The European Commission cleared the treatment for use against the relapsing-remitting form of multiple sclerosis, Basel, Switzerland-based Novartis said in a statement today. Doctors can prescribe the drug as the second choice of treatment for patients with an active form of the disease who’ve used beta interferon, or as the first drug for those with a rapidly evolving form of the disease.

Novartis Pharmaceuticals Canada Inc. announced last week it has received Health Canada approval to market fingolimod, sold under the brand name Gilenya, to treat the relapsing-remitting form of multiple sclerosis, the most common type found in adults.

Novartis has set a wholesale price at about $48,000 annually, Eric Althoff, a spokesman for the Basel, Switzerland- based company, said by e-mail. The company has programs to help patients with the cost of the drug, he said.

The Food and Drug Administration cleared the medicine for use against relapsing forms of the neurological disease, the Basel, Switzerland-based company said today in a statement. Novartis changed the spelling of the pill’s name to Gilenya from Gilenia during the FDA’s review.

The FDA is set to make a decision on the approval of Novartis’  oral MS drug Gilenia by Tuesday, and in all likelihood, the drug will be approved. A panel of experts voted in June to recommend approval of the drug, despite some small safety concerns.

NEW YORK–(BUSINESS WIRE)–In a study published this week by Majestic Research, almost 60% of neurologists expressed unaided concern about the side effects/safety of oral MS therapies in development, including NVS’s Gilenia and MRK/EMD Serono’s oral cladribine. Despite their concerns, the vast majority of neurologists expect to prescribe these drugs if they are approved, as the new oral MS therapies are expected to be highly efficacious and more convenient for patients than available injectable therapies.

By Angela Maas, Managing Editor

Another drug in the self-injected multiple sclerosis (MS) class recently came onto the marketplace. But many within the pharmaceutical industry are saying that other than giving Novartis an entry into the MS market before its oral MS therapy gains FDA approval, it is unclear what significant advantages the drug Extavia (interferon beta-1b) — identical clinically to Betaseron (interferon beta-1b), which has been on the market for more than 16 years — offers over the other products. And health plans are likely to react accordingly.

The self-injected MS specialty drugs — Avonex (interferon beta-1a), Rebif (interferon beta-1a), Betaseron and Copaxone (glatiramer acetate) — have an average wholesale price in the $2,500 to $3,000 per month range. Launched in 1993, Betaseron was the first of these players onto the marketplace. Schering AG, now Bayer Schering Pharma AG, acquired the rights to Betaseron in a deal with Chiron Corp. After Novartis acquired Chiron, Novartis and Bayer Schering worked out a deal allowing Novartis to seek approval for its own branded interferon beta-1b

So why is Novartis bringing another branded interferon beta-1b onto the marketplace?

“It may sound silly, but at a basic level, there does not appear to be any unmet medical need met by the introduction of Extavia — the reality is that Betaseron is already filling any need,” says Richard Tinsley, a partner at Putnam Associates, a pharmaceutical and biotechnology consulting firm. He adds that “we have not heard of any medical need or even drug transition strategy that would explain the introduction of a ‘me-too’ Betaseron.”

“We’re still trying to figure out exactly” what Novartis’ motivation was with Extavia, says Sean Karbowicz, Pharm.D., manager of clinical pharmacy services for RegenceRx, The Regence Group’s PBM.

Tinsley tells SPN that an MS physician he spoke with “hoped that Novartis might be looking to offer a price discount. I think most people would agree that Betaseron could have done better in the market had its marketing and launch strategies been designed differently.”

