WALTHAM — Radius Health Inc., a biotech company that has operated largely under the radar for most of the past decade, is preparing later this month to submit its first drug for approval by US regulators.
But unlike many of the state’s biotech startups working on specialized treatments for rare diseases, Radius is targeting osteoporosis, a bone-depleting condition that is estimated to affect as many as 25 million Americans and tens of millions of others worldwide.
The company’s experimental drug — a bone-building hormone with the scientific name abaloparatide — could become a mass-market “blockbuster,” topping $1 billion in annual sales, executives believe. Radius, which has applied for its approval in Europe, will request a US brand name when it files its application with the Food and Drug Administration, the first Massachusetts biotech company to seek approval this year.
“This is a very unique situation,” Radius chief executive Bob Ward, 58, who took the helm at the end of 2013, said in an interview. “Rarely does a biotech company have the opportunity to address a condition that affects millions of people with an unmet medical need. This drug has the ability not only to transform Radius but the treatment of osteoporosis.”
Anticipating the launch of abaloparatide in Europe later this year and in the United States next year, Radius expects to roughly triple its 100-person workforce in 2016, adding jobs at its Waltham headquarters and a research lab in Cambridge’s Kendall Square. The company, founded in 2003, also has sites in New Jersey and Pennsylvania.
Radius will be building a US sales force for its injectable osteoporosis drug, and is working on another version that could be delivered through the skin with a transdermal patch. (It will sell the drugs in Europe through a marketing partner that has yet to be named.)
As the US population ages, demand for osteoporosis drugs is expected to increase.
The company, which went public in 2014, is also stepping up development of drugs that treat hot flashes and breast cancer that has spread to the brain. “We expect to have three product launches in women’s health in the next five to six years,” Ward said.
Osteoporosis, caused by hormonal changes or calcium deficiency, makes patients’ bones brittle from loss of tissue and more susceptible to fracturing. It is most common in postmenopausal women, but also affects many men and can occur in people of both sexes while in their forties.
“Many people are walking around with osteoporosis who don’t know they have it,” said physical therapist Valerie Hodgson, who runs a rehab practice in North Dighton, outside Taunton, and works on exercises and body mechanics training with patients recovering from osteoporotic fractures. “Most patients aren’t sure what osteoporosis is or how to take care of it.”
Primary care doctors typically prescribe as first-line osteoporosis therapies a class of generic pills called bisphosphonates that slow the progression of bone loss. Radius’s drug candidate is part of a new generation of once-a-day injectable treatments, called anabolics, that promote bone formation and are more likely to be prescribed by specialists known as endocrinologists.
The only anabolic currently on the market is Forteo, marketed by pharmaceutical giant Eli Lilly and Co. That injectable rings up annual sales of about $1.4 billion. Radius is running ahead of rival biotech Amgen Inc. in the race to be second to the market.
Initially, at least, anabolics are being prescribed as so-called second-line therapies for those who can’t tolerate or don’t respond to bisphosphonates, according to industry analysts. That means Radius will have to take market share from Lilly and fend off Amgen when its drug enters the market. In a late-stage clinical trial involving 2,400 patients in 22 countries, patients taking the Radius drug showed a larger reduction of vertebral fractures compared with patients taking the Lilly drug or a placebo, according to Radius clinical data.
“Radius is hoping they displace or outcompete Lilly’s Forteo,” said Eric Schmidt, biotech analyst at investment bank Cowen & Co. in New York. “We believe Radius has a better drug, better at building bone in places like the hip and the wrist. It show a modest improvement in efficacy and [unlike Forteo] it doesn’t have to be refrigerated” before patients take it.
Because most osteoporosis medicines are prescribed by primary care doctors, a new drug typically ramps up slowly, Schmidt said, taking up to five years to reach peak sales.
About Radius Health
Went public: 2014
Lead drug candidate: Abaloparatide for osteoporosis
Chief executive: Bob Ward
SOURCE: Radius Health