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APPROVAL OF EXPANDED INDICATION FOR PrGENOTROPIN® IN CANADA

31/07/20

The growth hormone injection somatropin is now indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS)

July 31, 2020 – KIRKLAND, QC / TORONTO, ON – Pfizer Canada and the Foundation for Prader-Willi Research are pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for PrGENOTROPIN® (somatropin [rDNA origin] for injection) for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing. GENOTROPIN is also indicated for improvement of body composition in children with Prader-Willi syndrome. Of note, GENOTROPIN is contraindicated in patients with Prader-Willi syndrome who have uncontrolled diabetes, active psychosis, have active cancer, are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment.

Prader-Willi syndrome (PWS) is a rare genetic life-threatening medical disorder caused by loss of active genetic material on chromosome 15 which affects: hormones, muscle strength, appetite, behavior, cognition and learning, temperature regulation, pain tolerance and sleep patterns.[1]

“Pfizer Canada heard the challenges faced by parents of children with PWS, as no medication was approved for this indication in Canada. Despite the very limited data, the Canadian team along with key colleagues around the world mobilized and worked with pediatric endocrinologists, the Foundation for Prader-Willi Research Canada and Health Canada to make this come through,” says Frederick Little, Rare Disease Canada Lead, Pfizer Canada. “This is a great example of Pfizer's relentless pursuit to bring patients rare disease therapies that meet unmet medical needs.”

“Our journey has not been an easy one. However, Pfizer’s successful Health Canada submission has meant that the growth hormone indication has finally been extended. I can say without question that our collective efforts will improve the lives of so many children with PWS, including my own daughter,” adds Celine Lepage, Drug Access Lead, Foundation for Prader-Willi Research Canada.

“Children living with PWS face unique challenges which can lead to physical, emotional and behavioural issues,” says Dr. Jill Hamilton, Head, Division of Endocrinology, Professor of Paediatrics, University of Toronto and Senior Associate Scientist, Research Institute at The Hospital for Sick Children. “Despite having an insatiable appetite, individuals with PWS have decreased amount of muscle, low muscle strength, and are prone to osteoporosis. It's important for pediatric endocrinologists to have treatments available for patients with Prader-Willi syndrome."

Prader-Willi syndrome affects approximately 1 in 15,000 people—males and females equally, from all races and ethnicities.1

About Pfizer Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world’s best known and most prescribed medicines and vaccines. In 2017, Pfizer Inc. invested US$ 7.65 billion globally toward developing safe and effective medicines and took part in more than 180 new R-D collaborations. Canadian headquarters of Pfizer’s Biopharmaceutical Group are located in Kirkland, Quebec. To learn

more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.

About the Foundation for Prader-Willi Research (FPWR)

The Foundation for Prader-Willi Research was established in 2003 by a small group of parents who saw the need to foster research that would help their children with Prader-Willi syndrome lead more healthy and fulfilling lives. Today, FPWR is composed of hundreds of parents, family members, researchers, and others who are interested in addressing the many issues related to PWS.

Through our world-class grants program, translational research programs, and the development and support of PWS research tools, FPWR is playing an active role in research in order to develop new treatments for PWS and improve the health and well-being of those with PWS.

With the support of the PWS community, FPWR’s research programs have grown from funding small pilot studies to encompassing a robust and diverse research portfolio that facilitates and guides the PWS research agenda. We have played an instrumental role in advancing the field of PWS research by supporting innovative research, encouraging collaboration, engaging pharmaceutical companies, and enabling a research-ready community.                                                                                                              

About PrGENOTROPIN®
GENOTROPIN (somatropin [rDNA origin] for injection) is a polypeptide hormone of recombinant DNA origin. It was initially launched in Canada in 2013 and is indicated for:

Children: long-term treatment of growth failure due to growth hormone deficiency (GHD) – other causes of short stature should be excluded; growth failure (as defined by SDS) in short children born small for gestational age and who fail to achieve catch-up growth by 2 to 4 years or later; short stature associated with Turner syndrome in patients whose epiphyses are not closed; long-term treatment of idiopathic short stature (as defined by height SDS), and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means, and whose epiphyses are not closed; growth failure due to Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing and for improvement of body composition in children with PWS.

Adults: the replacement of endogenous growth hormone in adults who meet the following criteria: Adult Onset (AO) – patients who have GHD either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; Childhood Onset (CO) – patients who were GHD during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients treated with somatropin for GHD in childhood and whose epiphyses are closed should be re-evaluated. Diagnosis of adult growth hormone deficiency is confirmed by an appropriate GH provocative test, except in: patients with multiple other pituitary hormone deficiencies due to organic disease; and patients with congenital/genetic GHD.

®Pfizer Health AB Pfizer Canada ULC, Licensee

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For further information:
Corporate Affairs Canada
Pfizer Canada Media Line: 1-866-9Pfizer (1 866 973-4937)

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[1] Foundation for Prader-Willi Research, What is Prader-Willi Syndrome?, https://www.fpwr.org/what-is-prader-willi-syndrome-fact-sheet, accessed July 8, 2020.