A new FDA Fast Track designation for Zambon
Zambon, a multinational pharmaceutical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives,today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Liposomal Cyclosporine A for Inhalation (L‑CsA‑i), in late-stage clinical development for the treatment of Bronchiolitis Obliterans Syndrome (BOS). L‑CsA‑i, developed by Breath Therapeutics which was acquired by Zambon in 2019, previously received orphan drug designation from the FDA and European Medicines Agency for the treatment of BOS.
“Zambon is committed to its mission of innovating cure and improving the quality of life for people living with severe respiratory diseases worldwide. The FDA’s Fast Track designation for L‑CsA‑i represents an important recognition of its potential to address the unmet medical need of patients with BOS, a devastating rare disease with currently no approved treatment,” said Roberto Tascione, Zambon’s CEO.
The FDA Fast Track program facilitates the development and review of potential new drugs intended to treat serious conditions with unmet medical need, allowing important new drugs, if requisite criteria are met, to become more quickly available to people suffering from serious conditions.
“We believe Fast Track designation provides an opportunity for frequent interactions with the FDA which may potentially expedite the development and registration of L‑CsA‑i,” said Paola Castellani, CMO at Zambon. “We will work closely with the FDA to advance the BOSTON clinical program and accelerate our efforts to develop an effective therapy for the treatment of BOS.”
Fast Track Designation may allow a therapy to be eligible for several benefits including enhanced interaction with the FDA and the potential for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) filing, if relevant criteria are met. Additional information about FDA Fast Track designation is available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
Bronchiolitis Obliterans Syndrome (BOS)
Bronchiolitis Obliterans Syndrome (BOS), also known as obliterative bronchiolitis (OB), is caused by T‑cell mediated inflammation that leads to blockage of bronchioles, the small and medium airways in the lungs, resulting in respiratory failure and death. BOS most commonly affects people who have received lung transplant or allogeneic hematopoietic stem cell transplant (alloHSCT), although it is also associated with autoimmune disease and exposure to environmental contaminants. Based on 2019 company market research, an estimated 30,000 lung transplant and alloHSCT recipients worldwide are affected by BOS.
Liposomal Cyclosporine A for Inhalation (L-CsA-i)
Liposomal Cyclosporine A for Inhalation (L-CsA-i) is a novel liposomal formulation of cyclosporine A developed for inhaled delivery to the lungs. Calcineurin inhibitors (CNIs), like cyclosporine A, are highly potent immunosuppressive drugs and a cornerstone of lung transplant medicine. L‑CsA‑i is administered via a drug-specific Investigational eFlow® Technology nebulizer system (PARI Pharma GmbH). The investigational drug-device combination is designed to deliver L‑CsA‑i to the site of disease in the lung.
BOSTON Clinical Development Program
L-CsA-i is being evaluated for the treatment of BOS in patients age six and older. Five clinical trials are currently ongoing or planned. BOSTON-1 and BOSTON-2 are pivotal Phase 3 studies of adults with BOS following lung transplantation. BOSTON-3 is an open-label extension study for eligible study participants who complete BOSTON-1 or BOSTON-2. BOSTON-4 is a safety and exploratory efficacy study and is the first trial of L‑CsA‑i in adults with BOS following allogeneic hematopoietic stem cell transplant. BOSTON-5 is a planned safety study in pediatric patients with BOS.
About Zambon S.p.A.
Zambon is a multinational pharmaceutical company that focuses on innovation and development with the aim to improve patients’ lives. Based on a valuable heritage and strongly focused on the future, its goal is to improve people’s health through the development of innovative and quality healthcare solutions.
Zambon products are commercialized in 87 countries. The company has 20 subsidiaries in three different continents – Europe, America and Asia – and owns manufacturing units in Italy, Switzerland, China and Brazil. The company today has a strong focus on the treatment of rare diseases and specialties, on top of respiratory, pain management and women’s care. Zambon was established in 1906 in Italy and today counts 2,500 employees all over the world. For further information, please visit www.zambon.com
About Breath Therapeutics, a Zambon company
Founded in 2016, Breath Therapeutics is a biopharmaceutical company specializing in advanced inhaled therapeutics for severe respiratory diseases with high unmet medical need. The company’s proprietary drug formulations have been specifically designed for inhaled administration with exclusively licensed, high performance nebulizer technology. L‑CsA‑i is advancing in clinical trials as the first potential therapy for BOS, a rare and devastating lung disease with no currently approved treatments. In July 2019, Breath Therapeutics was acquired by Zambon. Please visit www.breath-therapeutics.com.
L-CsA-i and the eFlow® for L-CsA-i are investigational and their safety and efficacy have not been established for the uses described here.
