Drug Infusion Systems Global Market Report 2024: Demand for Personalized Medicine and Adaptive Dosing Spurs Growth – Long-term Forecast to 2028 and 2033 – ResearchAndMarkets.com




Drug Infusion Systems Global Market Report 2024: Demand for Personalized Medicine and Adaptive Dosing Spurs Growth – Long-term Forecast to 2028 and 2033 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Drug Infusion Systems Global Market Report 2024” report has been added to ResearchAndMarkets.com’s offering.

The drug infusion systems market has grown strongly in recent years. It will grow from $12.8 billion in 2023 to $13.78 billion in 2024 at a compound annual growth rate (CAGR) of 7.6%. The drug infusion systems market is expected to see strong growth in the next few years. It will grow to $18.74 billion in 2028 at a compound annual growth rate (CAGR) of 8.0%.

The expansion observed in the historical period can be ascribed to the transition towards electronic infusion devices, a rise in the prevalence of chronic diseases, advancements in patient care, the adoption of home-based infusion therapy, and the growth of ambulatory care settings.

The anticipated growth in the forecast period can be linked to a shift towards disposable systems, a rising prevalence of chronic diseases, the expansion of ambulatory care facilities, the adoption of personalized medicine and adaptive dosing, and an increasing demand for home-based care. Noteworthy trends in the forecast period encompass wireless connectivity and remote monitoring, integration with electronic health records (EHR), the implementation of smart pump technology, the adoption of personalized and adaptive dosing, and the utilization of minimally invasive infusion techniques.

The anticipated growth in the drug infusion system market is expected to be propelled by the increasing prevalence of chronic diseases. Chronic conditions such as cancer, diabetes, cardiovascular diseases, and autoimmune disorders often necessitate long-term or continuous infusion therapy. Drug infusion systems provide a secure, efficient, and effective means of administering medication to patients with these conditions. The prevalence of chronic diseases is rising more rapidly in low- and middle-income countries compared to high-income nations.

Diabetes, for example, is a significant contributor to renal failure, heart attacks, strokes, blindness, and lower limb amputation. According to the International Diabetes Federation (IDF), in 2021, 537 million adults aged between 20-79 were living with diabetes (1 in 10 individuals), and this number is projected to reach about 643 million by 2030 and 783 million by 2045. Therefore, the increasing demand due to the rising prevalence of chronic diseases is a driving factor for the growth of the drug infusion system market.

The growth of healthcare expenditure is expected to drive the expansion of the drug infusion systems market. Healthcare expenditure refers to the total amount spent on healthcare goods and services within a specific period, typically a year. With increased healthcare expenditures, hospitals, clinics, and other healthcare institutions have more resources to invest in advanced drug infusion systems, leading to a higher demand for these devices.

The adoption of advanced drug delivery technologies stands out as a prominent trend in the drug infusion systems market. Leading companies in the market are actively engaged in developing innovative products that incorporate advanced technologies to maintain a competitive position. For example, in June 2021, Ivenix, a medical device company based in the United States, introduced a smart infusion system integrated with an advanced informatics platform.

This infusion therapy system by Ivenix features new pump technology that automates secondary infusions, ensuring patients receive the complete prescribed therapy. The system also integrates a state-of-the-art informatics platform, allowing secure access to patient-specific infusion and pump management from any computer or mobile device. It seamlessly integrates with ADT interfacing, alarm notification systems, charge capture solutions, and electronic medical records (EMR) for smooth workflow integration.

Major players in the drug infusion systems market are directing their efforts towards developing innovative products, such as medication delivery systems, to gain a competitive advantage. Medication delivery systems encompass a diverse range of innovative tools and systems designed to enhance the safe, accurate, and efficient administration of medications.

North America was the largest region in the drug infusion systems market in 2023. Asia-Pacific is expected to be the fastest-growing region in the global drug infusion systems market report during the forecast period. The regions covered in the drug infusion systems market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the drug infusion systems market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Key Topics Covered:

1. Executive Summary

2. Drug Infusion Systems Market Characteristics

3. Drug Infusion Systems Market Trends and Strategies

4. Drug Infusion Systems Market – Macro Economic Scenario

4.1. Impact of High Inflation on the Market

4.2. Ukraine-Russia War Impact on the Market

4.3. COVID-19 Impact on the Market

5. Global Drug Infusion Systems Market Size and Growth

5.1. Global Drug Infusion Systems Market Drivers and Restraints

5.1.1. Drivers of the Market

5.1.2. Restraints of the Market

5.2. Global Drug Infusion Systems Historic Market Size and Growth, 2018-2023, Value ($ Billion)

5.3. Global Drug Infusion Systems Forecast Market Size and Growth, 2023-2028, 2033F, Value ($ Billion)

6. Drug Infusion Systems Market Segmentation

6.1. Global Drug Infusion Systems Market, Segmentation by Product, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion

• Elastomeric Infusion System
• Disposable Infusion System
• Syringe Infusion System
• Peristaltic Pump
• Multi-Channel Pump
• Patient-Controlled Analgesia (PCA) Pump
• Insulin Pump
• Implantable Infusion System

6.2. Global Drug Infusion Systems Market, Segmentation by Route of Administration, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion

• Intravenous
• Subcutaneous
• Arterial
• Epidural
• Other Routes of Administration

6.3. Global Drug Infusion Systems Market, Segmentation by Application, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion

