Access to ibalizumab uncertain in Europe: TaiMed looking for new partner after Thera quits
On 27 April 2022, Theratechnologies announced that the company will no longer look to market ibalizumab in the EU, ending their contract with TaiMed Biologics within the next six months. 
This means that future access to ibalizumab, a monoclonal antibody recently approved by the FDA in March 2018 and in the EMA in September 2019, is now uncertain. [2, 3]
However, TaiMed who developed ibalizumab and own the license said they are determined to continue to make ibalizumab to people who need it globally and that they are already looking for a new commercial partner for the European region. Their press release suggests that TaiMed might have had a roll in setting the minimum floor price for ibalizumab, that was not acceptable to countries in the EU. 
Ibalizumab is indicated for treatment of people with multiclass HIV drug resistance.
The press release blamed ‘pricing and reimbursement conditions in key European countries’ where sales have be low, accounting for less than 2% of the company’s revenue and less than 10% of global sales.
The annual price for ibalizumab in the US is $118,000 (WAC/Wholesale Acquisition Cost), which doesn’t include costs for providing the two-weekly infusions.
Ibalizumab will continue to be marked in North America under the tradename Trogarzo.
Theratechnologies is a Canadian company that is also responsible for marketing tesamorelin (Egrifta) in Canada and the US. This is a treatment for central fat accumulation that is was never approved in the EU.
Similar to Gilead’s withdrawal of the EU application for F/TAF for PrEP last year, this is due to corporate financial rather than clinical decisions. This is driven by inflated drug pricing in the US together with a limited EU market.
A few days before this announcement, NHS England has recently circulated the draft commissioning report for ibalizumab to stakeholders for comment. 
Although uncontrolled multiclass resistance is thought to affect very few people in the UK, likely less than 20, in these cases ibalizumab could be a life-saving option.
Neither press statement gave an indication that people in Europe will continue to access ibalizumab, other than in the immediate short-term. TaiMed has said that they are committed to making ibalizumab available to those who need it in the EU but it is difficult to see how this will happen.
Thera say that the price offered in France of €40,000 would not cover manufacturing costs, but this is linked to the price of fostemsavir which shows similar efficacy data. But if TaiMed were involved in directing the minimal acceptable price, then finding a new marketing partner won’t fix the problem that caused Thera to quit.
Even if demand across the EU is less than several hundred people (anecdotally, about 20 in Germany, 70 in Italy, less than 20 in the UK etc) this might suggest the need for a new European approach for very difficult cases. These low numbers should be used for orphan drug designation for similar compounds.
More recent bNAbs should have similar or greater efficacy compared to ibalizimab, assuming baseline sensitivity, but will have easier dosing. Researchers focused on prevention could perhaps be persuaded to also work collaboratively on with an MDR cohort.
TaiMed might also be legally obliged to continue to supply treatment to people currently using ibalizumab, as part of the conditions of EU approval, as the drug is still being used in other regions.
- Theratechnologies press statement. Theratechnologies to focus its commercialization activities on the North American territory. (27 April 2022).
- FDA approves ibalizumab in the US to treat multidrug HIV resistance. HTB (March 2018)
- Ibalizumab approved in the EU. HTB (November 2019).
- TaiMed press statement. TaiMed receives from Theratechnologies notification of returning commercialization rights for Trogarzo in European territory. (27 April 2022).
- NHS England, Policy testing: Ibalizumab for multi-drug resistant HIV-1 infection. Draft circulated 22 April 2022.
This report was first posted on 28 April 2022, with comments updated on 4 May 2022.