Friday, October 18, 2024

Amicus Therapeutics Shares Rise After Lawsuit Settlement, Deal With Teva

(10/17, Chris Wack, Dow Jones) ...Amicus Therapeutics shares were up 11% to $11.67 after the company entered into a license agreement with Teva Pharmaceuticals USA and Teva Pharmaceuticals...Under the agreement, Amicus will grant Teva a license to market its generic version of Galafold in the U.S., beginning Jan. 30, 2037... Full

Amicus stock Jumps After Resolution of Galafold Patent Litigation Against Teva

(10/17, Nicole DeFeudis, Endpoints News) ...Amicus Therapeutics resolved a patent dispute with Teva on Thursday, allowing Teva to launch a generic version of its Fabry disease treatment Galafold in 2037. Leerink Partners analysts called it a "near best-case outcome" for Amicus, considering some Galafold patents begin to expire in the late 2020s. Amicus' stock $FOLD was up nearly 15% on Thursday afternoon following the announcement... Full

Leerink Says Galafold Settlement with Teva 'A Near Best-Case Outcome' for Amicus

(10/17, The Fly) ...Leerink analyst Joseph Schwartz notes Outperform-rated Amicus Therapeutics disclosed the settlement of the Galafold patent litigation with Teva Pharmaceuticals , allowing generic entry in 2037. While there are other ANDA filers, the firm thinks this is an encouraging step forward for the broader Galafold litigation and suggests that other parties may also settle... Full

Teva Pharms. Inc. v. Amneal Pharms. LLC (D.N.J. 2024)

(10/17, Kevin E. Noonan, Patent Docs) ...The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC... Full

Baxter to Import 18,000 Tons of IV Products to US by Year-End

(10/17, Mariam Sunny and Leroy Leo, Reuters) ...Baxter International said on Thursday it will import 18,000 tons of intravenous products from its newly cleared international plants to the U.S. by the end of the year to mitigate a shortage caused by Hurricane Helene. The medical device maker expects the products from Europe and Asia to be delivered to the U.S. in about 200 Boeing 747 airplanes. Baxter said it is pursuing other avenues such as expiration date extension requests to manage shortage of the medical product... Full

Hurricane-Related IV Fluid Shortage Could Hurt Medical Device Makers

(10/17, Manas Mishra and Christy Santhosh, Reuters) ...The big question for medical device makers is how soon the shortage can be resolved, said Barclays analyst Matt Miksic in an interview. If resolved soon, "whatever gets pushed out of this quarter will likely get picked up the following quarter in terms of delayed surgeries," said Miksic. "We wouldn't expect at this point (a) significant.. sustaining impact on the stocks." J&J became the first medical device company to flag a potential hit on Tuesday, when it warned that the IV saline shortages could impact surgical procedures across its portfolio if they persist... Full

Long Before Helene, IV Fluid Shortages Plagued Hospitals

(10/18, Berkeley Lovelace Jr., NBC News) ...As is often the case with drug shortages, it comes down to money, and IV fluids don't bring in much of it for manufacturers, said Erin Fox, senior pharmacy director at the University of Utah Health...That means when one manufacturer shuts down, it hits U.S. hospitals hard, Fox said. "Any little glitch in the system can really disrupt things and create some shortages," said Fox, who said her hospital hasn't received any IV fluid shipments since the end of September. "Unless we're going to pay these companies to have extra capacity that is sitting there waiting — which is very, very expensive — this is a shortage that we can't stockpile our way out of."... Full

The Real Reason Walgreens and Other Pharmacies Are Failing

(10/17, Helaine Olen, MSNBC) ...The woes facing pharmacies have little to do with either shoplifting or stores locking up products to prevent shoplifting. Walgreens and other pharmacies' struggles reflect the financial headwinds besetting the sector, which is reeling under the combined pressure from pharmacy benefit managers, changing consumer retail habits and, when it comes to the giant corporate chains, disastrous expansions... Full

Amgen, Biogen and Takeda Talk About R&D On Tough Targets

(10/18, Elizabeth Cooney, STAT Plus) ...Leaders of research and development at the three biopharma companies shared a stage Thursday at the STAT 2024 Summit in Boston and offered their insights on their differing challenges in a hot space for obesity drugs, an industry that doesn't favor midsize companies, and a disappointing market for Alzheimer's treatments — so far. Their common strategy, in Amgen Chief Scientific Officer Jay Bradner's words, is to "make medicines for some of the toughest targets for the toughest diseases."... Sub. Req’d

