Up Close and Personal

“The key to innovation is developing compounds that are differentiated and have clear clinical benefit”
-Fereydoun Firouz

As President and CEO of EMD Serono, Fereydoun Firouz is driven by the belief that innovation is fundamental to success in the biopharmaceutical industry. Innovation is the cornerstone of the company's business model, driven by a pipeline that includes late stage-products, unique partnering models, and a growing R&D organization focused on delivering future medicines.

In the limelight is EMD Serono's late-stage pipeline, primarily its investigational short-course oral multiple sclerosis drug, cladribine. For Firouz, cladribine is the essence of innovation, with the potential to be the first oral, short-course therapy to treat MS.

"As a leader in the area of multiple sclerosis, we believe that if approved, cladribine could possibly transform the way people living with relapsing MS approach their therapy options."

In common with many companies within the industry, the recent financial downturn has not left the company completely untouched. Firouz points out that EMD Serono is an employer, and is limited by constraints every employer faces in difficult times. "Acting fiscally responsible during these times is important to ensure a sustainable business in the future and in the healthcare business. It also impacts, to a certain extent, the drug reimbursement system in America,," notes Firouz.

"As a commitment to ensuring patients have access to our products through our patient assistance programs, we are also in a fierce competition across our formulary positions on the insurance business, and that is important for us to manage."

"The economy has obviously had an impact on our business model: some of our compounds, mainly our infertility franchise, have an out-of-pocket personal pay. That means it is a cash segment, so patients may have to pay with their own money. It's not fully insured in certain states, so we're seeing some decline in that segment of our business, as people must make choices," he explains.

Community focus
Firouz believes the business drives the prerogative of a successful biopharmaceutical company to become part of the community in which it operates, and he certainly proves to be a man of his word. EMD Serono has immersed itself in a number of collaborations with its patients, employees and communities: the company supports many local and national organizations, including the American Cancer Society, and the National Multiple Sclerosis Society.

In order to better impact the local community near its Boston location, the company is involved with initiatives to train the next generation of scientists, such as the Massachusetts Biotechnology Education Foundation's BioTeach program, which aims to integrate biotechnology into every school in Massachusetts.

"We don't behave like a standalone company in our community and only take care of our business,," says Firouz. "We need to be active within our community and help, and as we grow we want the community around us to grow and to benefit also."

Why has EMD Serono so emphasis on community values? As a subsidiary of Merck KGaA, Darmdstadt, Germany, it is able to run an efficient, more community-focused operation without the corporate mindset of big pharma. The company has a long history of corporate social responsibility and for the organization this is key to being a successful biopharmaceutical company.

Firouz's tenure with the organization spans nearly 20 years. His leadership abilities first came to prominence during his stint as Vice President of Latin America for Serono SA, where he oversaw the successful launches of multiple products and the company made the transition from a pharmaceutical to a biotech company.

"I learned a great deal from my time in Latin America, from when we began synergizing our manufacturing capabilities that were based at that time in raw material collection. We were trying to shut that down because we had already gone to a biotechnology platform and had introduced the first generation biotech products in the region, beginning with our multiple sclerosis product, Rebif," he says.

The company continues to be a leader in the Latin American market, expanding and introducing new products.. Under Firouz's leadership, its Rebif therapy for relapsing remitting MS patients was approved by the FDA in the US in 2002. Additionally, his experiences in global regions including Latin America, and the Middle East have helped him shape the culture and success of EMD Serono.

Today, as part of his day-to-day responsibilities, Firouz takes advantage of the company's size and its experience in the sector to understand and take part in the conversations surrounding healthcare reform. Firouz believes that one of the main current issues is whether sufficient incentives can be provided to the industry in order to drive innovation, so that patients can get the cutting-edge, life-changing treatments they need.

Neither has the company has not ignored the emerging trend toward tailored therapies and Firouz notes the importance of recognizing this. "One way, we think about personalized medicine as bringing the biomarker angle into the debate, and we are quite active in that. One of our drugs in oncology, Erbitux, for example, which is marketed outside of the US by Merck KGaA, is being targeted at tumors bearing a normal or 'wild-type' KRAS gene. As an R&D organization, we have wholeheartedly embraced personalized medicine and its value to the customer, the payer. We see that as a critical advantage, and we have instituted that in our R&D and commercial organizations."

