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Forest Labs Clinical Development Profile

  • February 2014
  • -
  • Industry Standard Research
  • -
  • 50 pages

ISR’s report provides a thorough analysis of Forest Laboratories’ R&D pipeline, clinical trial activity, patents, FDA submissions, and includes profiles of Forest’s key products.

What you will learn in this report:

How you can use this report:
- Drug sales and company financial condition over the past four years
- Number, length, and patient enrollment of clinical trials segmented by phase and trial type
- Current R&D pipeline overview
- Important aspects of Forest’s key products such as MOA, dosing, and interaction characteristics
- Pharmaceutical Companies: Identify the clinical and commercial status of competing compounds and understand how these will affect the launch of similar products.
- For Service Providers: Learn Forest’s strategic direction and better understand their clinical development pipeline.

Clinical trial activity
Data used in this analysis was pulled from ClinicalTrials.gov (www.clinicaltrials.gov) on 10 December 2013. The analysis includes all trials conducted by Forest Laboratories
listed on ClinicalTrials.gov.
Data/ clinical trials were segmented into three groups:
- Ongoing trials (N=51 trials)—these clinical studies are currently ongoing.
- Past 2 years (N=84 trials)—these trials were completed in the past two years.
- Historic trials (N=141 trials)—these trials were completed more than two years ago and were not analyzed for this report.
The analyses that follow center on only the 135 clinical trials that are currently ongoing and those that have been completed in the past two years.

For definitional purposes:
- An “ongoing” trial is a trial with an ending date after 1 December 2013.
- A “recently completed” trial is one with an ending date occurring after 1 December
2011 but before 1 December 2013 (past two years).

Table Of Contents

Forest Labs Clinical Development Profile
Table of Contents

Copyright and Usage Guidelines ..3
Background and strategy .4
Financial condition .10
Drug sales .11
Stock performance ...12
RandD pipeline overview ..13
Clinical trial activity 14
Number of clinical trials, by phase ...15
Study type distribution (e.g. interventional) 15
Interventional trials, by phase .16
Observational trials, by phase ..16
Industry-funded study type distribution ..17
Industry-funded interventional trials, by phase ..17
Industry-funded observational trials, by phase ...18
Average trial length, by phase .19
Average interventional trial length, by phase .20
Average observational trial length, by phase ..20
Average industry-sponsored interventional trial length, by phase .21
Average industry-sponsored observational trial length, by phase ..22
Projected vs. actual ongoing trial length, by phase .23
Projected vs. actual ongoing interventional trial length, by phase .23
Projected vs. actual ongoing observational trial length, by phase ..24
Projected vs. actual ongoing industry-sponsored interventional trial length, by phase .24
Average enrollment by phase ..25
Interventional enrollment, by phase ...25
Observational enrollment, by phase 26
Industry-sponsored, interventional trial enrollment, by phase ...26
Industry-sponsored, observational trial enrollment, by phase 27
Patents .28
FDA submissions 32
Approved drugs 32
Discontinued drugs ...34
Key product profiles ...36
Bystolic .36
Daliresp 37
Lexapro 38
Linzess ..39
Namenda ..40
Namenda XR .41
Savella ..42
Teflaro ..43
Tudorza 44
Viibryd ..45
Summary 46
RandD spending ..46
Clinical development highlights ...46
Forest: key compound MOA and trial overview ..47
Aptalis: key compound MOA and trial overview .48
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