Dance 501 is a drug-device combination product, which includes a preservative-free formulation of inhaled recombinant human insulin delivered via a smart, handheld soft mist device. Dance 501 has been designed to enable convenient and confident delivery of insulin into a patient’s lungs in just a few breaths, yielding high lung deposition and distribution.Dance Bipharm Holdings Inc.
Dance Biopharm had a lot to celebrate in 2018 and if all goes according to plan the private biotech company will have even more to celebrate this year. The company's flagship product – an insulin product delivered via a smart handheld soft mist inhaler – is currently in two confirmatory phase II studies in type 1 and 2 diabetes patients, and Dance plans to initiate two phase III programs in type 2 diabetes patients in 2019.
"2018 was a year where Dance really started to build momentum and come out of stealth mode to move toward a commercially focused company," said Anne Whitaker, who joined Dance in September as director and CEO. Whitaker has worked with diabetes pharmaceutical products at all stages of the product lifecycle and is expected to lead the company's transformation from late-stage development to preparing its lead clinical asset, Dance 501, for commercialization.
In June 2018, the company completed a new private equity financing round securing $24.5 million. SternAegis Ventures, through Aegis Capital Corp., acted as the exclusive placement agent for the offering. Molex Ventures, a subsidiary of Koch Industries also made a substantial equity investment in Dance and helped anchor the round.
Whitaker told MD+DI that the company is currently in the middle of another fundraising round that has raised $10.7 million already and is expected to raise $15 million by the final close on Feb. 4. The proceeds of that round should give Dance the runway to finish its phase II trials and ramp up manufacturing for the device as well as the insulin product.
"This company is well positioned to transform diabetes care by taking the complexity out of insulin delivery and addressing the specific needs of an industry that is experiencing a 9% global growth in new diabetic patients each year," said Lily Yeung, vice president of Molex Ventures and a board observer at Dance.
Dance operates a lean and agile organization that engages with key partners across the value chain. Throughout 2018, the company continued to fortify its relationship with partners such as Dongbao Pharma, its insulin API provider and development joint venture partner in China. Dongbao has committed to equally sharing the development cost of Dance 501 in China. With this approach to strategic partnerships, Dance avoids the capital investment usually required for staffing and building manufacturing facilities.
"Dance is at an exciting stage, and we are preparing the market for Dance 501 by building awareness of our company innovations, value to patients and healthcare providers, and our product IP," Whitaker said. "We also seek to demonstrate patient preference for our soft mist inhaled medicine over injections and how this new generation of inhaled drug delivery has the potential to improve medication adherence and patient outcomes.”
Inhaled insulin delivery offers a potentially promising needle-free alternative. Dance 501 has been designed to enable convenient and confident delivery of insulin into a patient’s lungs in just a few breaths, yielding high lung deposition and distribution.
The Dance-501 insulin inhaler is based on vibrating mesh micropump technology developed and commercialized by Aerogen. Dance chose to develop a liquid formulation of insulin, instead of a dry powder, to lower manufacturing costs, eliminate coughing, and facilitate ease-of-use.
The International Diabetes Federation’s (IDF) Diabetes Atlas eighth edition estimates that roughly 425 million adults were living with diabetes in 2017. According to Atlas, 325 million people were at risk of developing type 2 diabetes in 2017, and $727 billion dollars was attributed to the treatment of patients with diabetes that year. IDF forecasts the number of adult patients with diabetes to grow to about 629 million by 2045.