Thursday, October 17, 2024

Amicus Therapeutics Announces Settlement of Galafold® (Migalastat) Patent Litigation with Teva

(10/17, Amicus Therapeutics) ...Amicus Therapeutics today announced that it has entered into a License Agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). This Agreement resolves the patent litigation brought by Amicus in response to Teva's Abbreviated New Drug Application seeking approval to market a generic version of GALAFOLD® (migalastat) 123mg capsules prior to expiration of the applicable patents... Full

Amicus Announces Settlement of Galafold Patent Litigation with Teva

(10/17, The Fly) ...Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration and unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD patents pending in the U.S. District Court for the District of Delaware... Full

Kids With Cancer Fight for Their Lives, But The Drugs They Need Are Hard to Find

(10/17, Adrianna Rodriguez, USA Today) ...Several pediatric cancer drugs are in shortage and others have been discontinued, according to the Food and Drug Administration. The most widely used of them is injectable methotrexate sodium, a chemotherapeutic often used for acute lymphoblastic leukemia, brain tumors, non-Hodgkin lymphoma and osteosarcoma, according to St. Jude Children's Research Hospital. The FDA shortage list also includes leucovorin, a drug used to reduce the side effects of methotrexate... Full

Lupin Gets CGT Advantage For First US Pred Forte Generic

(10/16, Dave Wallace, Generics Bulletin) ...Lupin is expecting to reap the benefits of 180 days of competitive generic therapy exclusivity as it launches the first US generic rival to AbbVie's Pred Forte (prednisolone acetate) 1% eye drops brand. Citing IQVIA data for the year to August 2024, the Indian firm said the Pred Forte brand had estimated annual sales of $198m in the US... Global Sub. Full

Richter And Bio-Thera Shake Hands On $100M+ European Ustekinumab Deal

(10/16, Dave Wallace, Generics Bulletin) ...Gedeon Richter has snapped up European rights to Bio-Thera's proposed biosimilar to Stelara (ustekinumab) in a deal that could end up being valued north of $100m. With Bio-Thera having previously licensed US rights to its BAT2206 ustekinumab candidate to Hikma – in a 2021 deal worth as much as $150m – the Chinese developer has now announced an "exclusive commercialization and license agreement" with Gedeon Richter that gives the Hungarian firm "exclusive rights to commercialize the product in the EU, the UK, Switzerland and selected other countries."... Global Sub. Full

Novartis Loses Latest Bid to Block Generic Version of Blockbuster Heart Drug

(10/16, Brendan Pierson, Reuters) ...U.S. District Judge Dabney Friedrich in Washington, D.C., in an order made public on Tuesday, said the U.S. Food and Drug Administration did not overstep its authority in approving MSN Pharmaceutical's generic of Entresto, despite a slightly different label and alleged differences between the drugs. Novartis said in a statement that it disagreed with the ruling and is appealing the decision... Full

MSN Largely Loses On US Cabometyx Patents But Dodges Infringement Charge

(10/16, Dean Rudge, Generics Bulletin) ...Equity analyst Leerink Partners, which maintained its ‘hold' rating on Exelixis stock following the Delaware court's second patent-infringement order, surmised that the latest ruling "takes off the table the worst-case scenario of earlier generic entry in 2026 upon composition patent expiry." Meanwhile, the originator's president and CEO, Michael Morrisey, said the firm was pleased with the ruling... Global Sub. Full

Exelixis Stock Rises As Key Drug Cabometyx Withstands Patent Challenge

(10/16, Angus Liu, Fierce Pharma) ..."Overall, we believe the verdict removes all uncertainties associated with Cabometyx's U.S. market exclusivity, which has been a persistent overhang on Exelixis shares," William Blair analysts wrote in a Tuesday note. As a result, the William Blair team said Cabometyx's U.S. market exclusivity is likely to be retained until 2030. Previously, Exelixis had settled with Teva and Cipla, granting the two generics makers licenses to market their Cabometyx copycats beginning on Jan. 1, 2031... Full

Q&A: Sanofi's R&D Head Reflects On His First Year, A Post-Dupixent Future, and Finding An Identity

