Adalimumab-AFZB

President Donald Trump's TrumpRx drug purchasing platform pledges the “lowest cash prices" for 54 drugs. Much of President Donald Trump’s campaign promises to lower drug prices in the U.S. were said to have been delivered through TrumpRx, a recently launched direct-to-consumer platform built on most-favored-nation pricing that benchmarks domestic prices against international rates.But, according to a new report from The New York Times, TrumpRx’s claims of offering “the world's lowest prices on prescription drugs” might have some caveats. A review conducted by the NYT and German news organizations Süddeutsche Zeitung, NDR and WDR found that drug prices in Germany were lower than many listed on TrumpRx when directly compared. Last May, the president issued an executive order mandating MFN drug pricing while calling out “inflated prices” in the U.S. that force American patients to pay “almost three times more” for the same medicines than those in other developed nations. Trump, in a Truth Social post at the time, insisted that this order would see prescription drug prices reduced by 30% to 80%.  Seventeen of the world’s largest drugmakers were then sent letters that demanded them to match their U.S. drug prices with other nations’ and to sell their products through DTC platforms. Pfizer was the first to sign on to the arrangement, with its peers following suit. In February, Trump wrapped his MFN pricing deals into action with the launch of drug purchasing platform TrumpRx. The website states that “the days of Big Pharma price-gouging are over” and assures that the president has “ensured every American gets the lowest prices on prescription medicine in the developed world.”To illustrate its point, the site displays a side-by-side of EMD Serono’s fertility treatment Gonal-f at its previous price and its new MFN price compared to its price in Canada, which is listed as a “global reference.” The NYT, however, put this claim to the test. When looking at worldwide drug prices for Novo Nordisk’s popular Wegovy, the TrumpRx price for the injection is in fact lower than Canada’s but remains higher than the cost in seven other countries including Germany, Britain and Japan, the news org found. When comparing German prices specifically, the price discrepancy was the starkest for branded drugs that still have patent protection, such as Pfizer’s hormone treatment Ngenla. For two injection pens of that drug, the German public health system pays $2,723 less than a patient using TrumpRx discounts would, according to the report, which used data from German health insurance provider AOK. That said, Pfizer’s Humira biosimilar Abrilada goes for $500 less on TrumpRx than it would in Germany, before discounts, according to the NYT. Meanwhile, the investigation determined that patients without insurance are paying the lowest out-of-pocket prices for obesity drugs such as Eli Lilly’s Zepbound in Japan, with a four-week supply available for $155 versus $399 on TrumpRx. In response, White House officials told the NYT that TrumpRx prices can still be cheaper than those of other countries even with a listed price difference when accounting for the economic conditions in each country, a point that Eli Lilly further endorsed.“A dollar goes further in some countries than others,” Lilly spokesperson Misty Fuller told the news org. “A medicine isn’t necessarily cheaper abroad if wages and living costs are lower there.” TrumpRx callouts Trump’s broad claims of “huge savings,” as TrumpRx mentions, have been scrutinized by lawmakers as well. A late February report (PDF) from democrats on the U.S. House of Representatives’ Energy and Commerce Committee found that cheaper generic drugs are available for at least 15 drugs listed on the website and that drug savings platform GoodRx had already offered the same discount for at least seven medicines touted on the site. “At best, the platform offers discount coupons that are readily available elsewhere. At worst, it appears to intentionally withhold information about more affordable generic alternatives and in some instances even charges consumers more than if they purchased the drug directly from the manufacturer,” ranking committee member Frank Pallone, D-N.J., commented, calling the website “not a serious effort to lower prescription drug prices.”The lawmakers’ qualms are shared by the Center for American Progress, which found that, when accounting for GoodRx prices, lower-cost generics and existing manufacturer coupons, only one drug available on TrumpRx, EMD Serono’s Cetrotide, offers a price not previously accessible to cash-paying patients.  TrumpRx currently touts 54 drugs, available at the “lowest cash prices.” As the website does not sell the products directly, much of the medicine listed on the site can be purchased through the respective direct-to-patient platforms run by drugmakers, while others offer TrumpRx coupons that can be presented at the pharmacy. The website uses GoodRx as a “core integration partner,” GoodRx said at the time of launch. GoodRx’s role is to offer drugmakers a “scalable way” to extend discounted cash prices to TrumpRx, allowing them to “rapidly operationalize most favored nation (MFN) and other policy-aligned pricing programs at national scale.” Either way, the only patients who stand to benefit from any TrumpRx savings are those who self-pay at the pharmacy, leaving out the 85% of the U.S. population that has prescription drug insurance coverage, University of Washington health economics and policy professors Sean Sullivan, Ph.D., and Ryan Hansen, Ph.D., pointed out in a Stat opinion piece last month. As the professors put it, the “real winners” at play are the pharmaceutical manufacturers themselves, which can “preserve their ability to maintain higher prices while appearing magnanimous through selective discounting.”

