Osiris Therapeutics (OSIR)

Competition

        Our industry is subject to rapid and intense technological change. We face, and will continue to face, intense competition from pharmaceutical, biopharmaceutical and biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in drug discovery activities or funding, both in the United States and abroad. Some of these competitors are pursuing the development of drugs and other therapies that target the same diseases and conditions that we target in our commercial, clinical and preclinical programs.

        Many of the companies competing against us have financial and other resources substantially greater than our own. In addition, many of our competitors have significantly greater experience in testing pharmaceutical and other therapeutic products, obtaining FDA and other regulatory approvals of products, and marketing and selling those products. Accordingly, our competitors may succeed more rapidly than we will in obtaining FDA approval for products and achieving widespread market acceptance. If we obtain necessary regulatory approval and commence significant commercial sales of our products, we will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have limited or no commercial-scale experience.

        Our two biologic drug candidates, if approved, would compete with several marketed products and other future biologic drug candidates. For our existing product and each of our clinical-stage biologic drug candidates, the primary competitors include:

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Prochymal.  If approved, Prochymal will likely be the first drug indicated for the treatment of acute GvHD. The competitive landscape in Crohn's disease is more crowded and if approved for this indication, Prochymal will compete with Johnson & Johnson's Remicade®, Abbott's HUMIRA®, Biogen's Tysabri® and UCB's Cimzia®.

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Chondrogen.  If approved, Chondrogen will compete with pain relievers such as acetaminophen, nonsteroidal anti-inflammatory drugs intra-articular injection of corticosteroid or hyaluronic acid. However, none of these have proven disease-modification, one of the goals of Chondrogen development.

        We may face competition in the future from other companies that are researching and developing stem cell therapies. We are aware of many companies working in this area, including: Aastrom Biosciences, Advanced Cell Technology, Athersys, Cellerant Therapeutics, Cognate Therapeutics, Cytori Therapeutics, Gamida Cell, Geron, Mesoblast, MultiCell Technologies, Neuronyx, Theradigm, ViaCell and StemCells.

        We expect to compete based upon, among other things, our intellectual property portfolio and the efficacy of our products. Our ability to compete successfully will depend on our continued ability to attract and retain skilled and experienced scientific, clinical development and executive personnel, to identify and develop viable biologic drug candidates and to exploit these products and compounds commercially before others are able to develop competitive products.

        In addition, our stem cell therapies may be expensive as compared to other therapies and this may make it more difficult for us to compete with other pharmaceuticals.

Competition

        Our industry is subject to rapid and intense technological change. We face, and will continue to face, intense competition from
pharmaceutical, biopharmaceutical and biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in drug discovery activities or funding, both in
the United States and abroad. Some of these competitors are pursuing the development of drugs and other therapies that target the same diseases and conditions that we target in our commercial,
clinical and preclinical programs.

        Many
of the companies competing against us have financial and other resources substantially greater than our own. In addition, many of our competitors have significantly greater
experience in testing pharmaceutical and other therapeutic products, obtaining FDA and other regulatory approvals of products, and marketing and selling those products. Accordingly, our competitors
may succeed more rapidly than we will in obtaining FDA approval for products and achieving widespread market acceptance. If we obtain necessary regulatory approval and commence significant commercial
sales of our products, we will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have limited or no commercial-scale experience.

        Our
two biologic drug candidates, if approved, would compete with several marketed products and other future biologic drug candidates. For our existing product and each of our
clinical-stage biologic drug candidates, the primary competitors include:

•

Prochymal.  If approved, Prochymal will likely be the first
drug indicated for the treatment of acute GvHD. The competitive landscape in Crohn's disease is more crowded and if approved for this indication, Prochymal will compete with Johnson & Johnson's
Remicade®, Abbott's HUMIRA®, Biogen's Tysabri® and UCB's Cimzia®.

20

HREF="#bg14501a_main_toc">Table of Contents

•

Chondrogen.  If approved, Chondrogen will compete with pain
relievers such as acetaminophen, nonsteroidal anti-inflammatory drugs intra-articular injection of corticosteroid or hyaluronic acid. However, none of these have proven
disease-modification, one of the goals of Chondrogen development.

        We
may face competition in the future from other companies that are researching and developing stem cell therapies. We are aware of many companies working in this area, including:
Aastrom Biosciences, Advanced Cell Technology, Athersys, Cellerant Therapeutics, Cognate Therapeutics, Cytori Therapeutics, Gamida Cell, Geron, Mesoblast, MultiCell Technologies, Neuronyx, Theradigm,
ViaCell and StemCells.

        We
expect to compete based upon, among other things, our intellectual property portfolio and the efficacy of our products. Our ability to compete successfully will depend on our
continued ability to attract and retain skilled and experienced scientific, clinical development and executive personnel, to identify and develop viable biologic drug candidates and to exploit these
products and compounds commercially before others are able to develop competitive products.

