PERTH, Australia – CSL Ltd. said its subsidiary, CSL Behring, has agreed to exercise an option to acquire Canadian biotech Vitaeris Inc. for its lead phase III asset for rejection in solid organ kidney transplant patients.
The two companies entered a partnership in 2017 to expedite the development of clazakizumab, a humanized anti-interleukin 6 (IL-6) monoclonal antibody (MAb), and CSL had the option to acquire Vitaeris in full.
Under the 2017 terms of the agreement, Vitaeris retained control of projects through end of phase III, and it received an up-front cash payment of $15 million from CSL, followed by R&D milestone payments. The agreement granted CSL an exclusive option to acquire Vitaeris, including future sales-related payments to Vitaeris, and a royalty to Alder Biopharmaceuticals Inc., the innovator of clazakizumab.
CSL will incur additional R&D expenses associated with the completion of the phase III trial, which are estimated to be between $30 million to $50 million. Additional terms for the deal were not disclosed.
Clazakizumab binds to and inhibits IL-6, an important driver of the inflammatory response that is known to play a key role in transplant rejection. The MAb was originally discovered and developed in autoimmune conditions by Bothell, Washington-based Alder.
Acquisition grows CSL’s transplant franchise
Vitaeris complements CSL’s transplant franchise, which includes a phase III program for CSL-964, an Alpha-1 antitrypsin for treatment of steroid-refractory acute graft-vs.-host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT); and CSL-842, a C1-esterase inhibitor for the treatment of refractory antibody-mediated rejection (AMR) in adult renal transplant recipients.
“Clazakizumab has been a promising monoclonal antibody in the transplant therapeutic area since we started working with Vitaeris several years ago,” said CSL’s executive vice president and head of R&D, Bill Mezzanotte.
“Acquiring Vitaeris and their associate expertise helps us to continue to grow our strategic scientific platform of recombinant proteins and antibodies. We look forward to continuing to advance this treatment candidate as a potential option for people experiencing rejection, an area where current treatment options for transplant recipients are limited, at best,” he said.
While advances in transplantation techniques and therapies have markedly improved short-term success rates over the past 15 to 20 years, long-term graft survival remains one of the greatest challenges, with AMR recognized as the most common cause of long-term kidney allograft failure. There are currently no approved treatments for transplant recipients who develop AMR.
“We’re pleased to become part of CSL Behring, a well-established, global industry leader, and know that the future of clazakizumab is in excellent hands,” said Vitaeris President and CEO Kevin Chow. “Together, we have already achieved much progress through our partnership over the past few years and are now in an even stronger position to realize our collective goal of addressing one of the greatest unmet needs in the organ transplant community."
Just days earlier, CSL and the University of Queensland have entered a development agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate development, manufacture and distribution of a COVID-19 vaccine candidate developed by the University of Queensland.
The agreement formalizes support provided by CSL to UQ and CEPI from the outset of the COVID-19 pandemic earlier this year.
CSL Behring Australia, a subsidiary of CSL Ltd., announced separately that it would begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19 in Australia.
Australia’s largest biotech company, CSL Ltd. operates in more than 60 countries and had more than $8.5 billion in revenue in 2019. It invested more than $3.3 billion in R&D over the last five years.
CSL is the largest global plasma therapy company and the second-largest in influenza vaccines. Its pipeline includes treatments for immunology and neurology, hematology and thrombosis, transplants, respiratory, cardiovascular and metabolic disease and influenza.
North America represents 49% of CSL’s revenue, Europe represents 26%, Asia 11%, Australia 8% and the rest of the world 6%.
CSL’s immunoglobulin franchise brought in $3.5 billion in revenue in 2019, while its Seqirus unit brought in $1.1 billion. The firm’s albumin franchise brought in $1.01 billion, hemophilia brought in $1.05 billion and specialty medicines brought in $1.5 billion.
With a market cap of AU$129.5 billion (US$89.61 billion), CSL’s shares on Australia’s Securities Exchange (ASX:CSL) were down 2.39%, trading at AU$278.50 per share on market close June 9.