Asenapine therapy was cleared in the U.S. in 2009 to treat schizophrenia and bipolar disorder mania.

Merck & Co’s non-U.S. business, MSD, reported approval throughout the EU for Sycrest®, a sublingual asenapine drug for treating moderate to severe manic episodes in adult patients with bipolar I disorder. Sycrest was first approved in the U.S. in 2009, where it is marketed as Saphris® for the treatment of schizophrenia and mania in bipolar disorder.

EU approval was based on data from trials involving some 1,300 patients with bipolar mania. Studies included two montherapy trials comparing Sycrest with olanzapine and placebo and a 326-patient study evaluating the drug as  adjuctive therapy to lithium or valproate.

The results of the 12-week placebo-controlled trial found that giving asenapine to patients who were partially nonresponsive to lithium or valproate monotherapy resulted in improved reduction of manic symptoms compared to what either approved drug could achieve when given alone.

Source: GEN

Popularity: 1% [?]

Aestus’ preclinical candidates will be evaluated.

Aestus Therapeutics and Eisai have agreed to work together on the R&D of therapeutics for psychiatric disorders. The multiyear collaboration will entail preclinical validation of Aestus’ compounds leading to clinical proof-of-concept studies.

Aestus’ candidates were identified through its proprietary analysis of gene-expression datasets, coupled with biological pathway mining on data from relevant disease models. Along with Eisai, the firm will work toward picking lead candidates for further development.

Aestus reports that it has several products for neuropathic pain that are ready to enter Phase II studies. On June 28, Aestus licensed Astellas Pharma’s FK614, a PPAR-gamma agonist, to develop the product for postherpetic neuralgia. The first clinical trial is expected to start later this year. On June 9, the company was awarded a $2 million SBIR grant from the NIH to advance its pain candidates.

Beyond neuropathic pain, the Aestus technology is currently being applied to ALS and schizophrenia. On March 17, the ALS Therapy Development Institute and Aestus reported plans to test potential small molecule compounds to slow or stop the progression of ALS.

Source: GEN

Popularity: 3% [?]

More than 135 brain diseases including autism, chronic pain, schizophrenia and dementia are linked to defects in proteins in the junctions between nerve cells, scientists have found.

Researchers have been able for the first time to map the protein structure of human synapses, the junctions between nerve cells responsible for transmitting information, offering scientists a new way of looking at diseases that affect millions of people around the world.

It also opens potential new ways of finding and developing drugs for brain diseases, and may in future allow doctors to make genetic diagnoses of the conditions, said Seth Grant, the neuroscientist at Cambridge University’s Sanger Institute who led the study.

“We now recognize that these synapse proteins are the molecular basis of many brain diseases,” he told reporters before presenting his findings at the Forum for European Neuroscience in Amsterdam on Monday. “We know of no other molecular structure which is responsible for more brain diseases — so we think it’s a major discovery.”

Grant’s team used a technique called proteomics to analyze all the proteins in human brain cells. Humans have around a million billion brains cells and these are connected by synapses, which play a pivotal role because they create circuits that allow the brain to learn and remember things.

The scientists found around 1,500 proteins in human synapses, each of which is encoded by a gene. They then managed to link genetic defects in some of these with key diseases such as autism, bipolar disorder, depression and schizophrenia.

“By understanding the composition of the synapse, we can also ask which proteins are important to diseases, and therefore get a sense of the disease burden that the synapse is involved with,” Grant said.

“Rather than thinking that a gene causes a particular disease, what we’re seeing now is that the gene mutation disrupts the (protein) complexes that cause the disease. We found that defects in the genes that encode these human synapse proteins are really a major cause of diseases.”

In a follow-up study using mice, Grant’s team found that by using various drugs to change the proteins in the synapse, the link to disease was also altered.

Grant said his team now planned to investigate whether the links between defects in synapse proteins and disease that they found in mice are also borne out in humans.

“If they are, then it has the potential to radically refocus scientists’ approach to the study of brain diseases,” he said.

Source: Reuters

Popularity: 4% [?]

British scientists believe they have found specific patterns of brain activity in children and young people which could be signs or “markers” of those who will later go on to develop mental illnesses such as schizophrenia.

Researchers from Nottingham University, who presented their study at the Forum for European Neuroscience in Amsterdam, said the patterns suggest it may be possible in future to identify those at risk of becoming ill before they develop symptoms.

“If we can identify people who are at particularly high risk of developing schizophrenia, perhaps using neurocognitive brain markers, then we might be able to reduce that risk and also help them to function better,” said Dr Maddie Groom, who worked on the study and gave a briefing to reporters in London.