• Oncology and Chemotherapy
• Diabetes
• Analgesia
• Nutrition
• Hematology
• Pediatrics
• Other Applications

6.4. Global Drug Infusion Systems Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion

• Hospitals
• Ambulatory Surgical Centers
• Diagnostic Centers
• Other End Users

7. Drug Infusion Systems Market Regional and Country Analysis

7.1. Global Drug Infusion Systems Market, Split by Region, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion

7.2. Global Drug Infusion Systems Market, Split by Country, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion

A selection of companies mentioned in this report includes, but is not limited to:

• Medtronic plc
• Baxter International Inc.
• ICU Medical Inc.
• Becton Dickinson and Company
• Smiths Group plc
• Tandem Diabetes Care Inc.
• Terumo Corporation
• Acromed AG
• Halyard Health Inc.
• Insulet Corporation
• Zyno Medical Inc.
• Braun Melsungen AG
• Flowonix Medical Inc.
• IRadimed Corporation
• Moog Inc.
• Debiotech S.A.
• Fresenius SE & Co. KGaA
• Johnson & Johnson
• Hospira
• Alaris Health Systems Inc.
• B. Braun Melsungen AG
• Disetronic Medical Systems AG
• Accu-Chek
• Abbott Diabetes Care Inc.
• Novo Nordisk A/S
• Eli Lilly and Company
• Sanofi-Aventis
• Ypsomed Holding AG
• Valeritas Inc.
• Proteus Digital Health Inc.
• Pear Therapeutics Inc.
• Huma Inc.

For more information about this report visit https://www.researchandmarkets.com/r/95p5ew

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Zura Bio Announces Oversubscribed $112.5 Million Private Placement




Zura Bio Announces Oversubscribed $112.5 Million Private Placement

– Financing includes new and existing leading life sciences institutional investors

– Strengthened balance sheet expected to fund operations through 2027

HENDERSON, Nev.–(BUSINESS WIRE)–Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that it has entered into subscription agreements for a private placement that is expected to result in gross proceeds of approximately $112.5 million, before deducting placement agent fees and offering expenses (the “Private Placement”).

The Private Placement is led by Access Biotechnology and a leading life sciences-focused institutional investor, and includes participation from other new and existing investors, including RA Capital Management, Deep Track Capital, Great Point Partners, LLC, Suvretta Capital, funds managed by Allostery Investments LP, Armistice Capital, and other large investment management firms.

Zura Bio has agreed to sell an aggregate of approximately 20.1 million Class A ordinary shares at a purchase price of $3.108 per share, and, in lieu of Class A ordinary shares to certain investors, pre-funded warrants to purchase up to an aggregate of 16.1 million Class A ordinary shares at a purchase price of $3.107 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.001 per ordinary share, and will be immediately exercisable and remain exercisable until exercised in full. The Private Placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules). The private placement is expected to close on April 22, 2024, subject to satisfaction of customary closing conditions.

Anticipated proceeds from the private placement are expected to support the accelerated development of tibulizumab (ZB-106), including the planned Phase 2 clinical trial in systemic sclerosis (SSc), the initiation of a Phase 2 trial evaluating tibulizumab for the treatment of hidradenitis suppurativa (HS), and general corporate purposes. The combination of anticipated net proceeds with existing cash and cash equivalents is expected to support operations through 2027.

Piper Sandler, Guggenheim Securities, and Cantor served as lead placement agents for the Private Placement.

The securities are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Zura Bio has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission (the “SEC”), for purposes of registering the resale of the Class A ordinary shares and the Class A ordinary shares underlying the pre-funded warrants issued or issuable in connection with the Private Placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the shares under the resale registration statement will only be by means of a prospectus.

ABOUT ZURA BIO

Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies and are Phase 2 ready. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), ZB-168, and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.

FORWARD-LOOKING STATEMENTS

This communication includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” “strategy,” “future,” “opportunity,” “would,” “seem,” “seek,” “outlook” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements in this release include, but are not limited to, statements regarding Zura Bio’s anticipated proceeds to be received in the proposed Private Placement, expected timing of closing of the proposed Private Placement and the size, completion and use of proceeds of the proposed Private Placement, the forecast of cash runway and the Company’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives, statements related to Zura Bio’s abilities to achieve anticipated internal readouts and achieve them in expected time periods, Zura Bio’s product candidates, clinical trials and the design and timing thereof, statements with respect to expected therapeutic potential and statements regarding Zura Bio’s product candidates ability to proceed into Phase 2 clinical trials. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability.

Actual events and the ability to consummate the proposed Private Placement and the timing and proceeds thereof; are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of Zura Bio’s 10-K for the year ended December 31, 2023 and other filings with the SEC, including: Zura Bio’s expectations regarding product candidates and their related benefits; Zura Bio’s beliefs regarding potential benefits or limitations of competing products both in development and approved; information regarding Zura Bio’s vision and strategy; anticipated timing of key events and initiation of Zura Bio’s studies and release of clinical data; Zura Bio’s expectations regarding the general acceptability and maintenance of our products by regulatory authorities, payors, physicians, and patients; Zura Bio’s ability to attract and retain key personnel; the accuracy of Zura Bio’s future operating expenses, capital requirements and needs for additional financing; Zura Bio’s ability to obtain funding for operations, including funds that may be necessary to complete development of our product candidates; the fact that Zura Bio has not completed any clinical trials and has no products approved for commercial sale; the fact that Zura Bio has incurred significant losses since inception, and it expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio’s ability to renew existing contracts; Zura Bio’s reliance on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio’s ability to obtain regulatory approval for our products, and any related restrictions or limitations of any approved products; Zura Bio’s ability to effectively manage growth and competitive pressures from other companies worldwide in the therapies in which Zura Bio competes; and litigation and Zura Bio’s ability to adequately protect intellectual property rights. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, including projections, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, or should circumstances change, except as otherwise required by securities and other applicable laws.

