Launching cancer treatments in Canada

Josh Neiman of BeiGene discusses his experiences with Health Canada and stakeholders (640 words, 3 minutes)

NPC Healthbiz Weekly is presented to you in cooperation with Peak Pharma Solutions

While some believe Canada can be a challenging national market for Pharma to launch new treatments, BeiGene’s recent introduction of zanubrutinib has Josh Neiman envisioning a long-term partnership between the drugmaker and Canada.

He is Chief Commercial Officer and senior vee-pee at BeiGene, a global biotech working to accelerate oncology Txs for Ca patients globally. 

In March, BeiGene received Health Canada approval for zanubrutinib for Tx of adult patients with Waldenström’s macroglobulinemia, a rare white blood cell cancer. The approval was based on the Aspen trial, a phase 3 head-to-head study of the BTK inhibitor zanubrutinib versus the standard care BTK inhibitor, ibrutinib. 

According to Neiman, BeiGene filed for approval in several countries, but Canada was the first to progress through the dossier and get to approval. 

“What we found in working with Health Canada was they were very thoughtful in their assessment of the data, but they saw what we saw, and that is [zanubrutinib] is an option that needs to be made available for patients,” said Neiman (photo below). “Fortunately, the filing was fast-tracked and led to a very speedy approval.”

Neiman discussed BeiGene’s process with Health Canada on the Season Four premiere episode of the NPC Podcast, a program for Pharma executives. (Listen to the episode here.)

Although zanubrutinib has received Health Canada approval, Neiman admitted there is more to do to ensure patients across the country have broad access to the treatment.

Neiman said he found the Health Canada approval procedures similar to Europe. He added there were similarities in the Canadian reimbursement process and the role that the various provinces play in determining whether or not patients have access to treatments.

However, while a country such as Germany is similar to Canada because it has a rigorous assessment process for reimbursement, Neiman notes that Germany is focused on creating immediate access for patients once a treatment receives approval. 

“In contrast, in a place like Canada, there are private markets that offer the opportunity [to access treatments], but there are [only] a minority of patients who can access those,” Neiman said. “Really, the question for us is just how long is it going to take for us to get reimbursement and be able to provide a drug that we think is meaningful, and Health Canada agrees is meaningful, for all patients? Just how long is it going to take for us to be able to really maximize the number of patients who will be able to access it?”

BeiGene is focused on getting their treatment to as many patients as fast as they can. Still, Neiman said Canada’s reimbursement policies do not affect the company’s decisions regarding where it launches a treatment. 

“We are really focused on getting our medicines everywhere as fast as we can,” he said. “Canada really represents a phenomenal opportunity because we see a real, strong clinical benefit in zenubrutinib for Waldenström’s [patients]. We anticipate that our other studies in other malignancies will also [produce] similar results. Hopefully, this is the beginning of what we anticipate will be a very long relationship with the Canadian government and, most importantly, with Canadian patients.”

The Takeaway: After successfully working through the approval process on zanubrutinib with Health Canada, Neiman sees BeiGene’s relationship with Canada as a long-term partnership.

“We have one drug that’s been approved; we have a very robust pipeline with other molecules that are under development [and we are] constantly looking to in-license other molecules as well,” Neiman explained. “Five to 10 years from now, you’re going to see that BeiGene is a strong partner for Canadian patients in the fight against cancer, and it's not going to be just one drug. It'll hopefully be many more.”

Further reading: Research published in The Lancet shows a 60 per cent decrease in new clinical trials for cancer treatments during the pandemic. Read the study here

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YOUR HEALTHBIZ WEEK 05/11/21

  • GlaxoSmithKline and Vir Biotechnology announced that the European Medicines Agency started a rolling review of data on sotrovimab, an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and with Covid-19 who do not require oxygen supplementation and who are at risk of progressing to severe infection.

  • BeiGene announced that its PARP inhibitor pamiparib received conditional approval from the China National Medical Products Administration to treat patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. The new drug application was previously granted priority review by the Center for Drug Evaluation in July 2020. BeiGene is preparing to launch pamiparib in China this month.

  • The U.S. FDA has approved Merck’s checkpoint inhibitor pembrolizumab combined with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. It was approved under an accelerated approval pathway based on tumour response rate and durability of response.

  • Biogen’s potential treatment for Alzheimer’s, aducanumab, received a poor report from the Institute for Clinical and Economic Review because of insufficient efficacy and the drugmaker’s recommendation of a low price point if approved. The report comes weeks before an expected decision from the U.S. FDA. 


