Thursday, August 29, 2024

Piper Sandler Reiterates Overweight Rating On Teva Pharma (TEVA)

(8/28, StreetInsider.com) ...Piper Sandler analyst David Amsellem reiterated an Overweight rating and $23.00 price target on Teva Pharma. The analyst commented, "With Evernorth announcing that it will remove brand Humira from its Express Scripts (ESI) commercial formularies starting in 2025, contribution from Teva's Humira biosimilar (bHumira) product Simlandi is set to grow...Given that backdrop (also bearing in mind that Teva will be entering the biosimilar Stelara (bStelara) space in February 2025), the setup for Teva's U.S. generics/biosimilars business in 2025 looks favorable"... Sub. Req'd

Celltrion Partners with Cigna Healthcare to Expand Access to Zymfentra

(8/29, Kim Ji-hye, Korea Biomedical Review) ...Celltrion said Thursday that its subcutaneous infliximab therapy, Zymfentra—branded as Remsima SC outside the U.S.—is set for accelerated prescribing and broader patient access across the United States following an agreement with Cigna Healthcare. Effective Aug. 1, the deal positions Zymfentra as the preferred medication on Cigna's medical formulary, boosting its availability and ensuring reimbursement for Cigna's 16.1 million members... Full

Eli Lilly's Lauded Discount of its Obesity Drug Zepbound Comes with Caveats

(8/28, Elaine Chen, STAT Plus) ...Doctors noted that the price of the vials will still be out of reach for many patients, and only the starter doses will be offered in the vials, not the higher doses that many patients need to achieve significant weight loss. Additionally, not all patients will be able to pick up vials; they will only be available to patients who are paying for their own medication without insurance and who exclusively order through Lilly's online portal. On the same day Lilly launched the vials, it also quietly increased costs for other patients... Sub. Req'd

Germany's Stada Reports Rosy Earnings As CEO Tempers Expectations Around Possible Sale, IPO

(8/28, Fraiser Kansteiner, Fierce Pharma) ...All three of Stada's business segments—consumer healthcare, generics and specialty pharma—contributed to the revenue growth, with specialty pharma delivering the biggest year-over-year change. The company also said it enjoyed a boon from its "rapidly growing" biosimilar offerings and from the launches of differentiated neurology and nephrology products... Full

Complex Generics And Biosimilars Drive First-Half Growth For Stada

(8/29, David Wallace, Generics Bulletin) ...Stada delivered solid growth in the first half of 2024, with complex generics launches and an increasingly prominent biosimilars business enabling two of its three operating divisions to report double-digit sales increases. Meanwhile, management also addressed persistent rumors of a possible sale by Stada's owners... Global Sub. Full

Biocon Expands Settlement For Stelara Rival To Cover Global Markets

(8/29, David Wallace, Generics Bulletin) ...Biocon Biologics has followed up a US settlement on Stelara (ustekinumab) by striking a further deal with originator Janssen that clears the way for the Indian biosimilars giant to launch its Bmab 1200 version of the top-selling $10bn+ immunology brand in Europe, the UK, Canada and Japan...Biocon had already secured a US launch date of "no later than February 22, 2025" for its ustekinumab through a settlement with Janssen announced earlier this year... Global Sub. Full

Neurocrine's Schizophrenia Data Are Good Enough for Phase 3 — But Maybe Not Enough to Beat Karuna

(8/28, Max Gelman, Endpoints News) ...In a Phase 2 readout Wednesday morning, Neurocrine reported that its drug NBI-'568 improved patients' schizophrenia. The data appear good enough to move the candidate into Phase 3 — and potentially win an approval if it continues to hold up — but the biotech would likely face questions over whether it can compete on the market...William Blair analyst Myles Minter said that while the data weren't a "home run," the program warrants further development in Phase 3 studies... Full

Novartis Taps Lindy to Turn Biologic Drugs into At-Home Injectables, Puts Nearly $1B On the Line

(8/28, Angus Liu, Fierce Pharma) ...For $20 million upfront, Novartis has obtained exclusive global rights to use Lindy's Microglassifiction suspension technology to design high-concentration, self-administered drugs against multiple biologic targets, Lindy said Wednesday. If everything goes according to plan, Lindy may receive up to $934 million in milestone payments, plus tiered single-digit royalties on potential sales... Full

