A Medical Device Daily

Prometheus (San Diego), a specialty pharmaceutical and diagnostic company, and Rosetta Genomics (Philadelphia/Rehovot, Israel), a molecular diagnostic company, reported a license and collaboration agreement under which Rosetta will grant Prometheus U.S. rights to three recently introduced microRNA-based cancer diagnostic tests: miRview mets, miRview squamous and miRview meso.

The agreement calls for payments to Rosetta, either as milestones or R&D funding, as well as royalty payments on net sales in the U.S. Under a separate stock purchase agreement, Prometheus will also make an equity investment in Rosetta of $8 million at $4 per ordinary share, representing roughly a 41% premium over the closing price of Rosetta stock over three business days. The license-and-collaboration agreement and the stock purchase agreement are expected to close before the end of April and are subject to customary closing conditions.

In addition, Prometheus and Rosetta have agreed to collaborate to develop two new microRNA-based gastroenterology tests, which may result in additional, success-based milestones and royalty payments to Rosetta. Prometheus will provide the funding to develop these tests.

"Prometheus has established its position as a leader in the gastroenterology market by building an integrated portfolio of diagnostic and pharmaceutical products as well as a highly trained and efficient sales force," said Joseph Limber, president/CEO of Prometheus. "Leveraging our core strengths, we intend to apply this business model to oncology, where there is an unmet need to guide the use of a growing number of targeted therapies. We believe these three molecular diagnostic tests can help oncologists personalize therapy and are ideally suited to lead our entry into the oncology market, while complementing our emerging internal oncology diagnostics program."

"We believe that with this agreement Rosetta has proven the great commercial value of its first three products, and has established itself as a leader in the development of novel, molecular diagnostic products based on microRNAs. We are delighted to enter into this comprehensive partnership with Prometheus," said Amir Avniel, president/CEO of Rosetta. "With Prometheus these tests now will be available across the U.S., and will be supported by an organization with a proven ability in diagnostic testing services and in launching new products."

miRview mets is designed to accurately identify the primary tumor site in patients presenting with metastatic cancer, as well as in patients whose tumor has not been identified and consequently has been labeled Cancer of Unknown Primary. As metastases need to be treated according to their primary origin, accurate identification of the primary origin is critical for determining optimal treatment, enabling better patient outcomes. According to Rosetta, current diagnostic methods to identify the origin of a metastasis include a range of costly, time-consuming and at times inefficient tests. miRview mets offers physicians a fast, accurate and easy-to-interpret diagnosis of the predicted primary origin.

Using a single microRNA, miRview squamous is designed to differentiate squamous from non-squamous non-small cell lung cancer (NSCLC). When administered targeted therapy, whether currently available or under development, patients with differing histology, i.e. squamous or non-squamous NSCLC, have demonstrated histologic-specific response patterns ranging from a high incidence of severe or fatal bleeding in the lungs to poor response to treatment. Current methods for differentiating squamous from non-squamous NSCLC are not standardized, are difficult to reproduce and can have low accuracy, Rosetta said. miRview squamous produces a single objective measure that indicates whether a sample is squamous or non-squamous NSCLC.

miRview meso leverages microRNA's high-specificity biomarkers to differentiate mesothelioma, a cancer connected to asbestos exposure, from other carcinomas in the lung and pleura, a medically and legally important differential diagnosis. As mesothelioma patients require specific treatment regimens, an accurate diagnosis is critical. Rosetta said that currently there is no single diagnostic test that is conclusive for this differentiation. In addition, pathological diagnosis may suffer from significant inter-observer variability, and in the absence of a single specific and reliable marker, mesothelioma can be difficult to identify from other cancers, the company noted. According to Rosetta, miRview meso is a highly accurate test that may also assist physicians in ruling out mesothelioma in patients diagnosed with adenocarcinoma in the lung who have been exposed to mesothelioma-related substances, primarily asbestos particles and heavy metals.

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