Second Tranche Of $91 Million Venture Round Will Help Advance Two Formulations Of Radius’ Osteoporosis Drug
This article was originally published in The Pink Sheet Daily
Executive Summary
Radius, which reverse-merged into a public company this past May, has advanced an injectable formulation of BA058 into Phase III, while it is preparing to move a transdermal version into Phase II.
Radius Health Inc. drew down the second portion of a three-tranche venture financing Nov. 23, bringing in $27.65 million to help advance two formulations of lead candidate BA058, a novel compound for postmenopausal osteoporosis. The second tranche consists of $21.4 million in equity financing from the firm’s existing investors, as well as $6.25 million in debt financing from GE Capital, Healthcare Financial Services and Oxford Finance LLC.
In May, Radius raised the first $28 million of what it calls a Series A round, but also acknowledges it is its third institutional financing [See Deal]. To date, the Cambridge, Mass.-based biotech has raised $57.3 million of a planned $91 million (Also see "Radius Takes $91MM To Support Osteoporosis Drug, Moves Toward Public Listing" - Pink Sheet, 24 May, 2011.).
Radius says the most recent funds will help continue a Phase III study of ‘058, a novel analog human parathryroid hormone-related protein (hPTHrP), in an injectable formulation. The data from that Phase III trial is intended to back regulatory filings in the U.S. and Europe.
“Our goal is to provide a new treatment option for patients with osteoporosis that builds new bone, reduces risk of future fractures, improves convenience and optimizes patient outcomes,” Radius CFO Nick Harvey said in a release.
The funds also will help Radius initiate a Phase II trial of BA058 Microneedle Patch, a transdermal formulation of the drug being co-developed with 3M Drug Delivery Systems[See Deal].
Trials have been providing increasing evidence that hTPHrP is a critical cytokine for promoting new bone formulation, Radius says. The company is developing ‘058 to compete directly with Eli Lilly & Co.’s Forteo (teriparitide (rDNA origin) injection), a parathyroid hormone-based drug which is the only current drug therapy for osteoporosis that builds bone, rather than slowing the rate of bone resorption.
Radius believes its candidate can provide better efficacy, faster benefit and a shorter duration of therapy than Forteo, while building bone with a lower associated risk of inducing hypercalcemia as a side effect. In Phase II trials, the injectable formulation produced faster and greater bone mineral density at the spine and hip after six months and 12 months of therapy, respectively, with a lower incidence of hypercalcemia. Forteo was used as a reference drug in those studies.
In addition, Radius believes its product will offer a convenience advantage because it can be stored long-term at room temperature, while Forteo requires refrigeration.
Osteoporosis offers a significant market opportunity, as Lilly reported last month that Forteo yielded nine-month sales of $687.3 million through the third quarter, a 14% increase from the first three quarters of 2010. Radius obtained worldwide rights, ex-Japan, to develop, manufacture and commercialize ‘058 from Ipsen in 2005 [See Deal].
Although it raises funds currently through venture capital backers, Radius went public in May by reverse-merging with MPM Acquisition Corp., a shell company established by one of Radius’ investors, MPM Capital [201110103]. Radius currently offers stock on the OTC Bulletin Board and plans to apply for a Nasdaq listing in 2012 (Also see "Financings Of The Fortnight: Radius Finds An Alternate Route For Going Public" - Pink Sheet, 27 May, 2011.).
In addition to the two formulations of ‘058, Radius also has in its pipeline RAD1901, a novel tissue-selective estrogren receptor modulator in Phase II for menopausal hot flashes, and RAD140, a selective androgen receptor modulator in preclinical development for osteoporosis and aging-associated frailty.