NEW YORK, Feb. 4, 2020 /PRNewswire/ -- Osteoporosis is defined as a systemic skeletal disorder characterized by low bone mass, deterioration of bone tissue leading to enhanced bone fragility, and a consequent increase in fracture risk. This asymptomatic condition often remains undiagnosed until it manifests as a low-trauma fracture which frequently leads to hospitalization.
The goal of pharmacological treatment of osteoporosis is to maintain or increase bone strength, to prevent fractures, and to minimize osteoporosis-related morbidity and mortality caused by fractures throughout the patient's life. The currently offered medications to treat osteoporosis are categorized as either antiresorptive (bisphosphonates, estrogen agonist/ antagonist, estrogens, calcitonin, and Denosumab) or anabolic (teriparatide). Antiresorptive medications primarily decrease the rate of bone resorption while anabolic medications primarily increase bone formation.
Despite the wide availability of several classes of approved osteoporosis medications, and even after documented osteoporotic fractures occur, initiation of treatment rates has been observed to be quite low. The two most effective osteoporosis drugs on the market today are injections. The most recent entrant-Prolia® (Denosumab), developed by Amgen, is a monoclonal antibody that blocks a cascade of signals causing bone breakage, given as an injection every 6 months to prevent bone loss. In 2017, its sales reached approximately $2 billion, and are expected to increase further. The second drug, Forteo®, developed by Eli Lilly, is the only anabolic osteoporosis agent on the US market that increases bone mineral density by increasing bone formation. Forteo® is a recombinant form of PTH, administered by daily subcutaneous injections and recommended for people with osteoporosis who are at high risk for fractures. 2017 worldwide sales of Forteo® were $1.7 billion.
Amgen has emerged as the leader in this therapeutic area with its flagship brand, Prolia® which launched in 2010, and EVENITY ® which launched in Q2 2019. In addition, the company has announced on a research collaboration and license agreement with Entera Bio, in which the latter will use its proprietary oral drug delivery platform to develop oral formulations for three preclinical large molecules, one of which has already been selected by Amgen. Entera Bio developed a drug carrier platform that can be applied to an array of molecular and biological solutions. The company addresses large biological substances with proven therapeutic and side effect profiles that are commonly given as injections for under-attended diseases, in an attempt to provide even greater efficacy to the injectable treatments. In essence, the company turns injectable drugs into oral ones.
Entera Bio's main focus is applying its technology to develop an oral formulation of human parathyroid hormone (PTH), which was approved in the U.S. in injectable form in 2002. Their lead oral PTH product candidate is EB613 for the treatment of osteoporosis. Entera bio has the potential to be the first oral bone-building therapy for osteoporosis.
To get a deep understanding of the osteoporosis drug market please refer to Frost & Sullivan's slide deck.
Dr. Hadar Cohen-Halevy
Frost & Sullivan
SOURCE Frost & Sullivan