3 for 3 on Orphan Drug Requests

In hockey they call it a “hat trick” and in horse racing they call it the “trifecta”.  At Advaxis, we call it “mission accomplished”.

Late last week, we received notice from the U.S. FDA Office of Orphan Products Development that our lead immunotherapy drug candidate, ADXS-HPV, has been granted orphan drug designation for the treatment of Stage II-IV invasive cervical cancer.

The benefits of orphan status are considerable and for each of our multiple orphan designations we qualify for various financial benefits and incentives, including:

  • clinical protocol assistance with the FDA
  • tax credits for the cost of clinical research
  • waiver of PDUFA (prescription drug user fee act) filing fees (potentially millions)
  • annual grant funding to defray the cost of clinical testing
  • seven year period of exclusive marketing after an orphan drug is approved

This is our third orphan designation granted in about 6 months, adding to the previously granted indications for HPV-associated head & neck and anal cancers.

It’s important to keep in mind that the FDA grants orphan designation to drugs/products to promote the development of products intended to treat rare diseases affecting fewer than 200,000 individuals in the United States. Based on the relatively few women that develop invasive cervical cancer in the U.S., we believed that ADXS-HPV would qualify for orphan status in this indication.  However, the FDA initially denied our request for orphan drug status in cervical cancer on the basis that the total number of women who have ever had cervical cancer exceeded the statutory maximum of 200,000.

Our regulatory team went back to the drawing board and provided an additional analysis that supported ADXS-HPV for the treatment of a medically relevant subset of patients – patients with Stage II-IV invasive cervical cancer – a subset that did qualify for orphan status. The new request resulted in a hard-earned and very valuable orphan status for Stage II-IV invasive cervical cancer. Our determination to continue to work with the FDA through this process has allowed us access to the benefits of orphan status that may be helpful in making our drug candidate available to women with cervical cancer.

We intend to pursue the financial and regulatory advantages available under orphan designation to make a difference in HPV-associated cancers worldwide and to bring value to our supportive stockholders.

We will continue to identify other orphan drug indications for our proprietary immunotherapies. Why stop at three when there is the potential for more?

Warm Regards,
Dan O’Connor

 

  • frankel.alan@gmail.com

    May 5, 2014 - 8:25 am

    Dan:

    When are we going to see a revised proxy that is more in line with shareholders interests?

    Our market cap is about $40M. It should be much higher but investors are afraid that you are
    more interested in you and the BOD than us.

    We need to see a proxy very soon or our stock will continue to languish

    Can we do a conference call to air our concerns?

    Please let us hear from you

  • momfitz

    May 5, 2014 - 1:46 pm

    From a patient point of view, we are grateful for all that Advaxis is doing. Will we soon see an orphan drug designation for a treatment for the 5% of men with testicular cancer who cannot be cured right now? There is a set protocol of treatment that works for many, but for those whose cancer does not respond, there is no hope of cure, and life expectancy drops to mere months.

  • dwal1977

    May 6, 2014 - 9:08 am

    ADXS BOD & CEO,

    Congratulations on another step forward. It is a shame that another good news item is wasted because of poor Corporate governance. You have diluted shareholders 5 times in the last year, you have attempted to award yourselves excessive amounts of RSU’s and compensation packages, you have placed offerings substantially below market value through questionable sources and you continue to spend excessive amounts on pay packages without delivering any significant share appreciation.

    As a long term shareholder, I ask you, who do you think you are that you can line your pockets with excessive awards, grants and compensation packages at the full expense of shareholders prior to delivering anything?

    You have 3 people drawing salaries equal to CEO pay (not to mention the extra awards and bonuses). This is beyond ridiculous for a company in our position.

    This greed by management and BOD is out of line and will result in litigation. Deliver a shareholder friendly proxy soon or continue to watch as each good news item is met by market apathy. The market and ADXS shareholders do not trust you.

    Get aligned with shareholders or leave, your behavior toward shareholders is disgusting.

    The compensation committee needs to resign. Appel and Moore need to resign. Dan O’Connor is next in line to resign. You all have failed the shareholders and have tried to line your own pockets at our expense and we are tired of it.

  • Sanjalino

    May 6, 2014 - 12:23 pm

    Dan,

    I wanted to follow up and re-iterate the sentiment expressed in the previous comment. When you came on board you initially gave us shareholders renewed hope, impressed us with your engagement and leadership style and laid out what was a well thought plan for moving the company forward with defined plans and milestones. Unfortunately some of that enthusiasm was blunted by the multiple proxy revisions that we went thru in regards to the compensation and equity plans. We got past that and we even got past the significant reverse split that many of the long time shareholders were not particularly in favor of. Since then the company has hit many key milestones including 3 Orphan drug designations, some very good trial results and a couple of partnerships. At this point, we should all be reveling in the accomplishments, enjoying some significant recognition by the markets and a significant stock price increase. And yet we once again here we sit with a depressed stock price that is out of synch with the potential of the science and the progress that the company has made. What makes it all the more troubling is that once again it is related to compensation, equity grants and what on the surface seems to be an issue of a lack of corporate governance. We all invested in this stock to progress the science but to be very frank in the end we all want to profit from our investments. Most of us would also agree that management should be appropriately incentivized and rewarded for moving the company forward. Where we have disagreement on is the imbalance and misalignment between management compensation and shareholder value. I implore you to provide us with a balanced and reasonable proposal that gets us past this impasse, allows the company to focus on the task at hand and in the end rewards us all in a fair and equitable manner.

    Thanks

  • JP1951

    May 6, 2014 - 8:19 pm

    Dan,
    Why not apply for “Breakthrough Status” on any Advaxis Vaccine?

Dan joined Advaxis in January 2013 as Senior Vice President, Chief Legal and Business Development Officer, was promoted to Executive Vice President in May 2013, and was appointed President and Chief Executive Officer of Advaxis in August 2013.

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