Thursday, August 8, 2024

Amgen Lines Up Biosimilar Launches For Early 2025

(8/7, David Wallace, Generics Bulletin) ...Murdo Gordon, the firm's executive vice president for global commercial operations, said Amgen was "positioned for future growth with upcoming launches," most notably its Wezlana (ustekinumab-auub) and Bkemv (eculizumab-aeeb) biosimilars that were "expected to launch in the US in Q1 of 2025."...On Stelara, the Teva-Alvotech partnered Selarsdi (ustekinumab-aekn) and the Sandoz-Samsung Bioepis allied Pyzchiva (ustekinumab-ttwe) are both now approved in the US, with launch dates in late February 2025 under settlements with Janssen... Global Sub. Full

After 2023 Snub, Amneal Clinches Approval for Extended-Release Parkinson's Disease Med Crexont

(8/7, Fraiser Kansteiner, Fierce Pharma) ...Late Wednesday, the FDA granted approval to Amneal's Crexont—formerly known as IPX203—which is an oral, extended-release formulation of the common Parkinson's disease (PD) drugs carbidopa/levodopa (CD/LD). The capsule, which contains a mix of immediate-release CD/LD granules and extended-release LD-coated beads, is expected to launch in the U.S. in September, Amneal said in a release... Full

Indian Drugmaker Alembic Pharma Posts Q1 Profit Rise On Strong US Sales

(8/8, Kashish Tandon, Reuters) ...Indian drugmaker Alembic Pharmaceuticals reported a 12% rise in first-quarter profit on Thursday, led by strong demand for its generic drugs in its key market of North America...Indian generic drugmakers earn a significant share of their revenue from the U.S., which is the world's biggest pharmaceutical market. Alembic's larger rivals Cipla, Dr Reddy's all beat their June quarter profit estimates on strong demand in the U.S. However, these generic drugmakers have also been grappling with lower prices of their drugs in key U.S. markets amid stiff competition... Full

Lupin Expects to Up its Research Spends Over the Next Two Quarters

(8/7, PT Jyothi Datta, The Hindu BusinessLine) ...Drugmaker Lupin expects to see an increase in its research spends over the next couple of quarters, with investments in research and development touching ?1,800 crore for FY2025, said Vinita Gupta, Chief Executive Officer of the company. This would include investment towards an increasing percentage of complex generics and biosimilars, she said in an analyst call on Wednesday, outlining the growth path for the company... Full

Hikma Pharmaceuticals Shares Surge On Earnings, Guidance Raise

(8/8, Helena Smolak, Dow Jones) ...Hikma Pharmaceuticals' shares surged after the company posted higher and better-than-expected first-half net profit and revenue, which led it to lift its full-year guidance...Its core operating profit--a company-preferred metric that strips out exceptional and other one-off items--remained flat on-year at $402 million as profit growth in its Branded business segment offset an expected reduction in generics profitability... Sub. Req'd

Sandoz 2Q Results Show Improved Pricing -- Market Talk

(8/8, Helena Smolak, Dow Jones) ...Improved pricing stood out in Sandoz's 2Q results as its net prices didn't decrease for the first time since the last quarter of 2021, Intron Health Research analysts say in a note. The Swiss pharma company lifted its sales guidance from mid-single digits to high-mid-single digits based on its sales beat, driven by biosimilars offsetting a miss in generics... Sub. Req'd

Sandoz Raises Sales Growth Target as Copycat Drugs Flourish

(8/8, Paula Doenecke, Bloomberg) ...While the larger generics business saw flat sales, the more lucrative biosimilars division grew strongly in the first six months of the year. The market launch of the biosimilar Hyrimoz against inflammatory diseases and the acquisition of Cimerli for eye disease propelled biosimilar sales to $1.3 billion. A ramp-up of Hyrimoz in the US, the launch of psoriasis drug Pyzchiva in Europe and the anticipated US launch of Tyruko for multiple sclerosis could drive margins in the second half, the company said... Sub. Req'd

Viatris Reports Second Quarter Financial Results for 2024

(8/8, Viatris) ...Viatris Inc. today announced strong financial results for the second quarter of 2024, including total revenues of $3.8 billion and new product revenues of $210 million, demonstrating the Company's ability to continue to grow its diversified base business. With the substantial completion of its divestitures the Company believes it has increased its financial strength and has a strong foundation from which to accelerate growth and shareholder return... Full

