This month is World Osteoporosis Day, and Ben Hargreaves takes a look at treatment options for patients living with the disease.
Osteoporosis is a condition that causes bones to become weak and brittle, making them more likely to break due to a fall or even something as small as a sudden movement. The condition is the most common chronic bone disease, seen more frequently in the elderly population. In many nations of the worldThe population aged 65 and over is growing faster than the total population, which means that age-related diseases are becoming more prevalent and will require effective treatment.
However, there is a problem facing the treatment of osteoporosis, and that is the lack of research into new therapies, leading to a limited portfolio of new treatments emerging. In the UK, a new treatment for severe osteoporosis in the form of Evenity (romosozumab) was recently approved, but only after a wait of more than a decade. Standard treatments for osteoporosis are usually bisphosphonates, such as alendronate or risedronate, which were approved for use decades ago. This begs the question why investment has been slow in the area and there are signs of change on the horizon.
A scarce pipe
In 2021, Michael McClung, founding director of the Oregon Osteoporosis Center, border that the pipeline for potential new osteoporosis treatments was empty and stated that it would be several years before new treatments for the condition emerged. ResearchandMarkets also recently published a reportwhich singled out biosimilars as emerging treatments for osteoporosis.
In September 2022, the International Osteoporosis Foundation (IOF), together with the NCD Alliance, called for increased action and investment directed at noncommunicable diseases (NCDs). The organizations highlighted that although the diseases are mostly preventable, they remain the leading cause of death and disability worldwide.
IOF CEO Philippe Halbout stated: “Within the NCD spectrum, osteoporosis and related musculoskeletal diseases are too often overlooked. Many people don’t realize that fractures due to osteoporosis are often life-changing events that cause pain, immobility, isolation, and dependency. For older adults affected by a fragility fracture, even the simplest daily tasks can become difficult or even impossible, resulting in significant cost to patients and their informal caregivers.”
Halbout went on to say that due to the aging of the world’s population, the projected health care costs due to fragility fractures will increase tremendously in the coming years. This is projected to lead to a situation where the financial burden would be “unsustainable for most health systems,” he concluded.
A biological breakthrough
One of the few new treatments to emerge in the space was the aforementioned approval for Evenity, a monoclonal antibody treatment. therapy has been on the market in Europe since 2019, which is marketed by UCB in the region, although by Amgen and Astellas in other areas. UCB recently revealed that a study had been conducted using 3D models to visualize and assess ongoing treatment for osteoporosis. The study found that patients treated with Evenity achieved increases in volumetric cortical bone mineral density (BMD), cortical thickness, cortical surface BMD, and trabecular volumetric BMD, compared to comparison groups.
Cesar Libanati, head of bone medical strategy at UCB, spoke with pharmaphorum about the study results and about the treatment of osteoporosis in general. Regarding the condition in Europe, Libanati highlighted that “osteoporosis and the 4.3 million fragility fractures it causes each year cost health care systems more than 56 billion euros, according to 2019 data. 3% of this money was spent on medical treatment.”
Regarding how Evenity may offer advantages over standard treatment, Libanati said it is the only therapy available that has a dual effect: increasing bone formation and decreasing bone resorption. She further added: “Our data show that the dual effect of romosozumab leads to greater improvements in BMD at the spine and hips compared to other available treatments. Greater improvements in BMD result in greater gains in bone strength and are associated with significant reductions in future fracture risk.”
The ability to use 3D modeling now gives researchers more detail about how treatments work, as there is no radiation risk associated with a computed tomography (CT) scan. At the patient level, this allows researchers to understand the impact of therapies on different compartments of the bone and thus better tailor individualized patient treatment options.
Emerging research and biosimilars
Amgen reported that full-year global sales of Evenity reached $530 million in 2021. The company also has another product in its portfolio for osteoporosis, in the form of denosumab, which has become crucial to its overall revenue and a treatment highly successful. The level of income for these osteoporosis treatments should suggest the attractiveness of working in the area and this has become a reality, but mainly for those companies that work on biosimilars.
Sandoz recently announced positive clinical trial results from a phase 1/3 to its biosimilar to denosumab. Sandoz is just one of several companies looking to make progress on their own biosimilars, a list that includes Samsung Bioepis, Celltrion and AryoGen Pharmed. With denosumab patents expiring in some European markets in June 2022, if the European Commission finds these treatments to be equivalent, they could hit the market soon. However, patent protection remains in some major markets including France, Italy, Spain and the UK until 2025.
However, while biosimilars will offer cheaper treatment options to health systems, they do not advance current treatments or provide patients with an alternative type of treatment. As a result, there will still be pressure to develop new therapies in the future. Amgen’s portfolio has shown that this type of treatment can be lucrative. The question is whether other major pharmaceutical companies will be attracted to the space, particularly when areas like oncology and orphan drugs currently provide a higher return on investment.