MediQuest Vying to Get First Drug Across FDA Goal Line, Put Raynaud’s in Your Vocabulary

Punch “Raynaud’s disease” into a simple Google search, and the first site you get is one from the Mayo Clinic that says it’s a condition of limited blood circulation that causes numbness in the fingers and toes in cold temperatures. “For most people, Raynaud’s disease is more a nuisance than a disability,” according to the site. Usually, it means people with the condition have to avoid the ice cream aisle at the grocery store, or wear a pair of gloves.

To the people at MediQuest Therapeutics, a privately-held biotech company in Bothell, WA, it represents a lot more. Like the chance to become an enterprise with products to sell for the first time, potentially reach as much as $400 million a year in sales, and relieve the pain of millions of people who have basically been told to suck it up and live with it.

“All too often, the physicians don’t take it as seriously as the patients. If it’s your fingers that are hurting, it’s more than a nuisance,” says MediQuest CEO Fred Dechow, during a visit to the company’s offices.

MediQuest’s pursuit of Raynaud’s is one of those rare stories in biotech, of a company that limped along for years, reinvented itself, and then got its act together. Founded as Oridigm with angel investment in 1994, the company originally developed anti-cancer compounds that didn’t work, because they couldn’t penetrate cell membranes. In 2002, Dechow was brought in from PrimeCyte, and decided to shift gears to develop the anti-cancer drugs as topical formulations that could treat skin conditions, without needing to be absorbed in the bloodstream like most drugs.

Six years later, with just $31 million of venture capital (including cash from Seattle-based Integra Ventures) and a staff of just 29 employees, MediQuest is approaching the mother of all milestones for a fledgling biotech company. The FDA is giving the company an expedited six-month review of its product, with an official deadline of October 25 to say yes or no to MQX-503, the company’s squeeze-on gel for patients with Raynaud’s. It could be the day MediQuest gets clearance to sell its first product in the U.S., and the first-ever treatment specifically for Raynaud’s. An estimated 2.1 million people, mostly women, have a severe enough case of the disease that they have sought medical treatment, Dechow says.

The opportunity is too big for a small company like MediQuest to handle, so it is negotiating with potential partners who could deploy a sales force of about 400 representatives across the country to get the word out about the new drug. Dechow says they will aim the pitch at rheumatologists as a specialty, primary care physicians who see most patients, and possibly help put together a direct-to-consumer TV ad campaign designed to raise the profile of Raynaud’s. Somewhat like Restless Leg Syndrome, a once-obscure disease with limited treatment options, MediQuest wants to transform Raynaud’s into a new pharmaceutical market worth hundreds of millions to companies like London-based GlaxoSmithKline (NYSE: GSK), the world’s number-two drugmaker

“We want a partner willing to address the market with the right sales force, the right resources, and let people know there is finally something available for Raynaud’s,” Dechow says.

First, though, is the matter of persuading the FDA to give the green light. MediQuest filed its application with the agency based on two pivotal clinical trials that showed its product was better than a placebo. The gel, which is squeezed on the fingers with a spongy material the size of a quarter, showed improvement in a patient-reported scoring system that measured the number of Raynaud’s flare-ups, how long they lasted, and the severity of pain, numbness, and tingling, said Jeffrey Gregory, the company’s chief medical officer. The drug was 13 percent better than the placebo in one trial and showed 24 percent improvement in the other, he says.

The product works by delivering nitroglycerin, a high-blood pressure medicine, through the skin to open up blood vessels and bring back blood flow to the extremities when encountering cold weather. The product is given as a daily pill to some patients with Raynaud’s, but only a small fraction stick with it because it causes headaches, Dechow says. However, the headache rate for patients on the MediQuest drug was about the same as those on a placebo, he says.

“We will need to let people know that you can finally treat this disease. There’s a patient education program, and a physician education program that will be necessary,” Dechow says. “The feedback we get is that patients really like the idea of a local solution to a local problem.”

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