 The Oral Salmon Calcitonin Program in Collaboration with Novartis
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On May 24, 2007, Emisphere was notified that
Novartis Pharma AG and its development partner
Nordic Bioscience have initiated a Phase III
clinical program of oral calcitonin (referred to as
SMC021) for the treatment of osteoarthritis, a
chronic, irreversible and degenerative condition.
The oral calcitonin product is a new drug candidate
with the potential to be the first disease-modifying
drug for osteoarthritis. The salmon calcitonin is
formulated in a tablet form using Emisphere's novel eligen®
delivery technology.
Earlier this year, Novartis Pharma AG and its
development partner Nordic Bioscience initiated a
Phase III clinical trial for the treatment of
osteoporosis with the oral form of salmon calcitonin
The use of Emisphere's novel eligen®
technology reflects the potential that for the first
time salmon calcitonin may also be available as a
convenient oral medication, rather than the
currently available injectable or intranasal
options.
Project Background
In February 2000, Emisphere entered into a licensing agreement with Novartis for the development and commercialization of a tablet dosage form of salmon calcitonin for the treatment of osteoporosis and its related indications.
In 2003, Novartis reported positive Phase IIa study results at the American Society for Bone and Mineral Research. The study demonstrated activity on bone markers over a three month dosing period when the peptide was delivered in combination with the EMISPHERE® delivery agent.
The purpose of the study was to assess the efficacy and safety of various doses of the oral tablet formulation of calcitonin in post-menopausal women and to confirm the activity of calcitonin when given orally, as reflected by changes in markers of bone formation or resorption. The multi-site study was conducted in Europe and included 277 post-menopausal women who were dosed over a three-month period. Five calcitonin doses were administered with a fixed amount of an EMISPHERE® delivery agent. A placebo arm was also included in the study design.
The data from the study demonstrated that in comparison to placebo, there was a significant reduction in bone resorption markers observed for one of these doses (1 mg/day; p = 0.0016). Furthermore, only two serious adverse events were reported, neither of which were related to the EMISPHERE® delivery agent or to calcitonin. The side effects seen with the highest doses of calcitonin were consistent with those normally seen with high plasma levels of calcitonin when administered by injection. These side effects were mainly gastrointestinal in nature. In summary, the innovative oral formulation of sCT (salmon calcitonin) is effectively absorbed and provides a strong cyclic inhibition on bone resorption.
Market Opportunity / Expansion
According to the International Osteoporosis
Foundation, osteoporosis is a major public health
threat for an estimated 75 million people in the
U.S., Europe and Japan alone.
According to DataMonitor Reports, the total world
market for osteoporosis drugs are forecasted to
reach $10.4 billion by 2011, from approximately $5.0
billion in 2003.
About Calcitonin
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland. Calcitonin enables the bone to retain more of its mass and functionality by inhibiting the bone-tissue resorbing activity of specialized bone cells called osteoclasts. Calcitonin is involved in the regulation of calcium and the decrease of bone loss and fractures. Calcitonin derived from salmon is estimated to be about 30 times more potent than the human version. Synthetic salmon calcitonin, which is identical to the natural salmon calcitonin, is currently available only as nasal spray or as an injectable therapy.
Clinical Indications
IInjectable calcitonin is used to treat osteoporosis and Paget’s disease. Osteoporosis, or porous bone, is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures, especially of the hip, spine and wrist, although any bone can be affected. After menopause, the rate of bone loss accelerates. In women with osteoporosis, calcitonin has been shown to increase bone density and strength, while decreasing the rate of bone fractures.
Paget's disease is a bone disease characterized by a disorderly and accelerated remodeling of the bone, leading to bone weakness and pain. Calcitonin can decrease bone turnover and bone pain in patients with Paget's disease. Injectable calcitonin is also used to treat seriously elevated blood calcium levels.
Novartis Pharmaceuticals Corporation markets synthetic salmon calcitonin in the United States as Miacalcin®, which is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass and should be reserved for postmenopausal women who refuse or cannot tolerate estrogen, or for whom estrogens are contraindicated.
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