Norgine B.V.

Cross Towers
Antonio Vivaldistraat 150
Amsterdam, 1083 HP
Netherlands
Telephone: (+31 20) 567 09 00
Fax: (+31 20) 567 09 99
Web site: http://www.norgine.com

Private Company
Founded:
1906
Employees: 1,000
Sales: €368 million ($435.97 million) (2016)
NAICS: 325412 Pharmaceutical Preparation Manufacturing

Norgine B.V. is a European pharmaceuticals manufacturer focused especially on the European, Australian, and New Zealand markets. The company positions itself as a specialist pharmaceuticals producer, manufacturing and marketing medicines in the fields of gastroenterology, hepatology, and cancer and supportive care. The company's flagship products include Movicol, a constipation treatment, which generates nearly half of the company's total revenues; MoviPrep, used in colonoscopy procedures; and Xifaxan, a diarrhea treatment. Headquartered in Amsterdam, Netherlands, the company operates a research and development center in Hengoed, Wales, and manufacturing facilities in Hengoed and in Dreux, France. Europe represented 94 percent of the company sales in 2016, with Germany, the United Kingdom, and France as its largest markets, respectively. In 2017 the company acquired Merus Labs International Inc., adding its operations in Europe, Canada, and other markets. Norgine is led by CEO Peter Stein.

ALGINATE PIONEER: 1906

Norgine was the brainchild of Victor Stein, a chemist born in Teplice, in the Ústí nad Labem region of the future Czech Republic, in 1879. Stein became one of a number of scientists investigating the extraction of nutritional ingredients and other substances from seaweed. Among these substances, sodium alginate held particular promise as a stabilizer for ice cream, yogurt, and other foods. The discovery that brown seaweed, found in the North Sea and Nordic regions, was particularly rich in sodium alginate led Stein to orient the company's operations toward this region.

In 1906 Stein founded Norgine, combining parts of the words north and alginate, and acquired a seaweed-processing factory in L'Armor-Pleubian, along the North Sea coast in the Brittany region of France. That factory had originally been built in 1896 in order to extract iodine. Norgine set to work developing a method for extracting sodium alginate. The lack of a commercial market for the ingredient at the time, however, coupled with the beginning of World War I, forced Norgine to end production by 1916. Norgine sold the factory in 1917.

COMPANY PERSPECTIVES

Our vision is to be the “go to” European specialist pharma company

We are a leading European specialist pharmaceutical company with 110 years' heritage. We have a presence in all major European markets and employ over 1,000 people. We operate a well-established European infrastructure to develop, manufacture and commercialise products.

What sets us apart from other companies is our flexible and agile approach to partnering and collaboration. We are able to integrate new products quickly for the benefit of healthcare systems and patients in Europe, Australia and New Zealand.

Stein's Ústí nad Labem factory grew quickly and the company soon became a major supplier of insulin in much of Europe. During the 1920s and into the 1930s, the company opened sales subsidiaries in a number of markets, including in Belgium, France, Germany, and the United Kingdom. Stein was joined in the business by his younger brother, Oswald, born in 1883. Following Victor Stein's death in 1934, Oswald Stein took over as head of the company. He was joined by his son, Walter Stein, then still in his 20s.

Both Oswald and Walter Stein were forced to flee after Nazi Germany invaded and occupied Czechoslovakia and instituted its “Aryanization” program, taking over Norgine and other Jewish-owned businesses in 1938. Actively hunted by the Gestapo, Oswald Stein managed to make it to England, where he became an adviser to the British government. Walter Stein initially fled to France, and then to Spain, and ultimately found safety in South America. Other members of the Stein family were not as fortunate, and many were murdered in Auschwitz.

POSTWAR GROWTH

Walter Stein returned to Europe at the end of World War II and regained control of Norgine in 1945. Stein revived the company, which had ceased production during the war. Because Czechoslovakia, however, soon fell under Soviet control, Norgine moved to Western Europe. The company opened factories in Argenteuil, France, and in London during the 1950s, and later established its headquarters in Amsterdam. During the 1960s the company added new factories in Dreux and Hengoed. These later grew into the company's primary manufacturing centers.

