TIDMERGO
RNS Number : 8032D
Ergomed plc
02 May 2017
PRESS RELEASE
FOR IMMEDIATE RELEASE
Ergomed notes announcement by co-development partner, Aeterna
Zentaris, of results from Phase 3 clinical trial with Zoptrex(TM)
in advanced endometrial cancer
London, UK - 02 May 2017: Ergomed plc (LSE: ERGO) ('Ergomed' or
'the Company'), a company dedicated to the provision of specialised
services to the pharmaceutical industry and the development of new
drugs, notes that its co-development partner Aeterna Zentaris has
announced that its Pivotal Phase 3 Clinical Trial of Zoptrex(TM) in
women with advanced, recurrent or metastatic endometrial cancer did
not meet its primary endpoint of demonstrating a statistically
significant increase in the median period of overall survival of
patients treated with Zoptrex(TM) as compared to patients treated
with doxorubicin. The trial's secondary endpoints were also not
met. The press release from Aeterna Zentaris is reproduced in full
below.
Ergomed has been conducting the clinical trial in more than 100
study sites globally generating service revenues. As co-development
partner, Ergomed contributed to the costs of the trial in return
for a share in the revenues generated from the product's
commmercialisation. Despite the failed trial, the Company already
received a portion of upfront payments from several license
agreements entered into by Aeterna Zentaris in the important
markets of China, Israel, Taiwan and Southeast Asia as well as
Australia and New Zealand.
Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed,
said:
"While it is obviously disappointing that this Zoptrex trial was
not successful - especially for our partner Aeterna Zentaris- it
does highlight the resilience of our hybrid business model. Success
for Ergomed does not hinge on just one asset, but rather the
overall potential of a diversified development pipeline,
underpinned by reliable earnings from a strong Services business
that continues to significantly outperform the market, enjoying
excellent growth. Indeed, in contrast to this trial outcome with
Zoptrex, we recently reported excellent news from our insomnia
programme."
The full text of the announcement from Aeterna Zentaris is as
follows:
"Aeterna Zentaris Announces that ZoptEC Phase 3 Clinical Study
of Zoptrex(TM) Did Not Achieve its Primary Endpoint
Company Expects to Submit Macrilen(TM) NDA in Third Quarter of
2017
CHARLESTON, S.C., May 1, 2017 - Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZS) (the "Company") today announced that the ZoptEC
Phase 3 clinical study of Zoptrex(TM) (zoptarelin doxorubicin) in
women with locally advanced, recurrent or metastatic endometrial
cancer did not achieve its primary endpoint of demonstrating a
statistically significant increase in the median period of overall
survival of patients treated with Zoptrex(TM) as compared to
patients treated with doxorubicin.
Dr. Richard Sachse, the Company's Chief Scientific Officer,
stated, "The median overall survival period for patients treated
with Zoptrex(TM) was 10.9 months compared to 10.8 months for
patients treated with doxorubicin. This is not a statistically
significant, clinically meaningful increase in overall survival and
thus the ZoptEC Phase 3 clinical study did not meet its primary
endpoint. In addition, Zoptrex(TM) generally performed no better
than the comparator drug with respect to the secondary efficacy
endpoints. For example, the median period of progression-free
survival of the patients in the Zoptrex(TM) arm of the study was
identical to that for patients in the doxorubicin arm. Finally,
there was no meaningful difference between the two arms with
respect to safety; the number of patients with cardiac disorders
was similar - eight in the Zoptrex(TM) arm and nine in the
doxorubicin arm. Therefore, the results of the study are not
supportive to pursue regulatory approval."
David A. Dodd, the President and Chief Executive Officer of the
Company, stated, "We are very disappointed with the outcome of the
ZoptEC Phase 3 clinical study. Based on this outcome, we do not
anticipate conducting clinical trials of Zoptrex(TM) with respect
to any other indications. I would like to thank my colleagues
within Aeterna Zentaris and our external team of clinical
investigators for their dedication to and contributions on this
project." Commenting on the Company's plans, Mr. Dodd continued,
"Our focus has now shifted entirely to filing our new drug
application for Macrilen(TM) and, if the product is approved, to
its commercial launch as soon as possible. We will also optimize
our resources to be consistent with our focus on
Macrilen(TM)-related efforts. We continue to believe in the
potential that Macrilen(TM) provides for us to become a focused
specialty pharmaceutical company. Our intention is to submit the
Macrilen(TM) NDA in the third quarter of 2017 and, if the product
receives FDA approval, to commercially launch the product in the
first quarter of 2018."
Conference Call
The Company will host a conference call to discuss the results
of the ZoptEC Phase 3 clinical study of Zoptrex (TM) on Monday, May
1, 2017, at 8:30 AM, Eastern Time. Participants may access the
conference call by using the following number: 201-689-8029,
Confirmation 13660857.
