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Clashing Over Rx/Dx Rights, Roche Files Suit Against DxS to Enforce Distribution Deal for KRAS, EGFR Tests

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Originally published Feb. 16.

By Turna Ray

A web of competing commercial interests in DxS' complex development and distribution structures for its diagnostic tests may have led Roche to file a lawsuit against the Qiagen subsidiary.

Roche filed a suit last week in the US Southern District Court of New York, alleging that DxS is trying to renege on a distribution agreement between the two firms for KRAS and EGFR mutations tests.

In June 2008, Roche and DxS signed a distribution deal which gave Roche exclusive global distribution rights for DxS' TheraScreen KRAS Mutation Test and the TheraScreen EGFR 29 Mutation Test in all markets except the US, Canada, Mexico, and Hong Kong [see PGx Reporter 06-04-2008].

According to Roche, which refused to provide a copy of the suit, DxS is trying to get out of it is distribution deal because the firm believes Roche has not fulfilled its obligation to assist DxS in developing software. Roche maintains that there is no such obligation in the agreement.

"Roche is confident it is not in breach of its distribution agreement and intends to enforce its rights to exclusive, worldwide distribution of K-RAS and EGFR products for in vitro diagnostic use, and for research use only in Japan," a Roche spokesperson said in a statement sent to PGx Reporter sister publication GenomeWeb Daily News. Beyond this, Roche would not comment further on the suit.

Naturally, the UK-based diagnostics firm denies the allegations in the Roche suit. "DxS/Qiagen was not planning to end its distribution deal with Roche and this was part of the company’s plans through to 2012," a DxS spokesperson told Pharmacogenomics Reporter this week in an e-mail.

In turn, the DxS spokesperson assured that since the lawsuit only concerns the distribution deal with Roche regarding DxS' KRAS test, it is not expected to impact DxS' overall business.

The 2008 deal between DxS and Roche came about when DxS was still an independent company. Since then DxS was acquired by Qiagen, one of Roche's competitors in the molecular diagnostics market [see PGx Reporter 09-23-2009].

Further complicating things is the fact that last year DxS inked separate deals with Amgen and Bristol-Myers Squibb to develop KRAS mutation test kits to accompany two colorectal cancer drugs, Vectibix and Erbitux [see PGx Reporter 09-02-2009].

Although DxS is asserting the lawsuit only concerns the KRAS test, Roche's statement about "enforcing its rights to exclusive, worldwide distribution of KRAS and EGFR products" suggests the legal kerfuffle may concern both of DxS' flagship TheraScreen products.

DxS has an Rx/Dx deal with AstraZeneca to develop a companion test for Iressa in non-small cell lung cancer in the European market [see PGx Reporter 08-05-2009].

Separately, Boehringer Ingelheim announced in May that it would use DxS' EGFR Mutation Kit to identify best responders in clinical trials for its investigational NSCLC drug BIBW2992. Under the terms of the agreement, DxS and Boehringer Ingelheim together commercialize a companion diagnostic test kit globally, if BIBW2992 is approved by the FDA. BIBW 2992 is said to be the first dual inhibitor of EGFR and HER2 to reach Phase III development in NSCLC [see PGx Reporter 05-29-2009].

Roche would not comment on whether its global distribution rights were for DxS' laboratory-developed tests or the companion diagnostic test kits being developed with various pharmaceutical firms.

For a global pharmaceutical company investing to develop a companion genetic test for one of its drugs, it is critical that there are global distribution channels for the diagnostic to ensure a simultaneous Rx/Dx launch. It is unclear how Roche's lawsuit to enforce its global distribution rights for DxS' tests will impact the company's ongoing Rx/Dx deals.

In the US, a territory where Roche does not have distribution rights, DxS' KRAS test is currently available as a laboratory-developed test distributed by Exiqon. The company has submitted the test to the US Food and Drug Administration for premarket approval.

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