Intract Pharma has announced signature to a joint development agreement with Celltrion Inc. and Celltrion Healthcare Co., Ltd. (Celltrion Group) for development of the world’s first oral antibody therapeutic for treatment of inflammatory bowel disease.
The oral product, along with intravenous and subcutaneous formulations (Remsima IV and Remsima SC) are expected to secure Celltrion’s leading position in the TNF-α inhibitor market.
Development of the product through clinical validation will be the responsibility of Intract, with support, including supply of drug material for generation of the oral product, from Celltrion Group. Celltrion Group retains the right to complete clinical development of the product following completion of Phase 2 clinical trials and to take to market.
The joint development is geared towards launch of the first orally administered antibody targeting inflammatory bowel disease (IBD), which is anticipated to impact not only the Infliximab market but more widely the market for treatment of IBD. Intract Pharma is at the forefront in the field of technology platforms that stably deliver antibodies to the intestine. Collaboration between the two parties is expected to open new doors for the development of additional orally-delivered antibodies.
The oral infliximab product has been cleared by the UK regulatory body (MHRA) to proceed to Phase 1b/2a clinical trials in IBD patients during the second half of 2021, without the requirement for further preclinical research or a clinical safety study. The product is likely to be stable at room temperature, offering simple distribution, storage and administration for patients at home.
Bill Lindsay, CEO of Intract said “We anticipate that the oral infliximab product which we will co-develop with Celltrion Group will have an improved safety profile and will offer a less expensive biotherapeutic treatment for IBD. We are hopeful that the product will address a large proportion of the IBD market, potentially replacing steroid and immune-suppressive drugs in addition to capturing a large share of the biologics market”.
Celltrion Group official said, “A technical alliance between Intract Pharma and Celltrion Group allows for the development of oral Infliximab that is safe, highly efficacious, and convenient”; “We are delighted to have this deal with Intract Pharma and we will continue on with further development starting with clinical design through close consultation”.
About Celltrion Group
Celltrion Inc. is headquartered in Korea is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion previously received EMA approval for Remsima which is the world’s first biosimilar mAb to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.
Celltrion Healthcare Co., Ltd. is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, visit https://www.celltrionhealthcare.com/en-us.
About Intract Pharma
Intract Pharma is an oral drug delivery specialist, developing state-of-the-art formulation and unique gastrointestinal models to develop advanced new therapeutics. Since its inception, Intract has pursued innovation in oral drug delivery as a means to improve on current therapies, making them safer and more effective for patients. The drug delivery technologies Phloral, for precise colonic drug delivery and Soteria for delivery of biotherapeutics to gastrointestinal tissue, are available for license exclusively from Intract Pharma. For more information, visit www.intractpharma.com.