ZGEN » Topics » Competition

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

Competition

We currently face competition from a range of biotechnology and pharmaceutical companies as well as academic and research institutions. We compete with these entities to discover and obtain proprietary rights to new genes and their corresponding proteins and to commercialize the products we develop from these genes and proteins. Some of our competitors have greater resources and experience than we have in discovering, developing, manufacturing and selling protein-based products. We expect that competition in our field will continue to be intense.

RECOTHROM, which was approved in January 2008 by the FDA for use as a topical hemostat in the United States, faces substantial competition in the topical hemostat market. In addition to RECOTHROM, there are two stand-alone thrombin products currently available in the United States: Thrombin-JMI, a bovine plasma-derived thrombin from King Pharmaceuticals, Inc., and Evithrom, a pooled human plasma-derived thrombin, from Ethicon, Inc., a Johnson & Johnson Company. Also, a number of other hemostatic agents are currently available on the market, including topical hemostats and fibrin sealants from Johnson & Johnson Wound Management, a division of Ethicon, Inc. and the BioSurgery business unit of Baxter BioScience. Furthermore, new products and technologies could be developed in the future to limit or control bleeding during surgeries.

We anticipate that our other product candidates currently in research or development will face intense competition in their respective therapeutic areas from gene- or protein-based products as well as other therapies. In our efforts to research and develop new therapeutic proteins we will compete with other entities that are involved in the research and development of therapeutic proteins, including Genentech, Inc., Human Genome Sciences, Inc., Medarex, Inc. and Biogen Idec Inc., among others. We also will face competition from large pharmaceutical and other companies that develop other types of products related to particular diseases.

Although we believe that we are well positioned to compete effectively with respect to our existing and potential competitors, our ability to compete successfully in the future will depend on many factors, including our ability to:

 

   

successfully maintain and expand as appropriate RECOTHROM commercial infrastructure, including the product supply and sales force, and establish commercial infrastructure for other product candidates as necessary;

 

   

develop products that are safer, more efficacious or more convenient to administer than other products in the marketplace;

 

   

leverage our established collaborations and enter into new collaborations to support the development of our products;

 

   

obtain timely regulatory approvals;

 

   

manufacture our products in a cost-effective manner in quantities sufficient to meet market demands;

 

   

obtain adequate reimbursement from government health administration authorities, private health insurers and health maintenance organizations;

 

   

identify new product candidates through our internal discovery efforts or through in-licensing; and

 

   

obtain and enforce adequate patent protection for our genes, proteins and technologies.

This excerpt taken from the ZGEN 10-K filed Feb 29, 2008.

Competition

We currently face competition from a range of biotechnology and pharmaceutical companies as well as academic and research institutions. We compete with these entities to discover and obtain proprietary rights to new genes and their corresponding proteins and to commercialize the products we develop from these genes and proteins. Some of our competitors have greater resources and experience than we have in discovering, developing, manufacturing and selling protein-based products. We expect that competition in our field will continue to be intense.

RECOTHROM, which was recently approved by the FDA for use as a topical hemostat in the United States, is expected to face substantial competition in the topical hemostat market. In addition to RECOTHROM, there are two stand-alone thrombin products currently available in the United States: Thrombin-JMI, a bovine plasma-derived thrombin from King Pharmaceuticals, Inc. and Evithrom, a pooled human plasma-derived thrombin, from Omrix Biopharmaceuticals, Inc. and Ethicon, Inc. Also, a number of other hemostatic agents are currently available on the market, including topical hemostats and fibrin sealants from Johnson & Johnson Wound Management, a division of Ethicon, Inc., and the BioSurgery business unit of Baxter BioScience. Furthermore, new products and technologies could be developed in the future to limit or control bleeding during surgeries.

We anticipate that our other product candidates currently in research or development will face intense competition in their respective therapeutic areas from gene- or protein-based products as well as other therapies. In our efforts to research and develop new therapeutic proteins we will compete with other entities that are involved in the research and development of therapeutic proteins, including Genentech, Inc., Human Genome Sciences, Inc., Medarex, Inc. and Biogen Idec Inc., among others. We also will face competition from large pharmaceutical and other companies that develop other types of products related to particular diseases.

