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Exclusive Life Science Feature founding 110 years ago. of standard medicines. Complex generics — such as injectable, Teva's first original product to go global was Copaxone (glatliposomal, long-acting release, nasal, patch or device-delivered iramer acetate) for multiple sclerosis (MS), launched in 1996. drugs — present real development challenges, Levin says, because Copaxone may lose IP protection as soon as May 2014, and the it may be difficult to engineer the optimized molecule, formulate company also faces patent losses on other branded products it the API, or overcome other technological barriers. An essential markets. Levin, who joined the company as CEO in May 2012, has ingredient of the new business model he describes is a company's been under pressure from analysts and shareholders to boost the ability to develop and manufacture complex and special products pipeline and cut costs simultaneously, speeding up the one while in a broad variety of types and at a scale sufficient to keep costs for deepening the other. They would like to see him repeat his celcompany and customers as low as possible. ebrated "string of pearls" strategy at Bristol-Myers Squibb, bringing "Whether it's a simple generic or a complex one, high-value or in new products through partnering and acquisitions. otherwise, integrated generics companies like Teva are all workThough seemingly two different issues — industry's innoing toward the same end — we're all basically bringing greater vator-generics convergence competition that will ultimateand Teva's against-the-odds ly lead to more patient access growth strategy — a common for critical medicines," Levin challenge unites them. Put says, in what he calls his "apple simply, the industry and Teva pie" statement. His main point have met at the crossroads of highlights an objective change medical need and industrial in the pharmaceutical/biopharinvention. In Teva, you can maceutical business model: see the industry's uphill strugProducts will no longer comgle to bring new therapeupete only upon price, in genertics into the world that help ics' case, or upon first-to-marpatients and give vitality to the ket in the case of the original enterprises that develop and patent holders, but also upon supply them. And you can see finished-unit quality. the wide range of approaches Levin cites Teva's "capabilithis company is taking to meet ties in formulation" as one of its humanitarian and business the areas where it has stepped challenges. ahead of traditional pharma Jeremy Levin, CEO, Teva Levin gives positive credit in manufacturing. Advanced to conventional generics formulation allows the comfor greatly widening patient pany to explore a nontradiaccess to critical medicines tional but medically needed and lowering the cost of care. He views low prices as a key benefit form of innovation. Rather than drawing on drug discovery, it of follow-on medicines and the original Paragraph IV process — by puts products through a rebirth. Its NTEs, siting on proven targets which generics makers must seek to invalidate originators' patents with known efficacy and safety profiles, improve on the original — as a necessary, even heroic mechanism for healthcare progress. products with optimized formulations, new delivery technology, "America's pharmaceutical landscape was historically driven by or even repurposed applications to address unmet patient needs. large, high-priced drugs. Companies that introduced generics The company's first initiated NTE project deals with HIV, where were not well-thought-of, and the large pharmaceutical companies it aims to improve adherence by significantly reducing the pill battled against them. But in effect, the penetration of generics was burden for patients. Other targets of Teva's NTE focus include proinitially very minimal," he says. "Now it's 83 percent, and generics longation of drug half-life to reduce frequency of administration, have had a huge, multibillion-dollar effect in reducing healthcare modification of pharmacokinetic profiles to reduce side effects, costs. Today, generics are part of our life, and they will be forever." converting drugs from parenteral to oral or other favorable routes Indeed, that seems to be the case — even if generics will not of administration, drug delivery systems for special patient populaforever be the same. Levin says two main developments are forcing tions, such as children and the elderly, and drugs developed for changes in the generics business model: greater challenges with new indications. "The model of the future is managing complexity; the character and reproducibility of molecules coming off patent, we can create better and better medicines which improve compliand a steep decline in the value of Paragraph IV products, with ance, rather than relying on small Paragraph IV products." dozens of companies now typically sharing marketing exclusivity So, does the new model predict the demise of the traditional for a single drug. mom-and-pop generics company that plowed the first ground Both factors encourage the emergence of "high-value" generics, in this field? "I believe the integrated strategy is the one that is follow-on versions of complex medicines, and improved versions required," says Levin. "Some individual companies will be able "Teva's approach to specialty products is industrial scale. You need to produce them consistently and in an industrial fashion." 26 LifeScienceLeader.com October 2013