BioWorld International Correspondent
PARIS - BioAlliance Pharma SA created a 50:50 joint venture with Spepharm Holding BV to market Loramyc in Europe. The agreement brings BioAlliance €3 million (US$3.9M) up front and potentially €29.5 million.
Spepharm is a specialty pharmaceutical company based in Amsterdam, the Netherlands, whose European operations are managed out of the Paris offices of its French subsidiary. It was created in 2006 by Jean-François Labbé, a former executive of Hoechst Marion Roussel and the Warner Lambert group, with the support of two venture capital funds. The company already markets two specialized drugs in the fields of oncology and endocrinology.
Loramyc is a 50-mg, once-a-day topical formulation of miconazole incorporating BioAlliance's Lauriad adhesive technology, which allows early and prolonged release of therapeutic agents at the site of the disease. It received marketing approval in France last October for the treatment of oropharyngeal candidiasis in immunodepressed patients, particularly those with head and neck cancers who have undergone radiotherapy, and those infected by HIV.
The approval was granted by the French Health Products Safety Agency and a European mutual recognition procedure is now under way.
Paris-based BioAlliance currently is negotiating the price of Loramyc with the French authorities prior to launching the product in France later this year. In addition, it currently is carrying out a pivotal Phase III clinical trial of Loramyc in the U.S., where the company hopes to file the product for regulatory approval 2008.
The joint venture with Spepharm will market Loramyc in all European Union countries except France (where BioAlliance has its own sales force), plus Switzerland and Norway. The new joint venture will be based in the Netherlands.
The joint-venture agreement provides for BioAlliance to receive up to €29.5 million from its partner. First, Spepharm is to purchase €5 million worth of new BioAlliance shares at a subscription price of €12.79 per share. In addition, BioAlliance stands to receive €24.5 million in license fees, starting with an up-front payment of €3 million. Part of the balance will be payable once Loramyc has received marketing approval in two other leading European countries, while the rest is linked to the sales performance of Loramyc in the territory covered by the joint venture.
BioAlliance also has the right to buy out its partner and its distribution rights at any time after the fifth year of the commercialization of Loramyc on predetermined and agreed terms and conditions.
BioAlliance is specialized in the development of therapeutics to treat drug resistance in cancer, HIV and severe, opportunistic infections. It has two other products in advanced clinical development. Late last year it filed a Phase III trial protocol for aciclovir Lauriad in the treatment of labial herpes in six countries and has so far received approval in Australia, France and the Czech Republic.
In December, it initiated a Phase II/III trial of doxorubicin Transdrug for the treatment of primary liver cancer. Transdrug is a proprietary nanotechnology that allows intracellular drug targeting for optimal efficacy and tolerability, while doxorubicin is a chemotherapeutic agent that has proved effective in treating many forms of cancer.