Partnering opportunities abound in oncology, CNS and infectious diseases

Analysis

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
Systemic Anti-infectives 71 94.1
Cardiovascular 40 65.7
Gastro-Intestinal 39 27.8
Genito-Urinary 36 25.7
Musculoskeletal 31 56.4
Endocrine 26 52.6
Respiratory 21 45.7
Dermatology 20 12.7
Blood 14 52.1
Sensory Organs 8 17.8
Various 9 17.1
Unclassified Rx + OTC sales 177.7
Total 612 842.9

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.

Status Opportunity Count
Marketed
   Marketed 72
   Approved 6
Total (Marketed) 78
R&D
   Filed 4
   Phase III 34
   Phase II 147
   Phase I 94
   Pre-clinical 165
   Research project 57
Total (R&D) 501
Suspended in R&D 33
Total Opportunities 612

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.

Technology Opportunity Count
Biotechnology
   Recombinant product 77
   Bioengineered vaccine 39
   Monoclonal antibody 28
   Other biotechnology product 19
   Gene therapy 13
   Antisense therapies 12
   Cell therapy 4
   Monoclonal antibody (conjugated) 2
   Transgenic product 0
Sub total 194
Conventional
   Small molecule chemistry 385
   Plant extract 13
   Protein extract 9
   Chiral chemistry 7
   In vivo diagnostics 2
   Vaccine 2
   Miscellaneous 0
Sub total 418
Total 612

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
Talactoferrin talactoferrin alfa Agennix Immunomodulator Immunosuppressants
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.

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