ROCKLAND — EMD Serono, one of the few foreign-owned biopharmaceutical companies to plant its Massachusetts base outside the Boston area, has long gone about its business quietly in this Plymouth County town about 25 miles south of the state’s life-sciences hub.
But this year, the company will be raising its profile as it embarks on a research expansion north of Boston and seeks US approval of its first targeted cancer therapy.
EMD Serono, the US arm of the German drug maker Merck KGaA, is set to announce Monday a $12 million expansion of an existing research-and-development complex in Billerica. It plans to hire about 100 scientists and 50 commercial employees in 2016 at a new 30,000-square-foot building to focus on cancer and immunology treatments. The company currently has 400 employees in Billerica.
Later this year, the company plans to seek Food and Drug Administration approval for Avelumab, an experimental medicine for a rare skin cancer called Merkel cell carcinoma. It would be the company’s most significant product launch in years. It would also give EMD Serono an entry into the emerging field of immuno-oncology, which develops drugs that harness the immune system to fight cancers.
“If you look at our pipeline, Avelumab is really the foundation, going forward,” Gary Zieziula, an industry veteran who took over as president and managing director EMD Serono in January, said in an interview. “It will establish our footprint in immuno-oncology.”
EMD Serono has about 1,200 employees in the United States, including about 800 in Rockland and Billerica. It was formed through the German Merck’s blockbuster $13.3 billion acquisition in 2006 of Switzerland’s Serono SA, which had its US headquarters here. The buyer, a separate company from the US drug giant Merck & Co., was barred from using the Merck name in the United States and Canada, so it adopted the name EMD Serono here.
The business rang up $1.6 billion in North American sales last year, about 11 percent of parent Merck’s overall sales of $14.6 billion, which includes life-sciences tools and materials as well as drugs. Historically, EMD Serono has developed “specialized therapies” aimed at smaller patient populations. It relies heavily on sales of four approved drugs.
Its biggest seller, the multiple sclerosis drug Rebif, vies with Avonex, made by Cambridge’s Biogen Inc., and other treatments in a class of MS injectables known as interferons. (That segment itself faces heavy competition from newer oral treatments for the neurological disease.)
EMD Serono’s other main drugs — Gonal-f for infertility, Saizen for growth hormone deficiency, and Serostim for increasing body weight in people with HIV — are all mature products.
Zieziula said he will seek to boost sales of these marketed drugs in 2016 even as the company begins its pivot to immuno-oncology.
The transition will be key to EMD Serono’s future success at a time when immunotherapies, such as Merck & Co.’s melanoma drug Keytruda and Bristol-Myers Squibb Co.’s lung cancer drug Opdivo, are among the top-selling medicines globally.
During a visit to Boston last year, Merck KGaA health care group’s chief executive, Belen Garijo, who oversees EMD Serono, said developing cancer treatments is “our top priority.”
Merck KGaA struck an alliance with drug giant Pfizer Inc. in November 2014 to collaborate in the immuno-oncology field. The two companies will jointly commercialize Avelumab, which was initially discovered by the German company. Beyond its use in Merkel cell carcinoma, EMD Serono and Pfizer have been testing the drug as a potential treatment for ovarian, bladder, gastric, and lung cancers in a half dozen clinical trials. The two companies are also co-promoting Xalkori, a lung cancer chemotherapy developed by Pfizer.
Zieziula, who is leading the charge for EMD Serono, worked for Big Pharma companies Roche AG, Merck & Co., and Bristol-Myers Squibb before joining the Rockland company in 2014 as chief commercial officer. He was promoted to the top job late last year when his predecessor, Paris Panayiotopoulos, accepted a job leading Ariad Pharmaceuticals Inc. in Cambridge.
Parent Merck’s investment in the Billerica expansion is a sign of confidence in EMD Serono, said Zieziula, who added that he is enthusiastic about hiring more employees.
“I think we’re in the best shape we’ve been in for many years,” he said. “The challenges are bringing the right people and the right resources to the organization.”