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BioAlliance Pharma Gains US FDA Approval for Oravig® (Loramyc® in EU)
And is eligible for a $20 million milestone payment from Strativa Pharmaceuticals, its commercial partner in the US
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
AMEPTM (Invasive melanoma): Phase I
Clonidine Lauriad® (Mucositis): Phase II
Doxorubicine Transdrug® (Liver cancer): Phase II