FDA Play: Soligenix, Poised for a Stellar Comeback (OTC:SNGX.OB) Print E-mail
By Michael Vlaicu   
Friday, 02 October 2009 03:57
FDA Play: Soligenix, Poised for a Stellar Comeback (OTC:SNGX.OB)

The past year and a half has come to be known as the rise of the small cap biotechs — Anyone want to contact Steven Spielberg for a movie suggestion? Terminator: Rise of the Machines, oh please. Nothing seems to stand in the way of these once forgotten ghosts, as they are now appearing as front page news on just about every large major financial news portal. Welcome to Soligenix Inc., a company that has such a vast potential, we really aren’t sure if we can fit all of the information on our server — No really, we aren’t kidding about that. When we first stumbled upon this company, it felt like it was Christmas over and over again.

Sure we’ve all heard the same old story: Phase III results, deep pipeline, government grants for one or two million, comparisons to other more successful companies, the list goes on and on. So why Soligenix? Simple, it simply tears through the potential of practically every other company we have profiled. Don’t expect this market cap of 56.92M to last much longer.

And the horses are off, we start out of the gates with patents, follow that up with eight treatments/vaccines in the pipeline, their main drug (orBec) which has received Orphan Drug status and been under phase III with a market potential of $300M annually, take a lead from the pack with a presentation from the President and CEO at the Rodman &  Renshaw, $3.85M financing from partners and institutional investors, go on for more institutional investors, $9.4M NIH grant, there are more grants but we will leave that to the profie, potential $30M North American partnership, positive clinical trials plastered all over the latest press releases, orphan drug status obtained on their main phase III drug –  There are so many things going on with this company, it will literally make your head spin by the finish line. We can practically go on and on about the positives of this company, however, let’s finally get to the company profile. And so, the story begins… oops we meant novel.

About Soligenix, Inc.

Soligenix, Inc., formerly DOR Biopharma, Inc., research and development biopharmaceutical company focused on developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases where there remains an unmet medical need; as well as several biodefense vaccines. The Company maintain two active business segments: BioTherapeutics and BioDefense. During the year ended December 31, 2008, the Company had two customers, the United States Federal Government and Orphan Australia Pty Ltd. (Orphan Australia), a specialty pharmaceutical company based in Melbourne, Australia. The Company’s biodefense business segment intends to convert its ricin toxin, botulinum toxin, and anthrax vaccine programs from early stage development to advanced development and manufacturing.

The company is primarely a late-stage biopharmaceutical company committed to the development of life-saving therapeutics and vaccines. Soligenix has two areas of focus: 1) a therapeutics platform dedicated to the development of products for life-threatening conditions such as gastrointestinal Graft-versus-Host disease and cancer, and 2) a biodefense platform to develop vaccines for military and civilian applications.



*All information taken from company website

orBec® GVHD Treatment

Their main product, the only Phase III for the past six months, which also has obtained the illustrious FDA Oprhan Drug Status. Soligenix’s lead product orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal (GI) manifestation of Graft-versus-Host disease (GVHD), the organ system where GVHD is most frequently encountered and highly problematic. orBec® is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. orBec® is formulated for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.

Acute GI GVHD is a debilitating and painful disease and constitutes an unmet medical need. It is a common disorder among immunocompromised cancer patients after receiving hematopoietic cell transplantation. Unlike organ transplants where the patient’s body may reject the organ, in GVHD it is the donor cells that begin to attack the patient’s (host’s) body – most frequently the gastrointestinal tract, liver and skin. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea. If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

Soligenix has reached agreement on the design of a confirmatory, pivotal Phase 3 clinical trial evaluating its lead product orBec® for the treatment of acute GI GVHD with both the FDA and EMEA. The agreement with the FDA was gained via the FDA’s Special Protocol Assessment (SPA) procedure. An agreement via the SPA procedure is an agreement with the FDA that a Phase 3 clinical trial design (e.g., endpoints, sample size, control group and statistical analyses) is acceptable to support a regulatory submission seeking new drug approval. The agreement with the EMEA was obtained via the procedure for requesting Protocol Assistance. Based on data from the prior Phase 3 study of orBec®, the upcoming confirmatory Phase 3 clinical trial will be a highly powered, double-blind, randomized, placebo-controlled, multi-center trial and will seek to enroll an estimated 166 patients. The primary endpoint on the new study is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value 0.005) in the previous Phase 3 study which enrolled 129 patients. This clinical trial is expected to begin in the second half of 2009.

