AUTH/3592/12/21 - Bayer v Janssen

Promotional material for Erleada (apalutamide)

  • Received
    17 December 2021
  • Case number
  • Applicable Code year
  • Completed
    03 March 2023
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This inter-company dialogue case was in relation to a promotional on-demand video recording for Erleada (apalutamide) tablets.

The Panel ruled no breach of the following Clause(s) of the 2021 Code in relation to the Erleada video, on the basis that it did not consider that:

Bayer had established that Janssen had promoted apalutamide off licence; nor on the evidence before it that Bayer had established that Janssen had limited the discussion to selected adverse events (AEs); nor that the narrative of the speaker in relation to the frequency of capturing adverse events was purely speculative and incapable of substantiation or that because the ARAMIS trial protocol stipulated that all AEs experienced during the trial could be reported at any time point by the subjects that the speaker’s narrative in relation to the frequency of capturing adverse was factually inaccurate ; nor that in the particular circumstances of this case, the presentation of the adverse events of the three trials side-by-side was a misleading comparison and disparaged another pharmaceutical company’s product.

No Breach of Clause 11.2


Requirement not to promote a medicine for an unlicensed indication

No Breach of Clause 6.1

Requirement that claims must not be misleading

No Breach of Clause 6.2

Requirement that claims must be capable of substantiation

No Breach of Clause 6.3

Requirement that all artwork must conform to the letter and spirt of the Code

No Breach of Clause 6.4

Requirement that claims must reflect the available evidence regarding possible adverse reactions

No Breach of Clause 6.6

Requirement that another company’s medicines must not be disparaged

No Breach of Clause 14.1

Requirement that misleading comparisons must not be made

No Breach of Clause 5.1

Requirement to maintain high standards

No Breach of Clause 2

Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 

This summary is not intended to be read in isolation.
For full details, please see the full case report.