As big pharma continues to ramp up its search for external sources of pipeline assets – AstraZeneca has set an ‘externalisation’ target of 40% for its R&D portfolio – the fields of oncology, CNS and infectious disease appear to hold the most opportunity, according to new partnering data* from EvaluatePharma.
These three therapeutic areas alone account for more than half of the 600 partnering opportunities identified from 2,500 private and public companies. Meanwhile, of the 279 clinical stage assets looking for a home, half are undergoing phase II trials to generate that all-important proof-of-concept data (see tables below).
Oncology to the fore
Unsurprisingly, new therapies for cancer dominate the opportunities list. Despite a gradual decline in deal volumes and value in recent years, cancer products still attract the most partnering interest compared to other therapeutic areas (Resurgence of conventional and untrendy therapy area product deals in 2009, February 25, 2010).
|Therapeutic category||Opportunity Count||Forecast branded drug sales in 2016 ($bn)|
|Oncology & Immunomodulators||193||113.7|
|Central Nervous System||104||83.8|
|Unclassified Rx + OTC sales||177.7|
Perhaps more surprising is the relative scarcity of blood products – so far just 14 pipeline assets have been flagged up as requiring a partner for further development or commercialisation, despite the field being one of the biggest therapeutic areas with strong sales growth expected over the next six years.
Phase II heavy
The table below highlights the preponderance of phase II assets available for partnering. Although recent trends in licensing have suggested that more deals and money are being committed to earlier stage assets, the data below indicates the traditional partnering trigger point of phase II data remains the target.
|Suspended in R&D||33|
As to what kind of fees these assets might attract, our analysis of deals conducted in the first half of 2010 suggest the going upfront rate for phase III, II and I products is $35m, $27m and $15m, respectively (First half 2010 sees a return to more conventional deal values, July 28, 2010).
In addition, at each of the clinical phases, cancer, CNS and infectious disease products are by far the most prevalent.
Small molecules still reign
Despite the recent clamour for biotech products and technology platforms, it is interesting that small molecule drugs continue to dominate the partnering scene, accounting for almost two-thirds of the 600 assets identified.
This ratio reflects the proportion of small molecules in development throughout the industry, while the majority of the most valuable deals struck so far this year were for small molecule drugs.
|Other biotechnology product||19|
|Monoclonal antibody (conjugated)||2|
|Small molecule chemistry||385|
|In vivo diagnostics||2|
As for the some of the highest profile unpartnered assets, the table below highlights a few in late stage clinical development.
A number of the assets face critical developmental hurdles, the clearance of which will likely accelerate licensing talks.
For example, MAP Pharmaceuticals’ migraine candidate, Levadex, has been touted for some time as a product with the potential to secure a lucrative licensing deal. So far the company has reported encouraging efficacy data with the orally inhaled drug, although certain safety hurdles remain, including results from a QT trial and a study in asthmatic patients.
A clean bill of health from these trials and the successful filing to the FDA early next year should help bring any partnering discussions to a conclusion.
As for Optimer Pharmaceuticals, the lack of a partner at this late stage for its anti-bacterial agent, fidaxomicin, has disappointed investors. However, should the product gain approval in Europe and the US by the middle of next year Optimer should be in a position to reward its long-term shareholders (Optimer and investors playing the waiting game, February 15, 2010).
|Selected Late Stage Partnering Opportunities|
|Status||Product||Generic Name||Company||Pharmacological Class||Therapeutic category|
|Filed||Difimicin (OPT-80)||fidaxomicin||Optimer Pharmaceuticals||Bacterial RNA polymerase inhibitor||Anti-bacterials|
|Phase III||Gattex||teduglutide||NPS Pharmaceuticals||Glucagon-like peptide 2 (GLP-2) agonist||Anti-spasmodics & anti-cholinergics|
|Levadex||dihydroergotamine mesylate||MAP Pharmaceuticals||5-HT1B (serotonin) & 5-HT1D (serotonin) agonist||Anti-migraine preparations|
|Telcyta (TLK286)||canfosfamide||Telik||Alkylating agent||Alkylating agents|
|AS1413||amonafide malate||Antisoma||Topoisomerase II inhibitor||Alkaloids|
|Aplidin||plitidepsin||Zeltia||Cell cycle inhibitor & VEGF inhibitor||Other cytostatics|
|Glufosfamide||glufosfamide||Threshold Pharmaceuticals||Alkylating agent||Alkylating agents|
|Belinostat (PXD101)||belinostat||TopoTarget||Histone deacetylase (HDAC) inhibitor||Other cytostatics|
|Diamyd||glutamate decarboxylase||Diamyd Medical||Glutamate modulator||Anti-diabetics|
|Orplatna||satraplatin||Agennix||Platinum compound||Platinum compounds|
|Tecarfarin||tecarfarin||ARYx Therapeutics||Vitamin K antagonist||Anti-coagulants|
|Arenegyr (NGR-hTNF)||-||MolMed||CD13 aminopeptidase N (APN) inhibitor||Anti-angiogenics|
|EPA Project||-||S.L.A. Pharma||Anti-FAP agent||Other cytostatics|
|GS-101||aganirsen||Gene Signal||IRS-1 antisense||Immunosuppressants|
* The new partnering service from EvaluatePharma has so far scoured the bulk of companies in its coverage and identified specific products whose owners have indicated that a partner is required for further development or commercialisation.
The service is also asking companies to submit their own partnering opportunities into the database.