Proprietary Product Pipeline
Proprietary
development activities are currently focused primarily on expanding
the Company’s portfolio of female healthcare products
including oral contraceptives and treatments for menopause/perimenopause
and endometriosis, through internal development and business
development activities. An important part of the product development
strategy in the area of female healthcare is to develop a broad
line of products designed to meet the unmet medical needs of
women. The Company is also pursuing two urology products, one
that utilizes its transvaginal ring technology to treat urinary
incontinence, and a second that is an oral product targeted
to treat the symptoms associated with the treatment of prostate
cancer.
In addition,
the Company is developing an oral vaccine product to prevent
Adenovirus (Types 4 & 7) infections in U.S. military personnel
under contract with the Department of Defense (DOD). In 2005
the Company signed an agreement with PLIVA Croatia Ltd. and
PAM Kft., to develop, and upon FDA approval to market, the generic
biopharmaceutical Granulocyte Colony Stimulating Factor (G-CSF).
The parties intend to develop and seek approval to market the
product in the United States and Canada as a generic version
of Amgen's NEUPOGEN® (filgrastim) product. This initiative
builds upon the Company’s experience developed as a result
of the Adenovirus project.
The Company
continues to identify other proprietary product candidates that
further expand its product offerings in these areas and is actively
evaluating additional therapeutic categories to add to its proprietary
portfolio. As a result of internal development and business development activities, at the end of fiscal 2006 Barr had a broad pipeline of short, mid- and long-term opportunities that include several proprietary products in clinical development, one of which is in Phase III studies, and several NDAs pending at the FDA.
The proprietary
research and development team has experience in managing clinical
development programs and regulatory matters. This team works
closely and leverages synergies with our generic formulation,
manufacturing and regulatory groups.