(10/16, Andrew Dunn, Endpoints News) ...The stock has recovered, and the pipeline, with a focus on immunoscience, is moving ahead, built around a dozen potential blockbusters. The company is in active deal talks with a potential buyer for its consumer health business. The French company's big bet on R&D means that [Sanofi’s R&D Head, Houman Ashrafian] will be key to Sanofi's future, as well as Hudson's legacy. Earlier this month in New York, Endpoints News sat down with Ashrafian to look back on his first year and what lies ahead for the $140 billion company... Full

Germany's Merck Open to More M&A for its Life Science Division

(10/17, Tristan Veyet and Marleen Kaesebier, Reuters) ...German science and technology group Merck is open to more acquisitions for its Life Science business after announcing in May it would buy Mirus Bio for $600 million, it said ahead of its Capital Markets day on Thursday. "Our guiding principle is and always has been, the right target, at the right time, for the right price," CEO Belen Garijo said in a statement... Full

McKinsey to Pay at Least $500 Million in DOJ Opioid Probe

(10/16, Ambereen Choudhury, Sabrina Willmer and Chris Strohm, Bloomberg) ...McKinsey & Co. is nearing a deal with US prosecutors to pay at least $500 million to settle federal probes into its past work helping opioid makers boost sales, according to people familiar with the matter. A settlement, which could be announced in the coming weeks, would resolve criminal and civil investigations by the Justice Department, said the people, who asked not to be identified discussing a confidential matter. The terms haven't been finalized and could still change... Full

The Opioid Epidemic Continues While Effective Medication Is Underutilized

(10/16, Giuliana Grossi, AJMC) ...In a recent interview, former Oregon State Representative Maxine Dexter, MD, pulmonary critical care physician at Kaiser Permanente, and candidate for Oregon's Third Congressional District, shed light on the complex factors contributing to the opioid crisis and how she addressed this during her time in office in Portland. At the intersection of decriminalization, the COVID-19 pandemic, and a surge in unsheltered homelessness, she described these significant contributors as "The Perfect Storm."... Full

New Migraine Guidelines Aim to Help Patients Beat the Pain

(10/16, Reemal Zaheer, PharmD, Pharmacy Times) ...CGRP inhibitors come in 2 main classes: monoclonal antibodies and small molecule receptor antagonists, also known as gepants. The monoclonal antibodies include medications such as erenumab (Aimovig; Amgen Inc), fremanezumab (Ajovy; Teva Pharmaceuticals USA, Inc), galcanezumab (Emgality; Eli Lilly and Company), and eptinezumab (Vyepti; Lundbeck Seattle BioPharmaceuticals, Inc)...As the field of migraine treatment evolves, the AHS position statement represents a significant step toward personalized care by designating CGRP inhibitors as first-line therapies, thereby eliminating the need to trial nonspecific preventive medications... Full

Panel Discussion: Innovation Strategies for the Next Decade

(10/17, Express Pharma) ...Panelists in this video: Mr Mahesh Gurnasinghani, Former Director -MS&T, Teva & Visiting Faculty, Goa College of Pharmacy (Moderator), Mr Subhrangshu Chaudhury, VP & Head of Quality, Centaur Pharmaceuticals, Mr Urmila Naik, Head of Quality Assurance, FDC, Dr. Rajashree Gude, Head of Department (Pharmaceutics), Goa College of Pharmacy, Mr Nilesh Hegu, Director, Cipla... Full

Humira Biosimilars Got Off to a Slow Start. Has That Changed? | AMCP Nexus 2024

(10/16, Ashley Gallagher, Managed Healthcare Executive) ...Although there are now 10 biosimilars to Humira (adalimumab) on the market, they are struggling to compete against their brand-name reference product, the top-selling drug of all time, according to panelists at session today on increasing adoption of Humira biosimilars at the 2024 Academy of Managed Care Pharmacy Nexus in Las Vegas... Full

Overcoming Barriers to Biosimilar Adoption

(10/16, Pearl Steinzor, AJMC) ...At The Academy of Managed Care Pharmacy NEXUS 2024 meeting, a panel of experts discussed the current state of the biosimilars market, sharing insights on pricing trends, utilization patterns, and the critical role of health plan policies in driving greater biosimilar utilization... Full

How Invisible Medical Groups Are Powering Telehealth's GLP-1 ‘Gold Rush'

(10/17, Katie Palmer, STAT Plus) ...The telehealth GLP-1 boom wouldn't be possible without clinicians willing to write prescriptions for those hundreds of thousands of patients. Companies are rarely transparent — with patients or the public — about the medical groups behind the screens. But a STAT examination found that just a handful of networks of doctors, nurse practitioners, and physician assistants are writing prescriptions for dozens of websites offering the weight loss drugs, including the compounded versions that have been the subject of conflict and debate among clinicians and industry members... Sub. Req’d

