Biogen Idec CEO James Mullen may be ready to walk out the door, but the big biotech doesn’t have a replacement lined up yet. It appears there is no clear internal successor for the top spot, so Biogen Chairman Bill Young is looking both internally and externally to fill one of the most attractive open jobs in the industry.

“We have a whole list of criteria, but the most important of which is that we find someone who has managed and understands the role of science in a biotech company, and how that needs to be bridged to the commercial side of things,” Young tells Xconomy. “That may mean it’s a scientist or someone who understands how that fits into what biotech companies are designed to do, which is develop products.” He adds that while some internal candidates are being evaluated, the company’s CEO hunt is focused on external talent.

The new CEO will be joining one of the industry’s leading biotechs, but it won’t be a cakewalk. He or she will be facing some substantial challenges. There are ongoing questions about the safety of Biogen’s multiple sclerosis drug Tysabri, which has been linked to a serious disease called PML. And investor Carl Icahn blasted the company last year for what he considered to be poor R&D performance. Icahn was also critical of Mullen’s leadership, which likely contributed to the CEO’s decision to make a career change.

The board has hired recruitment firm Spencer Stuart to help find candidates and hopes to announce a hiring in 90 to 120 days. Biogen is also looking for a new R&D chief, but Young says that position will remain unfilled until a CEO is named, so that the company is sure its new CEO and R&D chief are comfortable working together.

Source: FierceBiotech

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Novartis has won U.S. approval for its key Menveo meningococcal vaccine and got priority review for its oral treatment for multiple sclerosis (MS), underlining the promise of the Swiss group’s pipeline.

The U.S. Food and Drug Administration has licensed the vaccine to help protect people aged between 11 and 55 years against potentially deadly meningitis.

Meningococcal disease infects more than 500,000 people each year, resulting in around 50,000 deaths globally, and many of these could be prevented through vaccines, Novartis said in a statement on Monday.

Novartis also pulled further ahead of German rival Merck KGaA in the bid to get the first oral MS treatment to market after its drug Gilenia, FTY720, was granted U.S. priority review status.

Novartis is competing with Merck MGaA’s pill cladribine against the debilitating nervous disease and has edged ahead since the German group suffered a setback last year, when U.S. regulators held up its application to bring its cladribine drug to market.

The priority review for Gilenia, which cuts the standard review time to six months from 10, comes after the U.S. Food and Drug Administration accepted the regulatory submission made in December for the drug.

“The priority review status is a nice little surprise which may move the launch forward from late 2010,” said Thomas Maul, an analyst at DZ Bank, who expected sales of the drug to reach at least $1 billion a year.

Novartis shares were 0.2 percent higher in early trade, while Merck, which reports its fourth quarter results on Tuesday, slipped 0.7 percent.

The U.S. approval of Menveo was based on a Phase III head-to-head clinical trial that showed it achieved a higher immune response than the other currently available vaccine, Novartis said.

Novartis plans to seek a license for Menveo in infants and children aged between two and 10 years, the group said.

The group is awaiting marketing approval in Europe after the drug watchdog there backed the vaccine at the end of last year.

Source: Reuters

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Generic maker Teva Pharmaceutical posted higher quarterly results that included stronger sales of its branded multiple sclerosis treatment Copaxone.

The Israeli company will save “hundreds of millions of dollars” starting later this year after it ends royalty payments of 25% on U.S. sales of Copaxone that it has been making to Sanofi-Aventis, Teva’s CFO told Reuters. Sales of Copaxone, the top-selling MS therapy, rose 25% to $747 million in the quarter and to $2.8 billion for the year. (Generics remain its chief business but about 30% of Teva’s product mix is from branded drugs.)

The company reported a net profit of $379 million, or 42 cents a share, compared with a loss of $694 million, or 88 cents a share, a year earlier. Sales rose 33% to $3.8 billion.

The takeover of Barr, which it acquired in 2008 for about $7.5 billion, helped boost Teva’s sales total and the company remains on the acquisition prowl, especially outside the U.S. Teva is bidding for German generic maker Ratiopharm, competing with Pfizer, Swedish private equity firm EQT and Iceland’s Actavis.

Source: The Wall Street Journal

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More than 55% of multiple sclerosis patients have been found to have constricted blood vessels in their brains, a US study says.

The preliminary results are from the first 500 patients enrolled in a trial at the University of Buffalo.

The abnormality was found in 56.4% of MS patients and also in 22.4% of healthy controls.

