Developing Products for a Global Market

As a business unit leader for a major biopharmaceutical company, Mike Yasick has an unusual background. He started out, as he calls it, ‘carrying a bag’ – working as a sales representative. In fact, he has 20 years of experience working in the industry in sales, marketing, new product development and commercialization. He also spent a couple of years living and working in London, so he knows the markets on both sides of the ocean.

As Head of Shire’s GI Business Unit, Yasick has been focusing on the implementation of the company’s new global operating model in the GI therapy area. In the past, the company was run on a regional basis but the new model allows it to focus more on the products themselves and on optimizing them for the global marketplace.

“It’s a conscious decision,” he says. “You can decide that you want to set up your company to be really good in a particular geography, or you can decide that you want to commercialize medicines in a way that they can be successful across markets. We decided to have our focus on developing the best possible global products.

“What that means in terms of implementation is that everything gets aligned around product development and commercialization, rather than what is the best fit for a particular geography. We have team members who are dual specialists, in that they know what it’s like to work in particular countries, and at the same time are experts in regulatory affairs, or marketing or other disciplines.”

This means having more focus on individual product characteristics and individual product traits. Yasick admits this is less efficient than simply saying, “We’re going to have a geographic area expert,” but he says it’s much better in terms of building products that will be valuable and also deliver the most benefit for patients, governments and payors.

Differentiation

According to Yasick, the biggest challenge in the European marketplace is the effort to differentiate products – to create products that have real value for physicians and patients. “I think the days of being able to have a product with very small incremental benefit and to have that product become successful are behind us. The challenge for us in the pharmaceutical industry is to identify compounds that bring real benefits to patients in countries where the market dynamics are so different from those here in the US.”

“For example in Europe, you’re not going to get reimbursement, you’re not going to get on to state formularies, you’re not going to get compensated for products that don’t bring real, distinguishing value to patients. There are legions of examples, but literally now you’re in a position where if you bring a product that is delivering a similar result to medications that are on the market you may get regulatory approval, but you won’t get pricing by the European pricing bodies.”

Yasick underlines that the old way of bringing out a product that’s only slightly better than what’s out there is not likely to be successful in the future. This means that differentiation will become crucial, as will showing strong pharmacoeconomic benefits of products in existing classes, and making sure that when patients get those products they use fewer resources in the healthcare system.

“It’s a much more evolved position in Europe than in North America,” Yasick says. “But having said that, if you develop drugs that will be successful there, they are also going to be successful here. It’s only a matter of time before some of the application of the cost management and disease management systems that are being introduced and starting to mature in European markets will be applied in the US.

“The world is getting smaller, and from a scientific perspective, information isn’t local to any particular country or region. Information is global and the divergence of opinion about how to treat diseases is getting smaller and smaller. The ideas for new ways to treat diseases are not just coming from one region or another; they’re coming from everywhere.”

A strong core

At the foundation of any successful medicine is a core of very important information that can be consistent throughout the world, regardless of whether you need a particular study to get approval in France or you need a particular key opinion leader from the United States involved in that development. Doing the kind of market research and clinical research that strengthens the core of the product gives companies the most flexibility to address those particular issues as they go out and launch in the other markets.

“While building this core, it’s absolutely critical to have a depth of understanding in the local marketplace,” he explains. “One of the things that Shire is focusing on as we become more of a global organization in GI is having people who are familiar with the markets and having them participate in clinical and commercial research. Global consistency is important, but local flavor is important too. ”

As Yasick points out, the key is to have people participate in the commercialization of the brand who have both global experience and knowledge of local markets. “They need to know what it will take to be successful in each individual country. Each market will have a slightly different perspective, and incorporating these in the commercialization process lets you build a global brand that can be successful in many different places.”

Taking risks

One example of a successful international launch for Shire is Mezavant in Europe (launched as Lialda in the US). The product launch has been very successful in both Europe and in the US, thanks to the depth of understanding Shire developed early on regarding the key stakeholders in both markets. Mezavant was developed with an eye toward differentiation, and this meant not always choosing the safest path, Yasick says.

“For this product we took a risk in development, in that we added a reference arm that is in many countries in the world the market leader. It was an unusual thing to do, but it was also very important, when you consider the way products are priced and reimbursed. Having that information is absolutely critical for a health authority to be able to decide if a product will ultimately be approved. Should I even have this on formulary? Is it worth paying for? How do I pay for it if it is worth paying for?

