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 TransCon^TM PTH (palopegteriparatide) in Canada. Financial terms of the agreement are not disclosed.

TransCon^TM 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. TransCon^TM 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 TransCon^TM 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 TransCon^TM 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 TransCon^TM 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 TransCon^TM 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 TransCon^TM PTH (palopegteriparatide)

TransCon^TM 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

1. YORVIPATH (palopegteriparatide) EU Summary of Product Characteristics.
2. Khan AA, Rubin MR, Schwarz P, et al. J Bone Miner Res. 2023;38(1):14–25.