The MS Society said it was intriguing but not proof that this caused MS – as one leading expert claims.

Testing theory

The New York researchers were testing a theory from Italian researcher, Dr Paolo Zamboni who claims that 90% of MS is caused by narrowed veins.

He says the restricted vessels prevent the blood from draining fast enough and injure the brain by causing a build up of iron which leads to MS.

He has already widened the blockages in a handful of patients including his wife.

MS is a long-term inflammatory condition of the central nervous system which affects the transfer of messages from the nervous system to the rest of the body.

The Buffalo team used Doppler ultrasound to scan the patients in different body postures to view the direction of venous blood flow.

The 500 MS patients, both adults and children, also underwent MRI scans of the brain to measure iron deposits in surrounding areas of the brain.

The full results will be presented at an American neurology conference in April.

There were 161 healthy controls.

‘Cautious optimism’

Robert Zivadinov who led the study at the University of Buffalo, said he was “cautiously optimistic and excited” about the preliminary data.

“They show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis.

“We will know more when the MRI and other data collected in this study are available.”

Dr Doug Brown, Biomedical Research Manager at the MS Society, said: “These results are intriguing but it is important to remember that although people with MS may show evidence of chronic cerebrospinal venous insufficiency in screening studies, there’s no proof as yet that this phenomenon is a cause of MS, nor that treating it would have an effect on MS.

“The next step is to determine what this actually means for MS and an investigation into whether there’s any potential therapeutic benefit from treatment will be pivotal for this novel theory.”

Source: BBC NEWS

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FDA sent out a new Tysabri warning Friday, one emphasizing that the risk of a rare brain infection increases as treatment continues. Biogen Idec, which markets the multiple sclerosis drug, said the FDA’s warning–and revision of Tysabri’s labeling–was not new. ”Either it was included as part of our last label update or it was information that we are making available on a monthly basis,” a spokeswoman told Reuters.

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In any case, the FDA’s statement points out that the overall risk of a Tysabri patient acquiring progressive multifocal leukoencephalopathy is still within the ratio that’s been on the drug’s label for a while. What’s different is the addition of numbers for PML risk by the number of Tysabri infusions received by a patient, broken down for patients in the U.S. and outside the country.

In both locales, the risk more than doubles from the first infusion to the 24th, 0.7 per 1,000 to 1.9 per thousand outside the U.S., and 0.3 to 0.8 in the U.S. These stats include all 31 new cases through January 10, FDA says. Nevertheless, FDA maintains that Tysabri’s benefits outweigh its risks. About 66,000 people have been treated with Tysabri since it came back onto the market in 2006.

Source: FiercePharma

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Fueled by windfall profits from swine flu vaccine sales, GlaxoSmithKline reported a big spike in revenue for the fourth quarter. But the extra money hasn’t stopped the pharma giant from sharpening its budget-cutting axe once again. Glaxo executives this morning outlined an additional 500 million pounds ($791.6 million) of budget cuts as it scales back on R&D.

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Specifically, Glaxo says it will stop R&D efforts in certain neurological areas, with work grinding to a halt in depression and pain, according to Bloomberg. The company will focus on Alzheimer’s, Parkinson’s and multiple sclerosis and create an R&D unit that will concentrate on new therapies for rare diseases. Glaxo makes it quite clear that this new unit would be an active collaborator.

“We are allocating capital to areas where we can get the best return on investment,” the company says in the statement. CEO Andrew Witty told reporters that the budget cuts included a further reduction in the company’s workforce that would amount to the “hundreds rather than thousands” in the U.K.

“In addition to our existing discovery effort, alternative opportunities need to be explored to make treatments available for rare diseases,” says Marc Dunoyer, GSK’s president of Asia Pacific and chairman of Japan, who will head the new rare diseases unit. “This complementary approach will combine our existing global expertise with specialist partners. Over time, this new unit has the potential to deliver multiple therapies responding to high medical needs of underserved populations of patients.”

Source: FierceBiotech

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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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A trio of new studies has underscored both the distinct therapeutic advantages as well as the blockbuster market potential of two new oral drugs for multiple sclerosis. But while the studies demonstrated a reduction in the number of relapses and a slowing of disease progression–while beating an established interferon therapy after 12 months of treatment–the drugs’ ability to suppress the human immune system also triggered a higher rate of infections.

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The news in the NEJM articles was a clear plus for Novartis and Merck KGaA, which have both been advancing oral MS drugs through the pipeline. Novartis recently applied for approval of FTY720 in Europe and the U.S. Merck KGaA, meanwhile, recently ran into an unexpected hurdle at the FDA when regulators handed back its application for cladribine, calling it incomplete and delaying any U.S. launch. That leaves Novartis clearly in the lead for a groundbreaking approval.

The results “provide a new horizon for patients with relapsing-remitting multiple sclerosis and a welcome increase in the range of treatment options,” neurologist William Carroll wrote in the New England Journal of Medicine.

Novartis’ chief of global drug development told Bloomberg that the sales of FTY720 could “absolutely” surge past the billion-dollar mark to achieve blockbuster status. The drug, he added, is a “potentially game-changing therapy.”

While news of the higher infection rate may spur some caution around the drugs, analysts also note that Tysabri has been very successful in the MS market despite several deaths linked to a rare brain infection. That demonstrates that patients are willing to accept considerable risk when the therapy helps them to manage the disease.

Source: FierceBiotech

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A day after ending a collaboration with Genmab on an antibody program, Roche pulled the partnership rug out from underneath Actelion, dropping out of their pact for ACT-128800, which has shown promise for autoimmune diseases such as multiple sclerosis.

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Analysts say that Switzerland’s Actelion stands to gain more in the long run, but has to face a short-term drop in revenue without any milestone money coming from Roche. “One balances out the other in terms of balancing cash flows, but it does mean near-term earning estimates need to be reduced by roughly 5%,” Bank Vontobel analyst Andrew Weiss told Dow Jones. And Olav Zilian, analyst with independent brokerage Helvea, says that Actelion now faces a hard test of its vow to become the ‘Genentech of Europe.’

Actelion did its best to put a positive spin on the news, noting that Roche’s decision was driven by its concentration on Genentech now that the big biotech is operating under the pharma company’s wing. It added that ACT-128800–which is in a Phase IIb MS trial to test dosages–is also being moved into the clinic for psoriasis.

“I am convinced that Actelion’s selective S1P1 receptor agonist, an oral and rapidly reversible immunotherapy – has the potential to improve therapy for patients,” said CEO Jean-Paul Clozel. “Especially, I expect that our selective S1P1 receptor agonist could have a wider safety margin compared to other therapies currently available or in development, whether they are long-acting biological immunosuppressive or other oral approaches.”

Source: FierceBiotech

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Biogen Idec has raised its bid for Facet Biotech by $3 after claiming for three months that its original $14.5 per share proposal was the final one. The firm now says that the latest $17.50 per share price represents its best and final offer. The acquisition is valued at roughly $429.66 million.

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While Biogen started by valuing Facet at a 64% premium over its closing price on September 3, the day before the original offer, the latest proposal has a 98% premium. Facet, however, has consistently traded above $14 per share since September 4, reaching a high of $17.84.

Facet has vehemently rejected Biogen’s takeover attempts calling them low-ball offers that were not in the best interest of its shareholders. The firm now says that it is reviewing Biogen’s $17.5 bid and has advised its stockholders to stay put until further notice.

A successful transaction would mean that Biogen would take on $176.5 million worth of Facet’s milestone obligations to Trubion Pharmaceuticals plus lease obligations. On the other hand, Biogen could also save up to $630 million in milestone fees that it owes Facet under their ongoing partnership to develop and commercialize daclizumab as a multiple sclerosis treatment. The first milestone of $30 million would be due early next year with the initiation of a Phase III study.

“Over the past three months we have had conversations with certain Facet stockholders which lead us to believe there is strong sentiment to bring this process to a conclusion,” said James C. Mullen, president and CEO, in a letter to Facet. “Taking into account its monthly cash burn rate and its significant lease obligations, Facet does not have the cash to fund its operations beyond 2012, well before completion of the daclizumab clinical program, without obtaining additional financing, which we believe will be dilutive. “We already own a 50% interest in daclizumab. We do not intend to overpay for the rest.”

Facet’s cash position as of September 30 was $331.9 million. This does not account for lease obligations held by the firm.

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Biogen actually first offered to pay $15 per share for Facet on August 17, but asked the company not to enter any external deals. Facet outright snubbed Biogen’s offer and request, signing an agreement with Trubion with $20 million up front. Biogen then went public on September 4 with a $14.5 per share acquisition offer, saying that the arrangement with Trubion reduced Facet’s value; Facet signed on to develop Trubion’s Phase I lead candidate, TRU-016, in chronic lymphocytic leukemia.

Source: GEN News

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