For more information, please contact:
Global Head of Pharma Communication
Breath Therapeutics, a Zambon company
VP, Corporate Communications
FTI Consulting (media relations)
Victoria Foster Mitchell/Sam Purewal
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Takeda Provides Updates on Its Pharmacokinetic-guided Prophylaxis Studies at ISTH 2020, Reinforcing Its Commitment to Advancing Personalized Care for People with Bleeding Disorders12.7.2020 14:30:00 CEST | Press release
Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502/NYSE:TAK) today announced that 13 abstracts are being presented from the company’s Hematology portfolio and pipeline at the International Society on Thrombosis and Haemostasis 2020 Virtual Congress (ISTH 2020). Among the data, Takeda spotlighted four abstracts to highlight its commitment to advancing personalized care through pharmacokinetic (PK)-guided prophylaxis in people living with hemophilia or von Willebrand Disease (VWD) – including scientific updates in patients with hemophilia A from the Phase 3 PROPEL and Phase 3b CONTINUATION studies investigating potential benefits of personalized TAK-660 (rurioctocog alfa pegol) prophylaxis. Two population studies into the PK/pharmacodynamic (PD) profiles of recombinant von Willebrand factor (rVWF), which provide data to assist in the optimization of rVWF personalized dosing strategies, were also presented. Takeda addresses the unique needs of each patient with personalized care
VR Fitness Developer FitXR Secures $7.5 Million In Series A Venture Round Led by Hiro Capital10.7.2020 08:00:00 CEST | Press release
FitXR, the leading VR fitness company, today announces that it has secured $6.3m in investment funding, led by Hiro Capital, with continued support from U.S.-based BoostVC, Maveron and TenOneTen Ventures, together with an additional $1.2m in the form of an innovation loan, from Innovate UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005856/en/ Cherry Freeman, Co-Founding Partner, Hiro Capital (Photo: Business Wire) FitXR, who had previously secured $1.25 million in seed funding from investors, will use the new investment to expand its operations in Europe and North America, and to accelerate launch of several exciting new products and services for people to keep fit in Virtual Reality. The investment marks a significant show of belief in FitXR, who over the last year has grown to become one of the leaders of the VR fitness sector, with its mission to put the fun back into fitness. Its first product, the boxing rhyt
Laboratory Studies Confirm BETADINE® Antiseptic Products’ Effectiveness Against COVID-19 Virus10.7.2020 00:37:00 CEST | Press release
Mundipharma today announced that laboratory testing at the Duke-NUS Medical School in Singapore, has confirmed the effectiveness of its BETADINE® antiseptic products against the novel coronavirus (SARS-CoV-2) which causes COVID-19 disease. Testing has demonstrated BETADINE’s® strong in-vitro virucidal activity, killing 99.99% of the SARS-CoV-2 virus in 30 seconds. The products subjected to testing were: BETADINE® antiseptic products, namely Solution (10% PVP-I), Skin Cleanser (7.5% PVP-I), Gargle and Mouthwash (1.0% PVP-I) and Throat Spray (0.45% PVP-I). The research has been published in the respected Infectious Disease and Therapy Journal on 08 July 2020. “These results confirm our view that BETADINE® antiseptic products, used appropriately and in conjunction with other preventative treatment options including PPE, can play a role in limiting the spread of infections, including COVID-19,” said Raman Singh, CEO Mundipharma. “It also provides the medical community as well as consumers
New Evidence Shows Morinaga Milk’s Probiotic Bifidobacterium breve A1 Improves Memory of Older Adults With Cognitive Dysfunction9.7.2020 20:00:00 CEST | Press release
Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company and a key global probiotics manufacturer, confirmed that its proprietary probiotic strain Bifidobacterium breve A1 (a.k.a. B. breve MCC1274) is safe and effective for improving memory functions of older adults with suspected mild cognitive impairment (MCI) in a randomized, double-blind, placebo-controlled trial (RCT). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005032/en/ Figure 1. Changes of RBANS scores at 16 weeks from baseline. Values are indicated as mean with error bars as the standard error. **p<0.001, ***p<0.0001, inter-group difference, Student’s t-test. (Graphic: Business Wire) The new study, published recently in the Journal of Alzheimer’s Disease, has produced breakthrough results uncovering a novel promising probiotic intervention for early dementia prevention. The clinical study conducted by a clinical research orga
rf IDEAS and Ricoh Simplify Secure Access to Multifunction Printers9.7.2020 18:05:00 CEST | Press release
rf IDEAS, a leading manufacturer of credential readers for authentication and logical access, today announced with Ricoh the integration of its WAVE ID® Plus dual-frequency card reader technology with Ricoh’s Smart Operation Panel (SOP), Gen 2.5. The new WAVE ID Ricoh Universal SOP Reader is the most innovative reader for secure pull-print applications with Ricoh multifunction printers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005764/en/ WAVE ID® Ricoh Universal SOP Reader (Photo: Business Wire) rf IDEAS and Ricoh have a proven record of working together to deliver secure workplace solutions that feature the most advanced identification and authentication capabilities. “As we continue our worldwide partnership with a leader in the print industry, we are delighted that Ricoh chose rf IDEAS to develop an innovative credential reader design that connects to its A3 multifunction devices,” said Tod Besse, senior vice
Immersive Labs Adds Tenable Co-Founder and Security Industry Veteran Jack Huffard to its Board of Directors as Demand for Improving and Measuring Cyber Talent Grows9.7.2020 17:46:00 CEST | Press release
Immersive Labs, the company empowering organizations to equip, exercise, and evidence human cyber capabilities, announced Jack Huffard, a co-founder and board member of Tenable (Nasdaq: TENB) will join its board of directors to help drive growth. This comes on the heels of Immersive Labs’ recent expansion into the U.S. market, backed by Goldman Sachs and Summit Partners with $50M in financing, after four successful years of fast-growth and an impressive customer roster in the UK and the U.S. With the addition of Huffard to the board, a cybersecurity industry business leader who helped Tenable through its fast growth and successful IPO, the Immersive Labs team is well-suited for its next phase of innovation and market leadership. Huffard also currently serves as a board director for Norfolk Southern Corporation (NYSE: NSC) and is a member of the National Security Telecommunications Advisory Committee (NSTAC), helping the US government navigate pressing national security issues and stren
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom