BioAlliance Pharma Announces Positive Preliminary Pivotal Phase III Results in Herpes Labialis with Acyclovir Lauriad

Update: Sitavig (acyclovir buccal tablets) Now FDA Approved - April 12, 2013

PARIS--(BUSINESS WIRE)--Aug 26, 2009 - Regulatory News:

BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, is pleased today to announce positive preliminary results in its LIP phase III pivotal study (Lauriad® Immunocompetent Patients Study ). This multicenter randomized, double-blind, placebo controlled study compared the efficacy and safety of a single dose acyclovir Lauriad® 50mg Mucoadhesive Buccal Tablet (MBT) versus matching placebo in patients suffering from recurrent oro-facial herpes.

In the acyclovir Lauriad® patient group among the 722 patients included, the duration of episode from the first prodromal symptoms to healing was significantly decreased (p= 0.0062). In addition, the percentage of patients with abortive lesions (without vesicular lesion) was increased (p=0.051) and among patients presenting primary vesicular lesions, the time to healing was reduced (p=0.058).

“These data show that acyclovir Lauriad® brings a strong clinical benefit to patients both in preventing and treating recurrent oro-facial herpes. This trial provides a good basis for a constructive dialog with the regulatory authorities. These results strongly validate the Mucoadhesive Buccal Tablet concept based on early targeted treatment”, said Dominique Costantini, President and CEO of BioAlliance Pharma.

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: August 2009

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