As Merck KGaA wrestles with FDA regulators over its application for the oral MS drug cladribine, the German pharma company won its first approval for the drug–in Russia.

Merck KGaA’s cladribine filing was stiff-armed at the FDA last fall when the agency refused to accept it for review. The pharma company refiled in the U.S. in June. But Russia has already offered its approval, and Merck Serono says it expects more markets to follow in short order.

“This is an important milestone reinforcing Merck Serono’s leadership position and ongoing commitment to fight against the devastating disease of multiple sclerosis,” says Elmar Schnee, president of Merck Serono.

Cladribine had been in a hot race to the marketplace with Novartis’ Gilenia, which was handed a resounding endorsement from a federal expert review panel on its way to an expected approval. A number of big developers, including Sanofi, Teva and Biogen Idec, have been developing new oral MS therapies. MS patients frequently spurn currently available biologics for a range of reasons.

Source: FierceBiotech

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German pharmaceuticals and chemicals company Merck KGaA is banking on an experimental multiple sclerosis (MS) pill to lift operating margins at its embattled drugs unit, it said on Wednesday.

Earnings before interest, tax and special items at its Merck Serono prescription drugs unit could rise to 25 percent of sales in the long term, up from 22.4 percent in the first quarter, analysts at Exane BNP Paribas quoted the unit’s head, Elmar Schnee, as saying in remarks confirmed by a Merck spokesman.

Merck resubmitted the U.S. application for its MS pill cladribine on June 8, trying to catch up with Novartis AG in the race to bring to market the first oral treatment against the debilitating disease.

If key pipeline drugs such as cladribine get rejected by regulators the margin could be 20 percent in the long term, Schnee said.

Merck’s drug unit, which accounts for about three quarters of group sales, is in need of a morale booster after it failed last year to win regulatory approval for the use of its blockbuster-hopeful Erbitux against lung tumors, the most common form of cancer.

In addition, prospects remain uncertain for U.S. approval of its experimental multiple sclerosis pill cladribine and for its cancer vaccine Stimuvax.

Schnee also told the BNP analysts he expected the U.S. Food and Drug Administration (FDA) to formally accept its reworked request for regulatory approval of cladribine in early August.

The pill could still win U.S. priority review status, as long as Novartis’ rival product Gilenia has not yet come to U.S. markets, he added.

Schnee also said he expected rival Gilenia to have only limited impact on demand for the current standard treatment of MS, so-called interferon beta injections, citing concern about Gilenia’s side effects.

Interferon betas, which account for much of the $8.6 billion spent each year on MS treatments, include Merck’s best-seller Rebif, Biogen Idec Inc’s Avonex, Bayer AG’s Betaferon and Novartis’ Extavia.

Schnee’s assessment contrasts with a ringing endorsement from U.S. experts for Gilenia this month, which cemented the pill’s blockbuster potential and suggested consensus sales estimates need to rise.

Gilenia is likely to be approved to treat U.S. patients with relapsing multiple sclerosis (MS) as early as the third quarter.

Some investors had been skeptical about Gilenia due to its side effects, but feedback from a panel of experts advising the FDA was more positive than many had expected.

Source: Reuters

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Another round of earnings reports today, and this time, they’re mostly good. GlaxoSmithKline, Hospira and Merck KGaA all posted Street-beating earnings, while pharmacy benefits manager Medco Health Solutions reported an increase in profits. Here are the highlights:

• GSK’s net income grew by 19 percent to 1.34 billion pounds, or $2.04 billion. Sales of the H1N1 flu vaccine helped lift revenues to 7.36 billion pounds, or $11.1 billion, an increase of 13 percent. Emerging markets sales were up 43 percent and Asian sales up 45 percent, helping to offset a 1 percent decline in U.S. sales. Interestingly, the company said it was able to “absorb” the cost of U.S. healthcare reform during the first quarter, and that it hopes to offset future reform-related costs with “continued operational performance.”

• Medco saw Q1 profit and sales grow by 10 percent to $320.5 million and $16.3 billion, respectively. The company said it started doing business with several large new clients, boosting its numbers. Also aiding results: Higher prices on branded drugs and higher sales of cheaper, higher-margin generics.

