- Loramyc® sales triple
- submission of a marketing authorization application for Setofilm® in Europe
- submission of a new drug application for Loramyc® in the USA
- significant progress in the supportive care portfolio
- OSEO funding validates the company's innovations
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris – BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today presented its consolidated half-year accounts to June 30, 2009.
The first half of 2009 was marked by several significant events that testify to the company’s progress:
- Submission of a new drug application (NDA) for Loramyc® to the United States Food and Drug Administration (FDA) and a marketing authorization application (MAA) for Setofilm® in Europe.
- The preparation of clinical trial applications (CTAs) for four products (fentanyl Lauriad® for cancer-related pain, AMEP™ in metastatic melanoma, clonidine Lauriad® for post-chemotherapy/post-radiotherapy mucitis and corticoid Lauriad® for erosive lichen planus) for submission by the end of 2009 or in early 2010.
- Progression and completion of recruitment in the first Phase III clinical trial of acyclovir Lauriad® in labial herpes (results expected in Q3 2009).
- Promising preclinical results for the company's programs in cancer (AMEPTM and irinotecan Transdrug®) and AIDS (HIV integrase inhibitor).
- Receipt of €6.4 million in funding from OSEO (the French state innovation agency) for two cancer programs (AMEPTM and Zyxine).
Commenting on BioAlliance Pharma's performance in the first half of 2009, President and CEO Dominique Costantini said: “Our first product, Loramyc®, is continuing to make progress, with steadily growing sales in France and submission of an NDA for marketing authorization in the United States, which will constitute a key milestone in commercial and financial terms. In the first half of 2010, we should be able to commercialize our second product, Setofilm®, which is currently being registered in 16 countries across Europe. Loramyc® (for the treatment of oropharyngeal candidiasis (OPC) in immune-compromised patients) and Setofilm® (for the treatment of post-chemotherapy and post-radiotherapy nausea and vomiting) are spearheading the high-quality supportive care franchise that BioAlliance is building. With two other products (fentanyl Lauriad® and clonidine Lauriad®) set to enter the clinic before the end of the year, BioAlliance will be able to offer a therapeutic arsenal in a field with many unmet needs and in which innovative approaches will significantly improve patient care. These are significant assets for attracting new corporate partners notably in Europe - a strategic objective for the company”.
Chief Financial Officer Nicolas Fellmann added: “We are very proud to have obtained €6.4 million in OSEO funding in the field of invasive cancers for our AMEPTM and Zyxine programs. The grant will part-finance the product development through to market launch. Furthermore, this non-dilutive funding reinforces our short- and medium-term cash position and fits well with other initiatives, such as the Seroplex® co-promotion agreement that we signed with Lundbeck for the second half of the year”.
Analysis of the H1 2009 accounts
Revenues for the first half of 2009 amounted to €4.1 million. In France, Loramyc® posted sales of €0.9 million – a threefold increase on the €0.3 million generated in the first half of 2008. Besides revenues include €3.2 million received under the terms of Loramyc® out-licensing agreements.