Formycon Points To Positive Results For Keytruda Biosimilar

(10/17, Dave Wallace, Generics Bulletin) ...With clinical trials for its FYB206 proposed biosimilar to Keytruda (pembrolizumab) currently ongoing, Formycon has highlighted analytical studies that suggest its version is "structurally and functionally highly similar to the reference product."..."In summary, the results of the extensive data package from all assessments covering structure, purity, protein variants, binding and potency confirm the high similarity between FYB206 and Keytruda."... Global Sub. Full

Zentiva Bolsters Branded Interests With Bid For Apontis Takeover

(10/17, Dave Wallace, Generics Bulletin) ...Zentiva has launched a bid to take control of German "single pill company" Apontis Pharma, with a €10-per-share offer that values the enterprise at €85m. If successful, Zentiva plans to establish the firm as a standalone branded division... Global Sub. Full

3rd Time's the Charm: AbbVie Scores FDA Nod for Continuous Parkinson's Disease Therapy Vyalev

(10/17, Zoey Becker, Fierce Pharma) ...AbbVie made history in 2015 with its Parkinson's disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfalls associated with oral treatments. Now, after multiple delays, the Illinois pharma giant has a new offering on the table as it has scored FDA approval for its more convenient, subcutaneous follow-up Vyalev... Full

Pfizer's RSV Vaccine Has 90% Efficacy Against Severe Respiratory Disease

(10/12, Max Bayer, Endpoints News) ...Pfizer's RSV vaccine was 90% effective at preventing the most severe outcomes in the first-ever vaccination season, the company said, underscoring its potential benefits as another respiratory virus season kicks off. The new data, presented at IDWeek Thursday, are a clearer look at how Abrysvo fared at preventing severe illness and hospitalizations. The results come from Kaiser Permanente of Southern California, though the trial was paid for by Pfizer and includes Pfizer co-authors... Full

Merck Unveils RSV Antibody Data, in Bid to Compete with AstraZeneca and Sanofi

(10/18, Nicole DeFeudis, Endpoints News) ...Merck's experimental antibody for RSV reduced infants' risk of certain lower respiratory infections by 60.4% compared to placebo, meeting the trial's primary endpoint. The Phase 2b/3 data, presented at IDWeek Thursday, will form part of Merck's regulatory filing for clesrovimab. The numbers also offer an early look at how clesrovimab compares against AstraZeneca and Sanofi's rival antibody Beyfortus... Full

FDA Expands Label for Avadel's Narcolepsy Drug into Children

(10/17, Katherine Lewin, Endpoints News) ...The Thursday approval of the supplemental NDA for Lumryz, allowing the drug to treat cataplexy or excessive daytime sleepiness in children with narcolepsy, came after FDA missed its Sept. 7 PDUFA date. Avadel says Lumryz is now the only FDA-approved, once-per-night treatment in this population... Full

Viatris Makes Good On CEO's Dealmaking Promise with $25M Licensing Pact for Lexicon's Heart Med Inpefa

(10/17, Fraiser Kansteiner , Fierce Pharma) ...After Viatris' CEO earlier this year promised to be "opportunistic" about future business development moves, the company is making good on that pledge with a new licensing pact to bolster its cardiovascular portfolio. Viatris is ponying up $25 million upfront to obtain the rights to sell Lexicon Pharmaceuticals' SGLT1/SGLT2 heart med sotagliflozin, known commercially as Inpefa, in all global markets beyond the U.S. and Europe... Full

Genentech Executive Fritz Bittenbender: Beware Political Soundbites

(10/18, Fritz Bittenbender, STAT Plus) ...To see real change in the system, we have to remain focused on solutions that save both patients and the government money while preserving our industry's ability to invest heavily in new medicine development, instead of being distracted by political rhetoric that consistently gets us nowhere... Sub. Req’d

Pharmacies Weigh PBM Practices in US Drug Price Negotiation Plan

(10/18, Nyah Phengsitthy, Bloomberg Law) ...Independent pharmacies are increasingly concerned about potential unfair reimbursements under Medicare's drug price negotiation plan, voicing doubts about the Biden administration's final guidance outlining how it will monitor pharmacy benefit manager practices. The PBMs functioning as middlemen between drugmakers, insurers, and pharmacies could pressure pharmacies to close their doors by not reimbursing the full negotiated price for drugs selected under the negotiation program, some pharmacy groups say... Full

