OravigTreatment for Oral Thrush
Update: Oravig (miconazole mucoadhesive buccal tablet) Now FDA Approved - April 16, 2010
Bioalliance Pharma to Resubmit Loramyc NDA in the Second Quarter of 2009
PARIS--(BUSINESS WIRE)--May 7, 2009 -
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris: BIO), the specialty pharmaceutical company focused on the treatment of opportunistic infections, on cancer and on AIDS, today announced that based on a recent ad hoc meeting held with the FDA, the NDA for Loramyc will be resubmitted in the second quarter of 2009. If approved, Par Pharmaceutical/Strativa, BioAlliance Pharma's partner for Loramyc commercialization in the USA, could launch Loramyc in the second half of 2010.
About BioAlliance Pharma
As a preferred partner for hospital-based specialists, BioAlliance Pharma is a specialty biopharmaceutical company which develops and markets innovative products, 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.
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 forwardlooking 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 11 2008 under the number R. 08-021, 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
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59 / email@example.com
Posted: May 2009
- FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis - April 16, 2010
- BioAlliance Pharma: FDA Accepts Drug Application for Miconazole Lauriad (Loramyc) to Treat Oropharyngeal Candidiasis - August 19, 2009
- Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws - June 16, 2009
- Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet - April 9, 2009