OUR PRODUCT PIPELINE

The following table summarizes certain of our product candidates currently in development either by us or through our sub-licensees:

Product Candidate/

Discovery Program

 

Indication(s)

 

Status(1)

Development and

Commercialization Rights
Clinical      
DOV 21,947

Depression

Obesity

Phase II

Phase I

DOV

DOV
Bicifadine Pain Phase II/III(2) XTL
DOV Diltiazem Hypertension and Angina Phase I/III(3) BLUE NOTE
DOV 102,677 Alcohol Abuse Phase I(4) DOV
Pre-Clinical

 

 

 
DOV 216,419

Depression Pain

Pre -IND(5) DOV
Uptake inhibitor Various CNS Disorders Discovery DOV
GABA Modulators Various CNS Disorders Discovery DOV
Program Subject to Regulatory Review      
Indiplon: 5mg and 10mg capsules Insomnia FDA has deemed approvable (6)

NEUROCRINE/DAINIPPON SUMITOMO PHARMA

 

(2) XTL initiated a Phase II clinical trial in neuropathic pain in September 2007 and expects the results to be available in the fourth quarter of 2008. Bicifadine has been studied in five Phase III clinical trials.

(3) Blue Note has advised us that it is conducting a Phase III development program expected to culminate in a 505(b)(2) NDA filing for use in the treatment of hypertension and angina at the end of 2009.

(4) We may initiate a Phase I clinical trial administering repeat doses of DOV 102,677 to volunteers in 2009 if adequate funding is available.

(5) We may file an IND for DOV 216,419 in the fourth quarter of 2009 and undertake the necessary expenditures to enable initiation of a Phase I clinical trial in the second quarter of 2010 if adequate funding is available.

(6) Neurocrine has stated that it has received a letter from the FDA which indicated additional requirements necessary for approval.