Thursday, March 7, 2024

Viatris Quiet On Generics As Clock Ticks On Value-Add Copaxone Opportunity

(3/6, Dean Rudge, Generics Bulletin) ...News of a further partnership fuelling its novel ambitions caught the eye from Viatris's Q4 and annual financial results, as the US-based firm reported quietly on its still sizeable, but much changed global Generics business – "flat in 2023," it said, "and expected to show slight growth in 2024."...The firm named generics to Victoza (liraglutide), Sandostatin LAR Depot (octreotide), and Venofer (iron sucrose) among its expected product launches – the latter one that notably failed to materialize in the last several quarters. Moreover, Viatris and partner Mapi Pharma are scheduled to find out imminently whether they can move ahead with their proposed once-monthly glatiramer acetate product, a follow-on to Teva's Copaxone treatment for multiple sclerosis... Global Sub. Full

Sandoz Gets US Denosumab Approvals – But When Will They Launch?

(3/6, David Wallace, Generics Bulletin) ...Sandoz has received the first FDA approvals for denosumab biosimilar rivals to Prolia and Xgeva under the names Wyost and Jubbonti...However, plenty of competition will be on the horizon for Sandoz, as multiple other developers chase approval for Prolia and Xgeva rivals...Teva has a denosumab biosimilar in Phase III trials and Fresenius Kabi is also targeting future denosumab filings, while Samsung Bioepis late last year reported positive trial results for its SB16 proposed denosumab biosimilar... Global Sub. Full

Mark Cuban's Company Will Manufacture Own Drugs To Combat Drug Shortages

(3/6, Urte Fultinaviciute, Generics Bulletin) ...At a recent US White House roundtable, titled "Lowering Healthcare Costs and Bringing Transparency to Prescription Drug Middlemen," the co-founder and CEO Alex Oshmyansky said that the Cost Plus Drug Company was addressing the drug shortage crisis in the US. The company's manufacturing facility in Dallas, Texas, has finished the construction qualification and validation process. As such, the manufacturing of the first commercial batches is starting this week... Global Sub. Full

Mark Cuban Cost Plus Drugs Will Start Manufacturing its First Drugs

(3/6, Irving Mejia-Hilario, The Dallas Morning News) ...Dallas billionaire Mark Cuban's health care venture, Mark Cuban Cost Plus Drugs Company, will begin manufacturing its own drugs at its Deep Ellum facility for the first time Thursday. The company will make epinephrine, an emergency treatment used in EpiPens for allergy reactions, and norepinephrine, a blood pressure medication, according to Cost Plus Drugs CEO and founder Dr. Alex Oshmyansky... Sub. Req'd

Boehringer to Cut Out-Of-Pocket Costs for Inhalers to $35

(3/7, Pratik Jain, Reuters) ...Boehringer Ingelheim will cap out-of-pocket costs for the company's inhaler products for a chronic lung disease and asthma at $35 per month starting June 1, the German drugmaker said on Thursday...Boehringer will also decrease the list price on some of its inhaler products, the company said, without providing further details. The company has cut out-of-pocket costs for its full range of inhaler products including Atrovent, Combivent Respimat and Spiriva HandiHaler, used to treat respiratory conditions such as asthma and chronic obstructive pulmonary disease, a disease that commonly affects smokers... Full

Boehringer Ingelheim to Cap Asthma Inhaler Out-Of-Pocket Costs at $35

(3/7, Ed Silverman, STAT Plus) ..."It's a quite unique and certainly impactful initiative. We believe with this solution, patients will have a fair and more predictable experience when they come to the pharmacy counter," said Jean-Michel Boers, who heads Boehringer Ingelheim operations in the U.S., adding that he expects the program will also assist people who are underinsured...Notably, the company and three of its rivals — GSK, AstraZeneca, and Teva Pharmaceutical — were recently denounced by Sen. Bernie Sanders (I-Vt.) and other lawmakers for charging Americans considerably more than what consumers pay elsewhere for the same inhalers. The inhaler makers were also accused of anticompetitive practices that unfairly drive up costs for consumers... Sub. Req'd