“The understanding that the world would likely be different when we launched our product than it was when we started, and having a good knowledge of the markets in Europe, allowed us to create development and commercialization plans with an eye toward differentiation. These are what have made Lialda/ Mezavant a successful medicine.”

Mezavant uses a novel multimatrix delivery system to provide a high strength of 5-ASA per tablet. With this technology, ulcerative colitis patients are able to treat their disease with a once daily dose. The technology ensures continued and prolonged exposure of the colonic mucosa to the active ingredient, allowing 24-hour treatment. In addition, Mezavant helps improve compliance and reduce pill burden for irritable bowel disease sufferers.

Shire is conducting a global study investigating the use of Mezavant to treat diverticulitis, a condition in which small pouches bulge through weak spots in the colon, which then become infected or inflamed. The prevalence of diverticulitis is increasing in Western Europe, and in the US about 10 percent of people over 40, and 50 percent of those over 60, suffer from the disease.

“We’re pretty excited about this potential use for Mezavant, and again it’s a good example of looking at the assets you have and deciding whether it makes more sense to spend millions of dollars bringing a product into the company, or invest those millions of dollars in a product you know well that may actually have a better risk profile and a better return on that investment. One of the things a company of Shire’s size does particularly well is thinking about all the ways that the products we currently have might benefit patients.”

Shire has also just acquired the rights in Europe to a compound for celiac disease, a disease of the immune system in which there is a significant immune system overreaction to gluten in diet, and which affects all the systems in the body.

Symptoms can range from mild to severe, including bloating, diarrhea, nausea, gas, tiredness, constipation, anemia, mouth ulcers, headaches, weight loss, depression, infertility, recurrent miscarriages and pain in the joints. Sufferers can also display symptoms of malnourishment, and can even develop neurological symptoms. There is currently no treatment, apart from eliminating gluten completely from the diet, which is extremely difficult to do.

It’s not surprising, then, that Yasick is enthusiastic about this new compound: “It’s exciting because there is such a need for better treatments. In many countries – Spain, Italy, the Nordic countries and others – health authorities screen routinely for celiac disease in infancy and also reimburse some of the costs of diet. We’re developing a treatment that we hope will make it much simpler for people to manage their disease, with the potential to eliminate some of the serious consequences and that may even help patients who are not able to not comply with a diet. It’s also a completely new way to look at treating autoimmune disease.”

Secret to success

When asked where the next generation of drugs will come from, given that blockbusters are becoming harder to find, Yasick is unfazed. “The interesting thing about Shire is that while we would love to find blockbuster products, it’s not necessary for the success of our business model. Historically, our success has largely been driven by products that would be considered mid-sized to even small-sized in the big pharma world. The reason these products work for us is that they can be commercialized and developed very efficiently, and the result is having multiple medicines with each potentially contributing $200 to $500 million annually to our revenue stream.”

According to Yasick, the Holy Grail would be to find traditional small molecule approaches to address very specific targets, where you know by activating or deactivating a specific gene or turning on or off a specific receptor, you will see a beneficial therapeutic result.

“I think there’s room for both approaches, and you’re seeing it with even bigger companies that are starting to realize that some of these smaller, non-blockbuster, less than $1 billion kinds of products are very attractive because they can be commercialized much more efficiently.

“Everybody would love to find a blockbuster, no doubt about it. Those products can have remarkable benefits for patients. Because blockbusters often break new ground in therapeutic areas, they’re extremely attractive to find; and to meet an unmet need like that is what any company would like to be able to do. That’s also what makes them rare.

“At Shire, our business model is predicated on products that address high unmet medical needs, to help patients, and that have a very good financial perspective – but maybe won’t generate $1 billion in sales. Often, in big companies, those projects can’t overcome the internal hurdles to get the kind of resources needed to make them a success, but at Shire, that’s our expertise and part of the secret to our success.”

About Mike Yasick

Mike Yasick is Head of the GI Business Unit at Shire. He came to Shire from CellTech Pharmaceuticals, and before that worked with GlaxoSmithKline and Glaxo, for whom he spent several years working in London. He started out as a sales representative, and has also worked in sales management, product management and marketing.