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Exclusive Life Science Feature insufficiency, one of which was produced until then by Eurand under not only would we have the financial room to innovate but, with the contract. Eurand had launched its first market product — Zenpep pharmaceutical technology platform, we would also have the capabili(pancrelipase) delayed-release capsules, a pancreatic enzyme for the ties to do it." treatment of exocrine pancreatic insufficiency (EPI) due to cystic Innovation has grown along with the company in the form of new fibrosis (CF) or other conditions. Eurand was mainly a supplier and indications as well as novel molecules. More than a decade ago, the licensor of drug-delivery technology and manufacturing services: the FDA stimulated new research into pancreatic enzyme products (PEPs) root of Aptalis' pharmaceutical technology unit. But it also came to the by requiring NDA (new drug application) approval for continued marmerger with its own U.S. sales and marketing group, plus a pipeline of keting of PEPs, which until then were "grandfathered" on the market development products for CF and GI, including some new-indication for treating indigestion because they predated the 1962 FD&C; Act. candidates. With the addition of Zenpep alone, the merged company's Axcan then responded by putting its two existing PEPs through the portfolio continued to expand into the CF area. NDA process for exocrine pancreatic insufficiency — one with timeShowing market and patient awareness postmerger, Aptalis expandrelease delivery; Eurand took the different route of developing its own ed the usefulness of the pancrelipase line by introducing two addi"specialty" PEP, Zenpep, from scratch. The merged portfolio in Aptalis tional Zenpep dosages to achieve the broadest range of strength in the now accounts for three out of six PEPs on the market. class (six dose levels from 3K to 25K lipase units). The expansion was Postmerger, the company's experience with CF led it to take a look an important strategic as well as therapeutic gain because CF patients at the pulmonary area. It soon identified a large unmet need for treatmust have the right dosage to help them stay active, ing recurring lung and each patient's dose must be titrated according infections. So in to body weight and indiApril 2011, Aptalis vidual treatment needs. acquired Mpex A medical doctor by training, President and CEO Frank Beyond such practical Pharmaceuticals, Verwiel loved the scientific environment, but felt drawn to but strategic moves, the which was develthe business side of healthcare. Yet his first encounter with company has set its sights oping Aeroquin, industry, a brief marketing internship with a pharmaceutical on larger strategic goals (levofloxacin company, convinced him to finish medical school in his since the merger. One is solution for native country, the Netherlands. Thereafter, Verwiel resumed to follow the implications inhalation) for his search in the pharmaceutical industry and landed a job of the biology displayed patients with CF with Servier. He then moved to Merck & Co., starting on the in the areas its products and chronic lung commercial side and moving up the executive management now target — the overinfection, an track during the next ten years, where his last position was lapping relationships of inhaled form of heading the global hypertension franchise. In 2005, he was the gut, the lung, and the normally oral approached by Axcan, the predecessor of Aptalis, and soon the pancreas. Another is antibiotic levofloxbecame the company's CEO. to push the envelope in acin. In January exploring the patient-centric mission of specialty 2013, Aptalis pharma in those areas. announced results from its two global Phase 3 trials of Aeroquin for lung infections in CF, MODEL: SP INNOVATION TRAILBLAZER and the company is now preparing an EU marketing authorization For Aptalis, the CF and GI indications share a common trait. Verwiel application. "If you have a foothold in one part of specialty pharma, says, "Our products target a limited number of patients and physione of the ways to expand your business is to go into adjacent areas cians, but their impact on the quality of care that physicians give to that you already know well," Verwiel concludes. patients is very significant. Our model combines that focus with the The company has practiced the same principle of expansion in the pharmaceutical technology part of our business and allows us to go GI area, but this time in a marketing rather than research mode. It beyond developing formulations for other companies, to leveraging has licensed in the product Rectiv (nitroglycerin ointment 0.4%), the technology and expertise for our own pipeline." indicated for moderate to severe pain associated with chronic anal For examples, he points to Aptalis' core technologies: taste maskfissures, for which there is no other FDA-approved treatment. Before ing, oral disintegrating tablets, bioavailability enhancement for poorly Rectiv, compounding pharmacies supplied the only remedies for the water-soluble drugs, and customized drug release for targeting delivcondition, though its introduction in 2012 predated the compoundery to specific parts of the GI tract. All of the platforms can apply to ing controversy that year. either existing or novel drugs. One application, in fact, follows logiMeanwhile, the company branched out on the pharmaceutical cally and practically from the other, to paraphrase Verwiel. technology side as well. Aptalis codeveloped Gilead's pediatric oral"As the company grew, we had more room to develop more innovapowder form of the antiviral Viread (tenofovir disoproxil fumarate) for tive products. One reason the two companies came together was that, the treatment of HIV-1 infection in combination with other antiretro- VERWIEL: THE ROAD TO APTALIS 26 LifeScienceLeader.com July 2013