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DOR BioPharma Receives $3 Million From Sigma-Tau Pharmaceuticals for Exclusive Right to Negotiate orBec(R) Strategic Alliance Thursday January 4, 8:30 am ET
MIAMI, FL--(MARKET WIRE)--Jan 4, 2007 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) ("DOR" or the "Company") announced today that it has received $3 million under a non-binding letter of intent with Sigma-Tau Pharmaceuticals, Inc. ("Sigma-Tau"), which grants Sigma-Tau an exclusive right to negotiate terms and conditions for a possible business transaction or strategic alliance regarding orBec® (oral beclomethasone dipropionate) and potentially other DOR pipeline compounds until March 1, 2007. ADVERTISEMENT
Under the terms of the agreement, Sigma-Tau has purchased $1 million of DOR's common stock at the market price of $0.246 per share, representing approximately four million shares. An additional $2 million was paid in cash, and will be considered an advance payment to be deducted from upfront monies due to DOR by Sigma-Tau pursuant to any future orBec commercialization arrangement reached between the two parties. If no agreement is reached by March 1, 2007, DOR will return the $2 million to Sigma-Tau within 60 days. If DOR does not pay Sigma Tau back in cash by May 31, 2007, interest will accrue at a rate of 6% compounded annually and Sigma Tau will have the option in its sole discretion of converting the accrued amount into common stock at a price per share equal to 80% of the market price at the time the payment is made.
"We are exceptionally pleased with Sigma-Tau's interest in orBec® and in DOR's pipeline products," said Christopher J. Schaber, Ph.D., President and CEO of DOR. "We view Sigma-Tau as an excellent potential partner for orBec® especially with regard to the EU territory. We look forward to productive discussions with Sigma-Tau to reach a mutually beneficial arrangement."
The common stock sold to Sigma-Tau has not been registered under the Securities Act or any state securities laws, and the securities may not be offered or sold absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.
About orBec®
orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of Graft-versus-Host Disease ("GVHD"), the organ system where GVHD is most frequently encountered and is highly problematic. orBec®, if approved by the EMEA and the FDA, would be the first approved treatment for GI GVHD and the first oral formulation of beclomethasone dipropionate ("BDP") available in the European Union and the United States, respectively. orBec® is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the U.S. 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 more distal portions of the GI tract.
About Sigma-Tau Pharmaceuticals, Inc.
Sigma-Tau Pharmaceuticals, Inc. is a U.S. based, wholly owned subsidiary of the Sigma-Tau Group, and is dedicated solely to the global development and commercialization of medicines for patients with rare ("Orphan") diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland.
The Sigma-Tau Group is a privately held, research focused pharmaceutical company headquartered in Pomezia (Rome), Italy, with subsidiaries in France, Switzerland, the Netherlands, Portugal, Germany, Spain, and the U.S. Employing 2,400 people worldwide (400 in R&D), the Sigma-Tau Group focuses on several therapeutic areas, including cardiovascular, metabolism, central and peripheral nervous system, immunology and oncology, with a portfolio comprising 48 projects and clinical trials currently being conducted in 32 different indications.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA with the FDA for the treatment of GI GVHD, and has received an FDA PDUFA date of July 21, 2007. An MAA with the EMEA for orBec® has also been filed and validated. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation.
Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. The ricin toxin vaccine, RiVax(TM), has been evaluated successfully in a Phase 1 clinical trial in normal volunteers.
For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.
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orBec(R) Pivotal Phase 3 Clinical Trial Results Published in Journal "Blood" Tuesday January 23, 3:00 pm ET
Results Show Statistically Significant Improvements in Long-Term Survival in Patients With GI GVHD and Are Included in DOR's Pending NDA and MAA Filings
MIAMI, FL--(MARKET WIRE)--Jan 23, 2007 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) (DOR or the Company) announced that data from its pivotal Phase 3 and supportive Phase 2 clinical trials using orBec® (oral beclomethasone dipropionate, or BDP) to treat gastrointestinal Graft-versus-Host disease (GI GVHD) have been pre-published this afternoon in the online edition of Blood, the peer-reviewed Journal of the American Society of Hematology, as a First Edition paper, including long-term survival analyses from these two randomized, double-blinded, placebo-controlled trials not previously made public. Lead author of the study, entitled "A Randomized, Placebo-controlled Trial of Oral Beclomethasone Dipropionate as a Prednisone-Sparing Therapy for Gastrointestinal Graft-versus-Host Disease," is David M. Hockenbery, M.D., Member of the Clinical Research Division, Fred Hutchinson Cancer Research Center and Professor of Medicine, University of Washington School of Medicine, both located in Seattle, Washington. The full article is available online at www.bloodjournal.org.
The Blood paper covers comprehensive results from two studies: DOR's 129-patient pivotal Phase 3, randomized, double-blinded, placebo-controlled multi-center clinical trial of orBec® conducted at 16 leading bone marrow/stem cell transplant centers in the U.S. and France; and survival data from its 60-patient Phase 2, randomized, double-blinded, placebo-controlled clinical trial conducted at the Fred Hutchinson Cancer Research Center.
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