Eli Lilly Raises Annual Profit Forecast as Zepbound Quarterly Sales Cross $1 Billion

(8/8, Bhanvi Satija and Sriparna Roy, Reuters) ...Eli Lilly raised its annual sales forecast by $3 billion on Thursday, driven by surging demand and ramped up manufacturing capacity for its popular weight-loss drug Zepbound, lifting its shares more than 10% premarket...Analysts have said the companies will likely split the U.S. market roughly 50-50 by the end of 2024, as Lilly bolsters its manufacturing capacity and closes the gap with Novo. Lilly has said it expected manufacturing in its new production lines to start over 2024 and for a new plant in Concord, North Carolina, to begin operations towards the end of the year... Full

McKesson Misses Quarterly Revenue as U.S. Pharmaceutical Segment Weighs

(8/7, Christy Santhosh, Reuters) ...McKesson Corp reported weaker-than-expected first-quarter revenue on Wednesday due to soft demand for branded and specialty drugs that dragged sales down in its U.S. pharmaceuticals segment. The drug distributor's pharmaceutical segment in the U.S. is its largest unit by revenue that sells drugs used to treat complex conditions such as cancer... Full

Novo Nordisk's Wegovy Sales Disappoint

(8/7, Dominic Chopping and Jared S. Hopkins, The Wall Street Journal) ...Novo Nordisk shares tumbled more than 7% Wednesday after its blockbuster weight-loss drug Wegovy missed sales expectations as a result of the pharmaceutical giant's bigger discounts to U.S. buyers...Wegovy weekly prescriptions grew to 200,000 from 100,000 at the start of the year and benefited from gaining additional coverage through Medicaid and commercial insurance, Chief Financial Officer Karsten Munk Knudsen said in an interview Wednesday. The CFO said prices were lower for several reasons the company had expected, including rebates to payers to win access and the entrance of a competitor... Sub. Req'd

FDA Approves Purdue Pharma's Controversial New Overdose-Reversal Medication

(8/7, Lev Facher, STAT) ...Purdue Pharma, the company best known for fueling the opioid crisis by misleadingly marketing the infamous painkiller OxyContin, received approval on Wednesday for a new auto-injector device used to reverse opioid overdoses...Many corners of the addiction advocacy community view Purdue with immense suspicion, and resent the company's attempts to play a role in addressing a crisis it helped create. In its statement, the company noted that it plans to sell Zurnai at cost, and that it also doesn't turn a profit on its existing nalmefene drug, which is used in hospital settings... Full

Novartis Takes Fight To The FDA After US Entresto Generic Approval

(8/7, Dean Rudge, Generics Bulletin) ...Citizen petitions, Hatch-Waxman, and now a lawsuit against the FDA itself: Novartis continues to fight tooth and nail to protect its core $3bn Entresto brand in the US, following the latest agency approval of a generic version. Generics Bulletin dives into the originator's complaint against the FDA... Global Sub. Full

Novo Nordisk Axes Once-Monthly GLP-1/GIP Agonist and MASH Prospect

(8/7, Nick Paul Taylor, Fierce Biotech) ...Novo Nordisk has axed its once-monthly dual GLP-1/GIP receptor agonist, ending development of a drug candidate that it singled out as an exciting part of its pipeline earlier this year...Novo disclosed the termination of the once-monthly GLP-1/GIP program alongside the news that it has stopped a phase 1 trial of its VAP-1 inhibitor in metabolic dysfunction-associated steatohepatitis. The drugmaker again cited "portfolio considerations" as the reason for stopping the study and ending development of the candidate... Full

Third Trial Over Zantac Cancer Claims Ends with Hung Jury

(8/7, Brendan Pierson, Reuters) ...The third trial over claims that discontinued heartburn drug Zantac ended in a mistrial on Wednesday when jurors could not agree about whether pharmaceutical company Boehringer Ingelheim was responsible for an Illinois man's cancer...Boehringer Ingelheim said in a statement that it was "disappointed" that the jury had not reached a verdict and that "the  totality of the scientific  evidence" supports "only one conclusion: Zantac does not cause any type of cancer."... Full

Big Pharma Cuts R&D, Sending Shudders Through Industry

(8/8, David Wainer, The Wall Street Journal) ...Charles River Laboratories International, which provides drug-development services, plunged 12.6% on Wednesday, the most in four years, after sounding the alarm over pharma research spending plans. The Massachusetts-based company said it now expects to post a decline in sales for the full year, primarily owing to lower demand from pharma clients. The company previously expected to grow this year. "There are profound cuts at pharmaceutical companies," James Foster, Charles River's chief executive officer, told analysts. Foster called the reduction in pharma research spending "unusual" and "sudden."... Sub. Req'd

