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French Biotech ExonHit to Acquire RedPath for $32M to Boost US Presence

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By Justin Petrone

ExonHit Therapeutics this week announced its intentions to spend as much as $32 million in cash and stock to acquire RedPath Integrated Pathology, a clinical molecular lab.

Under the terms of the agreement, the Paris-based drug and diagnostic developer plans to buy RedPath, which sells DNA-based cancer tests, for $12.5 million upfront, another $10 million in stock, and sales milestone payments that could total another $9.5 million.

ExonHit CEO Loïc Maurel said that the transaction, scheduled to close in July, is a "significant milestone in ExonHit’s strategy to become an internationally recognized player in molecular diagnostics," and will "strengthen" the firm's presence in the US.

Founded in 1997, ExonHit has a number of therapeutic compounds and tests in development. The company has since 2005 offered a line of Affymetrix-manufactured splice-variant arrays, and has an agreement to develop and sell tests on the array vendor's GeneChip microarray platform.

The furthest along of ExonHit's diagnostics is AclarusDx Alzheimer's, an array-based clinical test for diagnosing the disease. Specifically, the test, which is covered by some insurance plans, is designed to discriminate AD patients from healthy individuals and can be used with existing methods to improve patient selection in drug trials, according to the firm.

The test became available in the EU for research use in December 2009. ExonHit has said that it hopes to begin selling the test for clinical use in Europe by the first quarter of 2011, and it hopes to have the assay cleared by the US Food and Drug Administration in early 2012 (BAN 2/16/2010).

ExonHit has other potential tests in development that will most likely be deployed on the Affy platform, including two breast cancer diagnostic assays licensed from Paris' Institut Gustave Roussy, and an early-stage prostate cancer diagnosis co-developed with BioMérieux.

RedPath, meantime, offers its flagship PathFinderTG pancreatic cancer assay through its Clinical Laboratory Improvement Acts-compliant lab. The assay relies on a "broad panel of microsatellite markers" to detect difficult-to-diagnose tumors in tissue, cytology, and fluid samples, according to the firm.

RedPath's assay starts with the microdissection of cells from targeted areas of interest on chemically fixed histology and cytology slides. The process "incorporates DNA amplification, as well as molecular profiling against a broad panel of mutations in 15 to 20 different markers that include tumor suppressor genes and oncogenes known to be part of the mutational profile for each tumor type," the firm says on its website. The company’s analysis is completed with a histological review.

RedPath has a number of other cancer molecular assays in various stages of development: one designed to differentiate primary from metastasis tumors, which is set to launch, and a pair of tests in late-stage development and several in earlier-stage development.

ExonHit said that by integrating RedPath's DNA technology with its RNA-based platform business, the combined firm will be able to offer "more accurate diagnostic tests" with a "stronger IP position." Maurel said the acquisition will give ExonHit's diagnostics business a "new dimension" due to RedPath's background in oncology, which he described as the "fastest-growing segment in molecular diagnostics."

In addition, ExonHit said it believes the acquisition will help expand the market for its AclarusDx platform. Likewise, RedPath believes it will gain European Union customers by drawing on ExonHit's resources.

RedPath CEO Mark Myslinski, who will lead ExonHit's global diagnostics division and get a seat on the firm's board following the closing of the deal, said in a statement that combining the two companies' "technologies, know-how, and resources" will "maximize the potential" of both PathFinderTG and AclarusDx. Myslinski said that RedPath will "constitute a key asset for the commercial success of AclarusDx in the US" and that the company is "eager to bring the clinical solutions to the EU patients and clinicians."

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