AVGN » Topics » Competition

These excerpts taken from the AVGN 10-K filed Mar 16, 2009.

Competition

     Pharmaceutical drug development is characterized by rapidly evolving technology and intense competition. Many companies of all sizes, including major pharmaceutical companies and specialized biotechnology companies, engage in activities similar to our activities. Many of the companies we compete with have substantially greater financial and other resources and larger research and development and clinical and regulatory affairs staffs. We expect our potential products, if approved, will face competition from both branded pharmaceuticals and generic compounds and may include other drug development technologies, other methods for preventing or reducing the incidence of disease, including vaccines, and other classes of therapeutic agents. In addition, colleges, universities, governmental agencies and other public and private research organizations continue to conduct research and are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed. We also must compete with these institutions in recruiting highly qualified scientific personnel. Some of our competitors’ products and technologies are in direct competition with ours. In addition, we are aware that physicians may utilize other products in an off-label manner for the treatment of disorders we attempt to target.

     Neuropathic Pain. Therapies for chronic pain range from over-the-counter compounds, such as aspirin, to opioids, such as morphine. We anticipate that our products will compete with other drugs that are currently prescribed by physicians, including anti-epileptics such as: gabapentin and pregabalin, marketed by Pfizer as Neurontin and Lyrica, respectively; and antidepressants, including duloxetine, marketed by Eli Lilly & Co as Cymbalta. We are aware of additional compounds for chronic neuropathic pain that are currently in development at numerous companies including Bayer, GlaxoSmithKline, Merck & Co., Inc., Novartis AG, Pfizer, Cognetix, Inc., GW Pharmaceuticals plc, Indevus Pharmaceuticals, Inc., Nastech Pharmaceutical Company Inc., Avanir Pharmaceuticals, Solace Pharmaceuticals, Pain Therapeutics, Inc., and XenoPort, Inc.

     Opioid Withdrawal and Methamphetamine Addiction. Management of opioid induced withdrawal symptoms often involve the substitution of one opioid with a longer-acting opioid, followed by a gradual reduction in the dosage of the substitute drug or the use of various medications which are not approved, but are used off-label to mitigate physical symptoms and signs of withdrawal such as benzodiazepines and/or clonidine. We anticipate that our products will compete with other drugs that are currently prescribed by physicians to treat withdrawal symptoms, including narcotics such as generic methadone and buprenorphine, marketed in the U.S. by Reckitt Benckiser Pharmaceuticals, Inc, as Suboxone (buprenorphine) and Subutex (buprenorphine + the narcotic antagonist naloxone). Limited non-narcotic drug candidates for withdrawal symptoms exist. Lofexidine, marketed in the U.K. by Britannia Pharmaceuticals as BritLofex and licensed for development in U.S. clinical trials to US WorldMeds is an alpha adrenoceptor agonist like clonidine which may have somewhat less orthostatic hypotension limitations. Importantly, the commercial potential for a new-class alternative is great as the existing buprenorphine treatments are exceeding initial sales projections and yet still carry the opioid class concerns. Besides lofexidine, we believe there are currently no other clinically-advanced nor clinical proof-of-concept enabled drug candidates that would compete with AV411 although we are aware of no more than a few other compounds potentially useful for opioid withdrawal that are in development.

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     Companies that complete clinical trials, obtain required regulatory approvals, and commence commercial sales of their products before their competitors may achieve a significant competitive advantage. In order to compete successfully, we must develop proprietary or otherwise protected positions in products for therapeutic markets that have not been satisfactorily addressed by current alternatives. These products, even if successfully tested and developed, may not be adopted by physicians over other products and may not offer economically feasible alternatives to other therapies.

Competition


     Pharmaceutical drug development is characterized by rapidly evolving
technology and intense competition. Many companies of all sizes, including major
pharmaceutical companies and specialized biotechnology companies, engage in
activities similar to our activities. Many of the companies we compete with have
substantially greater financial and other resources and larger research and
development and clinical and regulatory affairs staffs. We expect our potential
products, if approved, will face competition from both branded pharmaceuticals
and generic compounds and may include other drug development technologies, other
methods for preventing or reducing the incidence of disease, including vaccines,
and other classes of therapeutic agents. In addition, colleges, universities,
governmental agencies and other public and private research organizations
continue to conduct research and are becoming more active in seeking patent
protection and licensing arrangements to collect royalties for use of
technologies that they have developed. We also must compete with these
institutions in recruiting highly qualified scientific personnel. Some of our
competitors’ products and technologies are in direct competition with ours. In
addition, we are aware that physicians may utilize other products in an
off-label manner for the treatment of disorders we attempt to target.