The PBM Bills in Play for a Lame Duck

(10/17, Peter Sullivan and Victoria Knight, Axios Pro) ...A desire to address PBMs' role in drug pricing has translated to a lot of bills - a handful of which remain in play for inclusion in a year-end funding package. The projected savings from any of these could provide valuable offsets to other health programs... Sub. Req’d

If Based On Merit, The FTC Should Lose PBM Suit

(10/18, Pat Toomey, Townhall) ...FTC Chairwoman Lina Khan, with her fellow Democratic Commissioners, recently filed a suit against the leading PBMs in an effort to undermine, or even prohibit, their use of rebates to secure savings in the prescription drug supply chain. In a September 25, 2024 editorial, The Wall Street Journal notes that if the FTC is successful, it will result in higher drug costs for American consumers. The Congressional Budget Office (CBO) analysis of a Trump administration proposal to restrict rebates came to the same conclusion... Full

ANALYSIS: Pharma Firms Still Trust Board Oversight as Risks Grow

(10/17, Kate Azevedo. Bloomberg Law) ...The pharmaceutical industry is operating within a marketplace of heightened risk, according to a Bloomberg Law analysis of Form 10-K filings. But pharma companies aren't changing their risk governance approach, clearly favoring board oversight over other recommended means. A Bloomberg Law EDGAR Advanced Search of Form 10-K, Item 1A Risk Factor filings submitted by companies categorized with a Standard Industrial Classification (SIC) of pharmaceutical preparations shows that the number of corporate risks filings—and the amount of detail in them—that these pharma companies have disclosed over the past decade has more than doubled... Sub. Req’d

One-Size-Fits-All Drug Pricing

10/17, Peter Rheinstein, RealClearHealth) ...Price controls inherently restrict the supply of any good or service, whether it's oil in the 1970s or medicines in the 2020s. But by disincentivizing post-approval research, officials are compounding the IRA's damage -- and needlessly depriving patients of potentially lifesaving new uses for already approved therapies... Full

Editorial: Bring Down the Price of Weight Loss Drugs Like Ozempic and Wegovy

(10/18, The Boston Globe) ...The potential for extraordinarily high costs has led some insurers to limit coverage, and policies vary widely. Medicare Part D plans, which are private plans that cover prescription drugs for seniors, are prohibited from covering weight loss drugs. MassHealth began covering weight loss drugs when medically necessary in January 2024 after negotiating manufacturer rebates. But starting in January 2025, MassHealth will begin requiring patients with obesity to first try an oral appetite suppressant before being approved for a GLP-1 drug... Sub. Req’d

ASPR Weighs Additional DPA Opportunities As IV Shortages Continue

(10/17, Jessica Karins, InsideHealthPolicy) ...The Administration for Strategic Preparedness and Response (ASPR) is actively assessing whether more invocations of the Defense Production Act will be needed to respond to the drug shortage fallout from Hurricanes Helene and Milton, the office told Inside Health Policy. ASPR said it is communicating with Baxter and two additional domestic IV drug makers on whether to take additional action, and is coordinating with FDA on enforcement discretion... Sub. Req’d

Consumer Groups Ask FTC to Block Novo Holdings-Catalent Deal

(10/18, Jody Godoy, Maggie Fick, Reuters) ...U.S. consumer groups and two large labor unions urged the U.S. Federal Trade Commission on Thursday to block Novo Holdings, the controlling shareholder of Novo Nordisk, from acquiring contract drug manufacturer Catalent, saying the deal threatens competition in weight loss drugs and cutting-edge gene therapies... Full

House's Prominent China Critic Jim McGovern Leads Opposition to Biosecure Act: ‘I Would Prefer to Go Back to the Drawing Board'

(10/17, Jared Whitlock, Endpoints News) ...As distrust of China reaches a fever pitch in Congress, drugmakers with supply chains threatened by Biosecure have been unwilling to publicly oppose the legislation for fear of political blowback. The opposition mantle has been assumed by McGovern, who argues the bill lacks due process and resembles how the Chinese government operates. "I'm at the point in my career where I'm going to vote in ways I think [are] right. I'm not going to go along to get along," McGovern said in an interview with Endpoints News... Full

