It's no secret that there are millions of people who suffer greatly from different forms of arthritis and with all the oral medications on the market, it's still a growing problem. I would now like to explain what Antares Pharma (ATRS) is trying to accomplish by coming up with their very own product to try to make taking an arthritis drug more effective.
But first, let's examine some facts about arthritis. The most common form of arthritis is called Rheumatoid Arthritis and it can really take a toll on the human body. RA is a chronic autoimmune disorder characterized by a painful inflammation of the synovial tissues lining the joints. RA generally starts between the ages of 40 and 60 and if left untreated it often progresses to the deteriorating of the tissues surrounding the joints and destruction of bones and cartilage, which can restrict normal movement of the joint.
Methotrexate, MTX for short, is the more complex treatment of Rheumatoid Arthritis. The most common form of treatment is an oral method and these methods have not arrived at the promising results once prescribed by doctors due to the length of time it takes to enter into the blood cells in the body. Oral methotrexate has many side effects and the risk is a lot greater with higher dosages. They include nausea and vomiting, rash, mild hair loss, headache, mouth sores, and muscle aches. Arthritis patients have been searching for an easier, more comfortable way to take an arthritis drug and I think that time will come soon.
A Quest For A Better Method
Antares Pharma just raised nearly $50 million in a stock offering back in October. The purpose was to take full advantage of the arthritis market and to provide an easier, less costly method through its own injection device. Management at Antares sees a lot of opportunity to make a better form of a drug intake for arthritis patients and research shows that it's a very demanding industry. Here is a quote from a research group which have done relentless studies on the subject.
"GBI Research analysis shows that the global arthritis therapeutics market was estimated at $20.6 billion in 2010, during the forecast period the market grew at a Compound Annual Growth Rate (CAGR) of 7.2% between 2010 and 2018 to a $38 billion."
With the growing demand in the arthritis therapeutics market, you can now understand why Antares are ramping up their efforts to get their product on the market. They are in the process of gearing up to make a strong showing of their very own MTX injector and management has already said they will file with the FDA come Q1 of 2013, if not sooner. With a standard 6-8 months FDA review, sales could start to come to light by late 2013 or early 2014.
Antares is the only US based Company with proprietary Auto-Injector, Multi-dose Pen and Needle Free Injection Technology Device Platforms. This is where their Vibex MTX medi-jet injector comes into play for the growing demand of suffering arthritis patients. The extent of oral absorption of MTX varies considerably between patients and has been shown to decline with increasing doses. Studies have also reported that switching patients from oral to Vibex MTX improves absorption providing superior therapeutic response resulting in longer duration of use and with less side effects as its oral counterpart. The Vibex MTX has already been put through the test and had an outstanding 96% positive result. From the CEO, Paul Wotton:
"Independent market research commissioned by Antares with 200 rheumatologists has confirmed that physicians, if offered a reliable and patient-friendly method for self-injection, would like to switch many patients to an injection form of MTX, potentially providing improved absorption, reduced side effects, and a better therapeutic response."
It should be noted that some doctors feel that an oral method is just as acceptable as a direct injection. Their concerns with the direct injection are with the liver being damaged if taken to much at one dose. But as with all types of drugs, it's the patients responsibility on how they properly use the drug to the manufacturers' and/or doctors' request. Here is what Dr. DaDavid Pisetsky, MD, PhD, an expert rheumatologist, had to say.
"Although the injections may help improve the medication's effectiveness, the potential side effects and benefits of methotrexate are virtually the same whether it is given orally or by injection. Liver damage remains the main concern, and is monitored by frequent blood tests. Taking 1 mg of folic acid per day can help reduce other side effects related to methotrexate use, such as mouth sores or gastrointestinal irritation."
So to some the jury is still out on which is a better method. But again, going back to Antares' testing, (see slide #11 from the November healthcare presentation) the individuals who were privately tested said that they like the direct injection through Antares' Vibex MTX medi-jet better due to the easiness of the product and the comfort of the device. And to add, it gave greater results. I think once more patients become better familiarized with the product, it will become even more acceptable to the overall arthritis world.
How It Works
The Vibex MTX device is easy to use while it employs a coil spring power source to rapidly deliver its medication into the cell tissue. This method works faster and a study already shows that it's more effective. Teva Pharmaceuticals (TEVA) already uses Antares' epi-pen injectors and the new Vibex MTX media injector will be similar in form. The device will come pre-loaded in a 10mg, 15mg, 20mg, and 25mg dosage form depending on the patient's need and it will only be taken once a week where as the oral pills are taken on a daily bases. The Vibex MTX system is designed to be more economical and will provide a highly reliable subcutaneous injection with reduced discomfort. Antares has already run vigorous tests with the safety of their Vibex MTX medi-jet, so therefore, I do not see any hold ups upon FDA review. Antares has full patent rights until 2020, so there will not be any infringement for a great length of time.
After researching the field, there is no reason to think Antares will not play an important role in the arthritis industry. Studies have shown that patients have clearly stated that they want an easier, cheaper method and I believe Antares has the product that will answer the call. It will now be up to management to show how they can market their new product and I would like to believe that they have many rheumatologists lined up to help with this task. I personally think the Vibex MTX medi-jet will have a huge impact on the arthritis market and it will catapult Antares' share price after it has been on the market for a few months. Having said this, just as I stated in my last article, I would be cautious when entering the stock. The markets are still in turmoil over the Fiscal Cliff talks in Washington and those concerns could possibly give you a better opportunity to get a lower entry point. As for me, I am long in the stock and willing to ride the turbulence because the reward will be well worth the wait.