Press Release

DOR BioPharma Receives $1.5 Million From Sigma-Tau Pharmaceuticals for Exclusive Right to Negotiate orBec(R) Strategic Alliance

Font Scale:
Posted 01 December 2008 @ 07:00 am ET

EWING, NJ -- (Marketwire) -- 12/01/08 -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the"Company") announced today that it has received $1.5 million under a letterof intent with Sigma-Tau Pharmaceuticals, Inc. ("Sigma-Tau"), which grantsSigma-Tau an exclusive right to negotiate terms and conditions for apossible business transaction or strategic alliance regarding orBec®(oral beclomethasone dipropionate or oral BDP) and potentially other DORpipeline compounds until March 1, 2009.

Under the terms of the letter of intent, Sigma-Tau has purchased $1.5million of DOR's common stock at the market price of $0.09 per share, whichwill be considered an advance payment to be deducted from upfront moniesdue to DOR by Sigma-Tau pursuant to any future orBec® commercializationarrangement reached between the two parties.

Gregg Lapointe, Chief Executive Officer of Sigma-Tau, commented, "As aresult of our long-standing relationship with DOR, we are confidentorBec® will prove successful in the confirmatory Phase 3 clinicalprogram. orBec® is also a very good fit with our rare disease focus,particularly with our other development activities in the transplant area. We look forward to finalizing our collaboration with DOR in theprogression of this important compound."

"We are very pleased with Sigma-Tau's interest in orBec®," saidChristopher J. Schaber, PhD, President and CEO of DOR. "We have knownSigma-Tau for a long time and have observed their strong commitment inworking with other biotech companies, and have confidence in theirexpertise in commercializing orphan products. We look forward toproductive discussions with Sigma-Tau to reach a mutually beneficialcollaboration."

The common stock sold to Sigma-Tau has not been registered under theSecurities Act of 1933 (the "Act") or any state securities laws, and thesecurities may not be offered or sold absent registration or an applicableexemption from the registration requirements of the Act and applicablestate securities laws.

About orBec®

orBec® represents afirst-of-its-kind oral, locally acting therapy tailored to treat thegastrointestinal manifestation of GVHD, the organ system where GVHD is mostfrequently encountered and highly problematic. orBec® is intended toreduce the need for systemic immunosuppressive drugs to treat GI GVHD. BDPis a highly potent, topically active corticosteroid that has a local effecton inflamed tissue. BDP has been marketed in the US and worldwide since theearly 1970s as the active pharmaceutical ingredient in a nasal spray and ina metered dose inhaler for the treatment of patients with allergic rhinitisand asthma. orBec® is formulated for oral administration as a singleproduct consisting of two tablets; one tablet is intended to release BDP inthe proximal portions of the GI tract, and the other tablet is intended torelease BDP in the distal portions of the GI tract.

Two prior randomized, double-blind, placebo-controlled Phase 2 and 3clinical trials demonstrated that orBec® provides clinically meaningfuloutcomes when compared with the current standard of care, including alowered exposure to systemic corticosteroids following allogeneictransplantation. Currently, there are no approved products to treat GIGVHD. The Phase 3 trial was a 129-patient pivotal Phase 3 multi-centerclinical trial of orBec® conducted at 16 leading bone marrow/stem celltransplantation centers in the US and France. Although orBec® did notachieve statistical significance in the primary endpoint of its pivotaltrial, namely median time to treatment failure through Day 50 (p-value0.1177), orBec® did achieve statistical significance in other keysecondary endpoints such as the proportion of patients free of GVHD at Day50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time totreatment failure through Day 80 (p-value 0.0226), as well as a 66%reduction in mortality among patients randomized to orBec® at 200 dayspost-transplant with only 5 patient (8%) deaths in the orBec® groupcompared to 16 patient (24%) deaths in the placebo group (p-value 0.0139).At one year post randomization in the pivotal Phase 3 trial, 18 patients(29%) in the orBec® group and 28 patients (42%) in the placebo group diedwithin one year of randomization (46% reduction in mortality, hazard ratio0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).

About Sigma-Tau Pharmaceuticals, Inc.

Sigma-Tau Pharmaceuticals, Inc. is a U.S. based, wholly owned subsidiary ofthe Sigma-Tau Group, and is dedicated solely to the global development andcommercialization of medicines forpatients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based inGaithersburg, Maryland.