FDA Orphan Drug Status

DOR BioPharma Receives FDA Orphan Drug Designation for orBec® for the Treatment of Chronic Gastrointestinal GVHD

Princeton, NJ – August 4, 2009 – DOR BioPharma, Inc., (OTCBB: DORB) (DOR or the Company), a late-stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Oral BDP (beclomethasone 17,21-dipropionate, or orBec®) for the treatment of gastrointestinal symptoms associated with chronic Graft-versus-Host disease (cGVHD) in patients who have undergone allogeneic hematopoietic cell transplantation.

The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven-year term of market exclusivity for orBec® upon final FDA approval, orphan drug designation also positions DOR to be able to take advantage of a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for orBec®, and certain tax credits.

orBec® is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP, the active component of orBec®, has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. orBec® and oral BDP are currently in development by DOR for the treatment and prevention of GVHD, the prevention of acute radiation enteritis and the treatment of Crohn’s disease.

“The FDA’s decision to grant orBec® Orphan Drug Designation for the treatment of GI symptoms of cGVHD marks another step in the expansion of our orBec®/oral BDP pipeline,” stated Christopher J. Schaber, PhD, President and CEO of DOR BioPharma. “Based on data we have already generated in the treatment of acute GI GVHD, we believe that orBec® has the potential to be of significant benefit to cGVHD patients.”

Market Potential

GVHD has a market size of approximately $300 million yearly.

orBec® GVHD Prevention

orBec® is currently being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial for the prevention of acute GVHD after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens. The trial is being conducted by Paul Martin, MD, at the Fred Hutchinson Cancer Research Center in Seattle, WA and is being supported, in large part, by a National Institute of Health (NIH) grant. The Phase 2 trial will seek to enroll up to 138 (92 orBec® and 46 placebo) patients. The primary endpoint of the trial is the proportion of subjects who develop acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation. Patients in the orBec® group will begin study drug at the start of the conditioning regimen and continue through day 75 following HCT. Trial enrollment is expected to complete in the second half of 2009.

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, orBec® also benefits from orphan drug designations in the US for the prevention of GI GVHD, which provide for seven years of post-approval market exclusivity.

FDA News

The following excerpt was taken from BioMedreport’s FDA Calendar

Recent News

Usually we copy and paste excerpts of the most important information, along with the link in order to simply things. However, in this particular case, there are so many of them — We just have to simply copy and paste all of them so that you may spend the hours reading yourself. Really, there is no way to filter them, because they are all simply that beneficial to know!

Wednesday, September 30, 2009

DOR BioPharma Announces Corporate Name Change to Soligenix and Begins Trading Under New Ticker Symbol “SNGX”

[read more]

Thursday, September 24, 2009

DOR BioPharma Announces Private Equity Financing of $3.85 Million with its Partner Sigma-Tau and Other Institutional Investors

[read more]

Monday, September 21, 2009

DOR BioPharma Announces $9.4 Million NIH Grant Award to Develop Thermostable and Rapidly Acting Vaccines

[read more]

Tuesday, September 08, 2009

DOR BioPharma Announces NIH Grant Award to Support Phase 1/2 Clinical Trial of DOR201 in Radiation Enteritis

[read more]

Thursday, September 03, 2009

DOR BioPharma to Present at the Rodman & Renshaw Annual Global Investor Healthcare Conference, Presentation to be Webcast Live

[read more]

Friday, August 14, 2009

DOR BioPharma Reports 2nd Quarter and 1st Half 2009 Financial Results and Reviews Recent Accomplishments

[read more]

Tuesday, August 04, 2009

DOR BioPharma Receives FDA Orphan Drug Designation for orBec® for the Treatment of Chronic Gastrointestinal GVHD

[read more]

Wednesday, July 08, 2009

DOR BioPharma Announces Issuance of European Patent for its LPM™ Oral Drug Delivery Technology

[read more]

Tuesday, July 07, 2009

DOR BioPharma Announces Christopher P. Schnittker, CPA, as Vice President of Administration and Controller

[read more]

Monday, June 29, 2009

DOR BioPharma Announces Publication of orBec® Clinical Pulmonary Data in Bone Marrow Transplantation

[read more]

Tuesday, June 09, 2009

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec® in GI GVHD

[read more]

Friday, May 15, 2009

DOR BioPharma Reports 1st Quarter 2009 Financial Results and Reviews Recent Accomplishments

[read more]

Tuesday, March 31, 2009

DOR BioPharma Reports Year-End 2008 Financial Results and Reviews Recent Accomplishments

[read more]

Wednesday, March 25, 2009

DOR BioPharma, Inc. Executes $400,000 Equity Investment Agreement with Numoda Corporation

[read more]

Monday, March 16, 2009

DOR BioPharma Appoints Gregg Lapointe, CPA, MBA, to its Board of Directors

[read more]

Friday, March 13, 2009

DOR BioPharma Appoints Brian L. Hamilton, MD, PhD, as Chief Medical Officer

[read more]