Partnering up
EMD Serono undertakes three types of partnership: the typical one with another biotech pharma company, with an arm of a patient advocacy group, and with an academic institution.

"We are not limited to partnering with a smaller biotech company or a bigger pharmaceutical company," Firouz explains. "An example of this is our partnership with the Canadian biotech company, Theratechnologies. We are working toward bringing a compound to the US market, a growth releasing hormone for the indication of lipodystrophy. The commitment is a follow-through to our HIV franchise that we have only in the United States. It's public that the filing at the FDA has happened, and our partner is working to bring the compound to the market.

"That's the type of partnership we've done with a biotech company, successfully expanding a franchise where we have the know-how, where we already have product expertise, and then delivering a late-stage compound to market. The second kind of partnership we do, which is quite a breakthrough, is with certain investment arms of patient advocacy groups, such as Fast Forward.

"Fast Forward, a wholly-owned subsidiary of the National Multiple Sclerosis Society, is a collaboration centered on supporting early-stage research in the areas of multiple sclerosis, and there's a certain amount of investment earmarked to drive this goal. We are now in the process of screening some of the proposals that are coming to us, and a cross-organizational committee between Fast Forward and EMD Serono will look at these proposals and will make the appropriate decisions to advance those compounds to a later stage of development."

The third type of partnership is purely R&D, as Firouz explains. "An example of this is the collaboration with MD Anderson within our oncology pipeline, focused on early stage compounds. They evaluate the potential of compounds and then we decide together if we want to develop them for any specific indication," he says.

This type of collaboration is reflective of EMD Serono's own R&D organization, in which compounds are discovered and evaluated for their longer-term clinical value. EMD Serono's activities are heavily focused on oncology, as well as neurodegenerative diseases. The company has its neurodegenerative research operations in a new facility in Cambridge, Massachusetts, where it is hiring scientists across different disciplines to strengthen its global neurodegenerative platform. One of the core principles of the research organization is to also focus on disease prevention, and reversal – understanding the pathology behind the disease to ultimately help people live healthier lives, Firouz explains.

Despite the economic downturn, EMD Serono's future looks promising. In a time when healthcare reform is on almost everyone's lips, the change of system is sure to bring those companies making the major breakthroughs, such as a potential oral therapy for MS, into the limelight. "We need to be part of that dialog, and that is going to be our first step," says Firouz. "We support a balanced approach to reforming healthcare, and we want the administration to be successful in that.

"We also want to continue to tap into the resources that we have in Boston, in the northeast and the whole of the country, and that would mean strengthening our position in R&D and having more yielding investments in the United States, having products that are going to cover unmet medical needs and bring options to patients. We'll be continuing on that path as we go forward."

In Firouz's view, the key factor that will pull the industry through the financial crisis is innovation: "The key to innovation is developing compounds that are differentiated and have clear clinical benefit on efficacy, safety and convenience. We're fortunate in that we have those products in the market and our pipeline is about creating those types of compounds," he concludes.

 

Partnership

EMD Serono's agreement with Fast Forward, a wholly owned subsidiary of the National Multiple Sclerosis Society, was announced on May 1, 2009. The collaboration, which committed $3 million, is aimed at supporting innovative, early-stage projects to develop therapies to prevent treat or reverse nervous system damage in multiple sclerosis (MS). Fast Forward had already received strong presence in the early-stage development for MS with its ongoing research funding; it was agreed that Merck KGaA would provide up to $19 million in total funding.

Expansion

In April, 2008 the company announced a planned investment of more than $75 million at its Billerica research facility, also in Massachusetts. The investment is due to create more than 100 new jobs. On March 30, 2009, EMD Serono announced its plans to expand its research capabilities and open a new site in Cambridge, Massachusetts. The site incorporates the company's drug discovery activities in neurodegenerative diseases and will accommodate almost 50 scientists to work at the location.