April 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff
In a recent interview with BioSpace, Mike Clayman, co-founder and chief executive officer of Flexion, took time out to discuss the direction the company is heading and what it looks for in hiring. “Our goal has been and continues to be to create a great company that can make a real difference in healthcare,” says Clayman. “We believe that beginning with FX006 we have that opportunity by addressing a very large and growing unmet medical need of providing meaningful and sustained pain relief to patients with osteoarthritis.”
Optimistic about the possibility of filing a New Drug Application (NDA) in the second half of 2016 for FX006 on the heels of having recently initiated a Phase III clinical trial, the company’s plan is to commercialize the product itself with its own 100-person salesforce. In the U.S., these types of injectable therapies are administered by specialty physicians such as orthopedists and rheumatologists, and the company plans to bring on up to 100 new sales staff to target this market.
Over the next three to five years, Clayman says, “There will be several areas of focus. We need to continue to execute on the business plan, delivering pivotal clinical data and filing our NDA. In addition, we are committed to building commercial capability to enable the most successful launch of FX006 possible. We also aim to progress other drugs in the pipeline and thoughtfully add capability and capacity to all of our other functions.”
The company’s lead product, FX006, is a sustained release steroid that is currently in pivotal, late-stage trials for osteoarthritis knee pain. The pivotal Phase IIb confirmatory clinical trial is a double blind, randomized study of 310 patients designed to gather data for FX006 compared to placebo. The company expects to announce topline results in the fourth quarter of 2015.
In addition to FX006, Flexion also has FX007, a preclinical, small-molecule TrkA receptor antagonist for the treatment of post-operative pain, and FX005, a sustained-release p38 MAP (mitogen-activated protein), kinase inhibitor that in addition to pain release, has anti-inflammatory properties. It has completed a Phase IIa (PoC) study.
Clayman says, “My highest priority is and continues to be attracting and retaining outstanding talent. Our success to date is a direct reflection of our strong team of people.”
With an ongoing and growing need for talent, Clayman says, “We want people who have both the requisite experience and expertise and who also have passion and drive for what they do. We also want people who have an approach to their work that always makes room for fun.”
This is a seemingly unusual employment priority, but Clayman goes on to say, “We strive to have a workplace where we really enjoy the people we work with and look forward to coming to work each day. Be good at what you do, be passionate and don’t take yourself too seriously.”
Founded seven-and-a-half years ago, Burlington, Mass.-based Flexion Therapeutics focuses on local, injectable therapies for the treatment of pain. The company’s original model was to in-license assets from larger pharmaceutical companies and progress these to “value inflection.” The company’s co-founder, Neil Bodick, came up with the name Flexion to reflect the concept. Over time, the business model changed and the company has focused on the orthopedic space. What was a clever spin on a business model became an even better and less esoteric name for a company that focuses on alleviating joint pain.
In February 2014, Flexion closed on its initial public offering of 5,750,000 shares of common stock at an initial offering price of $13.00 per share, which garnered gross proceeds before expenses of approximately $75 million. At the end of 2014, the company announced the closing of a second public offering of common stock, selling 5,796,000 shares at a public price of $17.00 per share garnering over $98 million gross proceeds.
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