Contacts

Megan K. Weinshank

Head of Investor Relations

IR@zurabio.com

Lee M. Stern

Meru Advisors

lstern@meruadvisors.com

Ferring Pharmaceuticals and SK Pharmteco Enter into Commercial Gene Therapy Manufacturing Deal




Ferring Pharmaceuticals and SK Pharmteco Enter into Commercial Gene Therapy Manufacturing Deal

• Biopharmaceutical contract manufacturer SK pharmteco commits to production, testing, and release of Ferring’s U.S. approved ADSTILADRIN^® (nadofaragene firadenovec-vncg)

• The deal assures diversity of supply to meet future long-term plans for expanded availability of the gene therapy

• Two additional state-of-the-art manufacturing facilities for ADSTILADRIN are near completion in Finland and the U.S.

PARSIPPANY, N.J. & KING OF PRUSSIA, PA.–(BUSINESS WIRE)–Ferring Pharmaceuticals and SK pharmteco today announced an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical non-replicating gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organization (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA).

ADSTILADRIN was approved by the FDA in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.¹

This additional scale up and diversification of drug substance capacity demonstrates Ferring’s commitment to securing future long-term supply of ADSTILADRIN to meet the projected commercial growth of its non-replicating gene therapy. In addition to this contract manufacturing agreement, dedicated capacity expansion of ADSTILADRIN is well underway at state-of-the-art facilities in Ferring’s existing site in Finland and its U.S. campus in Parsippany, New Jersey. Ferring will provide updates on the progress of these near-term projects later in 2024.

“Ferring takes its responsibilities to patients with high-risk BCG-unresponsive NMIBC very seriously – especially when pioneering in the emerging field of gene therapy commercial manufacturing,” said Bipin Dalmia, Global Head, Uro-Oncology Franchise, Ferring Pharmaceuticals. “Following our January announcement of full availability of ADSTILADRIN across the U.S. and expansion of our clinical trials program, this agreement with SK pharmteco comes alongside major investments in our own manufacturing capabilities to assure the breadth of our long-term supply base. Stable and sustainable supply is a vital part of our mission to fill this unmet clinical need for the patients we serve.”

The need to scale up supply of strategically important medicines for bladder cancer across geographies is demonstrated by the trend of increased disease prevalence worldwide. The World Bladder Cancer Patient Coalition has reported that bladder cancer became the ninth most common cancer in the world (a rise from tenth) according to new data published in February 2024 (IARC GLOBOCAN 2022)². In the United States, it is the seventh most common cancer, fourth among men,^3-4 and 75% of bladder cancer presents as NMIBC.⁵

“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy ADSTILADRIN,” said Joerg Ahlgrimm, Chief Executive Officer for SK pharmteco. “Our integrated approach, incorporating customizable clinical and commercial GMP manufacturing solutions with comprehensive in-process testing, quality control, and lot release programs, provides unparalleled support to our partners throughout their product lifecycle and is in perfect alignment with our mission of expediting the delivery of potentially life-saving therapies to patients across the globe.”

SK pharmteco was selected based on their competencies and alignment on core values across the two companies following a thorough assessment of potential CDMOs with gene therapy development and GMP manufacturing capabilities.

###

About ADSTILADRIN

ADSTILADRIN^® (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alpha-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high quantities of interferon alpha-2b protein, a naturally-occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-grade, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849).⁶

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is a form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.⁷ In the United States, bladder cancer is the seventh most common cancer, fourth among men^3-4, and it is estimated that there will be approximately 83,190 new cases of bladder cancer in the U.S. in 2024.⁸ Historically, 75% of bladder cancer presents as NMIBC.⁵ In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.⁸ Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).⁹

INDICATION

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

• Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.

• Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.

DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

Please click to see the full Prescribing Information.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.

For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X (Twitter).

About SK pharmteco

SK pharmteco is a global contract development and manufacturing organization (CDMO) with 13 offices and manufacturing facilities across the U.S., Europe, and Korea. The company partners with biopharmaceutical companies of all sizes to manufacture Active Pharmaceutical Ingredients (API) and intermediates, cell and gene therapy technologies, registered starting materials, and analytical services for the biopharmaceutical industry worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.

Learn more at www.skpharmteco.com, or connect with us on LinkedIn.

