MONTREAL, July 4, 2024
/CNW/ - Pendopharm, a division of Pharmascience Inc., announced
today that it has signed an exclusive distribution agreement with
Ascendis Pharma A/S (NASDAQ: ASND) ("Ascendis"), a global
biopharmaceutical company headquartered in Copenhagen, Denmark. Under the terms of the
agreement, Pendopharm is responsible for regulatory approval and
commercialization of Ascendis' hypoparathyroidism treatment
TransConTM PTH (palopegteriparatide) in
Canada. Financial terms of the
agreement are not disclosed.
TransConTM PTH is a parathyroid hormone (PTH)
replacement therapy designed to treat chronic hypoparathyroidism, a
rare condition caused by absent or insufficient levels of PTH. It
is approved under the brand name YORVIPATH® in the European
Union, European Economic Area, and Great Britain as a PTH replacement therapy for
the treatment of adults with chronic
hypoparathyroidism1. TransConTM PTH is also
in development for the treatment of adults with chronic
hypoparathyroidism in the United
States, Japan, and other
countries.
A leading Canadian Parathyroidologist Dr Aliya Khan noted that TransConTM
PTH will be the first approved treatment option available to
Canadian patients living with chronic hypoparathyroidism.
"Hypoparathyroidism can seriously impact quality of life and has
potentially life-threatening consequences," Dr Khan said.
"To have an option that is able to treat the underlying cause of
the disease, moving beyond standard oral calcium and active vitamin
D, is a great step forward."
"This partnership represents Pendopharm's commitment to bringing
innovative medicines that address unmet medical needs to Canadian
patients," said Jad Isber, VP and
GM of Pendopharm. "We look forward to working with Canadian
endocrinologists to make TransConTM PTH available to all
patients who may benefit from it."
Ascendis Pharma Executive Vice President and Chief Commercial
Officer Camilla Harder Hartvig said
"We are delighted to partner with Pendopharm to bring
TransConTM PTH to Canada, contributing to our shared goal of
making a meaningful difference in the lives of patients living with
chronic hypoparathyroidism."
This new partnership aligns with Pharmascience's ambition to
establish itself as a leading organization in the life sciences
ecosystem.
"We are excited by the addition of TransConTM
PTH to our portfolio and the life-changing impact it will have
on patients. Our wide range of generic and specialty products
demonstrates Pharmascience's continued commitment to improve access
to medicines and bring new innovation for patients in Canada and globally" stated Martin Arès,
Chief Executive Officer of Pharmascience.
© 2024 Pendopharm, division of Pharmascience Inc. All rights
reserved.
About Pendopharm
Pendopharm, a division of Pharmascience Inc., is a leading
Canadian specialty pharmaceutical company providing patients with
innovative medicines that address unmet medical needs. Its areas of
focus are gastroenterology, sports medicine and orthopedics,
neurology and cardiology. Pendopharm has extensive experience
and knowledge to successfully manage its growing product
portfolio.
Additional information: www.pendopharm.com
About Pharmascience Inc.
Pharmascience Inc. is one of the largest pharmaceutical
manufacturers in Canada and is
headquartered in Montreal, Canada.
Pharmascience delivers high-quality medicines to over 50 countries
worldwide. Pharmascience's global presence and agile business
development model provide healthcare communities around the world
with the high-quality Canadian medicines to respond to patients'
needs.
About Ascendis Pharma
Ascendis Pharma is applying its innovative TransCon technology
platform to build a leading, fully integrated biopharma company
focused on making a meaningful difference in patients' lives.
Guided by its core values of Patients, Science and Passion,
Ascendis uses its TransCon technologies to create new and
potentially best-in-class therapies. Ascendis is headquartered in
Copenhagen, Denmark and has
additional facilities in Europe
and the United States. Please
visit https://ascendispharma.com to learn more.
About TransConTM
PTH (palopegteriparatide)
TransConTM PTH is a prodrug of parathyroid hormone
(PTH 1-34) administered once daily, designed to provide parathyroid
hormone levels within the normal physiological range across the
24-hour dosing period. YORVIPATH was granted marketing
authorization by the European Commission (EC) and European Economic
Area (EEA) in November 2023 and by
the United Kingdom's Medicines
& Healthcare products Regulatory Agency (MHRA) in April 2024 as a PTH replacement therapy indicated
for the treatment of adults with chronic hypoparathyroidism. In
the United States, the U.S. Food
& Drug Administration (FDA) has set a PDUFA date of
August 14, 2024 to complete their
review of Ascendis Pharma's New Drug Application for TransCon PTH
for adults with chronic hypoparathyroidism. TransCon PTH is also in
development in Japan through
Teijin Ltd. and in China through
VISEN Pharmaceuticals.
About Hypoparathyroidism
Hypoparathyroidism is an endocrine disease caused by
insufficient levels of PTH, the primary regulator of calcium and
phosphate balance in the body, acting directly on bone and kidneys
and indirectly on the intestine. Hypoparathyroidism is considered
chronic if it persists >12 months following surgery per the 2022
Guidelines from the Second International Workshop.2
Individuals with hypoparathyroidism may experience a range of
severe and potentially life-threatening short-term and long-term
complications, including neuromuscular irritability, renal
complications, extra-skeletal calcifications, and cognitive
impairment. Post-surgical hypoparathyroidism accounts for the
majority of cases (70-80%), while other etiologies include
autoimmune, genetic, and idiopathic causes.
References
- YORVIPATH (palopegteriparatide) EU Summary of Product
Characteristics.
- Khan AA, Rubin MR, Schwarz P, et al. J Bone Miner Res.
2023;38(1):14–25.
SOURCE Pendopharm