Richard Beckman, M.D.

Has Regeneron been successful with EYLEA HD® (aflibercept) Injection HCP as the patent for regular Eylea expires in June 2027? There will be 5 biosimilars, including 2 labeled as interchangeable, available next year. Regeneron reported their earnings yesterday and below 👇 you see their quarterly sales of both regular Eylea and HD. Sales of Eylea HD grew 30% Q over Q from $304M to $392M ($40M of Q3 is due to increased distributor inventories). But is that enough? The problem is over $1.1 B or 2/3 of Eylea sales remain in regular Eylea. With loss of its patent, Eylea will lose its pricing power, its moat, entirely. It will become one of 6 equivalent commodities. Basic economics dictates that without a moat, competition will drive prices to marginal costs and the profits to zero. The stock market seems to agree with my analysis as $REGN stock is down 10% overnight and 30% in 2 months. In the end, patients will be the winners. #retina #ophthalmology #optometry

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#ASH24 GLPG5201 incorporates stem-like early memory T cells, features rapid manufacturing (7-day vein-to-vein time), and requires no cryopreservation. R/R CLL (n=6): Double-refractory to BTKi and BCL2i; median prior therapies: 4. Richter transformation (n=9): Treated with CLL-directed therapy before RT diagnosis and chemo(immuno)therapy after; median prior therapies: 3. Efficacy: - ORR: 86.7% (13/15). - CR: 66.7% (10/15), with 80% (8/10) maintaining remission. Safety: - CRS: 53% (8/15), all Grade 1-2; no Grade ≥3 CRS or ICANS. - Grade ≥3 AEs: Hematological (lymphopenia 100%, leukopenia 88.2%, neutropenia 76.5%, thrombocytopenia 52.9%, anemia 47.1%).

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Great article Adam Fein . Thanks for your insight Benjamin Hinton II, PharmD, RPh ! “Adding a manufacturing arm brings undeniable advantages for PBMs, from better cost control to smoother supply chain dynamics. Payer-production entities can align an entire product distribution chain in their favor, excluding competitors and preferring their designated agents. But how will these integrated powerhouses impact the industry?”

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Nice short article on medtech ups and downs. Don’t need a subscription on this one! Reduced biopharma funding could slow medical device growth—50% of revenue in life sciences comes from biopharma. Physician visits suggest fewer surgeries—impacting demand for surgical devices. FDA LDT rules could raise costs & limit competition in diagnostics. R&D spending & clinical trials remain strong, a high number of device approvals & active clinical trials — 756 as of May 2024 — point to a promising future. Automation & supply chain optimization can improve margins during lower sales periods. Data can optimize inventory management, logistics, and geographic footprint. How can MedTech companies adapt further? #FutureOfWork #MedTech #RandD

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𝙑𝙞𝙨𝙞𝙤𝙣 According to the American Cancer Society (ACS) 610,000 people died due to cancer in 2023. 𝙒𝙝𝙖𝙩 𝙞𝙛 𝙬𝙚 𝙘𝙤𝙪𝙡𝙙 𝙙𝙤 𝙗𝙚𝙩𝙩𝙚𝙧 𝙛𝙤𝙧 𝙩𝙝𝙚𝙨𝙚 𝙥𝙖𝙩𝙞𝙚𝙣𝙩𝙨 𝙖𝙣𝙙 𝙨𝙩𝙞𝙡𝙡 𝙜𝙧𝙤𝙬 𝙩𝙝𝙚 𝙗𝙤𝙩𝙩𝙤𝙢 𝙡𝙞𝙣𝙚? Throughout my career, I’ve wondered what it would take for the cures for cancer to be 10X more profitable (for everyone at the table) than the therapies that often manage the diseases. I believe a sustainable solution that benefits patients, providers, hospitals, pharmaceutical companies, etc. lies in integrating the key players' needs into win-win-win solutions for all. Working with clients developing assays for cervical and colorectal cancer, personalized therapies, radioactive tiles to prevent recurrent glioblastoma, histology devices, novel biopsy devices, and 3D ultrasound diagnostics for breast cancer, I believe a more holistic Target Product Profile (TPP) can be reverse engineered thinking about all the industry players’ needs and that the innovation can be found collaboratively via program management and partnering across institutions- not just purely physician or researcher driven. And where profits are diminished by a diminishing patient population, why not move on to the next innovation and indication to make up the monetary shortfall? And for platforms where a cure might not be feasible, focus on diagnostics and prevention which could be financially evergreen as our life expectancies burgeon again in the USA (hopefully). We can’t stop thinking outside the box at Desert Platforms, and we’d love to partner with the intrepid. If this resonates, please comment or message me directly and let’s start a conversation. 😊 𝘿𝙧𝙚𝙖𝙢. 𝙋𝙡𝙖𝙣. 𝘿𝙤. (𝘼𝙣𝙙 𝙝𝙖𝙫𝙚 𝙩𝙝𝙚 𝙜𝙧𝙞𝙩 𝙩𝙤 𝙠𝙚𝙚𝙥 𝙙𝙤𝙞𝙣𝙜.) #cancer #MedTech #medicaldevices #innovation #productdevelopment