# # #

Contacts

SK pharmteco
Keith Bowermaster

Modig Group

(+01) 770-891-9247

Keith@ModigGroup.com

Ferring Pharmaceuticals
Carol Ready

Director, Brand Communications

(+1) (973) 765-7307

carol.ready@ferring.com

Ferring Pharmaceuticals
Matthew Worrall

Director of Corporate Communications

(+44) 7442 271 811

Matthew.Worrall@ferring.com

ESCMID Global 2024: Shionogi presents real-world data demonstrating efficacy of Fetcroja® / Fetroja® (cefiderocol) in critically ill patients with certain difficult-to-treat bacterial infections




ESCMID Global 2024: Shionogi presents real-world data demonstrating efficacy of Fetcroja® / Fetroja® (cefiderocol) in critically ill patients with certain difficult-to-treat bacterial infections

New data from the largest European real-world evidence study of cefiderocol demonstrate positive outcomes including high rates of clinical success and day 28 survival across Gram-negative pathogens considered as critical priorities by the WHO in patients with limited treatment options^1,2

OSAKA, Japan–(BUSINESS WIRE)–Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announces new data from the largest European real-world evidence study (PERSEUS) of Fetroja^®/Fetcroja^® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of critically ill patients with carbapenem-resistant (CR) Gram-negative (GN) bacterial infections at the 34^th ESCMID Global (formerly ECCMID) in Barcelona, 27–30 April, 2024.

Please see below under About Cefiderocol for full indications of Fetroja in the U.S.

The PERSEUS study is a retrospective, multicenter, observational chart review study designed to describe the efficacy and safety of real-world cefiderocol use in adult patients with GN bacterial infections.¹ The analysis found patients receiving cefiderocol achieved an overall clinical success rate (primary endpoint, defined as the composite of clinical cure and/or survival at Day 28) of 84.3% and a 28-day all-cause mortality of 21.5%.¹

The majority of patients had respiratory tract infections (47.9%) caused by Pseudomonas aeruginosa (66.7%), Klebsiella pneumoniae (10.0%) and Stenotrophomonas maltophilia (7.7%) as principal pathogens. Additionally,19.5% of patients had polymicrobial infections.¹

The study included 261 critically ill adult patients with limited treatment options who received cefiderocol for less than 28 days as part of Shionogi’s Early Access Program in Spain. Of these, 64.8% were resistant to all tested antibiotics and 44.4% experienced treatment failure with prior antibiotics.¹ The patients received cefiderocol consecutively for ≥72 hours for a confirmed GN bacterial infection. The patients included in the analysis were critically ill with nearly two-thirds (63.2%) in the intensive care unit, 47.1% on mechanical ventilation and 28% with septic shock.¹ In addition to GN bacterial infections, patients also had serious comorbidities including immunosuppression (30.3%), solid or hematological tumors (23.8%), diabetes (22.2%), transplant (20.7%), chronic renal disease (13.0%) and chronic obstructive pulmonary disease (10.3%).¹

Across these 261 patients, cefiderocol was generally well tolerated with six patients experiencing an adverse drug reaction.

Dr. Alex Soriano, Head of Infectious Diseases Service at Hospital Clinic in Barcelona, says: “The increasing resistance of Gram-negative bacterial infections to current therapies makes them difficult to treat. Real-world evidence is particularly important when reviewing antibiotic use for multidrug-resistant pathogens because of the challenges of conducting randomized clinical trials. These new data reinforce the importance of cefiderocol and contribute to the growing body of real-world evidence in patient care for those with difficult-to-treat pathogens that were resistant to other antibiotics.”

Isao Teshirogi, Ph.D, Chief Executive Officer of Shionogi, adds: “Shionogi is proud of its 60-year leadership in developing anti-infective medicines and we remain committed to our focus on innovative research that may help address the growing threat of antimicrobial resistance. Cefiderocol is included in the World Health Organization’s 23 Model List of Essential Medicines⁶, and these data demonstrate its continued importance in helping to improve outcomes for patients with some of the most difficult to treat infections.

We also know how important it is to ensure equitable, global, access to essential medicines like cefiderocol. That’s why we are working with like-minded partners GARDP and CHAI, to support the availability of this important antibiotic for people living in low- and middle-income countries.”

About Shionogi & Co. Ltd.

Shionogi & Co., Ltd. is a 146-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders.

For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.

About Shionogi in AMR

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on R&D in anti-infectives.

About Cefiderocol

In Europe, cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.³ In the U.S., cefiderocol is available under the brand name Fetroja® and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms.⁴ In Japan, cefiderocol is commercially available under the brand name Fetroja® and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species.⁵

U.S. INDICATIONS

Fetroja^® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.

Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.

USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.

WARNINGS AND PRECAUTIONS

Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections

An increase in 28-Day all-cause mortality was observed in Fetroja-treated nosocomial pneumonia, bloodstream infections, or sepsis patients compared to those treated with best available therapy (BAT) in a clinical study (NCT02714595). Most BAT regimens contained colistin. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49.

Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed with Fetroja. Before Fetroja is instituted, inquire about previous hypersensitivity to cephalosporins, penicillins, or other beta-lactam drugs. If an allergic reaction occurs, discontinue Fetroja.

Clostridioides difficile-associated Diarrhea (CDAD)

CDAD has been reported with nearly all systemic antibacterial agents, including Fetroja. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued.

Seizures and Other Central Nervous System (CNS) Adverse Reactions

Cephalosporins, including Fetroja, have been implicated in triggering CNS adverse reactions such as seizures. Encephalopathy, coma, asterixis, and neuromuscular excitability have been reported with cephalosporins particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. If focal tremors or seizures occur, evaluate patients to determine whether Fetroja should be discontinued.

