McNeil Consumer & Specialty Pharmaceuticals, Inc.

Sometime next year, well-known consumer products like Tylenol, Band-Aid and Listerine mouthwash will be sold by a new company called Kenvue.On Wednesday, Johnson & Johnson, the worlds largest drugmaker and familiar brand to millions, announced the name as the corporate identify of its planned spin-out, which will separate from J&Js pharmaceutical and medical device businesses next year.J&J has been planning for the split since November 2021, when it revealed its intentions to break in two and create a large and independent consumer health company. The shakeup is meant to boost the value of each half and is expected to be completed sometime in 2023.The naming follows several steps by J&J to put in place Kenvues leadership. In August, J&J named Larry Merlo, the former CEO of CVS Health, as chair-designate of Kenvues board of directors. In May, Thibaut Mongon was appointed as the new companys CEO and Paul Ruh was named as its chief financial officer.The new name brings the consumer health company one step closer to officially being an independent entity. The name, according to J&J, is inspired by two ideas: ken, an English word meaning knowledge, and vue, which references sight.J&Js consumer business earned nearly $15 billion in revenue last year, led by brands like Tylenol and Band-Aid, as well as Neutrogena, Aveeno and Listerine.The split follows similar moves taken by other large pharmaceutical companies in recent years. Pfizer, Merck & Co. and Novartis have each split off divisions focused on consumer health or generic drugs, aiming to create more focused drug development organizations.J&J plans to release more information regarding the split, Kenvues finances and its board of directors in the future. '

Vienna, June 09, 2022 (GLOBE NEWSWIRE) -- The European Hematology Association (EHA) Conference published four independent studies of Voraxaze® (glucarpidase) by various investigators for inclusion in its June 2022 EHA Hybrid Congress abstract book and for publication in HemaSphere, EHA’s peer-reviewed, open access journal. All four abstracts are the result of independent studies in Europe and the United States; three explore whether routinely giving Voraxaze® in combination with high-dose methotrexate (“planned use”) might alleviate toxicity, manage the risk to patients and help them to complete therapy. PLANNED-USE GLUCARPIDASE FOR OUTPATIENT HIGH DOSE METHOTREXATE (HD-MTX) ADMINISTRATION IN PATIENTS WITH CNS LYMPHOMA (CNSL) DURING THE COVID-19 PANDEMIC, by Lauren Schaff, Mina Lobbous, Dean Carlow, Lisa DeAngelis, Louis Burt Nabors, and Christian Grommes, demonstrates the feasibility of planned-use Voraxaze to facilitate the outpatient administration of HD-MTX for patients with CNS lymphoma. Twenty outpatient treatments of HD-MTX with glucarpidase were administered to a total of 7 patients. Some grade 1 and grade 2 adverse events attributable or possible attributable to Voraxaze were noted. None of the patients required hospital admission during treatment. [Link to abstract] REDUCTION OF METHOTREXATE (MTX) LEVELS AFTER GLUCARPIDASE IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) AT RISK OF CENTRAL NERVOUS SYSTEM (CNS) INVOLVEMENT WHO RECEIVE HD-MTX: PHASE 2 by Adolfo De La Fuente, Francisco Javier Peñalver, Pilar Herrera, Raul Cordoba, Carmen Martinez Chamorro, Maria Teresa Olave, Isidro Jarque, and Mónica Estévez, is an open-label, interventional, non-randomized, phase 2 pilot multicenter study in diffuse large B-cell lymphoma patients at high risk of CNS relapse to assess prophylactic effect of glucarpidase in MTX related-toxicity administered after 12 hours of HD-MTX. The study aims to describe the reduction of MTX levels after systematic administration of glucarpidase 12 hours following start of HDMTX infusion in DLBCL patients at high risk for CNS involvement. This trial has not been completed. [Link to abstract] INTENDED USE OF GLUCARPIDASE IN PATIENTS WITH CENTRAL NERVOUS SYSTEM LYMPHOMA AND IMPAIRED RENAL FUNCTION – THE VALIDATE STUDY by Sven Liebig, Susen Burock, Immanuel Merz, Franz Knörnschild, Peggy Kießling, Kai Kappert, Ulrich Keller, and Stefan Schwartz evaluates the safety as well as pharmacological efficacy of intended and repeated use of glucarpidase following HD-MTX in patients with CNSL and impaired renal function. Glucarpidase administration resulted in a rapid and pronounced reduction of MTX blood levels (> 97%) within 15 minutes and in all 12 treatment cycles for four patients, demonstrating that treatment with HD-MTX and glucarpidase is feasible in patients with CNSL and impaired renal function. [Link to abstract] A POPULATION PHARMACOKINETIC MODEL OF HIGH-DOSE METHOTREXATE IN ADULTS WITH CANCER IDENTIFIES BASELINE ALBUMIN, BODY WEIGHT, AND TIME-DEPENDENT CREATININE AS PREDICTORS OF ACUTE KIDNEY INJURY by Scott Howard, Manuel Ibarra, Ryan Combs, and Paula Schaiquevich, describes a population pharmacometric model of HD-MTX elimination developed by the authors that considers weight, albumin, and time-dependent creatinine to predict AKI and guide supportive care in patients with delayed HD-MTX elimination. Patients with AKI who did not receive glucarpidase experienced significantly longer hospital length of stay (p<0.01) and time to methotrexate elimination (p<0.01). [Link to abstract] “We are excited to see top researchers working to explore how routinely giving Voraxaze® in combination with methotrexate might improve cancer care for appropriate patients,” said Christon Hill, Group Chief Innovation Officer for SERB and BTG Specialty Pharmaceuticals. “These encouraging early findings suggests that such regimens may help to manage the risk to patients and ensure more patients are able to complete their cancer therapy.” About Voraxaze® (glucarpidase) Voraxaze® (glucarpidase) is currently approved in all members states of the European Union as well as Iceland, Liechtenstein, and Norway, where it is designated an orphan medicine. Voraxaze® is approved by the European Commission to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity. Detailed recommendations for the use of Voraxaze ® are described in the Summary of Product Characteristics (SmPC) and in the U.S. prescribing information (USPI). SERB Specialty Pharmaceuticals market Voraxaze® in the European Union. BTG Specialty Pharmaceuticals market Voraxaze® in the United States. SERB acquired BTG Specialty Pharmaceuticals in March 2021. Glucarpidase is sold in Japan as Megludase® by BTG’s marketing partner, Ohara Pharmaceutical Co. About SERB and BTG Specialty Pharmaceuticals Together, SERB and BTG Specialty Pharmaceuticals are a growing specialty pharmaceutical company and a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. Learn more about SERB: Learn more about BTG Specialty Pharmaceuticals: btgsp.com. Chris Sampson SERB and BTG Specialty Pharmaceuticals +44 7773 251 178 chris.sampson@btgsp.com