Thursday, February 12, 2009

DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec® in the Treatment of Graft-versus-Host Disease

[read more]

Tuesday, January 27, 2009

DOR BioPharma Announces Appointment of Christopher J. Schaber, PhD, to BioNJ Board of Directors

[read more]

Monday, January 26, 2009

DOR BioPharma Announces Formation of Acute Radiation Enteritis Medical Advisory Board

[read more]

Tuesday, January 20, 2009

DOR BioPharma Announces Engagement of Amper, Politziner & Mattia, LLP as New Auditors

[read more]

Monday, January 12, 2009

DOR BioPharma Announces Private Equity Financing of $2.28 Million with Single Institutional Investor

[read more]

Tuesday, January 06, 2009

DOR BioPharma Obtains Fast Track Designation for DOR201 in the Prevention of Acute Radiation Enteritis

[read more]

Monday, January 05, 2009

DOR BioPharma Receives SPA Clearance from the FDA to Begin Confirmatory Phase 3 Clinical Trial of orBec® in GI GVHD

[read more]

Experienced Leadership

Never before have we profiled a company with such a rich mix of MDs, MBAs, past Presidents, CEOs — Quite frankly, you name the title, they have it. What’s even more impressive is the fact that they have scientific advisors from the North American Medical Advisory Board, European Medical Board and Radiation Medical Advisory Board.

Live Webcast at Rodman & Renshaw

Princeton, NJ – September 3, 2009 – DOR BioPharma, Inc. (DOR or the Company) (OTCBB: DORB), a late-stage biopharmaceutical company, announced today that Christopher J. Schaber, PhD, President and Chief Executive Officer, will present at the Rodman & Renshaw 11th Annual Global Investor Healthcare Conference. Dr. Schaber is scheduled to present at 4:55 PM on Thursday, September 10, 2009 in the Spellman Salon of the New York Palace Hotel, New York.  The presentation will be webcast live and may be accessed by visiting http://www.wsw.com/webcast/rrshq15/dorb.ob

TheStreet’s Top 10 Open-Market Purchases

To the left is a list of the top 10 open-market insider purchases and sales filed at the Securities and Exchange Commission Wednesday as ranked by dollar value. Company executives and directors are in the best position to assess the attractiveness of their firms’ shares, and here is how many of them are voting their wallets! Please note, however, that these are factual lists, not buy and sell recommendations. Dollar value is only one metric to assess the importance of an insider transaction. For the full story visit TheStreet.com

Investors love insider buying, it is generally perceived as a sign of confidence from management towards the near future. It spells out the fact that good things are well on their way. Thus, when Soligenix’s President an CEO decided to buy 79,051 shares today, a siren should have gone off atop everyone’s head.

In fact, over the last four weeks insiders at DOR BioPharma, Inc. (DORB.OB) have bought more than $3.00M. For the full story visit this Trading Markets press release

CTIC Comparison from Seeking Alpha Contributor

“So can DORB make a CTIC style comeback following the same good news from the second phase III trial for orBec?  Indeed, a quick look at DORB shows many similarities that poise DORB for a CTIC type share price come-back with phase III trial news.  However, a closer look under the DORB and CTIC hood show marked differences that suggest DORB has even a better chance at a CTIC style comeback than even CTIC itself ever did in the first place.” Read the full Seeking Alpha article here

Technical Analysis ( click image to enlarge )

SNGX has clearly broken the gap resistance established back in October of 2007. It has also moved into the upper levels of a price channel (Blue lines on the chart) that has been in control since that gap occurred back in 2007.  This year’s price movement has indicated the channel is now trending up.  An extremely interesting aspect of this well established price channel is that the top quarter of the price channel currently corresponds with the price level needed to fill the gap at .45 cents. In April, a strong bullish signal was given when the daily 100 SMA (Orange line) crossed up and over the daily 200 SMA (Yellow line).  Another bullish sign is that both these moving averages have been trending up ever since.  It’s also good to keep in mind that the volume has currently reached levels that last occurred when this stock traded at prices above .45 cents. This is a very positive sentiment and coupled with all the bullish signals the price seems ready to finally fill that gap quickly and move even higher given the top trend-line of the price channel is currently above .50 cents.

Overall Sentiment

We can sit here and recap the gazillion of great aspects and potentials this company has, but we also believe that our readers are literate and don’t need to be spoon fed to a baby’s extent. The amount of news, press releases, grants, products, pipeline, clinical trials, experienced management team is so vast that nothing can really encompass what the true worth of this company truly is — All we know is, 56.92M won’t be here much longer, the rest you can figure out on your own. Where’s that ice bucket for our fingers?


Disclosure: Short term position in SNGX

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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