AstraZeneca v Altana (AUTH/1941/1/07): “Equivalent/comparable” claims for Protium vs Nexium and secondary endpoint ‘2 days faster’ messaging

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Key facts

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Case number	AUTH/1941/1/07
Parties	AstraZeneca v Altana Pharma
Product(s)	Protium (pantoprazole) vs Nexium (esomeprazole)
Materials	Mailings PAN208/071205/P and PAN291/020806/P; clinical paper summary PAN202/291105/P
Complaint received	04 January 2007
Case completed	08 June 2007
Applicable Code year	2006
Key issues	Misleading/unsubstantiated comparative claims; “equivalent/comparable” in healing and symptom relief; secondary endpoint “2 days faster” claims without primary endpoint context; accuracy of presented data/metrics
Breach Clause(s)	Three breaches 7.2, two breaches 7.3 and two breaches 7.4
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal outcome (high level)	For “comparable healing” claim: breach upheld for 7.2; no breach for 7.3/7.4 on appeal. Other Clause 7 breach rulings upheld.

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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AstraZeneca complained about Altana Pharma’s promotion of Protium (pantoprazole) versus Nexium (esomeprazole).
Materials: two mailings (PAN208/071205/P; PAN291/020806/P) and a clinical paper summary (PAN202/291105/P).
Key comparative claims included:
- “Endoscopic healing rates equivalent to esomeprazole 40mg”
- “Endoscopic healing rates comparable to esomeprazole 40mg”
- “40 mg pantoprazole and 40mg esomeprazole are equivalent in the healing of esophageal lesions”
- “Once daily pantoprazole 40mg and esomeprazole 40mg have equivalent overall efficacy in relieving GERD-related symptoms”
- “Fast symptom control – 2 days faster than esomeprazole 40mg” / “daytime symptom relief – 2 days faster” / “2 days faster than esomeprazole 40mg”
The “equivalent/comparable” healing claims were referenced to Gillessen et al (2004) (non-inferiority/equivalence-type design), while AstraZeneca argued the later, larger EXPO study (Labenz et al 2005) showed statistically superior healing for esomeprazole at 4 and 8 weeks.
The “equivalent symptom efficacy” and “2 days faster” claims were referenced to Scholten et al (2003); AstraZeneca argued non-significant primary endpoint results were being presented as equivalence and that secondary endpoint advantages were being promoted without the primary endpoint context.

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Healing claims: Panel ruled the “equivalent/comparable” healing claims were incorrect, misleading and not capable of substantiation (breaches of Clauses 7.2, 7.3, 7.4).
On appeal (healing “comparable” claim): Appeal Board upheld a breach of Clause 7.2 for the “comparable” claim (too broad/ambiguous and implied statistical similarity across any GERD grade). It overturned the Panel on Clauses 7.3 and 7.4 for that claim (no breach of 7.3/7.4 in that regard).
GERD symptom equivalence claim: Panel ruled misleading and not substantiated (breaches of Clauses 7.2, 7.3, 7.4).
“2 days faster” claims: Panel ruled misleading and not reflective of available evidence (breaches of Clauses 7.2, 7.3, 7.4). Appeal Board upheld these breaches, stating it was unacceptable to claim an advantage from secondary endpoints when the primary endpoint did not show a statistically significant difference and this failure was not made clear.

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