SPPI » Topics » Competition

These excerpts taken from the SPPI 10-K filed Mar 31, 2009.
Competition
 
The pharmaceutical industry is characterized by rapidly evolving biotechnology and intense competition. We expect biotechnological developments and improvements in the fields of our business to continue to occur at a rapid rate and, as a result, expect competition to remain intense. Many companies are engaged in research and development of compounds that are similar to our research. Biotechnologies under development by these and other pharmaceutical companies could result in treatments for the diseases and disorders for which we are developing our own treatments. In the event that one or more of those programs are successful, the market for some of our drug products could be reduced or eliminated. Any product for which we obtain FDA approval must also compete for market acceptance and market share.
 
Competing in the branded product business requires us to identify and quickly bring to market new products embodying therapeutic innovations. Successful marketing of branded products depends primarily on the ability to communicate the effectiveness, safety and value of the products to healthcare professionals in private practice, group practices, hospitals and academic institutions, and managed care organizations. Competition for branded drugs is less driven by price and is more focused on innovation in treatment of disease, advanced drug delivery and


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specific clinical benefits over competitive drug therapies. Unless our products are shown to have a better safety profile, efficacy and cost-effectiveness as compared to other alternatives, they may not gain acceptance by medical professionals and may therefore never be successful commercially.
 
Companies that have products on the market or in research and development that target the same indications as our products target include Neurocrine Biosciences, Abraxis Bioscience, Inc., Astra Zeneca LP, Amgen, Inc., Bayer AG, Bioniche Life Sciences Inc., Eli Lilly and Co., Novartis Pharmaceuticals Corporation, Genentech, Inc., Bristol-Myers Squibb Company, GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc., Cephalon, Inc., Sanofi-Aventis, Inc., Pfizer, Inc., AVI Biopharma, Inc., Genzyme Corporation, Shire Pharmaceuticals, Abbott Laboratories, Poniard Pharmaceuticals, Inc., Roche Pharmaceuticals, Johnson & Johnson and others who may be more advanced in development of competing drug products or are more established and are currently marketing products for the treatment of various indications that our drug products target. Many of our competitors are large and well-capitalized companies focusing on a wide range of diseases and drug indications, and have substantially greater financial, research and development, marketing, human and other resources than we do. Furthermore, large pharmaceutical companies have significantly more experience than we do in pre-clinical testing, human clinical trials and regulatory approval procedures, among other things.
 
As noted above, we launched our proprietary product, Fusilev, in August 2008. Fusilev is the levo-isomeric form of the racemic compound calcium leucovorin, a product already approved for the same indications our product is approved for. Leucovorin has been sold as a generic product on the market for a number of years. There are two generic companies currently selling the leucovorin product and therefore we are competing against a low cost alternative. Also, Fusilev will be offered as part of a treatment regimen, and that regimen may change to exclude Fusilev. For these reasons, we may not recognize the full potential value of our investment in the product.
 
Regarding Zevalin, there are three products which are potential competitors for the indications it is currently approved for.
 
Treanda® (bendamustine hydrochloride) for Injection, for Intravenous Infusion, marketed by Cephalon, is indicated for the treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
 
Also, the BEXXAR® therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab), a radiopharmaceutical marketed by GlaxoSmithKline, is indicated for the treatment of patients with CD20 antigen-expressing relapsed or refractory, low-grade, follicular, or transformed NHL, including patients with Rituximab-refractory NHL.
 
Finally, Rituxan® (rituximab), marketed by Genentech and Biogen, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone combination) chemotherapy; and non-progressing (including stable disease), low-grade, CD20-positive B-cell NHL, as a single agent, after first-line CVP chemotherapy. Rituxan is administered as a part of various chemotherapy regimens and schedules, the vast majority of which, could be used in concert with other therapeutic agents, such as Zevalin, as part of a treatment plan.
 
Please also read our discussion of competition matters in Item 1A “Risk Factors” of this report.
 
Competition


 



The pharmaceutical industry is characterized by rapidly evolving
biotechnology and intense competition. We expect
biotechnological developments and improvements in the fields of
our business to continue to occur at a rapid rate and, as a
result, expect competition to remain intense. Many companies are
engaged in research and development of compounds that are
similar to our research. Biotechnologies under development by
these and other pharmaceutical companies could result in
treatments for the diseases and disorders for which we are
developing our own treatments. In the event that one or more of
those programs are successful, the market for some of our drug
products could be reduced or eliminated. Any product for which
we obtain FDA approval must also compete for market acceptance
and market share.


