Lonza has signed a new long-term product supply agreement with Alexion Pharmaceuticals, a specialty biopharmaceutical company specializing in rare diseases. Under the agreement Lonza will construct and launch a new biologics manufacturing suite dedicated to Alexion manufacturing. Lonza will own and operate the suite as part of its Portsmouth, New Hampshire site. This contract is an expansion of an existing manufacturing agreement, and The agreement will supplement existing production of Alexion products at multiple Lonza facilities.

Alexion’s key product is Soliris (eculizumab) for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare disorders. In late June, Alexion completed the acquisition of Synageva BioPharma Corp, a pharmaceutical specializing in rare diseases. With Soliris, and the anticipated approvals of Strensiq and Kanuma, Alexion is poised to have three innovator products in 2015. Kanuma is currently under priority review with the US Food and Drug Administration (FDA) and has been granted accelerated assessment of its marketing authorization application (MAA) by the European Medicines Agency (EMA). Regulatory decisions in the US and Europe are expected in the second half of 2015. In addition, a new drug application for Kanuma was submitted to Japan’s Ministry of Health, Labor and Welfare (MHLW).

Alexion now has eight product candidates in clinical trials for 11 indications, including SBC-103, an investigational enzyme replacement therapy in an ongoing Phase 1/2 trial for patients with mucopolysaccharidosis IIIB (MPS IIIB), a genetic and progressive rare metabolic disease. SBC-103 was granted Fast Track designation by the FDA in January 2015. Additionally, the combined preclinical pipeline includes more than 30 diverse programs across a range of therapeutic modalities, with at least four additional programs to enter the clinic in 2016.

Source: Lonza and Alexion Pharmaceuticals