Novartis Gains FDA Approval For Oral MS Drug

Glivec (Gleevec) film tablet made by Novartis.Image via WikipediaNovartis is now a game changer in MS market. Novartis is usually known for their vaccines, is the first in the oral pill MS drug market. Top News from Novartis as MS drug, Gelenya was approved from the FDA Monday.

Wikinvest: Novartis AG (NVS)

WASHINGTON, D.C. (TheStreet) --U.S. regulators approved Novartis'(NVS) Gilenya, the first treatment for multiple sclerosis that patients take as a once-daily pill, the company announced Wednesday.

Gilenya's approval by the U.S. Food and Drug Administration instantly changes the competitive landscape for multiple sclerosis (MS) drugs. Existing MS drugs made by Biogen Idec(BIIB), Merck (MRK) , Bayer (BAYRY) and Teva Pharmaceuticals(TEVA) are all administered by injection.

Novartis is now the only company to offer an oral MS drug, which may spark instant demand from doctors and patients eager for the convenience of a pill. Studies have also demonstrated that Gilenya works better than some of its competitors at tamping down the symptoms of MS. One of the pivotal studies used to approve Gilenya showed the drug to be superior to Biogen's Avonex in preventing MS relapses.

Counteracting the excitement for the new MS pill, however, is a side effect profile that may make doctors hesitant to use Gilenya ahead of older, more established MS drugs.

Investors were widely expecting FDA to approve Gilenya, although the agency did so without a restrictive black box warning for safety concerns and a patient monitoring system less onerous than expected.

"Gilenya has been approved for multiple sclerosis in the U.S. with a prescribing label and a REMS [risk management] requirement that are probably the best possible outcome both Novartis and investors could have hoped for," wrote J.P. Morgan European pharmaceutical analyst Alexander Hauber in a Wednesday note to clients.

Analysts, on averge, forecasts more than $1 billion in peak sales for Gilenya.

Biotech investors are most interesting to see what impact Gilenya has on Biogen Idec, which markets Avonex, the best-selling MS drug used primarily in patients newly diagnosed with the disease; as well as Tysabri, considered the most effective MS drug but one that can also cause the serious brain infection progressive multifocal leukoencephalopathy (PML). As a result, doctors use Tysabri more as a second-line treatment in MS.
Biogen shares fell in pre-market trading Wednesday on news of Gilenya's approval. Biogen released a statement on Gilenya: "The long-term safety profile of Gilenya has yet to be established and there is limited data for it in patients with certain common comorbidities."

JP Morgan biotech analyst Geoff Meacham, in a recent note to clients, said his polling of MS doctors found that Gilenya would likely have minimal impact on front-line MS drugs such as Biogen's Avonex, Merck's Rebif, Bayer's Betaseron or Teva's Copaxone but could have a larger effect on Biogen's Tysabri (which is co-marketed by the Irish drug maker Elan(ELN).) He rates Biogen at neutral with a $55 price target.

Jefferies biotech analyst Thomas Wei is telling clients that Gilenya's approval and financial impact on Biogen's MS franchise is already largely baked into the stock's valuation. He rates Biogen a buy with a $66 price target.

Biogen isn't lying down while the MS market undergoes big changes. The company has its own oral MS drug, BG-12, in phase III studies, with data expected in the middle of 2011. Biogen is also developing a long-acting form of Avonex and another MS drug, daclizumab, in partnership with Abbott Labs(ABT).

Merck is also developing an oral MS drug, cladribine, currently under FDA review with a decision possible in December.

Novartis shares closed Tuesday at $56.46, while Biogen closed at $58.23.

From the WSJ Health Blog: Novartis Drug First to Cross Oral MS Therapy Finish Line in U.S.
September 22, 2010, 4:12 PM ET.

We have a winner in the U.S. race to market a pill for multiple sclerosis — Novartis! The FDA said today it approved the Swiss drug maker’s Gilenya (known generically as fingolimod) for use against the most common type of MS.

Here’s the WSJ story on the agency’s decision. An FDA advisory committee voted unanimously in June to recommend the drug for approval.

Merck is awaiting an FDA decision on its own MS pill, cladribine. And Biogen Idec has a pill, BG-12, in late-stage trials. Biogen shares slid today on fears Gilenya will compete with its existing MS therapies Avonex and Tysabri.