 



Competing in the branded product business requires us to
identify and quickly bring to market new products embodying
therapeutic innovations. Successful marketing of branded
products depends primarily on the ability to communicate the
effectiveness, safety and value of the products to healthcare
professionals in private practice, group practices, hospitals
and academic institutions, and managed care organizations.
Competition for branded drugs is less driven by price and is
more focused on innovation in treatment of disease, advanced
drug delivery and





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Table of Contents






specific clinical benefits over competitive drug therapies.
Unless our products are shown to have a better safety profile,
efficacy and cost-effectiveness as compared to other
alternatives, they may not gain acceptance by medical
professionals and may therefore never be successful commercially.


 



Companies that have products on the market or in research and
development that target the same indications as our products
target include Neurocrine Biosciences, Abraxis Bioscience, Inc.,
Astra Zeneca LP, Amgen, Inc., Bayer AG, Bioniche Life Sciences
Inc., Eli Lilly and Co., Novartis Pharmaceuticals Corporation,
Genentech, Inc., Bristol-Myers Squibb Company, GlaxoSmithKline,
Biogen-IDEC Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc.,
Cephalon, Inc., Sanofi-Aventis, Inc., Pfizer, Inc., AVI
Biopharma, Inc., Genzyme Corporation, Shire Pharmaceuticals,
Abbott Laboratories, Poniard Pharmaceuticals, Inc., Roche
Pharmaceuticals, Johnson & Johnson and others who may
be more advanced in development of competing drug products or
are more established and are currently marketing products for
the treatment of various indications that our drug products
target. Many of our competitors are large and well-capitalized
companies focusing on a wide range of diseases and drug
indications, and have substantially greater financial, research
and development, marketing, human and other resources than we
do. Furthermore, large pharmaceutical companies have
significantly more experience than we do in pre-clinical
testing, human clinical trials and regulatory approval
procedures, among other things.


 



As noted above, we launched our proprietary product, Fusilev, in
August 2008. Fusilev is the levo-isomeric form of the racemic
compound calcium leucovorin, a product already approved for the
same indications our product is approved for. Leucovorin has
been sold as a generic product on the market for a number of
years. There are two generic companies currently selling the
leucovorin product and therefore we are competing against a low
cost alternative. Also, Fusilev will be offered as part of a
treatment regimen, and that regimen may change to exclude
Fusilev. For these reasons, we may not recognize the full
potential value of our investment in the product.


 



Regarding Zevalin, there are three products which are potential
competitors for the indications it is currently approved for.


 



Treanda®

(bendamustine hydrochloride) for Injection, for Intravenous
Infusion, marketed by Cephalon, is indicated for the treatment
of patients with indolent B-cell NHL that has progressed during
or within six months of treatment with rituximab or a
rituximab-containing regimen.


 



Also, the
BEXXAR®

therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab),
a radiopharmaceutical marketed by GlaxoSmithKline, is indicated
for the treatment of patients with CD20 antigen-expressing
relapsed or refractory, low-grade, follicular, or transformed
NHL, including patients with Rituximab-refractory NHL.


 



Finally,
Rituxan®

(rituximab), marketed by Genentech and Biogen, is indicated for
the treatment of patients with relapsed or refractory, low-grade
or follicular, CD20-positive, B-cell NHL as a single agent;
previously untreated follicular, CD20-positive, B-cell NHL in
combination with CVP (cyclophosphamide, vincristine and
prednisolone combination) chemotherapy; and non-progressing
(including stable disease), low-grade,
CD20-positive
B-cell NHL, as a single agent, after first-line CVP
chemotherapy. Rituxan is administered as a part of various
chemotherapy regimens and schedules, the vast majority of which,
could be used in concert with other therapeutic agents, such as
Zevalin, as part of a treatment plan.


 



Please also read our discussion of competition matters in
Item 1A “Risk Factors” of this report.


 




These excerpts taken from the SPPI 10-K filed Mar 14, 2008.
Competition
 
The pharmaceutical industry is characterized by rapidly evolving biotechnology and intense competition. We expect biotechnological developments and improvements in the fields of our business to continue to occur at a rapid rate and, as a result, expect competition to remain intense. Many companies are engaged in research and development of compounds that are similar to our research. Biotechnologies under development by these and other pharmaceutical companies could result in treatments for the diseases and disorders for which we are


16


Table of Contents

developing our own treatments. In the event that one or more of those programs are successful, the market for some of our drug products could be reduced or eliminated. Any product for which we obtain FDA approval must also compete for market acceptance and market share.
 
Competition for Proprietary Products
 
Competing in the branded product business requires us to identify and quickly bring to market new products embodying therapeutic innovations. Successful marketing of branded products depends primarily on the ability to communicate the effectiveness, safety and value of the products to healthcare professionals in private practice, group practices, hospitals and academic institutions, and managed care organizations. Competition for branded drugs is less driven by price and is more focused on innovation in treatment of disease, advanced drug delivery and specific clinical benefits over competitive drug therapies. Unless our proprietary products are shown to have a better safety profile, efficacy and cost-effectiveness as compared to other alternatives, they may not gain acceptance by medical professionals and may therefore never be successful commercially.
 