New First-Line Therapies for Migraine

(8/7, Neil Skolnik, MD, Medscape) ...I'm Dr Neil Skolnik and today we are going to talk about the position statement from the American Headache Society "Calcitonin Gene-Related Peptide-Targeting Therapies Are a First-Line Option for the Prevention of Migraine," which is focused on calcitonin gene-related peptide (CGRP)–targeting therapies. This update is of critical importance because about three fourths of people with migraine get their migraine care from a primary care clinician, not from a neurologist or a headache specialist. CGRP-targeting therapies have transformed migraine care at the specialty level, but many of us in primary care are not yet familiar with this class of medicines. Until this new statement was released, CGRPs were not viewed as first-line agents for migraine. That has now changed... Full

Generics Bulletin's Top 50 Ranking For 2024

(8/8, David Wallace, Generics Bulletin) ...Across three separate articles, we showed how the global top ten companies are seeing change, despite remaining a stable leading group; we looked at the ups and downs of mid-table players; and completed our ranking with a look at how some firms have altogether dropped out of the bottom of our table this year. Now, we compile all of the data from these three articles in one place for ease of reference... Global Sub. Full

UNC Health Launches PBM

(8/7, Paige Twenter, Becker's Hospital Review) ...UNC Health, a 15-hospital system based in Chapel Hill, N.C., launched a pharmacy benefit management platform Aug. 7. The organization designed the new service, UNC Health Pharmacy Solutions, to be a transparent model for prescription drug cost management for employers in North Carolina and South Carolina, according to a news release... Full

Alternative PBMs Arise to Compete With the 'Big Three'

(8/7, Joyce Frieden, MedPage Today) ...But these alternative PBMs operate in a different way -- they charge a flat per-member-per-month fee to employers and then pass along 100% of rebates to them, which they contend is a better deal for their employer customers. "We are markedly different than the Big Three model," Jordan Feldman, CEO of Rightway Health, one of the alternative PBMs, said during a phone interview at which a public relations person was present. "We don't retain rebates, don't utilize spread pricing, and don't own mail order or specialty facilities. We simply charge a per-member, per-month administration fee such that we can take care of the member and not be financially misaligned with our underlying client."... Full

Senate Appropriators Ask For Copay Accumulator Enforcement Brief

(8/7, Luke Zarzecki, InsideHealthPolicy) ...Pressure is building for HHS to enforce its 2020 rule requiring insurers to count cost-sharing assistance paid by drug manufacturers towards annual patient cost-sharing limits, with Senate appropriators requesting in their fiscal 2025 HHS funding bill report a briefing on CMS' enforcement... Sub. Req'd

How Little Denmark Got Homegrown Giant Novo Nordisk To Lower Ozempic Prices

(8/8, Arthur Allen, KFF Health News) ...In Denmark, with prescriptions for the drugs gobbling up 18% of regional drug budgets in 2023, officials were considering the unthinkable in a system that prides itself on free cradle-to-grave coverage: forcing patients to pay out-of-pocket for Ozempic — a drug made in the country. In America, meanwhile, tightening insurance policies are making it harder for patients to get the drugs, which are listed at up to $1,350 a month... Full

Decoding Rebates: Study Highlights Need for Further Research into Drug Pricing, Employer PBM Choices

(8/7, Brooke McCormick, AJMC) ...In the second part of our interview on his recent study published in the American Journal of Managed Care®, "Prescription Rebate Guarantees: Employer Insights," John M. O'Brien, PharmD, MPH, president and CEO of the National Pharmaceutical Council, discusses the potential impact of its limitations and areas for further research. He also highlighted how the study's findings tie into the recent conversation surrounding pharmacy benefit managers and drug rebates, gaining the attention of Mark Cuban, co-founder of the Mark Cuban Cost Plus Drug Company... Full

Untangling The $500 Billion PBM Web: The Opaque Relationship Between Employers And Drug Middlemen

(8/7, Rita Numerof, Forbes) ...Even changing the whole PBM segment, without making broader system-level changes–to healthcare delivery, payers, pharmaceuticals and wholesalers–would not fix American healthcare. Doing so would be like patching a hole in a tapestry that's rapidly unraveling. Looking forward, regulatory shifts and alternatives to the current PBM model may emerge, offering hope for a more balanced industry. Aligning incentives and creating a transparent system that genuinely serves employers and empowers patients is imperative... Full

