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Novartis Has Blockbuster Diovan Plans After Patent Expires

Joseph "Joe" Jimenez, chief executive officer of Novartis AG, speaks during a panel discussion at the World Health Care Congress in Washington. Photographer: Andrew Harrer/Bloomberg

Aug. 5 (Bloomberg) -- Novartis AG Chief Executive Officer Joseph Jimenez had worked in the pharmaceutical industry only four years before taking the helm of the Swiss drug giant in February 2010.

Yet his brief tenure in the business hasn’t kept him from crafting a bold solution to a problem that’s long stumped drug industry veterans: how to manage the so-called patent cliff when lucrative medicines lose patent protection. Veteran executives at some companies, such as Sanofi, are acquiring smaller rivals with more promising drug pipelines. Others, such as managers at Pfizer Inc., are cutting back on expensive research and development to save cash.

Jimenez, only 13 months away from the U.S. patent expiration of his company’s best-selling drug, Diovan, doesn’t feel pressed to do either, Bloomberg Businessweek reports in its Aug. 8 edition. Instead, he’s targeting administrative costs while aggressively promoting medicines in emerging markets and cranking out new drugs from his own labs.

The longtime consumer-products executive is betting Novartis can maintain a third of the $6.1 billion in annual sales of Diovan, a hypertension drug, by focusing on sales in emerging markets. While that may seem like a big drop, it’s smaller than the post-patent nose dives suffered by former blockbusters such as Pfizer’s Norvasc hypertension pill and Merck & Co.’s cholesterol drug, Zocor.

“We can get through the Diovan patent expiration if things go to plan,” Jimenez said in an interview at Novartis’s Basel, Switzerland, headquarters. “The market hasn’t digested that fully.”

Shares Decline

Novartis fell 1.08 Swiss francs, or 2.4 percent, to 43.42 francs in Zurich trading. Investors have beaten down Novartis shares 21 percent this year, making it the third-worst performer in the Bloomberg Europe Pharmaceutical Index. The company also faces the loss of patents on its second-best seller, the cancer medicine Gleevec, starting in 2014. That puts an additional $4.27 billion in annual sales at risk.

“They’ve got two cliffs with Diovan and Gleevec,” said MF Global analyst Justin Smith in London.

Jimenez said that shifting Diovan’s growth focus to emerging markets in Latin America and parts of Asia, where the blood pressure medicine already competes largely without patent protection, will help keep its blockbuster status.

Keep $2 Billion Sales

Diovan sales are rising in those fast-growing parts of the world even though the drug costs more than generic versions. Many patients in markets where drug counterfeiting is widespread are willing to pay more for a brand’s perceived quality.

Jimenez figures he can expand promotion of the drug to doctors in these markets aggressively enough to retain at least $2 billion in Diovan sales worldwide. If he’s right, the strategy might buy him time for Novartis’s year-old Gilenya pill for multiple sclerosis and an asthma treatment to gain momentum in Western markets where drugs sell at much higher prices.

The U.K.’s National Institute for Health and Clinical Excellence, which advises the state-run National Health Service on treatment costs, rejected Gilenya in draft guidance today. The agency said the drugmaker failed to show that the pill reduces relapses sufficiently to justify the annual cost of about 19,196 pounds ($31,300). Eric Althoff, a Novartis spokesman, said the drug is “highly efficacious and cost-effective” and that the company will work with the agency to ensure the appropriate patients can get the medicine.

Patent Cliff

Novartis isn’t alone at the edge of the patent cliff. Drugs with $139 billion in combined annual sales will be going off patent in the next five years, according to researcher EvaluatePharma. Yet history suggests Jimenez’s stick-it-out strategy is risky: Sales of brand-name medicines often plunge more than 90 percent within a few years after the introduction of generic competition. Zocor, which logged $5.2 billion in revenue in 2004, had sales of just $468 million last year.

