Spectrum Pharmaceutical’s CEO Rajesh Shrotriya, M.D presented an overview of the company today in Las Vegas at the Noble Financial Conference. I wanted to view the presentation in order to see if I could get additional information that may have been overlooked during my previous reviews of this company. For those of you who haven’t read my initial review of Spectrum, I recommend doing so before continuing here.

The presentation was a no-nonsense review of the company’s pipeline along with an overview of their management team which often gets a bad rap by shareholders. This is often the case when a company’s stock is in the gutter, but if things turn around, management is then viewed as competent, visionary, or whatever other positive adjectives you want to label management.

A couple points to mention about today’s conference was that management reaffirmed the filing timeline for their Fusilev sNDA in CRC by October of this year. Also mentioned was that Fusilev represents a market potential of approximately $100 million if they are granted FDA approval for the CRC indication. If the company achieves sales even close to this range, they will be wildly successful as revenue will go straight to their bottom line. They haven’t mentioned any plans on co-marketing this drug so I have to assume that all revenue stays in their pocket.

The other bit of information worth mentioning was related to EOquin, the company’s other late-stage drug for treating bladder cancer. Management stated that there were more than 250,000 TUR surgical procedures performed each year. Some of these are attributed to newly diagnosed cases of SBC and others due to the high relapse incidence with SBC patients. This type of bladder cancer is considered very expense to treat because it so frequently relapses and to date there haven’t been any newly approved therapies for 30 years.

The primary end-point of the two trials Spectrum is conducting is the rate of tumor recurrence by year two, so it will be some time yet until we see important data. What I like about the trials they are conducting is that they have a well-defined registrational path meaning they’ve received what’s called a “Special Protocol Assessment” or SPA from the FDA. Reaching an agreement with the FDA on an SPA basically provides that, upon request, the FDA will evaluate within 45 days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor. This by no means assures final FDA approval of a drug, but it does provide for what could be considered a strictly adhered to clinical trial protocol which may result in fewer mistakes along the way.

In the meantime we will await news on what kind of partnering deal Spectrum negotiates with another pharma company. Hopefully, as management has stated, we will hear something by year end. I will continue to update readers as new events unfold.

Disclosure:

I hold shares of Spectrum Pharmaceuticals.