Jazz still FAAH from replacing Xyrem

Snippets

Shrewd deals are key when a company faces looming generic competition for its lead product, but the subject of today’s transaction between Jazz and Springworks looks like a long shot. Jazz has acquired global rights to PF-04457845, a FAAH inhibitor, and wants to develop it for post-traumatic stress disorder; this class has been a developmental dead end so far. To Jazz’s credit it is being cautious by handing over just $35m up front, and the deal is heavily backend loaded. PF-04457845 originated at Pfizer, and was offloaded to Springworks in 2017 a year after Bial’s FAAH inhibitor BIA 10-2474 was linked with haemorrhagic and necrotic brain lesions. The issue with Bial’s asset looks to have been caused by off-target activity on several lipases, while PF-04457845 is said to be more selective. Safety aside, several other FAAH inhibitors have failed in indications including osteoarthritis, cancer pain and neuropathic pain, and just two others appear to be in development. Jazz needs new avenues for growth as its blockbuster narcolepsy drug, Xyrem, is set to lose patent protection in 2023. This might not be the deal that investors were hoping for. 

The FAAH inhibitor clinical pipeline (all phase II)
Product Company Note
JNJ-42165279 Johnson & Johnson Study in autism ongoing, primary completion 2022, NCT03664232
PF-04457845 Jazz/ Springworks  $35m up-front payment from Jazz, development planned in PTSD (Yale running a trial in cannabis use disorder, NCT03386487)
V158866 Vernalis/ Neuritek Deal signed earlier this year, plan to develop for PTSD & other CNS diseases
Sources: EvaluatePharma, clinicaltrial.gov, company releases.

 

Jazz's biggest-selling drugs by 2026
    Annual sales ($m)  
Product Therapy area 2019 2026e Status 
Sunosi Narcolepsy 4 451 Marketed
Xywav Narcolepsy - 420 Approved
Xyrem Narcolepsy 1,643 287 Marketed
Zepzelca Small cell lung cancer - 277 Marketed
Vyxeos Acute myeloid leukaemia 121 256 Marketed
Erwinaze Acute lymphoblastic leukaemia 177 156 Marketed
Defitelio Hepatic veno-occlusive disease 173 152 Marketed
JZP-458 Acute lymphoblastic leukaemia - 33 Phase III
Source: EvaluatePharma.

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