Monday, 4 November 2019

Xiapex to be discontinued

Well the news is official. Endo has already discontinued Xiapex in Australia and Asia, and plans to do the same to Europe by the end of 2019. The reason? They won't say. We suspect the higher prices in the US and the pending license for cellulite play a role. Even if they proclaim to be an ethical company, they want more return for their shareholders and bonusses for their CEO's. At the cost of depriving patients, and denying them a treatment that may help keep their hands mobile, straighten their penis, keep their life normal.
This is the letter Endo and Sobi published, but keep in mind Sobi wanted to keep supplying and Endo made the decision one sided.

Healthcare Professional Information regarding de-registration of XIAPEX® 


Dear Healthcare Professional

This letter is to inform you that Sobi will discontinue the commercialisation of XIAPEX by the end of 2019.

XIAPEX is a product owned by Endo Ventures Limited (‘Endo’). Currently, XIAPEX is commercialised in the EU and other European and Middle Eastern countries by Sobi. Endo and Sobi have agreed to terminate the cooperation agreement for Xiapex effective December 31, 2019. The decision to withdraw is not based on safety or efficacy concerns.

Endo and Sobi are committed to managing the de-registration of Xiapex from the Sobi territories in an ethical and transparent manner and Sobi will process the withdrawal of the EU Marketing Authorisation, which will be effective from 1 March, 2020.

Please be assured that the wellbeing of patients during the discontinuation process is of paramount importance to Sobi and we are committed to the safety and comfort of all patients during the process of transition to other therapies. We want to emphasize that, subject to product availability from our supplier, Sobi is committed to providing XIAPEX up until the end of 2019.

We would like to thank you for your interest in XIAPEX over the years and deeply regret any inconvenience this may cause you.

If you have any questions or concerns, please do not hesitate to contact us at your convenience. 

After de-registration, all enquiries, questions or requests for Named Patient Use of Xiapex must be referred directly to Endo. Contact www.endo.com/contact

Yours Sincerely,
Carolyne Dyson
Business Unit Director


Sobi
 
And this is the letter I send to Endo:

It has come to my attention that Endo Pharmaceuticals is planning to withdraw Collagenase Clostridium Histolyticum (CCH) injection from the whole of the European market. I sincerely hope I have been misinformed, but would like to express our Societies view on this to make you aware of how we feel about this possible development.

CCH is an important addition to the limited treatment options for Dupuytren's Contracture. The only alternative treatment would be a type of surgical procedure, and not every patient, not every hand or finger is suitable for that. For some patients CCH is their main or indeed only hope of regaining and keeping hand function. Similarly for Peyronie's patients CCH is an important additional treatment option, one that allows non surgical treatment and regaining normal function and appearance of their penis.

We as a charity have spent a lot of time and effort fighting to get CCH accepted by NICE as a treatment for Dupuytren's Contracture, so it is now used by the NHS under the right circumstances. It has been an enormous joint effort of Sobi UK, Auxilium, The British Dupuytren's Society for the patients, the British Society for Surgery of the Hand and the British Association of Hand Therapists for the health care providers to reach an acceptance by NICE.
By withdrawing CCH from the UK (and indeed EU) market you are making a mockery of all the arguments we used to explain why the drug is needed and is a revolutionary treatment for patients.

There are several trials ongoing or about to start, at least two in the UK, to evaluate the effects directly and long term of CCH compared to some of the surgical options available. These trials have a lot of money and manpower put into them already, and if they can not proceed that will be wasted, careers of the researchers may be damaged and awarding bodies may be reluctant to back similar trials in the future. Important questions will not be answered about the effects of CCH compared to more traditional surgical treatments.

Withdrawing CCH would leave patients in limbo; there will be Peyronie's patients who are somewhere in the cycle of injections where the treatment can't be finished, and both Dupuytren and Peyronie's patients who have agreed with their physicians that CCH is the best option for them, who will be denied that treatment.

Withdrawing CCH for what may well be profit reasons is reinforcing "Big Pharma's" bad name. Endo Pharmaceuticals has a code of conduct for their employees, that states "Endo is committed to conducting business in an ethical and compliant manner". How can it be ethical to withhold treatment from a large population group, and the group that statistically tends to be the worst affected with the disease the treatment was developed for? You would be turning your back on exactly those patients your treatment is supposed to help.

Endo is supposed to have a commitment to patients and communities, to "provide better access to care for patients". This decision would achieve the opposite of what you aim to achieve according to your Code of Conduct.

Your president Mr Patrick Berry said in his speech in 2017 : "Endo is committed to delivering quality medicines to patients in need". If Endo is withdrawing CCH from the European market in order to have more of the drugs accessible for cellulite treatment (at a higher price), you would be doing the exact opposite of what your president wants. Cellulite is not a disabling condition and does not impact on basic daily activities, whereas Dupuytren's and Peyronie's are disfiguring and impede normal functioning of the affected body part, leaving the patient disabled. Surely patients needs should come before profits in a health care company that professes to have an ethical stance.

Yours
A S Schurer, for the British Dupuytren's Society

What more can we do? I emailed Endo (ok, to all 10 different email addresses I found online), emailed all news papers that published articles on Xiapex in the last few years that I could find.
I think patients should let Endo know what they think. Email them!! The more comments they get the better. We need to show them that Dupuytren's and Peyronie's patients stand united in the fight for better treatments and eventually hopefully a cure.
 
 
 

12 comments:

  1. To withdraw this priceless product is ruining people's quality of life and employment, how can some people continue to work when their job entails manual jobs..climbing ladders etc?! It boils down to money as usual.....profit for the pharmaceutical companies.

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