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Barr Pharmaceutical
 Barr
Pharmaceutical
Barr Pharmaceuticals, Inc. is a holding company,
whose principal subsidiaries, Barr Laboratories, Inc. and Duramed
Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary
pharmaceuticals. The Company’s product portfolio includes more than 100
generic and proprietary pharmaceutical products in core therapeutic categories
including female healthcare (including oral contraceptive and hormone therapy
products), oncology, cardiovascular, anti-infective and psychotherapeutic
pharmaceuticals.
The Company is listed on the New York Stock Exchange
under the symbol BRL.
With fiscal 2004 revenues of $1.3 billion, the
Company currently manufactures and distributes more than 100 pharmaceutical
products in core therapeutic categories including female healthcare (including
oral contraceptives and hormone therapy), oncology, cardiovascular,
anti-infective and psychotherapeutic pharmaceuticals.
History of Barr
Pharmaceuticals
Founded in 1970 in New York, Barr was one of the
first generic pharmaceutical companies in the United States. In 1972, the
Company launched its first generic product and was one of the earliest
producers of antibiotic products. However, the growth of the Company, and the
generic pharmaceutical industry as it is known today, did not begin in earnest
until more than a decade later.
The milestone that is acknowledged as
the start of the modern generic pharmaceutical industry was the Drug Price
Competition and Patent Restoration Act in 1984. This law, often called
Hatch-Waxman Act, opened the floodgates for generic competition for
pharmaceutical products, creating the modern generic pharmaceutical industry.
Hatch-Waxman established the criteria which has become the foundation of
generic product approval.
Following the approval of Hatch-Waxman, Barr
and other members of the generic pharmaceutical industry experienced
significant and rapid growth in both the number of products offered and the
market share captured by these products.
In the mid-1990s, Company
management refocused the development manufacturing and marketing focus of the
Company on distinctive products in five core therapeutic categories: cancer
treatments, female healthcare therapies, treatments for heart disease,
anti-infectives, and psychotherapeutics. Today, the Company manufacturers,
markets and distributes over 100 pharmaceutical products. The Company’s
generic products are marketed under the Barr label and ite proprietary products
are marketed under the Duramed label.
In 2003, the Company ranked among
the top 10 independent companies in the $11 billion generic pharmaceutical
business.
The Company’s generic product development activities are
focused on the selection of pharmaceutical products where these selection
criteria may limit the potential number of generic competitors. Product
candidates can include those products where Barr has unique research and
development skills, or those that represent difficult to manufacture products
where Barr has capabilities largely unmatched by competitors. The Company has
invested in the state-of-the-art technologies that allow it to maximize
development. For example, Barr has added such tools as robotics to aid in
product testing, and has designed superior quality control labs to ensure
products meet the highest standards.
As an adjunct to its generic
product development efforts, the Company also selectively challenges the
patents protecting brand products, where it believes that the patents are
invalid or unenforceable. Under this process, which is a component of the
Hatch-Waxman provisions, the Company must complete the research and development
necessary to file an application for the generic product, and then must also
prove through a patent infringement trial that the patents protecting the brand
product should be invalidated. Upon successful completion of such a trial, the
Company enjoys a period of generic exclusivity as a result of its success. In
1997, the Company announced its commitment to build a portfolio of proprietary
products that would have some period of exclusivity, as a complement to its
generic pharmaceutical business. As a result of this strategy, the Company
currently has thirteen proprietary products, six of which it actively markets
utilizing its sales forces. The Company is currently developing additional
products that it expects to compete in the oncology, oral contraceptive,
hormone therapy and anti-viral categories.
The Generic
Pharmaceutical Marketplace
Generic pharmaceuticals, such as those
manufactured and marketed by Barr, represent an increasing proportion of
medicines dispensed in the U.S. In 2000, the U.S. generic pharmaceutical
industry had total U.S. sales of approximately $11 billion. By 2005, analysts
project that the generic pharmaceutical products will have annual sales in
excess of $22 billion.
In 1984, generic pharmaceuticals accounted for
approximately 18.6% of all prescriptions fill. Today, nearly 50% of all
prescriptions filled with generic products annually. Financial analysts project
that U.S. generic products will surpass brand name products in the number of
new prescriptions written over the next several years.
Proprietary
History and Strategy
In 1997, Barr announced plans to extend its
pharmaceutical research and development activities into proprietary product
development. The Company’s strategy is to focus on the development and
commercialization of existing molecules that should take less time to develop,
cost less money to gain approval and have some period of exclusivity.
In
January 2000, the Company dramatically strengthened its commitment to
proprietary product development with the formation of Duramed Research Inc., a
wholly owned subsidiary of Barr Pharmaceuticals, Inc. Duramed Research is
headquartered in Philadelphia, Pennsylvania and headed by Carole Ben-Maimon,
M.D. The primary focus of Duramed Research is the continued development of
proprietary product strategies and the expansion of proprietary product
activities through the successful development of New Drug Application (NDA)
products. The Duramed Research team has extensive brand product experience in
the areas of clinical trials, toxicology, regulatory, pharmacokinetics,
statistics, medical writing and product commercialization.
The
Company’s strategy is designed to exploit the weaknesses of mega-companies
that their size creates. It is no longer possible for a global brand company to
effectively pursue products that would be considered of nominal-to-limited
potential. However, this creates a reservoir of product opportunities for a
company such as Barr, where the prospect of developing a product in the $10 -
150 million annual sales range creates significant growth potential.
The
Company is committed to consolidating its leadership position in Women’s
Healthcare, as well as pursuing additional therapeutic categories. Barr’s
proprietary pipeline of products includes products in the therapeutic areas of
female healthcare, including oral contraceptives, hormone therapy and trans
vaginal ring technology products; oncology; urology; and
anti-infective/anti-viral products.
Barr Pharmaceuticals further
inforation
www.barrlabs.com
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