Taking Ubrogepant May Prevent Migraines if Taken at First Warning Signs

(8/28, Chelsie Derman, HCP Live) ...Taking the drug ubrogepant at the first signs of a migraine, before a headache starts, may be effective in preventing migraines, according to a new study published in the online issue of Neurology, the medical journal of the American Academy of Neurology. Participants on the medication went about their day with little or no migraine symptoms... Full

Navigating The Legal Risks Of Using AI To Optimize The Pharma Supply Chain

(8/28, Eliza Slawther, Pink Sheet) ...AI has the potential to save vast amounts of time and money by optimizing pharma supply chain processes, but companies must think about legal risk and liability from all angles, Ewan Townsend, partner at law firm Arnold & Porter, tells the Pink Sheet... Sub. Req'd

Pharmacies, Drugmakers On Edge for Rollout of US Drug Price Cuts

(8/29, Nyah Phengsitthy, Bloomberg Law) ...Major drugmakers and pharmacy groups are weighing how they will implement the first Medicare negotiated drug prices amid concerns about reimbursement practices and the impact of pharmacy benefit managers on how prices reach eligible individuals...Manufacturers also point to PBMs, arguing the middlemen will make it unclear if the negotiated prices will benefit patients. "Pharmacy benefit managers remain unchecked by the process and can continue to drive up patients' out-of-pocket costs," AstraZeneca PLC said in a statement. "AstraZeneca urges CMS to protect patient out-of-pocket costs as part of this process."... Sub. Req'd

Report Shows IRA's Impact On Increasing Biosimilar Uptake

(8/29, The Pharma Letter) ...Drug development consultancy Certara has published a report on the Inflation Reduction Act's impact on oncology biosimilar uptake...The research found that 59% of respondents reported an increase in biosimilar utilization as a result of the IRA, while 89% believe usage will increase in the next five years and 74% believe IRA add-on payments will be a factor in the rise. Top considerations driving biosimilar were found to be net price and clinical equivalency to the original drug... Sub. Req'd

Biden Cap On Drug Costs Will Save US Seniors Over $1,000 a Year, Study Finds

(8/28, Ahmed Aboulenein, Reuters) ...More than 1 million people in the U.S. will save over $1,000 a year beginning in 2025, when an annual $2,000 cap on prescription drug out-of-pocket costs kicks in, the leading lobbying group for older Americans said on Wednesday... Full

Biden Drug Cost Cap Will Save Seniors About $1,100 a Year, AARP Study Finds

(8/28, Alejandra O'Connell-Domenech, The Hill) ..."We want every senior in America to know, thanks to the new annual cap which limits their out-of-pocket costs, they will have more money to invest in their families, spend on their broader health needs or simply save to achieve greater financial stability," said AARP CEO Jo Ann Jenkins... Full

More Than 3 Million Older Americans Will See Rx Savings With Out-of-Pocket Cap

(8/28, Rachel Nania, AARP) ...By 2029, more than 4 million people with a Medicare drug plan who do not receive the program's low-income subsidy will hit the annual ceiling and see savings when they go to fill their prescriptions, according to a new report published by AARP...An estimated 1.4 million adults with a Medicare prescription drug plan who reach the new out-of-pocket cap between 2025 and 2029 are expected to see an average annual savings of $1,000 or more, the AARP report shows. More than 420,000 Medicare Part D enrollees will save $3,000-plus... Full

Casey Heralds Lower Prescription Drug Costs for Seniors, Warns GOP Would Reverse Progress

(8/28, Lydia McFarlane, WVIA) ...Denise Parashac expects to save $1,000 a year with a provision to the Inflation Reduction Act designed to lower prescription drug prices..."This is a huge relief for me and for so many Americans across the country suffering from this condition," Parashac, 69, said. Parashac spoke about her experiences at the Pittston Adult Activity Center this week as U.S. Senator Bob Casey visited to speak about the new provision, which he advocated for in Congress... Full

Republicans Ask CBO For Budgetary Impact Of Part D Premium Demo

(8/28, Dorothy Mills-Gregg, InsideHealthPolicy) ...House and Senate Republicans are diving deeper into the consequences of the Biden administration's Medicare Part D Premium demonstration, asking the Congressional Budget Office to provide a detailed breakdown of the cost of the Biden administration's last-minute bid to avert expected Part D premium hikes in 2025 along with the average projected payout to individual prescription drug plan sponsors... Sub. Req'd