Jimenez is following a different course to retain sales of Gleevec, which will lose protection in Japan, the U.S., and Europe by 2016. He’s ramping up sales of Tasigna, a medicine based on Gleevec which, like its cousin, is approved for use against leukemia.

Gleevec Expiration

Tasigna, with $399 million in sales last year, could bring in more than $2 billion in 2015, according to the average estimate of analysts surveyed by Bloomberg.

“We have time to convince physicians and the industry that patients are better off with Tasigna,” Jimenez said.

Besides maneuvering the patent transition in its pharma business, Jimenez is still managing the integration of Alcon Inc., the eye-care company that his predecessor, Daniel Vasella, bought in stages for $50 billion starting in 2008.

Vasella figured eye care holds faster growth prospects than pharmaceuticals. The business has come with a learning curve. While Novartis already sold contact lenses and the Lucentis eye drug, the drugmaker has no experience in Alcon’s main business: products for eye surgery.

Alcon Devices

“We partly bought Alcon for the management team because it’s a device business and we’re not a device company,” Jimenez said. “I’m spending a lot of my time ensuring that the management team is getting what it needs from Novartis so that they can maximize the value of their business for Novartis shareholders.”

The company’s real hope, however, lies in its promising new drugs. Products introduced since 2007, such as Afinitor for kidney cancer, now account for 28 percent of its business. Afinitor had sales of $102 million in the second quarter, almost double its revenue the year before. Gilenya’s revenue was $79 million and may exceed $2 billion by 2015, based on the average estimate of six analysts.

“You can easily build a case that said that because the pipeline is so rich, that we could get through this period” without having to look outside the company for growth, Jimenez said. “I can’t guarantee that it’s going to happen, but I can say that there’s a clear path to deliver it.”

Heinz Cuts

Jimenez joined Novartis’s drug division in 2007 after eight years at H.J. Heinz Co. and a short stint at Blackstone Group LP. He made a name for himself by aggressively bringing down costs while he was head of Heinz’s European division, said CEO William Johnson.

“He was very analytical and decisive, and he was prepared to make decisions that were very unpopular,” Johnson said.

Soon after becoming Novartis CEO, Jimenez overhauled U.S. pharma operations, eliminating the company’s primary care unit and cutting 383 jobs. This March he proposed reducing operations at a research site in Horsham, England, and in November announced that about 1,400 sales positions will be cut in the U.S., in part because of the Diovan patent loss.

Jimenez inherited a company that Vasella, who remains Novartis’s chairman, forged out of the Swiss drugmakers Sandoz and Ciba-Geigy. That created an entity diversified much like Johnson & Johnson, which sells prescription drugs, eye care, vaccines, consumer-health products and animal medicines.

“Some have said that Vasella built an empire, now the focus should be on making it more efficient,” said Gbola Amusa, a UBS analyst in London.

Numbers Guy

The executives have differing approaches. “Daniel was a guy who came from a medical perspective,” said James Shannon, head of Novartis’s development unit until 2008. “Joe is very much a numbers-oriented guy.”

One area where Jimenez isn’t wielding the knife is research. Novartis’s R&D spending last year rose 21 percent, to more than $9 billion, and was about $4.6 billion in the first half of 2011. By contrast, rival Sanofi’s R&D spending last year fell 4 percent, and Pfizer plans to cut its budget to develop new drugs by as much as $3 billion in the next two years.

“If the industry is about innovation and growth, you’d better keep your R&D spending strong,” Jimenez said. “All of the non-innovation costs need to be aggressively managed.”

To accomplish that, Jimenez aims to boost the use of Novartis’s manufacturing capacity to 80 percent from 50 percent. He also has introduced cost-saving purchasing methods such as reverse auctions, where suppliers bid against one another to give Novartis the lowest price for goods and services.

The company already has found more than the targeted $300 million of annual cost savings from the Alcon purchase, Jimenez said. Yet managing Diovan’s decline will be his real test.

To contact the reporter on this story: Eva Von Schaper in Munich at

To contact the editor responsible for this story: Phil Serafino at

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