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Gunning for Europe, Clinical Data Acquires Genome Express; Reorganizes Second Time in Two Months


Clinical Data last week took steps to expand its position in pharmacogenomics by reorganizing its businesses for a second time in as many months. This week, the company acquired Genome Express of Mevlan, France, as it tries to expand its pharmacogenomic footprint in Europe.

Clinical Data paid approximately $3.16 million for Genome Express, with about $238,000 of that amount paid in cash and the remainder paid by 123,179 newly issued shares, the companies said this week in a statement.

According to a Genome Express spokesperson, the company employs 37 staffers, six of whom are sales people. It sells its services mostly to customers in France, Italy, Spain, Belgium, and Switzerland. The firm's largest customers tend to be academics who contract its services for public research projects, the spokesperson said.

Even without creating a stand-alone unit for pharmacogenomics products, Clinical Data seems to have done well since it embarked into molecular diagnostics. The company reported a 39-percent jump in revenues to $19.9 million in its third quarter, which ended Dec. 31, 2005, from $14.3 million one year earlier.

The Reorg: Part II

The acquisition followed on the heels of Clinical Data's second reorganization in two months, which the company said was necessary in order to create a revenue stream from its pharmacogenomics holdings that is separate from its services business. The New Haven, Conn.-based diagnostic firm announced plans in January to split into two divisions focused on blood-based diagnostics and pharmacogenomics, and it has now opted for three divisions: the Vital Diagnostics division, comprising the more traditional blood tests and other assays that make up its legacy business; PGxHealth for its biomarker-discovery and pharmacogenomic products, which are mostly former Genaissance assets; and Cogenics, which will offer molecular and pharmacogenetics services, which are made up of the former assets of Icoria, Lark, and Genaissance.

Clinical Data made no mention of its new reorganization, disclosed March 1, in its third-quarter earnings report, which it filed with the US Securities and Exchange Commission in mid-February. Nor did the company mention it in a statement it released about two weeks ago to update its strategy and milestones.

But the partition made more official a division between services and pharmacogenomics products within the molecular unit.

A key part of the re-reorganization is the introduction of its Therapeutic Diagnostics line of genetic tests to identify patients likely to benefit from new and existing therapies. Clinical Data plans to partner with pharmaceutical, biotechnology, and academic organizations as part of its new diagnostic push, the company said in a statement last week.

The move may enable the company to focus its pharmacogenomics efforts on sales and marketing, Reed said this week. The Cogenics segment addresses a market made up of "people buying laboratory services and buying expertise, whereas on the PGxHealth side, it's the development and eventual sales and marketing of tests, and the customers here are providers and payors," she said. "So, I think internally, in terms of how resources are allocated and how individuals are focused, it's a very helpful division."

In its late-February strategy and milestones update, Clinical Data mentioned only biomarker discovery partnerships it has through its PGx Health division with Organon, Sankyo, and Otsuka — relationships the company had previously made public. With Organon, the company is searching for biomarkers related to drug response in undisclosed psychiatric disorders in a deal announced in July. In its agreements with Otsuka and Sankyo, made public in September and October, respectively, the company will be searching for biomarkers of response to undisclosed drugs.

The PGxHealth division's current projects all appear to derive from former Genaissance efforts, including tests it currently offers or is developing in central nervous system, cardiovascular, and oncology applications.

In the psychiatric field, the firm is working on Vilazodone, a selective serotonin reuptake-inhibitor and its efficacy biomarker, as well as the anti-psychotic candidate Clozapine and its safety biomarker. Should these two compounds make it to market with the aid of their respective biomarkers, Clinical Data plans to couple them with companion diagnostics to identify patients for whom each drug is appropriate.

According to documents Clinical Data filed with the US Securities and Exchange Commission late last month, the company plans to validate the results of its Clozapine study and to launch a diagnostic within the year.

The firm also plans to complete a phase III Vilazodone study by mid-2007 and file the drug for approval with the FDA "as early as year-end 2008," according to a separate company statement.

In cardio, the company plans to develop and launch a test to help clinicians dose patients with the anticoagulant warfarin.

Clinical Data currently sells genetic tests for the drug- and heredity-related heart problems Familial Long QT syndrome, Brugada syndrome, Short QT syndrome, and others.

In oncology the firm has licensed a test for the gene known as TPMT to Prometheus Labs, which owns Imuran, known generically as azathioprine, which is one of three cancer drugs metabolized by the gene's protein product. Testing for TPMT alleles can help patients avoid adverse reactions to Imuran, GlaxoSmithKline's Thioguanine (6-thioguanine), and Purinethol (6-mercaptopurine), a product of Teva.

Clinical Data plans to maintain its licensing relationship with Prometheus at least until the end of the year, the company said in a statement.

The rest of Genaissance remains joined with Icoria's assets in the Cogenics unit. Generally, Icoria brought biomarker discovery, metabolomics, and gene-expression technologies into the union, while Genaissance brought sequencing, genotyping, and biobanking capabilities.

Even without creating a stand-alone unit for pharmacogenomics products, Clinical Data seems to have done well since it embarked into molecular diagnostics. The company reported a 39-percent jump in revenues to $19.9 million in its fiscal third quarter, which ended Dec. 31, 2005.

The firm attributed its higher revenues to the larger asset base resulting from its acquisitions of Genaissance, Icoria, and Electa Lab — factors that also contributed to the company's third-quarter net loss, which surged to $42.8 million from $1 million in the year-ago period. Clinical Data also recognized $40.1 million in aggregate purchased in-process R&D expenses related to the development of biomarkers for Vilazodone and Clozapine.

— Chris Womack ([email protected])

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