Curis Announces the Conditional Approval of Erivedge(R) in the European Union
-Triggers $6 Million Milestone Payment to Curis-
LEXINGTON, Mass., July 15, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS),
an oncology-focused drug development company seeking to develop novel drug
candidates for the treatment of human cancers, today announced that the
European Commission has granted conditional approval to Erivedge^®
(vismodegib) for the treatment of adult patients with symptomatic metastatic
basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery
or radiotherapy. This conditional approval makes Erivedge the first licensed
treatment in Europe for patients with advanced BCC, a rare form of skin cancer
which can be disfiguring, debilitating and even fatal.
"We are extremely pleased that Erivedge will now be available as the first
approved medicine in the European Union (EU) for patients with advanced basal
cell carcinoma, a serious medical condition," stated Dan Passeri, Curis' Chief
Executive Officer. "Roche's development and commercialization efforts have
significantly expanded global patient access and the market opportunity for
Erivedge, with regulatory approvals for Erivedge in the United States,
Switzerland, Australia, Israel, South Korea, Mexico, and Ecuador, in addition
to the EU. We expect that Roche will seek approval of Erivedge in several
other territories and anticipate that these efforts will continue to expand
the number of patients that will have access to this important medicine in the
The European Commission granted the conditional approval based upon the
positive recommendation received in April this year from the Committee of
Medicinal Products for Human Use of the European Medicines Agency (EMA). The
European Commission's decision will be applicable to all 28 European Union
member states. As a result of this conditional approval, Curis earned a $6
million milestone payment from Genentech, a member of the Roche Group, and
will continue to be entitled to receive royalties on future sales of Erivedge.
Roche is responsible for commercializing Erivedge in the EU.
A conditional marketing authorization is granted to medicinal products with a
positive benefit/risk assessment that satisfy an unmet medical need and whose
availability would result in a significant public health benefit. Under the
provisions of the conditional approval, Roche is expected to provide
additional data on Erivedge in advanced BCC from an ongoing global safety
About Basal Cell Carcinoma and the Hedgehog Pathway
Basal cell carcinoma (BCC) is the most common type of skin cancer in Europe,
Australia and the United States. The disease is generally considered curable
if the cancer is restricted to a small area of the skin. In advanced BCC, if
the disease is left untreated or recurs in the same location after surgery or
radiotherapy, it may progress and spread further into surrounding areas such
as sensory organs (ears, nose and eyes), bone or other tissues. Depending on
the location of the lesion, some cases of advanced BCC can be disfiguring, and
treatment with surgery or radiation can lead to the loss of sensory organs and
their functions such as eyesight or hearing.
The Hedgehog signaling pathway plays an important role in regulating proper
growth and development in the early stages of life and becomes less active in
adults. Abnormal Hedgehog signaling is implicated in more than 90 percent of
Erivedge is designed to selectively target the Hedgehog signaling pathway,
which is implicated in the development of certain types of cancer, including
Roche has developed Erivedge under a collaboration agreement with Curis.
Erivedge was discovered by Genentech and jointly validated by Genentech and
Curis through a series of preclinical studies. Through this collaboration,
Genentech (U.S.), Roche (ex-U.S. excluding Japan) and Chugai Pharmaceuticals
(Japan) are responsible for the clinical development and commercialization of
Erivedge. Curis is eligible to receive cash payments upon the successful
achievement of specified clinical development and regulatory approval
milestones, as well as royalties upon commercialization of Erivedge.
In January 2012, Erivedge became the first licensed medicine for patients with
advanced basal cell carcinoma when the U.S. Food and Drug Administration (FDA)
approved it under the priority review program that provides for an expedited
six-month review of drugs that offer major advances in treatment. Erivedge has
since also been approved in Switzerland, Australia, Israel, South Korea,
Mexico, and Ecuador.
About the ERIVANCE BCC Study
The EU conditional approval is based on findings from the primary analysis (26
November 2010) in the pivotal ERIVANCE study which enrolled 104 advanced BCC
patients (71 had locally advanced and 33 had metastatic disease) from 31 study
centers in the U.S., Australia and Europe.
The study showed that Erivedge substantially shrank tumors or healed visible
lesions, as defined by objective response rate, in 42.9 percent of patients
with locally advanced and 30.3 percent of patients with metastatic disease as
assessed by independent review.