Heather Rose, a Novartis spokesperson, declined to disclose Extavia’s price, but she says it will be “the lowest-priced first-line injectable disease-modifying therapy for multiple sclerosis.” However, an industry insider who asked to not be identified tells SPN that the wholesale acquisition cost of Extavia is $2,459 per package — “per vial a little less” than the cost of Betaseron, which itself costs a little bit more than the other self-injectables. Aside from a “support program for Extavia users,” Rose adds, “as part of each monthly prescription, patients will receive 15 vials of Extavia, resulting in a net gain of 12 vials per year compared to other interferon beta-1b therapies — nearly a month of additional treatment for no additional cost.” Sara Deno, Pharm.D., director of clinical services at BioScrip, explains that Extavia will offer a 30-day supply, as opposed to a 28-day supply of Betaseron. Asked about the cost and packaging differences, Elizabeth Engelhardt, vice president of clinical services and product development at BioScrip, Inc., says Novartis “wasn’t very aggressive.”

Novartis Hopes to Have First Oral MS Drug

Most of the industry sources who spoke with SPN speculate that Novartis’ real interest in the MS market is not Extavia but rather FTY720 (fingolimod), an oral therapy that the company hopes will be the first orally administered MS drug to hit the marketplace. “The introduction of Extavia allows us to establish our presence in the MS market ahead of the planned introduction of other products for the treatments in MS,” says Rose, who adds that “Novartis has a significant commitment to multiple sclerosis.” Industry sources tell SPN that the company’s reasoning is entirely logical.

Extavia gives Novartis “their entrée into a particular market space where they have no experience,” says Nick Calla, vice president of trade relations for Walgreens Specialty Pharmacy. “There are a lot of nuances to dealing with” MS. According to Karbowicz, “There is some logic to this.…We’ve seen similar kinds of maneuvers in the past where a company will adopt” such an approach, particularly with some pain medications. Extavia “gives them a huge opportunity to get to know the [MS] players and understand the market,” adds Engelhardt.

A leading MS specialist from Miami who asked not to be identified contends that FTY720 is “a promising oral drug.” Rose tells SPN that the drug is in Phase III development and that the company’s plans to submit the drug for approval in both the U.S. and European Union by the end of this year “remain on track.” The company released initial results from a two-year study of the drug Sept. 30 that show “FTY720 reduced relapse rates by 54-60% compared to placebo, and disability progression by 30-32%.” Sources tell SPN that assuming everything goes as planned, the drug should hit the marketplace in late 2010 or early 2011.

Both Extavia and Betaseron are injected subcutaneously every other day, and the dose is the same. Debbie Stern, vice president of consulting firm Rxperts, Inc., notes that Rebif is subcutaneously injected three times a week, and Avonex is administered intramuscularly weekly. Copaxone is subcutaneously injected daily. Betaseron’s prescribing information notes that a prefilled, single-use syringe of the drug comes with a 30-gauge needle. Rose says that Extavia has a 27-gauge needle with its auto-injector. However, she adds, it is up to physicians as to what size they prescribe for a patient to use for self-injection. “The smaller needle size of Betaseron is one of their selling points,” says Stern. Rebif and Copaxone have 29-gauge needles. Avonex has a 23-gauge needle with a 25-gauge option.

The MS specialist says that Copaxone is the most prescribed of the MS self-injectables, with percentage market share in the upper 30s to around 40%. “The other 60% is divided among the interferons,” the source tells SPN. Engelhardt says that Rebif is probably the biggest competitor for Copaxone. Extavia is the third high-dose interferon available, with Avonex the sole low-dose interferon. The “gold standard” in the medical world is “a high-dose interferon or Copaxone” as a starting prescription, says Engelhardt. “Then it falls to patient preference and patient tolerability.” All of the drugs are fairly similar in terms of their clinical efficacy and their safety profiles, say sources interviewed for this article.

Physician Pickup of Extavia May Be ‘Minimal’

Stern projects that Extavia pickup among physicians will be “very minimal — Betaseron has the lowest national market share of all MS therapies, and it is unlikely that neurologists will switch their prescribing.” Tinsley adds that “without a financial incentive or a world-class patient program, I am not sure why physicians would prescribe the product. The Novartis sales force is likely to be new, which adds some complexity for rapid physician uptake. This applies not only to new patients but also — even more so — to switching existing patients.”

