Oral fumaric XP23829 for psoriasis seeks USA licensing approval

[Fred]

Dr. Reddy's Laboratories and XenoPort, Inc announce they have entered into a license agreement pursuant to which Dr. Reddy's Laboratories will be granted exclusive U.S. rights for the development and commercialization of XenoPort's clinical-stage oral new chemical entity, XP23829 for psoriasis.

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Dr. Reddy's Laboratories and XenoPort, Inc. announced today that they have entered into a license agreement pursuant to which Dr. Reddy's Laboratories will be granted exclusive U.S. rights for the development and commercialization 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 U.S. rights to develop and commercialize 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 United States.

Dr. Mark Jackson, M.D., clinical professor of medicine, Dermatology, University of Louisville, stated, "Based on today's available treatments, physicians need additional oral medications that are both safe and effective for patients with psoriasis. Fumaric acid esters possess a unique anti-inflammatory mechanism of action and have been used to treat psoriasis in Germany for over 20 years. XP23829, a novel fumaric acid ester, has the potential to be a meaningful treatment option for patients with moderate-to-severe psoriasis."

"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 U.S. market," said Raghav Chari, Executive Vice President, Proprietary Products Group, Dr. Reddy's Laboratories.

"We are very pleased to announce this agreement with Dr. Reddy's Laboratories," said Vincent J. Angotti, Chief Executive Officer, XenoPort, Inc. "As one of our key objectives for 2016, we were interested in finding a strong partner that would recognize the opportunity of this innovative therapy that we believe will make a significant difference in the lives of psoriasis and MS patients. We are now fully focused on our HORIZANT® (gabapentin enacarbil) Extended-Release Tablets commercialization effort."

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.

About XP23829
XP23829 is an investigational drug discovered by XenoPort. It is a novel, oral fumaric acid ester compound that is a prodrug 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 United States and relapsing-remitting MS in the European Union and FUMADERM, which is approved in Germany for psoriasis, are based on another MMF prodrug known as dimethyl fumarate (DMF). XP23829 is protected by a U.S. 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.

Source: xenoport.com

[jiml]

Hooooooooray at last fumaric acid esters are getting a bit more attention and may give the American market this drug to treat psoriasis.
It's a step in the right direction and at last being recognised as a safe oral drug for the treatment of psoriasis in America
I look forward to reading the progress of this drug and it's approval in the US  

I have been using Fumaderm safely for over 4 years and it has been used in Germany for almost 30 years
I hope this doesn't spell the end for Fumaderm in favour of a more expensive version

[mataribot]

It's nice to have another option, but I think everyone will agree the price will high. I know it costs 11 million usd for fda approval but

[Caroline]

It's nice to have another option, but I think everyone will agree the price will high. I know it costs 11 million usd for fda approval but

11 million ???? For one signature? That's nuts...

Strange, this is MMF. It is well known that MMF does nothing. I have seen this XP 23829 mentioned before. I wonder if it will work.
I also wonder how these pills will work.
Is there a stomach protecting mechanism.
Is there an intestine protecting mechanism?

I really wonder.

O.... And of course, there is nothing "Novel" to it.

[jiml]

You are right Caroline there's nothing novel about it it's a proven drug widely used in Germany and now the UK
And your version in the Netherlands

Of course it will work

[Caroline]

You are right Caroline there's nothing novel about it it's a proven drug widely used in Germany and now the UK
And your version in the Netherlands

Of course it will work

I read it again, they are talking about a pro drug of MMF.

DMF is, after is has been absorbed also rapidly changed into MMF in your body. That's the mechanism. I now remember that MEF, is the thing that does not work in e.g. Fumaderm. MEF is monoethylfumarate. MMF is monomethylfumarate

I wonder what this XP23829 in reality is... What other substance changes in your body into MMF?

[jiml]

You are right Caroline there's nothing novel about it it's a proven drug widely used in Germany and now the UK
And your version in the Netherlands

Of course it will work

I read it again, they are talking about a pro drug of MMF.

DMF is, after is has been absorbed also rapidly changed into MMF in your body. That's the mechanism. I now remember that MEF, is the thing that does not work in e.g. Fumaderm. MEF is monoethylfumarate. MMF is monomethylfumarate

I wonder what this XP23829 in reality is... What other substance changes in your body into MMF?

Thanks for pointing that out, I had misread the article and was assuming it was DMF but yes reading it properly it is another prodrug of MMF could be interesting to follow .......they obviously believe it will have similar effects on the disease as DMF ...

[Fred]

they obviously believe it will have similar effects on the disease as DMF ...

Yep

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XP23829 is protected by a U.S. composition-of-matter patent that currently has an expiration date of 2029. In addition XenoPort holds 48 issued patents worldwide, including those providing coverage for XP23829 and other MMF prodrug compositions and their uses, crystalline forms of XP23829, methods of treatment with MMF prodrugs and oral dosage forms.

XP23829 has novel chemical structure that produces the same active metabolite as TECFIDERA (dimethylfumarate)

[Caroline]

they obviously believe it will have similar effects on the disease as DMF ...

Yep

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XP23829 is protected by a U.S. composition-of-matter patent that currently has an expiration date of 2029. In addition XenoPort holds 48 issued patents worldwide, including those providing coverage for XP23829 and other MMF prodrug compositions and their uses, crystalline forms of XP23829, methods of treatment with MMF prodrugs and oral dosage forms.

XP23829 has novel chemical structure that produces the same active metabolite as TECFIDERA (dimethylfumarate)

So they are working around Tecfidera. That might be nice.
It also might be nice if they would be able to actually reduce the intestine problems lots of people have with the DMF, while still reaching the same results.
U.S. composition-of-matter patent...... Sound like a typical workaround patents possibility, we should have an E.U. composition-of-matter patent also, that would make things easier.