EWING, N.J., Feb. 12 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company) announced today that it has signed a potential $30 million partnering agreement with Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) for the development and commercialization in North America of orBec(R) (oral beclomethasone dipropionate or Oral BDP).
As part of the agreement, Sigma-Tau will make a $6 million upfront investment in DOR, inclusive of the $1.5 million which was recently completed under a letter of intent dated November 26, 2008. The remaining $4.5 million investment was priced at a 50% premium to the five day trailing average of DOR stock, putting the investment price at $0.18 per share. In addition, Sigma-Tau will make payments to DOR totaling $10 million, subject to the achievement of certain milestones. The first of these, a $1 million payment, will be made upon the enrollment of the first patient in DOR's upcoming confirmatory Phase 3 clinical trial of orBec(R) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), which is expected to occur in the first half of 2009. In exchange for commercialization rights, Sigma-Tau will pay DOR a 35% royalty on Net Sales pursuant to which DOR will supply the drug product while maintaining worldwide manufacturing rights. Commercialization expense, including launch activities, could potentially reach $15 million by the end of the first year after launch. Additionally, DOR will grant Sigma-Tau a seat on its Board of Directors.
Gregg Lapointe, Chief Executive Officer of Sigma-Tau, commented, "As a result of our longstanding relationship with DOR, we have great confidence in the DOR team, in the pharmacology that orBec(R) has already demonstrated, and in the likelihood of orBec(R)'s success in the confirmatory Phase 3 clinical program. Oral BDP is also an excellent fit with our current pipeline of transplant/oncology products. We are committed to the success of this collaboration in the development of this important compound."
"We are very pleased to begin this partnership with Sigma-Tau," said Christopher J. Schaber, PhD, President and CEO of DOR. "Sigma-Tau's premium investment in DOR shares gives us the cash necessary to complete our upcoming confirmatory Phase 3 clinical trial of orBec(R) in GI GVHD. This partnership will also provide for the launch and commercialization of orBec(R) in North America, without any further related expense to DOR or its shareholders. It also provides us with the potential for ongoing development funding across multiple indications for orBec(R) and oral BDP."
Dr. Schaber continued, "We have known Sigma-Tau for a long time, as they have been an investor in DOR for several years. We are confident in their strong commitment to working with other biotech companies, and recognize their expertise in commercializing orphan products. We welcome them to our Board of Directors. Together with Sigma-Tau, we are optimistic about the prospects for our orBec(R) and Oral BDP pipelines and look forward to the possibility of having these products approved by the FDA."
About orBec(R) and Oral BDP
Two prior randomized, double-blind, placebo-controlled Phase 2 and 3 clinical trials support orBec's(R) ability to provide clinically meaningful outcomes when compared with the current standard of care, including a lowered exposure to systemic corticosteroids following allogeneic transplantation. Currently, there are no approved products to treat GI GVHD. The first trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Research Center. The second trial was a 129-patient pivotal Phase 3 multi-center clinical trial of orBec(R) conducted at 16 leading bone marrow/stem cell transplantation centers in the US and France. Although orBec(R) did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time to treatment failure through Day 80 (p-value 0.0226), as well as a 66% reduction in mortality among patients randomized to orBec(R) at 200 days post-transplant with only 5 patient (8%) deaths in the orBec(R) group compared 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(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).
In the Phase 2 study, the primary endpoint was the clinically relevant determination of whether GI GVHD patients at Day 30 (the end of treatment) had a durable GVHD treatment response as measured by whether or not they were able to consume at least 70% of their estimated caloric requirement. The GVHD treatment response at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec(R) and placebo groups, respectively (p-value 0.02). Additionally, the GVHD treatment response at Day 40 (10 days post cessation of therapy) was 16 of 31 (52%) vs. 5 of 29 (17%) in the orBec(R) and placebo groups, respectively (p-value 0.007).
orBec(R) represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec(R) 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(R) 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.
In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to DOR, orBec(R) also benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, which provide for seven and 10 years of post-approval market exclusivity, respectively.
About GI GVHD
GI GVHD is a debilitating and painful disease and constitutes an unmet medical need. It is a life-threatening condition and one of the most common causes for bone marrow and stem cell transplant failure. It is a common disorder among immunocompromised cancer patients after receiving hematopoietic cell transplantation. These procedures are being increasingly used to treat patients with leukemia and other cancers to eliminate residual disease and reduce the likelihood of relapse. 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. orBec(R) represents a novel oral, locally active therapy and is intended to reduce the need for systemic immunosuppressive drugs such as prednisone, which is currently used off label to prevent and control GI GVHD.
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 diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland.
Since 1989, the company's products have been focused on rare diseases, kidney disease, and cancer. With more than 6,000 identified rare diseases that affect approximately 25 million patients in the Unites States, Sigma-Tau places its considerable scientific resources behind the development and commercialization of compounds that benefit the few. The company has a substantial development program focused on transplant, cancer, inherited genetic disorders, malaria, and other areas of unmet medical need. For more information about the company, please visit www.sigmatau.com.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. (DOR) is a late-stage 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(R) (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of HCT. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec(R) for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of Oral BDP in radiation enteritis in 1H 2009. orBec(R) is also currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.
Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the 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, botulinum toxin and anthrax. DOR's ricin toxin vaccine, RiVax(TM), has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
For further information regarding DOR BioPharma, Inc., please visit the Company's website at www.dorbiopharma.com.
This press release contains forward-looking statements that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec(R), particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not exceed projected levels, [assuming you have enough cash to meet anticipated operating expenses and Phase 3 trial costs] that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec(R) for gastrointestinal GVHD include the risks that: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec(R) will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec(R) may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec(R). These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Forms 10-Q and 10-KSB. Unless required by law, DOR assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
|SOURCE DOR BioPharma, Inc.|
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