Since 1989, the company's products have been focused on rare diseases,kidney disease, and cancer. With more than 6,000 identified rare diseasesthat affect approximately 25 million patients in the U.S., Sigma-Tau placesits considerable scientific resources behind the development andcommercialization of compounds that benefit the few. The company has asubstantial development program focused on transplant, cancer, inheritedgenetic disorders, malaria, and other areas of unmet medical need. For moreinformation about the company, visit www.sigmatau.com.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical companydeveloping products to treat life-threatening side effects of cancertreatments and serious gastrointestinal diseases, and vaccines for certainbioterrorism agents. DOR's lead product, orBec® (oral beclomethasonedipropionate or BDP), is a potent, locally acting corticosteroid beingdeveloped for the treatment of gastrointestinal Graft-versus-Host disease(GI GVHD), a common and potentially life-threatening complication ofhematopoietic cell transplantation. DOR expects to begin a confirmatoryPhase 3 clinical trial of orBec® for the treatment of GI GVHD in thefirst half of 2009. orBec® is also currently the subject of anNIH-supported, Phase 2, randomized, double-blind, placebo-controlled trialin the prevention of acute GVHD. Oral BDP may also have application intreating other gastrointestinal disorders characterized by severeinflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM(TM)) drugdelivery technology for the oral delivery of leuprolide for the treatmentof prostate cancer and endometriosis.

Through its Biodefense Division, DOR is developing biomedicalcountermeasures pursuant to the Project BioShield Act of 2004. DOR'sbiodefense products in development are recombinant subunit vaccinesdesigned to protect against the lethal effects of exposure to ricin toxin,botulinum toxin and anthrax. DOR's ricin toxin vaccine, RiVax(TM), has beenshown to be well tolerated and immunogenic in a Phase 1 clinical trial innormal volunteers.

For further information regarding DOR BioPharma, Inc., please visit theCompany's website at www.dorbiopharma.com.

This press release contains forward-looking statements that reflect DORBioPharma, Inc.'s current expectations about its future results,performance, prospects and opportunities. Statements that are nothistorical facts, such as "anticipates," "believes," "intends," or similarexpressions, are forward-looking statements. These statements are subjectto a number of risks, uncertainties and other factors that could causeactual events or results in future periods to differ materially from whatis expressed in, or implied by, these statements. DOR cannot assure youthat it will be able to successfully develop or commercialize productsbased on its technology, including orBec®, particularly in light of thesignificant uncertainty inherent in developing vaccines against bioterrorthreats, manufacturing and conducting preclinical and clinical trials ofvaccines, and obtaining regulatory approvals, that its cash expenditureswill not exceed projected levels, that it will be able to securepartnerships or obtain financing within the next nine months to meetoperating expenses and to conduct its upcoming confirmatory Phase 3 trialof orBec®, that product development and commercialization efforts willnot be reduced or discontinued due to difficulties or delays in clinicaltrials or due to lack of progress or positive results from research anddevelopment efforts, that it will be able to successfully obtain anyfurther grants and awards, maintain its existing grants which are subjectto performance, enter into any biodefense procurement contracts with the USGovernment or other countries, that the US Congress may not pass anylegislation that would provide additional funding for the Project BioShieldprogram, that it will be able to patent, register or protect its technologyfrom challenge and products from competition or maintain or expand itslicense agreements with its current licensors, or that its businessstrategy will be successful. Important factors which may affect the futureuse of orBec® for gastrointestinal GVHD include the risks that: the FDA'srequirement that DOR conduct additional clinical trials to demonstrate thesafety and efficacy of orBec® will take a significant amount of time andmoney to complete and positive results leading to regulatory approvalcannot be assumed; DOR is dependent on the expertise, effort, prioritiesand contractual obligations of third parties in the clinical trials,manufacturing, marketing, sales and distribution of its products; orBec®may not gain market acceptance if it is eventually approved by the FDA; andothers may develop technologies or products superior to orBec®. These andother factors are described from time to time in filings with theSecurities and Exchange Commission, including, but not limited to, DOR'smost recent reports on Forms 10-Q and 10-KSB. Unless required by law, DORassumes no obligation to update or revise any forward-looking statements asa result of new information, future events.

Add to Digg Bookmark with del.icio.us Add to Newsvine

Company Contact:Evan MyrianthopoulosChief Financial Officer(609) 538-8200www.dorbiopharma.comDOR BioPharma, Inc.850 Bear Tavern Road, Suite 201Ewing, NJ 08628


PR RSS
E-Newsletters : Enter your Email for Fast News & Opinions
Sponsored By
Click here!
advertisement
advertisement
Advertisement
POS Magnetic Card Readers

Online distributor for point of sale equipment, TYSSO and Pegasus.

 
IBTimes.com Web
Partners
International Business Times© 2009 The Ibtimes Company. All Rights Reserved. Terms of service | Privacy Policy | Advertising | About Us | Contact Us | Archives