Q3 2009: Strong Sales Growth and Significant Progress in Clinical Development

BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced a consolidated turnover of €1.6 million for the third quarter of 2009.
Turnover and cash reserves
Quarterly sales of Loramyc® in France remained strong over the summer, totaling €0.5 million – more than twice the figure for the equivalent period in 2008. A total of more than 42,000 patients have now been treated since the product’s launch at the end of 2007.
“The clear commercial success of our first product has been made possible by a cutting-edge sales and marketing organization” commented Dominique Costantini, President and CEO, BioAlliance Pharma. “Our specialist sales force is a true asset that has already been acknowledged by a major pharmaceutical company – Lundbeck, which signed a co-promotion agreement with us in July for in-hospital prescription of its star antidepressant, Seroplex®. These two products confirm our strong brand image as a pharmaceutical company with skills ranging from R&D expertise to direct hospital sales”.
The Q3 2009 turnover from licensing agreements amounted to €1 million, compared with €1.2 million in the same period in 2008. This variation is due to the payment schedule for one-off fees.
“The dynamism of our international licensing activities has been accentuated by the progress of our registration procedure for Loramyc® in the United States, where the FDA accepted our new drug application in August” added Nicolas Fellmann, CFO. “We expect to receive marketing authorization in the first half of 2010. That would be a significant milestone for our company and would trigger the payment of $20 million by our US licensee Par Pharmaceutical. We also expect to receive $1.5 million in 2010 from Handok (our licensee for south-east Asia) when Loramyc® is launched on the Korean market. As of September 30, 2009, our consolidated cash reserves stood at €18.4 million”.
Very significant advances in clinical development programs
Along with acceptance of its new drug application in the United States, Loramyc® made other notable progress during Q3 2009: European approval of Loramyc® tablet embossing and extension of its shelf life to 36 months, plus marketing authorization in Switzerland.
BioAlliance Pharma has also announced significant clinical progress in its other muco-adhesive tablet programs:
- Strongly positive interim results in the acyclovir Lauriad® Phase III clinical trial, which will constitute a solid basis for discussions with the regulatory agencies on the drug’s subsequent development. This is the second product to use the company’s patented Lauriad® technology.
- Approval in France of a Phase I clinical trial application for fentanyl Lauriad® in the treatment of chronic pain in cancer patients. The effective initiation of this study was announced on October 12, 2009.
- The filing (on October 12, 2009) of a Phase II clinical trial application in France for clonidine Lauriad® – a promising product in the treatment of oral mucositis (inflammation of the oral mucosa) which is very frequent in cancer patients but currently lacks an effective treatment.