You're slipping,...you missed posting the NR with all the goodies :-)
Nuvo forms panel of FDA experts in anticipation of pivotal trial results
- Company expands licensing discussions for Pennsaid(R) and
Pennsaid(R) Plus -
MARKHAM, ON, Dec. 15 /CNW/ - Nuvo Research Inc. (TSX:NRI) today announced
that it anticipates completing its pivotal phase III trial for Pennsaid(R) by
year-end and disclosing preliminary results from the trial in January 2006. In
anticipation of filing an amended New Drug Application for Pennsaid(R) with
the U.S. Food and Drug Administration (FDA) in mid-2006, Nuvo has formed an
FDA advisory panel to guide its FDA submission. Pennsaid(R), a topical non-
steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis,
is approved for sale in Canada and several European countries.
"We expect to release preliminary efficacy results from our Phase III
clinical trial for Pennsaid(R) in January, with long-term safety trial results
to follow in February. These results will form the basis of our FDA
submission," said Dr. Henrich Guntermann, Nuvo's President and CEO. "Our
advisory panel has extensive experience with FDA submissions and will prove
invaluable as we prepare for this event. If approved by the FDA, we believe
Pennsaid(R) will be the first topical NSAID to market in the U.S."
The Company continues to pursue discussions with potential U.S. licensing
partners for Pennsaid(R) and its proprietary next generation product,
Pennsaid(R) Plus. Nuvo has contracted the services of California-based
pharmaceutical consulting firm, Resources Development Inc. to identify
suitable licensing partners and negotiate an appropriate licensing
arrangement. Resources Development will supplement the previously announced
consulting services of Canadian-based licensing consultant, Diane Kalina.
About Nuvo's FDA Advisory Panel
Dr. Jonathan Wilkin is a pharmaceutical industry consultant and recently
retired director of the FDA's Dermatology and Dental Products Division. Prior
to joining the FDA, Dr. Wilkin was a Professor at The Ohio State University in
the Departments of Medicine and Pharmacology and he was the Director of the
Dermatology Division. Currently, Dr. Wilkin serves on the American Academy of
Dermatology's: Ad Hoc Task Force on the Academy's Efforts with the FDA and the
Environment and Drugs Committee.
Dr. Lee Simon is an Associate Clinical Professor at Harvard Medical
School and head regulatory consultant with MEDACorp, a management consulting
group that offers strategic advice to leading life sciences and healthcare
companies. Previously, Dr. Simon was the Division Director of the Arthritis,
Analgesic and Ophthalmologic Drug Product Division of the FDA. Prior to his
tenure at the FDA, Dr. Simon was Director of Rheumatology Clinical Research
and Associate Chief of Medicine at Beth Israel Deaconess Medical Center in
Boston, MA.
Dr. Sanford Roth is a renowned rheumatologist and CEO and Medical
Director of Arizona Research and Education, a center dedicated to clinical
research that is affiliated with Arthritis Care & Research. Prior to his
current role, he was appointed to the Arthritis Advisory Committee of the FDA
and was a Liaison Consultant to the FDA for more than 30 years where he
chaired the Anti-Rheumatic Disease Guidelines Committee. He was a Professor
and Director of the Aging and Arthritis Program of the College of Public
Programs, Arizona State University and continues to serve as Adjunct Professor
to the School of Health Management and Policy.
Dr. Joseph Rodricks is the founding principal of Environ, a strategic
risk management and technical consulting services company for human health and
environmental risk issues. Dr. Rodricks is an internationally recognized
expert in the field of toxicology and risk analysis. Previously, he was the
Deputy Associate Commissioner, Health Affairs and Toxicologist, at the FDA for
over 15 years. Dr. Rodricks has consulted for pharmaceutical companies,
government agencies and the World Health Organization. He has served on 15
Boards and Committees of the National Academy of Sciences and the Institute of
Medicine.
Peter Hutt is a partner with the Washington, D.C. law firm of Covington &
Burling specializing in food and drug law. He teaches food and drug law at
Harvard Law School and previously he taught at Stanford Law School. Previous
to his current positions, he served as the General Counsel for the FDA. He
serves on a wide variety of academic and scientific advisory boards, including
the panel on the Administrative Restructuring of the National Institutes of
Health.
Dr. Hartmut Derendorf is a Professor and Chairman of the Department of
Pharmaceutics at the University of Florida College of Pharmacy. Dr. Derendorf
specializes in the areas of Biopharmaceutics, Pharmacokinetics and Clinical
Pharmacokinetics. He is currently the President of the International Society
of Antiinfective Pharmacology, a member of the Nutrition and Therapeutics
Committee of the NASA Space Medicine Program, a member of the FDA Clinical
Pharmacology Advisory Committee and the President-elect of the American
College of Clinical Pharmacology.
About the Pennsaid(R) Pivotal Phase III Trial
The Phase III efficacy trial, designated '112', is a randomized, multi-
site, double blinded and controlled trial enrolling at least 750 patients with
osteoarthritis of the knee and compares Pennsaid(R) versus a placebo lotion.
Nuvo is also conducting a long-term safety study of Pennsaid(R),
designated '112E', in which approximately 360 patients with osteoarthritis of
the knee have been treated with Pennsaid(R) for six months and approximately
145 of those patients will have continued with Pennsaid(R) treatment for a
further six months.
Change in Year-End
The Nuvo Board of Directors has approved the change of the Company's
year-end to December commencing December 31, 2005. As a result of the change,
Nuvo will begin to report results on a calendar-year basis effective January
1, 2006. The change to a calendar year for Nuvo will make its results more
comparable with those of many other biotechnology companies.
About Nuvo Research Inc.
Nuvo is focused on developing innovative therapeutics that are delivered
transdermally using the Company's skin-penetrating technologies. Nuvo's lead
product is Pennsaid(R), a topical non-steroidal anti-inflammatory (NSAID) used
for the treatment of osteoarthritis. Nuvo intends to leverage its skin-
penetrating technologies to create a portfolio of transdermal products
targeting a variety of indications.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company
headquartered in Markham, Ontario, with manufacturing facilities in Varennes,
Québec and Wanzleben, Germany. For more information, please visit
www.nuvoresearch.com. |
