CHIESI Farmaceutici SpA

In the field of immunotherapy, the market for oral peptide therapies is gradually emerging. Recently, AbbVie announced that it has reached a final acquisition agreement with Nimble Therapeutics. This transaction will enable AbbVie to obtain Nimble's core assets, including its oral peptide IL-23 inhibitor project, which is in the preclinical research stage and aims to treat psoriasis, as well as an innovative pipeline of oral peptide candidates targeting various autoimmune diseases. Additionally, AbbVie will gain access to Nimble's peptide synthesis, screening, and optimization platform, which employs proprietary technology to accelerate the discovery and optimization of peptide candidates targeting multiple pathways. AbbVie has long been active in the field of immunotherapy, and as its flagship product Humira faces patent expiration, the company is actively seeking new growth opportunities. This acquisition of Nimble Therapeutics not only enriches AbbVie's product pipeline but also strengthens its research and development capabilities in the field of oral peptide therapies. In the realm of oral medications for psoriasis, Johnson & Johnson's JNJ-2113 shows best-in-class potential, leading over other competitors. Just last month, Johnson & Johnson announced that the ICONIC-LEAD clinical trial achieved top-line results, marking the imminent market entry of the world's first targeted oral peptide Icotrokinra that selectively blocks IL-23 receptors. In light of Johnson & Johnson's progress, AbbVie is making every effort to ensure it maintains a leading position in this competition. Globally, there are over 125 million psoriasis patients, and this chronic disease requires long-term treatment, giving rise to a substantial treatment market. The global psoriasis market has reached $26.5 billion, and it is expected to maintain a 8.6% compound annual growth rate (CAGR) from 2022 to 2030. For the treatment of plaque psoriasis, 22 targeted therapies have been approved worldwide. Among these therapies, AbbVie and Johnson & Johnson are undoubtedly market leaders. Oral medications are increasingly favored by long-term treatment patients due to their convenience. Current oral medications include PDE4 inhibitor apremilast, TYK2 allosteric inhibitor deucravacitinib, and JAK inhibitor upadacitinib. Moreover, numerous multinational companies are actively entering the oral medication market for psoriasis. Johnson & Johnson's JNJ-2113 (Icotrokinra), as the world's first oral IL-23 receptor antagonist, relies on Protagonist Therapeutics' unique peptide technology platform, successfully overcoming challenges related to the low bioavailability, permeability, and stability of oral peptides, as well as gastrointestinal degradation. In the Phase III ICONIC-LEAD study, it demonstrated superior data compared to other oral competitors. With strong efficacy data, Johnson & Johnson is highly confident in JNJ-2113, predicting that the drug could achieve a market potential of $5 billion. Observing Johnson & Johnson's breakthrough progress in the oral medication space for psoriasis, AbbVie is also stepping up its efforts to expand its product line and maintain its leadership in the treatment of autoimmune diseases. AbbVie has turned its attention to Nimble Therapeutics, a biotechnology company focused on developing oral peptide therapies. Nimble's research achievements, particularly the IL-23R inhibitor, are noteworthy; this is a preclinical oral therapy designed to provide new treatment options for patients with psoriasis and inflammatory bowel disease (IBD). Importantly, this target shares the same profile as AbbVie's existing blockbuster injectable Risankizumab, indicating that Nimble's research results could synergize with AbbVie's current product line. Nimble claims that its designed drugs not only inherit the strong activity of injectable IL-23 medications but also have an extended half-life. Furthermore, Nimble has disclosed two additional candidates targeting systemic severe myasthenia gravis and IBD, both of which are also in preclinical testing. Through this acquisition, AbbVie will not only incorporate Nimble's product line but also gain advanced technology from this Madison, Wisconsin-based company for synthesizing, screening, and optimizing peptide candidates. This will provide powerful technical support for AbbVie in the field of oral peptide therapies, accelerating its R&D progress in this emerging area. In fact, AbbVie’s acquisition of Nimble marks its third significant acquisition in the immunotherapy developer space this year. This series of consecutive acquisitions not only highlights AbbVie's proactive positioning in the field of immunotherapy but also reveals the company's urgency in maintaining its market leadership, especially against the backdrop of competitors like Johnson & Johnson making strides in oral medications for psoriasis. The peptide industry is currently experiencing an unprecedented golden development period. Compared to small molecular chemical