$2 Generics List Not the Solution

(10/16, AAM) ......"AAM appreciate CMS's interest in lowering seniors' costs through encouraging generic adoption. Unfortunately, this proposal does nothing to prevent PBM rebate games, ensure adoption of new generics, or otherwise secure the long-term sustainability of generic drug competition," said AAM. "Further, the demonstration project runs counter to a multi-year trend whereby PBMs and plans continue to move generics to formulary tiers with higher patient copays."... Full

Experts: Lack Of Transparency In Drug Price Talks Weakened CMS Leverage, Left Generics Guessing

(10/16, Maaisha Osman, InsideHealthPolicy) ...An industry expert claims that greater transparency from CMS during Medicare drug price negotiations under the Inflation Reduction Act could have boosted the agency's leverage to achieve lower prices, as initial negotiated rates remain higher than prices in other countries. In response, CMS told Inside Health Policy that its negotiation program aims to enhance affordability while promoting innovation, which is why negotiated prices exceed international benchmarks... Sub. Req’d

Novo Disputes US Pick of Insulin for Drug Talks at Third Circuit

(10/16, Nyah Phengsitthy, Bloomberg Law) ...Novo Nordisk A/S is arguing before the Third Circuit that the Medicare agency unlawfully selected six of its insulin products and aggregated them as one under a government drug price negotiation program. The Centers for Medicare & Medicaid Services rewrote the Inflation Reduction Act's "express numerical limits" when it imposed price controls on six products and grouped them as one under the Medicare Drug Price Negotiation Program, Novo wrote Tuesday in its opening brief to the US Court of Appeals for the Third Circuit... Full

Independent Pharmacies Present Medicare Negotiated Drug Access Obstacles

(10/16, Cathy Kelly, Pink Sheet) ...As Medicare works to ensure price reductions can be processed on the first 10 drugs in the negotiation program, independent pharmacies are warning that the current plan for manufacturers to provide retrospective rebates is not financially workable for them. Half of independent pharmacies surveyed are "strongly considering" not stocking the drugs because they expect to wait at least 30 days to receive manufacturer rebates on the products after they acquire them, respondents told the National Community Pharmacists Association... Global Sub. Full

Eli Lilly Chief Scientist Daniel M. Skovronsky: Beware Elected Leaders Who Would Weaken Patents

(10/17, Daniel M. Skovronsky, STAT Plus) ...Unfortunately, today there is need to recommend to our elected officials a strong, predictable, and robust patent system that will yield great innovations and better medicines to help people and society. As Election Day approaches, support candidates who believe strengthening U.S. leadership and competitiveness — not weakening patents — is the proven path to fuel America's biopharmaceutical innovation that the world depends on to advance patient care... Sub. Req’d

PBMs Float Their Own Report In Bid To Debunk FTC's Findings

(10/16, Maaisha Osman, InsideHealthPolicy) ...Three pharmacy benefit managers currently facing a lawsuit from the Federal Trade Commission and congressional efforts to overhaul their industry have funded a report that aims to debunk explosive findings by FTC staff in July that PBM practices are inflating drug prices... Sub. Req’d

Axios: PhRMA "Laser-Focused" On Lame Duck PBM Bills

(10/16, PCMA) ...While Big Pharma is "laser-focused" on undermining the market-based role of PBMs to boost their bottom line, at the expense of employers and patients, PBMs are focused on solutions that would increase competition and make prescription drugs more affordable. PBMs continue to support effective policies that crack down on Big Pharma's patent abuse, including recent legislation that eliminates patent thickets that would save $1.8 billion, and policies to increase biosimilar competition within the marketplace to improve access to more affordable alternatives to brand name prescription drugs... Full

Skinny-Label Lives to See Another Day

(10/17, Sara W. Koblitz, FDA Law Blog) ...The skinny label-whether utilizing omission or labeling modification-can continue to exist, allowing generic manufacturers to come to market earlier for non-protected uses of RLDs. We note, however, that this is unlikely to be the last affront to the skinny-label, which clearly remains a target for RLD sponsors... Full

IV Shortage ‘Creates Havoc' for Hospitals, Exposing Supply Chain ‘Whack-a-Mole'

