Wednesday, April 24, 2024

US Supreme Court Denies Vanda's Bid to Revive Sleep Drug Patents

(4/23, Marisa Woutersen, LSIPR) ...Vanda Pharmaceuticals' bid to resurrect patents for its sleep-disorder drug, which had been ruled invalid in its dispute with Teva Pharmaceuticals and Apotex, has been denied...Mihael Polymeropoulos, president, CEO and chairman of the board at Vanda, said: "We are disappointed that the Supreme Court has decided not to hear our case and clarify the lower court standard for obviousness in patent law. "However, we are pleased that our case has drawn attention to an area of law that has broad and significant implications in life sciences innovation," he added... Full

What is Next for Enablement and Written Description of Antibody Claims?

(4/23, Dennis Crouch, Patentlyo) ...Although the jury sided with Teva, District Judge Allison Burroughs rejected the verdict and instead concluded that Teva's patent claims were invalid as a matter of law for lacking both written description and enablement. The appeal is now pending with Teva is asking the Federal Circuit to reinstate the verdict. Lilly filed its own conditional cross appeal – arguing that the future lost profit award was not supported by the evidence or permitted by law. The case has direct parallels to the Supreme Court's 2023 decision in Amgen v. Sanofi, but also includes some distinguishing features... Full

Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, A Proposed Biosimilar for Simponi® (Golimumab)

(4/24, Alvotech) ...Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech's proposed biosimilar to Simponi® and Simponi Aria® (golimumab). Alvotech is the first company to announce positive topline results of a clinical trial using a proposed biosimilar to Simponi and Simponi Aria and is one of only two companies known to have initiated such a patient study... Full

Sandoz And Samsung Celebrate Stelara Rival's EU Approval

(4/23, David Wallace, Generics Bulletin) ...Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings...While Sandoz and Samsung Bioepis have not revealed launch plans for Pyzchiva, another European ustekinumab biosimilar has already been approved and is preparing for launch. Developer Alvotech and marketing partner Stada received approval for their Uzpruvo ustekinumab biosimilar earlier this year, and have previously indicated a European launch in July... Global Sub. Full

Novo Nordisk's Move to Discontinue An Insulin Leaves Patients to ‘Pick Up The Pieces'

(4/24, Elaine Chen, STAT Plus) ...A year ago, when Novo Nordisk announced it would cut the price of multiple insulin products by up to 75%, President Biden, lawmakers, and patient groups all counted the move as a win. But several months later, Novo decided to discontinue one of those products, the basal insulin Levemir... Sub. Req'd

Eli Lilly Inks Deal to Acquire Nexus Manufacturing Plant in Wisconsin as Mounjaro and Zepbound Shortages Drag On

(4/23, Fraiser Kansteiner, Fierce Pharma) ...As doctors and patients in the U.S. grapple with widening shortages of the popular diabetes therapy Mounjaro and its obesity counterpart Zepbound, the maker of the tirzepatide drugs, Eli Lilly, is forging ahead on its quest to expand capacity for its injectable medicines. Lilly is paying an undisclosed sum to acquire Nexus Pharmaceuticals' injectable production facility in Pleasant Prairie, Wisconsin, in a bid to further expand its manufacturing network and respond to "increased demand for the company's medicines," according to a Monday press release... Full

Big Pharma Market Caps Surge to Start 2024 Despite Economic Headwinds

(4/23, Lecia Bushak, MM+M) ...The top 20 drugmakers — including Johnson & Johnson, Merck and AbbVie — reported a total increase of 9.6% in market capitalization for the first three months of 2024, the GlobalData report found. Seven of the 20 companies — including Eli Lilly, Novo Nordisk, Merck, AbbVie, GSK, Daiichi Sankyo and Regeneron Pharmaceuticals — reported more than 10% growth in market capitalization compared to Q1 2023... Full

Samsung Biologics Posts Record High Quarterly Profit of $161M in Q1

(4/24, Sarah Chea, Korea JoongAng Daily) ...Samsung Biologics logged an all-time high quarterly profit of 221.3 billion won ($161 million) in the first quarter on the growing sales of biosimilars, a copycat biologics business...Samsung Biologics attributed "active operation of a massive 240,000 liter [63,400 gallon] No. 4 factory" and "robust biosimilar sales in overseas markets" for the record-high quarterly figures... Full