drugs, peptide drugs exhibit higher bioactivity and specificity; compared to biological drugs, they stand out due to low immunogenicity, high purity, and lower production costs. Overall, peptide drugs are favored for their high activity, low dosage, and low toxicity. Frost & Sullivan predicts that the global peptide drug market will grow from $60.7 billion in 2018 to $89.5 billion in 2023, and is expected to reach $189 billion by 2028. When efficacy reaches a certain level, oral medications often become the treatment choice for patients due to their adherence advantages. However, due to the unique chemical and biological characteristics of peptide drugs, their oral delivery remains one of the significant challenges in the pharmaceutical field. Since the discovery of insulin, research on oral peptides has never ceased. Due to the poor permeability of peptide drugs and their susceptibility to degradation by proteases in the gastrointestinal tract, most available peptide drugs are in injectable form. However, the long-term repeated injection not only affects patients' quality of life but also increases the complexity of manufacturing and storage, ultimately leading to higher medical costs. Thus, although the development of oral peptide drugs has been a research hotspot in the pharmaceutical field, few successful products have emerged due to the numerous challenges in absorption. With in-depth studies on the absorption mechanisms of peptides, innovative technologies developed by scientists are gradually breaking the barriers to peptide absorption in the gastrointestinal tract, and some oral peptide drugs have successfully hit the market. For example, the recently spotlighted Semaglutide is a GLP-1 peptide drug that traditionally has been administered via subcutaneous injection. With the help of the innovative SNAC absorption enhancer, the Semaglutide tablet (Rybelsus) has successfully overcome technical barriers, achieving a historic breakthrough in the oral administration of GLP-1 drugs, thus becoming the first truly oral peptide drug. The active pharmaceutical ingredient (API) of Rybelsus is identical to that of its injectable counterpart and is modified with a fatty acid chain, additionally incorporating 300 mg of SNAC molecules. The inclusion of SNAC instantaneously raises the gastric pH, promoting transcellular absorption through the gastric mucosa at specific concentrations. In human NCI-N87 gastric epithelial cell models, adding SNAC increased the absorption capacity of gastric epithelial cells by 100 times. After entering the market, Rybelsus also performed impressively, with demand so great that it led to supply shortages. In the first half of 2024, Rybelsus achieved sales of $1.587 billion, representing a 32% year-over-year growth. Equally noteworthy is the Israeli pharmaceutical company Chiasma Inc., which successfully developed the oral capsule Mycapssa through innovative formulation and received approval in the U.S. in 2020 via the 505(b)(2) regulatory pathway. Mycapssa is the first and only approved oral somatostatin analog capsule for treating acromegaly, offering patients a new treatment option. The transient permeability enhancer (TPE™) technology employed by Chiasma provides critical technical support for developing oral peptide drugs. Merck has also recognized the potential of oral peptides. In January 2024, Merck signed a $220 million collaboration agreement with Unnatural Products. Through this collaboration, Merck intends to leverage Unnatural Products' technology to develop cyclic peptide candidates, primarily targeting the challenging oncology field. Merck has previously likened cyclic peptides to "Goldilocks," as their molecular size falls between small molecules and biologics, offering numerous unique advantages. Previously, Merck launched the Phase III clinical project for MK-0616, a cyclic peptide that binds to PCSK9. Currently, PCSK9-targeted therapies can only be administered via injection, and the cost-effectiveness issues related to using biologics to lower cholesterol have yet to be effectively addressed. Developing an oral PCSK9 inhibitor is a goal in this field, and the R&D of MK-0616 cyclic peptide is expected to make significant breakthroughs in this area. According to a report by MARKET MONITOR GLOBAL, INC (MMG), the global oral peptide therapeutic drug market was approximately $1886.4 million in 2023, with an expected annual compound growth rate (CAGR) of 15.8% over the next six years, reaching $7843.2 million by 2030. Industry perspectives generally indicate that the treatment market for autoimmune diseases is experiencing rapid growth. As the technology for oral peptide therapies continues to advance and the market expands quickly, AbbVie is solidifying its R&D position in the oral peptide field through the acquisition of Nimble Therapeutics. Whether AbbVie can reclaim the title of "King of Immunology" and continue leading innovation in the treatment of autoimmune diseases will be closely monitored by Pharmaceutical Economic News.

