Pre-NDA / FDA submission studies:
• Human use and human factors usability studies produced
• Studies showed Otrexup was safe and effective for RA patients w/ moderate to severe hand function impairment AND self administration of MTX using Antares Medi-Jet device is ALSO safe and well tolerated with virtually no pain.
• Completed successfully the final and most important clinical study necessary to support the NDA – study compared the relative systemic abailability of MTX following old method of administration to Sub Q self administration of Otrexup and the systemic availability of MTX increased proportionately at every dose, 5, 10, 20 and 25 milligrams.
• Several in place, new patent applications for Otrexup along with filing a trademark application with the USPTO for the brand name Otrexup.
• A Pre-(Otrexup) NDA meeting with the FDA resulted in awareness (oh, by the way!) of an additional treatment option – psoriasis.
• All clinical trials completed with positive results.
• Antares conducted a 4Q12 meeting with the FDA and reconfirmed regulatory pathway.
• Antares is proactive with the Agency.
• Head of the Otrexup program is Leroux Jooste, who previously in 1999, personally brought the DMARD Enbrel to market.
FDA / NDA filing:
• Completed. No refusal to file (RTF) from the FDA. No missing information experienced with the filing.
• Filing was accepted resulting in PDUFA October 14, 2013, no omissions of data or other deficiencies.
• Antares continues proactive FDA communications and Mid-cycle review with the FDA went “very well.”
• 6 ½ months have past, 3 ½ months left till approval and “no news (from the Agency) is good news.”
What is Methotrexate (MTX)?
• An already approved and marketed drug.
• Considered the “gold standard” or “foundation of RA treatment.”
• MTX is the most commonly prescribed (DMARD) in use today.
Sentiment: Strong Buy
Newbie if something is going to screw the approval up then my guess is the FDA would ask for a larger study. ATRS did the minimal in all of the studies which is not always a good thing. Does the FDA have enough data to show that a 100 lb person & a 300 lb person have the same absorption via the SQ route. I don't think this will occur but I just want this on the record.
Some may have questions about the FDA inspection and approval of the production facility. Some have already expressed their concerns about this. Again, still others seem to enjoy FUD. (This stock seems to have more than its share of swing traders, and a number of them regulars on this board, at times with multiple IDs chosen for use as the occasion warrants.)
Whatever the case, it is suggested to put Uman and methotrexate into Google. This should produce an ATRS news release from 2010, I believe, outlining the agreement between Uman and ATRS for the supply of methotrexate and its loading into injectors. It should be clear, therefore, where Otrexup comes from.
Then, google Uman and with a little effort a news release can be located dated at the beginning of this month, informing of the FDA approval of Uman as a supplier of their products for the US market.
Therefore, one can put to rest any doubts about the FDA approval of the supplier of Otrexup and its manufacturing and move on to other topics.
What are clinical trials and how do they relate to drug approval?
• Whether the drug has the effect it is suppose to have. (Confirmed by usability studies)
• How much of the drug to give to a patient and how often. (Confirmed 5, 10, 20 and 25 mg)
• What side effects are associated with the drug. (Safe and effective)
• How a drug is broken down in the body and how long it stays in the body. (Confirmed, safety and efficacy studies)
• Which foods, drinks, or other drugs can be used at the same time or should be avoided (contraindicated). (Confirmed, no treatment-emergent serious adverse events related to MTX)
• Clinical trials results allow the FDA to make decisions about whether or not a drug should be approved for marketing.
The first five bullet points have been satisfied by the clinical trials conducted by Antares and through the historical documentary on the already approved medicament, methotrexate. The sub Q delivery of the already approved drug, mtx, via Antares Medi-Jet device along with the positive, complete and thorough studies point to FDA approval for Otrexup and its marketing.
Sentiment: Strong Buy
Excellent information.....and more importantly, FACTS. Please take notes whatwhat and others...present facts and you may earn an ear to listen to your negativity! good luck longs!
Sentiment: Strong Buy
Thank you jab91252 and rearviewforecaster this info is very succinct and extremely positive.You guys aren't part of the in-house sales force are you?If you are I am sold although I don't suffer from arthritis yet.THANKS AGAIN.
It is worth noting that the FDA did not convene an advisory panel, and this normally indicates an absence of controversial, challenging issues.
It is, of course, customary to use the uncertainty of approval for FUD, but in this case it seems a waste of time. If the seeds of uncertainty need to be planted, the size of the market and ATRS' ability to sell to it seem much more tenable. Investors are not wild about small outfits doing in house marketing, and the record of such efforts justifies the doubts. IMO, this is what put the kibash on ATRS' stock last year, together with the effort to raise the cash needed for it.