Development of Drug-Resistant Bacteria

Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

ADVERSE REACTIONS

The most common adverse reactions occurring in ≥2% of patients receiving Fetroja in the cUTI trial were: diarrhea (4%), infusion site reactions (4%), constipation (3%), rash (3%), candidiasis (2%), cough (2%), elevations in liver tests (2%), headache (2%), hypokalemia (2%), nausea (2%), and vomiting (2%). The most common adverse reactions occurring in ≥4% of patients receiving Fetroja in the HABP/VABP trial were: elevations in liver tests (16%), hypokalemia (11%), diarrhea (9%), hypomagnesemia (5%), and atrial fibrillation (5%).

Please click here for Full U.S. Prescribing Information for Fetroja^® (cefiderocol).

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

References

¹ Ramirez P et al. Real-world effectiveness and safety of cefiderocol in patients with Gram-negative bacterial infections in the early access programme in Spain: results of the PERSEUS study. Abstract. ECCMID 2024.

² World Health Organization. WHO priority pathogens list for R&D of new antibiotics. Available at: https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed. Accessed: March 2024.

³ Fetcroja^® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf . Accessed: March 2024.

⁴ Fetroja^® Prescribing information. Available at: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf. Accessed: April 2024.

⁵ Press release on November 30, 2023. Regarding the Acquisition of Manufacturing and Marketing Approval for the New Siderophore Cephalosporin Antibiotic Fetroja(cefiderocol) Intravenous Infusion 1g vial in Japan

⁶ WHO Model List of Essential Medicines – 23rd list, 2023. WHO Model List of Essential Medicines – 23rd list, 2023 Accessed: April 2024

Contacts

SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html
SEU Press Office: pressoffice@shionogi.eu
U.S. Media Contact: ShionogiCommunications@shionogi.com

GSK3528869A (Bepirovirsen) for Chronic Hepatitis B Drug Pipeline Research 2024: Market Size, Forecast, and Emerging Insights 2019-2032 – ResearchAndMarkets.com




GSK3528869A (Bepirovirsen) for Chronic Hepatitis B Drug Pipeline Research 2024: Market Size, Forecast, and Emerging Insights 2019-2032 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “GSK3528869A Bepirovirsen Market Size, Forecast, and Emerging Insight – 2032” report has been added to ResearchAndMarkets.com’s offering.

The report provides comprehensive insights about GSK3528869A Bepirovirsen for chronic hepatitis B in the seven major markets and China. A detailed picture of the GSK3528869A Bepirovirsen for chronic hepatitis B in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China for the study period 2019-2032 is provided in this report along with a detailed description of the GSK3528869A Bepirovirsen for chronic hepatitis B.

The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the GSK3528869A Bepirovirsen market forecast analysis for chronic hepatitis B in the 7MM and China, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in chronic hepatitis B.

Drug Summary

GSK3228836 (also known as bepirovirsen) is under the developmental process of the collaboration of GlaxoSmithKline (GSK) and Ionis Pharma. It is an investigational antisense oligonucleotide (ASO) designed to specifically recognize the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) that facilitate chronicity of the disease by helping to avoid clearance by the immune system. Bepirovirsen has the additional property of stimulating immune responses via Toll-like receptor 8 (TLR8), which may help the immune system to achieve durable clearance of the virus from circulating blood.

GSK3528869A is a three-component therapeutic vaccine:

• ChAd155-hIi-HBV: replication-defective simian (chimpanzee-derived) Group C adenovirus serotype 155 viral vector encoding sequences of two HBV protein antigens: the truncated hepatitis B core antigen (HBcAg) and the full-length small hepatitis B surface antigen (S-HBsAg)
• MVA-HBV: encoding the above two HBV protein antigens Modified vaccinia Ankara (MVA), which is a highly attenuated vaccinia virus strain
• HBc-HBs/AS01B-4: the above two HBV protein antigens enhanced by the AS01B-4 adjuvant, which is a liposomal combination of 3-O-desacyl-4′-monophosphoryl lipid A (MPL) from Salmonella minnesota and a saponin molecule (QS-21) from plant extract of Quillaja saponaria.

GSK3528869A Bepirovirsen Analytical Perspective

In-depth GSK3528869A Bepirovirsen Market Assessment

This report provides a detailed market assessment of GSK3528869A Bepirovirsen for chronic hepatitis B in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China. This segment of the report provides forecasted sales data from 2029 to 2032.

GSK3528869A Bepirovirsen Clinical Assessment

The report provides the clinical trials information of GSK3528869A Bepirovirsen for chronic hepatitis B covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for chronic hepatitis B is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence GSK3528869A Bepirovirsen dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to GSK3528869A Bepirovirsen and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of GSK3528869A Bepirovirsen in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of GSK3528869A Bepirovirsen from 2029 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the GSK3528869A Bepirovirsen in chronic hepatitis B.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of GSK3528869A Bepirovirsen?
• What is the clinical trial status of the study related to GSK3528869A Bepirovirsen in chronic hepatitis B and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the GSK3528869A Bepirovirsen development?
• What are the key designations that have been granted to GSK3528869A Bepirovirsen for chronic hepatitis B?
• What is the forecasted market scenario of GSK3528869A Bepirovirsen for chronic hepatitis B?
• What are the forecasted sales of GSK3528869A Bepirovirsen in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China?
• What are the other emerging products available and how are these giving competition to GSK3528869A Bepirovirsen for chronic hepatitis B?
• Which are the late-stage emerging therapies under development for the treatment of chronic hepatitis B?

