Magazine Article | August 9, 2017

Ipsen In The USA — Building & Leading The Subsidiary As Startup

Source: Life Science Leader

By Wayne Koberstein, Executive Editor, Life Science Leader magazine
Follow Me On Twitter @WayneKoberstein

Cynthia Schwalm, president, North American commercial operations for Ipsen, heads a historic initiative by a company few people on the west side of the Atlantic have ever heard of. It all started about three years ago when the company decided to take a literal leap and go where it had only stealthily gone before — into North America, with the United States as the primary goal.

Previously, outside of the U.S., Paris-based Ipsen had both specialty care and primary care businesses. It had conducted some basic R&D at a facility in Massachusetts and acquired several small biopharma companies that enabled it to be commercially active in the U.S. since 2009.

But Schwalm says the company’s focus shifted to specialty and biotech starting in 2012 with the overall goal of becoming a truly global specialty biopharma company. “The trajectory of the company changed when we decided to actively research, develop, and market biotech specialty products in the United States instead of just being a partner to others.”

By 2013, Ipsen had completed a “worldwide landmark registration trial” on Somatuline Depot (lanreotide) for neuroendocrine cancer, an indication estimated to be worth almost $1 billion in the United States. “When the trial data was delivered and published in the New England Journal of Medicine, that was the tipping point for the company to make its bid for the $800 million U.S. market,” she says.

A QUICK START FOR A NEW LEADER
To spearhead this U.S. initiative, the decision was made to bring in a new team based in a new Basking Ridge, NJ, headquarters. Schwalm was asked to lead that team.

Their primary task was to launch the company’s position in oncology and drive its position in neuroscience and other rare diseases. Only five months after Schwalm joined the company, the FDA approved Somatuline Depot for treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Things continued to move quickly when, in 2015, she began overseeing the R&D Center in Massachusetts and — possibly more impressively — created a Canadian satellite (now employing about 30).

“Ipsen had never been in Canada therapeutically,” Schwalm explains. “I actually had set up a Canadian operation prior to this for another company, so I knew how important it was to understand all of the differences between the two countries, from clinical development to health outcome, pricing policy, and launch processes. The classic mistake I’ve seen companies do is just to send Americans or Europeans into Canada, but Canada is not the United States or Europe; it is the tenth largest market in the world, and it’s unique, so it deserves due respect.” As such, she adds that Ipsen’s locations in the two North American countries operate distinctly.

"WE CAN GO DOWN IN THE RECORD BOOKS AS ONE OF THE FASTEST ONCOLOGY STARTUPS IN RECENT HISTORY."

CYNTHIA SCHWALM, President, North American Commercial Operations, Ipsen

This year, Ipsen purchased the oncology assets of Merrimack Pharmaceuticals, led by a U.S.-marketed product, ONIVYDE (irinotecan liposome injection), for metastatic pancreatic cancer. And recently Schwalm was put in charge of a new manufacturing site in Cambridge, MA. In all, the U.S. organization has about 300 employees.

She emphasizes the already-positive effects of Ipsen’s North American landing. “Our stock price has increased on average by about 50 percent per year since early 2015 when we launched an oncology organization in the United States, and our shareholder return has increased more than 153 percent. With those kinds of metrics, we’re now starting to catch the attention of U.S.-based investors. So, we’re gaining momentum. We can go down in the record books as one of the fastest oncology startups in recent history.”

EXPLORER AND BUILDER
In the European custom of prosaic executive ranking, Schwalm’s title downplays her responsibilities; she is more like an American CEO, building and heading a new company subsidiary with its own focus and portfolio — in oncology, neuroscience, and rare diseases. She manages the “legal entities” of Ipsen in North America (the United States and Canada) in an organization that is effectively an operating company. She also carries a worldwide EVP title, reflecting her membership in the company’s worldwide operating committee.

Schwalm came into this industry more than 30 years ago from her initial career in medicine, starting as an oncology and critical care nurse with ambitions to become a physician. While she was studying to take entry exams to medical school, she received a job offer to be a medical device sales rep. She took the job and found she enjoyed it so much she decided to continue her career on the industry side. Soon, she was recruited to be one of the first 50 founding sales representatives for Janssen Pharmaceutical.

“I’ve always maintained positions where I could stay extremely close to the patient agenda. That is what drew me into the biotech and specialty settings, and it’s what has kept me in the specialty setting.” To help master business management along with her desire to help patients, Schwalm later earned an Executive MBA from The Wharton School.

Since embarking on the industry course, she has managed multiple businesses globally working in Europe, Asia, and Latin America. From J&J’s Janssen and Ortho Biotech, she went on to run oncology at Amgen, serve as president of Eisai U.S., and work as an adviser to biotech and specialty companies for two years, before joining Ipsen.

MOMENTUM BEYOND ONCOLOGY
These days, any oncology startup will likely face the question of whether or how its portfolio might include immunotherapy. Ipsen has already licensed, tested, and abandoned a Phase 3 immuno-oncology candidate but is still looking for other IO opportunities for itself or with partners.

But although Ipsen’s new U.S. arm is a self-identified oncology startup, it brings a few nononcology assets over from the parent company. First among them is Dysport, the biologic forming a “therapeutic” and “aesthetic” product line rivaling Botox and marketed for more than 20 years only outside the United States. In 2010, Ipsen’s exclusive global commercial partner for Dysport, Nestleowned Galderma, won FDA approval for the product in treating cervical dystonia, a rare neurological condition. Since then, Ipsen U.S. has gained additional approvals for the product in treating adult spasticity, as well as childhood spasticity primarily related to cerebral palsy.

