Antares to Launch Otrexup

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To succeed in the pharmaceutical industry, companies need patience — sometimes decades’ worth. One good example is Antares Pharma in Ewing, which has a corporate history that stretches back into the 1980s, and which only now is poised to become a major player in the industry, with its Otrexup product launching this month on the heels of FDA approval in October.

Back in the late 1980s in Minneapolis, a doctor named Franklin Pass looked at the state of drug research and saw a plethora of drugs that were being researched that could only be delivered by injection. Many of these drugs would require many doses over a long period of time. At the time, patients who needed injections almost always would go to a doctor or clinic of some sort and receive them from a professional. Self-injection was only for diabetics injecting their own insulin.

On the horizon was a world where there would be a huge demand for devices that would allow patients to administer their own injections rather than returning to a clinician’s office on a regular basis. Compliance and convenience seemed to demand it. Pass realized that there was a big market available for anyone who could come up with a better way to deliver those injectable drugs.

So he set out to make one. Pass founded a company called Mediject to market a pen-like needle-free device that injected drugs in a high-pressure stream that penetrated the skin. However, by the late 1990s, the company had yet to find a foothold in the marketplace and was on the verge of going under.

Paul Wotton, who has been CEO of Antares since 2008, believes the firm’s early lack of success was due to underfunding, not a flaw in its technology. “As often happens in technology situations, the technologies get so far and then when they encounter bad economic times, they peter out and die,” he says. That was nearly the fate of Mediject.

The company was saved in 2001 by a merger with Swiss company Permatec, led by Dr. Jacques Gonella. Permatec was marketing transdermal cream that delivered human growth hormone. The combined company was called Antares Pharma. Since the company stabilized, Wotton is looking to move past the transdermal cream market and focus on injector technology. He has led three rounds of funding, all through the public equity markets, since 2009. The most recent, when the company was listed on NASDAQ, raised $50 million.

When Wotton came on board, the company only had $5 million to work with. “We didn’t have the critical mass financially to exploit opportunities,” he says. “Today we have as much money as we need. We have $70 million on our balance sheet. We were one of the pioneers of auto-injectors.”

Wotton remembers the day he and other Antares officers rang the bell at the exchange. “It was the best day of my career,” he says.

The most recent milestone for Antares came in October, when the FDA approved Otrexup, its injector designed to treat chronic arthritis and psoriasis. The injector is a mechanism to deliver the already proven 50-year-old anti-inflammatory drug methotrexate, which is traditionally taken as a pill. To win FDA approval, Antares had to prove that its injector was a more effective delivery mechanism for the drug, offering greater absorption, and ultimately greater relief to arthritis and psoriasis patients.

Though the name is a mouthful, the way Otrexup works is relatively simple. “The idea is empowering patients to give themselves injections,” Wotton says. The injector is a syringe enclosed in an auto-injector. To give yourself an injection, you hold the pen on your thigh or stomach. The needle is hidden within the pen. Then you press a button, and a spring releases and pushes down on a plunger. The needle entering your skin is hidden by a collar. Then, it retracts. The entire process is over in three seconds.

The device is designed top-to-bottom to minimize pain. It uses an extremely fine needle, it enters the skin at a 90 degree angle, it goes very shallow — just under the skin — and the collar stretches the skin out before the needle goes in. Company studies of patients using the device found they assigned the needle a “2” on a subjective pain score of 0 to 100.

Like all of Antares’ products, Wotton has tested the injector on himself. “I’m not keen on giving myself needles, but I can honestly tell you that with these things, you really don’t feel a thing,” he says.

Otrexup was launched in January, and its next product, an injector for testosterone, is close on its heels. Antares has also formed partnerships with Israel-based drugmaker Teva and Denmark-based Leo Pharma to develop several other projects. With Teva, Antares is making delivery vehicles for human growth hormone, an anti-migraine drug, a diabetic pen, and a generic version of the EpiPen auto-injector, which is used to treat anaphylactic shock

Antares is based in Princeton South Corporate Center in Ewing, where about 30 people perform the company’s corporate functions. With the launch of Otrexup, they have recently added or are ready to add 35 new staffers, mostly in sales. A smaller team of engineers and designers works in Minneapolis, where the company actually develops its products.

Antares is not Wotton’s first foray into the high-tech field. Since moving to the United States from his native Britain 20 years ago, he has worked for Penwest Skye Pharma and several other companies. Around 2003 he spent five years working for Topigen Pharmaceuticals in Montreal (and learning French) before returning to the states to lead Antares. Wotton grew up in London, where his father was an architect who designed the Playboy Club and the London Hilton. He earned his Ph.D. in pharmaceutical science from Nottingham University.

Wotton says the key to success for Antares has been planning. Especially long-term planning. “The vision which was introduced 25 to 30 years ago is just now coming to fruition,” he says.

Antares Pharma Inc. (AIS), 100 Princeton South, Suite 300, Ewing 08628; 609-359-3020; fax, 609-359-3015. Paul K. Wotton, president and CEO. www.antares­pharma.com.

CE – US1

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