BOSTON & COPENHAGEN, Denmark--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (NASDAQ:ZEAL) today announced a collaboration to discover and develop novel peptide therapies for complement-mediated diseases. Peptides offer a number of advantages, including being highly selective and potent, allowing low dosage volumes for ease of administration, and having the potential to treat a broad range of complement-mediated diseases. The agreement provides Alexion with exclusive worldwide licenses, as well as development and commercial rights, for up to four targets within the complement pathway.
“We know that uncontrolled activation of the complement pathway is responsible for many devastating diseases, and through the development of the first two complement inhibitors – SOLIRIS and ULTOMIRIS – we have shown the transformative impact of C5 inhibition on several of these diseases,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. “We are excited by the potential to explore different targets in the complement pathway and look forward to building on Alexion’s more than 20 years of complement expertise with the development of next-generation peptide therapies in collaboration with Zealand Pharma, which may provide the opportunity to treat many additional diseases.”
“Collaborating with Alexion is further evidence of the strength of our peptide discovery platform, which has delivered both approved novel peptide-based therapeutics and a deep late-stage pipeline,” said Adam Steensberg, Interim CEO and Chief Medical and Development Officer at Zealand. “We believe that peptide-based therapies hold great promise in inhibiting complement activation. Alexion’s demonstrated expertise in treating rare and complement-mediated diseases makes this the ideal collaboration to advance Zealand’s complement-focused peptide programs.”
Under the terms of the agreement, Alexion and Zealand will enter into an exclusive collaboration for the discovery and development of subcutaneously delivered peptide therapies directed to up to four complement pathway targets. Zealand will lead the joint discovery and research efforts through the preclinical stage, and Alexion will lead development efforts beginning with IND filing and Phase 1 studies. The agreement provides Alexion with exclusive worldwide licenses and commercial rights to the peptide therapies developed in the collaboration. Zealand will receive an immediate upfront payment of $25 million for the first target, with Alexion making a concurrent $15 million equity investment in Zealand Pharma at a premium to the market price as of the collaboration effective date. For the lead target, the agreement provides the potential for development-related milestones of up to $115 million, as well as up to $495 million in sales-related milestones and the potential for high single- to low double-digit royalty payments. Each of the three subsequent targets can be selected for an option fee of $15 million and has the potential for additional development milestones and sales milestones and royalty payments at a reduced price to the lead target.
Alexion will discuss the collaboration further during today’s Investor Day event and webcast. Zealand will host a conference call on Thursday, March 21, at 4 p.m. CET.
About Alexion
Alexion is a global biopharmaceutical company
focused on serving patients and families affected by rare diseases
through the discovery, development and commercialization of
life-changing therapies. As the global leader in complement biology and
inhibition for more than 20 years, Alexion has developed and
commercializes two approved complement inhibitors to treat patients with
paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only
approved complement inhibitor to treat atypical hemolytic uremic
syndrome (aHUS) and anti-acetylcholine receptor (AchR) antibody-positive
generalized myasthenia gravis (gMG), and is also developing it for
patients with neuromyelitis optica spectrum disorder (NMOSD). Alexion
also has two highly innovative enzyme replacement therapies for patients
with life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In
addition, the company is developing several mid-to-late-stage therapies,
including a second complement inhibitor, a copper-binding agent for
Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare
Immunoglobulin G (IgG)-mediated diseases as well as several early-stage
therapies, including one for light chain (AL) amyloidosis and a second
anti-FcRn therapy. Alexion focuses its research efforts on novel
molecules and targets in the complement cascade and its development
efforts on the core therapeutic areas of hematology, nephrology,
neurology, and metabolic disorders. Alexion has been named to the Forbes
list of the World’s Most Innovative Companies seven years in a row and
is headquartered in Boston, Massachusetts’ Innovation District. The
company also has offices around the globe and serves patients in more
than 50 countries. This press release and further information about
Alexion can be found at: www.alexion.com.
[ALXN-G]
About Zealand Pharma
Zealand Pharma is a biotechnology
company focused on the discovery and development of innovative
peptide-based medicines. The company’s peptide discovery platform is
built on 20 years of experience and has been extensively validated by
their clinical pipeline, partnerships and marketed products; these
include more than 10 drug candidates invented by Zealand that have
advanced into clinical development, of which two have reached the
market. Zealand’s current pipeline of internal product candidates focus
on specialty gastrointestinal and metabolic diseases. Zealand’s
portfolio also includes two clinical license collaborations with
Boehringer Ingelheim. Zealand is based in Copenhagen (Glostrup),
Denmark. For further information about the company's business and
activities, please visit www.zealandpharma.com.
Forward-Looking Statement
This press release includes
forward-looking statements. Such forward-looking statements are subject
to risks and uncertainties that could cause actual results to differ
materially from those expressed or implied in such statements. Examples
of forward-looking statements include, among others, statements we make
regarding: (i) the therapeutic and commercial potential of peptide-based
therapies; (ii) research and development plans related to peptide-based
therapies; (iii) the potential of peptide-based therapies for the
treatment of complement-mediated diseases; (iv) the potential for the
collaboration between Alexion and Zealand; and (v) the closing of the
equity investment by Alexion into Zealand, which is subject to standard
closing conditions. The process by which early stage products such as
Zealand’s peptide-based therapies could potentially lead to an approved
product is long and subject to highly significant risks, particularly
with respect to a preclinical research collaboration. Applicable risks
and uncertainties include those relating to preclinical research and
other risks identified under the heading "Risk Factors" included in
Alexion’s and Zealand’s most recent Form 10-K and 20-F filings and in
other future filings with the SEC. The forward-looking statements
contained in this press release reflect Alexion’s and Zealand’s current
views with respect to future events, and neither Alexion nor Zealand
undertakes and specifically disclaims any obligation to update any
forward-looking statements, except as required by law.