GNBT: Shares of Generex Biotechnology Corporation traded higher by over ten percent on Monday when the company announced that an agreement had been reached with a major US pharmacy chain to market Crave-NX, Generex's 7-day diet aid spray.
The name of the "major US pharmacy chain" was withheld from the press release, but my speculation would leave me to believe that CVS is the one - the 7,000 locations noted in the PR line up with the numbers of CVS stores.
Crave-NX, which suppresses appetite, could generate significant revenue for Generex as the pipeline advances, which includes Oral-Lyn, a Phase III insulin spray for diabetics that has already been approved by the FDA for emergency use.
Full approval could come as early as late 2010, based on when the Phase III trial concludes and results are released.
The Crave-NX news is a welcomed event for investors and I continue to believe that the GNBT stock will march towards the one dollar mark during the first quarter of this year.
Positive Oral-Lyn data would push the price even higher, in my opinion.
Disclosure: VFC is long GNBT.
VNDA: Vanda Pharmaceuticals announced on Monday that Fanapt (Iloperidone), the company's schizophrenia drug that will be marketed and distributed by Novartis, has launched in the United States.
The VNDA share price remained stagnant on the news, but with pharmaceutical powerhouse Novartis distributing Fanapt, the potential is there for large first year sales numbers in a schizophrenia market that has the lowest selling drug still raking in a billion dollars of sales a year.
The Fanapt launch is also welcome news to Titan Pharmaceuticals (TTNP.pk) and its shareholders. Titan will receive, through a long-existing licensing agreement, between eight and ten percent of Fanapt sales.
Disclosure: Long TTNP, no position VNDA.
EPCT: Shares of Epicept rallied to ninety cents on Monday after the company finally announced a partner for the marketing and distribution of Ceplene in Europe.
According to Monday's press release, Meda AB will market Ceplene in Europe, Japan, China and Australia. Epicept will receive an immediate cash infusion of $3 million, according to the agreement, and an additional $2 million upon the launch of Ceplene in the first major European market, expected to be later this year.
Epicept will also receive a double digit royalty of net sales and can receive additional milestone payments if/when certain thresholds are met. The "double digit" comment leaves a lot of room for interpretation, but usually when a company lists royalties as in the "double digits", it means mid to low teens, in my opinion.
It took a very long time for Epicept to get this deal finalized, but now that it is a done deal, investors - who were decently rewarded on Monday - can now look towards revenue growth on Ceplene sales and the filing for approval with the US FDA that should take place later this year.
As readers of VFC's Stock House know, I bailed on the stock late last year to put the money elsewhere, but congrats to those that held onto the stock - although I ahve to admit that I'm disappointed that the share price did not reach higher than ninety cents.
While I do believe that EPCT will trade for over a dollar in short time, I think that the relatively modest gains on Monday are due to a somewhat negative perception of the agreement by investors.
Had I still held shares of EPCT, I would have sold into the spike and moved on - I think there are a lot better speculative plays still out there with the potential to realize higher percentage gains than EPCT over the short to mid term.
Disclosure: No position.
LLBO.pk: Shares of Lifeline Biotechnologies traded higher by twenty percent on no news Monday as investors are most likely anticipating news from the FDA regarding the classification of the company's 'First Warning System', a radiation-free system designed to detect breast cancer in the early stages.
It has been prviously speculated that the FDA would render the classification decision in the first half of January.
Lifeline has the potential to garner a few headlines in the near future, based on the fact that breast cancer and the dangers of radiation have already made recent headlines.
Disclosure: VFC is long LLBO.pk.
BIEL.pk: BioElectronics is also awaiting classification news from the FDA, and the stock traded down to nearly four cents on Monday when no news was released.
While I recognize the risks of a further short term drop in price if investors get nervous while anticipating news (or lack of it) from the FDA and decide to bail out, I couldn't resist adding to my position for just over four cents.
I think that eventually BIEL's products, as safe and effective alternatives to Tylenol and Ibuprofen (and their associated health risks), will win over the FDA at a time when international sales should already be increasing.
It won't be too long, in my opinion, before BIEL will be looked back upon as a steal for four cents.
The products are just too good.
Disclosure: VFC is long BIEL.