House Oversight Chair Tells PBM CEOs to Correct Testimonies from July Hearing

(8/28, Zachary Brennan, Endpoints News) ...House Oversight Chair James Comer (R-KY) has told the CEOs of the three major PBMs — CVS Caremark, Express Scripts and Optum Rx — to correct what he's claiming are contradictions in their statements before the committee last month...A CVS spokesperson told Endpoints News, "We are reviewing the Chairman's letter and look forward to further engaging with the Committee."... Full

US House Oversight Chair Questions PBM Leaders' Testimony

(8/28, John Tozzi, Bloomberg) ...During the hearing, the PBM executives said that they don't steer patients to their own pharmacies or pay them more favorable rates...A spokesperson for Cigna's Express Scripts unit said the company stands behind the testimony and refutes the letter's allegations. A CVS spokesperson said the company is reviewing the letter... Sub. Req'd

ICYMI: Leading Economist Debunks Misconceptions Surrounding the PBM-Pharmacy Relationship

(8/28, PCMA) ...The analysis provides further evidence that PBMs work to provide patients with a higher quality, lower cost pharmacy experience. Pharmacy benefit companies are committed to partnering with pharmacies to increase patient access to prescription drugs... Full

Patent Thickets in Federal Government's Crosshairs As Election 2024 Looms

(8/28, Greg Slabodkin, BioSpace) ...Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma's practice of filing multiple, overlapping patents that stifle generic and biosimilar competition... Full

FDA Officials Resist Calls to Further Delay DSCSA Enforcement

(8/28, Joanne S. Eglovitch, Regulatory Focus) ...US Food and Drug Administration's officials say they are aware of industry's concerns about complying with the track and trace requirements of the Drug Supply Chain and Security Act (DSCSA) yet insist that the agency will stick to its November 27, 2024 implementation timeline. They also urged experienced companies who have track and trace systems in place to assist those with less experience at a August 27 meeting sponsored by the Healthcare Distribution Alliance (HDA)... Full

AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role

(8/28, Sue Sutter, Pink Sheet) ...Regulatory uncertainty and the biopharma industry's longstanding aversion to risk are hindering adoption of artificial intelligence and machine learning in drug and biologic development, panelists said at a recent US FDA/CTTI workshop...[Novartis' Nicole Mahoney] "We need some more clarity about requirements or expectations during inspections."...However, uncertainty runs deeper than just inspection concerns, Mahoney said... Sub. Req'd

These Middlemen Say They Keep Drug Prices Low. California Lawmakers Don't Buy It

(8/28, Kristen Hwang, Cal Matters) ...Consumer advocates and health economists are placing some of the blame on pharmaceutical middlemen, which they say needlessly drive up costs by tacking on fees and withholding discounts as profit. It's a problem that has plagued regulators across the country. This week, California lawmakers are set to vote on first-time regulations aimed at curtailing their tactics... Full

UK Government Partners with Pharma On New £400M Life Science Infusion

(8/28, Max Bayer, Endpoints News) ...The new five-year pact, announced Wednesday by the Association of the British Pharmaceutical Industry, will potentially funnel hundreds of millions of dollars toward new clinical-stage drug development. The UK government said that about 75% of the newly-established Voluntary Scheme for Branded Medicine Pricing, Access, and Growth will go toward clinical trials, aiming to boost the workforce and infrastructure necessary to run studies... Full

The Economic Impact of Etanercept Biosimilar Remonopolization in Poland

(8/28, Skylar Jeremias, The Center For Biosimilars) ...Market remonopolization by a biosimilar drug led to a significant increase in the pricing of etanercept, resulting in higher treatment costs for patients and excess costs for the health care system, estimated at over €3.42 million, according to a study published in BioDrugs... Full

Greek Prescription Drug Prices Surge, Some Up by 448%

(8/28, Bill Kouras, Greek City Times) ...Greek consumers are experiencing significant price hikes on over 800 prescription medications, with some prices soaring as much as 448%, according to Ta Nea. Around 100 drugs have seen a twofold increase in cost. Notably, a dermatological antibiotic containing tyrothricin has risen from €0.96 to €5.26, marking a 448% jump... Full

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