Extending a prior relationship, Biolex Inc. entered a broader alliance with Centocor Inc. to manufacture certain proteins using the Biolex LEX System.
"To be aligned with Centocor, a company with a strong pipeline and commercial line of therapeutic proteins, is a real validation of the company," Biolex President and CEO Jan Turek told BioWorld Today, adding that Centocor chose the Biolex deal after evaluating numerous other expression methods, such as animal-based and plant-based systems. "We're very proud that a company that has looked at all these systems has entered into what we call a groundbreaking and unprecedented collaboration with us."
Terms of the deal call for privately held Biolex to employ its technology in developing and scaling up the production of proteins that stem from Centocor's therapeutic pipeline. Specifically, Biolex will advance up to 10 such proteins in its LEX System, which couples natural characteristics of an aquatic plant, the Lemna, with genetic engineering and protein recovery methods.
"This allows us to develop and produce therapeutic proteins at very competitive and even transformational cost benefits in terms of operating and capital costs," Turek said. "One of our collaborators at Centocor said, There are five reasons we're interested in working with Biolex. Four of them are capital.'"
For Biolex, which is based in Pittsboro, N.C., the arrangement marks its largest collaboration to date, both in terms of its monetary value as well as its scope. In exchange for its work, Biolex has received an undisclosed up-front payment and is due three years of funding from Centocor, a Malvern, Pa.-based division of Johnson & Johnson, to support the scale up of certain aspects of the LEX System. For each of the therapeutic proteins developed under the alliance, Biolex will receive milestone payments based on their clinical advancement and approvals, as well as supply fees for GMP materials. Biolex also stands to receive royalties on product sales.
"It's a classic biotechnology deal, where we are participating in the value created by their drugs," Turek said, noting the up-front, milestone and royalty payments built into the collaboration, "as well as providing them with supply of GMP material."
In addition, Johnson & Johnson Development Corp. will make an investment in Biolex's next equity financing round. Turek said his company is in "a very strong situation right now" that positions it to soon access private funding. It last raised capital a year and a half ago in a fourth-round financing worth $24.4 million. The J&J venture capital arm also agreed to provide Biolex further investments to assist in establishing additional large-scale GMP biomanufacturing facilities, and Biolex is eligible to receive manufacturing-related milestone payments from Centocor upon establishment and validation of those facilities.
Biolex, which began its initial collaboration with Centocor in May 2003, since has scaled up two Centocor antibodies in the LEX System for preclinical testing under subsequent expansions of that original collaboration. Ferghana Partners Group, which has operations in New York and London, advised Biolex in the latest transaction between the companies.
On its own, Biolex is developing recombinant human therapeutic proteins through its LEX System to generate an internal pipeline of products. Its lead development candidate, an alpha-interferon labeled BLX-883, is in Phase I. A backup alpha-interferon product, called Locteron, a controlled-release compound, is partnered with OctoPlus Technologies BV, of Leiden, the Netherlands. Deeper in Biolex's pipeline is BLX-155, an anti-clotting agent for peripheral arterial occlusive disease, slated to move into preclinical studies at the end of this year.
And similar to its Centocor relationship, Biolex has partnered its protein development and production capabilities with Medarex Inc., of Princeton, N.J., and other drug development companies.
"We have a lot of things moving forward very rapidly," Turek said. "The company has clearly advanced into development stage, where we're developing therapeutic proteins either from our own line of products or working together with partners."