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Product Pipeline
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Augment™ Product Pipeline
>> A printer-friendly PDF version of this information is available for download.
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Product candidate |
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Periodontal |
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GEM 21S |
Periodontal bone defects and gum tissue recession |
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Orthopedic |
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Augment™ Bone Graft |
Open surgical treatment |
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Augment™ Injectable Bone Graft |
Closed surgical treatment (percutaneous) |
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Local bone augmentation for osteoporosis |
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Spine |
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Augment Injectable Bone Graft |
Prophylactic vertebral compression fracture |
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Local bone augmentation for osteoporosis |
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Sports injury |
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Augment™ C |
Cartilage |
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Augment™ LT |
Ligament and tendon |
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rhPDGF – Key Stimulator for Tissue Repair
BioMimetic's product and product candidates use rhPDGF, one of the principal wound healing stimulators in the body. The Company believes that rhPDGF is well suited for various applications due to its stimulation of a broad spectrum of cellular events critical for the initiation and progression of periodontal and orthopedic tissue healing. rhPDGF acts like a magnet to attract cells necessary for tissue healing through a process known as chemotaxis, while also stimulating an increase in the number of healing cells through a process known as mitogenesis, thereby expanding the number of cells available for the repair process. In addition, published in vivo and in vitro studies demonstrate that rhPDGF may enhance processes important in new blood vessel formation at the wound site, a process critical for wound healing.
GEM 21S for Periodontal Indications
BioMimetic's first drug-device combination product, GEM 21S Growth-factor Enhanced Matrix, received FDA approval in November 2005 for the treatment of periodontal bone defects and gum tissue recession associated with periodontal disease. GEM 21S is a fully synthetic regeneration system that combines the tissue growth factor rhPDGF with a synthetic bone matrix, beta-tricalcium phosphate (β–TCP). It is the first totally synthetic product combining a purified recombinant growth factor with a synthetic bone matrix to be approved by the FDA for human application.
The combination of the two components of GEM 21S are key to the overall effectiveness of the product. The rhPDGF provides the biological stimulus for tissue repair by stimulating the proliferation and in-growth of osteoblasts, cells responsible for the formation of bone while the β–TCP provides the framework or scaffold for new bone growth to occur.
In January 2008, BioMimetic sold the remainder of its dental business, including the downstream formulation, fill and finish manufacturing rights of GEM 21S, to Luitpold Pharmaceuticals, Inc., a group company of Daiichi Sankyo Co., Ltd. of Japan. Luitpold will market the GEM 21S product through its Osteohealth Company division.
Augment™ for Orthopedic Indications
Following the proven ability of GEM 21S to stimulate bone formation in jaw bone defects, the Company is advancing an array of product candidates based upon its Augment™ technology, which incorporate rhPDGF as the growth factor component with a tissue specific bio-resorbable matrix.
These product candidates are designed to target a broad range of clinical indications in bone, cartilage, ligament and tendon repair. More specifically, BioMimetic's Augment family of product candidates are being developed to treat open fractures (Augment Bone Graft), closed fractures (Augment Injectable Bone Graft) and areas of the skeleton, such as the vertebral bodies of the spine in osteoporotic individuals, that are susceptible to fracture and where stimulation of new bone formation could have a prophylactic therapeutic benefit (Augment Injectable Bone Graft). In addition, the Company has preclinical programs focused on the development of biologically enhanced drug-device combination products for various sports injuries, including those requiring cartilage, ligament and tendon repair.
Open (surgical) treatment
There are more than one million procedures each year in the United States involving fusions and corrective surgeries of the foot and ankle. Many of these procedures, which utilize an open surgical approach, require the use of a bone graft material to stimulate the healing of the bone following surgery. Open, or surgical, reduction of fractures of the long bones account for an additional 550,000 surgical procedures in the Unites States annually. Bone graft materials are frequently used in these procedures to fill voids and stimulate the wound healing process.
BioMimetic's goal is to develop approval for its product candidates for a broad range of bone grafting indications. To achieve this goal, the Company has initiated clinical studies with Augment Bone Graft, its most advanced orthopedic product candidate, in multiple clinical indications. Studies are currently being held in the United States, Canada and Sweden.
