The prestigious Canadian Prix Galien award for Pharmaceutical Innovation for 2014 has been presented to InterMune Canada, a subsidiary of multinational drug firm Roche, for its Esbriet (pirfenidone) pharmaceutical medicine for treatment of idiopathic pulmonary fibrosis (IPF). Esbriet is currently the only Health Canada approved medication with a specific IPF indication for treating mild to moderate IPF in adults.
The Prix Galien is the most prestigious Canadian award in the field of pharmaceutical research and innovation as part of the non profit organization Innovation Life Canada’s mission to celebrate life sciences innovators. Sometimes referred to as the Nobel Prize of pharmaceutical research, the Prix Galien recognizes efforts and achievements in pharmaceutical research and development of pharmaceutical products — the efficacy, safety and innovation of which contribute to enhancing Canadians’ quality of life.
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating, and ultimately lethal lung disease estimated to affect as many as 1,443 people per 100,000 worldwide, and characterized predominantly by progressive fibrosis (scarring) of the alveoli (air sacs) leading to loss of lung function over time. As tissues thicken and stiffen due to scarring, the lungs lose their ability to efficiently transfer oxygen to the bloodstream, and as a result vital organs will be starved for oxygen. Typically as a result, individuals with IPF experience shortness of breath, develop chronic cough and often find participation in everyday physical activities difficult.
IPF is more common in men than women and is usually diagnosed between the ages of 40 and 80. Based US and European data, it is estimated that 5,000 to 8,000 Canadians suffer from IPF, with 3,000 to 5,000 having mild to moderate disease. Three thousand Canadians die annually from the disease. Treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.
Pirfenidone (Esbriet) is a heterocyclic pyridone, the mechanism of action of which is somewhat unclear, although it is thought to be mediated, at least partly, through inhibiting expression of transforming growth factors beta 1. The drug was originally developed as an anti-inflammatory agent in the 1970s, and was rediscovered as an antifibrotic agent in the 1990. In 2002 pirfenidone was licensed in North America, Europe and Australia by InterMune, and for Japan by Shionogi and Co. Ltd. Roche, which had sponsored the majority of Esbriet clinical trials, acquired InterMune In 2014.
Approved by Health Canada in 2013, pirfenidone is the first drug available to IPF patients that apparently alters the disease’s course. While the pirfenidone compound has been around for almost three decades now, new recognition of its potential therapeutic benefits tested in carefully-conducted, large-scale clinical trials investigating its activity in treatment of what is a relatively rare disorder, offers new hope to persons living with IPS. Esbriet’s safety and effectiveness were established in three clinical trials involving 1,247 patients with IPF in whom decline in forced vital capacity — that is the amount of air that can be forcibly exhaled after taking the deepest breath possible — was significantly reduced in patients receiving Esbriet compared with those receiving a placebo.
The U.S. Food and Drug Administration approved Esbriet, for which it had previously granted fast track, priority review, orphan product, and breakthrough designations, for treatment of IPF on October 15, 2014. Pirfenidone has also been granted Orphan Drug status in Europe. According to the FDA, Esbriet acts on multiple pathways thought to potentially be involved in lung tissue scarring. Esbriet’s most common side effects are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased/loss of appetite, gastro-esophageal reflux disease, sinusitis, insomnia, decreased weight, and arthralgia.
“We are honored the Prix Galien has recognized the important role Esbriet can play in treating many Canadian patients living with IPF, a disease that has limited treatment options and a poor prognosis,” says Ronnie Miller, President and Chief Executive Officer, Roche Canada. “As a company, we are committed to advancing science that brings a benefit to patients, whether that happens through our own productive pipeline or mergers with companies such as InterMune.”
“We are humbled and proud to have received the acknowledgement, and to have been of service to patients and healthcare providers,” says Michael Cloutier, President and General Manager, InterMune Canada, in a release.
Roche Canada, which was founded in 1931 employs approximately 900 people nationwide. The company’;s pharmaceuticals head office located in Mississauga, Ontario, and its diagnostics division is based in Laval, Quebec. Roche Canada invests in charitable organizations and partners with health care institutions across the country. For more information, visit:
For more information about the Prix Galien, visit:
Prix Galien Award
The U.S. Food and Drug Administration
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