An FDA advisory panel has handed Novartis a big win, voting overwhelmingly to endorse the efficacy and safety of its new oral MS drug Gilenia (fingolimod).

The only serious hitch today came on the safety side, with the experts backing a proposal to have Novartis study an even lower-dose version of the drug than had been under the microscope in late-stage studies. But the advisers agreed that the new study could commence after Novartis began marketing the therapy. The vote in its favor leaves Novartis with a commanding lead in its race with Merck KGaA to get the first MS pill to the market, where it’s expected to gain blockbuster revenue in competition with the injectables now available.

All 25 nervous system experts agreed that Gilenia is effective at reducing the frequency of relapses. By a 24 to 1 vote the panel also concluded that the therapy delayed physical disability among patients, controlling tremors and improving the concentration of patients as well as other symptoms of the disease.

The panel also concluded that the drug’s safety profile was acceptable after hearing from senior FDA reviewer Lourdes Villalba. Villalba outlined a number of potential safety issues linked to the therapy, including a low heart rate, macular edema in the eyes and a slight drop in lung function. But the safety issues were not seen as a deal-breaker at the FDA, which also endorsed the need for more therapies to treat multiple sclerosis. Villalba specifically noted that the lower of two doses studied by Novartis had fewer side effects, and Novartis has already stated it intends to go with the low-dose version of Gilenia, which researchers say is about equally effective as the 1.25 mg dose that was also studied.

The FDA advisers were so intrigued by the combination of efficacy and improved safety at the lower dose that they recommended that the FDA require Novartis to mount a new trial to study an even lower dose, but agreed that the pharma company should be allowed to roll the therapy out now rather than wait years for more data.

Source: FierceBiotech

Popularity: 2% [?]

Swiss drugmaker Novartis AG moved closer to bringing the first oral multiple sclerosis treatment to market after new data showed its Gilenia cut relapse rates in the disease on Tuesday.

Novartis pulled further ahead of rival Merck KGaA’s pill cladribine to treat the debilitating nervous disease last February when Gilenia, FTY720, was given U.S. priority review status.

Data presented at the American Academy for Neurology (AAN) showed the annual relapse rates were reduced by 62 percent in newly treated patients, while relapse rates were lowered by 44 percent in previously treated patients, Novartis said.

New extension data also showed that Gilenia worked over two years, with patients taking the drug for the period having a significant reduction in relapses and MRI brain lesions compared to the group which first took interferon beta-1a and later switched to Gilenia.

U.S. and EU regulatory reviews are underway for Gilenia.

Source: Reuters

Popularity: 3% [?]

Novartis has won U.S. approval for its key Menveo meningococcal vaccine and got priority review for its oral treatment for multiple sclerosis (MS), underlining the promise of the Swiss group’s pipeline.

The U.S. Food and Drug Administration has licensed the vaccine to help protect people aged between 11 and 55 years against potentially deadly meningitis.

Meningococcal disease infects more than 500,000 people each year, resulting in around 50,000 deaths globally, and many of these could be prevented through vaccines, Novartis said in a statement on Monday.

Novartis also pulled further ahead of German rival Merck KGaA in the bid to get the first oral MS treatment to market after its drug Gilenia, FTY720, was granted U.S. priority review status.

Novartis is competing with Merck MGaA’s pill cladribine against the debilitating nervous disease and has edged ahead since the German group suffered a setback last year, when U.S. regulators held up its application to bring its cladribine drug to market.

The priority review for Gilenia, which cuts the standard review time to six months from 10, comes after the U.S. Food and Drug Administration accepted the regulatory submission made in December for the drug.

“The priority review status is a nice little surprise which may move the launch forward from late 2010,” said Thomas Maul, an analyst at DZ Bank, who expected sales of the drug to reach at least $1 billion a year.

Novartis shares were 0.2 percent higher in early trade, while Merck, which reports its fourth quarter results on Tuesday, slipped 0.7 percent.