Lawsuit Claims Boehringer Misused US Patents to Delay Asthma-Drug Rivals

(3/6, Blake Brittain, Reuters) ...German drugmaker Boehringer Ingelheim was accused in a federal lawsuit in Boston on Wednesday of improperly submitting patents to the U.S. Food and Drug Administration to delay generic competition and inflate prices for its lung disease drugs Combivent Respimat and Spiriva Respimat. The Massachusetts Laborers' Health and Welfare Fund said in the lawsuit that Boehringer misused several patents related to its Respimat inhaler to extend its monopoly on the drugs by up to 10 years, from 2020 to 2030... Full

Germany's Merck Sees Return to Organic Earnings Growth in 2024

(3/7, Ludwig Burger, Reuters) ...Merck KgaA forecast a return to modest operating earnings growth this year but only when adjusted for currency headwinds, citing a gradual recovery in demand for specialty materials used to make biotech drugs and semiconductors. In a statement on Thursday, the German group said that 2024 earnings before interest, taxes, depreciation and amortisation, adjusted for one-offs, would likely see "slight-to-moderate" currency-adjusted growth... Full

Japan's Eisai Says US Introduction of Alzheimer's Drug Leqembi Slower Than Expected

(3/7, Rocky Swift, Reuters) ...Japanese drugmaker Eisai on Thursday said the distribution of its Alzheimer's drug Leqembi in the United States has proceeded slower than it expected. The company expects to reach 90% of its target for integrated delivery networks used to administer the drug in the U.S. in the fiscal year ending this month, Chief Executive Haruo Naito said... Full

Polish Maker of Sandoz Biosimilar Can't Evade Biogen Patent Suit

(3/6, Christopher Yasiejko, Bloomberg Law) ...The Polish manufacturer of Sandoz's biosimilar version of Biogen's Tysabri failed to convince a federal judge in Delaware that it can't be held liable for the alleged infringement of patents for the lucrative multiple sclerosis treatment. Judge Gregory B. Williams issued an order Tuesday in the US District Court for the District of Delaware denying Polpharma Biologics SA's request to dismiss Biogen Inc.'s second amended complaint against it. No redacted version of his opinion, issued concurrently under seal, is yet available... Sub. Req'd

Zydus Life Hits Life High as Unit Gets USFDA Nod for Manufacturing APIs

(3/7, Business Standard) ...Zydus Lifesciences added 1.77% to Rs 979.05 after the firm informed that its Ahmedabad API facility has been allowed to commercially manufacture and supply the API (active pharmaceutical ingredient) by the US drug regulator. The said facility underwent for-cause current good manufacturing practice surveillance and pre-approval inspection for manufacturing of the drug substance Enzylutamide from 14 to December 22, 2023... Full

Biden to Call for Expanding Medicare Drug Negotiation Program

(3/6, Ahmed Aboulenein, Reuters) ...President Joe Biden will call on Congress to expand the number of drugs subject to annual Medicare price negotiations in his State of the Union address on Thursday, the White House said...The program currently foresees adding 10 to 20 drugs a year through 2029, and Biden will propose increasing this to 50, White House domestic policy adviser Neera Tanden told reporters on a media call on Wednesday... Full

Biden Will Tout Lower Drug Prices in State of the Union. Why Big Pharma Might Be Losing the Fight.

(3/7, Josh Nathan-Kazis, Barron's) ...The drug industry is running out of time to block the new Medicare drug price negotiation program, a White House initiative that President Joe Biden will showcase Thursday in his State of the Union address...Ahead of the president's State of the Union remarks on Thursday night, four drugmakers will be making their case against the program in a federal court in New Jersey earlier in the day, as they continue their legal efforts against the law... Full

Biden Says Medicare Should Negotiate Prices for at Least 50 Drugs Each Year, Up From a Target of 20

(3/6, Annika Kim Constantino, CNBC) ...President Joe Biden said the federal Medicare program should negotiate prices for at least 50 prescription drugs each year, up from the current target of 20 medicines. That proposal is one of several new health-care policy plans Biden will outline during his State of the Union address Thursday...But the fate of his new proposals will be in the hands of a divided Congress, making it highly uncertain whether they will pass into law. The president's call to raise the number of drugs eligible for negotiations with Medicare will likely face the fiercest blowback from the pharmaceutical industry... Full

