logo-loader

Alkermes and Biogen to develop and commercialise ALKS 8700 for relapsing forms of MS

Last updated: 10:58 27 Nov 2017 EST, First published: 03:58 27 Nov 2017 EST

Scientists
The drug candidate is also currently in a head-to-head study called EVOLVE-MS-2 aimed at evaluating GI tolerability compared to Tecfidera.

Alkermes PLC (NASDAQ:ALKS) and Biogen Inc (NASDAQ:BIIB) have entered into a global license and collaboration deal to develop and commercialise drug candidate ALKS 8700 for the treatment of relapsing forms of Multiple Sclerosis or MS.

In a joint statement issued by both companies, they said that they are targeting to make a New Drug Application (NDA) for ALKS 8700 in 2018.

READ: Biogen shares hit two-year high after brokers turn bullish ahead of third quarter results

Under the collaboration deal, Biogen will receive an exclusive, worldwide licence to commercialise ALKS 8700. In return, it will pay Alkermes a “mid-teens royalty” on worldwide net sales of the drug.

Development expenses for ALKS 8700

Biogen will also reimburse 50% of the 2017 development costs for ALKS 8700. This means, Alkermes is set to receive an upfront payment of US$28mln which represents Biogen’s share of the development expenses that have already incurred in 2017.

However, starting from January 1 next year, Biogen will take on the development expenses for ALKS 8700.

Alkermes may also receive milestone payments for the drug candidate, capped at US$200mln on certain clinical and regulatory achievements.

Biogen said the initial milestone payment of US$50mln will be recorded as an expense in 2017 in its books.

Clinicial trials

Alkermes will continue to maintain responsibility for the regulatory interactions with the US Food and Drugs Administration (US FDA).

Alkermes is planning to seek approval for ALKS 8700 under the regulatory pathway referencing Biogen’s Tecfidera (dimethyl fumarate)

ALKS 8700 is a novel, oral, monomethyl fumarate or MMF small drug molecule in Phase III development for the treatment of relapsing forms of MS.

The drug candidate is also currently in a head-to-head study called EVOLVE-MS-2 aimed at evaluating gastrointestinal tolerability compared to Tecfidera.

Initial data from the EVOLVE-MS-2 study are expected in the first half next year.

Biogen shares nudged 0.44% higher at US$310.34.

Alkermes shares lost 2.80% to  US$49.62.

Ramp Metals Launches Drilling Program in Pursuit of High-Grade Nickel in...

Ramp Metals CEO Jordan Black joined Steve Darling from Proactive to introduce the company to the public domain and share exciting developments in the mining industry. With a background as a geotechnical engineer and experience in venture capital, including a notable role in taking GoldSpot...

26 minutes ago