The U.S. approval of Menveo was based on a Phase III head-to-head clinical trial that showed it achieved a higher immune response than the other currently available vaccine, Novartis said.

Novartis plans to seek a license for Menveo in infants and children aged between two and 10 years, the group said.

The group is awaiting marketing approval in Europe after the drug watchdog there backed the vaccine at the end of last year.

Source: Reuters

Popularity: 3% [?]

Novartis AG handed drugs head Joe Jimenez its top job on Tuesday with a mission to guide the Swiss drugmaker through ever-increasing competition to its key medicines.

The chatty 50-year-old American steps up after just over two years running Novartis’s dominant drugs unit and faces a tough industry landscape as more blockbuster medicines lose patent protection and the sector struggles to generate new products.

[ad]

He takes over from Swiss Daniel Vasella, a medical doctor and the longest-serving CEO among big European drug companies, who steps down on February 1 after overseeing the acquisition of U.S. eyecare group Alcon Inc.

Vasella will remain as chairman.

“One thing we are aligned on is the strategy of the company, which is … one of focused diversification,” Jimenez told Reuters. “We both believe that the portfolio now is broadly right to help us grow into the future so I don’t anticipate seeing significant changes there.

“I’m going to step back and think through how we’re going to set the agenda for the next few years.”

The departure of Vasella, who headed Novartis since the merger that created it 14 years ago, marks the completion of a changing guard at the top of the European industry after rivals GlaxoSmithKline, Sanofi-Aventis, AstraZeneca and Roche all brought in new CEOs.

Novartis Chief Operating Officer Joerg Reinhardt, who had been tipped as a possible successor to Vasella, will leave the company and his position will disappear.

Jimenez joined Novartis’s consumer health unit in 2007 and soon took over the pharmaceuticals business, overseeing the progression of several promising new medicines including multiple sclerosis pill FTY720, or Gilenia, and cancer drug Afinitor.

His appointment at the head of a slimmed-down executive board came as the company reported a 54 percent rise in fourth-quarter net profit to $2.3 billion, helped by sales of its H1N1 swine flu vaccines — not far from analyst expectations of a 53 percent jump to $2.4 billion.

Novartis shares rose 1.5 percent to 56.50 Swiss francs by 1030 GMT, outperforming a slightly stronger DJ Stoxx European healthcare sector.

HOT TOPIC

“We see this as positive, placing a well respected progressive thinker as CEO,” Deutsche Bank analysts said in a note. “Together with new CFO Jon Symonds we expect Jimenez to tackle pharma costs.”

Shareholder group Ethos welcomed Novartis’s decision to give shareholders a vote on executive pay, a hot topic during tight economic times and particularly for the drugmaker as Vasella’s salary of over 20 million Swiss francs ($19 million) often draws criticism from the press and investors.

Novartis has agreed to buy a majority of Alcon from Nestle SA , using the acquisition to insulate against losing exclusivity on treatments like top-selling blood pressure drug Diovan, and has since come under fire for its lowball offer to minority shareholders.

Jimenez said he was happy with the current line up of new drugs and wide spread of the business into areas such as emerging markets and eyecare, which could all help offset lost Diovan sales when it loses patent protection in 2012.

The group still considered its Alcon offer — originally worth $11.2 billion but dependent on share price moves — as fair, Vasella said. Novartis has had no negative feedback from its own shareholders on the Alcon deal, said Vasella.

[ad]

Novartis expects group sales to grow at a mid-single-digit percentage rate this year, but said profit was difficult to predict given the Alcon deal.

Sector investors will be closely eyeing results from another diversified healthcare group, Johnson & Johnson, due later on Tuesday, for more clues on whether tapping new markets away from prescription medicines is helping some drugmakers.

Novartis trades at a premium to GlaxoSmithKline, AstraZeneca and Sanofi-Aventis thanks to promising new drugs such as multiple sclerosis pill FTY720 and a broad business base, but lags Swiss rival Roche.

Source: Reuters

Popularity: 5% [?]