     Neuropathic Pain. Therapies for
chronic pain range from over-the-counter compounds, such as aspirin, to opioids,
such as morphine. We anticipate that our products will compete with other drugs
that are currently prescribed by physicians, including anti-epileptics such as:
gabapentin and pregabalin, marketed by Pfizer as Neurontin and Lyrica,
respectively; and antidepressants, including duloxetine, marketed by Eli Lilly
& Co as Cymbalta. We are aware of additional compounds for chronic
neuropathic pain that are currently in development at numerous companies
including Bayer, GlaxoSmithKline, Merck & Co., Inc., Novartis AG, Pfizer,
Cognetix, Inc., GW Pharmaceuticals plc, Indevus Pharmaceuticals, Inc., Nastech
Pharmaceutical Company Inc., Avanir Pharmaceuticals, Solace Pharmaceuticals,
Pain Therapeutics, Inc., and XenoPort, Inc.


     Opioid
Withdrawal and Methamphetamine Addiction.
Management of opioid induced withdrawal symptoms often involve the
substitution of one opioid with a longer-acting opioid, followed by a gradual
reduction in the dosage of the substitute drug or the use of various medications
which are not approved, but are used off-label to mitigate physical symptoms and
signs of withdrawal such as benzodiazepines and/or clonidine. We anticipate that
our products will compete with other drugs that are currently prescribed by
physicians to treat withdrawal symptoms, including narcotics such as generic
methadone and buprenorphine, marketed in the U.S. by Reckitt Benckiser
Pharmaceuticals, Inc, as Suboxone (buprenorphine) and Subutex (buprenorphine +
the narcotic antagonist naloxone). Limited non-narcotic drug candidates for
withdrawal symptoms exist. Lofexidine, marketed in the U.K. by Britannia
Pharmaceuticals as BritLofex and licensed for development in U.S. clinical
trials to US WorldMeds is an alpha adrenoceptor agonist like clonidine which may
have somewhat less orthostatic hypotension limitations. Importantly, the
commercial potential for a new-class alternative is great as the existing
buprenorphine treatments are exceeding initial sales projections and yet still
carry the opioid class concerns. Besides lofexidine, we believe there are
currently no other clinically-advanced nor clinical proof-of-concept enabled
drug candidates that would compete with AV411 although we are aware of no more
than a few other compounds potentially useful for opioid withdrawal that are in
development.


4





     Companies
that complete clinical trials, obtain required regulatory approvals, and
commence commercial sales of their products before their competitors may achieve
a significant competitive advantage. In order to compete successfully, we must
develop proprietary or otherwise protected positions in products for therapeutic
markets that have not been satisfactorily addressed by current alternatives.
These products, even if successfully tested and developed, may not be adopted by
physicians over other products and may not offer economically feasible
alternatives to other therapies.


These excerpts taken from the AVGN 10-K filed Mar 17, 2008.

Competition

     Pharmaceutical drug development is characterized by rapidly evolving technology and intense competition. Many companies of all sizes, including major pharmaceutical companies and specialized biotechnology companies, engage in activities similar to our activities. Many of the companies we compete with have substantially greater financial and other resources and larger research and development and clinical and regulatory affairs staffs. We expect our products, if approved, will face competition from both branded pharmaceuticals and generic compounds and may include other drug development technologies, other methods for preventing or reducing the incidence of disease, including vaccines, and other classes of therapeutic agents. In addition, colleges, universities, governmental agencies and other public and private research organizations continue to conduct research and are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed. We also must compete with these institutions in recruiting highly qualified scientific personnel. Some of our competitors’ products and technologies are in direct competition with ours. In addition, we are aware that physicians may utilize other products in an off-label manner for the treatment of disorders we attempt to target.

     Neuromuscular Spasm and Spasticity. Drugs marketed in the U.S. for the treatment of spasticity include tizanidine, marketed by Acorda Therapeutics as Zanaflex, and baclofen, marketed by Novartis as Lioresal. Drugs marketed in the U.S. for neuromuscular spasm include metaxalone, marketed by King Pharmaceuticals as Skelaxin, cyclobenzaprine, marketed by McNeil Consumer & Specialty Pharmaceuticals as Flexeril, and carisoprolol, marketed by Wallace Laboratories as Soma. In addition, there are several product candidates in development for these indications, including long-acting forms of baclofen by Xenoport and Impax Laboratories. GW Pharmaceuticals has also announced that they will be pursuing a spasticity indication for Sativex, their cannabinoid product marketed in Canada for pain associated with multiple sclerosis and in development in North America and Europe for pain and spasticity associated with multiple sclerosis and other diseases. These products may compete with AV650 or other products we may develop for neuromuscular spasm and spasticity.

