Full Press Release Details
terna Zentaris Inc. 1405 du
Parc-Technologique Blvd.
Canada G1P 4P5 T 418 652-8525 F 418 652-0881
Aeterna Zentaris Reports Second
Financial and Operating
All amounts are in U.S.
Quebec City, Canada, August 12,
2010 Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) ( the
Company ), a late-stage drug development company specialized in oncology and
endocrinology, today reported financial and operating results for the second
quarter ended June 30, 2010.
Pipeline development
Perifosine receives U.S. Food and Drug Administration ( FDA ) Fast Track Designation for the Phase 3 X-PECT
(Xeloda + Perifosine
Evaluation in Colorectal cancer Treatment) registration trial.
April 8, 2010: Initiation of the registration Phase 3 X-PECT
study with perifosine.
April 15, 2010: Positive Scientific Advice from the European
Medicines Agency ( EMA ) for the Phase 3 program with perifosine in multiple
the ongoing trial is expected to be sufficient for registration in Europe.
April 20, 2010: Presentations at the annual meeting of the
American Association for Cancer Research ( AACR ) in Washington, D.C. of
preclinical data from a study sponsored by the National Institutes of Health
with perifosine in oncology.
May 17, 2010: Publication of an article in
the May 12, 2010 issue of the Journal of the National
Cancer Institute, entitled In Vitro and In Vivo Inhibition of Neuroblastoma Tumor Cell Growth by Akt
Inhibitor Perifosine, demonstrating the single agent activity of perifosine in
neuroblastoma tumor preclinical models.
Presentation at the American Society of
Clinical Oncology ( ASCO ) annual meeting of Phase 1 data on single agent perifosine in the treatment of recurrent
pediatric solid tumors, including patients with advanced brain tumors and
2010: Report at the ASCO annual meeting of Phase 2 results confirming a
statistically significant improvement in both time to tumor progression and
overall survival with perifosine, in combination with capecitabine (Xeloda ),
in the treatment of advanced metastatic colorectal cancer.
issues positive Scientific Advice for Phase 3 trial with perifosine in
colorectal cancer. Therefore, the ongoing
trial is expected to be sufficient for registration in Europe.
May 6, 2010: Received
orphan drug designation from the FDA for AEZS-108, the Company s doxorubicin
targeted conjugate compound, for the treatment of ovarian cancer.
May 12, 2010: Received
approval from the FDA for the Company s Investigational New Drug ( IND )
application for AEZS-108 in luteinizing hormone-releasing hormone ( LHRH )
receptor-positive urothelial (bladder) cancer.
May 17, 2010: Received positive opinion for
orphan medicinal product designation from the Committee for Orphan Medicinal
Products of the EMA, for AEZS-108 for the treatment of ovarian cancer.
June 7, 2010: Presentation at ASCO s annual meeting of
positive efficacy and safety data for AEZS-108 in ovarian cancer.
Announcement of a collaboration with Almac Group Ltd. s ( Almac ) Diagnostic
division to develop a companion diagnostic for AEZS-108 in cancer.
2010: Presentation at the 92nd Annual Endocrine Society Meeting and Expo of
positive data on AEZS-130, a ghrelin mimetic for diagnostic and therapeutic
April 20, 2010: Presentations at AACR s annual meeting in
Washington, D.C., of preclinical data on Erk inhibitor, AEZS-131, and on
Erk/PI3K dual inhibitor, AEZS-132.
Corporate developments
April 20, 2010: Completion of a $15.0 million registered
direct offering with certain institutional investors.
April 23, 2010: Regained compliance with Nasdaq s minimum bid
price listing requirement.
Completion of a $12.1 million registered direct offering with
certain institutional investors.
Subsequent to Quarter-End
Presentation at the 7th International Congress of Neuroendocrinology
in Rouen, France, of a scientific poster entitled, Use of the Orally Active Ghrelin Mimetic AEZS-130 as
a Simple Test for the Diagnosis of Growth Hormone (GH) Deficiency (GHD) in
Perifosine receives orphan drug designation by the FDA for the treatment of
neuroblastoma, a cancer of the nervous system affecting mostly children and
infants for which there are no FDA approved therapies.
Ph.D., Aeterna Zentaris President and Chief Executive Officer commented, During
the second quarter, we made great strides in advancing our key compounds in oncology:
perifosine, our PI3K/Akt inhibitor and AEZS-108, our LHRH targeted
doxorubicin conjugate. In particular, we now have agreement from the FDA and
the EMA as to a clear pathway toward the registration of perifosine in both
multiple myeloma and refractory colorectal cancer. Both indications are
expected to gain approval following only one Phase 3 trial per indication,
which are currently progressing as planned. Regarding AEZS-108, we disclosed
positive Phase 2 survival data in advanced ovarian cancer, and we now look
forward to disclosing detailed Phase 2 results in endometrial cancer in the
second half of the year. We are also evaluating various opportunities regarding
the further development of AEZS-108, and our recent collaboration with Almac
will contribute to the success of that compound s development. Dr. Engel
added, Our focus is now on advancing our pipeline, while expanding our network
of partners to ensure the successful commercialization of perifosine in non-US
Dennis Turpin, Senior
Vice President and Chief Financial Officer of Aeterna Zentaris, added, With
more than $45 million in cash and equivalents at quarter-end and a burn
rate reduced to approximately $2 million per month, the Company is now in
a solid financial position to pursue activities leading to the creation of
value for our shareholders. Our strategy now calls for additional partnerships
to contribute to advancing our pipeline and to improving our cash position such
that Aeterna Zentaris becomes a successful long-term player in our industry.
CONSOLIDATED RESULTS FOR THE THREE
MONTHS ENDED JUNE 30, 2010
Revenues were $5.6 million for
the three-month period ended June 30, 2010, compared to $8.4 million
for the same period in 2009. The decrease is due mainly to the absence, in