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Has Izervay been a successful medication? We can debate whether Izervay is clinically meaningful. But there is another way to look at its success or failure. Astellas Pharma paid $5.9 B to acquire Iveric Bio. In their latest quarter, Q1 24, Izervay sales were $85M. Prorated, that’s $340M annually. The Free Cash Flow (FCF) margin for Astellas has averaged 15% over the last 5 years. For Izervay, that’s a current FCF of $51M annualized. At a generous discount rate of 10% and terminal rate of 2%, Astellas has to grow its revenue by a compounded rate of 34% for 10 consecutive years to be valued at 5.9B today. That is simply impossible for a medication that has no tangible benefit observed by patients. My guess is Astellas Pharma assumed that Izervay would capture a significant portion of the Total Addressable Market (TAM) for dry AMD. Watch for a write down in their goodwill very soon. #pharmaceuticals #Retina #ophthalmology #finance

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Great piece by Juliana "Julie" Reed in @Stat outlining the missed savings for the US healthcare system including employers and patients that have been caused by #PBMs greed in choosing higher priced drugs because all of the price concessions and profits they make are based on the list price of the drug. It never was a physician’s choice to choose a biosimilar as the PBMs control that. Now the big 3 ins cos/PBMs are mandating “fail first”biosimilars that physicians can’t afford to buy based on the cost of the drug and underwater reimbursement. We will never realize the true potential of biosimilar savings until the perverse incentive to choose medications that make the most money for these publicly traded PBMs is taken out of formulary construction.

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$100 million to develop covalent biologics for oncology ! Enlaza Therapeutics just secured $100 million in Series A funding, led by J.P. Morgan Asset Management’s Private Capital division, to advance its covalent biologic platform for novel protein drugs, particularly in oncology. ⚗️Safer and more tolerable tumor penetration : Enlaza's War-LockTM technology creates biologic drugs that bind irreversibly to disease targets, enhancing efficacy and safety. By promoting covalency, it improves therapeutic performance, reduces systemic exposure, and allows sustained biologic effects with minimal dosing. Using proprietary amino acids, Enlaza engineers precise biological medicines with enhanced properties, offering a versatile solution across different protein-drug formats. 💊Investors : J.P. Morgan led the funding round, joined by existing investors like Frazier Life Sciences and new ones including Amgen and Regeneron's investment arms.

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The collaboration between Virpax Pharmaceuticals Inc. (Nasdaq:VRPX) Pharmaceuticals and the National Center for Advancing Translational Sciences (NCATS) heralds a significant advancement in pain management research. Focused on the development of NES100, an intranasal peptide targeting acute and chronic non-cancer pain, this partnership utilizes innovative nanotechnology to enhance the delivery of enkephalin to the brain. By leveraging Molecular Envelope Technology (MET) and a specialized device, NES100 aims to provide analgesic effects without the adverse events commonly associated with opioids. This extended collaboration underscores the shift towards non-opioid alternatives for pain management, crucial in addressing the opioid crisis. The research aligns with the NIH’s HEAL initiative, emphasizing the national commitment to combat opioid addiction. The potential of NES100 lies in offering a non-addictive pain treatment, potentially transforming pain therapy and improving outcomes for individuals with chronic pain conditions. NES100's development presents a promising avenue for pain management, offering a safer alternative to traditional opioids. If proven effective in clinical trials, NES100 could emerge as a valuable tool for patients seeking pain relief. The intranasal delivery method not only enhances convenience but also holds the promise of improved patient adherence and treatment efficacy. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/dwMpJZf8 Gerald W. Bruce Matt Barnes

