BioAlliance Pharma Gains US FDA Approval for Oravig® (Loramyc® in EU)

Regulatory News:

BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, announces today the approval by the US FDA (Food and Drug Administration) of Oravig^® (miconazole Lauriad^®, known as Loramyc^® in Europe) for the treatment of Oropharyngeal Candidiasis (OPC) in adults.

Oravig^® is licensed to Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. and will be launched in the course of this second semester. The license agreement signed in July 2007 contemplates a $20 million milestone payment upon FDA approval, additional sales milestones and royalties on sales of the product.

"This is a major achievement and the first time for a French biotech company to gain a US approval. BioAlliance expertise in development and registration at the international level is here properly recognized and rewarded. Following our commercial partnership agreement with Therabel Group for Europe (Loramyc^® and Setofilm^®), we are very confident in Strativa’s commercialization ability to ensure Oravig^® success in the US”, said Dominique Costantini, President and CEO of BioAlliance Pharma.

"With Oravig^®, BioAlliance has developed an innovative local treatment for oral candida infection. We are very proud to now bring Oravig^® to health care providers and patients in the US”, added John Mac Phee, Strativa President.

The NDA submission was based on the European file and on data from a large Phase III study (577 patients, 28 sites in the United States, Canada, and South Africa) comparing Oravig^® (miconazole Lauriad^®) to Mycelex^® Troche (clotrimazole, the reference product in the USA) in the complete resolution of signs and symptoms of OPC.

About BioAlliance Pharma

As a preferred partner for hospital-based specialists, BioAlliance Pharma is a company which develops innovative products, especially in the fields of opportunistic infections and chemotherapy complications. In areas where medical needs are insufficiently met, its 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.
BioAlliance Pharma has developed an advanced product portfolio:
Loramyc^® (Oropharyngeal candidiasis in immunocompromised patients): Registered in 26 European countries
Setofilm^® (Prevention and treatment of -chemotherapy, radiotherapy and post operative- induced nausea and vomiting in adults and children): Registered in 16 European countries
Acyclovir Lauriad^® (Labialis herpes): Positive phase III final results
Fentanyl Lauriad^® (Chronic cancer pain): Positive preliminary Phase I results
AMEP^TM (Invasive melanoma): Phase I
Clonidine Lauriad^® (Mucositis): Phase II
Doxorubicine Transdrug^® (Liver cancer): Phase II
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com

About Strativa Pharmaceuticals

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE:PRX), excels at finding, enhancing, and bringing to market drugs that make a meaningful difference to patients. For more information about Strativa, visit www.strativapharma.com.

About Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is a US-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press release and other company information, visit www.parpharm.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 SA's website (http://www.bioalliancepharma.com).