Conservative Pressure Against CMS' Medicare Part D Demo Mounts

(8/7, Dorothy Mills-Gregg, Amy Lotven, InsideHealthPolicy) ...CMS' last-minute Medicare Part D premium stabilization demonstration amounts to a potential $10 billion bailout for insurers so the administration can avoid headlines about massive Part D premium increases during an election year, a Paragon Health Institute analysis says this week as Republican lawmakers urge the congressional watchdog to investigate the new demo's legality and cost...CVS Health's leader told investors the company feels this demo will restabilize Part D premiums and it hopes to participate in the demonstration... Sub. Req'd

Thanks to the IRA, Part D is Fighting for its Life.

(8/7, Joe Grogan, RealClearPolicy) ...Last year, the first year the IRA's Part D changes started to take effect, premiums increased 21 percent. Policymakers and insurance plans have been warning that this year would be even worse, but the Administration ignored these warnings, and publicly predicted premiums this year would be stable. But as the final bids came in from plans, reality set in... Full

Another Attack On the Carve-Out: Novartis Seeks a TRO Enjoining ENTRESTO Generic

(8/8, Sara W. Koblitz, FDA Law Blog) ...Increasingly the subject of induced infringement litigation, the viability of the carve-out has been questioned for several years now. But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements. In other words, the case asks how "same" a generic drug's labeling must be as compared to its Reference Listed Drug... Full

June 2024 Official OGD Statistics and Some Projections

(8/7, Bob Pollock, Lachman Consultants) ...The OGD issued fifty final full approvals along with fifteen tentative approvals in June. Of the fifty approvals, four were first time generic approvals and nine (18%) were first-cycle approvals. Of the fifteen tentative approvals, there were no first-cycle approvals. Based on the first nine months of the fiscal year, it appears that the OGD will likely issue about 670 full approvals this FY, assuming that the rate of approvals remains unchanged. If this number stands, it will be well below the number of approvals we have seen since FY 2015 under GDUFA... Full

Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel

(8/7, Sue Sutter, Pink Sheet) ...The public may attend the September 9, Antimicrobial Drugs Advisory Committee meeting to discuss Iterum Therapeutics' oral sulopenem product in person or virtually. The meeting is the first fully in-person adcomm on a drug application scheduled since the start of the COVID-19 pandemic. Iterum is seeking approval for uncomplicated urinary tract infections, and the application is in its second review cycle... Sub. Req'd

States Want to Lower Drug Prices. A Federal Law Stands in Their Way.

(8/8, Shalina Chatlani, Stateline) ..."Companies want to offer benefits, and they want to offer very good health plans for their employees," said James Gelfand, president of the ERISA Industry Committee, a trade group representing large employers covered by the law. "However, it would not be possible to do that if they had to follow different rules in every state, every city or every municipality." Having to follow state-specific regulations — such as the ones in the Oklahoma law — likely would make it more expensive for large employers to provide health care coverage to their employees, Gelfand said. In response, he suggested, employers might stop offering certain benefits... Full

New Law Requires $10 Dispensing Fee and Will Cost Kentuckians at the Pharmacy

(8/8, Stephanie Wright, Courier Journal) ...The truth is, PBMs negotiate lower drug prices with manufacturers and pharmacies, ultimately reducing prescription costs for Americans. They help drive affordability for consumers through their negotiations with drug manufacturers, despite some perceiving them as reducing revenue for pharmacists and pharmaceutical companies...Restricting PBM practices won't reduce prescription drug costs or improve health outcomes. Instead, we will see a direct cost increase and reduced drug adherence, as many can no longer afford their medications... Full

NPPA Fixes Retail Price of 70 New Drug Formulations

(8/8, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of a total of 70 new drug formulations, including 12 for which the companies launched the products without obtaining price approval from the Authority... Full

Russia Experiencing Growing Demand for Semaglutide-Based Drugs

(8/8, The Pharma Letter) ...The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk...Russian analysts believe the new generics of Ozempic have good chances to gain a significant share on the Russian market, as this segment is still being formed...Analysts also believe the number of companies, seeking to expand into the Russian semaglutide-based drugs markter will only grow in the near future. That will be mainly due to their lower prices compared to those of an original drug... Sub. Req'd

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