        In
addition, our stem cell therapies may be expensive as compared to other therapies and this may make it more difficult for us to compete with other pharmaceuticals.

Competition

        Our industry is subject to rapid and intense technological change. We face, and will continue to face, intense competition from pharmaceutical, biopharmaceutical and biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in drug discovery activities or funding, both in the U.S. and abroad. Some of these competitors are pursuing the development of drugs and other therapies that target the same diseases and conditions that we target in our commercial, clinical and preclinical programs.

        Many of the companies competing against us have financial and other resources substantially greater than our own. In addition, many of our competitors have significantly greater experience in testing pharmaceutical and other therapeutic products, obtaining FDA and other regulatory approvals of products, and marketing and selling those products. Accordingly, our competitors may succeed more rapidly than we will in obtaining FDA approval for products and achieving widespread market acceptance. If we obtain necessary regulatory approval and commence significant commercial sales of our products, we will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have limited or no commercial-scale experience.

        Our commercialized product, Osteocel, currently competes with established treatment options such as autograft bone and Medtronic's INFUSE® and potentially may compete with other products currently in development for the same indications. Our two biologic drug candidates, if approved, would compete with several marketed products and other future biologic drug candidates. For our existing product and each of our clinical-stage biologic drug candidates, the primary competitors include:

•

Osteocel.  Our commercialized bone regeneration product competes with autograft bone, synthetic biomaterials, growth factors and allograft bone. Competing products include Medtronic's INFUSE®, Stryker's OP-1, numerous bone void filler products such as Zimmer's CopiOs™ and autologous bone marrow products such as DePuy Spine's CELLECT®.



•

Prochymal.  If approved, Prochymal will likely be the first drug indicated for the treatment of acute GvHD. The competitive landscape in Crohn's disease is more crowded and if approved, Prochymal will compete with Johnson & Johnson's Remicade®, Abbott's HUMIRA® and Biogen's Tysabri®



•

Chondrogen.  If approved, Chondrogen will compete with products such as allograft menisci from cadavers, Conmed Linvatec's meniscal fixation system of screws and arrows and if approved, Regen Biologics' Collagen Meniscus Implant.

        We may face competition in the future from other companies that are researching and developing stem cell therapies. We are aware of many companies working in this area, including: Aastrom Biosciences, Advanced Cell Technology, Athersys, Cellerant Therapeutics, Cognate Therapeutics, Cytori Therapeutics, Gamida Cell, Geron, Mesoblast, MultiCell Technologies, Neuronyx, Theradigm, ViaCell and StemCells.

        We expect to compete based upon, among other things, our intellectual property portfolio and the efficacy of our products. Our ability to compete successfully will depend on our continued ability to attract and retain skilled and experienced scientific, clinical development and executive personnel, to

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identify and develop viable biologic drug candidates and to exploit these products and compounds commercially before others are able to develop competitive products.

        In addition, our stem cell therapies may be expensive as compared to other therapies and this may make it more difficult for us to compete with other pharmaceuticals

Competition

        Our industry is subject to rapid and intense technological change. We face, and will continue to face, intense competition from pharmaceutical, biopharmaceutical
and biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in drug discovery activities or funding, both in the U.S. and abroad. Some of
these competitors are pursuing the development of drugs and other therapies that target the same diseases and conditions that we target in our commercial, clinical and preclinical programs.

        Many
of the companies competing against us have financial and other resources substantially greater than our own. In addition, many of our competitors have significantly greater
experience in testing pharmaceutical and other therapeutic products, obtaining FDA and other regulatory approvals of products, and marketing and selling those products. Accordingly, our competitors
may succeed more rapidly than we will in obtaining FDA approval for products and achieving widespread market acceptance. If we obtain necessary regulatory approval and commence significant commercial
sales of our products, we will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have limited or no commercial-scale experience.

        Our
commercialized product, Osteocel, currently competes with established treatment options such as autograft bone and Medtronic's INFUSE® and potentially may compete with
other products currently in development for the same indications. Our two biologic drug candidates, if approved, would compete with several marketed products and other future biologic drug candidates.
For our existing product and each of our clinical-stage biologic drug candidates, the primary competitors include:

•

Osteocel.  Our commercialized bone regeneration product competes with autograft bone, synthetic biomaterials,
growth factors and allograft bone. Competing products include Medtronic's INFUSE®, Stryker's OP-1, numerous bone void filler products such as Zimmer's CopiOs™ and
autologous bone marrow products such as DePuy Spine's CELLECT®.