Rose would not disclose whether Novartis has any kind of deals for physicians, PBMs or other stakeholders designed to promote uptake of the drug. No one who spoke with SPN had heard whether any deals would be available. “One of the most fundamental challenges faced by pharma marketing organizations today,” says Tinsley, is “how do you differentiate a late-to-market — fourth entry in this case — ‘me-too’ product via clinical or financial strategies? If they do have something, it will be novel.”

Stern adds that “if the net price of Extavia is significantly lower than other interferons, I would expect that most payers would prefer Extavia to Betaseron, and some more controlling payers might list Extavia as preferred over other interferons.” She says that there is already product preferencing within this class of drugs. The fifth edition of the EMD Serono Injectables Digest, says Stern, shows that 67% of respondents from 69 payers have one or more preferred agents in the MS therapy class. Extavia “will find its place if plans want to be more aggressive with their contracting and product preferencing,” says Calla.

Lori McLaughlin, a spokesperson for WellPoint, Inc., tells SPN that the plan has not reviewed Extavia yet, and that it will be placed on the third tier of the payer’s three-tier formulary at this point. The other self-injectables are also on the third tier, but the plan has designated Avonex, Copaxone and Rebif as its preferred products. “We are able to offer these drugs at a better price to our members,” she explains. Both Extavia and Betaseron have a step edit requiring members to use both Avonex and Rebif first, she says. Karbowicz says that Regence has not looked at Extavia yet. It has prior authorization for Betaseron but not on Avonex and Rebif, the other interferons, he adds. “We don’t prefer Betaseron now anyway, so there would have to be a pretty significant reason for us to embrace” Extavia, he says.

According to Tinsley, “Assuming there is no clinical differentiation that has not been publicly disclosed and, without a price discount, Extavia will face a tough battle in the payer world. The current environment for ‘me-too’ products is difficult.” Based on a discussion with “a major plan,” he says that “Extavia will begin any negotiation on the third tier (possibly with restrictions) versus the other interferons on the second tier. Probably the best they could hope for is parity with the other interferons on the second tier.”

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Initial results from the two-year Phase III study show that oral FTY720 was significantly superior to placebo in reducing both relapses and disability progression in patients with relapsing-remitting multiple sclerosis, one of the main causes of neurological disability in young adults, Novartis said.

Comprehensive analyses of the data were ongoing, and detailed results are planned to be presented at a leading scientific congress in 2010, Novartis said.

(Reporting by Sven Egenter)

View entire post here: http://www.reuters.com/article/rbssHealthcareNews/idUSWEA288320090930

Extavia, a form of interferon beta-1b, can be used in patients with early and relapsing forms of multiple sclerosis, Basel, Switzerland-based Novartis said in a statement today.

Selling the treatment is a strategic step that allows Novartis to establish itself in the multiple sclerosis community before introducing its potentially best-selling FTY720 MS pill. The company aims for at least $1 billion in sales for its multiple sclerosis franchise, Joe Jimenez, the head of Novartis’ drug unit, said in an interview before the approval. Novartis plans to set up a network of sales people, nurses, as well as support hotlines to help sell Extavia and “build our commercial capability,” Jimenez said.

Racing to beat Novartis to the world’s biggest drug markets with a new oral therapy for multiple sclerosis, Merck KGaA has filed for regulatory approval of cladribine in Europe and plans to file in the U.S. later this quarter.

The application brings Merck ”closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis,” Executive Vice President Roberto Gradnik said in a statement. Last spring researchers reported that cladribine cut the risk of relapse in half, though some patients also experienced a depletion of white blood cells needed to protect them from infections. The therapy works by blunting the human immune system.

Analysts say that cladribine is likely to achieve blockbuster status, with a billion dollars in annual sales. “A market entry in Europe beginning of 2010 seems feasible, as should be the case for the U.S.,” wrote analysts for DZ Bank AG.

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ZURICH, April 29 (Reuters) – Novartis AG  said 80-83 percent of those taking its multiple sclerosis drug FTY720 are relapse-free compared with 69 percent on the leading current treatment, but it reported a new patient death.

