Daybreak clouds over for Lundbeck

A treatment-resistant schizophrenia drug would have been a blockbuster – but Lundbeck’s high risk, high-reward strategy has not paid off.

Specialising on one particular therapeutic area is not necessarily a bad strategy for a pharma group. A focus on CNS disorders, however, is a poor choice of basket in which to put all your eggs. The failure of Lundbeck’s treatment-resistant schizophrenia project Lu AF35700 in phase III has hurt the company badly, its 27% share price fall yesterday being its worst one-day collapse in its history.

Worse, there is nothing much else in its pipeline. Lu AF35700 was its only phase III-stage drug, and the only one at any stage to which sales forecasts have been appended. 

A look at the Danish group’s top 10 bestsellers shows just how badly it needed the antipsychotic to succeed. Onfi, the antiepileptic that is Lundbeck’s current biggest seller, saw its first generic competition launch on Tuesday and its sales are now forecast to decline by 28% each year. 

Only three of Lundbeck’s top 10 products are forecast to grow in sales out to 2024, and overall the company’s top line is forecast to shrink by 7% in the next six years, EvaluatePharma’s consensus data shows. 

Lundbeck's top 10 products
    Annual Sales WW ($m)      
Product Therapeutic Subcategory 2017 2024 CAGR WW phase Patent expiry
Trintellix Antidepressants 105 377 20% Marketed Jan 2023
Lexapro Antidepressants 360 223  -7% Marketed Feb 2012
Lu AF35700 Antipsychotics - 106 N/A Phase III -
Northera Cardiac therapy 250 97  -13% Marketed Feb 2019
Namenda Nootropics 108 64  -7% Marketed May 2012
Treanda Alkylating agents 40 57 5% Marketed -
Onfi Anti-epileptics 459 47  -28% Marketed Oct 2018
Azilect Anti-Parkinson's agents 30 43 5% Marketed Dec 2017
Sabril Anti-epileptics 229 36  -23% Marketed Aug 2017
Xenazine Other CNS drugs 159 28  -22% Marketed Aug 2015
  Other 123 77  -6%    
  Total 1,863 1,156  -7%    
Source: EvaluatePharma.

Lu AF35700’s own sales forecast is modest at $106m in 2024, but this is still enough to make it Lundbeck’s third biggest seller that year. It now has no chance of making that figure, and is almost certain to be abandoned entirely. That 7% annual drop in revenue is now closer to 8%.

Nightfall

The Daybreak study tested two doses of ’35700, 10 and 20mg, versus Risperdal and Zyprexa, following a six-week lead-in period with the generic combo. All that Lundbeck has said so far is that Daybreak’s primary endpoint, superiority versus the conventional therapy on change in score on the positive and negative syndrome scale after ten weeks of therapy, was not met.

Bernstein analysts cling to hope. They write that superiority may yet be proven with longer-term data from the Debut study, which doses the drug over more than a year and will report in late 2019. Another possibility they entertain is that the full Daybreak data might show a numerical advantage for ’35700. “Regardless,” they write, “this is a very bad outcome”.

Now Lundbeck finds itself with zero prospect of getting anything new on the market in the short term, and thus slowing its sales slide, unless it starts buying. It had a cash pile amounting to DKr4.6bn ($698m) at the end of June, and that will not get it much in the way of market-ready assets. 

Lundbeck's clinical pipeline
Product Mechanism Indication Indication status
Lu AF35700 Dopamine D1 receptor regulator Schizophrenia Phase III
OV101 (licensed from Ovid Therapeutics) GABA A receptor agonist Angelman syndrome Phase II
Fragile X syndrome Phase II
IMR-687 (licensed to Imara) PDE9 inhibitor Sickle cell disease Phase II
Foliglurax mGluR4 regulator Parkinson's disease Phase II
Lu AE04621 Dopamine receptor agonist Parkinson's disease Phase I
Lu AF82422 Alpha-synuclein accumulation antibody Parkinson's disease Phase I
Lu AF20513 Unclassified Alzheimer's disease Phase I
Brexpiprazole LAI 5-HT2 receptor antagonist; 5-HT1A receptor partial agonist; Dopamine D2 receptor partial agonist Schizophrenia Phase I
Lu AF76432 PDE1 inhibitor Alzheimer's disease Phase I
Lu AF28996 Unclassified Parkinson's disease Phase I
Source: EvaluatePharma.

 

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