Amy Abernethy, Former No. 2 at FDA, Outlines New Company's Plans to Streamline Clinical Research

(10/17, STAT) ...Former Verily executive Amy Abernethy outlined her plan to streamline clinical research on Thursday, revealing the first projects that her company, Highlander Health, will fund...Her resolve to make research more efficient has grown over the years as the cost of clinical trials has skyrocketed. On Thursday, at the 2024 STAT Summit, Abernethy recalled a presentation at last year's J.P. Morgan by BeiGene CEO John Oyler, who noted that the company spent about $150,000 per clinical trial patient in 2010. By 2023, that cost increased to around $300,000 per patient... Full

FDA Finalizes Guidance On Generic Drugs, Cancer Trials and Neonatal Drug Development

(10/17, Zachary Brennan, Endpoints News) ...The FDA on Thursday put the finishing touches on three final guidance documents focused on reviewing drug master files (DMFs) in advance of generic drug submissions, collecting patient-reported outcomes (PROs) in cancer trials, and when to conduct long-term clinical neurodevelopmental safety studies for neonatal products... Full

How a Drug Discount Program Intended to Benefit the Poor Got Entangled in a California Rent-Control Fight

(10/18, John Wilkerson, STAT Plus) ...Californians are about to vote on an aggressive policy proposals to reform a drug discount program that is a key source of revenue for hospitals and health...But obscure is not the same as trivial. The 340B program is a major source of money for nonprofit hospitals and health clinics that treat high volumes of low-income patients. Discounts from 340B are not publicly disclosed, but the Government Accountability Office estimated them at 20% to 50% of drug prices, and some estimates are even higher... Sub. Req’d

The False Promise of Maryland's Prescription Drug Affordability Board

(10/17, A. Mark Fendrick, Maryland Matters) ...Maryland lawmakers undoubtedly had good intentions when they established the PDAB. But PDABs are problematic since they focus exclusively on drug prices at the expense of a far more meaningful metric: drug value. This price-centered approach fails to account for the fact that the clinical value of medicines - or any health care service - is unique to each individual... Full

NJ's New Drug Price Transparency Rules Will Help Affordability Council Craft Reforms

(10/17, Gabrielle Wanneh, InsideHealthPolicy) ...New regulatory rules went into effect in New Jersey on Tuesday (Oct. 15) that require major manufacturing and distribution players across the prescription drug supply chain to provide the state with information related to high launch prices and significant drug price increases -- information the state's Drug Affordability Council will use to weigh legislative and regulatory proposals to reduce drug prices... Sub. Req’d

‘Serious Problem': EMA Director Criticizes Unpredictable Pharma Submissions

(10/17, Vibha Sharma, Pink Sheet) ...The European Medicines Agency's executive director said the current practice of companies frequently changing their planned dates for submitting their marketing submission via the centralized procedure was "playing havoc" and was "detrimental to the system."... Global Sub. Full

New UK Clinical Trials Regulation Expected To Apply From January 2026

(10/17, Eliza Slawther, Pink Sheet) ...Sponsors can expect to see a copy of final guidance on how to comply with the UK's new clinical trials regulation in August 2025, while the new framework is set to apply from January 2026...The proposed legislation is "currently in the final stages of legal checks and parliamentary processes that need to take place," and will be laid before parliament in November, Freya Newton, principal policy specialist for regulatory reform at the MHRA said during a October 15, webinar... Global Sub. Full

New German Research Law Fails To Stop Companies From Opting Out Of The Market

(10/17, Francesca Bruce, Pink Sheet) ...A new law in Germany fails to adequately address "flaws" in the pricing system that are discouraging companies from launching new, innovative products on the market, warned Alexander Natz, secretary general of EUCOPE, which represents small and medium-sized companies in Europe... Global Sub. Full

Eisai to Ask Australia to Reconsider Rejection of Alzheimer's Drug Leqembi

(10/17, Katherine Lewin, Endpoints News) ...Australia's Therapeutic Goods Administration (TGA) said Wednesday that while patients on the drug saw "a reduction in disease progression" compared to placebo, it wasn't "significant enough to provide a meaningful clinical benefit or to outweigh the associated safety risks." The TGA noted that it also took into account the frequency of amyloid-related imaging abnormalities (ARIA), a side effect of Leqembi that can cause brain swelling and bleeding... Full

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