Almost every RA patient can learn how to self inject MTX after a 15 minute training with the nurse by using the $2 standard needle from Becton Dickinson. I predict that Otrexup will not take off as nobody has any interest in this expensive needle, except ATRS:
Physicians will not prescribe Otrexup to keep the weekly revenue stream from one easy short shot. Furthermore, RA patients have to be monitored closely, so why to ask patient to self inject and don't come to the office.
Insurers aren't crazy either. Are they going to pay $100 for Otrexup while the same thing can be done with a $2 Becton-Dickinson needle?
Patients will not be willing to swallow the cost of Otrexup either.
If this fancy needle idea were anything worthwhile you bet some other company would have tried it before.
The only evidence about the market potential comes from Antares commissioned interviews with some rheumatologists. Beware of the conflict of interest.
Scott wrote an article on Jan 30, 2012; and one of the commentators, who happen to be a RA patient himself clearly doubted the market potential. Here is his (nick name EdEskimo) remarks for Scott's article for your own deliberation:
I happen to use MTX myself.
I do the injections very easily at home with minimal pain with a standard needle from Becton-Dickinson.
Many diabetics give themselves multiple injections a day.
I worked at a rheumatologists clinic for 3 months as a resident and really don't recall many patients ever coming in for us to give them a MTX injection and many patients were on MTX.
Is there really a big market for this injection method? Even if many patients want it, how many insurers would be willing to pay the extra cost for the needles?
COLUMBUS, Ohio and SAN DIEGO, Nov. 13, 2012 (GLOBE NEWSWIRE) -- Battelle, the world's largest independent research and development organization and Zogenix, Inc. (ZGNX), a pharmaceutical company commercializing and developing differentiated products through unique drug delivery systems, today reported preliminary findings from a survey of over 300 rheumatoid arthritis (RA) patients regarding adoption of self-injectable medications. While only 53 percent of RA patients are likely to accept a prescription for a self-injected therapy that number increases to 70 percent if a needle-free option were offered. This represents a significant 30 percent shift in patient acceptance of self-injected medication.
Patient adoption of injectable drug therapies such as disease-modifying anti-rheumatic drugs (DMARDS) and adherence to prescribed dosing regimens are critical to addressing disease progression and quality of life. Although recent advances in therapy for RA are promising, there remains no cure and patients require lifetime therapy.
The purpose of the survey was to understand factors that influence preference, adoption of and adherence to injectable drug therapies, and how the availability of both standard needle and syringe therapies and novel needle-free alternatives impact a patient's willingness to use injectable therapy.
"The ability to increase adoption and adherence to medication in any capacity can significantly help to improve patient outcomes. We encourage drug developers to consider all drug delivery alternatives which could improve adoption, adherence, and persistence with drug therapy," said Virginia Ladd, president of the American Autoimmune Related Diseases Association. The association was not involved in the survey.
Other important survey findings indicate that self-injectable needle-free delivery systems may provide important patient options for therapies:
Nearly half (45 percent) of patients report being needle-phobic (8 percent extremely, 14 percent very, and 23 percent somewhat), indicating "needle-free" delivery could be an alternative
More than 20 percent would not consider using a medication that required self-injection
This is actually the best of the basher arguments against a successful OTREXUP launch. Fortunately for ATRS, the short and bashers will be dead wrong and will lose their shirts when the OTREXUP initial sales numbers start rolling into the financials.
Becton-Dickinson and the other makers of the IM old fashion syringes have had decades to penetrate the methotrexate market and have barely captured 10%. Why is that? Google the following and read all of the steps associated with self-injecting with these cheap needles and then ask yourself how many people with impaired hand function would rather opt for OTREXUP: "Learning to Self Inject Methotrexate at Home."
Here is one of my older posts that provides a more detailed response to this common basher post:
Thanks for your comments. It's always good to hear from individual RA patients. But if you want to learn more about Vibex MTX, I strongly recommend listening to Antares prior conference calls that address your concerns. Here are some key points to consider.
Based on an independent survey of about 200 rheumatologists, Antares learned about a strong demand for a patient-friendly auto injector for RA patients. Despite that this drug has been on the market for decades, including in IM injection form (not SC), the rheumatologists said they would double or triple the amount of prescriptions if something like Vibex MTX came along.