Key Topics Covered:

1. Report Introduction

2. GSK3528869A Bepirovirsen Overview in Chronic hepatitis B

2.1. Product Detail

2.2. Clinical Development

2.2.1. Clinical studies

2.2.2. Clinical trials information

2.2.3. Safety and efficacy

2.3. Other Developmental Activities

2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. GSK3528869A Bepirovirsen Market Assessment

5.1. Market Outlook of GSK3528869A Bepirovirsen in Chronic hepatitis B

5.2. 7MM and China Analysis

5.2.1. Market Size of GSK3528869A Bepirovirsen in the 7MM and China for Chronic hepatitis B

5.3. Country-wise Market Analysis

5.3.1. Market Size of GSK3528869A Bepirovirsen in the United States for Chronic hepatitis B

5.3.2. Market Size of GSK3528869A Bepirovirsen in Germany for Chronic hepatitis B

5.3.3. Market Size of GSK3528869A Bepirovirsen in France for Chronic hepatitis B

5.3.4. Market Size of GSK3528869A Bepirovirsen in Italy for Chronic hepatitis B

5.3.5. Market Size of GSK3528869A Bepirovirsen in Spain for Chronic hepatitis B

5.3.6. Market Size of GSK3528869A Bepirovirsen in the United Kingdom for Chronic hepatitis B

5.3.7. Market Size of GSK3528869A Bepirovirsen in Japan for Chronic hepatitis B

5.3.8. Market Size of GSK3528869A Bepirovirsen in China for Chronic hepatitis B

6. SWOT Analysis

7. Analysts’ Views

8. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/wbaqkw

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Nemvaleukin Alfa (Previously known as ALKS 4230) Drug Landscape Report 2024: An Interleukin-2 Receptor Agonist for the Treatment of Solid Tumors – Size, Forecasts, and Insights 2019-2032 – ResearchAndMarkets.com




Nemvaleukin Alfa (Previously known as ALKS 4230) Drug Landscape Report 2024: An Interleukin-2 Receptor Agonist for the Treatment of Solid Tumors – Size, Forecasts, and Insights 2019-2032 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Nemvaleukin alfa Market Size, Forecast, and Emerging Insight – 2032” report has been added to ResearchAndMarkets.com’s offering.

“Nemvaleukin alfa Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about nemvaleukin alfa for ovarian cancer in the seven major markets. A detailed picture of the nemvaleukin alfa for ovarian cancer in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019-2032 is provided in this report along with a detailed description of the nemvaleukin alfa for ovarian cancer.

The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the nemvaleukin alfa market forecast analysis for ovarian cancer in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in ovarian cancer.

Drug Summary

Nemvaleukin alfa (previously known as ALKS 4230) is an interleukin-2 receptor agonist being developed by Alkermes for the treatment of solid tumors, including head and neck cancer, small cell lung cancer, ovarian cancer, fallopian tube cancer, and others. It is a fusion protein consisting of modified IL-2 and the high-affinity IL-2 alpha receptor chain.

This combination is designed to expand tumor-destroying immune cells while not activating immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The agent’s selectivity is meant to mitigate limitations while boosting the anti-tumor effects of IL-2 therapy.

It is currently being investigated in Phase III clinical trial (ARTISTRY-7) for the potential treatment of Platinum-resistant Ovarian Cancer that is estimated to be completed by December 2025.

Nemvaleukin alfa Analytical Perspective

In-depth Nemvaleukin alfa Market Assessment

This report provides a detailed market assessment of nemvaleukin alfa for ovarian cancer in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2024 to 2032.

Nemvaleukin alfa Clinical Assessment

The report provides the clinical trials information of nemvaleukin alfa for ovarian cancer covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for ovarian cancer is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence nemvaleukin alfa dominance.
• Other emerging products for ovarian cancer are expected to give tough market competition to nemvaleukin alfa and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of nemvaleukin alfa in ovarian cancer.
• Our in-depth analysis of the forecasted sales data of nemvaleukin alfa from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the nemvaleukin alfa in ovarian cancer.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of nemvaleukin alfa?
• What is the clinical trial status of the study related to nemvaleukin alfa in ovarian cancer and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the nemvaleukin alfa development?
• What are the key designations that have been granted to nemvaleukin alfa for ovarian cancer?
• What is the forecasted market scenario of nemvaleukin alfa for ovarian cancer?
• What are the forecasted sales of nemvaleukin alfa in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to nemvaleukin alfa for ovarian cancer?
• Which are the late-stage emerging therapies under development for the treatment of ovarian cancer?

Key Topics Covered:

1. Report Introduction

2. Nemvaleukin alfa Overview in ovarian cancer

2.1. Product Detail

2.2. Clinical Development

2.2.1. Clinical studies

2.2.2. Clinical trials information

2.2.3. Safety and efficacy

2.3. Other Developmental Activities

2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. Nemvaleukin alfa Market Assessment