     Neuropathic Pain. Therapies for chronic pain range from over-the-counter compounds, such as aspirin, to opioids, such as morphine. We anticipate that our products will compete with other drugs that are currently prescribed by physicians, including anti-epileptics such as: gabapentin and pregabalin, marketed by Pfizer as Neurontin and Lyrica, respectively; and antidepressants, including duloxetine, marketed by Eli Lilly & Co as Cymbalta. We are aware of additional compounds for chronic neuropathic pain that are currently in development at numerous companies including Bayer, GlaxoSmithKline, Merck & Co., Inc., Novartis AG, Pfizer, Cognetix, Inc., GW Pharmaceuticals plc, Indevus Pharmaceuticals, Inc., Nastech Pharmaceutical Company Inc., Avanir Pharmaceuticals, Pain Therapeutics, Inc., and XenoPort, Inc.

     Companies that complete clinical trials, obtain required regulatory approvals, and commence commercial sales of their products before their competitors may achieve a significant competitive advantage. In order to compete successfully, we must develop proprietary or otherwise protected positions in products for therapeutic markets that have not been satisfactorily addressed by current alternatives. These products, even if successfully tested and developed, may not be adopted by physicians over other products and may not offer economically feasible alternatives to other therapies.

Competition


     Pharmaceutical drug development is characterized by rapidly evolving
technology and intense competition. Many companies of all sizes, including major
pharmaceutical companies and specialized biotechnology companies, engage in
activities similar to our activities. Many of the companies we compete with have
substantially greater financial and other resources and larger research and
development and clinical and regulatory affairs staffs. We expect our products,
if approved, will face competition from both branded pharmaceuticals and generic
compounds and may include other drug development technologies, other methods for
preventing or reducing the incidence of disease, including vaccines, and other
classes of therapeutic agents. In addition, colleges, universities, governmental
agencies and other public and private research organizations continue to conduct
research and are becoming more active in seeking patent protection and licensing
arrangements to collect royalties for use of technologies that they have
developed. We also must compete with these institutions in recruiting highly
qualified scientific personnel. Some of our competitors’ products and
technologies are in direct competition with ours. In addition, we are aware that
physicians may utilize other products in an off-label manner for the treatment
of disorders we attempt to target.


     Neuromuscular Spasm and Spasticity.
Drugs marketed in the U.S. for the treatment of spasticity include tizanidine,
marketed by Acorda Therapeutics as Zanaflex, and baclofen, marketed by Novartis
as Lioresal. Drugs marketed in the U.S. for neuromuscular spasm include
metaxalone, marketed by King Pharmaceuticals as Skelaxin, cyclobenzaprine,
marketed by McNeil Consumer & Specialty Pharmaceuticals as Flexeril, and
carisoprolol, marketed by Wallace Laboratories as Soma. In addition, there are
several product candidates in development for these indications, including
long-acting forms of baclofen by Xenoport and Impax Laboratories. GW
Pharmaceuticals has also announced that they will be pursuing a spasticity
indication for Sativex, their cannabinoid product marketed in Canada for pain
associated with multiple sclerosis and in development in North America and
Europe for pain and spasticity associated with multiple sclerosis and other
diseases. These products may compete with AV650 or other products we may develop
for neuromuscular spasm and spasticity.


     Neuropathic Pain. Therapies for
chronic pain range from over-the-counter compounds, such as aspirin, to opioids,
such as morphine. We anticipate that our products will compete with other drugs
that are currently prescribed by physicians, including anti-epileptics such as:
gabapentin and pregabalin, marketed by Pfizer as Neurontin and Lyrica,
respectively; and antidepressants, including duloxetine, marketed by Eli Lilly
& Co as Cymbalta. We are aware of additional compounds for chronic
neuropathic pain that are currently in development at numerous companies
including Bayer, GlaxoSmithKline, Merck & Co., Inc., Novartis AG, Pfizer,
Cognetix, Inc., GW Pharmaceuticals plc, Indevus Pharmaceuticals, Inc., Nastech
Pharmaceutical Company Inc., Avanir Pharmaceuticals, Pain Therapeutics, Inc.,
and XenoPort, Inc.


     Companies
that complete clinical trials, obtain required regulatory approvals, and
commence commercial sales of their products before their competitors may achieve
a significant competitive advantage. In order to compete successfully, we must
develop proprietary or otherwise protected positions in products for therapeutic
markets that have not been satisfactorily addressed by current alternatives.
These products, even if successfully tested and developed, may not be adopted by
physicians over other products and may not offer economically feasible
alternatives to other therapies.


