Businessweek

Osiris Therapeutics, Inc., a stem cell company, focuses on developing and marketing products to treat serious medical conditions in the inflammatory, cardiovascular, orthopedic, and wound healing markets. Segments The company operates in two business segments, Therapeutics and Biosurgery. Therapeutics The Therapeutics segment is focused on developing biologic stem cell drug candidates from a readily available and non-controversial source—adult bone marrow. The company’s lead biologic drug candidate, Prochymal (remestemcel-L), is being evaluated in clinical trials for inflammatory, autoimmune, and cardiovascular indications, including acute graft versus host disease (GvHD), Crohn's disease, acute myocardial infarction, type 1 diabetes, and gastrointestinal injury resulting from radiation exposure (animal rule). Prochymal is the stem cell therapeutic granted both Orphan Drug and Fast Track status by the United States Food and Drug Administration (FDA). Prochymal is in Phase 3 clinical trial for biologics refractory Crohn's disease; Phase 2 clinical trial for type I diabetes mellitus; Phase 2 clinical trial for acute myocardial infarction; and Phase 3 clinical trial for acute radiation syndrome. The company’s pipeline of internally developed biologic drug candidates under evaluation also includes Chondrogen, which is in Phase 2 clinical trials for osteoarthritis in the knee and cartilage protection. The company has entered into a collaboration agreement with Genzyme Corporation (Genzyme), a Sanofi company, for the development and commercialization of Prochymal and Chondrogen. Under the terms of the agreement, the company retained the rights to commercialize Prochymal and Chondrogen in the United States and Canada, and Genzyme was granted rights to commercialize Prochymal and Chondrogen in all other countries, except with respect to GvHD in Japan, where Prochymal has been licensed to JCR Pharmaceuticals Co., Ltd. It also partnered with Genzyme to develop Prochymal as a medical countermeasure to nuclear terrorism and other radiological emergencies. Additionally, the company has partnered with the Juvenile Diabetes Research Foundation (JDRF) for the development of Prochymal as a treatment for the preservation of insulin production in patients with newly diagnosed type 1 diabetes mellitus. Biosurgery The Biosurgery segment works to harness the ability of cells and novel constructs to promote the body's natural healing with the goals of improving surgical outcomes and offering treatment options for patients and physicians. In this segment, the company manufactures, market, and distributes Grafix and Ovation for tissue repair. Grafix is a three-dimensional tissue matrix designed for application directly to acute and chronic wounds, including diabetic foot ulcers and burns. This cellular repair matrix provides a source of extracellular matrix, viable endogenous mesenchymal stem cells (MSCs) and epithelial cells, as well as growth factors directly to the site of the wound, protecting the area from inflammation, scarring, and infection. Ovation is a novel cellular repair matrix designed for use in surgical applications where bone tissue repair is needed. Applied to the site of injury, Ovation provides the three essential components of periosteum—collagen matrix, viable endogenous MSCs and key growth factors, such as BMPs and VEGF—to enable tissue regeneration. The company’s marketing of Ovation is targeted to orthopedic surgeons and neurosurgeons practicing in the United States. Grafix and Ovation are regulated by the FDA under 21CFR Part 1271, Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps). The company is registered with the FDA as a tissue establishment and is accredited by the American Association of Tissue Banks (AATB). The company markets and distributes both Grafix and Ovation through a network of distributors, as well as directly to hospitals and clinics. The company expended approximately $19.2 million in the period ended December 31, 2011 on research and development. The company’s marketing of Grafix is targeted at facilities caring for burn and chronic wound patients in the United States. Strategy The company's business strategy is to expand its pipeline of biologic drug candidates where its stem cell technology has a therapeutic potential; exploit its MSC technology, manufacturing ability and proprietary know-how to advance its pipeline; and internally develop and commercialize future biologic drug candidates and novel tissue products. Intellectual Property The company owns or has exclusive licenses to 46 issued U.S. patents. Foreign counterparts to these patents, including composition of matter claims, have been granted, and the company owns or holds licenses to 145 issued patents in Europe, Canada, Australia, and other countries. The patents and patent licenses included in its portfolio address composition of matter, methods of use, and methods of manufacture of mesenchymal stem cells. The company has 31 additional U.S. patent applications and 85 foreign patent applications pending. Competition The company's competitors include Advanced Biohealing; Organogenesis; and Medtronic. Regulations The company, in addition to privacy law requirements and regulations enforced by the FDA, is also subject to various local, state, and federal laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including chemicals, micro-organisms and various radioactive compounds used in connection with its research and development activities. These laws include the Occupational Safety and Health Act, the Toxic Test Substances Control Act, and the Resource Conservation and Recovery Act. History Osiris Therapeutics, Inc. was founded in 1992 as a Delaware corporation. The company reincorporated as a Maryland corporation in 2010.