5.1. Market Outlook of Nemvaleukin alfa in ovarian cancer

5.2. 7MM Analysis

5.2.1. Market Size of Nemvaleukin alfa in the 7MM for ovarian cancer

5.3. Country-wise Market Analysis

5.3.1. Market Size of Nemvaleukin alfa in the United States for ovarian cancer

5.3.2. Market Size of Nemvaleukin alfa in Germany for ovarian cancer

5.3.3. Market Size of Nemvaleukin alfa in France for ovarian cancer

5.3.4. Market Size of Nemvaleukin alfa in Italy for ovarian cancer

5.3.5. Market Size of Nemvaleukin alfa in Spain for ovarian cancer

5.3.6. Market Size of Nemvaleukin alfa in the United Kingdom for ovarian cancer

5.3.7. Market Size of Nemvaleukin alfa in Japan for ovarian cancer

6. SWOT Analysis

7. Analysts’ Views

8. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/sqtbgh

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

RenovoRx Regains Compliance with Nasdaq Stockholders’ Equity Requirement




RenovoRx Regains Compliance with Nasdaq Stockholders’ Equity Requirement

LOS ALTOS, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced that, in light of its recent successful fundraising activity, it has received written confirmation from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with the $2.5 million minimum stockholders’ equity requirement in Nasdaq Listing Rule 5550(b)(1). As a result, the Company’s previously announced hearing before a Nasdaq Hearings Panel on this matter is no longer required and has been cancelled. Further, the Company will not require any ongoing Nasdaq Hearings Panel monitor.

Shaun Bagai, Chief Executive Officer of RenovoRx, stated, “Regaining compliance with Nasdaq’s listing requirements represents another critical achievement for RenovoRx. This win for our company is the natural outgrowth of our successful 2024 capital raising efforts, which in addition to keeping us listed on Nasdaq, has provided $17.2 million in gross proceeds and a cash runway into 2026. We can now focus our efforts on value creation events over the next two years. These events include the continuation of our pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer as we move towards a second interim readout and ultimate completion, expansion of our TAMP™ (Trans-Arterial Micro-Perfusion) clinical development pipeline into additional cancer indications, and our ongoing exploration of new commercial business development opportunities with our therapeutic technologies.”

About RenovoRx, Inc.

RenovoRx is a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a proprietary local drug-delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel and patented approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGem™, a novel oncology drug-device combination product, is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer by the Center for Drug Evaluation and Research (the drug division of FDA.)

RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) the Company’s cash runway and ability to maintain its listing on Nasdaq, (ii) our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath®, RenovoGem™ or TAMP™ or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) the Company’s exploration of new commercial business development opportunities. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, clinical trials, therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “will,” “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) circumstances which would adversely impact our ability to maintain our listing on Nasdaq, (ii) the timing of the initiation, progress and potential results (including the results of interim analyses) of our preclinical studies, clinical trials and our research programs; (iii) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (iv) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (v) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vi) our ability to use and expand our therapy platform to build a pipeline of product candidates; (vii) our ability to advance product candidates into, and successfully complete, clinical trials; (viii) the timing or likelihood of regulatory filings and approvals; (ix) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (x) the commercialization potential of our product candidates, if approved; (xi) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiii) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xiv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xv) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvi) the implementation of our strategic plans for our business and product candidates; (xvii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage and reimbursement of our product candidates, if approved; and (xx) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

Contacts

KCSA Strategic Communications

Valter Pinto, Managing Director

T:212-896-1254

renovorx@kcsa.com

TriLink BioTechnologies® Announces New San Diego Facility for Late Phase mRNA Drug Substance Production




TriLink BioTechnologies® Announces New San Diego Facility for Late Phase mRNA Drug Substance Production

cGMP Facility Streamlines Clinical & Commercial mRNA Drug Substance Development;

Built by mRNA & Industry Experts to Meet Demand for mRNA-based Medicine

SAN DIEGO–(BUSINESS WIRE)–TriLink BioTechnologies (TriLink^®), a Maravai LifeSciences company (NASDAQ: MRVI) and global provider of life science reagents and services, has announced the grand opening of its new cGMP mRNA manufacturing facility. The 32,000-square-foot facility was specifically designed for mRNA manufacturing to support late-phase drug developers from Phase 2 to commercialization via TriLink’s robust mRNA manufacturing capabilities. The milestone opening is expected to help advance the field of mRNA-based medicine as developers flock to leverage the promising modality for a growing list of indications.

Located in the Sorrento Valley area of San Diego, the facility features individual Grade C cleanroom suites for mRNA manufacturing, increased mRNA capacity (1g to >100g per batch), comprehensive in-house analytical services, and laboratory space for on-site quality control testing. The manufacturing suites are outfitted with state-of-the-art equipment and ready to onboard clients with late-phase manufacturing needs.

“This facility is expected to help move the needle for life-saving breakthroughs in mRNA-therapeutics,” explained Kevin Lynch, Vice President & General Manager of TriLink’s GMP Operations. “The high-quality manufacture of mRNA drug substances is critical to ensuring the safety and efficacy of this new class of medicines for patients.”

Company and site leadership and industry guests gathered on April 17 to celebrate the facility’s grand opening with a ribbon cutting, expert-led panel discussion, and site tours – all centered around a core theme: Building the Future of mRNA. The thought-provoking panel included insights on the mRNA regulatory landscape, manufacturing evolution, and next-generation tools.

TriLink has reliably delivered GMP services to drug developers since the debut of its first cGMP facility in 2015. Since then, the company’s dedicated team of scientists has provided over 1,000 clients with custom mRNA synthesis, supported 350+ programs in biopharma development pipelines, and delivered over 100 GMP mRNA manufacturing batches.

“TriLink’s depth of industry experience – which spans over 25 years – coupled with its capabilities makes for an unmatched partner,” shared Drew Burch, President of Nucleic Acid Production. “This new facility codifies our commitment to advancing the field by playing a key role in the development of mRNA-based in vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.”