Why would these doctors double or triple their prescriptions of injectable methotrexate, as it completely runs counter to your opinion? I will give you a some ideas and then I need to hit the sack. First, 30-60% of RA patients do not tolerate oral methotrexate, but prescriptions are given for only 6-8% of RA patients. Do the math; there is a big gap here. Your point that institutions will first require RA patients to try the old fashion needle is actually correct, but that's already happening with the 6-8% who currently receive injectable methotrexate. Do you truly believe the old fashion needle providers will benefit from the doubling or tripling of injectable methotrexate prescriptions? They will not see an uptick in their sales because, as you pointed out, they've had a 50-year head start on Antares and could muster only 6-8%. If anything, it is very possible they will lose sales once Vibex MTX hits the market, which is why Antares will capture 15% of the methotrexate market after the rheumatologist double, triple or even quadruple their injection Rx's.
In addition, folks with severe cases of RA cannot easily self-inject with a standard syringe and IM needle. So, the Vibex MTX will provide them with an option that is now unavailable. Also, the Vibex MTX will have a measured dose and the patient will know when he or she receives the proper dose. Proper dosing is an important factor to the prescribing doctors. There are other reasons Vibex MTX will improve patient compliance, including a less painful SC injection. There are also safety issues associated with an RA's family member administering an injection, not the least of which is spillage of the hazardous drug onto their skin and a potential sharps injury.
As to your point about the low costs that you paid for a nurse to inject the methotrexate at your doctor's office, that's only the patient's cost. Don't forget about the total costs that are borne by the third-party payers. Moreover, the time savings and convenience factors associated with in-home, patient-friendly injections cannot be ignored.
Equally important, the third-party payers will jump at the opportunity to extend the period an RA patient receives methotrexate therapy before moving to an expensive biologic. The annual cost for biologics like Embrel can exceed $50K (by the way, the Embrel patent will soon expire and it would be very nice if Antares one day develops an Embrel biologic to which its Vibex MTX patients could step up after they stopped receiving relief from MTX). Indeed, if Antares can convince many of these third-party payers to insert Vibex MTX as a mandatory step in a patient's RA therapy cycle, its revenues from MTX will exceed my estimates.
Finally, to your point about a 50-year-old drug that has been administered orally and via IM injection for decades supporting your opinion that my estimates are too high, look no further than how Apple transformed the way we listen to music. There were much cheaper ways to enjoy listening to music before the iPod and iTunes came along. If you'd rather have a drug-device example, look no further than how Antares's needle-free injection technology has helped Teva significantly increase its human growth sales in a very short time.
Put simply, Antares will bring innovative and cutting-edge technology to significantly improve many aspects of an RA patient's methotrexate therapy. In my strong opinion, Antares is not deceiving its investors about the potential of Vibex MTX. On the contrary, I believe their statements at prior conferences that MTX could generate up to $200M in revenues is overly conservative. If I'm wrong, QST is waiting on deck, which will soon be followed by QS3 and QS4, plus all that other stuff in the pipeline.
Sentiment: Strong Buy
You will always have small percentage of patients use the 2 dollar needle. What about the severe cases of RA and convenience to other patients. I hope the end of the road your driving down doesn't have a cliff
Many diabetics give themselves multiple injections a day.
....you should inform Al Mann... Also, your example above explains how diabetes is well controlled in this country. I expected these types of posts, but once we were closer to $5.
This may be a far fetched example but compare the atrs business model with aapl. We're not inventing the wheel, just making a better one. And for aapl, why would anyone in 2008-2009 want a $200 iPhone when a free phone can make calls,texts and pictures? The same concept applies to otrexup vs standard needle.
Fwiw I am long and my only concerns are the ones you mentioned with insurance and ra doctors wanting more revenues.
First and only SUBCUTANEOUS MTX product for self-administration
• Single use, once weekly disposable device
• Dosages: 10, 15, 20 and 25mg
– 3-easy steps – easy to teach patients
– Hidden needle reduces patient apprehension, supports compliance
– Easy to use even for RA patients with moderate to severe hand
– Fast, complete and comfortable
• Virtually painless administration
– Avoids dosing errors and inadvertent exposure to cytotoxic agent
– Locking needle shield reduces risk of accidental needle sticks
• OTREXUP addresses a large and growing RA market opportunity
Results of the study showed that OTREXUP is safe and effective for RA
patients with moderate to severe hand function impairment
Market research with more than 200 rheumatologists confirms that
OTREXUP will address a significant unmet need.
SUBCUTANEOUS METHOTREXATE IS MORE EFFICACIOUS
AND BETTER TOLERATED THAN ORAL METHOTREXATE: THE EXPERIENCE
OF A LARGE GROUP OF PATIENTS IN THE RHEUMATOLOGY DEPARTMENT
OF A DISTRICT GENERAL HOSPITAL