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Our new provider-exclusive product is called MYOS MD, an all-natural supplement that helps reduce muscle loss associated with aging, disuse, and/or medical treatment. MYOS MD is powered by our proprietary ingredient, Fortetropin®, a unique bioactive composition derived from raw, fertile chicken egg yolks – clinically shown to lower myostatin, down-regulate the Ubiquitin pathway, and increase rate of muscle protein synthesis in older adults. Watch video below for more insight into the product, and/or visit myosmd.com for more info. #longevity #wellness #muscle #health #obesity #sarcopenia

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Once more into the IgA fray. We just learned Jade Bio and Aerovate will merge to focus on developing a potential “best-in-class” treatment for IgA nephropathy. Jade is the fourth spinout of Paragon Therapeutics, Inc. to go public via a reverse merger and the third this year, following Oruka Therapeutics and Crescent Biopharma. Paragon specializes in discovering promising new antibody drugs, which it then licenses to newly created companies to advance their development. In Jade’s case, JADE-001 targets a protein known as APRIL that’s thought to play a major role in the development of IgA nephropathy, which over time erodes kidney function. Jade aims to dose its drug every two months, compared to anti-APRIL antibodies being developed by Otsuka Pharmaceutical Companies (U.S.) and Novartis that are dosed once per month or once every two weeks. (Otsuka last week said its antibody, sibeprenlimab, succeeded in a Phase 3 trial, while Novartis expects data for its drug, zigakibart, in 2026.) The combined company will be named Jade Biosciences and will be led by Tom Frohlich, Jade’s current Chief Executive Officer (CEO). Jade’s existing Board of Directors will remain in place, chaired by Eric Dobmeier, former President and CEO of Chinook Therapeutics and current Venture Partner at Samsara BioCapital. Board members include Lawrence Klein, Ph.D., CEO of Oruka Therapeutics; Erin Lavelle, former Chief Operating Officer and Chief Financial Officer at ProfoundBio and Eliem Therapeutics; Chris Cain, Ph.D., Director of Research at Fairmount and Tomas Kiselak, Managing Member at Fairmount. IgAN has become a competitive area of drug development. • Novartis acquired Chinook Therapeutics last year • Biogen bought HI-Bio: A Biogen Company • Vertex Pharmaceuticals bought Alpine Immune Sciences, Inc. • Travere Therapeutics received full FDA approval this year • Calliditas Therapeutics's was first to market last fall There are 130,000 to 150,000 people who have IgAN in the U.S. Over time, their kidneys can no longer remove waste from the blood, leaving them at risk of progressing to end-stage renal disease (ESRD), which requires hemodialysis or kidney transplant. With the right focus on target therapies, patient access, physician engagement, and effective commercial strategies, we will see significant strides made in managing IgAN and improving outcomes for countless patients here in the U.S. and across the globe. *** What are you following in this space? What changes do you hope to see in the IgAN landscape over the next 3 to 5 years based on this flurry of positive results and investment? -- Sources: [1] Fierce: https://lnkd.in/eikyMsBs [2] Bio Dive: https://lnkd.in/ewDfgcJ3 [3] Jade PR: https://lnkd.in/eJ5xmesD [4] Novartis: https://lnkd.in/eYy72JzU [5] Otsuka: https://lnkd.in/ecQVvqku Photo: Jade Bio CEO Tom Frohlich Credit: Endpoints News

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AccendoWave - A Pain #Data Company The FDA on Monday declined to approve Johnson & Johnson’s subcutaneous formulation of its bispecific antibody Rybrevant (amivantamab), which the pharma was proposing for the treatment of certain patients with non-small cell lung cancer. In its Complete Response Letter, the regulator flagged issues detected during a standard pre-approval inspection of a manufacturer, according to J&J. The FDA did not raise concerns regarding product formulation or the company’s efficacy and safety data packages for subcutaneous Rybrevant. Monday’s rejection will also not affect Rybrevant’s existing approval as an intravenous therapy.

