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.

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

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

Oral cladribine (EMD Serono) reduced the relapse rate significantly more than inactive placebo in the phase 3 “CLARITY” study of 1,326 people with relapsing-remitting MS. These initial results – the first from any phase 3 study of oral therapy for MS — are reported in a press release from EMD Serono dated January 23, 2009. Additional study results will be submitted for presentation at an upcoming scientific meeting. Oral cladribine has been designated by the U.S. Food and Drug Administration as a “Fast Track Product,” which should expedite its future review. The company plans to file for FDA approval of oral cladribine in mid-2009.

Background: Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. Injectable cladribine is used to treat hairy cell leukemia. Studies have suggested a benefit in MS. In addition to the completed CLARITY study, other ongoing studies of oral cladribine funded by EMD Serono include:
• The ONWARD study, an investigation of the safety and effectiveness of adding high or low doses of oral cladribine to interferons in a trial recruiting 260 people with relapsing forms of MS (this study is currently recruiting participants); and
• The ORACLE MS study, designed to evaluate the safety and effectiveness of oral cladribine in people who have experienced a neurological episode that puts them at risk for developing MS (this study is currently recruiting participants).

The CLARITY Study: For the first year of the study, 1,326 participants were randomly assigned to receive a low dose of cladribine (two treatment cycles per year, each cycle consisting of one tablet per day for four to five consecutive days), a high dose (four cycles) of cladribine, or inactive placebo. In the second year, both treatment groups received a low dose of cladribine. The primary endpoint was the drug’s effect on relapse rate at two years compared with placebo. Secondary endpoints included effects on disease activity, as detected by MRI scans, the proportion of relapse-free participants, and disability progression.

The relapse rate was reduced significantly more than placebo in both treatment groups (by 58% in the low-dose group and by 55% in the high-dose group). The company reports that secondary endpoints of the CLARITY study were also met, although the details of these are not provided in the press release. Additional study results will be submitted for presentation at an upcoming scientific meeting.

Lymphopenia – a reduction of white blood cells – was the most frequent adverse event, and occurred more frequently in the groups on cladribine. Other adverse events reported in all three groups were headaches and cold symptoms.

“These are exciting initial results, and we look forward to seeing the full data,” says John Richert, MD, Executive Vice President of Research and Clinical Programs at the National MS Society. “If this pill proves to be safe and effective for people with relapsing MS, it represents a major treatment breakthrough – hopefully the first of many more in the pipeline.”

View full post here: http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=650

Teva’s laquinimod for MS gets fast tracked
February 12, 2009 — 3:34pm ET | By Calisha Myers

Israel-based Teva Pharmaceutical announced today that the FDA has granted the Fast Track designation to laquinimod, its investigational treatment for relapsing-remitting multiple sclerosis (RRMS). Laquinimod is a once-daily treatment administered orally. Teva licensed the compound from Swedish developer Active Biotech in 2004.

The first phase III clinical trials–Allegro–were completed in November 2008 and Teva is now enrolling patients globally for Bravo, the second Phase III study. Teva said that with the FDA’s decision, the drug could enter the market as soon as late 2011. “We are pleased that the FDA has awarded laquinimod with a Fast Track designation, and are hopeful it will be part of our growing portfolio of innovative therapies,” Moshe Manor, Vice President, Global Innovative Resources Group at Teva, said in a statement.

Shares of Teva rose 75 cents to $43.88 in afternoon trading on Thursday, while Active Biotech’s shares jumped $3.40 to $38.30.

ALSO: It seems that Teva is trying to make 2009 the year of generics. The company’s new campaign, “Year of Affordable Healthcare,” employs social media–including YouTube, Twitter and possibly Second Life– and various other tools to build its largest ever PR campaign. Teva tells PRWeek that 2009 is “a critical year for the future of both healthcare in America and the generic drug industry.” Report