Chronic Myeloid Leukemia is a Rare Disease

What a Rare Disease is? 

According to the European Commission, any disease affecting fewer than 5 people in 10,000 in the EU is considered rare. Although this might appear small, it translates into approximately 246,000 people.

Most patients suffer from even rarer diseases affecting 1 person in 100,000 or more. Approximately 5,000-8,000 distinct rare diseases affect 6-8% of the EU population i.e. between 27 and 36 million people.

In the USA, a disease is defined as rare when it affects fewer than 200,000 Americans at any given time. 

The actual prevalence of rare diseases can vary between populations, making it difficult to provide a precise numerical definition

• 80% of rare diseases have identified genetic origins whilst others are the result of infections (bacterial or viral), allergies and environmental causes, or are degenerative and proliferative.
• 50% of rare diseases affect children.

Click here to check more information about Rare Diseases at Eurordis, Rare Diseases Europe.

The World Health Organisation (WHO) has issued a medical product alert today that falsified versions of ICLUSIG (Ponatinib) have been discovered in Turkey, Argentina and Switzerland, and in Internet sales. The falsified (counterfeit) medicines do not contain any of the CML drug ponatinib, but only low quantities of paracetamol. These falsified medicines are not going to have any effect against CML. The falsified English language packs contain the lot/batch numbers

• PR072875 (UK/Ireland pack, English language, 60 tablets á 45mg, Expiry date 12/2019) and
• 25A19E09 (UK/Ireland pack, English language, 30 tablets á 15mg, Expiry date 10/2020).

In addition, on 20 February 2019, we were notified of a new falsified Iclusig pack:

• PR0834170 (German pack, German language, 30 tablets á 45 mg, Expiry date 06/2020).

The WHO page which is available in English, French, Russian and Spanish provides photos of the packages and pill bottles so patients can find the batch numbers. The WHO page has not yet been updated on the third falsified pack, which is expected those days.

To identify falsified product batches both the batch number and packaging (language, country of the pack) are important.

No UK/Ireland ORIGINAL product has been produced by the manufacturers Incyte/Takeda that carries those batch numbers in languages from those countries and with these languages. Products with the above batch numbers, country and language are most likely falsified.

In case of PR072875, the counterfeiters used this genuine lot number originally issued on a German ICLUSIG box and created a falsified UK packaging. In case of 25A19E09 and PR0834170, no original products were manufactured wih those batch numbers.

And so far, the manufacturer and medicines authorities are NOT aware of additional FALSIFIED ponatinib products bearing different batch numbers, so patients taking Ponatinib with other batch numbers than those listed above should NOT yet be concerned.

WHO alert No. 2

WHO alert No .3 (22.02.2019)

Incyte Press Release

Patients, physicians and distributors should make sure to obtain CML medication from validated and reliable sources that are able to demonstrate the authenticity of origin of the products.

In case of any concern, check the batch number against the two identified falsifications, and contact Incyte Medical Information in case of persisting suspicion at eumedinfo@incyte.com or +800 00027423.

Please let the CML Advocates Network know via info@cmladvocates.net if you come across the falsified product with these batch numbers, so we know whether the falsified medicines have been shipped to any other regions or countries. National CML patient groups are also encouraged to notify their local health authorities and leading physicians.

Important Notice: Changes to the CML Horizons 2019 Conference                                                      

Dear Members & friends of CML Advocates Network,

This is a very important announcement and follows up from our notice a few weeks ago named "emerging news regarding CML Horizons 2019" following the tragic events that took place in Nairobi, Kenya.

After careful consideration, discussions and investigation the CML Steering committee has decided that at this point of time it is better for the safety of our members to change the location of CML Horizons 2019 and at such short notice we will need to come back to mainland Europe. Horizons will now be held in Lisbon, Portugal at the Lisbon Marriott Hotel, Avenida dos Combatentes 45, Lisbon 1600-042 Portugal and the dates still remain the same 17-19 May 2019.

This does not mean that in future years we will not take Horizons to another continent and we will work hard to try and make this happen for 2020 and we will keep you updated.

What does this change of location mean for all our members? We will need you to start registration ASAP and depending on the country you come from if you need a Schengen Visa this process can take 6-9 weeks so we need you to take the following steps.

Step 1: Register for CML Horizons 2019 here: https://www.cmladvocates.net/cmlhorizons

Step 2: At the following link is a list of the nationalities that must process a Visa: https://www.vistos.mne.pt/en/short-stay-visas-schengen/general-information/who-needs-a-visa#countries-2

Step 3: Once you have registered, we will be in contact with you in regards to support documents for your visa application.

For those members who have already registered: Vanja and Lidija will be in touch with you soon and there is NO NEED to re-register. For those who need a VISA we will need to send you new documents for a Schengen Visa to Portugal and new flight itinerary.

Finally, please note that this decision did not come easy and does not take away from why we had chosen Nairobi as our original destination and that is to honour our dearly departed Ferdinand Micho who was the leader in the fight of CML in Africa and the Middle East but also for the challenges that CML patients face in law and middle-income countries in access to treatment and monitoring.

We look forward to seeing you all soon and please should you have any questions at all please do not hesitate to contact us.

