Thursday, January 9, 2025

Catalyst Pharmaceuticals in Settlement With Teva of Firdapse Patent Litigation

(1/8, Josh Beckerman, MarketWatch) ...Catalyst Pharmaceuticals and its licensor SERB entered into a settlement agreement with Teva Pharmaceuticals resolving patent litigation brought by Catalyst and SERB in response to Teva's plans for a generic version for Firdapse 10 mg tablets... Full

IBD Tech Leader Catalyst Rockets After Striking A Key Deal With Teva

(1/8, Allison Gatlin, Investor's Business Daily) ...Under the settlement, Teva won't market the proposed generic if it receives Food and Drug Administration approval until at least Feb. 25, 2035. The companies will also end all ongoing patent litigation over Firdapse... Full

US Analysts List Teva, Wix in 2025 Top Picks

(1/8, Shiri Habib-Valdhorn, Globes) ...Bank of America lists several factors that could have a positive impact on the stock in the coming year, including quarterly results - they estimate that Teva will be able to continue to show mid-single-digit growth, with some upside potential; a plan to sell the active ingredients division that could accelerate de-leveraging; and publication of additional data about duvakitug. As a reminder, this drug, which Teva is developing in collaboration with Sanofi, reported strong results in a Phase 2 trial last month, boosting Teva's stock. Bank of America believes that Teva's strong product pipeline leaves room for another target price increase in the future and supports a higher multiple... Full

Neuraxpharm Picks Up A Pair Of Narcolepsy Drugs As Deal Frenzy Continues Apace

(1/8, Dean Rudge, Generics Bulletin) ...European central nervous system disorders specialist Neuraxpharm is continuing expansion in the therapeutic area after striking a deal to acquire the narcolepsy brands Provigil (modafinil) and Nuvigil (armodafinil) "in most markets outside of the US." In a deal that has already closed, and for which financial details were not disclosed, Neuraxpharm said that the acquisition did not include Korea, Japan, and Thailand, as well as excluding the US... Sub. Req’d

Amneal Sues Sandoz to Block Copies of Crexont Parkinson's Drug

(1/8, Christopher Yasiejko, Bloomberg Law) ...Sandoz Inc.'s proposed copies of Crexont infringe 12 patents for the Parkinson's disease treatment, two Amneal Pharmaceuticals Inc. units said in the first federal infringement lawsuit over the drug since its September launch. The Sandoz Group AG subsidiary's generic versions of Crexont's extended-release capsules infringe 10 patents held by Amneal's Impax Laboratories LLC unit that expire in October 2034 and two owned by Amneal Pharmaceuticals LLC that expire in December 2041... Sub. Req’d

Formycon and Fresenius Kabi Canada Receive Health Canada's Approval for FYB202/Otulfi® (ustekinumab), a Biosimilar to Stelara®

(1/8, Formycon) ...Formycon AG and its commercialization partner Fresenius Kabi announce that Health Canada has issued a "Notice of Compliance" (NOC) for FYB202/Otulfi®1 (ustekinumab), a biosimilar to Stelara®2. This approval applies to subcutaneous and intravenous formulations for the treatment of adult patients with moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis... Full

Medicare Drug Price Explanations Shed Some Light on Future Talks

(1/9, Nyah Phengsitthy, Bloomberg Law) ...The Biden administration's justification of the first cycle of Medicare drug price negotiations is fueling curiosity and uncertainty about a process largely held behind closed doors, just as another round of talks begin in the coming weeks under a new administration. The Centers for Medicare & Medicaid Services released 10 highly anticipated explanations about its process for determining offers and counteroffers in its landmark Inflation Reduction Act program to set the prices of some of the most expensive and widely used drugs covered under Medicare... Sub. Req’d

Medicare Negotiated Prices Likely ‘Spilling Over' Into Commercial Market, Payers Say

(1/8, Cathy Kelly, Pink Sheet) ...The price reductions Medicare negotiated for 10 retail pharmacy drugs are "probably" influencing prices for the products in the commercial insurance market, 67% of payers responding to an annual survey conducted by the investment firm TD Cowen said. One respondent said the extent of the "spill over" will depend on the gross-to-net discount for the drug prior to negotiation, the survey report stated. Many of the drugs in the first round of price negotiation already were highly rebated, which leaves little room for further price reductions. The Medicare negotiated prices were announced in August and take effect in 2026... Sub. Req’d

Ozempic, Trulicity Among Medicare's Priciest Drugs, Report Finds

(1/9, Ken Alltucker, USA Today) ...The report from AARP Public Policy Institute said average list prices on these 25 drugs have nearly doubled since they hit the market and collectively cost Medicare - and therefore American taxpayers - nearly $50 billion in 2022. About 7 million older adults on Medicare used these drugs and had to pay a portion of the bill at the pharmacy or via mail order. One in five older adults don't fill prescriptions or skip doses to save money, the report said... Full

Crapo Pledges To Aggressively Oversee IRA, Mitigate Adverse Effects As Finance Chair

(1/7, Jessica Karins, Inside Health Policy) ...Sen. Mike Crapo (R-ID) said the Finance Committee under his helm will conduct aggressive oversight of the Inflation Reduction Act and enact policies that mitigate the adverse consequences of the law on patients, innovators and taxpayers. He also said he will fight high drug costs by modernizing Medicare prescription drug benefits and reforming the business practices of pharmacy benefit managers. Crapo, in a statement on his official appointment to the position Tuesday (Jan. 7), said his priorities also include a telehealth extension, long-term physician payment reform and better mental health care... Sub. Req’d