Partnership expands Henlius’ portfolio with license of exclusive China rights to develop, manufacture and commercialize lasofoxifene; Sermonix retains all other global rights Henlius to facilitate clinical development for the initiated Phase 3 MRCT (ELAINE-3) of lasofoxifene in the territory Sermonix receives upfront payment, milestone payments of up to $58M and royalties upon commercialization in the territory COLUMBUS, Ohio and SHANGHAI, China, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China. “In Phase 2 clinical trials, investigational lasofoxifene demonstrated its potential for the treatment of ER+/HER2- breast cancer harboring ESR1 mutation,” said Ping Cao, senior vice president and chief business development officer of Henlius. “Lasofoxifene will play a critical role in complementing Henlius' pipeline of its breast cancer product. In collaboration with Sermonix, we look forward to accelerating the access of more effective, personalized, precise and well-tolerated treatment solutions for Chinese patients.” “With a strong platform of R&D resources and commercialization capabilities, Henlius is an ideal partner to bring lasofoxifene into the therapeutic landscape in China,” said Dr. David Portman, Sermonix founder and chief executive officer. “Previous studies demonstrated lasofoxifene’s best-in-class potential and we will work with Henlius to accelerate the clinical development of the Phase 3 ELAINE-3 multi-regional clinical trial in China, making lasofoxifene available to Chinese patients as soon as possible." Breast cancer is the cancer with the highest incidence rate in the world, according to GLOBOCAN 2020. There were 2.26 million new cases of breast cancer in 2020 globally, including more than 410,000 in China [1]. ER+ breast cancer comprises 60-70% of all breast cancers [2]. Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor (AI) has been recommended by the National Comprehensive Cancer Network (NCCN) and Chinese Society of Clinical Oncology (CSCO) guidelines to be the adjuvant and first-line standard of care for patients with ER+/HER2- breast cancer [3-4]. However, almost all patients treated with AIs develop primary or acquired resistance [5], with acquired mutations in the estrogen receptor α gene (ESR1) being the most prevalent (up to 40%). This is a significant mechanism of resistance to endocrine therapy [6]. Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists. The Phase 3 ELAINE-3 multi-regional clinical trial (NCT05696626) is the third of Sermonix’s Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies. With the Phase 2 ELAINE-1 and ELAINE-2 studies both completed and having shown compelling anti-tumor activity against tumors with increasingly prevalent ESR1 mutations [7-8], Sermonix in December 2023 activated and began enrollment for ELAINE-3 in the U.S. ELAINE-3 will assess the efficacy of lasofoxifene and Eli Lilly and Company’s (NYSE:lly) CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. Henlius will fund the clinical development and patient enrollment of the ELAINE-3 study in China, and be responsible for regulatory approval and post-marketing manufacturing and commercialization in the region. About Lasofoxifene Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy, could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug development, strategic partnerships and commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 2 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. References: [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and MortalityWorldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. [2] Ignatiadis M, Sotiriou C. Luminal breast cancer: from biology to treatment[J]. Nat Rev Clin Oncol, 2013, 10(9): 494-506. doi: 10.1038/nrclinonc.2013.124. [3] Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines 2023 [4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2023 [5] Rozeboom B, Dey N, De P. ER+ metastatic breast cancer: past, present, and a prescription for an apoptosis-targeted future. Am J Cancer Res. 2019;9(12):2821-2831. Published 2019 Dec 1. [6] Spoerke JM, Gendreau S, Walter K, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun. 2016;7:11579. Published 2016 May 13. doi:10.1038/ncomms11579 [7] Goetz MP, Bagegni NA, Batist G, et al. Lasofoxifene versus fulvestrant for ER+/HER2- metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial. Ann Oncol. 2023;34(12):1141-1151. doi:10.1016/j.annonc.2023.09.3104 [8] S. Damodaran, C.C. O’Sullivan, A. Elkhanany, I.C. Anderson, M. Barve, S. Blau, M.A. Cherian, J.A. Peguero, M.P. Goetz, P.V. Plourde, D.J. Portman, H.C.F. Moore, Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2− breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2. Ann Oncol. 2023;34(12):1131-1140. doi:10.1016/j.annonc.2023.09.3103. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832 Henlius Contact: Bella Zhou/Janice Han PR@henlius.com