This excerpt taken from the AVGN 10-K filed Apr 25, 2007.
Competition

     Pharmaceutical drug development is characterized by rapidly evolving technology and intense competition. Many companies of all sizes, including major pharmaceutical companies and specialized biotechnology companies, engage in activities similar to our activities. Many of the companies we compete with have substantially greater financial and other resources and larger research and development and clinical and regulatory affairs staffs. We expect our products, if approved, will face competition from both branded pharmaceuticals and generic compounds. In addition, colleges, universities, governmental agencies and other public and private research organizations continue to conduct research and are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed. We also must compete with these institutions in recruiting highly qualified scientific personnel. Some of our competitors’ products and technologies are in direct competition with ours. In addition, we are aware that physicians may utilize other products in an off-label manner for the treatment of disorders we attempt to target.

     Neuromuscular Spasm and Spasticity. Therapies for acute and chronic spasm and spasticity include:

  • Skelaxin - metaxalone, by King Pharmaceuticals
     
  • Flexeril – cyclobenzaprine by McNeil Consumer & Specialty Pharmaceuticals
     
  • Zanaflex - tizanidine, by Acorda Therapeutics
     
  • Lioresal - baclofen, by Novartis, and
     
  • Soma - carisoprolol, by Wallace Laboratories.

     GW Pharmaceuticals has recently announced that they will be pursuing a spasticity indication for Sativex, their cannabinoid product marketed in Canada for pain associated with multiple sclerosis and in development in North America and Europe for pain and spasticity associated with multiple sclerosis and other diseases. We anticipate that our products will compete with all of these products. Controlled release formulations or other delivery or dosage forms of these products may be in development and generic versions of many of them are also available.

     Neuropathic Pain. Therapies for chronic pain range from over-the-counter compounds, such as aspirin, to opioids, such as morphine. We anticipate that our products will compete with other drugs that are currently prescribed by physicians, including anti-epileptics such as: Neurontin, also referred to as gabapentin by Pfizer, Lyrica, also referred to as pregabalin by Pfizer; and antidepressants, including Cymbalta, also referred to as duloxetine, by Eli Lilly & Co. We are aware of additional compounds for chronic neuropathic pain that are currently in development at numerous companies including Bayer, GlaxoSmithKline, Merck & Co., Inc., Novartis AG, Pfizer, Cognetix, Inc., GW Pharmaceuticals plc, Indevus Pharmaceuticals, Inc., Nastech Pharmaceutical Company Inc., Avanir Pharmaceuticals, and Pain Therapeutics, Inc.


     Companies that complete clinical trials, obtain required regulatory approvals, and commence commercial sales of their products before their competitors may achieve a significant competitive advantage. In order to compete successfully, we must develop proprietary or otherwise protected positions in products for therapeutic markets that have not been satisfactorily addressed by current alternatives. These products, even if successfully tested and developed, may not be adopted by physicians over other products and may not offer economically feasible alternatives to other therapies.

This excerpt taken from the AVGN 10-K filed Mar 16, 2007.

Competition

     Pharmaceutical drug development is characterized by rapidly evolving technology and intense competition. Many companies of all sizes, including major pharmaceutical companies and specialized biotechnology companies, engage in activities similar to our activities. Many of the companies we compete with have substantially greater financial and other resources and larger research and development and clinical and regulatory affairs staffs. We expect our products, if approved, will face competition from both branded pharmaceuticals and generic compounds. In addition, colleges, universities, governmental agencies and other public and private research organizations continue to conduct research and are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed. We also must compete with these institutions in recruiting highly qualified scientific personnel. Some of our competitors’ products and technologies are in direct competition with ours. In addition, we are aware that physicians may utilize other products in an off-label manner for the treatment of disorders we attempt to target.

     Neuromuscular Spasm and Spasticity. Therapies for acute and chronic spasm and spasticity include:

  • Skelaxin - metaxalone, by King Pharmaceuticals
     
  • Flexeril – cyclobenzaprine by McNeil Consumer & Specialty Pharmaceuticals
     
  • Zanaflex - tizanidine, by Acorda Therapeutics
     
  • Lioresal - baclofen, by Novartis, and
     
  • Soma - carisoprolol, by Wallace Laboratories.

     GW Pharmaceuticals has recently announced that they will be pursuing a spasticity indication for Sativex, their cannabinoid product marketed in Canada for pain associated with multiple sclerosis and in development in North America and Europe for pain and spasticity associated with multiple sclerosis and other diseases. We anticipate that our products will compete with all of these products. Controlled release formulations or other delivery or dosage forms of these products may be in development and generic versions of many of them are also available.

