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Lumavita AG Announces Marketing Authorisation for Pentamycin in Switzerland



8/27/2009 10:49:34 AM

27 August 2009, Basle, Switzerland: Lumavita AG, the Swiss biopharmaceutical company specializing in novel anti-infectives for Women’s Health announced today its first product approval. Following notice of Preliminary Approval issued in March 2009, the Swiss regulatory authority has granted final marketing authorisation to Lumavita’s proprietary prescription medication, pentamycin, for the treatment of all types of infectious vaginitis. Pentamycin vaginal tablets will be sold in Switzerland by Lumavita’s distribution partner Permamed AG under the brand name Pruri-Ex®. Outside of Switzerland, pending further approvals, pentamycin will be marketed under the brand name FemiFect®.

Pentamycin is a unique new treatment for all types of infectious vaginitis, a common condition affecting up to 10% of all women each year whose treatment generates more than 100 million prescriptions per year across Europe and North America. Pentamycin has been shown to be effective against all pathogens which cause infectious vaginitis without negative effect on critical components of the vagina’s natural flora. Pentamycin is not absorbed into the bloodstream and is well tolerated. In addition, its spectrum includes activity against pathogens resistant to current gold-standard treatment. Pentamycin is under further evaluation for its ability to reduce recurrent infections experienced by a high proportion of sufferers and for its safe administration in pregnancy.

Professor Dr. E.R. Weissenbacher, Professor of Gynaecology and Obstetrics at the University of Munich, Germany said “infectious vaginitis is caused by either fungal, bacterial, trichomonal infection or a combination of these. Pentamycin is the first therapeutic option which treats all types of vaginal infection without harmful disinfectant activity. It represents an important first-line treatment and promises to bring relief to frequent sufferers of this common condition.”

Nicholas Benedict, CEO of Lumavita, added: “Pentamycin vaginal tablets will be launched in Switzerland as soon as possible, and we anticipate further regulatory submissions and launches in more than 100 countries. Early sales revenues from pentamycin will be re-invested into key R&D including another potential breakthrough treatment, this time for patients suffering from cervical HPV infections. Cervical HPV infection is accepted as the cause of nearly all cases of cervical cancer and Lumavita aims to be the first with a cure for the infection. Meanwhile, forthcoming launches of pentamycin will help to establish Lumavita as a growing force in addressing the underserved medical needs in Women’s Health.”

About Lumavita AG

Lumavita AG is biopharmaceutical company focusing on novel anti-infectives for women’s health. Lumavita AG was founded in August 2008 and is engaged in globally targeted Development and Commercialisation activities for its proprietary product portfolio. In June 2009 Lumavita AG closed its Series A financing of CHF24m. The Series A investors were Atlas Venture, BB Biotech Ventures, BioMedInvest, Endeavour Vision and HealthCap. The Company’s product portfolio includes FemiFect® (pentamycin) a polyene macrolide with a unique spectrum of coverage for the treatment of vaginitis, and LMV-601, a first-in-class PC-PLC inhibitor for the potential treatment of cervical infections caused by Human Papilloma Virus. A dose-optimized formulation of FemiFect® is in Ph IIb clinical development, and LMV-601 is in late-stage pre-clinical evaluation for the treatment of cervical Human Papilloma Virus (HPV). Lumavita AG is headquartered in Basle, Switzerland.

Please visit our website at www.lumavita.com

Read at BioSpace.com


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