The recently published New England Journal of Medicine article showing kids exposed to peanuts at an early age had a significantly reduced risk of developing peanut allergies might have turned off investors.
"Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy"
CARA is hitting the market at the perfect time. The key thinking in anesthesia & other areas of pain management is a " Multimodal" approach where the use of different drugs or techniques are used to improve patient satisfaction. IV acetaminophen (Ofirmev) & longer acting local anesthetics (Exparel) are continuing to see growth due to dissatisfaction with current opioids. . Cost is no longer the number one priority when selecting a pain drug which will benefit CARA.
The science is pretty straightforward but its going to take awhile to prove the efficacy & safety.
I'm a nurse anesthetist & biotech trader by profession. Pain management & pharmacology is a big part of my daily work. I've been telling investors to jump on CARA. If the oral formulation continues to show comparable efficacy without the side effects of current opioids then it doesn't get bigger. I think previous failures by other companies trying to develop Kappa agonists has investors using a wait & see mentality toward the stock.
The IV formulation should do well in the market but its not in the same ball park as an oral med. CARA needs to get moving on the Phase II trial for oral CR845.
I'm guessing late 3rd qtr but wouldn't be surprised for someone to buyout Paypal before that time so it makes sense to not try & time the breakup. Ebay will do fine as a stand alone but shares may take a hit initially.
No idea how the distribution might look when they've got 1.2 billion shares.
I'm sort of waiting to see how the lack of storage space plays out in the oil market over the next few weeks. If we see prices revisit the recent lows then I'd expect to see a opportunity to enter some of the oil plays.
My biggest non-biotech play is E-bay. I'm following Icahn with this. Shareholders will get shares in Paypal & Ebay with the split & I'm expecting to see a big move in the Paypal shares. I'm not a big believer in the AAPL watch.
As far as biotech. You have a different strategy. My main investments are in some of the more recent IPO's . AAVL, AERI, ESPR, ONCE. ZFGN. I've also mentioned CARA. I then look for opportunities to make a quick 20 - 40% gain in some swing trades while I wait on the binary events from my main investments. Just sold LPCN & MEIP was my previous play.
I've cut down on the number of trades I'm making right now. I look for certain set-ups & lose interest if they don't fit.
The testosterone replacement market fell 14% in 2014 so some of the FDA concerns have had an effect whether you want to ignore it or not.
Nammuang, Do you have a reading comprehension problem? "impact on products in development unclear" this statement pertains to ATRS.
- Will QSM enter clinical trials this year?
- ATRS previously stated that Otrexup would achieve break even status with approximately $24 million in annual sales. What is your estimates for QST sales in 2015? Will the program be profitable in 2015 based on your sales estimates?
"Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear."
The headline & sentence above is from The Pink Sheet Daily. You have to hope the FDA doesn't make QST a test case for their new position on testosterone replacements.
Medac's concentration is 50 mg/ml for all doses. The largest volume is .6 ml's (30/50) & the smallest volume is .15ml (7.5/50). Manufacturing this looks pretty simple. They make one run & adjust the volume to achieve the desired dose.
Antares formulation is mg/.4. In order to achieve this they have to adjust the mg/ml which requires additional manufacturing. It looks like they would have to have a separate manufacturing run for each dose.
Medac's largest SQ volume of .6 ml is still pretty small. The largest recommended dose for a SQ injection is around 2ml.
If SQ administration was obvious then why wasn't this granted with the original applications? The only thing that makes sense to me is that its not obvious or it would have been included in the approval.
Doc's were injecting large volumes SQ which was painful. Medac developed a more concentrated formulation, got it patented, & approved for SQ administration.
I've heard that its a slam dunk for ATRS from day one but Medac has proven they have some pretty good defenders.
This is what you said;
1. "By listing concentration as a claim Medac is trying to say that they thought of high concentration methotrexate first. But I don’t see any information on them inventing any high concentration process. Lowering or increasing the concentration to create a similar dose relate response has many legal presidencies set for obviousness."
Have you looked at the 231 patent? Medac filed this in 2007 & the PCT was also filed at the same time.
The invention claimed is:
1. A method for the treatment of inflammatory autoimmune diseases in a patient in need thereof, comprising subcutaneously administering to said patient a medicament comprising methotrexate in a pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml.
Why its not prior art:
"Ready-made syringes for parenteral administration containing methotrexate solutions wherein the active substance is present at a concentration of up to 25 mg/ml in a pharmaceutically acceptable solvent (trade names: Lantarel.RTM. of the company Wyeth, Metex.RTM. of the applicant) are known from the prior art for the treatment of rheumatoid arthritis, wherein the injection solution Lantarel.RTM. with the concentration 25 mg/ml (trade name: Lantarel.RTM. FS 25 mg) is not approved for subcutaneous application."
"it has been found that a subcutaneous administration in particular has its difficulties. When treated with the preparations known from the prior art, patients showed a disapproving attitude. This was due to the problem of having to inject the required relatively large amount of active substance solution (e.g. up to 3 ml in the case of a certain dosage) under the skin every week, which was especially difficult to convey to children, including the weekly doctor's visit. "
Medac filed claims years before ATRS. It doesn't matter that ATRS was granted a patent in the US before Medac's patent was granted.
Investors think Medac's patent is invalid due to prior art. I don't think its that simple.
Aintno, I don't agree with your position on Medac's patent & I've stated so for the last few years.
ATRS investors get caught up on the concentration but the 231 patent also covers the use.
"medac is the lawful owner of all right, title and interest in U.S. Patent 8,664,231 (“the ‘231 patent”), entitled “Concentrated Methotrexate Solutions.” medac Pharma is an exclusive licensee of the ‘231 patent and has the right to use, supply, distribute, sell, offer for sale, and import into the United States products for the use in methods claimed in the ‘231 patent. "
The use of SQ methotrexate in a concentrated formulation was not prior art. Medac conducted trials with the SQ formulation & ATRS even used it as a basis for their filings.
I give ATRS a 50% chance at best.