Roche Eyes Return to Growth After Q1 Hit by Forex, Loss of COVID Sales

(4/24, Ludwig Burger, Reuters) ...Roche confirmed ambitions to return to sales growth this year on a continued boost from eye drug Vabysmo, after first-quarter sales slipped by 6% on the loss on COVID-19-related revenue. Quarterly sales fell to 14.4 billion Swiss francs ($15.80 billion), the family-controlled drugmaker said in a statement on Wednesday, hurt also by a strong Swiss franc that weighed on overseas revenue but in line with analysts expectations... Full

Biogen Beats Quarterly Profit Estimates, Alzheimer's Drug Sales Jump

(4/24, Sriparna Roy and Vaibhav Sadhamta, Reuters) ...Biogen beat Wall Street estimates for first-quarter profit on Wednesday, helped by a series of cost-cutting measures as older drugs face fierce competition. The company also said its Alzheimer's drug Leqembi, developed with Japanese partner Eisai, recorded global sales of about $19 million, nearly tripling from the fourth quarter of 2023... Full

AMPH: A Generic Drugmaker Looking to Expand Via Acquisition, Biosimilars Moves

(4/24, Douglas Gerlach, MoneyShow) ...Amphastar Pharmaceuticals Inc. is a generic drug company founded in 1996 that went public in 2014. Amphastar focuses on drugs that are either injected or inhaled. It looks for opportunities where its unique strengths, especially in manufacturing, allow it to earn attractive margins despite the generic status of the underlying molecule, highlights Doug Gerlach, editor of Investor Advisory Service... Full

Dr Reddy's Knocked Back On Rituximab In US

(4/23, David Wallace, Generics Bulletin) ...Dr Reddy's has disclosed that its US application for a biosimilar version of Rituxan (rituximab) has been knocked back by the US Food and Drug Administration, which has issued a complete response letter over the filing tied to a recent facility inspection as well as aspects of the firm's biologics license application... Global Sub. Full

Dr. Reddy's Recalls Sapropterin Dihydrochloride Oral Solution Powder in U.S. Due to ‘Sub Potency'

(4/24, The Hindu) ...Dr. Reddy's Laboratories Ltd on Tuesday announced that it is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg in the U.S. due to powder discoloration in some packets, leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints... Full

Lupin Receives EIR from US FDA for its Aurangabad Manufacturing Facility

(4/24, Pharmabiz.com) ...Global pharma major Lupin Limited announced that it has received the Establishment Inspection Report from the United States Food and Drug Administration for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated... Full

Kroger to Pay WA $47.5 Million Over Role in Opioid Crisis

(4/23, Claire Withycombe, The Seattle Times) ...The grocery chain Kroger is slated to pay the state of Washington $47.5 million for its role in the opioid epidemic, Washington Attorney General Bob Ferguson announced Tuesday. The state sued Kroger, along with Albertsons and Rite Aid, in December 2022 in King County Superior Court, arguing the chains failed to act as a check against the overprescription of opioids. The lawsuit against Albertsons and Rite Aid is still ongoing... Full

Trends in the US Insulin Market: New Prices, New Players, New Dynamics

(4/23, Alex Brill, Matrix Global Advisors) ...In the last few years, the insulin market has changed in important ways. First, the list price of insulin has collapsed...Second, the insulin market has become more competitive, and more products competing for the same patients foster new price pressures on manufacturers...Third, Washington has affected the insulin market... Full

New Studies Suggest GLP-1 Health Care Costs Have Only Begun to Climb

(4/24, Elaine Chen, STAT Plus) ...Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and they're set to cost the U.S. health care system and the federal government still more this year and beyond, two new reports released Wednesday show...Taken together, the reports provide a window into the pressure that GLP-1 drugs could place on overall health care spending going forward, especially as more people take the medications. The treatments have been in short supply, but drugmakers are ramping up manufacturing capacity to meet the unprecedented demand from patients. The pharma companies are also seeking approval for even more indications like heart failure and sleep apnea... Sub. Req'd

FTC Looking to Accelerate Inquiry into Prescription-Drug Middlemen, Chair Says

(4/23, Eleanor Laise, MarketWatch) ...The Federal Trade Commission is working to accelerate its inquiry into the prescription-drug middlemen known as pharmacy-benefit managers, while also expanding its scrutiny of drug patents that can keep prescription prices artificially high, FTC Chair Lina Khan told reporters Tuesday... Full

FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says

(4/23, Cathy Kelly, Pink Sheet) ...The Federal Trade Commission is planning to announce preliminary results from its ongoing in-depth investigation of potentially anti-competitive behavior in the pharmacy benefit manager industry much sooner than previous efforts, according to commission Chair Lina Kahn...Kahn also indicated there will be more news soon regarding the FTC's assessment of drug patents listed in the US Food and Drug Administration's Orange Book...Three of the companies, GlaxoSmithKline Pharmaceuticals Ltd., Impax Laboratories, Inc. and Kaleo Inc., agreed to delete their patents. But other companies including Boehringer Ingelheim GmbH, AstraZeneca PLC and Teva Pharmaceuticals USA Inc. rejected the FTC's claims... Sub. Req'd

Union Health Fund Sues Insulin Makers, PBMs On Price Conspiracy

(4/23, Ganny Belloni, Bloomberg Law) ...The International Union of Operating Engineers Local No. 478 Health Benefits Fund filed the complaint Monday in the US District Court for the District of Connecticut. The group alleges insulin makers Eli Lilly and Co., Novo Nordisk Inc., and Sanofi-Aventis U.S. LLC worked together with PBMs like CVS Caremark, Express Scripts, and OptumRx to artificially inflate insulin list prices... Sub. Req'd

FTC Chair: Orange Book Scrutiny Will Increase Despite Inhaler Price Caps

(4/23, Maaisha Osman, InsideHealthPolicy) ...Federal Trade Commission Chair Lina Khan says capping inhaler prices and not delisting patents from the Orange Book are two separate issues and the commission will continue to scrutinize patents wrongfully listed in the Orange Book despite the industry's moves to lower inhaler prices and plan to disclose additional information in the coming weeks...Seven of 10 companies FTC warned with a letter chose to delist their patents from the Orange Book. Boehringer Ingelheim, AstraZeneca and Teva declined to delist their patents but responded to FTC's criticism by capping their inhaler prices at $35 per month... Sub. Req'd

FTC's Noncompete Ban Would Force Sweeping Changes in Health Care, If it Survives Legal Battle

(4/23, Tara Bannow, STAT Plus) ...The Federal Trade Commission approved a far-reaching noncompete ban Tuesday that could force sweeping changes across the health care industry. But those changes may not take effect for years — if they ever do — because the contentious rule will almost certainly be held up in litigation... Sub. Req'd

FTC Votes 3-2 On Final Rule to Ban Noncompete Agreements, But Legal Challenges Expected

(4/23, Dave Muoio, Fierce Healthcare) ...The ban does not apply to nonprofits including many of the country's healthcare provider organizations due to the limitations of the FTC's jurisdiction, one of several points of contention that's been raised by hospital industry groups that have opposed the ban. The final rule will take effect 120 days after its publication in the Federal Register. To be in compliance, impacted employers will need to stop enforcing existing noncompetes with workers other than senior executives, inform those who are no longer bound by existing noncompetes and stop initiating new noncompetes for all workers going forward, FTC staff said during an open meeting on the final rule held Tuesday afternoon... Full

Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification

(4/23, Dean Rudge, Pink Sheet) ...Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services' Medicaid drug rebate program in a US court six years after the suggestion was first made...While Sandoz was "comfortable" that the six-year Administrative Procedure Act statute of limitations to seek judicial review "was not running," a recent batch of emails from the agency describing a backlog of open Medicaid clarification issues "included curious language that could be construed as an attempt to walk back CMS's previous clear statements that the 2018 letters were not final agency actions."... Sub. Req'd

Biosimilars Could Save the Healthcare System Billions

(4/23, Sally Pipes, Washington Examiner) ...Cost Plus Drug Company CEO Mark Cuban recently pointed out that self-insured businesses could save over $70,000 per employee annually by getting their workers to switch from AbbVie's blockbuster anti-inflammatory treatment Humira to a lower-cost biosimilar called Yusimry...Why doesn't every employer in America follow Cuban's advice? The answer has three letters: PBM... Full

Op-Ed: We Need a Deeper Conversation About Drug Prices

(4/24, Rich Bagger, NJ Spotlight News) ...There is no question that the issue of prescription drug access and affordability is one that needs to be addressed. No one should struggle to pay for the medications they need to preserve their health. That is why we should pursue proven policies that work, such as requiring PBMs to pass drug rebate savings on to patients in lower out-of-pocket costs and reducing patient cost-sharing for prescription medicines, not ones that sound good in a political ad but won't make a difference for patients and risk serious harm to jobs and the economy... Full

