Firm is in discussions with potential partners for Phase III development of EndoTAG-1.
MediGene is hoping to become profitable during 2011 as a result of a restructuring and cost-cutting exercise the firm says will not affect its development pipeline but will see its personnel base cut from 107 to about 55. MediGene aims to reduce its cash output by at least €5 million a year by removing redundancies mostly found within the teams involved in running and analyzing EndoTag™-1 clinical trials, and personnel involved in the conversion of the EndoTAG-1 manufacturing process from freeze-drying to spray drying.
The firm stresses that core competencies in preclinical development, clinical trial design, and clinical development will remain, and business development efforts on its marketed drugs, Eligard® and Veregen®, will continue.
EndoTAG is a liposomal formulation of paclitaxel, which has now completed Phase II studies in patients with pancreatic cancer or triple receptor-negative breast cancer. The drug is MediGene’s first product candidate derived from its EndoTAG platform technology. The firm previously confirmed that it aims to progress EndoTAG-1 into Phase III development in collaboration with a partner who will shoulder further costs. The full data package for EndoTAG is now available, and MediGene says a number of potential partner companies are in the process of due diligence.
The firm has not stated whether any changes will be made to its plans for the continued development of the oral rheumatoid arthritis candidate RhuDex™. Back in May MediGene confirmed that it plans to resume early clinical development of the CD80-targeting drug during late 2010 or early 2011, and out-license RhuDex once clinical proof of concept has been achieved, or possibly earlier.
MediGene’s marketed products include Eligard and Veregen. Eligard is a leuprolide acetate hormone compound combined with Tolmar Therapeutics’ Atrigel® depot drug-delivery technology, for the treatment of advanced, hormone-dependent prostate cancer. MediGene acquired the European marketing rights to Eligard from Tolmar, and took the drug through the approval procedures for Germany.
Astellas Pharma, MediGene’s marketing partner for Eligard in Europe, launched the drug in 2004, and since then one-month, three-month, and six-month products have been made available in most European countries. In July this year Astellas acquired the full European marketing and distribution rights to Eligard from MediGene, in return for a €25 million (about $33.7 million) up-front payment plus sales royalties. The new deal means MediGene will no longer have to shoulder any future costs, obligations, or risks associated with the supply of Eligard to Astellas, and has been absolved of any future procurement costs and license payments to Tolmar.
MediGene’s second marketed product, Veregen, is a green tea extract-derived treatment for external genital warts, and is currently available in the U.S. and Germany. The drug is distributed in the U.S. by Nycomed U.S., and since March 2010 has been distributed in Germany by Abbott Arzneimittel (previously Solvay), with whom MediGene signed a license and supply agreement for Germany, Austria, and Switzerland in 2009.
Approval for Austria has been granted and market launch in Austria is pending. MediGene has also been busy this year signing additional marketing agreements for Veregen, including deals with Teva (for Israel), Meditrina (for Greece and Cyprus), GC Rise (China), and JS Bio Pharm (South Korea).
In the first six months of 2010 MediGene reported sales revenues and income from royalties of €24.4 million (about $32.9 million), up 31% compared with the same period in 2009. The firm had cash and cash equivalents of €8.2 million (roughly $11 million) as of June 30, 2010.