Curis Announces Erivedge(R) Receives Positive CHMP Opinion for Conditional
Approval in European Union
- Recommended as Treatment for Advanced Basal Cell Carcinoma -
- Curis Eligible for $6 Million Milestone on European Commission Approval -
LEXINGTON, Mass., April 26, 2013 (GLOBE NEWSWIRE) -- Curis, Inc.
(Nasdaq:CRIS), an oncology-focused company seeking to develop next generation
targeted drug candidates for cancer treatment, today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has recommended a conditional approval of Erivedge
(vismodegib) for the treatment of adult patients with symptomatic metastatic
basal cell carcinoma, or locally advanced basal cell carcinoma that is
inappropriate for surgery or radiotherapy. Conditional approval would make
Erivedge the first licensed treatment in Europe for patients with advanced
basal cell carcinoma, a rare form of skin cancer which can be disfiguring,
debilitating and even fatal.
"We are extremely pleased that the CHMP has recommended the conditional
approval of Erivedge in the EU and we hope that this important medicine will
soon be available to patients in Europe," said Dan Passeri, Chief Executive
Officer of Curis. "We continue to be pleased by the strength of Roche's global
regulatory and commercialization efforts regarding Erivedge, which we
anticipate will significantly broaden patient access to Erivedge globally.
Erivedge is currently under review for approval by health authorities in
several countries outside of Europe, and regulatory submissions are planned in
many additional countries.We view Roche's broad efforts to expand patient
access to Erivedge as a testament to its commitment to this important,
The European Commission, which has the authority to approve medicines for use
in the European Union, generally delivers its final decision within three
months of the CHMP recommendation. The decision will be applicable to all 27
EU member states.A European Commission conditional approval would result in
Curis earning a $6 million milestone payment from Genentech, a member of the
Roche Group.Roche is responsible for commercializing Erivedge in the EU.
The CHMP stated, on the basis of quality, safety and efficacy data submitted,
considers there to be a favorable benefit-to-risk balance for Erivedge and
therefore recommended the granting of the marketing authorization. This
marketing authorization is conditional, and will require the submission of
additional data from ongoing studies. The CHMP grants conditional approval to
medicinal products that fulfill an unmet medical need.
About Basal Cell Carcinoma (BCC) and the Hedgehog Pathway
Basal cell carcinoma 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
basal cell carcinoma.
Roche is developing Erivedge under a collaboration agreement with Curis, Inc.
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 Mexico, Israel and South Korea.
About the ERIVANCE BCC Study
The CHMP opinion is based on findings from the pivotal ERIVANCE BCC study
which enrolled 104 advanced basal cell carcinoma patients (71 had locally
advanced and 33 had metastatic disease) from 31 study centers in the US,
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 basal cell
carcinoma 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 Curis, Inc.
Curis is an oncology-focused company seeking to develop and commercialize next
generation targeted drug candidates for cancer treatment. 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 developing its pipeline of proprietary targeted
cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP
proteins; CUDC-907, a dual PI3K and HDAC inhibitor; and CUDC-101, an EGFR/HER2
and HDAC inhibitor. For more information, visit Curis' website at
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including without
limitation statements regarding Curis' expectations regarding the timing for
an approval decision in Europe, Roche's expected regulatory plans, 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, the European Commission or 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 US, Mexico or Israel.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 advancedBCC.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.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 Annual Report on Form 10-K for the year
ended December 31, 2012 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: Michael P. Gray
Chief Financial Officer
Curis, Inc. Logo
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