In addition to CDMO services and unique mRNA, oligonucleotide, NTP, and plasmid production capabilities, TriLink has developed the award-winning CleanCap® mRNA capping technology used in the majority of approved COVID-19 mRNA and saRNA vaccines, adding momentum to the rapidly growing field.

To learn more about TriLink’s products and services, visit trilinkbiotech.com.

About TriLink BioTechnologies

TriLink BioTechnologies, a Maravai LifeSciences company, is a global leader in nucleic acid and mRNA solutions. TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its patented CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors, and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans.

For more information, visit trilinkbiotech.com.

About Maravai LifeSciences

Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics and novel vaccines. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world’s leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies.

For more information about Maravai LifeSciences, visit www.maravai.com.

Forward-looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release which are not strictly historical statements constitute forward-looking statements, including, without limitation, statements related to the expectation that the facility will help advance the field of mRNA-based medicine and will help move the needle for life-saving breakthroughs, constitute forward-looking statements identified by words like “expect,” “estimate,” “may,” “soon,” “nears,” “slated,” “anticipate,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, operational risks and competition. These and other risks and uncertainties are described in greater detail in the “Risk Factors” section of our most recent Annual Report on Form 10-K, as well as other reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from those contemplated by these forward-looking statements, and therefore you should not rely upon them. These forward-looking statements reflect our current views and we do not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.

Contacts

Investor Contact: Deb Hart

Maravai LifeSciences

+ 1 858-988-5917

ir@maravai.com

Media Contact:

Liz Robinson of CG Life

TriLink BioTechnologies

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Cybin Announces Publication of Research Manuscript in the Journal of Medicinal Chemistry




Cybin Announces Publication of Research Manuscript in the Journal of Medicinal Chemistry

– Publication explores structure-activity relationships (“SAR”) of a broad range of 2C-X analogs –

– Innovative research led to the discovery of CYB210010, a potent and long-acting serotonin 5-HT₂ receptor agonist with favorable pharmacokinetic properties –

TORONTO–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that its research manuscript, entitled “Synthesis and Structure-Activity Relationships of 2,5-dimethoxy-4-substituted phenethylamines and the discovery of CYB210010: A potent, orally bioavailable and long-acting serotonin 5-HT₂ receptor agonist,” has been published in the Journal of Medicinal Chemistry, a prestigious bi-weekly peer-reviewed publication.

“We are delighted that our research on phenethylamine serotonin 5-HT₂ receptor agonists was published in this important journal,” said Doug Drysdale, Chief Executive Officer of Cybin. “This study is an example of our expanding scope of innovative development work beyond our clinical tryptamine programs. This publication is a testament not only to our scientific leadership in the field of 5-HT₂ receptor agonists, the receptor family believed to mediate the therapeutic effects of classic psychedelics, but also to the depth and breadth of our expertise as we continue to advance the study of the role of next-generation psychedelic-based treatment options for mental health and neurological disorders.”

“In the past decade, there has been a revival of interest in serotonin (5-HT)-based psychedelics as pharmacotherapeutics for neuropsychiatric disorders,” said Geoff Varty, Ph.D., Head of R&D of Cybin. “Given the clinical potential of 2C-X phenethylamines, our studies explored the SARs of a broad range of 2C-X analogs, focusing on 4-thio derivatives, to identify novel 5-HT₂ receptor ligands with unique pharmacodynamic (“PD”) and pharmacokinetic (“PK”) properties. We synthesized 39 proprietary 4-substituted-2,5-dimethoxyphenethylamines and these phenethylamines were profiled for their ability to interact with the serotonin system and to induce psychedelic-like effects in preclinical models. This research led to the discovery of CYB210010, a potent and long-acting serotonin 5-HT₂ receptor agonist with favorable PK and PD properties,” concluded Dr. Varty.

Future investigations will focus on the development of CYB210010 and related molecules as novel therapeutics for psychiatric and neurological disorders with unmet needs.

Click here to view the full publication.

Title: Synthesis and Structure-Activity Relationships of 2,5-dimethoxy-4-substituted phenethylamines and the discovery of CYB210010: A potent, orally bioavailable and long-acting serotonin 5-HT2 receptor agonist

Authors: Geoff Varty, Clint Canal, Tina Mueller, Josh Hartsel, Richa Tyagi, Ken Avery, Mike Morgan, Amy Reichelt, Pradip Pathare, Erik Stang, Mike Palfreyman, Alex Nivorozhkin

About Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the development of CYB210010; and the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company’s operations; and the risk factors set out in each of the Company’s management’s discussion and analysis for the three and nine month periods ended December 31, 2023 and the Company’s annual information form for the year ended March 31, 2023, which are available under the Company’s profile on www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Cboe Canada, nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Contacts

Investors & Media:
Gabriel Fahel

Chief Legal Officer

Cybin Inc.

1-866-292-4601

irteam@cybin.com – or – media@cybin.com

Global Drug Delivery Companies Compendium 2024: Intelligence on Drugs in the Development Pipeline from the Lab to the Market – ResearchAndMarkets.com




Global Drug Delivery Companies Compendium 2024: Intelligence on Drugs in the Development Pipeline from the Lab to the Market – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Drug Delivery Companies Compendium 2024” directory has been added to ResearchAndMarkets.com’s offering.

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