There are always exceptions that prove a rule and Johnson & Johnson’s licensing of novel Bruton's tyrosine kinase inhibitor PCI-32765 from Pharmacyclics for a staggering $150m upfront is just such an example. Against the backdrop of a gradual decline in the volume and value of product licensing deals over the last few years, the J&J deal is a timely reminder of the handsome price that big pharma companies are still prepared to pay for innovative, first-in-class assets.
The $150m upfront received by Pharmacyclics is the biggest single-product licensing deal so far this year and greatest amount paid to license a phase II asset since AstraZeneca splashed the cash on Targacept’s anti-depressant TC-5214 in 2009 for $200m (see table below). J&J clearly believes PCI-32765 is worth it and the deal provides another important test of the theory that ‘you get what you pay for’ in licensing deals (Does a top dollar upfront payment give a greater chance of success?,August 4, 2011).
The table below, taken from EvaluatePharma, shows the biggest R&D product licensing deals in 2011. The deals struck by Eli Lilly and Lundbeck, with Boehringer Ingelheim and Otsuka respectively, have generated the biggest upfront fees so far this year but both transactions involved multiple products changing hands.
As such, the J&J-Pharmacyclics deal announced yesterday is the biggest single product licensing deal this year, illustrating the level of achievement by the California company’s negotiating team (J&J pays handsomely for first-in-class blood cancer drug, December 9, 2011). The deal is the biggest upfront to license a phase II asset since the Astra-Targacept collaboration; in a slightly different type of transaction Abbott Laboratories paid $450m to acquire Reata Pharmaceuticals' phase II bardoxolone outright last year.
|Top 10 Upfront Fees Paid in Product Licensing Deals in 2011|
|Rank||Company||Product||Therapeutic category||Pharmacological Class||Deal Partner||Status on Deal||Upfront Fee ($m)||Total Deal Value ($m)|
|1||Eli Lilly||Tradjenta + BI 10773||Anti-diabetics||DPP-IV inhibitor + SGLT2 inhibitor||Boehringer Ingelheim||Phase III||410||1,261|
|2||Lundbeck||Abilify Depot + OPC-34712||Anti-psychotics||Atypical antipsychotic + D2 dopamine agonist||Otsuka Holdings||Phase III||200||600|
|3||Johnson & Johnson||PCI-32765||Antineoplastics||Bruton's tyrosine kinase (Btk) inhibitor||Pharmacyclics||Phase II||150||975|
|4||Astellas Pharma||Tivozanib||Anti-angiogenics||VEGFr kinase inhibitor||AVEO Pharmaceuticals||Phase III||125||1,480|
|5||Abbott Laboratories||BT-061||Anti-rheumatics||Anti-CD4/CD25 MAb||Biotest||Phase II||85||85|
|6||Astellas Pharma||Difimicin||Anti-bacterials||Bacterial RNA polymerase inhibitor||Optimer Pharmaceuticals||Filed||68||224|
|7||Allergan||Levadex||Anti-migraine||5-HT1B (serotonin) & 5-HT1D (serotonin) agonist||MAP Pharmaceuticals||Phase III||60||157|
|8||Human Genome Sciences||HGS1036||Other cytostatics||Fibroblast growth factor (FGF) antagonist||FivePrime Therapeutics||Phase II||50||495|
|9||Sanofi||GBR500||Immunosuppressants||Anti-VLA-2 MAb||Glenmark Pharmaceuticals||Phase I||50||663|
|10||Allergan||MP0112||Eye preparations||VEGF-A antagonist||Molecular Partners||Phase II||45||420|
The top deal chart also shows that cancer remains hot property in terms of deal value, accounting for three of the top ten transactions in terms of upfront fees paid.
While Pharmacyclics managed to extract the largest upfront for a phase II asset, in bio-dollar terms Aveo’s deal with Astellas Pharma is larger; understandable perhaps give the drug in question has potentially broader utility in several solid tumour types.
A tyrosine kinase inhibitor that potently inhibits VEGF growth pathways, the first real test of the agent’s potential will emerge next year when a pivotal renal cell carcinoma study reports (Event – Aveo hoping for game-changing data from tivozanib, April 28, 2011).
Human Genome, meanwhile, paid handsomely for FivePrime’s FP-1039, now called HGS1036, one of the most advanced inhibitors of fibroblast growth factor ligands in development (Therapeutic focus - Expectations rising for FGF inhibitors, March 18, 2011). At the time the deal was struck a phase II study in patients with uterine cancer was being recruited; the companies plan to conduct further studies in multiple cancer types.
As to the ‘you get what you pay for’ theory, Astra’s high stakes gamble on TC-5214 is looking decidedly shaky after the recent failure of the first phase III trial of the Targacept drug (Targacept investors severely depressed by TC-5214 failure, November 8, 2011).
J&J will be hoping for much better luck in its bet on Pharmacyclics’ novel cancer agent.