(10/17, Nathaniel Weixel, The Hill) ...Experts have long warned about allowing critical supplies to be highly concentrated in one place, especially as climate change fuels more powerful and unpredictable storms. But manufacturing requirements for sterility means a high barrier to entry into the market, and with low returns on investment for manufacturers, hospitals and their suppliers have few options for recourse... Full

Compounding Association to Ask for Clarity Around Tirzepatide's Shortage Status

(10/16, Nicole DeFeudis, Endpoints News) ...The Alliance for Pharmacy Compounding wants clarity around the FDA's decision to reconsider tirzepatide's removal from its national shortage list...When asked for an update on its decision, the FDA told Endpoints News on Wednesday that it "generally does not comment on litigation." APC maintains that tirzepatide is "not commercially available in quantities needed to meet the demand" and should be added back to the shortage list... Full

FDA Guidance for Reconsideration at the Division Level Under GDUFA

(10/17, The Pharma Letter) ...This guidance, which finalizes the draft guidance published in January 2024, provides recommendations on the procedures for abbreviated new drug application (ANDA) applicants that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority... Sub. Req’d

AG Platkin, Division of Consumer Affairs Announce New Rules Aimed at Promoting Greater Transparency in Prescription Drug Pricing, Including How and Why Prices Are Increased

(10/16, New Jersey Division of Consumer Affairs) ...Under the new rules: Manufacturers must notify the Division of price increases and new drugs that meet statutory price thresholds, and then report more detailed information on those drugs to the Division; Carriers must report to the Division information on spending for the top 25 prescription drugs and drug groups in certain categories... Full

How Much Will That Prescription Cost? NJ Residents Can Soon Compare Drug Prices

(10/16, Scott Fallon, NorthJersey.com) ...New Jerseyans will soon get an inside view on how much their prescription drugs cost for wholesalers, those with insurance and people paying out of pocket under new state rules that are intended to keep price increases low, officials said Wednesday. The new rules took effect Tuesday and will require those involved in drug creation and distribution to supply key pricing data that will be published on a public website run by the state Division of Consumer Affairs... Full

Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges

(10/16, Skylar Jeremias, The Center For Biosimilars) ...The European Union's approach to biosimilars has revolutionized the biopharmaceutical market while driving innovation, lowering costs, and increasing biosimilar adoption. However, significant challenges remain, including gaps in education, concerns about the extrapolation of indications, and the need for robust real-world evidence to confirm long-term safety and efficacy, according to a recent review of European guidelines... Full

Urban Wastewater Treatment Directive Risks Undoing Europe's Efforts to Improve the Availability, Affordability and Accessibility of Medicines

(10/17, Medicines for Europe) ...The generic, biosimilar and value-added pharmaceutical sector represented by Medicines for Europe is seriously concerned about the impact of the Urban Wastewater Treatment Directive, which, if implemented in the current form without adjusting the systemic framework the industry is operating in, could lead to the disappearance of essential and critical medicines... Full

Pharma Package: Czechia Proposal Could Incentivise EU Research and Production

(10/17, Thomas Mangin, Euractiv) ...The Czech Republic has put forward a proposal that could provide valuable incentives to pharma companies while promoting research and production in Europe...Hungary will put forward a proposal, but part of a potential solution has been presented by the Czech government. "Our proposal was sent to our colleagues in the Hungarian Presidency of the EU Council in September. The section on production may be the most controversial, but no one has rejected it," said Deputy Minister of Health Jakub Dvorácek in response to a question from Euractiv... Full

Belgian Decree Sets Out Requirements for Importing Unlicensed Medicines.

(10/16, Francesca Bruce, Pink Sheet) ...A new Belgian decree has been published that sets out two pathways for importing medicines that do not have regulatory approval in the country in times of critical shortages. One pathway is for medicines that meet a special need for which treatment is unavailable in Belgium, while the other is for products that counter certain health threats... Global Sub. Full

Piyush Goyal Holds Meeting to Address Concerns of Pharmaceutical Exporters

(10/17, ANI) ...Union Commerce Minister Piyush Goyal engaged with key pharmaceutical industry stakeholders, including the IMDA's General Secretary, to tackle challenges faced by pharmaceutical exporters and enhance India's position in the global market. The meeting highlighted collaborative efforts to address hurdles and maintain competitiveness in quality and pricing... Full

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