With $50 MM cash, $58 MM market cap and HUGE PHASE 3 RESULTS SOON AEZS IS BEST BIOTECH BUY ON NASDAQ
AEZS expects to reach the Interim Analysis of Perifosine's Phase 3 clinical trial for Relapsed and Refractory Multiple Myeloma. The trial began in December of 2009, and AEZS decided to move ahead with this trial after it received the rights of Perifosine back from Keryx earlier this year, based on the strength of the Phase I/II trial results. The full trial is expected to be approximately 400 patients in 10 countries, including 40 to 50 sites in the U.S. The primary endpoint of the trial is progression free survival, with secondary endpoints of overall survival, overall response rate and safety. About 265 events, categorized as disease progression or death, will trigger data to be unblinded.
The Interim Analysis of safety, efficacy and futility is scheduled after 80 events. The management expects this threshold to occur in the first quarter of 2013. If positive activity trends are identified, the trial can continue to add patients. If this occurs, the stock should have a positive reaction.
On Tuesday, analysts at Maxim sent clients an initiation report covering AEterna Zentaris with a BUY recommendation and a $9 price target for recently discounted shares. Given the historical data and the current design and execution of the phase III trial in multiple myeloma, the banking firm's research team believes perifosine has a strong probability of meeting its SPA-approved primary endpoint. The analyst wrote:
"We are initiating coverage of AEterna Zentaris with a Buy rating and a 12-month price target of $9.00. We believe that Aeterna Zentaris is misunderstood as a result of the failed trial that partner Keryx (KERX-$2.78.NR) experienced with perifosine in colon cancer (the "X-PECT" trial). Data from phase I/II trials in multiple myeloma (MM) suggest that perifosine is an active molecule in this hematological malignancy. It is not uncommon in the cancer research paradigm to see a compound fail in one trial and then succeed in another when dosing and other parameters are varied, as was the case with Avastin (by Roche-RHHBY, $49.41, NR) and Nexavar (by Onyx-ONXX, $89.70, NR). "
I do tend to agree, we know that solid tumors are much more unpredictable than hematological tumors, thats a fact. Perifosine is reduced in attractiveness, but on the other hand a targeted therapy in Myeloma will be welcomed and especially one devoid of grave adversary effects. IF results are good, it will always be a gamble. That Keryx withdrew after the colon fiasco is another observandum, however they could just be ill informed, we dont know.
My take on KERX is that they simply were underfunded and not prepared for a failure. In their view, after announcing they wanted to be bought out, they decided to put all their eggs in their drug. Had a big Pharma been responsible for these trials, they'd have been much larger, probably more of them in other indications, and we'd probably had an approval by now.
Like most tiny biotechs, both KERX and AEZS look to do trials on a shoestring, while big Pharma has govt and the FDA convinced it costs them over $2 billion for each approved drug, which rolls all failure costs into the approved drugs. Tiny biotechs often put drugs through the process for tens or hundreds of millions, but their CEO's travel like we do, while the giant Pharma's need a fleet of executive jets for their key people.
By the way, I just got a reply from Roth, the offering is fully allocated, but they did send me the prospectus. Funny, I have a feeling that was true before the offering was even announced.