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.”

View full post here: http://www.aishealth.com/Bnow/hbd101609.html

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

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

Read entire article here: http://www.themalaysianinsider.com/index.php/business/23315-novartis-ms-drug-linked-to-new-side-effect