Norgine developed a number of popular products during the 1960s and into the 1970s. Among these were Normacol, an enema solution; Nortussine, a cough suppressant; Givalex, a mouthwash for the treatment of cold sores and other infections; and Contracide, a drinkable antacid. In 1974 the company completed its first acquisition, of Camden Chemical Company, based in Uxbridge, England. The addition of Camden expanded the company's product portfolio with a number of other strong-selling products, such as Camcolit, a lithiumbased mood stabilizer; Spasmonal, used in the treatment of irritable bowel syndrome and other intestinal conditions; Kamillosan, a topical ointment for skin infections; and Waxsol, used to soften and remove earwax.

While Norgine continued to build its own product portfolio, its business model expanded to include its first marketing partnerships, as the company acquired the licenses to produce and market products from thirdparty companies in Europe. The company's first major “in-licensing” partnership was with Birex Pharmaceuticals, later known as Helsinn Healthcare, to market its Klean-Prep colonic, used in preparation for colonoscopy exams. That partnership began in 1980.

During the 1980s Norgine, which remained controlled by the Stein family, launched a new strategy designed to position the company ahead of the creation of the European Union, slated for 1992. The company set out to establish itself as a Pan-European specialist pharmaceutical company. To this end, the company began building its international sales network, setting up subsidiaries in 15 countries into the 1990s. These included a number of Central and Eastern European countries, as these markets shrugged off decades of Soviet dominance during the decade.

BEST SELLER: 1995

KEY DATES
1906:
Victor Stein founds Norgine in Czechoslovakia to extract sodium alginate.
1919:
The company launches pharmaceuticals production.
1945:
Nephew Walter Stein takes over the company.
1995:
The company launches Movicol.
2018:
U.S. Food and Drug Administration approval is received for Plenvu.

Norgine's research became increasingly specialized, with a focus especially on the field of gastroenterology. This led to the development of another major product for the company, MoviPrep, a laxative used in the preparation for colonoscopies and gastrointestinal interventions. MoviPrep also paved the way for Norgine's entry into the United States, through a marketing agreement with Salix Pharmaceuticals of New Jersey in 2005. Sales of MoviPrep to the United States began in 2006, following the company's successful application for U.S. Food and Drug Administration (FDA) approval.

The innovative laxative quickly came into demand in other international markets. In Japan, for example, in 2008 the company teamed up with Ajinomoto to market MoviPrep there. This was followed by a partnership with Canada's Medical Futures Inc. that same year, and with another partnership, with PharmaSwiss SA, to market MoviPrep to Eastern European markets, in 2009. In 2011 MoviPrep was introduced into the Commonwealth of Independent States markets as well, through a partnership with Nycomed A/S. After only two years on the market, MoviPrep became Norgine's second-largest-selling product.

ON A RUN

In the meantime, Norgine had added another major project to its portfolio when it acquired the European marketing license for Xifaxan, an antibiotic used to treat traveling-related diarrhea and diarrhea associated with irritable bowel syndrome and other disorders, originally developed by Italy's Alfa Wassermann. Norgine acquired the license in 2008 and began marketing Xifaxan in Germany that same year. Xifaxan grew into the company's third largest-selling drug, particularly after the launch of a new formulation, Xifaxan 550, which extended the drug's therapeutic range into the treatment of hepatic encephalopathy. The formulation received approval from both the European and Australian authorities in 2012, and was launched in Europe in 2013.

The success of MoviPrep and Xifaxan, as well as the continued strong performance by Movicol, helped drive up Norgine's sales to nearly €233 million by the end of 2008. By 2010 the company had extended its sales and marketing reach into 15 countries, including Portugal, where Norgine added a subsidiary in 2008, and Egypt, which became the launchpad for the company's broader entry into the Middle Eastern markets. Norgine, which counted 1,000 employees by then, remained under the control of the founding Stein family, with Peter Stein serving as the company's CEO.

Norgine also maintained a strong research and development investment program through this period, paving the way for future growth. In 2008, for example, the company launched construction of a new technical development facility at its Hengoed plant. The facility, designed to produce novel pharmaceutical formulations for clinical trials, was commissioned in 2009.

Other new drugs included Zegerid, a combination of omeprazole and sodium bicarbonate used in the treatment of gastroesophageal reflux, peptic ulcers, and similar conditions, from Santarus, Inc., in 2009. In that year, after Alizyme Therapeutics Ltd. went into bankruptcy administration, Norgine acquired the global patent to cetilistat, then still in clinical trials. Norgine successfully completed clinical trials for the drug and began marketing it under the Cametor and Oblean brand names. Cetilistat was approved for use in Japan in 2013, and then in Europe and elsewhere, as a treatment for obesity, despite its side effects, which included diarrhea and increased flatulence.

