Celltrion partners with Intract to develop oral infliximab – BioWorld Online

HONG KONG Celltrion Group is partnering with Intract Pharma Ltd. to jointly develop an oral tablet form of infliximab.

Under the agreement signed between Celltrion Group (which includes Celltrion Inc. and Celltrion Healthcare Co. Ltd.) and Intract, of London, on Aug. 20, Celltrion will supply the drug material through clinical evaluation and into the market, while Intract will be responsible for performing clinical studies, Bill Lindsay, the CEO of Intract, told BioWorld.

Though Intract and Celltrion, of Incheon, South Korea, declined to disclose financial details, Lindsay said that Celltrion will retain the rights to sell the product in Korea, while Intract gets rights to make, sell and license the product globally. Celltrion has the option to match commercial terms in order to establish global rights.

Because infliximab is an established product, Intract can move quickly into clinical development, Lindsay said. For Celltrion, the partnership will strengthen the companys competitiveness in the TNF-alpha inhibitor market by offering infliximab in the intravenous injection and subcutaneous injection forms, and now as an oral tablet.

The U.K.s Department for International Trade connected the two companies, with Lindsay adding, Intract connected with Celltrion, the manufacturer of the first biosimilar infliximab, to establish a relationship which would allow generation of the first oral antibody treatment for IBD.

A Celltrion representative told BioWorld, Intracts reputation for developing oral biologics that can precisely be delivered to the intestines, in addition to Celltrions experience developing the intravenous injection-type Remsima IV and subcutaneous injection-type Remsima SC forms of infliximab, led to the partnership between the two companies for developing the oral version of the drug.

Intract already secured exemption from the U.K.s Medicines and Healthcare products Regulatory Agency (MHRA) to conduct nonclinical and phase I trials for oral infliximab. Phase IB/IIa trials targeting patients suffering from inflammatory bowel disease are scheduled to begin in the third quarter of 2021. The companies are targeting ulcerative colitis as a first indication, with Crohn's disease following later. Once developed, the product will be distributed globally and the two companies will continue to develop other oral biologics candidates under the partnership.

Developed by Johnson & Johnson arm Janssen Pharmaceutical Companies under the name Remicade, infliximab is a TNF-alpha inhibitor that treats autoimmune disease, including Crohns disease, ulcerative colitis and rheumatoid arthritis by controlling inflammation.

Celltrion obtained the European Unions marketing approval for Remsima SC for adult rheumatoid arthritis patients in combination with methotrexate in November 2019. The approval was granted on the basis of a phase I/III study that evaluated the intravenous versions pharmacokinetics, efficacy, and safety, the results of which were presented at the American College of Rheumatology Congress in the same month.

The Korean company also applied for patent protection in approximately 100 countries, including the U.S., which will expire in 2038. Competition is fierce in the global tumor necrosis factor-alpha inhibitor market, which includes Humira (adalimumab, Abbvie Inc.) and Enbrel (etanercept, Amgen Inc.)

Founded by Lindsey in 2015 as a spin-out from University College London, Intract commercializes oral therapeutics that replace injections. With 10 employees currently, most of whom are scientists with backgrounds in oral drug formulation, the companys name is taken from its aim for efficiency IN the gastrointestinal TRACT. The company currently has products in its pipeline for which the company hopes to start clinical trials in 2022, although no further details were given.

Celltrion has been busy. The company said on Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August. Both kits are awaiting the U.S. FDAs emergency use authorization, with applications submitted for the Diatrust COVID-19 IgG/IgM rapid test on July 8 and for the Sampinute COVID-19 Antigen MIA on July 24.

Celltrions antiviral antibody treatment for the COVID-19 virus, CT-P59, received MHRAs nod to begin phase I trials in the country earlier in the month, after Koreas Ministry of Food and Drug Safety (MFDS) gave the green light to the companys investigational new drug application in July. Interim results from both phase I trials are tentatively expected by the end of 2020.

Celltrion continues to develop the other biosimilars in its pipeline, which include Avastin (bevacizumab) biosimilar CT-P16, Xolair (omalizumab) biosimilar CT-P39, and Stelara (ustekinumab) biosimilar CT-P43. Celltrion also applied for EMA approval for its Humira biosimilar CT-P17 in March.

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Celltrion partners with Intract to develop oral infliximab - BioWorld Online