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Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily).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.
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.
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.
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