 "Dr Reddy’s enters into licensing pact for XenoPort’s under-trial psoriasis drug in US")
Dr Reddy's Laboratories has entered into a license agreement with XenoPort Inc granting the Hyderabad-based pharma company an exclusive US rights for the development and commercialisation of XenoPort’s clinical stage oral new chemical entity, XP23829. Dr Reddy’s Laboratories plans to develop XP23829 as a potential treatment for moderate-to-severe chronic plaque psoriasis and may potentially develop XP23829 for relapsing forms of multiple sclerosis (MS).
Under the terms of the agreement, Dr Reddy’s Laboratories will receive exclusive US rights to develop and commercialise XP23829 for all indications. In exchange for these rights, XenoPort will receive a $47.5 million up-front payment and an additional $2.5 million for transfer of certain clinical trial materials to Dr Reddy’s Laboratories. XenoPort will also be eligible to receive up to $190 million upon the achievement by Dr Reddy’s Laboratories of certain regulatory milestones, which could be achieved over a period of several years. In addition, XenoPort will be eligible to receive up to $250 million upon the achievement of commercial milestones, and up to mid-teens royalty payments based on potential net sales of XP23829 in the US.
“XP23829 complements our internal development efforts, which have primarily focused on the mild-to-moderate psoriasis segment to date. In other markets, fumarates have been used as first line choices of treatment prior to initiation of biologic therapies in patients with moderate-to-severe psoriasis. We intend to initiate the registration program for XP23829 as soon as feasible so that we can accelerate the availability of this important treatment choice for moderate-to-severe psoriasis patients in the US market,” said Raghav Chari, executive vice president, proprietary products group, Dr Reddy’s Laboratories.
The agreement is subject to review by the U.S. Government under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, as amended, and will become effective only after clearing HSR review.
XP23829 is a novel, oral fumaric acid ester compound that is a pro-drug of monomethyl fumarate (MMF). Fumaric acid ester compounds have shown immuno-modulatory and neuroprotective effects in cell-based systems and preclinical models of disease. Tecfidera, which is approved for relapsing forms of MS in the US and relapsing-remitting MS in the European Union and Fumaderm, which is approved in Germany for psoriasis, are based on another MMF pro-drug known as dimethyl fumarate (DMF). XP23829 is protected by a US composition-of-matter patent that currently has an expiration date of 2029.
In September 2015, XenoPort announced results of a Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis.