CARMIEL, Israel, Dec. 23, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, today announced the following letter from its President and Chief Executive Officer, Dror Bashan, to its stockholders. December 23, 2024 Dear Protalix Stockholders, As we conclude 2024, I am filled with a sense of accomplishment as well as excitement for the year ahead. This past year, Protalix has achieved significant milestones that position our company for long-term growth. The success we have achieved this year is a direct result of our team's hard work and dedication. We're proud to share these accomplishments with you. Our commercial partner, Chiesi Global Rare Diseases, is playing a pivotal role in our journey, and we continue to collaborate with Chiesi in its efforts. Most recently, the European Medicine Agency (EMA) validated Chiesi's Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen (every four weeks) for patients with Fabry disease in the European Union. This submission exemplifies Protalix's and Chiesi's mutual commitment to reducing the treatment burden faced by patients with Fabry disease. We have made important progress on our pipeline programs over the past year. We completed a phase I First-in-Human clinical trial evaluating PRX 115, our recombinant PEGylated uricase (urate oxidase) in development for the potential treatment of uncontrolled gout. Results from the trial demonstrate the potential of PRX-115 to be a safe and effective uric-acid lowering treatment with a potential wide dosing interval. We were proud to present this data to the medical community at the American College of Rheumatology (ACR) Convergence 2024 conference in November and are looking forward to advancing PRX-115 into a phase II clinical trial in patients with uncontrolled gout in the second half of 2025. We are also excited to have fine-tuned our R&D strategy moving forward, leveraging our ProCellEx platform and other capabilities in prioritized renal rare diseases. Our expert R&D team continues to evaluate plant-based drug delivery systems that may allow protective delivery of different modalities. The team is laser focused on these efforts, and we are eager to share more pipeline developments throughout the coming year. We are satisfied with the growth in our sales to Chiesi of Elfabrio®, Elelyso® to Pfizer Inc. and Uplyso® to Brazil which makes up our three revenue streams. We look forward to continuing growth of our sales in the coming years. Finally, by employing financial discipline over the last few years, we were able to repay in full all of our outstanding convertible notes, making us a debt-free company. We are proud of this achievement, and our strong balance sheet enables us to support ongoing operations. Our community continues to face the challenges of military activity in Israel. The suffering experienced by people in all sectors of these conflicts is heart-breaking. Despite the impact of these events on our colleagues and community, on both a personal and professional level, we have successfully maintained full, uninterrupted operations throughout the conflict. The continued dedication of our employees is a source of pride and we look forward to more peaceful times. Looking ahead, the future of Protalix is exciting. I am confident in our ability to deliver innovative solutions to improve the lives of patients in need. I want to express my sincere gratitude to our dedicated employees, our supportive Board of Directors and our valued shareholders. Your collective efforts and belief in our mission are instrumental in driving our progress. We sincerely thank you. Truly yours, Dror Bashan, President & Chief Executive Officer About Protalix BioTherapeutics, Inc. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Forward-Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; the possible disruption of our operations due to the war declared by Israel's security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the potential commercial value of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with global conditions and developments such as supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer Inc., or Pfizer, and Chiesi Farmaceutici S.p.A.; risks related to the amount and sufficiency of our cash and cash equivalents; risks relating to changes to interim, topline or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fundação Oswaldo Cruz, an arm of the Brazilian Ministry of Health, with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; and risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law. Investor Contact Mike Moyer, Managing Director LifeSci Advisors +1-617-308-4306 [email protected] Logo - SOURCE Protalix BioTherapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Seralutinib becomes XOMA Royalty’s seventh Phase 3 royalty asset, further building the late-stage pipeline beyond its six current commercial royalty assets Seralutinib is being developed and co-commercialized by Gossamer Bio, Inc., and Chiesi Farmaceutici S.p.A; a Phase 3 study for pulmonary arterial hypertension is ongoing and is expected to read out in the fourth quarter of 20251 XOMA Royalty has the potential to net up to $25 million in milestone payments and earn a low to mid-single digit royalty Dec. 02, 2024 -- XOMA Royalty Corporation (NASDAQ: XOMA) announced today it now owns an economic interest in seralutinib, a Phase 3 asset being studied in pulmonary arterial hypertension (PAH), through its acquisition of Pulmokine Inc., a privately held company. In 2017, Pulmokine licensed seralutinib to Gossamer Bio, Inc., and in 2024, Gossamer Bio signed a global collaboration and license agreement with Chiesi Farmaceutici S.p.A. “We acquired Pulmokine to add seralutinib, a Phase 3 asset with strong mechanistic rationale in PAH, to our growing royalty and milestone portfolio while creating a favorable outcome for Pulmokine’s founders and stockholders. In addition, we believe seralutinib has the potential to address several cardio-respiratory conditions beyond PAH in the future,” stated Brad Sitko, Chief Investment Officer of XOMA Royalty. “This transaction marks the second whole-company acquisition we have completed in 2024. We continue to offer creative royalty capital solutions to access assets with the potential to deliver attractive returns to XOMA Royalty’s diverse portfolio.” XOMA Royalty acquired all outstanding shares of Pulmokine for a $20 million cash payment at closing. In addition, XOMA Royalty will pay success-based consideration contingent on future development and commercial events to Pulmokine stockholders. XOMA Royalty’s net royalties will range from the low to mid-single digits on commercial sales; additionally, the Company will retain up to $25 million of the milestone payments. XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP. XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about XOMA Royalty and its portfolio, please visit www.xoma.com or follow the Company on LinkedIn. 1 https://ir.gossamerbio.com/news-releases/news-release-details/gossamer-bio-announces-third-quarter-2024-financial-results-and The content above comes from the network. if any infringement, please contact us to modify.