BioAlliance Pharma to Pursue Its Strategy for the Targeted Acquisition of Complementary Products Following the Announcement of the Discontinuation of Immtech Pharmaceuticals' Pafuramidine Program
PARIS, Feb 25, 2008 -- Regulatory News:
BioAlliance Pharma SA (Paris: BIO) today confirmed that it will pursue its advanced compound acquisition strategy for European oncology and HIV markets, despite Immtech Pharmaceuticals Inc.'s (AMEX: IMM: 1.09, -0.91, -45.50%) recently announced discontinuation of its pafuramidine program.
On Friday February 22, Immtech Pharmaceuticals Inc. (AMEX: IMM: 1.09, -0.91, -45.50%) informed BioAlliance that the US company "will focus on its novel anti-infectives. It will discontinue all Phase III programs concerning its novel chemical entity, pafuramidine (an investigational therapy for Pneumocystis pneumonia (PCP: 115.16, -0.78, -0.67%) in HIV patients and for African sleeping sickness)". The decision was made in response to recent reports related to unexpected adverse events (related to liver abnormalities) identified in volunteers in a December 2007 safety study involving the drug in South Africa. This prompted imposition of a clinical hold by the FDA in late December. In February, Immtech received information on additional events related to abnormal kidney function during the follow-up of the volunteers in the same safety study. The cause of the liver and kidney toxicity has not yet been fully clarified but the decision to discontinue the pafuramidine development program was taken by Immtech and the independent Data Safety Monitoring Board following a risk-benefit analysis of the compound.
BioAlliance Pharma signed an exclusive licensing agreement with Immtech Pharmaceuticals for the European sales rights to the new chemical entity pafuramidine on December 5, 2007. The financial exposure on this Phase III product is limited to the $3 million (EUR 2 million) paid on signature of the agreement.
"Pafuramidine's Phase II results were promising and did not raise any particular safety concerns; we were thus hopeful that this compound would successfully complete is pivotal Phase III clinical trial in patients with PCP. BioAlliance Pharma will actively pursue its product acquisition strategy in order to add complementary compounds to its own portfolio. We are seeking products for treating chemotherapy complications or rare diseases in oncology or HIV, for example", stated Dominique Costantini, the company's President and CEO.
In January 2008, Bioalliance Pharma obtained its first PMAs for the United Kingdom (triggering payment of a EUR 2.5 million license fee to BioAlliance Pharma) and Denmark. The company is preparing to launch Loramyc(R: 59.57, +0.78, +1.32%) in Europe. The company has a strong, diversified portfolio (including 3 well advanced (Phase III) programs - acyclovir Lauriad(R: 59.57, +0.78, +1.32%), doxorubicin Transdrug(R: 59.57, +0.78, +1.32%) and Loramyc(R: 59.57, +0.78, +1.32%) in the USA) and a promising R&D program.
On Friday February 29, BioAlliance Pharma will announce its 2007 full year financial results and make additional statements on its portfolio and strategy.
About BioAlliance Pharma
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(R: 59.57, +0.78, +1.32%)) 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(R: 59.57, +0.78, +1.32%) in oral herpes (based on the same Lauriad(R: 59.57, +0.78, +1.32%) muco-adhesive technology as Loramyc(R: 59.57, +0.78, +1.32%), which enables targeted release at the disease site) and doxorubicin Transdrug(R: 59.57, +0.78, +1.32%) in primary liver cancer (based on the Transdrug(R: 59.57, +0.78, +1.32%) 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 infectious disease markets.
In 2007, the company established strategic alliances for commercializing Loramyc(R: 59.57, +0.78, +1.32%) in Europe (with JV SpeBio) and the USA (with Par Pharmaceutical). For more information, visit BioAlliance Pharma's website at 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 6 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).