Aurinia Announces Long-Term Manufacturing Collaboration Agreement with Lonza for Clinical and Commercial Supply of Voclosporin
December 19 2016 - 3:05PM
Business Wire
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP) (“Aurinia”
or the “Company”), a clinical stage biopharmaceutical company
focused on the global immunology market, today announced it has
entered into a long-term agreement with Lonza for the manufacture
of voclosporin active pharmaceutical ingredient (API).
This agreement follows a successful multi-year clinical
manufacturing relationship where the companies have been refining
the process and analytical methods to produce clinical and
commercial supplies of voclosporin.
Under the terms of the agreement, Lonza agrees to produce
cGMP-grade voclosporin drug substance for use in Aurinia’s Phase
III lupus nephritis (LN) clinical program and for future commercial
use. The agreement also provides an option to have Lonza
exclusively supply API for up to 20 years.
“Throughout the company’s long relationship with Lonza, we have
developed substantial proprietary know-how in manufacturing
commercial scale voclosporin. We believe this know-how has the
potential to broaden our exclusivity position for voclosporin and
ensure high quality, reliable production of the API,” said Lawrence
Mandt, VP Regulatory and Quality at Aurinia.
“Our partnership with Lonza is the culmination of years of
collaboration in which we have optimized the complex manufacturing
process for voclosporin,” said Charles Rowland, Chief Executive
Officer of Aurinia. “As we prepare to advance voclosporin into an
LN Phase III program, we are investing in the infrastructure to
deliver this important therapy to patients living with this
devastating disease.”
“We’re looking forward to further developing our partnership
with Aurinia to supply this innovative medicine to lupus nephritis
patients around the world,” said Gordon Bates, Senior Vice
President, Business Unit Head, Chemical and Microbial Manufacturing
for Lonza.
“As Voclosporin requires a complex manufacturing process, our
expertise in scaling multi-step synthesis at clinical and
commercial scale allows us to support Aurinia to and through Phase
III clinical trials,” he added. “This latest agreement further
demonstrates Lonza’s commitment to developing customized supply
solutions for our customers as they meet some of the greatest
challenges in patient treatment, in this case for lupus nephritis
patients around the world.”
About LonzaLonza is one of the world’s leading and
most-trusted suppliers to the pharmaceutical, biotech and specialty
ingredients markets. We harness science and technology to create
products that support safer and healthier living and that enhance
the overall quality of life. Not only are we a custom manufacturer
and developer, Lonza also offers services and products ranging from
active pharmaceutical ingredients and stem-cell therapies to
drinking water sanitizers, from the vitamin B compounds and organic
personal care ingredients to agricultural products, and from
industrial preservatives to microbial control solutions that combat
dangerous viruses, bacteria and other pathogens. Founded in 1897 in
the Swiss Alps, Lonza today is a well-respected global company with
more than 40 major manufacturing and R&D facilities and
approximately 9,800 full-time employees worldwide. The company
generated sales of about CHF 3.8 billion in 2015 and is organized
into two market-focused segments: Pharma&Biotech and Specialty
Ingredients. Further information can be found at www.lonza.com
About VoclosporinVoclosporin, an investigational drug, is
a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical data in over 2,000 patients across indications.
Voclosporin is an immunosuppressant, with a synergistic and dual
mechanism of action that has the potential to improve near- and
long-term outcomes in LN when added to standard of care (MMF). By
inhibiting calcineurin, voclosporin blocks IL-2 expression and
T-cell mediated immune responses. It is made by a modification of a
single amino acid of the cyclosporine molecule which has shown a
more predictable pharmacokinetic and pharmacodynamic relationship,
an increase in potency, an altered metabolic profile, and potential
for flat dosing. The Company anticipates that upon regulatory
approval, patent protection for voclosporin will be extended in the
United States and certain other major markets, including Europe and
Japan, until at least October 2027 under the Hatch-Waxman Act and
comparable laws in other countries.
About Lupus Nephritis (LN)Lupus Nephritis (LN) in an
inflammation of the kidney caused by Systemic Lupus Erythematosus
(SLE) and represents a serious progression of SLE. SLE is a
chronic, complex and often disabling disorder and affects more than
500,000 people in the United States (mostly women). The disease is
highly heterogeneous, affecting a wide range of organs & tissue
systems. It is estimated that as many as 60% of all SLE patients
have clinical LN requiring treatment. Unlike SLE, LN has
straightforward disease outcomes where an early response correlates
with long-term outcomes, measured by proteinuria. In patients with
LN, renal damage results in proteinuria and/or hematuria and a
decrease in renal function as evidenced by reduced estimated
glomerular filtration rate (eGFR), and increased serum creatinine
levels. LN is debilitating and costly and if poorly controlled, LN
can lead to permanent and irreversible tissue damage within the
kidney, resulting in end-stage renal disease (ESRD), thus making LN
a serious and potentially life-threatening condition.
About AuriniaAurinia is a clinical stage
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are suffering
from serious diseases with a high unmet medical need. The company
is currently developing voclosporin, an investigational drug, for
the treatment of lupus nephritis (LN). The company is headquartered
in Victoria, BC and focuses its development efforts globally.
www.auriniapharma.com.
Forward Looking StatementsThis press release contains
forward-looking statements, including statements related to
Aurinia's manufacturing know-how, capabilities and strategy and
potential clinical and commercial supplies of voclosporin. It is
possible that such results or conclusions may change. Words such as
"plans," "intends," “may,” "will," "believe," and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Aurinia’s current
expectations. Forward-looking statements involve risks and
uncertainties. Aurinia’s actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risk that
Aurinia’s analyses, assessment and conclusions of the results of
the AURA-LV clinical study set forth in this release may change
based on further analyses of such data, and the risk that Aurinia’s
clinical studies for voclosporin may not lead to regulatory
approval. These and other risk factors are discussed under "Risk
Factors" and elsewhere in Aurinia’s Annual Information Form for the
year ended December 31, 2015 filed with Canadian securities
authorities and available at www.sedar.com and on Form 40-F with
the U.S. Securities Exchange Commission and available at
www.sec.gov, each as updated by subsequent filings, including
filings on Form 6-K. Aurinia expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in Aurinia's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based.
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Investor & Media Contact:Aurinia Pharmaceuticals
Inc.Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.com