UPCOMING NATIONAL PHARMA CONGRESS WEBINARS 

The National Pharma Congress Spring Webinar is scheduled for tomorrow (click here to register). The Summer Webinar is scheduled for Tuesday, June 22, 2021. Be sure to watch the NPC HealthBiz Weekly for updates on the events.


CANADIAN HEALTHCARE MARKETING HALL OF FAME

The Canadian Healthcare Marketing Hall of Fame awards were established in 2002 to honour healthcare marketers who have contributed to our avocation and are an inspiration to others.

More than 100 honourees have been selected during the past 18 years. In the selection committee's view, they stand for a representative cross-section of the qualities that make our business unique and fulfilling. Each week, NPC Healthbiz Weekly will acknowledge one past Hall of Fame Honourees.

2009 Inductee
Laurie Dotto 
Abbott Laboratories
Ottawa

Editor’s note: Laurie served as the Director of Strategic Projects at AbbVie until 2019, when he retired.

Working in the pharmaceutical industry for more than a quarter of a century, Laurie Dotto, a native of England who grew up in Sudbury, Ont. and completed an undergraduate science degree with a major in biochemistry at Sudbury’s Laurentian University, has witnessed an evolution in regulation and government influence on the business.

Today, bodies such as provincial drug boards, which decide which medications will appear on provincial drug formularies, the Patented Medicines Prices Review Board, which regulates the prices research-based pharmaceutical firms can charge for medications, and the Canadian Agency for Drugs and Technologies in Health, which provides formulary listing recommendations to most publicly funded drug plans in Canada, all exert a force on the pharmaceutical industry through the pricing of medications and determining the accessibility of medications to the public at large.

“I interface with these groups almost daily,” says Dotto, who holds the position of Director, Government and External Affairs for Montreal-based Abbott Laboratories Canada. “These organizations play a significant part in our industry.”

Dotto contrasts the present-day reality to the time in 1981 when he began in the pharmaceutical business. “There were sales positions, and there were marketing positions,” notes Dotto, whose first job in the industry was as a sales representative in Ottawa for Montreal-based Nordic Pharmaceuticals Ltd. 

An achievement he recalls as a sales representative for Nordic was the launch of Cardizem, a calcium-channel blocker that became the first $100 million product in Canada. He received a promotion to regional sales manager for Western Canada and later moved to Nordic’s head office, where he headed the firm’s continuing health education department. Under his direction, the firm re-launched Glucophage, an oral hypoglycemic, and tripled the product's sales in two years.

With the movement toward mergers in the industry, a trend that saw Nordic absorbed by a larger corporate entity, Dotto chose to travel down Highway 401 and assumed the job of group product manager at Syntex Inc. in Toronto, and then later took a position as marketing manager for Eli Lilly Canada Inc.

A longing for Montreal prompted Dotto to travel back to that city to take a position with Abbott. “I really missed Montreal,” says Dotto, an avid kayaker who negotiates the challenging waves of the Lachine Rapids in Montreal in the warmer months of the year. Dotto notes that he spent time in immersion programs in Jonquière, Que. to improve his French and is now very comfortable in his second language.

Since returning to Montreal in 1995 and joining Abbott, he has held six positions, including Director of Sales and Marketing, Business Unit Director for Abbott’s gastrointestinal and urology division, and Director of Business Development. A focal point of his career since joining Abbott was handling the company’s acquisition of Knoll Pharmaceuticals at the turn of the new millennium.

Inspired by his daughter’s volunteer work in central Africa, which she began as a teenager, Dotto has dedicated many vacation days in the last five years to performing humanitarian work in Africa, particularly in Malawi. 

Through a family charity, Dotto and his daughter Stephanie have contributed to the building of schools, have brought medicines to Malawi, and have worked on other health and educational projects for the population. In addition, Dotto has been instrumental in coordinating millions of dollars worth of product donations from Abbott to Africa through Health Partners International of Canada.

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NEXT WEEK

The 05/18 edition of NPC Healthbiz Weekly will feature Brenda Irwin, Founder and Managing Partner of the Relentless Venture Fund, about venture capital and angel investing in the life sciences, disrupting the standard of care status quo, and preventive health venture funds. It’s easy to get your no-charge subscription and have the issue sent to your phone or inbox each Tuesday at 6:00 a.m. sharp.

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