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I really enjoyed this edition of Consultants Corner, where they delved into an aspect of business operations that's often met with dread: FDA inspections. There are some really helpful medtech pod casts that will also come up if you use the link. While not anyone's idea of a good time, proper planning is crucial. It's not just about meeting compliance standards; it's about fostering an effective corporate culture and building long-term company value. Let's explore how strategic preparation can transform FDA inspections from daunting tasks to opportunities for growth! #MedTech #Medical #MedicalDevice https://lnkd.in/gXXYvE4n

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I just got around to watching Oppenheimer, and the quote, "The future is no longer what it was," rings true regarding the race to bring breakthrough therapies to market as AI continues revolutionizing drug discovery and development. As startups and pharma giants leverage AI to streamline clinical trials, improve patient targeting, and optimize the drug pipeline, we're entering a new era of precision and efficiency. But, to fully realize AI's potential and subsequent benefits, companies must prioritize transparency, patient safety, and ethical data usage by maintaining robust data privacy standards, ensuring AI outputs are interpretable, and committing to rigorous risk-benefit analyses. Organizations must prioritize a strategic AI implementation plan harmonizing platforms, people, and processes. When AI tools align with these best practices, they accelerate timelines and enhance patient outcomes across the board. As we continue to witness AI reshape life sciences, those who innovate responsibly and with foresight will shape a future where AI-driven drug development meets the highest standards, driving sustainable success for the industry and the patients it serves. https://lnkd.in/erKAM664

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“We see the potential for a pickup in #medtech M&A in 2025 with a more favorable regulatory environment, lower financing cost, more normalized end market growth rates, and even more time since peak [small-to-midcap] valuations.” That's from a Bank of America analysts' report. Associate Editor Sean Whooley has more details on MassDevice. Boston Scientific Johnson & Johnson MedTech #mergersandacquisitions #meddevice

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(2/2) A distinct advantage in hematologic cancers is the availability of hematopoietic stem cell transplantation (HSCT), which offers significant survival benefits to eligible patients. However, effective pre- and post-HSCT treatments are essential to extend the benefits of transplantation to a broader population. Two monoclonal antibodies have shown substantial efficacy in hematologic cancers: Rituximab in LBCL and Daratumumab in multiple myeloma. Both drugs rely on Fc-FcγR-mediated effector functions, particularly ADCC, with NK cells playing a critical role. While these antibodies are less effective as monotherapies, their combination with other treatments has demonstrated remarkable efficacy. Thanks to these therapies, although not perfect, the treatment algorithms for LBCL and MM have significantly advanced. The treatment of LBCL requires a harmonious integration of diverse modalities. Optimizing the combination and sequencing of CAR-T, bispecific antibodies, and ADCs remains a key challenge for future research. By prioritizing strategies that reduce tumor burden, enhance the effectiveness of immunotherapies, manage side effects, and establish long-term treatment plans, we can provide better therapeutic options for patients with LBCL.

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Apellis Pharmaceuticals reported Q3 earnings yesterday, revealing negative income, negative Free Cash Flow (FCF), and a decline in revenue from the previous quarter. Over the past 9 months, $APLS’s stock price and market cap have dropped more than 60%. 👇 This decline is due to the fact that a company without income or FCF relies on future growth expectations. Apellis’s quarterly year-over-year revenue growth has sharply declined, leading to lower future cash flow expectations and a reduced valuation.👇 During their conference call, Apellis emphasized their 65% market share. However, this should not be confused with the total addressable market (TAM) for geographic atrophy. Dominating a small market holds little value. #pharmaceuticals #retina #ophthalmology

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There's a deep personal history for me with this major acquisition today. Incyte (Rich Levy) had the vision at the time (2016) to let me design a very bold #phase2 #clinicaltrial with topical #ruxolitinib which ended up being the first FDA-approved JAK inhibitor in dermatology as OPZELURA® (ruxolitinib) HCP. Incyte acquires John E. Harris, MD, PhD's Villaris Therapeutics backed by Medicxi to go after #vitiligo. John E. Harris, MD, PhD and I are co-founders of Alys Pharmaceuticals which is going after #urticaria #itch #vitiligo and beyond again backed by Medicxi. In parallel in 2019, we publish an early and key paper in the journal Immunity (Meixiong et al. Immunity 2019) with Xinzhong Dong who discovered MRGPRX2 (actually, the entire family). I then start advising Escient Pharmaceuticals with the most bullish optimism about MRGPRX2 as target for #skin #diseases and witness a brilliant execution by Veena Viswanath et al. Incyte makes a bargain acquisition today for $750 million to transform skin disease in #dermatology and #allergy. The key point here is that MRGPRX2 antagonist will NOT be competing IMO with other more moderate-to-severe assets in #CSU like #barzolvolimab. They will mutually grow the market for #CSU across the mild to severe spectrum in a disease that is growing in incidence and poorly penetrated even by great drugs like #omalizumab. Keep in mind, #antihistamines are >$2 billion annual sales for #itch, which it does not even work for that well! This will accelerate new treatments for #urticaria and much beyond. Great for our patients.

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