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UCB S.A.. (11/30/21). "Press Release: UCB and Chiesi Enter Global License Agreement for Zampilimab a Novel Monoclonal Antibody for Fibrotic Lung Diseases". Brussels & Parma.

Region Region ALL
Organisations Organisation UCB S.A. (Euronext: UCB)
  Group UCB (Group)
  Organisation 2 Chiesi Farmaceutici S.p.A.
  Group Chiesi (Group)
Products Product therapeutic antibody
  Product 2 antifibrotic
Persons Person Eichholtz, Thomas (Almirall 201503 CSO)
  Person 2 Patel, Dhavalkumar (UCB 201802 CSO)
     


> UCB has granted to Chiesi global exclusive rights to develop, manufacture and commercialize zampilimab, a monoclonal antibody targeting transglutaminase 2 (TG2), an enzyme associated in fibrotic diseases

> UCB will receive upfront payment, future milestone payments and net sales royalties


UCB, a global biopharmaceutical company, and Chiesi Group, the international research-focused pharmaceutical and healthcare group, are pleased to announce that they have entered into an agreement that grants Chiesi a worldwide exclusive license to develop, commercialize and manufacture zampilimab, a clinical stage investigational transglutaminase 2 (TG2) inhibitor with the potential to be an anti-remodelling agent in fibrotic diseases such as Idiopathic Pulmonary Fibrosis (IPF).

“At Chiesi, we are exploring new programs that address the key pathways in the complex disease IPF. The goal is to offer new treatment options that delay or reverse lung function decline in patients suffering from such progressive interstitial lung diseases”, said Thomas Eichholtz, Head of Global Research and Development of Chiesi Group. “This will be the first monoclonal antibody in the Chiesi pipeline, thereby accelerating the company’s entry into biologics and thus diversifies our therapeutic platforms. I am excited at the possibilities of this new asset and pleased that we can benefit from the scientific and technical know-how of UCB”.

Idiopathic Pulmonary Fibrosis is a chronic lung disease in which the tissue of the lungs becomes scarred (fibrosis) and breathing becomes increasingly difficult. It is the most common of the idiopathic interstitial pneumonias and carries a poor prognosis, with median survival ranging from 2.5 to 3.5 years.1,2 Therefore, there is a need for novel treatments that could delay, or reverse, disease progression.

Dhaval Patel, UCB’s Chief Scientific Officer said, “Agreements such as this one are a testament to the calibre of our innovative science and antibody expertise as well as a clear demonstration of the value we are creating through strong research productivity.” He added, “We are confident that Chiesi, a company with an established global presence and a focus on the development of novel drug candidates for the treatment of idiopathic pulmonary fibrosis and other pulmonary fibrotic diseases, will quickly progress zampilimab.”

Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can modulate the biological activity of a specific target via an antigenetic site. The goal for this potential new treatment would be to ameliorate, if not reverse, the relentless fibrotic process of IPF.

Further financial details of the agreement were not disclosed.


About Zampilimab

Zampilimab is an anti-transglutaminase 2 monoclonal antibody intended for the treatment of fibrosis such as Idiopathic Pulmonary Fibrosis (IDF) and Chronic Kidney Disease (CAI). Transglutaminase 2 is a multi-functional enzyme that modifies proteins by catalyzing the formation of intermolecular isopeptide bonds between glutamine and lysine side-chains. It plays a role in several biological functions and is associated in the pathology of several diseases.3


References

1. American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American thoracic society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med 2000;161:646–664.

2. American Thoracic Society/European Respiratory Society international multidisciplinary consensus classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med 2002;165:277–304.

3. Siegel, M and Chaitan, K. Transglutaminase 2 Inhibitors and their Therapeutic Role in Disease States. Pharmacol Ther. 2007 August; 115(2): 232–245.


About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8 400 people in nearly 40 countries, the company generated revenue of € 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news


Forward looking statements UCB

This press release may contain forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.


About Chiesi Group

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative therapeutic solutions in its three focus areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support specialty care and consumer-facing self-care). The Group’s Research and Development centre is based in Parma and works alongside six other important research and development hubs in France, the U.S., Canada, China, the UK and Sweden to pursue its pre-clinical, clinical and regulatory programmes. In 2018 Chiesi changed its legal status to Benefit Corporation, according to the law in Italy, the USA and, more recently, in France, by incorporating common benefit objectives into its bylaws, to generate value for its business, for the society and the environment. Since 2019, Chiesi has been the world’s largest B Corp certified pharmaceutical group. B Corps are global leaders committed to using business as a force for good. Moreover, as a Benefit Corporation, Chiesi Farmaceutici S.p.A. is required by law to report annually in a transparent way about its progress in achieving the common benefits objectives it has incorporated. The Group is committed to becoming carbon neutral by the end of 2035.

For further information: www.chiesi.com


Contacts – UCB

R&D Communications, UCB
Scott Fleming
Scott.fleming@ucb.com / +44 7702777378

Media Relations, UCB
Laurent Schots
laurent.schots@ucb.com / +32.2.559.92.64

Investor Relations, UCB
Antje Witte
antje.witte@ucb.com / +32.2.559.94.14


Contacts – Chiesi

Carla Arrieta Martinez
Global External Communication & Media Relations Head, Phone +39 340.8879754, Email c.arrieta@chiesi.com

Alessio Pappagallo
Press Office Manager, Phone +39 339 5897483, Email a.pappagallo@chiesi.com

   
Record changed: 2021-11-30

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