• Merck KGaA’s strong results depended largely on the chemicals side of the business, though sales in its Merck Serono drug unit rose 7 percent to €1.41 billion, or $1.86 billion. Revenues were boosted by a 17 percent surge in revenue from the Rebif treatment for multiple sclerosis, which rose to €429 million, mostly because Merck shipped an extra 20 days’ supply to U.S. wholesalers in March.

• Hospira posted a stronger-than-expected first-quarter profit, helped by sales of a generic cancer drug and other specialty injectables. But it warned that voluntary product shipment halts–related in part to manufacturing problems with the anesthesia med propofol–would hold back full-year results.

Source: FiercePharma

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Multiple sclerosis patients won’t have to wait for the government say what drug works best against their disease: Biogen Idec and Elan, makers of Tysabri, hope to do it first. The two companies started enrollment in a 1,800-patient study pitting their drug against two other MS treatments, Copaxone from Teva and Merck Serono’s Rebif.

Known as SURPASS, the study aims to identify the drug that works best at staving off relapses, as measured by the annualized relapse rate. The trial will also look at lesion growth and at disease progression to identify the drug that best halts disease activity, and check up on the safety of switching to Tysabri from another treatment.

Safety has been an issue with Tysabri; the drug was pulled off the U.S. market several years ago when patients developed a potentially fatal brain infection called progressive multifocal leukoencephalopathy. The drug came back into use under a risk-management program, and Biogen has been regularly updating the PML case count, which most recently stood at 42 .

Source: FiercePharma

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Rigel Pharmaceuticals will earn $100 million up front as part of an exclusive, global agreement with AstraZeneca covering the late-stage rheumatoid arthritis (RA) candidate R788 (fostamatinib disodium). The deal gives AstraZeneca exclusive rights to develop and commercialize the oral spleen tyrosine kinase (Syk) inhibitor in RA and additional indications. AstraZeneca will also have exclusive rights to Rigel’s pipeline of oral Syk inhibitors.

Rigel could earn an additional $345 million in development, regulatory, and initial sales milestones plus another $800 million in specified sales-related milestones and double-digit sales royalties.

Rigel has already completed Phase II development of R788 for the RA indication. The company has also taken the candidate into Phase II trials as a treatment for immune thrombocytopenic purpura, B-cell lymphoma, and T-cell lymphoma.

AstraZeneca will be responsible for a global Phase III program in RA, which it anticipates starting during the second half of this year. The company will also take over all regulatory, manufacturing, and global commercialization activities for its licensed indications. First regulatory filings with FDA and European authorities are projected for 2013.

Fostamatinib disodium is being developed primarily as a next generation oral RA therapy in adults who have failed to respond adequately to a traditional disease modifying anti-rheumatic drug such as methotrexate and where a TNF biologic add-on treatment would be considered. The compound is believed to act by blocking the intracellular signaling of immune cells implicated in the destruction of bone and cartilage, Rigel states.

In July 2009, the company reported results from a Phase IIb study showing significant improvement in RA patients treated with R788 who had failed to respond to methotrexate treatment. Results from another study evaluating patients who had failed to respond to at least one biologic treatment such as TNF inhibitors treated with R788 did not demonstrate a response that was higher than placebo by a statistically significant margin in the primary and secondary endpoints.

Rigel has separately partnered with Pfizer for the development of another Syk inhibitor, R343, for the inhaled treatment of allergic asthma. Pfizer initiated a Phase Ib trial with R343 in the second quarter of 2009. A Phase II trial is expected to start in 2010, Rigel notes.

The firm’s lead oncology product, R763, is a small molecule inhibitor of aurora kinase. The program is partnered with Merck Serono, which has exclusive rights to the drug and has initiated Phase I trials.

Source: GEN News

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Late Friday afternoon regulators at the FDA approved Acorda’s multiple sclerosis drug Ampyra based on data demonstrating that patients taking dalfampridine were able to walk faster than a control group. And this is the first time the FDA has approved a therapy for improving walking speeds.

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“Trouble with walking is one of the most debilitating problems people with MS face,” said Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Acorda had the solid backing of the FDA’s experts for the drug. The advisory committee voted 12 to 1 in favor of a marketing approval. And investors were betting on an approval. Acorda’s shares jumped close to 10 percent on Friday, ahead of the announcement.

