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EUROAPI and Priothera, a biotechnology company specializing in the treatment of hematological malignancies and the improvement of CAR-T cell therapies, have signed a 5-year CDMO agreement EUROAPI will develop and industrialize the manufacturing process of innovative complex molecule for blood cancers June 18, 2024 – EUROAPI announces today the implementation of a 5-year development and manufacturing agreement with Priothera, a biotechnology company specializing in molecules for the treatment of hematological malignancies and for the improvement of CAR-T cell therapies. Priothera is headquartered in Dublin, Ireland, and has a subsidiary in Saint-Louis (Haut-Rhin), France. As part of this collaboration, EUROAPI will develop and industrialize the manufacturing process of mocravimod, an innovative oncology molecule, through its Contract Development and Manufacturing Organization (CDMO) activity. This project will be carried out at EUROAPI’s Budapest site, its center of excellence for complex chemistry. “Oncology is a major segment for EUROAPI’s CDMO business. Signing this development and manufacturing agreement with Priothera demonstrates our ability to adapt to state-of-the-art innovation and quality requirements,” said Cécile Maupas, Chief CDMO Officer of EUROAPI. “This contract is a true recognition of EUROAPI’s broad panel of technologies and capabilities to respond to the increasing demand across different modalities.” “Having EUROAPI as a commercial manufacturing partner brings a substantial value to Priothera who is accelerating its late development of mocravimod in a global phase 3 clinical study with a view of worldwide drug registration and commercialization by 2027,” said Florent Gros, Co-Founder and Chief Executive Officer of Priothera. Mocravimod is a S1P1 receptor modulator being developed as an adjunctive and maintenance treatment for blood cancers, with the objective to reduce relapses and increase survival of patients. It is being developed in a global phase 3 trial which is enrolling approximately 250 adult Acute Myeloid Leukemia patients, and is ongoing in the US, Europe, Asia and Latin America. It has been granted Orphan Drug designation by both EMA and US FDA. Oncology is a growing market worldwide: global spending on cancer medicines is expected to reach $375 billion by 2027, up from $196 billion in 20222. According to the US National Cancer Institute, approximately 1.6 percent of men and women will be diagnosed with leukemia at some point during their lifetime3. EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn. Priothera is leading the way in developing orally applied S1P receptor modulators for the treatment of hematological malignancies and for the improvement of CAR-T cell therapies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues. Mocravimod is increasing GvL benefits in patients receiving allogeneic HSCT while inhibiting GvHD. Priothera was founded in 2020 by an experienced team of drug development experts and is headquartered in Dublin, Ireland, and with an operational subsidiary in Saint-Louis, France. The Company is backed by international founding investors Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden), EarlyBird Venture Capital (Berlin, Germany), as well as non-dilutive financing in the form of loans from the European Investment Bank under its Venture Debt Instrument and Bpifrance (Grand Est Bpifrance) in the form of a R&D innovation loan. 1 sphingosine-1-phosphate 2 Source: Iqvia data, https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2023 3 Source: SEER Cancer Stat Facts: Leukemia. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/leuks.html The content above comes from the network. if any infringement, please contact us to modify.

Pfizer reported better-than-expected first-quarter revenue and raised its full-year profit outlook on Wednesday, benefiting from its broad cost-cutting programme, a smaller-than-feared drop in sales of its oral COVID-19 antiviral Paxlovid, and strong performance from some of its other products.The pharma now expects to book adjusted earnings of $2.15 to $2.35 per share for the year, up from its prior guidance of $2.05 to $2.25 per share. Pfizer also reiterated its previous revenue forecast of $58.5 billion to $61.5 billion.Paxlovid softens post-pandemic blowIts COVID-19 products, the vaccine Comirnaty it shares with BioNTech and oral antiviral Paxlovid, saw significant sales decreases as demand has sunk to new lows. However, the declines were less severe than anticipated.Paxlovid booked $2 billion in sales for the quarter, down 50% from the same period a year ago, yet coming in well above the $762.5 million analysts were expecting. The company recorded a $771-million favourable adjustment due to the return of unused Paxlovid treatment courses by the US government. Meanwhile, Comirnaty generated $354 million, down 88% from the year-earlier period and falling short of projections of $496.5 million.Oncology boost from SeagenExcluding COVID-19 products, Pfizer said revenue for the first quarter rose 11%. Growth was partly fueled by the company's $43-billion acquisition of Seagen, whose legacy products including the targeted cancer therapies Padcev and Adcetris contributed a combined $742 million in quarterly revenue. However, Adcetris sales still fell short of analyst expectations.Other non-COVID-19 products that helped spur sales growth included the blood thinner Eliquis (+9% to $2 billion), the Vyndaqel family of cardiomyopathy drugs (+66% to $1.1 billion), and the Prevnar pneumococcal vaccine franchise (+6 to $1.7 billion).However, Pfizer's new RSV vaccine Abrysvo saw just $145 million in sales, far short of analysts' estimate of $360 million, while the breast cancer drug Ibrance posted an 8% decline in revenue to $1.1 billion.Cost cuts fuel outlook raise"We believe stronger new launch performance and further progress on the pipeline will be necessary to change the current narrative on the stock," commented JP Morgan analyst Chris Schott.Pfizer said its updated profit guidance "takes into consideration our confidence in delivering on our cost realignment programme target," adding it is on track to deliver at least $4 billion in savings by the end of the year.First-quarter sales totaled $14.9 billion overall, which was 20% lower than the same period a year ago, while net income was down 44% at $3.1 billion.Pipeline cutsMeanwhile, the drugmaker also culled some programmes from its pipeline, including discontinuing development of VTX-801, a gene therapy candidate partnered with Vivet Therapeutics that was in Phase I for Wilson's disease. In addition, it scrapped potential new indications for its S1P inhibitor Velsipity (etrasimod) in atopic dermatitis and alopecia areata, as well as a migraine prevention programme for its oral CGRP receptor antagonist Zavzpret (zavegepant), all of which had reached Phase II testing.

AbbVie’s Skyrizi has demonstrated significantly higher rates of steroid-free clinical and endoscopic remission versus rival Johnson & Johnson’s Stelara in a Phase III trial, helping set the Crohn’s disease drug apart in an increasingly competitive market. Stelara won an FDA approval for Crohn’s disease in 2016, while Skyrizi was approved three years later in 2019. But the competition is heating up with Stelara biosimilars set to enter the market in 2025, government price negotiations in 2026, and a new rival emerging in the form of Pfizer’s oral S1P inhibitor Velsipity for ulcerative colitis. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.