The most common adverse events included muscle spasms, hair loss, altered
taste sensation, fatigue and weight loss. Serious adverse events (SAEs) were
observed in 26 patients (25 percent), however of these only four patients (4
percent) had SAEs that were considered to be related to treatment with
vismodegib. Fatal events were reported in seven patients (7 percent) although
none were considered by investigators to be related to treatment with
Erivedge. In all cases, patients had other pre-existing diseases or symptoms
that were related to their presumed cause of death.
About the STEVIE Study
The safety profile of Erivedge is also being evaluated in the STEVIE study, a
global, single-arm, open-label multicenter trial in patients with advanced
forms of BCC. The study is designed to enroll 1,200 patients. An interim
analysis from STEVIE presented at the American Society of Clinical Oncology's
(ASCO) 2013 Annual Conference confirmed a similar safety profile to that
observed in the ERIVANCE BCC study.
About Curis, Inc.
Curis is an oncology-focused drug development company seeking to develop novel
drug candidates for the treatment of human cancers. Erivedge is the first and
only FDA-approved medicine for the treatment of advanced basal cell carcinoma
and is being commercialized and developed by Roche and Genentech, a member of
the Roche Group, under a collaboration agreement between Curis and Genentech.
Curis is also seeking to further the development of its pipeline of
proprietary targeted cancer drug candidates, including CUDC-427, a small
molecule antagonist of IAP proteins, and CUDC-907, a dual PI3K and HDAC
inhibitor. For more information, visit Curis' website at www.curis.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including without
limitation Curis' expectations regarding: Roche's timelines for launch in
various EU countries, Roche's expected regulatory plans for other territories,
and the potential expansion of patient access to Erivedge. Forward-looking
statements used in this press release may contain the words "believes",
"expects", "anticipates", "plans", "seeks", "estimates", "assumes", "will",
"may," "could" or similar expressions. These forward-looking statements are
not guarantees of future performance and involve risks, uncertainties,
assumptions and other important factors that may cause actual results to be
materially different from those indicated by such forward-looking statements.
For example, other foreign regulatory agencies may not view favorably the
safety and efficacy profile of Erivedge in the treatment of advanced BCC, in
which case Erivedge will not be approved for sales and marketing for the
treatment of such indication in markets outside of the United States, EU,
Switzerland, Australia, Israel, South Korea, Mexico, and Ecuador. Genentech
and Roche may experience delays or failures in the manufacture and/or
commercial launch of Erivedge. Erivedge's benefit/risk profile may not be
widely accepted by the medical community or third party payors for the
treatment of advanced BCC. Regulatory and administrative governmental
authorities may determine to delay or restrict Genentech's ability to continue
to develop or commercialize Erivedge. Competing drugs may be developed that
are superior to Erivedge. Any of the foregoing risks could adversely affect
the royalty revenue that Curis may receive from sales of Erivedge.
Furthermore, Curis and its collaborators may experience adverse results,
delays and/or failures in their drug development programs. Curis' drug
candidates may cause unexpected toxicities and/or fail to demonstrate
sufficient safety and efficacy in clinical trials and may never achieve the
requisite regulatory approval needed for commercialization. Curis will require
substantial additional capital to fund the research and development of its
drug development programs. The proceeds of Curis' royalty-secured loan may not
be sufficient to fund its near-term capital requirements for advancing
programs. Curis may not obtain or maintain necessary patent protection for its
programs and could become involved in expensive and time consuming patent
litigation and interference proceedings. Curis faces substantial competition
from other companies developing cancer therapeutics. Unstable market and
economic conditions may adversely affect Curis' financial conditions and its
ability to access capital to fund the growth of its business. Curis also faces
other important risks relating to its business, operations, financial
condition and future prospects that are discussed in its Quarterly Report on
Form 10-Q for the quarter ended March 31, 2013 and other filings that it
periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views of Curis only
as of today and should not be relied upon as representing Curis' views as of
any subsequent date. Curis disclaims any intention or obligation to update any
of the forward-looking statements after the date of this press release whether
as a result of new information, future events or otherwise.
CONTACT: Mani Mohindru, Ph.D.
Vice President, Corporate Strategy and Investor Relations
Michael P. Gray
Chief Business and Chief Financial Officer
Curis, Inc. Logo
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