Lumavita Media Centre

Lumavita AG announces Marketing Authorisation for Pentamycin in Switzerland

27.08.2009

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®.

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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.

Lumavita AG announces new funding - €4m raised in Series A follow-on

18.06.2009

18 June 2009, Basle, Switzerland: Lumavita AG, the Swiss biopharmaceutical company specializing in novel anti-infectives for Women’s Health, announces today that it has raised CHF6m (€4m) in an extension to the Series A round the Company initiated in September 2008. The total raised in this financing round is CHF24m.

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The new funds have been raised from new investor HealthCap and existing investor, Endeavour Vision. Both Magnus Persson of HealthCap and Olivier Valdenaire from Endeavour Vision will join Lumavita’s Board of Directors.

In March, Lumavita received preliminary marketing approval in Switzerland for its first product, FemiFect® (pentamycin), for the treatment of all three causes of vaginitis. The funds raised will be used to build Lumavita’s commercial partnering network for Femifect in anticipation of its submission and launch in more than 100 countries around the world beginning this year, and to finance two on-going development projects.

Dr Magnus Persson, partner at HealthCap, said, “Lumavita is uniquely positioned as a European biopharmaceutical company in that it is close to launching its first product, has a compelling pipeline focussed on Women’s Health and a world-class management team. HealthCap has followed the projects for some time and is delighted now to invest in Lumavita and to take an active part in its future success.”

Nicholas Benedict, CEO of Lumavita, said, “We have a very strong group of investors and will undoubtedly benefit from their input and support in growing our company. Our priorities are to gain FemiFect marketing approvals and launch the product in our target markets, alongside completing the development of both the high-dose formulation of FemiFect and of LMV-601, an anti-viral currently under evaluation for the treatment of cervical HPV.”

About Lumavita AG
Lumavita AG is a 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 infection of the cervix 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 development. Lumavita AG is headquartered in Basle, Switzerland.

Lumavita AG announces receipt of Preliminary Approval for Marketing Authorisation of pentamycin in Switzerland for the treatment of three types of vaginitis

24.03.2009

24 March 2009, Basle, Switzerland: Lumavita AG, the Swiss biopharmaceutical company specializing in novel anti-infectives for women’s health, announces today its first preliminary product approval. The Swiss regulatory authority has stated it will grant marketing authorization for pentamycin pending minor clarifications. Pentamycin is Lumavita’s proprietary anti-infective for the treatment of vaginitis caused by fungal infections, trichomonal infections and mixed bacterial flora infections. Following final approval, pentamycin will be sold in Switzerland by Lumavita’s Swiss partner, Permamed AG, under the brand name Pruri-Ex®. Outside of Switzerland, pending further approvals, pentamycin will be sold as FemiFect®.

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Vaginal infections are extremely frequent, affecting up to 10% of all women each year whose treatment generates more than 100 million prescriptions across Europe and North America. Pentamycin is a unique medicine for these patients because, unlike currently available products, it is an antibiotic with an appropriate spectrum of activity to treat all three types of infections known to cause vaginitis: fungal infections, trichomonal infections and mixed infections including bacterial infections. Unlike some other treatments for vaginal infections, pentamycin has had no observed effect on the natural flora of the vagina. Maintenance of the vagina’s natural flora is known to be an important element to the healing process following an infection. In addition, pentamycin’s spectrum includes activity against pathogens resistant to current gold-standard treatments. Pentamycin is under further evaluation for its ability to reduce recurrent infections, experienced by a high proportion of sufferers and for safe administration in pregnancy.

Professor Dr. E.R. Weissenbacher, Professor of Gynaecology and Obstetrics at the University of Munich, Germany commented, “Pentamycin will offer an important step forward in the treatment of these frequent infections which are highly distressing for patients. No approved antibiotic currently exists with sufficient activity to treat all three causes of vaginitis. Pentamycin meets this important therapeutic goal, enabling gynaecologists to treat with an effective medicine first time around.”