Forbes’ The Medicine Show blog notes the surprise weighing on Biogen shares was the relative lack of restrictions the FDA placed on Gilenya. The drug carries the small risk of side effects (including herpes infections and some forms of cancer) and Novartis agreed to monitor patients for side effects as a condition of approval — but not as extensively as expected. Biogen issued its own press release today emphasizing its MS portfolio and pipeline and emphasizing the need for companies bringing these drugs to market to “be rigorous in monitoring” for safety problems.

Ah, you may ask — but how much will it cost? Novartis won’t put a dollar figure on Gilenya, reports NPR’s Shots Blog, but analysts put the annual price tag at $30,000 to $35,000 a year, in the same neighborhood as the currently available injectable drugs. Clinical trials showed Gilenya cut the risk of attacks compared to Avonex (an injectable) and a placebo.

From the Wall Street Journal: Novartis's MS Drug Wins U.S. Approval

The Food and Drug Administration approved for sale the U.S. market's first oral drug to treat multiple sclerosis—a disease typically treated with more cumbersome injections and infusions—in another sign of the improving picture for MS treatment.

The drug, fingolimod from Swiss pharmaceutical giant Novartis AG, is one of a group of new oral therapies being developed for MS, an often debilitating disease in which the body's immune system attacks a fatty substance protecting nerve fibers. In severe cases, this can lead to paralysis and loss of vision

Analysts said the new oral drugs could have significant commercial potential, possibly generating annual sales of $1 billion or more.

Howard Weiner, director of the Partners MS Center at Brigham and Women's Hospital in Boston, said in a telephone interview the drug's approval shows how MS treatment is improving. "I think it's a very exciting time and I think things are accelerating," he said. "There are drugs that work, and there is competition to get the next better drug. I think it's more exciting than it's ever been."

Novartis's drug has been approved in Russia and is awaiting approval in other markets. German drug maker Merck KGaA has started selling its oral MS drug, cladribine, in Australia and Russia, and is expecting regulatory decisions in the U.S. and Europe later this year. France's Sanofi-Aventis SA, meanwhile, is carrying out large clinical trials of an oral MS drug called teriflunomide.

Novartis will sell its drug under the brand name Gilenya in the U.S. The company is relatively new to the MS field, but began establishing a sales force last year, when it started selling a copy of an older injectable drug for MS originally sold by Germany's Bayer AG.

Fingolimod works by preventing immune cells from attacking myelin, the fatty substance that insulates nerves and helps them transmit impulses between the brain and the rest of the body. The FDA approved fingolimod as a first-line treatment for the most common form of MS, meaning patients can take it as their first treatment.

In clinical trials, patients taking fingolimod had a significantly lower risk of experiencing attacks, known as relapses, than those taking a placebo pill or an older drug called Avonex. A minority of patients experienced side effects while taking fingolimod, including herpes infections, some forms of cancer, abnormally slow heart rate, elevated liver-enzyme levels and an eye disease called macular edema.

As a condition of approval, Novartis has agreed to carry out a five-year global study to monitor side effects in patients taking the drug. Patients and doctors are also to be given printed materials about the drug's risks.

Dr. Weiner said some doctors would be reluctant to immediately switch MS patients from their current therapy if they are responding well to it. But "there are patients who do not like injections and do not tolerate them, and these patients may want to go onto" fingolimod, he said. He added that other clinical trials are needed to demonstrate fingolimod's efficacy against drugs other than Avonex. Dr. Weiner wasn't involved in fingolimod's development but said he does consulting work for a number of drug companies, including Novartis.

"We are proud to have worked successfully with the MS community toward a shared goal of bringing a novel efficacious treatment to people with relapsing forms of MS," Trevor Mundel, global head of development at Novartis Pharma AG, said in a statement Wednesday.

Ron Cohen, a physician and chief executive of Acorda Therapeutics Inc., a company in Hawthorne, N.Y. developing drugs for MS, said MS is "certainly one of if not the most exciting areas in neurology now because of the immense progress and the various projects that are going on."

"Up until about 15 years ago there was absolutely nothing you could do for people with MS. You might be able to give them an injection of corticosteroids when they had a bad relapse and that was it," he said in a phone interview.

Earlier this year, Acorda started selling a drug designed to improve walking in patients with MS. The next frontier of treatment, Dr. Cohen said, "will be repairing damage that has already been done to the nervous system. Right now you can slow down damage but you can't repair it." Acorda and others are developing drugs that attempt to do this by helping the body make new myelin.
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