Ozempic, Legos and Hearing Aids: What Trump's Greenland Plan Could Hit

(1/9, Ana Swanson and Jenny Gross, The New York Times) ...Putting tariffs on Denmark unless it cedes the island of Greenland could hurt access to a few key products, including popular medicines. President-elect Donald J. Trump has threatened tariffs on many countries for many different reasons. On Monday, he found a new purpose for his favorite economic tool. Mr. Trump said he would ''tariff Denmark at a very high level'' if it refused to allow Greenland -- a North American island that is an autonomous territory within the Kingdom of Denmark -- to become part of the United States... Sub. Req’d

NACDS Hails Momentum for PBM Reform at the State Level Heading into 2025

(1/8, NACDS) ...On January 2, 2025, in a major move, the Arkansas Legislative Council voted to make permanent Rule 128. Passage of Rule 128 will help preserve people's access to pharmacies by holding PBM middlemen accountable. Specifically, the permanent regulation will mandate that PBMs reimburse pharmacies at fair and reasonable rates, enforce the state's 2018 PBM law, and hold out-of-state PBMs accountable to Arkansas laws... Full

The Role of Importation in Remediating U.S. Generic Drug Shortages

(1/8, Thomas J. Bollyky, J.D., Sarosh N. Nagar, B.A., Chloe Searchinger, B.A., and Aaron S. Kesselheim, M.D., J.D., M.P.H., The New England Journal of Medicine) ...Benzathine penicillin G (BPG) is the primary treatment for early syphilis and the only approved syphilis treatment for pregnant women, so there was understandable alarm when Pfizer, the sole Food and Drug Administration (FDA)–approved U.S. manufacturer, reported a shortage of the drug in April 2023. The crisis was long in coming. Syphilis incidence in the United States had increased steadily since 2012 and accelerated during the Covid-19 pandemic, hitting its highest level since the 1950s in 2022. BPG is an effective, low-cost, off-patent injectable medicine, but it is complicated to manufacture... Sub. Req’d

Under New Policy, FDA Will Cut Off ‘Interim' Compounding Of Some New Drugs

(1/8, Jessica Karins, Inside Health Policy) ...FDA will limit the drug substances that can be compounded by 503A and 503B outsourcing facilities after being proposed for, but not yet approved for, its lists of bulk drug substances, the agency says in new guidance on the issue. 503A compounding pharmacies will be able to continue compounding most substances, including those that are the active ingredient in an FDA-approved drug, have a U.S. Pharmacopeia monograph, or are placed in FDA's "Category 1" list of proposed bulk drugs that do not pose a significant safety risk but have not yet been placed on the 503A bulks list... Sub. Req’d

Lilly Granted Permission To Intervene In GLP-1 Compounding Case

(1/8, Jessica Karins, Inside Health Policy) ...Eli Lilly will be allowed to intervene in a case over whether FDA was right to remove tirzepatide, the active ingredient its GLP-1 drugs, from the drug shortage list, allowing it to advance a broader argument that FDA is violating the law by allowing compounding of drugs that have not been added to the 503A bulks list under an interim policy. The Outsourcing Facilities Association, the plaintiff in the case, initially opposed Lilly's motion to intervene in the case but submitted a motion withdrawing its objection, saying it was satisfied that the brand-name drugmaker had met the bar to justify participation in the lawsuit... Sub. Req’d

European UPC Ruling Refuses Block On Soliris Biosimilars

(1/8, Dave Wallace, Generics Bulletin) ...Amgen and Samsung Bioepis can continue to sell their Soliris (eculizumab) biosimilars in Europe, after the Court of Appeal of the Unified Patent Court refused originator Alexion's request for injunctions. Alexion had sought injunctive relief based on its European patent 3,167,888,B1 covering the treatment of paroxysmal nocturnal hemoglobinuria. Amgen's Bekemv was the first eculizumab biosimilar to be endorsed in Europe, in early 2023, with Samsung Bioepis following shortly after with its Epysqli version... Sub. Req’d

Digital Leap: Industry Proposes Phased Rollout of ePI for Patient Safety and Environmental Sustainability

(1/8, Medicines for Europe) ...In a significant stride towards further modernizing patient care, regulatory efficiency, and environmental sustainability, Pharmaceutical Industry Associations (AESGP, EFPIA, and Medicines for Europe) have launched a new series of position papers advocating for the implementation of electronic Product Information (ePI) and improvement of the patient leaflet content. By transitioning to ePI, patients, healthcare professionals (HCPs), and civil society will benefit from the most up-to-date, accessible medicinal information, ensuring safer use of medicinal products... Sub. Req’d

Verona Touts 'Exceptionally Strong' Launch of Blockbuster Hopeful COPD Treatment Ohtuvayre

(1/7, Kevin Dunleavy, Fierce Pharma) ...Verona Pharma is off to a promising start as it launches its first product, Ohtuvayre, a maintenance treatment for chronic obstructive pulmonary disorder (COPD). In 2024, Ohtuvayre generated sales of $42 million, the company reported on Tuesday. When it was approved by the FDA in June of last year, Ohtuvayre became the first novel treatment advance in the indication in more than a decade. Then, three months later, the FDA signed off on Dupixent as the first biologic treatment for COPD, expanding its label to six indications and prompting analysts at Evercore ISI to proclaim its peak sales potential at $20 billion... Full

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