Tiny Accentia Biopharmaceuticals May Be On Its Way To Big Things

Accentia Biopharmaceuticals (ABPI) is an emerging biotech company that boasts a tiny $65 million dollar market capitalization. The company already does about $20 million in revenue and has two Phase 3 FDA fast tracked drugs that could give the company upon approval literally billions in revenue.

The first candidate is Sinunase for the treatment of Chronic Rhinosinusitis. This therapy was licensed from the Mayo clinic two years ago. Researchers there discovered that a certian group of CRS paitents are allergic to airbourne fungus, mold. So they are using a unique formulation of an already approved drug, Amphotericin-b, to treat the problem. Get rid of the fungus get rid of the disease. It is estimated that 37 million americans suffer fom CRS, Some say it is a larger market then Asthma, yet their are zero FDA approved treatments to treat CRS. If Accentia captures only 1% percent of the market that could equate to close to a billion dollars in revenue. Phase three should be completed by the end of 07.

Their next drug in the phase three line up is Biovaxid. A Non-Hodgkins lymphoma personalized cancer vaccine that has shown remarkable data in it 10 years in development at the National Cancer Institue. Research has shown that not only are their few side effects, all but those who did relapse after vaccination had their second remission become longer then the first. A total change in what happen to patients with the current therapy.

Accentia owns about 70% of Biovest International (BVTI.OB). Biovest has a market cap of about $56 million which gives Accentia roughly $40 million in value. Accentia, through contracts will receive a 19% royalty on all revenue from the Biovest product line. Biovest also will begin marketing Autovaxid, which is a self contain automated cell growth instrument. This is a small product that could replace current cell growth instruments that are ten times the size. I feel this could be big as we are on the dawn of personalized medicine.

Lastly, they just filed to meet with the FDA to start Phase three for their drug Reimmune to treat auto immune diseases. They are aiming at Multiple Sclerosis as their first Phase Three clinical trial. Dr Howard Weiner, who is the Robert L. Kroc Professor of Neurology at Harvard Medical School. He is founder and director of the Partners Multiple Sclerosis Center at the Brigham and Women\'s and Massachusetts General Hospitals in Boston and co director of the Center for Neurological Diseases at the Brigham and Women\'s Hospital, and author of \"Curing MS\" recently went on a nationwide tour discussing how this new treatment works.

Revimmune uses an ultra-high intensity, short-course of an intravenous formulation of an approved drug (cyclophosphamide), in a new patent-pending method to "reboot" a patient's immune system, thereby eliminating the autoimmunity, whereas current therapies including oral cyclophosphamide are used chronically to try to suppress the inflammation of autoimmunity. Based on long-term follow-up showing complete remissions, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases such as aplastic anemia and myasthenia gravis.

Accentia's lead indication for Revimmune is multiple sclerosis [MS]. This could truly put Accentia on the map. With so many late stage drugs in development and only a $65 Million market cap, I feel biotech investors should take a good look at the opportunity at Accentia.

ABPI 1-yr chart:

Comments

[Alan Brochs...:]

I beg to differ, but this one looks like it will be gone soon. I believe that one can already get "Sinunase" from a compounding pharmacy (ampotericin B + H20). I tried it and found it very unpleasant. I wonder if it will even get FDA approval. Call me a skeptic, but this company is short on cash and long on disappointment.

2007 Aug 13 05:59 PM

[Jim Glazen:]

Accentia just hit a new all-time low today. Sounds like Fred is trying to get someone to bail him out of his long position. I think bankruptcy is probably coming soon. Low on cash, no partnerships, high cash burn and lots of promotional press releases.

I have a very bad feeling about this one.

2007 Aug 13 07:09 PM

[bongoboy:]

I see that Accentia Bioparmaceuticals is also owned by PPDI tot he tune of 4,300,000 shares or over 10%. I also notice that Alan Brochstein above states that one can get "sinunase" already. That's true to an extent. Because The drug in Sinunase is already approved doctors are allowed to wrtie off label prescriptions. The fact that it is being prescribed so much by doctors give me a feeling that it just might be doing something good for paitents. The FDA from what I know is not comfortable with all that off label prescriptions w/o their approval. With a little bit of good results perhaps they will get the ok. Also Alan Brochstein just wrote an article about PPDI recently that wall street does not get PPDI and to buy it. You can find it here biotech.seekingalpha.c... . Yet PPDI presents all over the world and list only 4 partner drug compounds they believe could add significant value to shareholders. One of those drugs is SINUNASE. Thomas Weisel belives an approval of Sinunase could add a billion in mkt cap to PPDI. Well they only get 7% royalty on future revenue. Not including the other opportunities i think it is ignorant to say so bluntly that they will be gone so soon. Here is the latest link to PPDI conference. www.ppdi.com/corporate... page 34

2007 Aug 13 07:35 PM

[Alan Brochs...:]

Yes, I first came to know ABPI through PPDI. Trust me, they make investment mistakes - review their 10-Ks over the past few years and you will see lots of write-downs of investments such as ABPI. I wouldn't put too much into what the analyst says regarding the Sinunase potential for PPDI. I also would say that of course PPDI talks it up (at least for now). They have had failures in their compound partnering strategy - this won't be the first.

Like I said, I took the medicine, and it wasn't fun at all - they need a different delivery mechanism. Millions of people take Flonase or other types of suspensions - very tolerable. This is like an enema for the nose - not fun....

Even with FDA approval, which may not happen, the company will have a tough time on the reimbursement front in my opinion. I am sure that ABPI has lots of experience in that area - not!

By the way, this is the slowest "fast track" I have ever seen...

2007 Aug 13 07:49 PM

[bongoboy:]

It has been a slow Phase three. But as you know this is not uncommon. I found this off the internet. Yes it is fro m january 2007. But I like who it came from. www.thomsonpharma.com/... They talk about the opportunity. And by the way I think Revimmune and Biovaxid really bring the risk down. Remember it only has a 56 million mkt cap. Look at all the one drug companies who have gotton "no's" fro the fda and somehow maintain 200 to 300 million mkt caps. I have to believe at these prices risk/reward is in my favor. Imagine if they did get their products approved? $30 or $40 Dollars? Who knows, but I like what i see!

2007 Aug 13 08:08 PM

[Jim Glazen:]

Sinunase may or may not get approved. I doubt it personally. However, in my opinion, Biovax is worth zero. Favrille and Genitope have similar vaccines and Rituxan is already the class leader. I don't see Biovax first to market and I certainly don't see any value in an also ran. Revimmune is a pipe dream in my opinion.

What the funding crisis? I heard Biovest can't even make payroll. This company needs big cash and fast.

2007 Aug 13 11:53 PM

[gino :]

More positive blinded data today. 50% see something happinging to the tune of a reduction in symptoms. Also on the sec web site it appears the chairman purchased 875,000 shares in a private transaction at $8.75.00!! Maybe he knows something?

2007 Aug 15 01:05 PM

[gino :]

Thats's $8.75 per share or $7,700,000.00 !

2007 Aug 15 01:06 PM

[Alan Brochs...:]

Sorry, Fred, but ABPI is dead...

2008 Mar 24 09:25 PM