About the ZoptEC Pivotal Phase 3 Trial
The ZoptEC pivotal Phase 3 trial was a fully-recruited (512
patients), open-label, randomized-controlled study, comparing the
efficacy and safety of zoptarelin doxorubicin, a hybrid molecule
composed of a synthetic peptide carrier and a well-known
chemotherapy agent, doxorubicin, to doxorubicin alone. Patients
were centrally randomized in a 1:1 ratio and received either
Zoptrex(TM) (267 mg/m2) or doxorubicin (60 mg/m2) intravenously,
every three weeks and for up to nine cycles. Response was evaluated
every three cycles during treatment, and thereafter, every 12 weeks
until progression. All patients were followed for survival as the
primary efficacy endpoint ("EP"). Secondary EPs include
progression-free survival, objective response-rate, and clinical
benefit rate. The trial was conducted under a Special Protocol
Assessment with the U.S. Food and Drug Administration ("FDA"). For
more information on this trial, please consult (ClinicalTrials.gov
Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC:
Zoptarelin doxorubicin in endometrial cancer).
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. We are engaged in drug
development activities and in the promotion of products for others.
We recently completed Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition of licenses to products that are relevant to our
therapeutic areas of focus. We also intend to license out certain
commercial rights of internally developed products to licensees in
non-U.S. territories where such out-licensing would enable us to
ensure development, registration and launch of our product
candidates. Our goal is to become a growth-oriented specialty
biopharmaceutical company by pursuing successful development and
commercialization of our product portfolio, achieving successful
commercial presence and growth, while consistently delivering value
to our shareholders, employees and the medical providers and
patients who will benefit from our products. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. Forward-looking statements
may include, but are not limited to, statements preceded by,
followed by, or that include the words "expects," "believes,"
"intends," "anticipates," and similar terms that relate to future
events, performance, or our results. Forward-looking statements
involve known risks and uncertainties, many of which are discussed
under the caption "Key Information - Risk Factors" in our most
recent Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission ("SEC").
Such statements include, but are not limited to, statements about
the progress of our research, development and clinical trials and
the timing of, and prospects for, regulatory approval and
commercialization of our product candidates, the timing of expected
results of our studies, anticipated results of these studies,
statements about the status of our efforts to establish a
commercial operation and to obtain the right to promote or sell
products that we did not develop and estimates regarding our
capital requirements and our needs for, and our ability to obtain,
additional financing. Known and unknown risks and uncertainties
could cause our actual results to differ materially from those in
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue our
research and development projects and clinical trials, the
successful and timely completion of clinical studies, the risk that
safety and efficacy data from any of our Phase 3 trials may not
coincide with the data analyses from previously reported Phase 1
and/or Phase 2 clinical trials, the rejection or non-acceptance of
any new drug application by one or more regulatory authorities and,
more generally, uncertainties related to the regulatory process,
the ability of the Company to efficiently commercialize one or more
of its products or product candidates, the degree of market
acceptance once our products are approved for commercialization,
our ability to take advantage of business opportunities in the
pharmaceutical industry, our ability to protect our intellectual
property, and the potential of liability arising from shareholder
lawsuits and general changes in economic
conditions. Investors should consult the Company's quarterly and
annual filings with the Canadian securities commissions and the SEC
for additional information on risks and uncertainties. Given these
uncertainties and risk factors, readers are cautioned not to place
undue reliance on these forward-looking statements. We disclaim any
obligation to update any such factors or to publicly announce any
revisions to any of the forward-looking statements contained herein
to reflect future results, events or developments, unless required
to do so by a governmental authority or applicable law."
Enquiries:
Ergomed plc Tel: +44 (0) 1483
503205
Miroslav Reljanovic (Chief
Executive Officer)
Stephen Stamp (Chief Financial
Officer)
Numis Securities Limited Tel: +44 (0) 20
7260 1000
Michael Meade / Freddie Barnfield
(Nominated Adviser)
James Black (Joint Broker)
Stifel Nicolaus Europe Limited Tel: +44 (0) 20
7710 7600
Jonathan Senior / Ben Maddison
(Joint Broker)
FTI Consulting - for UK enquiries Tel: +44 (0) 20
3727 1000
Simon Conway / Mo Noonan /
Natalie Garland-Collins
MC-Services - for Continental Tel: +49 211 52925222
European enquiries
Anne Hennecke
About Ergomed
Ergomed plc is a profitable UK-based business providing drug
development services to the pharmaceutical industry and has a
growing portfolio of co-development partnerships. It operates in
over 50 countries.
Ergomed provides clinical development, trial management and
pharmacovigilance services to over 100 clients ranging from top 10
pharmaceutical companies to small and mid-sized drug development
companies. Ergomed successfully manages clinical development from
Phase I through to late phase programmes.
Ergomed has a wide therapeutic focus, with a particular
expertise in oncology, neurology and immunology and the development
of orphan drugs. Ergomed believes its approach to clinical trials
is differentiated from that of other providers by its innovative
Study Site Management model and the use of Study Physician Teams,
resulting in a close relationship between Ergomed and the
physicians involved in clinical trials.
As well as providing high quality clinical development services,
Ergomed is building a portfolio of co-development partnerships with
pharma and biotech companies which share the risks and rewards of
drug development. Ergomed leverages its expertise and services in
return for carried interest in the drugs under development. Lastly,
Ergomed recently acquired a pipeline of proprietary development
products for haemostasis in surgical settings. For further
information, visit: http://ergomedplc.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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