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This excerpt taken from the ELN 6-K filed Dec 15, 2009. DUBLIN, Ireland
– December 15, 2009 – Elan Corporation,
plc and Transition Therapeutics, Inc. today notified clinical investigators of
modifications to the Phase II study AD201 and open label extension study AD251
for ELND005, a compound being developed for the potential treatment of
Alzheimer’s disease. The AD201 study is evaluating three dose levels
of ELND005 compared to placebo in 353 patients.
Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily). The study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups. The AD251 study will be modified to dose patients only at 250mg twice daily. The decision by the companies to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study. Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established. -1-
The
ISMC and both companies concur that the tolerability and safety data are
acceptable among patients receiving the 250mg dose and that the blinded study
should continue for this dose and the placebo group.
“Today’s decision speaks to our strong commitment to
patient safety while allowing for the continued evaluation of ELND005 at the
250mg dose, twice daily,” said Menghis Bairu, M.D., EVP, Chief Medical Officer
and Head of Global Development at Elan. “We continue to expect the ongoing
study to provide important data to
guide the next steps in the development of ELND005 for the potential treatment
Alzheimer’s disease.” This excerpt taken from the ELN 6-K filed Dec 14, 2009. DUBLIN, Ireland – December 14,
2009 – Elan Drug Technologies, a business unit of Elan Corporation, plc
(NYSE: ELN) announces the approval by the Japanese Ministry of Health, Labour
and Welfare of EMEND®
(aprepitant) for the treatment of cancer chemotherapy-induced nausea and
vomiting. EMEND®,
which was developed by a subsidiary of Merck & Co Inc., Whitehouse Station,
N.J., USA and licensed to Ono Pharmaceuticals Co., Ltd. for the Japanese market,
is the first licensed product approved in Japan that incorporates Elan Drug
Technologies’ NanoCrystal®
technology.
NanoCrystal®
technology, enables formulation of poorly water soluble compounds for all routes
of administration. For EMEND®,
this technology advance eliminates a food requirement and improves
bioavailability by 600%. EMEND®
was confirmed to be effective for both acute and delayed phases of nausea and
vomiting in Japanese clinical trials, and becomes the first therapy approved for
treatment of delayed phase nausea and vomiting (24 hours or later
after start of cancer chemotherapy) in Japan.
“The
approval of EMEND®
is a significant achievement for our NanoCrystal®
technology, as it marks the first Japanese approval of a product incorporating
this technology in this very important market”, said Shane Cooke, Executive Vice
President and Head of Elan Drug Technologies. “We hope this is the first of many
products using our NanoCrystal®
technology to be launched in Japan.”
NanoCrystal®
technology is a proprietary technology developed by Elan Drug Technologies
through Elan Pharma International Limited and other Elan
affiliates. 1
Five
licensed products have now been approved using the NanoCrystal®
technology by various health authorities including the US Food and Drug
Administration (FDA). Products incorporating the NanoCrystal®
technology are sold in markets worldwide.
About
Elan Drug Technologies and NanoCrystal®
Technology
Elan Drug
Technologies (EDT), one of the world’s leading drug delivery businesses, is a
business unit of Elan Corporation plc. As a fully integrated drug delivery
business, Elan Drug Technologies delivers clinically meaningful benefits to
patients, by using its extensive experience and proprietary delivery
technologies in collaboration with pharmaceutical companies. For 40 years, Elan
Drug Technologies has been, and continues to be, a drug delivery provider of
choice for a broad range of pharmaceutical companies, including many of the
world’s leading pharmaceutical companies. Elan Drug Technologies offer clients
drug delivery expertise with a suite of commercially launched, proprietary,
technology-driven solutions, from NanoCrystal®
technology for poorly water soluble compounds, to customised oral controlled
release drug technologies. Products enabled by its technologies are used by
millions of patients each day. For more information go to
www.elandrugtechnologies.com
NanoCrystal®
is a registered trademark of Elan Pharma International Limited, Ireland, a
subsidiary of Elan Corporation plc.
EMEND®
is a registered trademark of Merck & Co Inc.
This excerpt taken from the ELN 6-K filed Dec 9, 2009. DUBLIN, Ireland – December 9,
2009 – Elan Corporation, plc (NYSE: ELN) today announced that it will
present at the Deutsche Bank Securities Biotech Boston Confab Conference, on
Tuesday, December 15, 2009, at 10:30 a.m. Eastern Time and 3:30 p.m.
GMT.
Interested
parties may access a live audio web cast of the presentation by visiting the
Investor Relations section of the Elan website at www.elan.com, then clicking on
the event icon. Following the live webcast, an archived version of
the presentation will be available at the same URL.
About
Elan
Elan
Corporation, plc is a neuroscience-based biotechnology company committed to
making a difference in the lives of patients and their families by dedicating
itself to bringing innovations in science to fill significant unmet medical
needs that continue to exist around the world. Elan shares trade on the New York
and Irish Stock Exchanges. For additional information about the company, please
visit http://www.elan.com.
Source:
Elan Corporation, plc
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