But what many speculators are looking for is an acquisition. Biogen has licensed the ex-U.S. rights to the drug. And BNET’s Trista Morrison is quoting Raghuram Selvaraju, an analyst with Hapoalim Securities, who believes that the approval sets the stage for an acquisition by one of the leading players in the field. Biogen, Merck Serono, Novartis, Sanofi and Teva were all mentioned as possible contenders.

Source: FierceBiotech

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Merck Serono, a division of Merck KGaA, will strengthen its global research and development capabilities by establishing a global R&D center in Beijing. Merck Serono is planning to invest more than €150 million ($225 million) and create more than 200 new qualified jobs over the next four years to set up the China R&D center and conduct R&D activities in China.

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“The creation of the China R&D center marks a new milestone in Merck Serono’s commitment to China, where there is a rising demand for more healthcare options,” says Elmar Schnee, president of Merck Serono. “We are committed to investing in areas that can help China to address some of its public health needs that currently are not met.”

The China R&D organization will become one of the key R&D hubs for the company. The China team will lead drug development for China and other Asian countries, for local clinical trials as well as for the participation in global clinical trials. The team also will ensure the management of collaborations with research institutions in China and continue to look for partnerships with local academic institutions and companies. Research activities conducted in the China R&D center will mainly focus on biomarker research including pharmacogenomics and bioanalytics activities.

Merck Serono already has some research collaborations in China and plans to further develop its collaboration network and build its R&D strategy on more innovation opportunities by tapping into the Chinese scientific expertise.

Source: GEN News

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There’s more bad news for ZymoGenetics’ experimental drug atacicept this morning. The developer (ZGEN) announced that Merck Serono has decided to suspend clinical trials of the drug as a treatment for multiple sclerosis after an independent data monitoring committee picked up an increase in disease activity in the treatment arm.

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Just a little more than two weeks ago Merck Serono announced that the drug failed to achieve its goal for controling rheumatoid arthritis in mid-stage trials. The developer said in a statement that the drug did not meet the “pre-specified level of disease control activity to support moving directly into Phase III clinical testing.” Merck Serono also in-licensed the therapy for lupus, but suspended a trial for that disease back in October.

Xconomy notes that ZymoGenetics handed over full development responsibilities for the drug to Merck Serono a year ago as it scaled down on its expenses. The Seattle-based developer accepted a smaller share of future royalties in exchange for eliminating development costs on a drug then headed into late-stage trials.

Source: FierceBiotech

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Lpath, Inc. (OTCBB: LPTN) has been advised by Merck Serono, a division of Merck KGaA, (Darmstadt, Germany) that Merck Serono has exercised its right to extend the “initial development period,” the period during which Lpath is responsible, in close collaboration with Merck Serono, for development of ASONEP(TM). While the ASONEP license agreement provided Merck Serono the right to extend this period to April 28, 2010, the parties agreed upon a revised date of June 27, 2010 in order to complete the Phase 1 study and various non-clinical studies undertaken to further the development of ASONEP as contemplated in the License Agreement.

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Lpath will continue to receive the previously agreed upon monthly research and development funding from Merck Serono until April 28, 2010. In addition, Lpath remains eligible to earn development milestone payments during the extension period.

Lpath is nearing completion of its ASONEP Phase 1 clinical trial in cancer patients. The drug candidate was well tolerated at all tested dose levels, and there have been no drug-related Serious Adverse Events reported. Lpath expects to complete enrollment in its Phase 1 trial within a few weeks, but dosing of these patients may continue for several months.

Scott Pancoast, Lpath’s CEO, commented: “We expect the additional insights gleaned from the remaining Phase 1 patients and the extended collaboration will be extremely valuable in designing Phase 2 clinical trials for ASONEP. We continue to work hand-in-hand with Merck Serono in a collaborative effort to advance the ASONEP program to the next level.”

Source: Lpath, Inc.

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India’s Glenmark Pharmaceuticals Ltd. and U.S.-based Forest Laboratories Inc. said Wednesday their drug to treat a breathing ailment failed to meet desired targets in a mid-stage trial.

The results of the study to treat chronic obstructive pulmonary disease, or COPD, with oglemilast sent Glenmark’s shares down more than 17% in initial trading. Read the full story

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