Nicholas Benedict, CEO of Lumavita, added: “The anticipated Swiss approval of Lumavita’s proprietary medicine pentamycin will be a major milestone for our young company and will be followed quickly by further regulatory submissions in more than 100 countries throughout the world. Pentamycin offers the first therapeutic breakthrough in the treatment of vaginitis for almost twenty years and the clinical benefits offered to both gynaecologists and patients are highly relevant to the medical needs still unmet by existing therapies. The early revenues from the first sales of pentamycin will help to finance Lumavita’s research efforts into our second project which is under evaluation for the treatment of cervical HPV, an infection associated with virtually 100% of all cases of cervical cancer.”

The clarifications requested by SwissMedic comprise degredation patterns and minor revisions to product specifications. These details will be supplied to SwissMedic within the coming weeks and it is anticipated that pentamycin will be launched in Switzerland thereafter.

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 September 2008 Lumavita AG closed its Series A financing of CHF18m. The Series A investors were Atlas Venture, BB Biotech Ventures, BioMedInvest and Endeavour Vision. 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 infections caused by Human Papilloma Virus and Herpes Simplex 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.

New biopharmaceutical company, Lumavita AG created in Switzerland with a Series A Financing of CHF18m

02.09.2008

2 September 2008, Basle, Switzerland: Lumavita AG, a newly-created specialty biopharmaceutical company focusing on anti-infectives for women’s health, announces today that it has raised a Series A financing of CHF18m (€11m). The lead investors are Atlas Venture, BB Biotech Ventures, and BioMedInvest. Dr. Jürg Eckhardt and Dr. Gerhard Ries join Dr. Karl Naegler of Atlas on the Board. The Company also announces the appointment of Nicholas Benedict as CEO.

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Lumavita AG is focused on worldwide development and commercialization of innovative treatments for infectious diseases in women’s health. The Company’s product portfolio includes FemiFect® (pentamycin) a polyene macrolide with a unique spectrum of coverage for the treatment of vaginitis, and SPK-601, a first-in-class PC­PLC inhibitor for the potential treatment of infections caused by Human Papilloma Virus and Herpes Simplex Virus. FemiFect® is already approved in Switzerland for the treatment of vaginitis and Lumavita anticipates an imminent launch. A dose­optimized formulation of FemiFect® is in Ph IIb clinical development, and SPK-601 is in Phase I. Lumavita was founded on the expertise of co-founder and Chief Scientific Officer, Dr Cees Winnips, who has a significant background in development within the pharmaceutical industry in several therapeutic areas, including anti-infective drugs.

Nicholas Benedict, Lumavita’s newly-appointed CEO, has extensive international leadership experience gained over 17 years in the pharmaceutical and biotechnology industries. Mr Benedict began his career at Roche. He moved to Novartis in 1998 and took positions of increasing responsibility including COO of Novartis UK and worldwide Business Unit Head in Primary Care, which incorporated the women’s health business. Most recently, Mr Benedict was Head of Commercial Strategy & Operations at the Swiss specialty anti-infectives biotechnology company, Basilea Pharmaceutica.

Dr Karl Naegler, principal at Atlas Venture and board member of Lumavita, said “We are joined in this compelling late-stage investment by additional top tier healthcare funds. This successful financing round enables the combined expertise of the newly­appointed senior management team to realize the value of the assets we have in Lumavita’s portfolio. Lumavita’s first product, FemiFect®, is awaiting launches in Switzerland and around the world.”

Dr. Jürg Eckhardt, partner at BB Biotech Ventures and Chairman of Lumavita, said “FemiFect has the potential to be the first-line choice for the empirical treatment of vaginitis, a widespread and common infection in women. Through launching this product and by progressing development of the other products in Lumavita’s pipeline, this new company has a tremendous opportunity to benefit female patients through novel and improved anti-infectives.”

The worldwide market for vaginitis is estimated at $2.4 billion. Lumavita has established a distribution network to launch FemiFect® in Switzerland, Latin America, Asia and CIS, which together comprise approximately 30% of the total market.

Lumavita AG is headquartered in Basel, Switzerland.

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