Dysport has received three therapeutic FDA approvals in less than two years and has just received approval in cervical dystonia in Canada. This past June was a milestone month, in which Dysport became the only botulinum toxin approved by the FDA for the treatment of spasticity in adults in upper and lower limbs and for the treatment of lower-limb spasticity in children ages two and older. It also has a Phase 3 clinical trial moving toward an expected registration in pediatric upperlimb spasticity during the next two years. The company recently announced a Dysport copromotion agreement with Saol Therapeutics to expand its commercial reach.

Galderma continues to market the Dysport aesthetics line globally, leaving Ipsen free to focus on therapeutic forms of the product. “Dysport is part of Galderma’s whole aesthetic portfolio, which covers the entire landscape from medical spas to plastic surgeons, so it’s a natural fit for them to market Dysport,” Schwalm explains. “We focus on pediatric neurologists, adult movement-disorder doctors, and adult and pediatric physical medicine and rehabilitation. Those are very different commercial models.”

Dysport’s competitive advantage in aesthetic and therapeutic uses alike seems to be its extended duration of benefit, Schwalm stresses. “As confirmed by all of our experience and data on the product, at least 20 percent of the patient population experiences a benefit from the therapy for over three months at a time. That is a distinguishing feature of Dysport, though it plays out differently in the therapeutics, aesthetics, pediatric, and adult populations.”

Today, the U.S. division is the number-one affiliate for the Ipsen Group. “The U.S. division has gone from being 4 percent of Ipsen’s worldwide revenue in 2013 to more than 20 percent currently, and it is now the innovation engine and commercial engine for the company,” says Schwalm. “A primary initiative for us this year — and going forward — is to help the rest of the markets in the United States and Canada understand all of the company’s capabilities.”


DRUG PRICING & KEEPING INNOVATION IN THE U.S.

Some companies in the specialty space also have led much of the debate over drug pricing — and not, in the most notable cases, by good example. Like most industry veterans, Ipsen’s top U.S. executive Cynthia Schwalm sees such overriding “external” issues as vital concerns for every biopharma company, and she has particular views based on her long experience.

“The sad part is looking at how the majority of the industry has not governed itself in pricing, but I think we are starting to see a tipping point,” she says. “The large American-based pharmaceutical companies are self-reporting what they plan to do with their pricing policy, which is a first. Also, PhRMA is starting to regulate its membership and ensuring that membership is based on companies that are putting at least 10 percent of their revenue back into innovative R&D.”

Schwalm also reserves some advice for the public sector: “I’m hopeful that we’ll continue to see some traction toward keeping the innovation and our people and our tax base here.” She recalls the former program of federal tax breaks for pharma companies that built factories in Puerto Rico as an example of effective but unfortunately abandoned policy. She believes close-to-home manufacturing also can keep companies innovative.

“We acquired not only the rights but the manufacturing facility for ONIVYDE from Merrimack, and it’s located right in Cambridge. ONIVYDE is a very difficult product to make, and we are also making some of the experimental medicines there that Merrimack kept. It is our intent to keep that manufacturing process in the United States, which may be unusual now, but it’s all part of innovation, especially in biotech, keeping that special capability close to the market.”

In time, more industry voices may join Schwalm and others in balancing the public debate over healthcare policy, company behavior, and innovation. Meanwhile, she will likely continue to prove her own worth as effectively the CEO of Ipsen’s U.S. startup. Her leadership and the company’s performance to date have already made their marks.


RECENT MILESTONES

JUNE 30, 2017
Dysport copromotion agreement with Saol Therapeutics to expand commercial reach in the United States

JUNE 16, 2017
FDA approval of Dysport for the treatment of lower-limb spasticity in adults

APRIL 3, 2017
Completed acquisition of ONIVYDE and additional oncology assets from Merrimack Pharmaceuticals

JANUARY 9, 2017
Ipsen to acquire oncology assets from Merrimack Pharmaceuticals

AUGUST 1, 2016
FDA approval of Dysport for the treatment of lower-limb spasticity in pediatric patients aged two and older


WOMEN AT C-LEVEL = WIN FOR EVERYONE

It is a simple fact that Cynthia Schwalm, who heads the U.S. startup company of Paris-based Ipsen, is a woman who has succeeded as an executive in an industry traditionally dominated by men. We asked her to discuss what her experience has been and what it means for women of her generation, as well as the next one, in their ongoing struggle to rise to equal participation at the highest levels of industry leadership.

SCHWALM: In the early years, when I was in my early 30s, I started to drive down the career path of becoming a general manager, with P&L responsibility. One of the issues women faced at that time — and still do — is the trade-off of work and family. I’ve been happily married for 31 years, I have two bright, beautiful daughters who are 23 and 24, and I had the good fortune of being able to travel through my life journey with the right leaders who didn’t penalize me for wanting to be a mother or saying no to a certain job at a certain time because I needed to do a certain thing. A greater opening is coming, when people can actively navigate their lives within their profession, but it has to come for young women and young men alike. I am hopeful that the day is coming when they can feel fully self-expressed with their families, even taking care of elders, and still choose the right job and be open to relocation at the right time. Unfortunately, the statistics still show that there is not only a glass ceiling, but a cement ceiling for C-suite females. Research shows that boards and companies do better when there’s more than one woman at the table, and that’s just good business sense. Given that women are over half the world’s population and are the majority purchasers of healthcare, one would argue that the focus needs to continue on the work toward diversity. I do not subscribe to the statement that there aren’t enough good women to do the job; there are. I happen to be an example, and I’ve been around for a while. I have been a member of the John F. Kennedy School of Government women’s leadership advisory board for almost eight years, and their systematic research shows how efforts to include women in the leadership agenda actually are better for society and for business.