•

Prochymal.  If approved, Prochymal will likely be the first drug indicated for the treatment of acute GvHD. The
competitive landscape in Crohn's disease is more crowded and if approved, Prochymal will compete with Johnson & Johnson's Remicade®, Abbott's HUMIRA® and Biogen's
Tysabri®




•

Chondrogen.  If approved, Chondrogen will compete with products such as allograft menisci from cadavers, Conmed
Linvatec's meniscal fixation system of screws and arrows and if approved, Regen Biologics' Collagen Meniscus Implant.

        We
may face competition in the future from other companies that are researching and developing stem cell therapies. We are aware of many companies working in this area, including:
Aastrom Biosciences, Advanced Cell Technology, Athersys, Cellerant Therapeutics, Cognate Therapeutics, Cytori Therapeutics, Gamida Cell, Geron, Mesoblast, MultiCell Technologies, Neuronyx, Theradigm,
ViaCell and StemCells.

        We
expect to compete based upon, among other things, our intellectual property portfolio and the efficacy of our products. Our ability to compete successfully will depend on our
continued ability to attract and retain skilled and experienced scientific, clinical development and executive personnel, to

21

identify
and develop viable biologic drug candidates and to exploit these products and compounds commercially before others are able to develop competitive products.

        In
addition, our stem cell therapies may be expensive as compared to other therapies and this may make it more difficult for us to compete with other pharmaceuticals

Competition

Our industry is subject to rapid and intense technological change. We face, and will continue to face, intense competition from pharmaceutical, biopharmaceutical and biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in drug discovery

20

activities or funding, both in the U.S. and abroad. Some of these competitors are pursuing the development of drugs and other therapies that target the same diseases and conditions that we target in our commercial, clinical and preclinical programs.

Many of the companies competing against us have financial and other resources substantially greater than our own. In addition, many of our competitors have significantly greater experience in testing pharmaceutical and other therapeutic products, obtaining FDA and other regulatory approvals of products, and marketing and selling those products. Accordingly, our competitors may succeed more rapidly than we will in obtaining FDA approval for products and achieving widespread market acceptance. If we obtain necessary regulatory approval and commence significant commercial sales of our products, we will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have limited or no commercial-scale experience.

Our commercialized product, Osteocel, currently competes with established treatment options such as autograft bone and Medtronic’s InFuse and potentially may compete with other products currently in development for the same indications. Our three biologic drug candidates, if approved, would compete with several marketed products and other future biologic drug candidates. For our existing product and each of our clinical-stage biologic drug candidates, the primary competitors include:

·       Osteocel. Our commercialized bone regeneration product competes with autograft bone, synthetic biomaterials, growth factors and allograft bone. Competing products include Medtronic’s InFuse, Stryker’s OP-1, numerous bone void filler products such as Zimmer’s CopiOs™ and autologous bone marrow products such as DePuy Spine’s CELLECT™.

·       Prochymal. If approved, Prochymal will compete with approved products such as Novartis’ Neoral® for the prevention of organ rejection in kidney, liver, and heart allogeneic transplant patients, Johnson & Johnson’s Remicade® and Abbott’s Humira for Crohn’s Disease and if approved DOR BioPharma’s orBec® for gastrointestinal GvHD.

·       Chondrogen. If approved, Chondrogen will compete with products such as allograft menisci from cadavers, Conmed Linvatec’s meniscal fixation system of screws and arrows and if approved, Regen Biologics’ Collagen Meniscus Implant.

·       Provacel. If approved, Provacel will compete with pharmaceutical therapies, mechanical therapies and cellular based therapies. Pharmaceutical therapies include anti-thrombotics, calcium channel blockers such as Pfizer’s Norvasc® and ACE inhibitors such as Sanofi’s Delix®. Mechanical therapies such as biventricular pacing, ventricular restraint devices and mitral valve therapies have been developed by companies such as Medtronic, Acorn Cardiovascular and Edwards Lifesciences. Cellular based therapies such as skeletal myoblasts and embryonic stem cells are being pursued by companies such as Bioheart, MG Biotherapeutics, a joint venture created by Medtronic and Genzyme, and Geron.

We may face competition in the future from other companies that are researching and developing stem cell therapies. We are aware of many companies working in this area, including: Aastrom Biosciences, Advanced Cell Technology, Athersys, Cellerant Therapeutics, Cognate Therapeutics, Cytori Therapeutics, Gamida Cell, Geron, Mesoblast, MultiCell Technologies, Neuronyx, Theradigm, ViaCell and StemCells.

We expect to compete based upon, among other things, our intellectual property portfolio and the efficacy of our products. Our ability to compete successfully will depend on our continued ability to attract and retain skilled and experienced scientific, clinical development and executive personnel, to identify and develop viable biologic drug candidates and to exploit these products and compounds commercially before others are able to develop competitive products.

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