Prophylactic treatment of osteoporotic bone
Osteoporosis is a condition of diminished bone mass, most frequently seen in post-menopausal women that have been identified as a contributing factor in an estimated 1.5 million fractures each year. According to industry reports, almost half of all women over age 65 may fracture a wrist, hip or spinal vertebrae due to weakened bone mass resulting from osteoporosis. While physicians have the ability to detect osteoporosis and to identify other risk factors for delayed fracture healing, there are few therapies that are well accepted for proactive treatment of these patients with a high risk for fracture. BioMimetic believes a market opportunity exists for the prophylactic treatment of bone at risk for fracture. The Company is developing the Augment Injectable Bone Graft product candidate for direct percutaneous injection into the vertebral bodies adjacent to those being treated with verteoroplasty or kyphoplasty for an existing VCF (vertebral compression fracture). Published data suggests that there is a higher incident of VCFs in vertebral bodies adjacent to those treated with verteoroplasty or kyphoplasty. Prophylactic treatment with PDGF to stimulate new bone growth in the adjacent vertebrae has the potential to dramatically minimize the number of new fractures occurring.
Closed fracture reduction
Per year in the United States, over 11 million radius, humerus, tibia, fibula and femur fractures occur where the treatment relies upon closed reduction or closed, non-surgical treatment. Of these fractures, an estimated five to 10% have impaired or delayed healing due to patient specific factors such as smoking, diabetes and osteoporosis.
It is anticipated that Augment Injectable Bone Graft treatment of fractures not requiring surgery may be an effective therapy to accelerate fracture repair, and minimize the level of fracture related complications. Augment Injectable Bone Graft combines rhPDGF with an injectable bone matrix. The product candidate will be injected through the skin into the fracture site, locally delivering rhPDGF to accelerate fracture repair. Closed fracture reduction procedures comprise the largest number of orthopedic procedures today. According to hospital and outpatient procedural data, 2.8 million closed fracture procedures are performed a year. While a significant number of these are treated with casts, BioMimetic believes that a large number of patients who require longer healing times would benefit from the Augment Injectable Bone Graft product candidate. The Company has advanced Augment Injectable Bone Graft into clinical development and initiated patient enrollment in two pilot studies. The first study is a 20 patient trial in which Augment Injectable Bone Graft is being evaluated for safety and clinical utility in closed fractures of the distal radius when delivered using minimally invasive surgical techniques. A second study is being conducted in Canada to evaluate Augment Injectable Bone Graft for the treatment of foot and ankle fusions.
Product Candidates for Sports Injuries
BioMimetic intends to use its proprietary technology to develop products addressing unmet medical needs in sports injury, initially targeting cartilage, ligament and tendon repair and regeneration.
Cartilage, ligament and tendon repair and regeneration represent significant unmet clinical needs. Each year there are over 22 million soft tissue related injuries in the United States, most of which are treated conservatively with rehabilitation techniques. Because of the lack of therapies that can stimulate healing and regeneration of these tissues, many of these injuries will result in a degree of permanent impairment and chronic pain.
Cartilage injuries
Cartilage is the soft tissue in the joints of the body that acts as a shock absorber and lubricant during motion of the joint. Because damaged cartilage does not heal by itself and slowly breaks down over time, the result can lead to a complete wearing away of cartilage, leading to osteoarthritis. Currently, there are limited therapies to regenerate cartilage although a number of therapeutic and surgical methods are used to minimize the pain and disability from cartilage injuries.
Ligament and tendon injuries
Ligaments, the tissue structures that connect bone to bone, and tendons, the tissue structures that connect muscles to bone, are crucial to the biomechanical functions of the body. Injuries to ligaments and tendons are very common, and while typically these injuries can be treated conservatively with rehabilitative techniques, these injuries are often slow to heal or do not heal completely. Currently there are limited therapeutic products that stimulate the healing and regeneration of ligament and tendon tissues.
Based upon the demonstrated biology found during in vivo and in vitro studies that show rhPDGF can stimulate proliferation of the structural cell types that make up cartilage, ligaments and tendons and published in vivo and in vitro studies that support the potential use of rhPDGF for accelerating healing of these tissues, BioMimetic believes that rhPDGF has the potential to be an effective therapy for the repair of these types of tissues. The use of rhPDGF to speed tissue repair across a broad spectrum of tissues is supported by the demonstrated clinical efficacy of rhPDGF to stimulate the healing of tissues as diverse as diabetic chronic non-healing ulcers of the skin (Regranex®) and bone defects of the jaws associated with advanced periodontal disease (GEM 21S).
Summary
Attributable to the successful performance of GEM 21S in its pivotal clinical study and the demonstrated ability of rhPDGF-BB to stimulate tissue healing, BioMimetic believes that its pipeline of orthopedic product candidates has the potential to positively impact patient care and influence a new generation of orthopedic therapies. Due to management expertise in the development of drug-device combination products, combined with the Company's intellectual property position and the proven biology and safety of rhPDGF, BioMimetic believes it is positioned to become a leader in the development and commercialization of novel therapeutics for the treatment of orthopedic injuries. |
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