Although we believe that we are well positioned to compete effectively with respect to our existing and potential competitors, our ability to compete successfully in the future will depend on many factors, including our ability to:

 

   

successfully maintain and expand as appropriate RECOTHROM commercial infrastructure, including the product supply and sales force, and establish commercial infrastructure for other product candidates as necessary;

 

   

develop products that are safer, more efficacious or more convenient to administer than other products in the marketplace;

 

   

leverage our established collaborations and enter into new collaborations to support the development of our products;

 

   

obtain timely regulatory approvals;

 

   

manufacture our products in a cost-effective manner in quantities sufficient to meet market demands;

 

   

obtain adequate reimbursement from government health administration authorities, private health insurers and health maintenance organizations;

 

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identify new product candidates through our internal discovery efforts or through in-licensing; and

 

   

obtain and enforce adequate patent protection for our genes, proteins and technologies.

This excerpt taken from the ZGEN 10-K filed Mar 1, 2007.

Competition

 

We currently face competition from a range of biotechnology and pharmaceutical companies as well as academic and research institutions. We compete with these entities to discover and obtain proprietary rights to new genes and their corresponding proteins and to commercialize the products we develop from these genes and proteins. Some of our competitors have greater resources and experience than we have in discovering, developing, manufacturing and selling protein-based products. We expect that competition in our field will continue to be intense.

 

rhThrombin, which is currently under regulatory review in the United States, is expected to face substantial competition upon its entrance into the topical hemostat market. Thrombin-JMI, a bovine plasma-derived thrombin from King Pharmaceuticals, Inc., is currently the only stand-alone thrombin product sold in the United States. In November 2006, Omrix Biopharmaceuticals, Inc. filed a biologics license application with the FDA for its pooled human plasma-derived thrombin, which it is developing in collaboration with Ethicon, Inc. In addition, a number of other hemostatic agents are currently available on the market, including topical hemostats and fibrin sealants from Johnson & Johnson Wound Management, a division of Ethicon, Inc., and the BioSurgery business unit of Baxter BioScience. Furthermore, new products and technologies could be developed in the future to limit or control bleeding during surgeries.

 

We anticipate that our other product candidates currently in research or development will face intense competition in their respective therapeutic areas from gene- or protein-based products as well as other therapies. In our efforts to research and develop new therapeutic proteins we will compete with other entities that are involved in the research and development of therapeutic proteins, including Genentech, Inc., Human Genome Sciences, Inc., Medarex, Inc. and Biogen Idec Inc., among others. We also will face competition from large pharmaceutical and other companies that develop other types of products related to particular diseases.

 

Although we believe that we are well positioned to compete effectively with respect to our existing and potential competitors, our ability to compete successfully in the future will depend on many factors, including our ability to:

 

   

establish commercial infrastructure for rhThrombin and other product candidates;

 

   

leverage our established collaborations and enter into new collaborations to support the development of our products;

 

   

develop products that are safer, more efficacious or more convenient to administer than other products in the marketplace;

 

   

obtain timely regulatory approvals;

 

   

manufacture our products in a cost-effective manner in quantities sufficient to meet market demands;

 

   

obtain adequate reimbursement from government health administration authorities, private health insurers and health maintenance organizations;

 

   

identify new product candidates through our internal discovery efforts or through in-licensing; and

 

   

obtain and enforce adequate patent protection for our genes, proteins and technologies.

 

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This excerpt taken from the ZGEN 10-K filed Mar 14, 2006.

Competition

 

We compete with others to identify, establish uses for and patent as many genes and their corresponding proteins as possible and to commercialize the products we develop from these genes and proteins. We face competition from other entities using sophisticated bioinformatics technologies to discover therapeutic proteins, including Genentech, Inc., Human Genome Sciences, Inc., Curagen, Inc., Amgen Inc., Schering-Plough Corp., Eli Lilly & Co. and Medarex, Inc. We also face competition from entities using more traditional methods to discover genes related to particular diseases, including other biotechnology and pharmaceutical companies. We expect that competition in our field will continue to be intense.

 

We believe the principal competitive factors affecting our markets are:

 

    rights to develop and commercialize therapeutic protein-based products, including appropriate patent and proprietary rights;

 

    safety and effectiveness of therapeutic protein-based products;

 

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    the timing and scope of regulatory approvals;

 

    the cost and availability of these products;

 

    the availability of manufacturing capacity for therapeutic proteins;

 

    the availability of appropriate third-party reimbursement programs; and

 

    the availability of alternative therapeutic products or treatments.

