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Barr Pharmaceuticals, Inc. (BRL) And Pliva D.D. (PLVGF) Sign Agreement To Develop And Market Generic Version Of G-CSF In United States And Canada



10/19/2005 5:13:10 PM

WOODCLIFF LAKE, N.J., March 30 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. and PLIVA d.d. today announced that Barr's subsidiary, Barr Laboratories, Inc., and PLIVA's subsidiaries, PLIVA Croatia Ltd. and PAM Kft., have entered into a development, supply and marketing agreement for 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(R) (filgrastim) product.

Under terms of the agreement, Barr owes PAM Kft. $5 million upon signing, and will make additional payments at the achievement of additional milestones.

PLIVA has responsibility for product development including development of data necessary to support the filing of an application with regulatory authorities; as well as the production of batches to support any studies necessary and scale-up to full commercial production. Barr has responsibility for all regulatory activities and has the right to exclusively market the approved G-CSF product in the United States and Canada following final regulatory approval. Barr will be responsible for all costs related to clinical trials and marketing activities, and will exclusively purchase the product from PLIVA's subsidiary, PLIVA Croatia Ltd., at a cost which will incorporate a mutually attractive incentive that will allow both parties to benefit from the success of the product.

"Barr is committed to helping to define a generic biopharmaceutical marketplace in the United States and Canada, and in developing and marketing more affordable versions of these important therapies," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "This strategic agreement with PLIVA will further our efforts to be a leader in this emerging marketplace, and we are confident that we bring together considerable expertise that will result in the successful introduction of G-CSF and future generic biopharmaceuticals."

Speaking about the strategic partnership, Mr. Zeljko Covic, President of PLIVA's Management Board and CEO commented: "We are very pleased to have an experienced and successful partner such as Barr for the development of this biological product. Barr's strong US regulatory capabilities and experience in commercializing technically complex products ideally complement PLIVA's long- term expertise in the development and production of biological products, which will increasingly become affordable medicines of choice for a growing number of patients. This is the second biogenerics partnership for PLIVA this year, a testament to our strong and recognized development capabilities in this highly attractive field."

G-CSF is the generic version of Amgen's NEUPOGEN(R) (filgrastim) product which is primarily indicated for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy induced neutropenia. G-CSF products have annual sales in the United States of approximately $900 million, based on IMS data for the twelve months ended January 2005. G-CSF was approved by the U.S. Food and Drug Administration (FDA) in 1991.

G-CSF Project Builds on Barr's Expertise in Developing Biologic Drug Products

The development of a generic biopharmaceutical version of G-CSF will build on Barr's initial efforts in biopharmaceutical development. In addition to G-CSF, Barr is developing an Adenovirus Vaccine with the U.S. Department of Defense (DOD). In September 2001, the DOD awarded Barr a six-year contract to develop two oral adenovirus vaccines. The contract provides funding to support Phase I development, Phase II and Phase III clinical studies and the filing of the biological license applications (BLA). Following successful approval, Barr will manufacture the vaccines under contract to the government specifically for dispensing to the armed forces. FDA approval of the new vaccines, the first biopharmaceutical developed by Barr, could come as early as calendar 2007.

PLIVA's Biological Program

PLIVA has more than 60 years of history in the area of classical biotechnology with several successful projects started in R&D and brought to full scale production and commercialization including: yeast, antibiotics, vitamins, enzymes and veterinary vaccines. Based on this experience and knowledge, PLIVA advanced its program with very structured R&D efforts in the area of recombinant proteins -- biogenerics. Currently, PLIVA's two most advanced projects are EPO and G-CSF, relying on extensive comparability studies between respective PLIVA products and respected Reference Products from markets of interest. Through quality of its scientific data and knowledgeable personnel, PLIVA continues to attract reputable partners such as Mayne and Barr for collaboration in this exciting field.

About Barr

Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

About PLIVA

With over 80 years of experience in the pharmaceuticals arena, PLIVA is now a global generics and specialty company, with operations in more than 30 countries in the US, CEE and Western Europe. Building upon a strong R&D history, the company specializes in the discovery, development, production and distribution of generic and proprietary branded pharmaceutical products. Since its listing on the London Stock Exchange in 1996, PLIVA has established a fully internationalized business, with the majority of revenues now realized on Western markets.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Companies' businesses. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time- to-time in the Companies' filings with the Securities and Exchange Commission and/or other relevant regulatory bodies.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.

Barr Pharmaceuticals, Inc.

CONTACT: Carol A. Cox, +1-201-930-3720, ccox@barrlabs.com or MarijaMandic, +385-1-6160-355, marija.mandic@pliva.com, both of BarrPharmaceuticals, Inc.


Read at BioSpace.com

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