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BioAlliance Pharma SA (Paris:BIO) announces that it has just received the following press release from Immtech Pharmaceuticals, Inc. , the US company from which it has licensed the European rights for pafuramidine:
"NEW YORK, Dec. 26 -- Immtech Pharmaceuticals, Inc. (The "Company")(Amex:IMM) announced today that it is working with clinical investigators at one South African site where a single safety study is in progress for pafuramidine (DB289), an investigational therapy. In preliminary findings from this study, abnormal laboratory values were found in volunteers following treatment with pafuramidine. The Company has discussed the preliminary findings with the U.S. Food and Drug Administration (USFDA), and as a precautionary measure, the pafuramidine program has been placed on clinical hold. The clinical hold may be released after FDA has received satisfactory data regarding the safety of pafuramidine. Volunteers in this single South African safety study were either dosed with pafuramidine 100 mg twice daily for 14 days or placebo. The subjects are undergoing close monitoring for any changes in the status of their liver function. No subject has required any treatment or hospitalization for the abnormalities. The Company's Chairman and Chief Executive Officer Eric L. Sorkin stated, "Our primary concern is the safety of the patients. We are working closely with independent experts and the Data Safety Monitoring Board for pafuramidine."
Carol Olson, M.D., Ph.D., Senior Vice President of Pharmaceutical Development and Chief Medical Officer of Immtech, stated, "This evaluation will continue until patients stabilize or return to baseline status. At that time, Immtech and the independent experts in liver toxicity will prepare a summary of the available safety data and recommendations for presentation to the FDA." This one South African study involving healthy volunteers is being conducted in one location to collect additional safety data regarding pafuramidine to support the indications of Pneumocystis pneumonia and African sleeping sickness. This study was planned in 2005, after discussions with USFDA, in order to provide a safety database of appropriate size for submission of these indications to regulatory authorities. These two diseases affect a relatively small number of patients (they are considered as orphan drug indications) and so there are fewer patients available than are generally required for Phase three trials. This study was designed to increase the number of subjects treated with pafuramidine."
After reviewing the available safety data and recommendations, BioAlliance Pharma will decide whether or not to go ahead with the product. BioAlliance's financial exposure is limited to the $3 million paid on signature. Furthermore, BioAlliance Pharma, with no less than three of its own products already in Phase III clinical trials, is pursuing its advanced compound acquisition policy with a view to building a mature portfolio dedicated to the treatment of opportunistic infections in cancer and AIDS.
About BioAlliance Pharma SA
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products which address resistance issues. The company has launched its first portfolio product (Loramyc®) in France and the compound is currently in Phase III clinical development in oropharyngeal candidiasis in the USA. In addition, two other innovative products are currently in Phase III clinical trials: acyclovir Lauriad® in oral herpes (based on the same Lauriad® muco-adhesive technology as Loramyc®, which enables targeted release at the disease site) and doxorubicin Transdrug® in primary liver cancer (based on the Transdrug® nanoparticle technology, designed specifically for intracellular targeting of resistant cells). The company is also developing a new therapeutic entities program focused on the oncology and HIV markets.
In 2007, the company has established strategic alliances for commercializing Loramyc® in Europe (with JV SpeBio) and the USA (with Par Pharmaceutical). For more information, visit www.bioalliancepharma.com.
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the reference document approved by the AMF on April 6th 2007 under the number R. 07-031, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com).
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BioAlliance Pharma SA
Nicolas FELLMANN, CFO
+33 1 45 58 71 00
+33 6 64 18 99 59
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