Drug companies used to produce branded, patent-protected medicine or they produced generic copies and rarely both, especially in the United States.
But the world is changing, including in the United States, and Teva Pharmaceuticals Ltd. is one of the companies trying to successfully mix more branded drugs into its long-established generic portfolio.
One of those branded prescription medicines is Qnasl, a steroid nasal allergy inhaler approved by the U.S. Food and Drug Administration in March for use in adults.
Teva's Dr. Tushar Shah, a senior vice president for research and development, worked on the branded side in previous jobs with other companies, including GlaxoSmithKline P.L.C.
"This was part of what attracted me to come to Teva, because it is one of the few that plays in both areas," Shah said recently in his office in Horsham. "We're the biggest generic company in the world, and in the U.S. by far. But we have a large, branded business already, and with the Cephalon acquisition, we acquired a whole portfolio."
The $6.8 billion purchase of Malvern-based Cephalon in 2011 was the big piece in Teva's diversification strategy. Cephalon makes branded drugs such as Treanda, Nuvigil, and Provigil. Qnasl was in the Teva pipeline before the Cephalon deal.
Generics occupy 70 to 80 percent of the U.S. drug market, and that percentage is likely to grow as cash-strapped businesses, governments, and patients look to reduce health-care costs. There is greater profit per dose in patent-protected branded drugs, but that only comes after incurring the cost and time of research, development, clinical tests, approval from government agencies, manufacturing, and marketing. Generic drugs require plenty of steps, but they are usually copies of the original.
Shah said the branded and generic sides of Teva have functioned independently. One key point of intersection is legal work related to patents. Drug companies employ patent lawyers to protect or challenge patents. Teva lawyers have to do both.
Teva, based in Israel, has its Americas division headquarters in North Wales, Montgomery County. New CEO Jeremy Levin noted recently that as important and different as the American market is, it is not the only market. "If you look at Teva's footprint throughout the world, different markets do not distinguish as much between generic and branded," Levin said.
That is a factor in Qnasl, which Shah said was produced only for the U.S. market because the stronger medicine (a corticosteroid) can be bought over the counter in several European countries. Teva says its research shows there is enough demand in the United States for stronger medicine so patients will get a prescription and insurers will cover some portion of the cost. The wholesale acquisition cost (what manufacturers report as the price for wholesalers) is $106.99 for a 30-day supply, though patient costs are determined by insurers and pharmacies. The first few months of a drug launch involve persuading drug plans to include the product on formularies.
Shah said the steroid in Qnasl is meant to treat the cause of the problem — inflammation of the nasal canal — instead of just the symptoms, such as a runny nose and sneezing. Nasal sprays can be messy, with the liquid coming back out the nose or running down the throat. Shah said the innovation Teva engineered was to make a dry spray and the "actuator," or nozzle attached to the can, delivers the spray in a "softer, less forceful" manner. Nostril happiness is so important.
"With seven to eight percent of the U.S. population needing or using a corticosteroid," Shah said, "it is a big market."