Companies that have products on the market or in research and development that target the same indications as our products target include Ardana Bioscience, Neurocrine Biosciences, Abraxis Bioscience, Inc., Astra Zeneca LP, Amgen, Inc., Bayer AG, Bioniche Life Sciences Inc., Eli Lilly and Co., Novartis Pharmaceuticals Corporation, Ferring Pharmaceuticals, NeoRx Corporation, Genentech, Inc., Bristol-Myers Squibb Company, GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc., Cephalon, Inc., Sanofi-aventis, Inc., Pfizer, Inc., AVI Biopharma, Inc., Genta Inc., Genzyme Corporation, Imclone Systems Incorporated, Millennium Pharmaceuticals, Shire Pharmaceuticals, TAP Pharmaceuticals, Inc., QLT Inc., Abbott Laboratories, Poniard Pharmaceuticals, Inc., Roche Pharmaceuticals, Schering-Plough, Johnson & Johnson and others who may be more advanced in development of competing drug products or are more established and are currently marketing products for the treatment of various indications that our drug products target. Many of our competitors are large and well-capitalized companies focusing on a wide range of diseases and drug indications, and have substantially greater financial, research and development, marketing, human and other resources than we do. Furthermore, large pharmaceutical companies have significantly more experience than we do in pre-clinical testing, human clinical trials and regulatory approval procedures, among other things.
 
As noted above, we plan to launch our proprietary product, LEVOleucovorin, in mid-2008, LEVOleucovorin is the levo isomeric form of the racemic compound calcium leucovorin, a product already approved for the same indications our product is approved for. Leucovorin has been sold as a generic product on the market for a number of years. There are a number of generic companies currently selling the product. If we are not able to demonstrate a competitive advantage over generic leucovorin, we may not be able to obtain a price premium over generic leucovorin. If we are not able to obtain a price premium, we may not be able to manufacture LEVOleucovorin in a cost-effective manner or at a cost below the generic leucovorin cost price. Also, LEVOleucovorin will be offered as part of a treatment regimen, and that regimen may change to exclude LEVOleucovorin.
 
Competition for Generic Products
 
The generic drug market is extremely price-competitive and revenues and gross profit derived from the sales of generic drug products tend to follow a pattern based on certain regulatory and competitive factors. As patents and regulatory exclusivity for brand name products expire, if a generic manufacturer has “first-to-file” status (as described below under “Paragraph IV Certification”) or has an authorized generic, such generic manufacturer generally enjoys a period of exclusivity with respect to other manufacturers of the generic drug, and can achieve significant market penetration. However, as competing generic manufacturers receive regulatory approvals on similar products, market share, revenues and gross profit typically decline, in some cases, dramatically. Accordingly, the level of market share, revenues and gross profit attributable to a particular generic product is normally related to the number of competitors in that product’s market and the timing of that product’s regulatory approval and launch, in relation to competing approvals and launches.
 
Companies that have a significant generic presence include Par Pharmaceutical Companies, Inc. Abraxis Biosciences, Inc., Bedford Laboratories, Mayne, Barr Laboratories, Teva Pharmaceuticals, Dr. Reddy’s


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Laboratories, Ranbaxy Laboratories, Mylan Laboratories, Inc., Sandoz (a division of Novartis), and Watson Pharmaceuticals, Inc.
 
As noted above, we have the right to market authorized generic versions of sumatriptan injection products in the United States. We expect to launch our products in the fourth quarter of 2008 prior to the expiration of the pediatric exclusivity period associated with sumatriptan injection.
 
Please also read our discussion of competition matters in Item 1A “Risk Factors” of this report.
 
Competition


 



The pharmaceutical industry is characterized by rapidly evolving
biotechnology and intense competition. We expect
biotechnological developments and improvements in the fields of
our business to continue to occur at a rapid rate and, as a
result, expect competition to remain intense. Many companies are
engaged in research and development of compounds that are
similar to our research. Biotechnologies under development by
these and other pharmaceutical companies could result in
treatments for the diseases and disorders for which we are





16





Table of Contents






developing our own treatments. In the event that one or more of
those programs are successful, the market for some of our drug
products could be reduced or eliminated. Any product for which
we obtain FDA approval must also compete for market acceptance
and market share.


 




Competition
for Proprietary Products



 



Competing in the branded product business requires us to
identify and quickly bring to market new products embodying
therapeutic innovations. Successful marketing of branded
products depends primarily on the ability to communicate the
effectiveness, safety and value of the products to healthcare
professionals in private practice, group practices, hospitals
and academic institutions, and managed care organizations.
Competition for branded drugs is less driven by price and is
more focused on innovation in treatment of disease, advanced
drug delivery and specific clinical benefits over competitive
drug therapies. Unless our proprietary products are shown to
have a better safety profile, efficacy and cost-effectiveness as
compared to other alternatives, they may not gain acceptance by
medical professionals and may therefore never be successful
commercially.