 

Although we believe that we are well positioned to compete adequately with respect to these factors in the future, our future success is currently difficult to predict because we have limited experience in developing and commercializing protein-based products. Also, although we believe that our bioinformatics technologies and exploratory biology capabilities provide us with a competitive advantage, other companies or entities may discover and establish a patent position in one or more genes or proteins that we have identified and designated or considered designating as a product candidate. In addition, any potential products based on genes or proteins we identify will face competition both from companies developing gene- or protein-based products and from companies developing other forms of treatment for diseases that may be caused by, or related to, the genes or proteins we identify. Furthermore, our potential products, if approved and commercialized, may compete against well-established existing therapeutic protein-based products. For example, upon rhThrombin’s anticipated entrance into the hemostasis market, we expect it to face substantial competition both from currently marketed plasma-derived thrombin products and from those presently under development. Also, a number of companies currently market other hemostatic agents that present additional competition to rhThrombin.

 

Our protein-based products would need to obtain adequate reimbursement coverage to compete successfully against existing products that are reimbursed by government health administration authorities, private health insurers and health maintenance organizations. Also, health care professionals and consumers may prefer existing or newly developed products to any product we develop.

 

In addition, there has been much recent public discussion regarding the creation of laws permitting “generic” or “follow on” versions of biologics. The FDA is studying the issue and there is increasing interest from lawmakers and the public. It is possible that laws will change to permit the approval of “generic” biologics requiring less than full clinical trials, and as a result, we could face greater competition in the marketplace.

 

This excerpt taken from the ZGEN 10-K filed Mar 14, 2005.

Competition

 

We compete with others to identify, establish uses for and patent as many genes and their corresponding proteins as possible and to commercialize the products we develop from these genes and proteins. We face competition from other entities using sophisticated bioinformatics technologies to discover genes, including Genentech, Inc., Human Genome Sciences, Inc., Curagen, Inc. and Amgen Inc. We also face competition from entities using more traditional methods to discover genes related to particular diseases, including other large biotechnology and pharmaceutical companies. We expect that competition in our field will continue to be intense.

 

Research to identify genes is also being conducted by various institutes and government-financed entities in the United States and in foreign countries, including France, Germany, Japan and the United Kingdom, as well as by numerous smaller laboratories associated with universities or other not-for-profit entities. In addition, a number of pharmaceutical and biotechnology companies and government-financed programs are engaged or have announced their intention to engage in areas of research similar to or competitive with our focus on gene discovery, and other entities are likely to enter the field.

 

We believe the principal competitive factors affecting our markets are:

 

    rights to develop and commercialize therapeutic protein-based products, including appropriate patent and proprietary rights;

 

    safety and effectiveness of therapeutic protein-based products;

 

    the timing and scope of regulatory approvals;

 

    the cost and availability of these products;

 

    the availability of appropriate third-party reimbursement programs; and

 

    the availability of alternative therapeutic products or treatments.

 

Although we believe that we are well positioned to compete adequately with respect to these factors in the future, our future success is currently difficult to predict because we are an early stage company; our internal product candidates are in early-stage clinical trials. Also, although we believe that our bioinformatics technologies and exploratory biology capabilities provide us with a competitive advantage, any of the companies or other entities we compete with may discover and establish a patent position in one or more genes or proteins that we have identified and designated or considered designating as a product candidate. In addition, any potential products based on genes or proteins we identify will face competition both from companies developing gene- or protein-based products and from companies developing other forms of treatment for diseases that may be caused by, or related to, the genes or proteins we identify. Furthermore, our potential products, if approved and commercialized, may compete against well-established existing therapeutic protein-based products, many of

 

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which may be currently reimbursed by government health administration authorities, private health insurers and health maintenance organizations. Also, health care professionals and consumers may prefer existing or newly developed products to any product we develop.

 

There has been much recent public discussion regarding the creation of laws permitting “generic” or “follow on” versions of biologics. The FDA is studying the issue and there is increasing interest from lawmakers and the public. It is possible that laws will change to permit the approval of “generic” biologics requiring less than full clinical trials. As a result, we could face greater competition in the marketplace.

 

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