On 12 June the Chinese Drug Administration approved the use of Cuba’s drug Nimotuzumab for the treatment of pancreatic cancer. The drug was developed by Cuba’s Centre for Molecular Immunology (CIM) and first approved for use in Cuba against nasopharyngeal cancers in 2002. It has since been approved for use against various types of cancer in numerous countries. Nimotuzumab is an antibody that targets a protein called ‘epidermal growth factor receptor’ (EGFR) on the surface of cells, which can cause uncontrolled cell division, the hallmark of cancer, if EGFR mutates.
A paper in the Cuban journal Biotecnología Aplicada from 2014 concluded that, ‘[Nimotuzumab has] an antitumor effect that is noted by the increase of the survival of patients with advanced head and neck tumours, malignant glial tumours and advanced esophagus tumours, demonstrated by controlled studies and in medical practice... [Nimotuzumab’s] safety profile surpasses that of other (anti-EGFR) monoclonal antibodies, thereby favouring its combined use with other conventional therapies, its utilisation as a prolonged maintenance medication, and in vulnerable populations as of the elderly and children’.
Nimotuzumab was granted orphan drug status in the EU in 2004. This designation is usually given to drugs which treat rare diseases, that can only be obtained by patients who have no other drugs available to treat them, whereas an approved drug would be available more readily on the market.
The US has tried to enforce its blockade of Cuba extraterritorially, punishing companies that trade with Cuba. This means that not only is Cuba restricted from accessing imports, but that other countries are restricted in their ability to access Cuban exports – including those of its world-class biopharmaceutical company. RATB asked Robert Ellerson, managing director of the German biopharmaceutical company Oncoscience which announced a named patient programme to provide Nimotuzumab in Britain in 2018, to find out more about the effect of the blockade of Cuba on the availability of Nimotuzumab in Britain and the EU.
Is the patient programme to provide Nimotuzumab still active in the Britain?
Nimotuzumab is available in the UK and Europe under the named-patient programme for patients who have no other treatment options, in accordance with local regulations.
In the process of being granted orphan drug designation in the EU in 2004, what were the complications given the sanctions on Cuba?
Thankfully the sanctions do not impact us as much in Europe but the major challenge is finding a development partner as nearly all medium to large pharma companies have some presence in the US which puts them under US jurisdiction. I strongly believe that if nimotuzumab would have been developed anywhere else it would already have been approved by now in the UK/EU/US and available for cancer patients as a treatment option.
Given that the drug has been approved in China, is there any reason why it hasn’t achieved further approval and distribution in the EU/Britain? What is the current status of its availability in Britain?
Oncoscience GmbH completed a Phase 2/3 clinical trial in Europe which was later expanded in China by our partner based on the data we initially generated. Their trial showed the same conclusions that Nimotuzumab was effective in the treatment of pancreatic cancer in combination with gemcitabine and especially so in KRAS wild type patients (pancreatic cancers without a mutation) which represent approximately 15% of the patients. This can be identified by a standard mutation test.
In Europe we are preparing for discussions with EMA to see if they would accept a similar study as was done in China focusing on the KRAS Wild Type patients group. We are now starting to look for fundraising options to fund such a trial.
Following on from the previous question, a search for the drug on the ‘Cancer Research UK’ database would seem to indicate that its availability in the Britain continues to be limited?
I am not sure about this but that's most likely the case as Nimotuzumab is not approved yet in Europe and therefore only available through a medical need application that needs to be submitted by the treating oncologist based on their patient’s need assessment.
In distributing the drug in the EU/Britain have there been any financial or legal difficulties that have been incurred due to the US sanctions on Cuba by Oncoscience?
Yes, there are some challenges because of the sanctions. Fortunately, our business is based in Germany, so our main focus is EU, and we do not have any direct affiliations with US based companies so the impact is much less. I also believe that most European countries are not in favour of the sanctions. We certainly do hope that this drug will be available more widely as we believe strongly in the efficacy and safety of the drug, and that the US sanctions will continue to be less of a barrier for its availability worldwide in the future.
What is the current availability of the drug outside of the EU/Britain?
Outside the EU/UK like in China, Latin America, South East Asian countries, India etc. Nimotuzumab is available (approved) on a normal basis for various indications including head and neck, pancreatic cancer and other cancers.
What is the future of licensing Nimotuzumab in the EU/Britain?
Our aim is to continue developing Nimotuzumab to get it approved in EU/UK as its already approved in more than 25 countries around the world with extensive real world evidence of its efficacy and safety.