Oravig

Treatment for Oral Thrush

Update: Oravig (miconazole mucoadhesive buccal tablet) Now FDA Approved - April 16, 2010

NDA Submitted for Loramyc

Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws

PARIS--(BUSINESS WIRE)--Jun 15, 2009 - BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment of cancer and AIDS patients and supportive care, today announced the submission of its New Drug Application (NDA) to the United States Food and Drug Administration (FDA), as planned, for the approval of Loramyc, Mucoadhesive Buccal Tablets (MBT), developed for the treatment of OroPharyngeal Candidiasis. If approved, Strativa Pharmaceuticals, the specialty pharma division of Par Pharmaceutical, Inc. (NYSE: PRX), the BioAlliance Pharma's partner for commercialization in the USA, could launch Loramyc in the second half of 2010.

« Loramyc® has already received a Market Authorization in 11 European countries and is currently marketed in France. This NDA filing at the FDA is an important milestone on the road to commercialization in the USA in 2010 via our partner Par Pharmaceutical/Strativa – a company that is already well established in the AIDS and cancer supportive care market», emphasized Dominique Costantini, BioAlliance Pharma's President and CEO.

In addition, BioAlliance Pharma is notifying its shareholders of an upcoming General Assembly meeting. Among the resolutions to be presented will be the change of the by-laws including the change of the dual structure “Directoire/'Conseil de surveillance'' into the more classical Board structure. BioAlliance aims therefore at simplifying its governance structures for a better reactivity in front of its new challenges. The Board structure is also the most used among French listed companies. The official notice of the Meeting will be published in the French Republic's Bulletin des Annonces Légales Obligatoires ("Bulletin of Mandatory Legal Announcements") in the coming days. The Assembly should be held in at least the next 35 days following the notice.

About BioAlliance Pharma

As a preferred partner for hospital-based specialists, BioAlliance Pharma is a company which develops and markets innovative products in France, especially in the fields of opportunistic infections and chemotherapy complications. In areas where medical needs are insufficiently met, our targeted approaches help overcome drug resistance and improve patient health & quality of life. BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs.

For more information, visit the BioAlliance Pharma web site at http://www.bioalliancepharma.com.

Disclaimer

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 2008 Reference Document filed with the AMF on April 7, 2009, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com).

Contact: BioAlliance Pharma SA
Dominique Costantini, President and CEO
Tel.: +33 1 45 58 76 01
dominique.costantini@bioalliancepharma.com or
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
nicolas.fellmann@bioalliancepharma.com
or
ALIZE RP
Caroline Carmagnol
Tel.: +33 6 64 18 99 59 / caroline@alizerp.com

Posted: June 2009

Related Articles

Oravig (miconazole) FDA Approval History

View comments

Hide
(web4)