Epirus Biopharmaceuticals (EPRS -0.7%) consummates a collaboration agreement with Guangdong-based Livzon Mabpharm to develop, manufacture and commercialize up to five biosimilar products.
The first collaboration product is BOW015 (infliximab), a Remicade biosimilar (JNJ -1.1%) that was recently approved in India. Livzon will be responsible for the development work necessary for approval in China and Taiwan. It will the preferred supplier of BOW015 following the transfer of Epirus' manufacturing platform and manage all commercialization activities in its territories.
India's Drug Controller General approves Epirus Biopharmaceuticals' (EPRS +1.7%) Remicade (infliximab) biosimilar, BOW015. It is the first infliximab biosimilar approved for sale in that country.
The company and commercialization partner Ranbaxy Laboratories expect to launch the product by Q1 2015 under the brand name Infimab.
Under the terms of their January 2014 license agreement, Epirus will develop and supply BOW015 and Ranbaxy will register and commercialize BOW015 in India and other territories in Southeast Asia, North Africa and selected other markets.
Zalicus (ZLCS) shareholders will own 19% of Epirus Biopharmaceuticals post merger. The precise proportion (14 - 19%) was to be determined by the level of net cash on Zalicus' balance sheet. Based on its current level, both companies have agreed on the maximum stake.
Zalicus (ZLCS) licenses its Sodium Channel Modulator program including IP and related pipeline assets to AnaBios Corporation. Under the terms of the agreement, Zalicus will be eligible to receive as much as $17.2M in clinical and regulatory milestone payments and up to 12% in royalties on future net sales of any product resulting from the license.
The deal will not impact the company's pending merger with Epirus Biopharmaceuticals.
A Phase 3 study on the efficacy and safety of Epirus' BOW015 rheumatoid arthritis drug relative to the currently-available Remicade "met its pre-specified statistical endpoint," and found "no meaningful differences observed in safety or immunogenicity."
Results from the open label testing phase, including "one year immunogenicity, one year safety, and long-term responder rates," are expected in Q3.
In an effort to maximize its ownership stake in its merger with Epirus Biopharmaceuticals, Zalicus (ZLCS +1.1%) sells its combination High Throughput Screening (cHTS) platform and related assets to Horizon Discovery Group for $8M. Based on the successful closing of the transaction, Zalicus shareholders will own 17% of the merged organization.
Zalicus' ownership stake will be determined by its cash position at a certain date prior to the closing of the merger and could range as high as 19% or as low as 14%. The company continues to look at additional asset monetization opportunities that will maximize its stake in the combined firm.
Zalicus (ZLCS) has agreed to sell itself to Boston-based Epirus Biopharmaceuticals, a developer of biosimilar monoclonal antibodies, in an all-stock deal.
The combined company will trade on Nasdaq and will be led by Epirus' management team, with Amit Munshi as CEO.
The deal comes after Zalicus' Z160 therapy for pain treatment failed in two Phase 2 trials.
Epirus has also just closed a $36M Series B financing round. The company's pipeline includes biosimilars to Merck's Remicade (inflammatory diseases), AbbVie's Humira (anti-inflammatory, such as for rheumatoid arthritis) and Roche's Avastin (cancer).
Zalicus' stockholders will own approximately 14-19% of the combined company at the closing of the deal and Epirus' shareholders 81-86%, based on the amount of cash that Zalicus will hold. If closing were today, Zalicus shareholders would get 14%.