Proprietary product development efforts may not result in commercial products. for Abraxis

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Abraxis BioScience (ABII)

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ABII » Topics » Proprietary product development efforts may not result in commercial products.

This excerpt taken from the ABII 10-K filed Mar 12, 2010.

Proprietary product development efforts may not result in commercial products.

We intend to maintain an aggressive research and development program for proprietary pharmaceutical products. Successful product development in the biotechnology industry is highly uncertain, and statistically very few research and development projects produce a commercial product. Product candidates that appear promising in the early phases of development, such as in early stage human clinical trials, may fail to reach the market for a number of reasons, including:

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

In addition, our discovery pipeline includes product candidates in the follow-on biologics area, also known as biosimilars. Although, like all pharmaceutical products, these product candidates must receive appropriate regulatory clearance before they can be marketed and sold in a particular country, including the United States, there does not currently exist a defined abbreviated regulatory approval process for obtaining this approval in the United States. As a result, considerable uncertainty exists regarding the pathway, timing and likelihood of approval for these types of product candidates in the United States. Because of the absence of a defined abbreviated regulatory approval process for biosimilars in the United States, it could take a longer amount of time to obtain regulatory approval for our biosimilar product candidates than for our other product candidates in our discovery pipeline, if at all. Any delay in, or the inability to receive, regulatory approval for our biosimilar product candidates could materially adversely affect our business plan and growth strategy.

This excerpt taken from the ABII 10-Q filed May 8, 2009.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

This excerpt taken from the ABII 10-K filed Mar 6, 2009.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

This excerpt taken from the ABII 10-Q filed Nov 14, 2008.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

This excerpt taken from the ABII 10-Q filed Aug 14, 2008.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

This excerpt taken from the ABII 10-Q filed May 15, 2008.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

This excerpt taken from the ABII 10-K filed Mar 31, 2008.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

This excerpt taken from the ABII 10-Q filed Dec 20, 2007.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

This excerpt taken from the ABII 8-K filed Nov 8, 2007.

Proprietary product development efforts may not result in commercial products.

•

the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive pre-clinical trial results;

•

the product candidate was not effective in treating a specified condition or illness;

•

the product candidate had harmful side effects in humans or animals;

•

the necessary regulatory bodies, such as the FDA, did not approve a product candidate for an intended use;

•

the product candidate was not economical to manufacture and commercialize;

•

other companies or people have or may have proprietary rights to a product candidate, such as patent rights, and will not let the product candidate be sold on reasonable terms, or at all; or

•

the product candidate is not cost effective in light of existing therapeutics.

EXCERPTS ON THIS PAGE:

10-K	Mar 12, 2010

10-Q	May 8, 2009

10-K	Mar 6, 2009

10-Q	Nov 14, 2008

10-Q	Aug 14, 2008

10-Q	May 15, 2008

10-K	Mar 31, 2008

10-Q	Dec 20, 2007

8-K	Nov 8, 2007

Abraxis BioScience (ABII)

ABII » Topics » Proprietary product development efforts may not result in commercial products.

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