Warm Regards

Giora and Lidija on behalf of the CML Advocates Steering Committee
CML Advocates Network

The World Health Organisation (WHO) has issued a medical product alert today that falsified versions of ICLUSIG (Ponatinib) have been discovered in Turkey, Argentina and Switzerland, and in Internet sales. The falsified (counterfeit) medicines do not contain any of the CML drug ponatinib, but only low quantities of paracetamol. These falsified medicines are not going to have any effect against CML. The falsified English language packs contain the batch numbers

• PR072875 (UK/Ireland pack, English language, 60 tablets á 45mg, Expiry date 12/2019) and
• 25A19E09 (UK/Ireleand pack, English language, 30 tablets á 15mg, Expiry date 10/2020).

The WHO page which is available in English, French, Russian and Spanish provides photos of the packages and pill bottles so patients can find the batch numbers.

To identify falsified product batches both the batch number and packaging (language, country of the pack) are important.

No UK/Ireland ORIGINAL product has been produced by the manufacturers Incyte/Takeda that carries those batch numbers. - so products with the above two batch numbers in UK/Ireland and English language are most likely falsified. In case of PR072875, the counterfeiters used this genuine lot number originally issued on a German ICLUSIG box and created a falsified UK packaging.

And so far, the manufacturer and medicines authorities are NOT aware of additional FALSIFIED ponatinib products bearing different batch numbers, so patients taking Ponatinib with other batch numbers than those listed above should NOT yet be concerned.

WHO alert

Incyte Press Release

Patients, physicians and distributors should make sure to obtain CML medication from validated and reliable sources that are able to demonstrate the authenticity of origin of the products.

In case of any concern, check the batch number against the two identified falsifications, and contact Incyte Medical Information in case of persisting suspicion at eumedinfo@incyte.com or +800 00027423.

Please let the CML Advocates Network know via info@cmladvocates.net if you come across the falsified product with these batch numbers, so we know whether the falsified medicines have been shipped to any other regions or countries. National CML patient groups are also encouraged to notify their local health authorities and leading physicians.

Emerging news regarding CML Horizons 2019    

Dear members and friends of the CML Advocates Network,

You are probably aware of the terrible attack that took place yesterday by terrorists in the Dusit hotel in Nairobi. 

These are terrible and sad news indeed. Our thoughts are with the lost innocent victims and their families. We live in a crazy world with crazy people. Terror is taking lives in almost every country and it is so difficult to understand and accept. We must not react rashly, and will not make a decision based on emotion, but rather consider the alternatives and then make a decision.

The steering committee will now study the facts and the extent of the sad event and will discuss the implications of CML Horizons in Nairobi in May.

Meanwhile, we are not stopping registration as we already have more than 20 delegates registered, but we are stopping any activity that increases our costs and commitment like we will not book more flights until the Steering committee discusses the issue and makes a decision.

We are in constant touch with our local member organization, Henzo Kenya, and with our logistics agency Safari Trails to better understand the Situation in Nairobi and all safety steps taken now and in the near future.

We are evaluating the situation and we will come back to our members with more information and the final decision as soon as possible within 2 weeks.

We must decide what is best for Horizons and for all our members and delegates. We will put the safety of our participants at the top of our priority.

It is a sad day.

With our hopes for a better future
Giora and all the CML Advocates Network steering committee members.

 Register here - Preliminary Program - Conference fee -  Scholarship Application

Call for Poster - Call for Nominations Travel - Visas - Venue & Accommodation - Acknowledgements  

Registration is now open - Join us for the 17^th “CML Horizons: Learn. Share. Grow" Conference

DATE: 17th to 19th MAY 2019
LOCATION: Lisbon, Portugal

Due to events beyond our control and with sad regret we have changed the location of this year's Horizons. Even though location has been changed  to Lisbon, Portugal this does not take away from why we had chosen Nairobi as our original destination and that is to honour our dearly departed Ferdinand Micho who was a leader in the fight of CML in Africa and the Middle East but also for the challenges that CML patients face in low and middle-income countries in access to treatment and monitoring.

We have secured top speakers from Western countries like Dr. Francois Mahon & Dr. Gianantonio Rosti, also African and Asian countries such as Dr. Qian Jiang from China, Dr. Abinya from Kenya and Dr. Benneh from Ghana. More speakers are expected to confirm soon.

The CML Horizons conference is dedicated to the development of our members as patient advocates and deals with topics such as: - What is the goal of CML Treatment? Improving access, Key initiatives in CML treatment & advocacy and Living with CML and the future outlook. Dealing with these types of questions is the essence of Learn. Share & Grow and our conference offers the opportunity to support and facilitate the quality of education. This one of a kind conference also provides opportunities to be able to exchange ideas, interact & share best practice and provide a platform to start networking across borders, build alliances and so much more for you to bring back to your own organization.

We very much hope that you will be able to attend the 17th conference of its kind - with an exciting program on CML advocacy and CML science.

Our conference will provide you with knowledge on how to make a difference to the lives of patients, identify opportunities in patient support & advocacy and learn from the experts - both patient advocates and physicians by networking opportunities with CML advocacy leaders around the globe.

CLICK HERE TO REGISTER