EU Critical Medicines Act Must Partner With Essential Industry

(4/24, Medicines for Europe) ...Medicines for Europe is honoured to be a part of the EU Critical Medicines Alliance. This initiative builds on the hard-learned lessons during the pandemic, where the secure supply of medicines was a matter of life or death. Our manufacturers worked tirelessly during that time to meet demands of essential ICU and other needed medicines, which had increased exponentially (up to 900%) in the early days of the covid outbreak...Signatories to this statement...Philippe Drechsle, Teva, VP EU Portfolio... Full

EMA Group Calls for Multi-Prong Measures to Tackle Shortages

(4/23, Joanne S. Eglovitch, Regulatory Focus) ...The European Medicines Agency's Medicines Shortages Steering Group has recommended a series of actions that Member States and marketing authorization holders can take to strengthen supply chains and avoid shortages of critically needed medicines... Full

Post-Brexit UK Risks Being ‘Left Out In The Cold' As EU Coordinates Action On Shortages

(4/23, Ian Schofield, Pink Sheet) ...When it comes to medicine shortages, the "Brexit effect" is barely mentioned by the UK's Conservative government, which took the UK out of the EU at the end of January 2020. But new research from UK independent health think tank Nuffield Trust suggests that while Brexit has not caused the recent spike in drug shortages, it is likely to have significantly weakened the UK's ability to address them by "splitting it from European supply chains, authorizations and collective efforts to respond to shortages."... Sub. Req'd

'Getting Production Off the Ground': EU Will Collaborate Better to Tackle Drug Shortages

(4/24, Maïthé Chini, The Brussel Times) ...EU Member States will soon start better collaborating to address drug shortages, following Belgium's push to launch the Critical Medicines Alliance. Eventually, more medicines should be produced in the EU again...Many drugs are simply no longer offered in the EU. "A quarter of generic drugs have already disappeared from the European market, either because they are no longer profitable or because we have production problems in Europe," [Federal Health Minister Frank Vandenbroucke] said...The problem, he said, is industrial politics: Europe no longer has the capacity to produce medicines... Full

Belgian Presidency Continues Push to Fight Medicine Shortages

(4/23, Nicole Verbeeck, Euractiv) ...Under the leadership of the Belgian Presidency, discussions on pharmaceutical legislation are underway, with a primary focus on addressing shortages. The objective is not to close the cluster but to achieve an interim compromise that could chart the way forward, a diplomat told Euractiv. The Presidency team is engaged in ongoing discussions and aims to reach conclusions during the upcoming working party at the end of May... Full

Irish Body Sets Out Five-Year Vision Strategy For Off-Patent Sector

(4/23, Urte Fultinaviciute, Generics Bulletin) ...As the off-patent sector continues to see challenges in sight, Medicines for Ireland has outlined its "ambitious vision" for the country's generics, biosimilars, and value-added medicines for the next five years. The vision strategy titled "Looking forward: Building the framework for a sustainable generic, biosimilar and value-added medicines industry in Ireland" aims to highlight the increasing impact of market factors on generic medicines and their role in delivering value to Irish patients and the country... Global Sub. Full

Indian Companies Face French Barrier for Generic Deal

(4/24, Rupali Mukherjee , The Times Of India) ...The French government is planning to block the sale of generic drugs firm Biogaran to potential foreign bidders, which include two Indian pharma companies, according to French media reports. Torrent Pharmaceuticals and Aurobindo Pharma have emerged as potential bidders, along with other entities, including a foreign PE firm, industry sources told TOI... Full

India's Pharma Exports Rise 10% to USD 27.9 Bn in FY24

(4/24, Press Trust Of India) ...The country's drugs and pharmaceuticals exports increased 9.67 per cent year-on-year to USD 27.9 billion in 2023-24, even as the total exports dipped by 3 per cent in the last fiscal. According to the commerce ministry data, pharma exports in March grew by 12.73 per cent to USD 2.8 billion...The top five export markets, for the sector during the last fiscal, are the US, the UK, the Netherlands, the United Kingdom, South Africa and Brazil... Full

AstraZeneca Calls On Russian Regulators to Ban Release of Generic Forxiga

(4/24, The Pharma Letter) ...UK pharma major AstraZeneca has appealed to the Russian Investigative Committee and the Federal Anti-Monopoly Service against Russian drug firm Akrikhin, which produces a generic of the diabetes drug Forxiga (dapagliflozin) during the validity of the patent. Akrikhin's generic is known as Fordiglif and, according to AstraZeneca' its launch in the Russian market is illegal, reports The Pharma Letter's local correspondent, as its Forxiga is protected by a patent until 2028... Sub. Req'd

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