This week Zalicus (ZLCS) announced the Phase 1 clinical launch of Z160. It was applauded by its investors and well-deserved by those who have weathered a brutal lashing by the market that tested lows below $1/share.
Zalicus management met its second 2011 promise in announcing the Phase 1 clinical launch of Z160 (its first promise was the entry of Synavive into its Phase 2B clinical study in June that appears to be on schedule for completion by next summer). Both achievements are very commendable. The leg-work leading up to the launch of Z160's Phase 1 clinical trial was nothing short of astronomical, including I have learned, the expert work of European scientists contracted to modify the chemical chain. It appears from reading the announcement that Zalicus will be evaluating more than one formulation.
In the absence of fanfare, the company accurately portrayed themselves as "a leader" (Ibid) in ion channel research. The subtlety of "a" versus "the," though less flattering, was more accurate given that their competition (e.g. Icagen-Pfizer (NYSE:PFE), Convergence spun off by Glaxo-Smith-Kline (NYSE:GSK), and little Hydra BioSciences) is slightly ahead of them in clinical trials. But that said, Zalicus is once again on the move and should gain ground on its competitors.
The modest pop in the price per share seems to be the clarion call of a biotech company that refuses to give up. Z160, once NMED-160, has had a long and arduous history, but a history I have the utmost respect for.
Company CSO Dr. Terrance Snutch, and the scientific core of an equally impressive list of ion channel leaders in research and academia (e.g. GW Zaponi, H Pajouhesh, ME Hildebrand, SM Cain et al.), was renowned in Canada for the introduction of NMED-160, when Merck partnered with then Neuromed for a lion's share in the development of the N-type ion channel drug candidate invented and targeted to block pain. But alas, NMED-160 ran into solubility and bioavailability problems, and Merck made a wider research decision to walk away from ion channel research.
Neuromed was stung, and Dr. Snutch, a brilliant thinker and bullish inventor, refused to go away defeated. With the help of European scientists and the cash infusion from Exalgo's $40M milestone, here in 2011, NMED-160 has been modified into what is now known as Z160. Ultimately, it could win Dr. Snutch the Nobel prize for what it could mean to pain sufferers addicted to opioids.
Therefore, in all fairness to Zalicus, this announcement deserves far more fanfare than it is being given. NMED-160 went in Phase 2 and was tested in 200 plus patients before being withdrawn, so when the company states they expect to quickly move through Phase I, investors should believe them. Zalicus is fine-tuning Z160 in this Phase 1 study; when it moves to Phase 2, I already expect positive results. Of course, only science and data can prove that, but I am among those believers who see Z160 making it to Phase 3.
But as another poster has often reminded me, the odds of success for any biotech candidate is slim; I concur, yet I also know that Z160 has a head-start. With good safety data in hand from Phase 1, I venture the scientists in Zalicus-Vancouver, British Columbia, already have a good handle on its pain-mitigating efficacy. (For investors with a scientific thirst to do due diligence on Z160, I suggest starting here.)
In conclusion, I also look forward to what the company may advance forward in its sodium and T-type channel research. Zalicus has mentioned other Z- ion channel types, but has kept that information closely guarded. By the way, on 29 November 2011, Zalicus was awarded a U.S. patent #8067433entitled "Methods, compostions, and kits for the treatment of ophthalmic disorders," and its chemistry points to Prednisporin that remains under development with Sanofi-Aventis (NYSE:SNY). The company's management style, though stoic, is pressing forward, and 2012 should be even more rewarding.
Finally, that I do not currently own any shares of Zalicus should not be interpreted as either a negative or a positive commentary, since I once had a vested interest in the firm for well over one year. Having twice tested near its pps bottom, its Tuesday close at $1.20/share signals that the market may be prepared to return the company to a much higher share valuation.
Should CEO Corrigan deliver on his third promise in 2011 for a new cHTS collaborator, the pps should equal the likes of AEterna Zentares (NASDAQ:AEZS) that closed at $1.74 on Tuesday and should re-approach $2/share very soon. For those who follow Zalicus, any price below $1.25/share is a great entry point, and I don't think it's going to stay there very long.
Disclosure: No position in any stocks mentioned, but I am free to buy or sell 72 hours after publication.
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Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.