BRANCHING OUT

Norgine continued to adjust its product portfolio as it refocused itself as a specialist pharmaceutical manufacturer into the new decade. This adjustment included the divestment of a number of products, including Spasmonal and Waxsol in 2010. Instead, the company added licenses to a number of other products. In 2010, for example, the company acquired the license for ulimorelin, a gastroenterological drug under development by Tranzyme Pharma, Inc. That drug, however, failed in its Phase III clinical trials in 2011. Norgine ended development of Zegerid in 2011 as well.

More promising for the company was Setofilm, an antiemetic, for which Norgine acquired the exclusive rights for the European, Middle East and North Africa, South African, and Australasian markets in 2011. The European launch of Setofilm was completed in 2013. In the meantime, the company's own product development brought another success, with the launch of the stool softener Giprocol in 2012.

Norgine had also begun to branch out into other areas. In 2010 the company acquired a 12.7 percent stake in Scotland's ProStrakan Group Plc. That company was acquired the following year by Kyowa Hakko Kirin Co., Ltd., and was renamed as Kyowa Kirin. In December 2012 Norgine teamed up with SpePharm Holding BV to form a 50-50 joint venture, SpePharm AG, in order to take over SpePharm Holding's entire product portfolio, including brands such as Dantrium, MuGard, PROther, Savene, and Xerotin. Also in 2012, Norgine created a capital investment firm, Norgine Ventures, to provide funding for health care and pharmaceutical start-ups.

Movicol continued to lead Norgine's revenue growth, as the company's sales topped €320 million by the end of 2015. Part of that growth came from China, after the company completed a licensing agreement for that market with China Medical Systems Holdings Ltd. This was followed by the successful launch of Movicol in Russia, through partner Takeda in 2016.

MERUS ACQUISITION

Norgine launched a new strategy in 2014 designed to confirm the company's status as a European-focused specialist pharmaceuticals manufacturer. To this end, Norgine divested its South African operations in 2015. The following year, the company shuttered its Egyptian subsidiary and divested all of its operations in the Middle East and North Africa region to Switzerland's Acino AG. Norgine also continued to streamline its product portfolio, selling the rights to Camcolit and Norgalax in the Benelux markets in 2016.

Norgine completed its largest acquisition to date in July 2017, when it paid CAD 342 million to acquire the Canadian-based Merus Labs International Inc. The purchase gave Norgine access to Merus's strong product portfolio, which included European-focused products such as Sintrom, Deponit, Elantan, Emselex, Estraderm, and Salagen, as well as Vancocin, marketed in Canada. The addition of Merus raised Norgine's annual sales, which reached €368 million ($434.97 million), by another CAD 111 million ($84 million).

Norgine soon followed up that acquisition with the launch of Plenvu, a new-generation bowel-cleansing preparation, in 2017. The company received marketing approval from the European Union that same year. This was followed, in May 2018, by FDA approval as well. Norgine hoped the product would become a new best seller as the company claimed a spot among Europe's leading independent, and family-controlled, pharmaceutical companies.

M. L. Cohen

PRINCIPAL SUBSIDIARIES

Arc Medical Design Ltd. (70%); SpePharm AG (50%).

PRINCIPAL DIVISIONS

Critical and Supportive Care; Gastroenterology; Hepatology.

PRINCIPAL COMPETITORS

Abbott Healthcare Products B.V.; Akzo Nobel N.V.; Brocacef Groep N.V.; Crucell N.V.; Ferring B.V.; Merck Sharp and Dohme B.V.; Pfizer B.V.; Royal DSM NV; S.C.A. Hygiene Products Zeist B.V.; Zentiva NV.

FURTHER READING

McKee, Selina. “Norgine Rejoins ABPI after Eight Year Absence.” Pharma Times, February 16, 2017.

“Next-Generation Preparation for Colonoscopies Receives FDA Approval.” Managed Care, May 8, 2018.

“Norgine Buys Merus Labs for $342M.” Contract Pharma, May 11, 2017.

“Norgine Completes Acquisition of 12 Products from Merus Labs.” PharmaBiz, July 19, 2017.

“Norgine Receives Austrian, French, Irish, Italian & Portuguese Regulatory Approval for Plenvu for Bowel Cleansing in Adults.” PharmaBiz, January 16, 2018.