Lilly pays USD 500m for first-in-class MS drug

Canada-based BioMS has licensed its first-in-class, phase III secondary progressive multiple sclerosis (SPMS) drug, MBP8298, to Lilly in a deal worth approximately USD 497m.

On the news, which was announced on 18 December, shares in the biotech increased 38 per cent (CAD 1.02) to close up at CAD 3.72 (USD 3.70).

Per the agreement, BioMS will receive USD 87m in up front payments, and as much as USD 410m in development and sales milestone payments.

The transaction is expected to become effective in the first quarter of 2008.

BioMS will manage and fund three ongoing clinical trials with MBP8298, while Lilly will fund all future trials, manufacturing and marketing. Lilly also wins exclusive global commercialisation rights to the drug in all forms of MS and will pay BioMS escalating royalties.

If approved, MBP8298 will compete with Biogen Idec's Avonex (interferon beta-1a), Teva's Copaxone (glatiramer), Berlex Labs' Betaseron (beta interferon 1b), Merck Serono's Rebif (beta interferon 1a) and Biogen Idec/ Elan's Tysabri (natalizumab). However, these drugs are approved to treat only the relapsing-remitting form of multiple sclerosis (RRMS).

MBP8298 is a synthetic peptide version of a portion of human myelin basic protein. The drug, which is the only one of its kind in phase III trials, is designed to restore immune tolerance, disrupting the disease's characteristic autoimmune attack against the myelin sheaths surrounding nerve fibres.

A subgroup of MS patients with codes for the HLA-DR2 or HLA-DR4 genes has shown the most benefit from MBP8298. BioMS estimates that 65 to 75 per cent of MS patients have the genes.

Giese says that the approved drugs for RRMS have had "limited success" in treating SPMS, and that MBP8298 is the only new drug in phase III trials specifically designed to address the SPMS patient population.

Ongoing trials
BioMS also is in the process of enrolling a US phase III trial, which should produce interim data in 2009 and full data in 2010.

In addition to the two pivotal programs in SPMS, BioMS has an EU phase II trial ongoing in RRMS, with data expected around the end of 2008.

Giese estimated that BioMS will spend USD 60m over the next few years to finish its trials. However, the company reported USD 49.2m in cash and short-term investments at the end of Q3 FY07, and adding the up-front payment from Lilly means BioMS probably would not approach the markets to fund MBP8298.