     Neuropathic Pain. Therapies for chronic pain range from over-the-counter compounds, such as aspirin, to opioids, such as morphine. We anticipate that our products will compete with other drugs that are currently prescribed by physicians, including anti-epileptics such as: Neurontin, also referred to as gabapentin by Pfizer, Lyrica, also referred to as pregabalin by Pfizer; and antidepressants, including Cymbalta, also referred to as duloxetine, by Eli Lilly & Co. We are aware of additional compounds for chronic neuropathic pain that are currently in development at numerous companies including Bayer, GlaxoSmithKline, Merck & Co., Inc., Novartis AG, Pfizer, Cognetix, Inc., GW Pharmaceuticals plc, Indevus Pharmaceuticals, Inc., Nastech Pharmaceutical Company Inc., Avanir Pharmaceuticals, and Pain Therapeutics, Inc.

     Companies that complete clinical trials, obtain required regulatory approvals, and commence commercial sales of their products before their competitors may achieve a significant competitive advantage. In order to compete successfully, we must develop proprietary or otherwise protected positions in products for therapeutic markets that have not been satisfactorily addressed by current alternatives. These products, even if successfully tested and developed, may not be adopted by physicians over other products and may not offer economically feasible alternatives to other therapies.

This excerpt taken from the AVGN 10-K filed Mar 16, 2005.

Competition

          Pharmaceutical drug development is a highly competitive arena.  We intend to pursue aggressively the acquisition or in-licensing of later-stage clinical development products in order to restructure and broaden our current portfolio.  However, we expect to face intense competition in achieving this goal.  Many of the companies and institutions that we will compete with to acquire later-stage development products have substantially greater capital resources, research and development staffs and facilities than we have, and substantially greater experience in conducting business development activities.

          In addition to the later-stage development products we may acquire access to, other companies are developing treatments, including other compounds in various stages of preclinical and clinical development, which could target the same neurological indications in which we have interest.  These companies are likely to include both public and private entities, including well-known, large pharmaceutical companies, chemical companies, biotechnology companies and research institutions.

          For our gene delivery programs, the arena of gene therapy drug development continues to be a new and rapidly evolving field that is expected to continue to undergo significant and rapid technological change. We expect that these programs will experience intense competition from products from other companies in the gene therapy field, as well as companies that have other forms of treatment for the diseases being targeted. Ultimately, we believe that if we do develop gene delivery products that receive regulatory approval for commercialization, we will compete primarily on the basis of the efficacy of the treatment with the products.

          We are aware of several development-stage and established enterprises, including major pharmaceutical and biotechnology firms that are exploring gene-based drugs or are actively engaged in gene delivery research and development. These include Cell Genesys, Inc., Corautus Genetics, Inc., GenVec, Inc., GlaxoSmithKline plc, and Targeted Genetics Corporation.

          Our products for neurological diseases will face competition from both branded pharmaceuticals and generic compounds.  Therapies for advanced Parkinson’s disease are marketed by companies including GlaxoSmithKline, Pfizer Inc., Boehringer-Ingelheim GmbH, and Medtronic Inc.  We are also aware of products for Parkinson’s disease currently in development at both pharmaceutical and biotechnology firms including Schering-Plough Corporation, Schwartz Pharma AG, NeuroSearch A/S, Ceregene Inc., and Juvantia Pharma Ltd.  Therapies for chronic pain range from over-the-counter compounds, such as aspirin, to opioids, such as morphine.  Companies with compounds previously used off-label such as the anti-epileptic Neurontin (gabapentin, Pfizer), have performed clinical studies that support expansion of the label to include the treatment of pain.  We are aware of additional compounds for chronic pain that are currently in development at numerous companies including Bayer, GlaxoSmithKline,  Merck & Co., Inc., Novartis AG, Pfizer, Cognetix, Inc., GW Pharmaceuticals plc, Indevus Pharmaceuticals, Inc., Nastech Pharmaceutical Company Inc., Renovis, Inc., and Pain Therapeutics, Inc.

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          Companies that complete clinical trials, obtain required regulatory approvals, and commence commercial sales of their products before their competitors, may achieve a significant competitive advantage. In order to compete successfully, we must develop proprietary positions in patented products for therapeutic markets that have not been satisfactorily addressed by current alternatives for both our compound-based and gene-delivery products.  These products, even if successfully tested and developed, may not be adopted by physicians over other products and may not offer economically feasible alternatives to other therapies.

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