmaceutical company announced a new license for a chemo mouth treatment.

Jaguar Health is looking to treat chemo mouth, a side effect of chemotherapy, with Gelclair. This treatment already has approval from the U.S. Food and Drug Administration (FDA).

Jaguar Health is licensing Gelclair from U.K.-based Venture Life Group. The product is a gel that makes it easier for patients undergoing chemotherapy to eat, drink, swallow, speak and sleep.


https://investorplace.com/2024/04/why-is-jaguar-health-jagx-stock-up-44-today/

Cancer-Drug Maker Janux Therapeutics Weighs Possible Sale

 

  • Janux is working with adviser after drawing takeover interest
  • Shares quadruple this year

Drugmaker Janux Therapeutics Inc. is exploring options, including a potential sale, after receiving takeover interest from larger pharmaceutical companies, people with knowledge of the matter said.

The company, which develops tumor-activated immunotherapies to treat cancer, is working with a financial adviser to evaluate possibilities including a sale, according to the people, who asked not to be identified discussing confidential information.

https://www.bloomberg.com/news/articles/2024-04-10/cancer-drug-maker-janux-therapeutics-said-to-weigh-possible-sale