Drugmakers Gear Up for Joint IRA Arguments as PhRMA Appeals Texas Verdict

(3/6, Nicole DeFeudis, Endpoints News) ...Legal experts anticipate a "full range" of constitutional and statutory arguments from drugmakers that are jointly set to have their cases heard against the Inflation Reduction Act. Despite objections from the government, Bristol Myers Squibb, Johnson & Johnson, Novartis and Novo Nordisk will have their cases heard together on Thursday in New Jersey federal court...On Wednesday, PhRMA and other associations moved to appeal a Texas court's February decision tossing their IRA case..."We disagree with the district court's legal assessment and have appealed the decision. We continue to believe the IRA's price setting provisions are unconstitutional," a PhRMA spokesperson told Endpoints... Full

Major Drugmakers to Team Up in Court Against Price Negotiations

(3/6, Nyah Phengsitthy, Bloomberg Law) ...Bristol Myers Squibb's Eliquis, Johnson & Johnson's Xarelto, Novartis' Entresto, and Novo Nordisk's Fiasp/NovoLog were selected for negotiated prices in the first program round...Federal judges in similar cases have shown doubt as recently as last week to industry claims. But despite those losses, this next hearing gives drugmakers another shot to defend their case that the program violates their constitutional and property rights. "They're trying to find anything that will stick on an individual rights or structural basis to potentially succeed through litigation in halting the program," said James G. Hodge, a health law professor at Arizona State University's Sandra Day O'Connor College of Law... Full

House Members Uncertain PBM Reform Will Pass This Session

(3/6, Joseph Choi, The Hill) ...Two House lawmakers expressed uncertainty Wednesday on when pharmacy benefit manager reforms would pass, despite widespread bipartisan support for some sort of action on the health care middlemen. Reps. Jake Auchincloss (D-Mass.) and James Comer (R-Ky.) spoke with The Hill's Editor-in-Chief Bob Cusack on Wednesday as part of the "Prescribing PBM Reform" event hosted by Transparency-Rx...The Pharmaceutical Care Management Association, which represents PBMs, said it was "disappointing" that neither the group nor any of its members were invited to participate in Wednesday's discussion... Full

Upended: Can PBM Transparency Succeed?

(3/6, Peter Wehrwein, Managed Healthcare Executive) ...Simmering tensions in the pharmacy benefit management (PBM) industry have turned into fault lines. The PBMs challenging the "big three" have formed a trade association. Purchaser coalitions want change. The head of the industry's trade group says inherent marketplace friction has spilled over into political friction... Full

AMCP CEO Discusses Adherence, Out-of-Pocket Costs, and Concerns Over the Inflation Reduction Act

(3/6, Briana Contreras, Managed Healthcare Executive) ...In the third part of this video series, Susan Cantrell, CEO of AMCP, discusses the impact of drug prices on patient adherence. While cost-sharing can be expressed as a well-intended benefit design, studies show it can negatively affect long-term adherence, Cantrell shared. AMCP supports efforts to reduce out-of-pocket costs, however when it comes to premiums and long-term consequences, there could be consequences... Full

House Passes Bipartisan $460 Billion Spending Bill to Avert a Partial Shutdown

(3/6, Catie Edmondson, The New York Times) ...The House on Wednesday passed a $460 billion spending bill to fund about half the federal government through the fall, moving to avert a partial shutdown at the end of the week and offering the first glimmer of resolution to bitter spending fights that have consumed Congress for months... Sub. Req'd

Republicans Consider a New Attack On Biden ‘March-In' Plan for Lower Drug Prices

(3/6, John Wilkerson, STAT Plus) ...Republicans in Congress might try to use a technical maneuver to block the Biden administration from using so-called march-in rights to seize pharmaceutical patents and lower drug prices...Sen. Bill Cassidy (R-La.) is trying to change that. He asked the Government Accountability Office to designate the draft framework as a formal regulation. If GAO determines that the proposal is indeed a rule, opponents could then challenge it under the Congressional Review Act... Sub. Req'd

Murphy's Measure Will Make Medication Easier to Obtain in Shortages

(3/6, Illinois Senator Laura Murphy) ...Under a new measure proposed by State Senator Laura Murphy, medications could be easier to obtain during shortages...Murphy's measure would require health insurance and managed care plans to cover brand name prescription drugs if the generic drug is unavailable during a nationwide shortage... Full

