Antares Pharma (AMEX:AIS) broke through last week with FDA approval of a topical gel to treat overactive bladder.
It’s a cash win for the New Jersey company, which will receive royalties from sales and milestone payments for delivery of the drug — called Anturol — to Watson Pharmaceuticals (NYSE:WPI), which will commercialize the product next year. About 33 million people suffer from overactive bladder, a number comparable to diabetes (Antares only received $432,000 from Watson up to this point, according to Antares’ recent earnings report).
Now, Antares will focus on leveraging new opportunities for the drug delivery portion of the business. The biosimilars market and a partnership with Teva will be the next potential windfalls for the company, Antares CEO Paul Wotton said.
“I think we face an exciting future because the market for pharma is trending towards biological products – antibodies and proteins – that have to be injected,” Wotton said. “Managed care likes good delivery technology because it improves patient compliance and saves a lot of money. All our technology is geared to being able to take drugs without fear of needles. Our auto-injector presses on the skin and triggers the device, which sends a little needle into a subcutaneous needle.”
Antares has two parts of its business. It has the drug-development side, which created Anturol, and a line of self-injectable drug delivery technologies.
Wotton likes his chances with biosimilars, a market analysts valued at up to $3 billion by 2015, because the biosimilars initiative in the Affordable Care Act will provide significant opportunities for companies like his.
Plus, the centerpiece of the self-injectable business is its VIBEX autoinjector for Methotrexate, a drug used to treat rheumatoid arthritis, geared for home use.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Three years ago we were a company with three technology platforms” Wotton said. “We really needed to focus on one segment – injectables. As a result, we have been very successful in executing a program with Teva and getting Methotrexate into clinical trials, facilitating a product launch in 2014 and been able to complete development of transdermal gel technology.”
Armchair analysts have pointed out the Teva deal could break either way for Antares, whose fortunes seem aligned with the results of a Pfizer-Teva lawsuit around the autoinjector technology scheduled to begin early next year.
The worst outcome for Antares obviously would be if Pfizer were to prevail in the suit. There are three other possibilities: (1) Teva wins and launches a generic in 2H, 2012, (2) Pfizer allows Teva to launch an authorized generic and (3) Pfizer and Teva reach a settlement in which Teva agrees not to launch for some time (perhaps two to three years). In the event of a settlement, Antares is entitled to a significant percentage of the settlement amount.
Antares also has a pipeline of drugs and drug delivery technology it is collaborating on with other pharmaceutical companies. One is with Biosante (NASDAQ:BPAX) for Libigel, a transdermal testosterone gel with a Phase 3 clinical trial for female sexual dysfunction. Antares owns the international rights and an NDA filing is planned for 2012.
Wotton joined Antares three years ago from Topigen Pharmaceuticals in Montreal, Canada where he was CEO. The company was acquired by Australian drugmaker Pharmaxisin 2010. Since then, Wotton said the company’s investor base has shifted from retail investors to institutional investors as its market cap has grown from about $23 million in December 2008 to about $270 million.