 



Companies that have products on the market or in research and
development that target the same indications as our products
target include Ardana Bioscience, Neurocrine Biosciences,
Abraxis Bioscience, Inc., Astra Zeneca LP, Amgen, Inc., Bayer
AG, Bioniche Life Sciences Inc., Eli Lilly and Co., Novartis
Pharmaceuticals Corporation, Ferring Pharmaceuticals, NeoRx
Corporation, Genentech, Inc., Bristol-Myers Squibb Company,
GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., OSI
Pharmaceuticals, Inc., Cephalon, Inc., Sanofi-aventis, Inc.,
Pfizer, Inc., AVI Biopharma, Inc., Genta Inc., Genzyme
Corporation, Imclone Systems Incorporated, Millennium
Pharmaceuticals, Shire Pharmaceuticals, TAP Pharmaceuticals,
Inc., QLT Inc., Abbott Laboratories, Poniard Pharmaceuticals,
Inc., Roche Pharmaceuticals, Schering-Plough,
Johnson & Johnson and others who may be more advanced
in development of competing drug products or are more
established and are currently marketing products for the
treatment of various indications that our drug products target.
Many of our competitors are large and well-capitalized companies
focusing on a wide range of diseases and drug indications, and
have substantially greater financial, research and development,
marketing, human and other resources than we do. Furthermore,
large pharmaceutical companies have significantly more
experience than we do in pre-clinical testing, human clinical
trials and regulatory approval procedures, among other things.


 



As noted above, we plan to launch our proprietary product,
LEVOleucovorin, in mid-2008, LEVOleucovorin is the levo isomeric
form of the racemic compound calcium leucovorin, a product
already approved for the same indications our product is
approved for. Leucovorin has been sold as a generic product on
the market for a number of years. There are a number of generic
companies currently selling the product. If we are not able to
demonstrate a competitive advantage over generic leucovorin, we
may not be able to obtain a price premium over generic
leucovorin. If we are not able to obtain a price premium, we may
not be able to manufacture LEVOleucovorin in a cost-effective
manner or at a cost below the generic leucovorin cost price.
Also, LEVOleucovorin will be offered as part of a treatment
regimen, and that regimen may change to exclude LEVOleucovorin.


 




Competition
for Generic Products



 



The generic drug market is extremely price-competitive and
revenues and gross profit derived from the sales of generic drug
products tend to follow a pattern based on certain regulatory
and competitive factors. As patents and regulatory exclusivity
for brand name products expire, if a generic manufacturer has
“first-to-file” status (as described below under
“Paragraph IV Certification”) or has an
authorized generic, such generic manufacturer generally enjoys a
period of exclusivity with respect to other manufacturers of the
generic drug, and can achieve significant market penetration.
However, as competing generic manufacturers receive regulatory
approvals on similar products, market share, revenues and gross
profit typically decline, in some cases, dramatically.
Accordingly, the level of market share, revenues and gross
profit attributable to a particular generic product is normally
related to the number of competitors in that product’s
market and the timing of that product’s regulatory approval
and launch, in relation to competing approvals and launches.


 



Companies that have a significant generic presence include Par
Pharmaceutical Companies, Inc. Abraxis Biosciences, Inc.,
Bedford Laboratories, Mayne, Barr Laboratories, Teva
Pharmaceuticals, Dr. Reddy’s





17





Table of Contents






Laboratories, Ranbaxy Laboratories, Mylan Laboratories, Inc.,
Sandoz (a division of Novartis), and Watson Pharmaceuticals, Inc.


 



As noted above, we have the right to market authorized generic
versions of sumatriptan injection products in the United States.
We expect to launch our products in the fourth quarter of 2008
prior to the expiration of the pediatric exclusivity period
associated with sumatriptan injection.


 



Please also read our discussion of competition matters in
Item 1A “Risk Factors” of this report.


 




This excerpt taken from the SPPI 10-K filed Mar 14, 2007.

Competition

The pharmaceutical industry is characterized by rapidly evolving biotechnology and intense competition. We expect biotechnological developments and improvements in the fields of our business to continue to occur at a rapid rate and, as a result, expect competition to remain intense. Many companies are engaged in research and development of compounds that are similar to our research. Biotechnologies under development by these and other pharmaceutical companies could result in treatments for the diseases and disorders for which we are developing our own treatments. In the event that one or more of those programs are successful, the market for some of our drug candidates could be reduced or eliminated. Any product for which we obtain FDA approval must also compete for market acceptance and market share.

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