Ampio Pharmaceuticals (AMPE): TheStreet.com's biotech blogger graced readers with an early edition of the Biotech Stock Mailbag this week, releasing it on Thursday vice its normal Friday publishing. In this week's edition he criticized Ampio Pharmaceuticals for taking its treatment for premature ejaculation (PE), Zertane, overseas. Ampio has been seeking regional partners to commercialize Zertane, with one agreement being announced last year to bring the product to market in South Korea, and another commercialization plan announced for Brazil last month.
Ampio then announced in report from earlier this week that the company would next seek an approval for the product in Australia.
In response to Ampio's strategy of bringing Zertane to regional markets overseas, the biotech blogger noted that small companies looking to seed approvals overseas do so for "stock promotion back home."
While Ampio does plan to initiate FDA-required trials for Ampion and Optina in the near future in seeking US approva, according to reports issued by the company earlier this year, it is true that the company is seeking approvals in other regions of the world for Zertane. However, as it has been stated in numerous company press releases, the reason is because the FDA does not recognize premature ejaculation as a medical condition, which is one significant fact omitted from this morning's biotech blog. It changes the story a bit and leads into a pattern of what some readers would call misleading.
Although wives and girlfriends all around America would undoubtedly disagree with the FDA on its assertion that PE is not a medical condition, the agency has never approved a drug to treat the condition, does not recognize it as a medical need and therefore there is no path for approval for Zertane in the United States - hence the company seeking overseas approvals while targeting the US market for its other pipeline products.
If an overseas approval boosts a company's share price back home, I don't see how that's a bad thing anyway, considering it's a chance for investors to bank some cash, but as for why Ampio is taking Zertane across the pond? You've got to go where the market it is, and, as numerous of the company's press releases have noted, there's not one in the US, at least not until there's a million-woman march demanding that the FDA sort out the problem of premature ejaculation in males.
Implant Sciences (IMSC): On Wednesday we noted the increasing interest in shares of Implant Sciences, a company that has commercialized explosives and narcotics detectors that are fit for the growing security needs of airports and transportation agencies world-wide. It was also noted that the company has made some recent personnel moves that could be indications that a swift increase in production and/or distribution is in the works, which could bode well for the IMSC share price that has been quietly on the move of late.
On Thursday morning another bit of news supports that theory, as Implant announced the hiring of a Quality Manager to "prepare company for increased production," according to a morning press release.
Implant President and CEO Glenn Bolduc also noted in the press release:
"With the hiring of Charles Fertitta as Quality Manager, Andy Anderson as Director of Engineering, and Bill McGann as COO, Implant Sciences has added significant security industry experience to our management team. These three individuals greatly expand our ability to meet the needs of our growing customer base. We are pleased that talented engineers who have worked at security companies many times our size are joining Implant Sciences to help support our anticipated growth."
It's possible that the company is taking "just in case" measures in the event they manage to land a significant deal or two, but the recent hirings could also be hints that there is something definitive in the works.
If nothing else, these are developments to watch, as one major contract could position Implant for the prime time.
Spectrum Pharmaceuticals (SPPI): Shares of Spectrum were dropping fast on Thursday morning after the company announced the failure of Phase III trials for apaziquone, a treatment for bladder cancer. Pre-market trading saw shares trading sixteen percent lower, a trend that followed at the opening bell.
Spectrum also announced that it will buy Allos Therapeutics (ALTH) for just over two hundred million dollars. That news spiked shares of ALTH by roughly thirty percent at the open, driving them to the $1.82 agreed-upon purchase price.
In the deal Spectrum acquires Folotyn, a treatment for refractory peripheral T-cell lymphoma, and helps the company diversify its portfolio.
SPPI has been a solid gainer over the past year, and although the Phase III news was a setback, the purchase of Folotyn, for which additional approvals could pan out, could eventually offset the failure of apaziquone.
Advanced Cell Technology (ACTC) opens another site for stem cell trial in severe blindness...Amarin (AMRN) pulls back towards ten dollars...Keryx Biopharmaceuticals (KERX) still dropping to $1.50...NovaBay Pharmaceuticals (NBY) launches CEO blog, but it's pending product launch and trial catalysts that keep this one on the radar...Galena (GALE) - swift retreat after recent price run...Nuvo Research (NRIFF) - as mentioned earlier this week, shares are moving in preparation for FDA decision this month...Happy Trading...
Disclosure: Long ACTC, AMPE, NBY, NRIFF, IMSC.
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