April 03, 2014 12:33pm EDT
Download as PDF
Scott Toner Joins as Vice President, US Marketing and Sales
Stephen A. Strugnell Joins as Senior Director, Scientific Affairs
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK )
today announced the hiring of key executives for its Renal Division.
Scott Toner will join as Vice President, US Marketing and Sales and Dr.
Steve Strugnell will join as Senior Director, Scientific Affairs.
Mr. Toner has over 30 years of pharmaceutical experience with a history
of developing effective marketing strategies for new drugs to treat
chronic kidney disease (CKD). Mr. Toner was previously Senior Director
of Global Marketing at Reata Pharmaceuticals with responsibility for the
marketing strategy supporting a new innovative therapy for CKD in type 2
diabetes patients; Executive Director of Marketing at AMAG
Pharmaceuticals where he led the launch of Feraheme ® , an iron
replacement product for dialysis patients; and Director of Renal
Commercial Development at Abbott Laboratories with responsibility for
Zemplar ® . Zemplar became the most successful vitamin D
therapy for secondary hyperparathyroidism (SHPT) in the US. Mr. Toner
also serves as a member of the Board of the American Association of
Kidney Disease Patients (AAKP).
Dr. Strugnell has extensive experience in the research and development
of new vitamin D drugs for CKD patients with vitamin D insufficiency.
Prior to OPKO, he was Associate Scientific Director at Genzyme Renal and
Associate Director of Preclinical Research at Bone Care International
where he managed research supporting Hectorol ® , the first
modern vitamin D product approved in the US for SHPT in pre-dialysis
patients. Dr. Strugnell received his PhD degree from Queens University
under the direction of Dr. Glenville Jones, and completed a
post-doctoral fellowship at the University of Wisconsin-Madison under
the direction of Dr. Hector DeLuca. Drs. Jones and DeLuca are
internationally regarded experts on vitamin D metabolism.
"Scott and Steve are powerful additions to our management team," said
Dr. Charles W. Bishop, CEO of OPKO Renal. "These two individuals have a
remarkable understanding of the renal market and provide unparalleled
experience in developing and launching proprietary renal disease
products."
“The hiring of Scott as Vice President, Marketing and Sales and Steve as
Senior Director, Scientific Affairs is an important milestone as we
continue to develop our pipeline of renal products and prepare for the
commercial launch of Rayaldee™ to treat CKD patients,” said Phillip
Frost, M.D., Chairman and CEO of OPKO. “We are pleased to welcome Scott
and Steve.”
About Rayaldee TM
Rayaldee is a first-in-class oral vitamin D prohormone treatment being
developed for SHPT in stage 3 and 4 CKD patients with vitamin D
insufficiency. It has a proprietary modified-release formulation
designed to gradually and reliably raise serum total 25-hydroxyvitamin D
(prohormone) concentrations to targeted levels (at least 30 ng/mL) while
avoiding upregulation of CYP24, a cytochrome P-450 enzyme that reduces
the parathyroid hormone (PTH) lowering potency of current vitamin D
supplements. Activation of calcifediol, the active ingredient in
Rayaldee, by the kidney is tightly regulated, preventing excessive
elevation of serum calcium and related side effects which encumber
current vitamin D hormone therapies and promote vascular and renal
calcification. Once approved, Rayaldee is expected to address the
approximately 4 million CKD stage 3 and 4 patients in the US and many
more, elsewhere, with SHPT and vitamin D insufficiency.
About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in kidney
function. The kidney is normally responsible for excreting waste and
excess water from the body, and for regulating various hormones. CKD is
classified in five different stages — mild (stage 1) to severe (stage 5)
disease — as measured by the kidney's glomerular filtration rate.
According to the National Kidney Foundation, CKD afflicts over 26
million people in the US, including more than eight million patients
with moderate (stages 3 and 4) and severe (stage 5) forms of CKD. In
stage 5 CKD, kidney function is minimal to absent and patients require
regular dialysis or a kidney transplant for survival.
About Vitamin D Insufficiency
Vitamin D insufficiency is a condition in which the body has low vitamin
D stores, characterized by inadequate blood levels of vitamin D
prohormone, known as 25-hydroxyvitamin D. An estimated 70-90% of CKD
patients have vitamin D insufficiency, which can lead to SHPT and
resultant debilitating bone diseases.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the
parathyroid glands secrete excessive amounts of PTH. SHPT arises as a
result of vitamin D insufficiency or impaired kidney function that
prevents sufficient production of vitamin D hormone to properly regulate
calcium and phosphorus metabolism, and PTH secretion. Prolonged
elevation of blood PTH causes excessive calcium and phosphorus to be
released from bone, leading to elevated serum calcium and phosphorus,
softening of the bones (osteomalacia) and calcification of vascular and
renal tissues. SHPT affects 40-60% of patients with moderate CKD and
approximately 90% of patients with severe CKD.
About OPKO
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and novel and proprietary technologies.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), regarding product development efforts and other
non-historical facts about our expectations, beliefs or intentions
regarding our business, technologies and products, financial condition,
strategies or prospects, including statements regarding our ability to
successfully launch and commercialize proprietary renal disease
products, expectations about Rayaldee™, its market potential, that
it will address the approximately 4 million CKD stage 3 and 4 patients
in the US and many more elsewhere, with SHPT and vitamin D
insufficiency, and that we will be able to successfully develop, obtain
approval for and launch sales of Rayaldee™. Many factors could
cause our actual activities or results to differ materially from the
activities and results anticipated in forward-looking statements. These
factors include those described in our filings with the Securities and
Exchange Commission, as well as risks inherent in funding, developing
and obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments, including the risks that the phase
3 clinical trials for Rayaldee™ may not be successful or achieve the
expected results or effectiveness, and may not generate data that would
support the approval or marketing of this product for the indications
being studied, that others may develop products which are superior to
Rayaldee TM , and that Rayaldee™ may not
have advantages or prove to be superior over presently marketed
products, including the currently used high monthly doses of
prescription vitamin D 2, activated vitamin D
hormone and over-the-counter vitamin D supplements. In addition,
forward-looking statements may also be adversely affected by general
market factors, competitive product development, product availability,
federal and state regulations and legislation, the regulatory process
for new products and indications, manufacturing issues that may arise,
patent positions and litigation, among other factors. The
forward-looking statements contained in this press release speak only as
of the date the statements were made and we do not undertake any
obligation to update forward-looking statements. We intend that all
forward-looking statements be subject to the safe-harbor provisions of
the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Charles W. Bishop, 305-575-4100
Source: OPKO Health, Inc.
Released April 3, 2014
email Email Alerts
location_city Company Profile
contact_page Contacts
rss_feed RSS News Feed
account_tree Sitemap
Apply on OPKO Health (Ireland)’s careers page