Charges Against Generic Drug Maker Highlight Foreign API Safety Concerns

(3/6, Jessica Karins, InsideHealthPolicy) ...A Pennsylvania generic drug manufacturer admitted as part of a plea agreement it sold adulterated drugs with an active pharmaceutical ingredient (API) made in a foreign facility it did not have FDA's permission to use, in addition to failing to comply with current good manufacturing practices. The incident highlights mounting concerns over generic drugs and APIs manufactured in foreign facilities, even as FDA touts generics as safe and a way for patients to save money... Sub. Req'd

US FDA's Cruse Outlines Paths To Quicker Inspections

(3/6, Bowman Cox, Pink Sheet) ...As US pharmaceutical inspectorate advances toward its pre-pandemic inspection cadence, there is a new focus on accelerating the site inspection process, as well as an effort to improve retention with quicker, more targeted training. OPQO chief Alonza Cruse reviews key ideas at GMP conference... Sub. Req'd

Cut In Data Protection Looms Large As EU Vote On Pharma Revision Nears

(3/6, Ian Schofield, Pink Sheet) ...The next major milestone for the European Commission's wide-ranging proposals for overhauling the EU pharmaceutical legislation is likely to be March 19, when the European Parliament's environment and public health committee is scheduled to vote on the plans. The so-called "pharmaceutical package" – consisting of a draft regulation, a draft directive and recommendations on tackling antimicrobial resistance – was launched almost a year ago in April 2023 but so far has only reached the parliamentary committee stage... Sub. Req'd

England's NICE Asks For Feedback On New Approach To Prioritizing HTAs

(3/6, Eliza Slawther, Pink Sheet) ...NICE, the health technology assessment body for England and Wales, plans to reform how it prioritizes therapies and topics for appraisal by introducing a single prioritization board and common framework. Pharmaceutical industry professionals and other stakeholders have until April 4, to comment on proposals from England's health technology assessment (HTA) body, NICE, to overhaul its prioritization process... Sub. Req'd

UK Body Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products

(3/6, David Wallace, Generics Bulletin) ...UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator's current approvals backlog that the association says is exacerbating shortages...But while the British Generic Manufacturers Association has welcomed a faster assessment process, it has also underlined the need to clear the MHRA's current backlog of approvals, urging more definite action on a problem that the BGMA says is exacerbating the UK's current shortages situation... Global Sub. Full

Positive Pharma and Biotech Response to UK Budget Proposals

(3/6, The Pharma Letter) ...The UK's leading pharmaceutical and biotechnology trade groups welcomed Chancellor Jeremy Hunt's Spring Budget to unlock investment in medical research and manufacturing that was announced on Wednesday...Steve Bates chief executive of the BioIndustry Association (BIA), said: "Three highlights from the Budget for UK life sciences: first, the new expert advisory panel for the HMRC is a smart way to maximize the efficiency of R&D tax relief support for life science innovators. Secondly, Alan Marchington's ICG winning the LIFTs scheme shows real movement to unlock pension funds for life sciences, and, thirdly, AstraZeneca's investment in next generation manufacturing in Speke and Cambridge shows the strength of our ecosystem... Sub. Req'd

Universal Pharmacare Makes Headway In Canada But Pharma Warns It Will Limit Access

(3/6, Neena Brizmohun, Pink Sheet) ...Among the provisions in a newly tabled bill seeking to introduce a national pharmacare system in Canada is a bulk purchasing strategy for prescription drugs that could help lower costs. Canada's innovative pharmaceutical industry association has expressed concern over the federal government's newly introduced bill that lays the foundation of a universal single-payer pharmacare system and could make it easier to negotiate lower drug prices... Sub. Req'd

Pharmaceutical Sector: Why India Needs a Regulatory Pathway for Biosimilar Drugs

(3/6, Dinesh Thakur and Prashant Reddy T, Scroll.in) ...Yet another controversy is brewing in the biosimilar space with Swiss company Roche falling back on a time-tested strategy to leverage India's inadequate regulatory laws to question the safety and efficacy of biosimilars manufactured by Indian competitors. This is the third time that Roche and its affiliates have deployed this strategy over the last two decades. A bit of context is necessary to understand this strategy and Roche's success in deploying it in India... Full

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