BioAlliance Pharma (France: BIO.PA) has cash/equivalents as of year-end 2008 that amounted to €31.7 million. Furthermore, and setting aside any new agreements signed in the coming years, BioAlliance Pharma expects to receive up to $21.5 million in milestone payments in 2009-2010 under the terms of its existing licensing and collaboration agreements. The company is also expecting to receive €4 million as a research tax credit.
On February 27, 2009, BioAlliance Pharma reacquired the sales rights to Loramyc® in Europe and terminated the exclusive license contract signed in 2007 with the company SpeBio. In order to obtain compensation for losses suffered as a result of delays in commercialization and sale of Loramyc®, BioAlliance Pharma has initiated legal proceedings against SpeBio at the Paris trade tribunal.
Despite the pharmaceutical market slow-down and a turbulent macro-economic situation, BioAlliance Pharma is confident of its ability to ensure the continued Europe-wide commercialization of Loramyc® directly via its own sales teams in some countries and through specialist oncology partners in others. Furthermore, in March, BioAlliance Pharma was awarded marketing approval for Loramyc® in South Korea and has now initiated pricing and reimbursement procedures with its partner, Handok.
The next key steps in BioAlliance Pharma's development are as follows:
1.) acceptance of US filing for Loramyc® in the United States: Q2 2009.
2.) a new European sales organization for Loramyc®: 2009.
3.) completion of the first Phase III trial of acyclovir Lauriad in Europe: H2 2009.
4.) integration of an advanced project (nursing): Q2 2009.
5.) new alliances in 2009.
6.) approval of Loramyc® by the FDA: Q1 2010.
7.) the European launch of ondansetron RapidFilm™: H1 2010.
8.) Filing for registration of ondansetron Oral Spray: H1 2010.
Commenting on BioAlliance Pharma's 2008 performance, Dominique Costantini (the company's President and CEO) declared: "At the end of the full first year of Loramyc® sales in France, we can see that our first marketed product is integrating well into prescribing habits and expert recommendations. Loramyc® has been administered to nearly 20,000 patients and consolidated sales have reached the symbolic €1 million threshold. We are going to build on this success in 2009. Internationally, we signed two new license agreements on Loramyc® in south-east Asia and prospects for the North American market are looking good, following this year's positive results in our Phase 3 study".
Dominique Costantini added, "In 2008, we sought to maximize the potential for value creation. This meant that in order to optimize our commercial organization, we licensed-in two complementary cancer supportive care products for Europe. The two products are close to registration and will generate commercial synergies in the near future. Lastly, we have refocused our resources on the most promising R&D projects by capitalizing on our unique technological know-how. Today, BioAlliance Pharma is in good shape to tackle the challenges of 2009 and pursue its balanced growth track".
