update

Epirus files for bankruptcy protection and hands Remicade biosim to Reliance Life Sciences

By Staff Reporter

- Last updated on GMT

iStock/Marcio Silva
iStock/Marcio Silva

Related tags: U.s. securities and exchange commission

Epirus Biopharmaceuticals has filed for Chapter 7 bankruptcy protection, settled with licensee Livzon Mabpharm and handed its Remicade (infliximab) biosimilar to Reliance Life Sciences (RLS).

According to a US Securities and Exchange Commission (SEC) filing on July 25​, Boston-based Epirus is relief under the provisions of Chapter 7 of Title 11 of the US Code.

The firm said: "As a result of this filing, a Chapter 7 trustee will be appointed by the Bankruptcy Court and will assume control of the Company. The assets of the Company will be liquidated and claims paid in accordance with the Code​."

Epirus also announced it will transfer Indian “rights, title, interest and obligations​” to its Remicade biosimilar – a product called Infimab (infliximab) that was previously known as B0W015 - to India-based RLS.

The US firm will also hand rights to use Catalent’s GPEx cell line, which is needed to make the drug, to Reliance.

Inflimab was launched by Epirus and partner Ranbaxy - now owned by Sun Pharmaceutical - in December 2014 under an agreement signed in January of that year.

Manufacturing

Originally, RLS was due to manufacture the biosimilar for the Indian market on Epirus’ behalf.

In September 2014, RLS was cleared by Indian regulatory authorities to make the biosimilar at its facility in Mumbai. However, the following December RLS said it wanted to terminate the deal.

In March 2015, RLS initiated an arbitration proceeding against Epirus alleging the firm and contractors hired in the interim period - Fujifilm Diosynth Biotechnologies and Livzon MabPharm – had violated the original manufacturing agreement.

Epirus settled last April​, agreeing to pay RLS $2.25m (€2m) in four instalments.

Cost savings

The bankruptcy filing and Infimab handover follow months​ after Epirus announced a “reprioritization of its pipeline​” and plans to reduce its workforce​ by 40%.

The firm also said it would halt development of B0W015 for other markets.

Since then​ Epirus has agreed to sell a CHO platform and IP it acquired with Bioceros Holding NV last September to Poland-based biosimilar developer Polpharma for $3.5m.

Epirus did not respond to a request for comment.

Related topics: Markets & Regulations, Cell lines

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