Full Press Release Details
Scott Carmer Named as CEO of Orgenesis North
GERMANTOWN, MD Aug. 4, 2014 Orgenesis Inc. (OTCQB:
ORGS), a leader in the emerging fields of cellular therapy and re-generative
medicine, today announced the appointment of industry veteran Scott Carmer as
CEO of the company s North American subsidiary. Carmer has more than 25 years of
diverse industry experience within both pharmaceutical and biotech companies.
Orgenesis is a pioneer in the field of cellular
trans-differentiation, a technology that has potential to regenerate
glucose-responsive insulin production and restore glycemic homeostasis for
patients suffering from various insulin-dependent disorders. By transforming a
patient s own liver cells into new insulin producing cells, Orgenesis hopes to
develop a breakthrough therapy for people living with Type 1 Diabetes. In his
new role, Carmer will oversee the Orgenesis drug development and
commercialization strategy in North America, focusing on the near-term
initiation of Phase I and Phase II clinical trials in the United States.
As the father of a child who is living with Type 1 Diabetes,
Carmer said. I am personally motivated to help bring the innovative science
pioneered by the Orgenesis team into the clinic. The technology of cellular
trans-differentiation, discovered in the research labs of Prof. Sarah Ferber,
has established pre-clinical Proof-of-Principle that human adult liver cells can
successfully be transformed into glucose responsive and functionally mature
insulin producing cells. I am honored and excited to be a part of this company
and its cause. It s extremely motivating to be working with a team of people
dedicated to curing Type 1 Diabetes as we know it today.
Before joining Orgenesis, Carmer led the US Specialty Care
Division of AstraZeneca, and had responsibility for the company s portfolio of
specialty care biopharmaceutical products. Prior to his role at AZ, he served as
Executive Vice President, Commercial Operations of MedImmune (which was acquired
by AstraZeneca). Previous to his roles at AZ/MedImmune, Carmer was Vice
President, Rheumatology Sales & Marketing for Genentech, where he was
responsible for the US launches of Rituxan and ACTEMRA in Rheumatoid Arthritis.
He joined Genetech from Amgen, Inc., where he last held the role of Global
Therapeutic Area Head for Bone and Metabolic Disorders, and was responsible for
global development and commercialization strategies for denosumab (Xgeva and
Prolia). Carmer began his career at GSK, where he held various positions of
increasing responsibility in the areas of sales, marketing, strategic pricing
and business development.
Scott is a natural leader with an established track record of
successfully building and leading teams. His vast commercialization experience
in the field of biologics from early clinical development to launch will be
a tremendous asset to Orgenesis as we work to quickly transition our technology
from research into P1 clinical trials, said Vered Caplan, chairperson and CEO
of Orgenesis. He has a proven ability to work in close partnership with
research, clinical, regulatory and manufacturing functions to successfully bring
complex biologics to market. Scott is a solutions-oriented, creative thinker,
and we are excited to have him as a part of our team.
About Orgenesis, Inc.
Orgenesis is a development
stage company that is committed to curing Type 1 Diabetes. In pursuit of this
goal, the company is developing a novel technology that combines cellular
therapy and regenerative medicine. Through a proprietary biologic process called
'cellular trans-differentiation,' Orgenesis has proven that, when exposed ex
vivo to certain pancreatic transcription factors and in specific sequence, human
adult liver cells can be transformed into fully functional, beta cell-like
insulin producing cells (IPCs). After ex vivo expansion, the IPCs are reinfused
via the portal vein. In pre-clinical models of Type 1 Diabetes (Non-Obese
Diabetic mice), the re-introduced IPCs remain in the liver, effectively respond
to glucose challenge and successfully maintain glycemic homeostasis. In the same
NOD model, the implanted IPCs were not subject to auto-immune attack or cellular
ablation. Orgenesis plans to initiate P1/2 trials in the next 12-16 months. For
more information visit: www.orgenesis.com.
Notice Regarding Forward-Looking Statements
news release contains "forward-looking statements" which are not purely
historical. Such forward-looking statements include, among other things, the
expectations of management that our regeneration technology can be developed as
therapeutic treatment for diabetes which could, if successful, mean the end of
diabetes as we know it; that we will initiate Phase I and Phase II clinical
trials in the United States in the near-term; that we can quickly transition our
technology from research into P1 clinical trials. No assurance can be given that
any of the events anticipated by the forward-looking statements will occur or,
if they do occur, what benefits Orgenesis will obtain from them. Actual results
could differ from those projected in any forward-looking statements due to
numerous factors, including, among others, the potential failure of development
candidates to advance through preclinical studies or demonstrate safety and
efficacy in clinical testing; the ability to pass clinical trials so as to move
on to the next phase; our ability to retain key employees; our ability to
finance development and operations; our ability to satisfy the rigorous
regulatory requirements for new medical procedures; and competitors may develop
better or cheaper alternatives to our products. These forward-looking statements
are made as of the date of this news release, and we assume no obligation to
update the forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking statements.
Investors should refer to the risk factors disclosure outlined in our periodic
reports filed from time-to-time with the Securities and Exchange Commission.