AMT Provides Business Update for the Third Quarter 2009
By Amsterdam Molecular Therapeutics B.v, PRNETuesday, November 17, 2009
Glybera(R) Clinical Data Presented at Meeting of American Heart Association
AMSTERDAM, November 18 - Amsterdam Molecular Therapeutics (EuroNext Amsterdam: AMT), a leader in
the field of human gene therapy, today provides its non-audited business
update in compliance with the EU transparency directive. This report
summarizes material events and AMT's financial position for the third quarter
of 2009.
Q3 2009 Highlights
- Jorn Aldag joins AMT as Chief Executive Officer - Glybera(R) remains on track for filing for regulatory approval in next three months
Jorn Aldag appointed as Chief Executive Officer
On September 24, 2009 AMT announced that Jorn Aldag, previously President
and CEO of Evotec AG, Germany, would join AMT as Chief Executive Officer as
of October 05, 2009. Jorn Aldag holds business degrees from the European
Business School and the Harvard Business School. He remains Chairman of
Molecular Partners AG, Switzerland, a privately-held biotech company focused
on the development of its proprietary DARPin scaffold technology and its
proprietary pipeline. Mr. Aldag's appointment was approved by AMT's
Extraordinary General Meeting of shareholders on November 4, 2009.
At the same time, Prof. Sander van Deventer stepped down as interim CEO.
He will continue to contribute his expertise and experience to AMT as
Chairman of the Scientific Advisory Board and Business Consultant.
Business Update
AMT's cash position(*) on September 30, 2009 amounts to EUR21.4 million
compared to EUR25.0 million on June 30, 2009. The cash outflow in the third
quarter of 2009, amounting to EUR3.6 million mainly represented operational
cash flow and is well within the guidance for this period. The Company is
adjusting its guidance for the year-end cash balance to approximately EUR17
million. AMT employed 88 persons as of September 30, 2009. Total expenses in
the third quarter of 2009 were EUR4.4 million compared to EUR4.7 million in
the same period last year.
(*) The Company's cash position is composed of cash and cash equivalents.
Material events after September 30, 2009
On November 11, 2009 AMT announced that it has successfully treated
Duchenne muscular dystrophy (DMD) in an animal model with its proprietary
gene therapy. The proof of concept studies were performed in collaboration
with the group of Professor Irene Bozzoni (University of Rome, La Sapienza,
Italy) and demonstrated efficacy in the heart as well as in skeletal muscles.
In a previous study, AMT's gene therapy approach was shown to be successful
in the treatment of diseased human muscle cells obtained from biopsies of DMD
patients. These data establish a robust basis for AMT's therapeutic approach
to DMD.
The ongoing trial with Glybera(R) for lipoprotein lipase deficient (LPLD)
patients in Canada was closed for patient recruitment on October 30, 2009
with 5 patients dosed. AMT is well on track to file for regulatory approval
for Glybera(R) within the next three months. The main aim of the ongoing
trial is to gain further insight in the mechanism of action of Glybera(R),
and data obtained from this trial will further strengthen the Glybera(R) data
package that will be filed with the EMEA.
On November 17, 2009, updated safety and efficacy data on Glybera(R) from
the first two clinical studies was presented at the meeting of the American
Heart Association in Orlando. These data confirm the sizeable decrease in
pancreatitis incidence after therapy with Glybera(R) and confirm its
excellent safety profile.
On October 29, 2009, AMT and Progenika Biopharma announced that they have
entered into a development and commercialization agreement for LPLchipTM, a
diagnostic tool to rapidly diagnose patients with complete and partial
lipoprotein lipase deficiency (LPLD).
On October 8, 2009 AMT received Orphan Drug Designation for its treatment
for Duchenne Muscular Dystrophy (DMD).
Prospects
The Company remains on track to file for regulatory approval of its lead
product Glybera(R) within the next three months. This gene therapy is to
control LPLD, a serious disease often complicated by potentially life
threatening pancreatitis incidents.
AMT will continue to develop its own technology platform and exploit its
advantages in AAV gene therapy by focusing its preclinical development on 4
projects: Hemophilia B, Duchenne Muscular Dystrophy (DMD), Acute Intermittent
Porphyria (AIP) and Parkinson's Disease. Other projects previously shown in
the Company's pipeline will be postponed or discontinued to control the
Company's cash burn.
About Amsterdam Molecular Therapeutics
AMT has a unique gene therapy platform that appears to
circumvent many if not all of the obstacles that have prevented gene therapy
from becoming a mainstay of clinical medicine. Using adeno-associated viral
(AAV) vectors as the delivery vehicle of choice for therapeutic genes, the
company has been able to design and validate what is probably the first
stable and scalable AAV production platform. As such, AMT's proprietary
platform holds tremendous promise for thousands of rare (orphan) diseases,
especially diseases that are caused by one faulty gene. Currently, AMT has a
pipeline with several AAV-based gene therapy products at different stages of
research or development.
Certain statements in this press release are "forward-looking
statements" including those that refer to management's plans and expectations
for future operations, prospects and financial condition. Words such as
"strategy," "expects," "plans," "anticipates," "believes," "will,"
"continues," "estimates," "intends," "projects," "goals," "targets" and other
words of similar meaning are intended to identify such forward-looking
statements. Such statements are based on the current expectations of the
management of Amsterdam Molecular Therapeutics only. Undue reliance should
not be placed on these statements because, by their nature, they are subject
to known and unknown risks and can be affected by factors that are beyond the
control of AMT. Actual results could differ materially from current
expectations due to a number of factors and uncertainties affecting AMT's
business, including, but not limited to, the timely commencement and success
of AMT's clinical trials and research endeavors, delays in receiving U.S.
Food and Drug Administration or other regulatory approvals (i.e. EMEA, Health
Canada), market acceptance of AMT's products, effectiveness of AMT's
marketing and sales efforts, development of competing therapies and/or
technologies, the terms of any future strategic alliances, the need for
additional capital, the inability to obtain, or meet, conditions imposed for
required governmental and regulatory approvals and consents. AMT expressly
disclaims any intent or obligation to update these forward-looking statements
except as required by law. For a more detailed description of the risk
factors and uncertainties affecting AMT, refer to the prospectus of AMT's
initial public offering on June 20, 2007, and AMT's public announcements made
from time to time.
PRN NLD
For information: Jorn Aldag, Chief Executive Officer, Tel +31-(0)20-566-7394, j.aldag at amtbiopharma.com
Tags: Amsterdam, Amsterdam Molecular Therapeutics B.V, Netherlands