BRYAN, Texas, Feb. 16, 2021 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech innovator and biologics contract manufacturing organization, today announced the appointment of Robert M. Lutz as its Chief Financial & Business Officer (“CFBO”), effective March 4, 2021. “I am pleased to welcome Rob to iBio where we expect he will make an immediate impact on our business during this transformative time,” said Tom Isett, Chairman & CEO of iBio. “His deep experience across corporate finance and business development functions, breadth of public company experience, and demonstrated expertise in building product portfolios is a tremendous fit for iBio as we seek to execute on our new business model.” Mr. Lutz brings more than 25 years of experience to the Company, joining most recently from Strongbridge Biopharma plc (“Strongbridge”), a Nasdaq-listed, commercial-stage biopharmaceutical company focused on rare diseases. He served as CFO since August 2019, and prior to that, as Chief Business Officer since October 2014. During his tenure, he led the search, evaluation, contracting, and financing of multiple assets which proved to be critical growth drivers for Strongbridge. Before joining Strongbridge, Mr. Lutz spent more than a decade at Shire Pharmaceuticals (“Shire”) in leadership positions with global responsibilities, including identifying opportunities for acquisition, licensing, partnership and development for Shire’s largest business unit (Neuroscience) and the financial management of approximately $5 billion in revenue for its Specialty Pharmaceuticals division. Prior to joining Shire, Mr. Lutz served in a variety of financial, strategic and executive positions after having started his career at Goldman Sachs & Company. He holds an MBA from the Kellogg School of Management and a BA in Economics and Computer Science from Amherst College. “It is an exciting time to be joining iBio,” Mr. Lutz commented. “There is a unique opportunity to leverage the strengths of the Company’s high-speed, plant-based biopharmaceutical production capabilities across multiple product categories and therapeutic areas. I look forward to working with the team to expand the product pipeline, accelerate growth, and enhance value for our shareholders.” As CFBO, Mr. Lutz will lead iBio’s finance organization and be responsible for building strong licensing capabilities and the financial planning & analysis function, as well as supporting iBio’s relationships with the investment community. About iBio, Inc. iBio is a global leader in plant-based biologics manufacturing. Its FastPharming® System combines vertical farming, automated hydroponics, and novel glycosylation technologies to rapidly deliver high-quality monoclonal antibodies, vaccines, bioinks and other proteins. iBio is developing proprietary products on the FastPharming Platform, which include biopharmaceuticals for the treatment of fibrotic and infectious diseases, amongst others. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services, including Glycaneering™ Development Services for advanced recombinant protein design. For more information, visit . FORWARD-LOOKING STATEMENTS Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding the expected contribution of Mr. Lutz, executing the Company’s new business model, and expanding the Company’s product pipeline, accelerating growth, and enhancing value for our shareholders. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the contribution of Mr. Lutz, the Company’s ability to expand its product pipeline, the Company’s ability to obtain regulatory approvals for commercialization of its product candidates, including its infectious disease vaccines, or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, its ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, competition, its ability to retain its key employees or maintain its NYSE American listing, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended June 30, 2020 and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Form 10-Q and Form 8-K. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. Contact: Stephen Kilmer iBio, Inc. Investor Relations (646) 274-3580 skilmer@ibioinc.com