SitavigTreatment for Herpes Simplex Labialis
Update: Sitavig (acyclovir buccal tablets) Now FDA Approved - April 12, 2013
BioAlliance Pharma SA : Receivability of Sitavig US Registration Dossier (NDA) for the Treatment of Recurrent Orofacial Herpes Validated by the FDA
PARIS--(BUSINESS WIRE)--May 29, 2012 - Regulatory News:
BioAlliance Pharma SA (Euronext Paris: BIO), a Company dedicated to orphan oncology products and specialty products, today announces the receivability of Sitavig® (Sitavir® in Europe) US registration dossier from the Food and Drug Administration(FDA) for the treatment of recurrent orofacial herpes.
According to the US registration procedure, the FDA has 60 days from the date of NDA (New Drug Application) submission to conduct a preliminary review of the registration dossier and to confirm its validity for a substantial review.
This preliminary and required step being achieved, the assessment of Sitavig® registration dossier by the FDA is now entering its effective phase.
“The receivability of Sitavig® registration dossier represents a major achievement for the product's progress in the United States. It also demonstrates the know-how of our preclinical, clinical and regulatory teams who, and for the second time, successfully bring one of our products to phase III and then to evaluation for registration in Europe and the United States as well”, comments Pierre Attali, in charge of Strategy and Medical affairs.
The registration dossier, submitted to the FDA first quarter 2012, is based on the results of the pivotal phase III clinical trial conducted in 775 patients. In this trial, one single application of Sitavig® 50mg significantly reduced the occurrence of vesicular lesions and crusts, their time to healing and the severity of symptoms. Moreover, a 9-month follow-up showed that Sitavig® had an effect on the long term, delaying the time to occurrence of the following herpes episode. These significant results are particularly interesting for the treatment of orofacial herpes, a pathology affecting nearly 100 million people worldwide of whom more than one third suffers from recurrent herpes (4 episodes and more a year).
“These successful achievements reinforce the potential value of Sitavig® which is becoming a suitable candidate to international partnership agreements, in line with the defined strategy of our portfolio “Specialty products”. These partnership agreements are important to BioAlliance as they generate direct revenues”, declares Judith Greciet, CEO of BioAlliance Pharma.
About BioAlliance Pharma
Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.
Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs. The company's teams have the key competencies required to identify, develop and register drugs in Europe and the USA.
BioAlliance Pharma has developed an advanced product portfolio:
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 28 countries (EU, US, Korea)
Sitavir®/Sitavig® (Acyclovir LauriadTM) (labialis herpes): Positive phase III final results; registration status
Fentanyl LauriadTM (chronic cancer pain): Positive preliminary Phase I results
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) in primary liver cancer: Phase III on going
Validive® (Clonidine LauriadTM) in mucositis: Phase II on going
AMEP® (invasive melanoma): Phase I on going
For more information, visit the BioAlliance Pharma web site 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 2011 Reference Document filed with the AMF on April 24, 2012, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
Contact: BioAlliance Pharma SA
Judith Greciet, CEO, +33 1 45 58 76 00
Nicolas Fellmann, CFO, +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59
Posted: June 2012
- BioAlliance Pharma's Sitavig Receives FDA Approval for the Treatment of Herpes Labialis - April 15, 2013