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Curetis And Laboratorios LETI Sign Exclusive Distribution Agreement For Unyvero™ In Spain And Portugal

1/9/2014 10:28:01 AM

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Holzgerlingen, Germany, January 9, 2014 -- Curetis AG today announced that the company has closed an exclusive distribution agreement in Spain and Portugal with Laboratorios LETI, which includes all existing and future Unyvero™ instruments and consumables. LETI is a biopharmaceutical company based in Tres Cantos, near Madrid, Spain. Its diagnostics business unit distributes and markets a broad portfolio of in vitro diagnostics (IVD) and research products, among other offerings.

The agreement, effective January 1, 2014, was finalized following positive market feedback and favorable outcome of a joint, extensive health economic assessment which included four major hospitals in Spain and Portugal. The commercial launch of Unyvero™ in this region is expected in the first quarter of 2014.

For the implementation, Curetis will provide Unyvero training, marketing materials and supporting health economic research. LETI will manage all marketing and sales activities as well as storage and logistics support. The partners are targeting a market share of more than 50 percent of relevant hospitals and ICU units in the region within the next five years.

“We have chosen to partner with LETI because of the company’s depth of experience and a strong presence in the Spanish and Portuguese markets,” said Oliver Schacht, CEO of Curetis AG. “Our in-depth analysis of the health economic benefits the Unyvero Solution will offer this market once again underscores Unyvero’s potential for both improved medical outcomes and for significant savings potential in health care costs. This is all the more important in markets that are under tremendous pressure to achieve overall savings in their healthcare systems due to the macroeconomic environment.”

“From our first exposure to the Unyvero solution, we recognized the unique potential of the system to solve one of the most pressing problems in today’s infectious disease management - addressing the need for a rapid and simple, but very reliable, near-patient molecular diagnostics solution to identify pathogens and antibiotic resistances,” said Jaime Grego, President of Laboratorios LETI. “Following our health economic analysis, we are also convinced of the economic viability of Unyvero and very much look forward to building the business as a long-term growth driver in partnership with Curetis.”

CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on the Curetis Unyvero™ technology is currently available for sale in the United States of America or Canada. The analytical and clinical performance characteristics of any Curetis Unyvero™ product which may be sold at some future point in time in the U.S. have not yet been established.

About the Unyvero™ System

The CE-marked Unyvero™ System is a versatile hardware platform for the detection of a broad panel of bacteria, fungi and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to result. It is marketed in Europe, Russia, the Middle East and various other non-European countries. In the U.S., Curetis is running a prospective multi-center clinical trial aimed at achieving FDA clearance registered under NCT01922024.

The platform enables the DNA-based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparation steps. The analysis thus can be performed with minimal operator time and without the need of skilled staff or special infrastructure.

Thereby, clinically relevant information is available within about four hours to support an informed therapy decision as early as possible.

The first CE-marked Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyses 39 DNA targets. The second application, the Unyvero™ i60 ITI cartridge for implant & tissue infections, is in late-stage product development. It covers 114 targets from many native clinical sample types and 8 distinct clinical indications. Cartridges for additional indications are in preparation.

About Curetis AG

Founded in 2007, Curetis AG is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis AG enable rapid multi-parameter pathogen and antibiotic resistance detection in only a few hours, a process that today can take up to days or even weeks with other techniques.

To date, Curetis has raised total funds of over € 49.1 million (~ USD 65 million). The company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed collaboration agreements with Heraeus Medical, Sanofi Pasteur and Cempra Inc. as well as several international distribution agreements covering more than 20 countries already.

About Laboratorios LETI

LETI is a research-based biopharmaceutical company. Besides diagnostics, the company is active in allergy immunotherapy, dermatology and immunology. LETI is based in Spain, has affiliates in Germany, Portugal, and the United States, as well as a network of international distributors.

Company Contact
Curetis AG
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10

International Media Inquiries
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

U.S. Media Inquiries
The Ruth Group
Melanie Sollid-Penton
Tel. +1 646 536 7023

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