MONTREAL, Sept. 22 /CNW Telbec/ - Enobia Pharma, a biotech company
focused on developing novel therapeutics for serious bone disorders, today
announced key appointments to add commercial and manufacturing expertise to
the Company's senior management team in conjunction with the recent initiation
of two clinical trials of ENB-0040 for the treatment of hypophosphatasia.
Julie Anne Smith has been appointed as Enobia's Vice President, Chief
Commercial Officer, and Jayant Aphale, PhD., MBA has been appointed as Vice
President, Manufacturing and Process Sciences. Prior to joining Enobia,
Ms. Smith was Vice President, Commercial at Jazz Pharmaceuticals Inc. where
she led commercial strategy and operations. Previously, Ms. Smith was Vice
President, Global Marketing for Genzyme and led the Global Marketing
department for Genzyme's rare disease therapeutics business division. Her
responsibilities included leading the worldwide commercialization and planning
for Myozyme(R), an enzyme replacement therapy for ultra-orphan Pompe disease.
Dr. Aphale was the former Vice President Operations and Project/Portfolio
Management at Acambis plc. At Acambis, Dr. Aphale was responsible for R&D
project management as well overseeing multiple vaccine manufacturing plants,
which included cGMP upstream and downstream manufacturing, and a
lyophilization facility. Dr. Aphale previously held Director level positions
at Wyeth Vaccines and Diosynth Biotechnology, a biologics contract
manufacturing organization. Prior to that, Dr. Aphale was a senior scientist,
cGMP manufacturing at Roche Molecular Systems where he was responsible for
technology transfer and manufacturing and release of heat stable enzymes.
"Julie and Jayant are seasoned executives who bring to Enobia extensive
industry experience that will be extremely valuable as we continue to progress
our clinical program for hypophosphatasia and to prepare our commercial
efforts," stated Robert Heft PhD., Chief Executive Officer.
Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone
disease. Patients have low levels of the tissue non-specific form of alkaline
phosphatase, an important regulator of bone mineralization, leading to rickets
in infants and children and osteomalacia ("soft bones" resulting from poor
mineralization) in adults. Disease severity is inversely proportional to the
age at symptom onset, but morbidity can be cumulative and worsen with age.
Clinical severity ranges from the severe perinatal or infantile form, with
profound skeletal hypomineralization and respiratory compromise often causing
death, to a more slowly progressive and debilitating osteomalacia in adults.
In the infantile form, infants may appear normal at birth but develop
serious symptoms in the first six months of life. These can include failure to
thrive, respiratory failure, fractures, and seizures. Radiographic findings
include generalized hypomineralization and rickets. Mortality in these
patients may be as high as 50%. In the childhood form, patients have varying
degrees of hypomineralization, frank rickets, short stature, bone pain, muscle
weakness, delayed motor milestones, early loss of deciduous teeth, and may
experience frequent, poorly-healing fractures. In the adult form, the
underlying osteomalacia causes bone pain due to overt or poorly-healing stress
fractures that in some cases stops ambulation.
ENB-0040 is a fusion protein that includes the catalytic domain of human
tissue non-specific alkaline phosphatase (TNSALP), and a patented peptide used
to target the enzyme to bone. Preclinical studies of ENB-0040 in the
"knockout" mouse model of severe hypophosphatasia were recently published in
the Journal of Bone and Mineral Research (June 2008:23:777-787) and showed
that subcutaneous administration of ENB-0040 significantly improved survival
and prevented the skeletal and dental manifestations of the disease.
About Enobia Pharma Inc.
Enobia Pharma Inc., is a private, Montreal based company focused on the
development of therapeutics to treat serious bone disorders for which there is
no currently approved drug therapy. Enzyme Replacement Therapy for the
treatment of hypophosphatasia is the Company's lead program. In 2007 Enobia
completed a $40M Series B financing lead by OrbiMed Advisors and CTI Life
For further information:
For further information: Julie Anne Smith, (514) 596-2901, extension