Asset sale

Asset sale strategies tend to be pursued predominantly smaller drug development companies seeking to generate income from their early development pipelines. For this reason, many of our asset sales case studies are similar to those for proof-of-concept. The same principles of simple investigational design and robust analytical insight are used in this context to show value to a potential buyer.

 


Speedel

CLINICAL INDICATION

Hypertension renin inhibitors

OBJECTIVE

Improve bioavailability of lead compound by investigating microdose amounts of different congeners in the clinic

SERVICE
  • Helped to design iterative microdose clinical approach
  • Managed project including partner preclinical and clinical organizations
  • Conducted all AMS analyses
OUTCOME

Increased lead compound bioavailability (2.6%) to >30%. Formed the basis of Speedel’s renin inhibitor series. Speedel subsequently bought by Novartis for $880MM in 2008 on the basis of this and other compounds in their development pipeline. Speedel highlighted:

  • Need only gram quantities of API – can be produced under less demanding manufacturing conditions
  • Reduced preclinical toxicology and ADME package
  • Duration of 4 to 6 months, compared with 12 to 18 months for standard Phase I safety and tolerability trial

 


US biotech company

CLINICAL INDICATION

Prostate Cancer

OBJECTIVE

Determine absolute bioavailability, and routes and rates of clearance with full quantitative metabolite profiles in urine and feces.

SERVICE
  • Helped to design an Enriched Phase I study design with 2 parallel cohorts – IVPK arm for absolute bioavailability and oral arm for mass balance and metabolite profiling.
  • Chromatographically separated parent from metabolites and conducted full quantitative analysis using AMS
OUTCOME

Company recently acquired by one of Xceleron’s European large pharma clients for $750MM US in order to obtain Phase II compound. The acquiring company appreciated the value of this data and are now discussing with Xceleron how to adopt the approach in their early clinical development programs. This drug, an androgen receptor antagonist, is now on Phase III in non-metastatic prostate cancer patients

 


Idenix

CLINICAL INDICATION

Anti-HIV-1 (NNRTI)

OBJECTIVE

Use a microdose investigation of two non-nucleoside reverse transcriptase inhibitors to select a lead candidate on the basis of clinical PK and metaolism

SERVICE

Helped to design a human microdose investigation

OUTCOME

IDX899 was taken into Phase II by Idenix before being licensed to GSK for an upfront payment of $34MM

 


US biotech company

CLINICAL INDICATION

CNS (Alzheimer’s)

OBJECTIVE

Determine blood-brain barrier penetration of two novel drug candidates by measuring drug CSF levels

SERVICE
  • Helped to design a microdose study
  • Full project management of partner companies conducting drug labelling, clinical dosing and CSF collection
OUTCOME

Lead candidate drug was eventually sold to a Japanese Big Pharma in a deal worth $760MM

 


Client case study links

Proof-of-concept »  Asset purchase »  Drug approval »


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