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AZ sues to block generic saxagliptin from Mylan

Attempt to protect diabetes treatments Onglyza and Kombiglyze XR
AstraZeneca AZ headquarters London UK

AstraZeneca has filed a lawsuit against Mylan in the US after it filed for approval of a generic version of diabetes drug Onglyza.

The complaint - filed in a district court in West Virginia - follows marketing applications for copycat versions of Onglyza (saxagliptin) as well as generic versions of AZ's combination line extension Kombiglyze XR (saxagliptin and metformin).

AZ says that Mylan is contravening three of its patents on DPP4 inhibitor saxagliptin, including one on the coated tablet formulation used in its products, which expires in the US in November 2028.

The company was also forced to sue Actavis last month after the Irish generics company filed for approval of its version of Onglyza. Actavis said at the time it believed it was the first applicant so would be entitled to 180 days' marketing exclusivity for its generic if approved by the FDA. Both Mylan and Actavis' marketing applications argue that AZ's patents on saxagliptin are invalid.

AZ's complaint asks the court to affirm the validity of all three patents and - in accordance with US law - the suit imposes an immediate 30-month stay on generic launches unless Mylan is able to overturn them in the courts.

AZ took control of the Onglyza and Kombiglyze franchise after buying out former partner Bristol-Myers Squibb from their diabetes alliance in a $4.1bn deal earlier this year.

Onglyza brought in $378m in alliance revenues for AZ last year - with $265m of that total coming from the US market - and it had around 16 per cent share of the world market for DPP4 inhibitors, a class which also includes Merck & Co's market-leading Januvia (sitagliptin), Novartis' Galvus (vildagliptin) and Boehringer Ingelheim/Lilly's Trajenta (linagliptin).

For the 12 months ending February 28, 2014, the drug had combined (AZ and BMS) US sales of approximately $532m, according to IMS Health data.

AZ is also rounding out its Onglyza franchise by developing a combination product based on the drug and SGLT2 inhibitor Forxiga (dapagliflozin), which should be submitted for approval by the end of the year.

2nd July 2014

From: Sales, Regulatory

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