America Health & Drug Benefits
"Otrexup (Methotrexate) Injection: Novel Methotrexate Delivery System for Patients with Rheumatoid Arthritis"
Lisa A. Raedler, PhD, RPh
March/2015 - Phase II data in Myelodysplastic Syndrome. One-One randomized trial comparing Pracinostat + Azacitidine vs Placebo + Azacitidine. 102 individuals with primary endpoint as complete response.
2009 International trial revealed a 17% complete response & 12% partial response for treatment with Azacitidine alone.
MEI pharma's pilot Phase II study showed 9/10 individuals with a CR/CRp when Azacitidine was combined with Pracinostat.
So what do we want to see in March?
Dr. Guillermo Garcia-Manero, investigator from the University of Texas MD Anderson Cancer Center stated that a 20 - 30% improvement would be a significant advance in the treatment.
Placebo + Azacitidine - 7 - 8 complete responses. (Based on past history)
Pracinostat + Azacitidine - 9 - 10 complete responses - positive trend, 12 complete responses would be good news. 15 would be great news, & 20 the stock will be a rocket ship.
Salty, the best thing they could do for everyone is find a buyer. They should beg TEVA to buy them for $500 million.
Lets think about it:
1. The current programs bring in $5 million a qtr
2. Sumatriptan - lets say $10 million a year
3. Otrexup - its not worth anything unless they get Medac out of the market
4. Epi-pen - $30 million a year
5. QST - There is nothing to stop someone from marketing a basic pre-filled needle & syringe at some point. It might take 4 yrs but I'd expect someone to do this if ATRS gains approval. QST will struggle if they try to go it alone. ATRS has previously stated they need a partner so any revenue estimates may need to be cut in half to account for a partner.
6. I'd assign zero value to the rest of the programs.
I think you could get the most value for ATRS if you sold it in the next 6 months so I don't want to see a secondary. I just don't see how ATRS is going to generate much excitement when you look at the pipeline. Yes, the stock can pop but it will fade back as investors face reality.
MEIP has some publications on their website which explain the rational for combining Pracinostat with a hypomethylating agent. Epigenetic changes fall broadly into 2 major categories: changes in DNA methylation and changes in histone modifications. Dysregulation by histone deacetylation or DNA methylation can potentially be reversed by chromatin-remodeling agents such as HDAC and DNA methyltransferase (DNMT) inhibitors, restoring tumor cells to a more transcriptionally normal state. We are going after both pathways with the combination & why monotherapy is not optimal. Its beyond my expertise but from what I can gather the drug has better PK/PD properties then other oral HDAC inhibitors.
I can't understand your thinking on the epipen. If they get an AB rating then wouldn't pharmacies refill with the cheapest product unless the name brand was specifically requested? As far as the "short shelf life" I'm confused on this also. I imagine Mylan/TEVA will go after any companies trying to enter the market.
The BB's own 1.6 million shares & the rest is warrants. I imagine the company will sell 20 - 22 million shares with 1.6 million of those owned by the BB. IDRA will receive the money from the shares not owned by the BB.
20 million @ .47 & 20 million at .01. The company will have over 140 million shares when everything is included. This is a bloated pig.
The stock will be dead money if investors can't point to big news.
I imagine Fresenius's plan is to only supply half the total market requirements with a slight discount. If they do this then no price war will occur & they can maintain the current prices.