Novartis said the patient died from aspiration pneumonia related to a progressive neurological condition.

Safety concerns have surrounded the drug for some time.

FTY720, has been associated with potentially fatal infections, skin cancer and a case of hemorrhaging focal encephalitis, an inflammation of the brain with bleeding. It is unclear whether the drug was responsible for the events.

Novartis, which is presenting new Phase III results to the American Academy of Neurology, said the data reinforced results announced in December that showed the annual relapse rate was 52 percent lower compared with patients taking Biogen’s injectable multiple sclerosis drug Avonex.

Novartis AG and Germany’s Merck KGaA are leading the charge to develop MS drugs that can be taken orally, rather than by infusion or injection, but the firms must persuade physicians and investors that the treatments are safe. [ID:nN24419113]

Novartis said serious adverse effects were reported in less than 2 percent of patients treated with FTY720 and said a role for the drug in the death of a patient in February who stopped taking FTY720 in August could not be confirmed or ruled out.

Sal. Oppenheim analysts said the news of the death was the main news in the report and said it was slightly negative.

“This and other reported serious events in the FTY720 arm significantly increase regulatory risks in our view,” they said.

Helvea analyst Karl-Heinz Koch said he was not too concerned, noting the long lapse between the time the patient stopped taking the drug and the death.

“We continue to believe that the safety-efficacy ratio remains positive and that the drug will find its way into the marketplace,” he said, predicting sales of $1.5 billion for FTY720 and a follow-on treatment.

Novartis shares were flat at 1230 GMT, in line with the DJ Stoxx European healthcare index .SXDP.

REGULATORY FILINGS THIS YEAR

Novartis said full results from the so-called TRANSFORMS study would be submitted to a peer-reviewed journal in the next few months, adding regulatory filings were on track for the United States and European Union at the end of 2009.

Lead investigator Jeffrey Cohen said the trial showed that FTY720 “may provide patients with an alternative choice to currently available medications for treating relapsing-remitting multiple sclerosis”.

Novartis also presented longer-term results from a Phase II study that showed continued low relapse rates after four years of treatment, with no change in the safety profile.

It added that the safety profile of a 0.5 mg dose appeared to be better than the 1.25 mg dose.

Merck’s drug, cladribine, has been linked to a reduction in white blood cells, which can lead to infection, and in January the company said four patients in a late-stage trial were diagnosed with cancer. It is also due to present study results at the neurology meeting in Seattle.

Earlier this year Merck said results of a late-stage trial showed cladribine reduced the number of relapses per year by as much as 58 percent, compared with those taking a placebo.

Biogen is developing an oral MS drug, known as BG-12, but it is not as far advanced as the Merck or Novartis drugs.

(Editing by John Stonestreet and David Cowell)

View full article here: http://www.reuters.com/article/rbssHealthcareNews/idUSLT73514220090429

A case report on the patient who developed the condition after taking part in a Phase III clinical trial of the medicine — one of the big hopes in the Swiss group’s pipeline — was published in the March edition of the journal Neurology.

Novartis said the patient concerned was recruited into the study seven months before hospital admission for the reported event, before which no new disease activity had occurred.

‘As per normal procedures, this particular case was communicated in a timely fashion to health authorities and study investigators,’ spokesman Eric Althoff said.

‘It is difficult to interpret an isolated case report without the benefit of the full Phase III data set. At this stage, a relationship with FTY720 can neither be excluded nor confirmed,’ Althoff said.

Citigroup analysts said they were still concerned about the safety of FTY720 and saw the most recent side effect report as a small positive for Merck KGaA, whose rival MS pill cladribine may be the first MS drug taken by mouth, as opposed to injection, to hit the market.

Novartis said last year that two patients taking FTY720 in clinical trials had problems with infections and one died, but the role of the drug in the cases was unclear.

Novartis shares fell 1.6 per cent to 41.80 Swiss francs by 1230 GMT, versus a 1.1 per cent drop in the European healthcare sector. Merck shares fell 2.6 per cent. — Reuters

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