ArQule eligible to receive up to $336 million
including upfront, regulatory and commercial milestone payments
ArQule to host investor conference call
including transaction details, AACR highlights and an update on
clinical strategy April 18, 2018 at 9:00 A.M. ET
ArQule, Inc. (NASDAQ:ARQL) today announced that it has entered
into an exclusive license agreement with Basilea Pharmaceutica
International Limited (Basilea, SIX: BSLN) to develop and
commercialize derazantinib, a pan-FGFR (fibroblast growth factor
receptor) inhibitor in the US, EU, Japan and rest of the world
excluding the People’s Republic of China, Hong Kong, Macau and
Taiwan, where Sinovant Sciences Ltd., a Roivant Sciences Ltd.
subsidiary, has rights to develop and exclusively commercialize the
drug.
Under the terms of the agreement, ArQule will receive an upfront
payment of $10 million and is eligible for up to $326 million in
regulatory and commercial milestones. ArQule is also entitled to
receive staggered single-digit to double-digit royalties on net
sales upon commercialization. Basilea will be responsible for all
costs and expenses of development, manufacture and
commercialization in its territory. Under certain circumstances,
ArQule may have the opportunity to promote derazantinib in the US
directly.
ArQule is currently conducting a registrational trial for
derazantinib in the United States,
Canada and Europe as a potential treatment for
intrahepatic cholangiocarcinoma (iCCA), a form of biliary tract
cancer. As part of the exclusive license agreement, Basilea intends
to continue this trial and the further development of derazantinib
in iCCA and other tumor types with FGFR dysregulation.
Ronald Scott, Chief Executive Officer of Basilea, said: “We are
very excited about this partnership with ArQule. Derazantinib is an
ideal match for our existing clinical oncology portfolio. It is a
targeted therapy building on a solid biomarker approach in an area
where patients currently have limited treatment options. This
transaction underscores our continued commitment to expand our
R&D portfolio with novel compounds focused on overcoming the
clinical problem of resistance in oncology and infectious diseases.
Our clinical oncology portfolio now includes three drug candidates
in different stages of development. We continue to focus on further
broadening our R&D portfolio through internal and external
innovation.”
“Partnering with Basilea, a company with global drug development
experience and expertise, will propel the advancement of
derazantinib in ways we could not have achieved independently,”
said Paolo Pucci, Chief Executive Officer of ArQule. “Basilea will
bring a wealth of skills to the expansion of the derazantinib
development plan at a time when it will benefit most from these
resources, allowing it to reach its full potential in iCCA and
beyond.”
ArQule will hold a conference call to discuss this agreement
tomorrow, April 18, beginning at 9 a.m. EDT. Paolo Pucci, Chief
Executive Officer of ArQule, will lead the call. As a result of
entering into the exclusive license agreement, ArQule will be
updating its financial guidance on the call.
The details of the call are as follows:
Wednesday, April 18, 2018 at 9:00 AM
EDT
Audio connection numbers:
US: 1 877-868-1831
Outside US: 1 914-495-8595 PIN: 4089669
A replay of the call will be available two hours after the
completion of the call and can be accessed in the “Investors and
Media” section of our website, www.arqule.com, under “Events and
Presentations.” The ArQule investor conference call will be
archived and can be accessed in the “Investors and Media” section
of ArQule’s website, www.arqule.com, under “Events and
Presentations.”
About Derazantinib
Derazantinib is a potent, orally administered inhibitor of the
fibroblast growth factor receptor (FGFR) family, a key driver of
cell proliferation, differentiation, and migration. In a Phase 1/2
study in patients with iCCA harboring FGFR2 gene fusions, treatment
with derazantinib resulted in an objective response rate of 21%,
nearly 3 times higher than standard-of-care chemotherapy. ArQule is
currently conducting a registrational study with derazantinib in
patients with FGFR2 fusion-positive second-line iCCA. The
open-label single-arm trial is recruiting in the United States,
Canada and Europe with objective response rate as the primary
endpoint. More information on that program is available here.
About Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma (CCA) is the most common biliary malignancy
and the second most common hepatic malignancy after hepatocellular
carcinoma (HCC).1 Depending on the anatomic location, CCA is
classified as intrahepatic (iCCA), perihilar (pCCA), and
extrahepatic (eCCA). iCCA originates from the intrahepatic biliary
ductal system and forms an intrahepatic mass. iCCA is an aggressive
cancer, with a median 5-year survival rate of 15% for patients
diagnosed with early-stage disease.2 In China, the incidence of
cholangiocarcinoma is more than 7 cases per 100,000 people, and the
majority of cases are intrahepatic.3
About ArQule
ArQule is a biopharmaceutical company engaged in the
research and development of targeted therapeutics to treat cancers
and rare diseases. ArQule's mission is to discover, develop and
commercialize novel small molecule drugs in areas of high unmet
need that will dramatically extend and improve the lives of our
patients. Our clinical-stage pipeline consists of five drug
candidates, all of which are in targeted, biomarker-defined patient
populations, making ArQule a leader among companies our
size in precision medicine. ArQule's proprietary pipeline includes:
Derazantinib, a multi-kinase inhibitor designed to preferentially
inhibit the fibroblast growth factor receptor (FGFR) family, in a
registrational trial for iCCA and in phase 1b for multiple oncology
indications; Miransertib (ARQ 092), a selective inhibitor of the
AKT serine/threonine kinase, in a phase 1/2 company sponsored study
for Overgrowth Diseases, in a phase 1 study for ultra-rare Proteus
syndrome conducted by the National Institutes of
Health (NIH), as well as in multiple oncology indications; ARQ
751, a next generation AKT inhibitor, in phase 1 for patients with
AKT1 and PI3K mutations; and ARQ 761, a β-lapachone analog being
evaluated as a promoter of NQO1-mediated programmed cancer cell
necrosis, in phase 1/2 in multiple oncology indications in
partnership with the University of Texas Southwestern Medical
Center. In addition, we have advanced ARQ 531, an investigational,
orally bioavailable, potent and reversible inhibitor of both wild
type and C481S-mutant BTK, in phase 1 for patients with B-cell
malignancies refractory to other therapeutic options. ArQule's
current discovery efforts are focused on the identification and
development of novel kinase inhibitors, leveraging the Company's
proprietary library of compounds. You can follow us
on Twitter and LinkedIn.
About Basilea
Basilea Pharmaceutica Ltd. is a commercial stage
biopharmaceutical company developing products that address the
medical challenge of increasing resistance and non-response to
current treatment options in the therapeutic areas of bacterial
infections, fungal infections and cancer. With two commercialized
drugs, the company is committed to discovering, developing and
commercializing innovative pharmaceutical products to meet the
medical needs of patients with serious and life-threatening
conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel,
Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN).
Additional information can be found at Basilea's
website www.basilea.com.
Forward Looking Statements
This press release contains forward-looking statements regarding
the Company’s clinical trials with derazantinib as well as the
potential for future milestone and royalty payments under its
License Agreement with Basilea. These statements are based on the
Company’s current beliefs and expectations, and are subject to
risks and uncertainties that could cause actual results to differ
materially. Positive information about pre-clinical and early stage
clinical trial results does not ensure that later stage or larger
scale clinical trials will be successful. For example, derazantinib
may not demonstrate promising therapeutic effect. In addition,
derazantinib may not demonstrate an acceptable safety profile in
current or later stage or larger scale clinical trials as a result
of known or as yet unanticipated side effects. The results achieved
in later stage trials may not be sufficient to meet applicable
regulatory standards or to justify further development. Problems or
delays may arise during clinical trials or in the course of
developing, testing or manufacturing derazantinib that could lead
the Company or Basilea to discontinue its development. Even if
later stage clinical trials are successful, unexpected concerns may
arise from subsequent analysis of data or from additional data.
Obstacles may arise or issues may be identified in connection with
review of clinical data with regulatory authorities. Regulatory
authorities may disagree with the Company’s or Basilea’s view of
the data or require additional data or information or additional
studies. In addition, we plan to develop and use a companion
diagnostic to identify patients with FGFR2 fusions and possibly
other fusions for our future derazantinib clinical trials. We
intend to outsource the development of such companion diagnostics
to one or more third party collaborators. Such collaborators may
encounter difficulties in developing and obtaining approval for
such companion diagnostics, including issues relating to
selectivity/specificity, analytical validation, reproducibility,
concordance or clinical validation. Any delay or failure to develop
or obtain regulatory approval of such companion diagnostics could
delay or prevent approval of derazantinib. Moreover, Basilea has
only a limited track record of drug development in oncology. If
derazantinib is not successfully developed and as a result of any
of the foregoing or other issues, risks or uncertainties, ArQule
may not receive any future milestones or royalties under the
License Agreement with Basilea. Drug development involves a high
degree of risk. Only a small number of research and development
programs result in the commercialization of a product. Furthermore,
ArQule may not have the financial or human resources to
successfully pursue drug discovery in the future. For more detailed
information on the risks and uncertainties associated with the
Company’s drug development and other activities, see the Company’s
periodic reports filed with the Securities and Exchange Commission.
The Company does not undertake any obligation to publicly update
any forward-looking statements.
1 Welzel TM, et al. Impact of classification of hilar
cholangiocarcinomas (Klatskin tumors) on the incidence of intra-
and extrahepatic cholangiocarcinoma in the United States. Journal
of the National Cancer Institute 2006; 98(12), 873-875.
2 American Cancer Society
3 Banales JM, et al. Cholangiocarcinoma: current knowledge and
future perspectives consensus statement from the European Network
for the Study of Cholangiocarcinoma (ENS-CCA). Nature Reviews:
Gastroenterology & Hepatology 2016; 13, 261-280.
Related links
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ArQule, Inc.Paolo Pucci, 781-994-0300Chief Executive
Officerwww.ArQule.com
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