“If we give them a better start, they may encounter the illness in a more positive way and not get quite so ill.”

Hundreds of millions of people worldwide are affected by mental, behavioral and neurological illnesses such as schizophrenia, attention deficit hyperactivity disorder (ADHD), depression, epilepsy and dementia.

Many people who go on to develop diverse mental health problems will have a history of behavioral problems going back to childhood, but experts say the problem with finding them at that stage is that differences then are often extremely subtle.

In one study, Groom and her colleagues investigated looked at the healthy siblings of people with schizophrenia, who also have a very slightly increased risk of developing schizophrenia compared with the general population.

Using brain imaging to read activity levels, the scientists asked the siblings to perform task which involved playing an alien-zapping computer game in which they needed to respond quickly, and crucially, halt the urge to respond if the wrong kind of alien popped up. The task was called a “go, no-go” task.

“When we measured the brain activity of the siblings of people with schizophrenia, their brain activity was reduced at the time when they needed to pay attention to the stimulus, and when they needed to inhibit their response,” Groom explained.

She said this suggested the subtle differences in brain activity may act as a risk marker for the disorder.

In a second study, scientists compared brain activity of children with ADHD — a mental disorder that affects between 8 and 12 percent of children, and 4 percent of adults worldwide.

The researchers used the same “go, no-go” task in various scenarios, including when the children were taking their medication, Ritalin, and when they were not, and then using an additional system of rewards and penalties.

Millions of people take ADHD drugs including Novartis Ritalin, which is known generically as methylphenidate, and Shire Plc’s Adderall and Vyvanse. In the United States alone, 2008 sales for these drugs was about $4.8 billion, according to data from IMS Health.

Groom’s results showed that children who were taking medication, and children given an incentive, performed better than those who had neither medicines nor incentives.

This suggests, Groom said, that doctors may be able to find new ways to treat children with ADHD using a combination of behavioral strategies and drugs.

Source: Reuters

Popularity: 5% [?]

Top Pfizer Inc research executive Martin Mackay has left the world’s biggest drugmaker to head research at rival AstraZeneca Plc as both companies brace for patent expirations on their top-selling medications.

Pfizer will consolidate its research and development under Mikael Dolsten, who had worked with Mackay as co-head of research and development since October in a split of duties created from the company’s $67 billion merger with Wyeth.

Pfizer is betting on drugs from Wyeth, where Dolsten served as research head, to help it endure plunging sales of its Lipitor cholesterol fighter when the world’s top-selling drug faces generic rivals late next year.

Pfizer said Mackay, a soft-spoken and personable native of Scotland, had resigned and left the company “immediately.” He will take on the new role of president of R&D at London-based AstraZeneca on July 1.

Mackay had been the company’s global research chief for two years and, after the Wyeth merger, led PharmaTherapeutics research at Pfizer, involving conventional drugs made from chemicals. Dolsten oversaw research of BioTherapeutics, biotech drugs made from complex proteins grown in living cells.

“That structure was unusual,” Leerink Swann analyst Seamus Fernandez said. “It struck me as potentially a vetting period for Dolsten,” to better assess his leadership skills.

Morningstar analyst Damien Conover said Dolsten is not well known by Wall Street and will be under pressure to galvanize Pfizer’s underperforming laboratories.

Wyeth brought Pfizer currently marketed biotech drugs, such as blockbuster arthritis drug Enbrel, but did not greatly remedy Pfizer’s dearth of drugs in late-stage testing.

“So Dolsten has a pipeline that is not as strong as it needs to be to offset Lipitor’s patent loss,” Conover said. He noted, however, that Pfizer is developing treatments for Alzheimer’s disease, arthritis and blood clots that have blockbuster sales potential should they eventually be approved.

Shares of Pfizer were up 1.5 percent to $15.29, while AstraZeneca fell 0.8 percent, both in afternoon trading on the New York Stock Exchange.

R&D PEDIGREE

Dolsten has a medical degree from the University of Lund in Sweden and led drug research for Germany’s Boehringer Ingelheim before joining Wyeth. He also had senior roles with other drugmakers, including AstraZeneca and Pharmacia & Upjohn.

“Anyone in leadership in R&D at Boerhinger Ingelheim, which has been an incredibly productive R&D organization over the last several years, should probably be viewed reasonably positively,” Fernandez said.

Pfizer itself has produced few big drugs since introducing anti-impotence pill Viagra in 1998, despite its later acquisitions of U.S. rivals Warner-Lambert and Pharmacia and an industry-topping annual $8 billion research budget.

“The Wyeth deal buys Pfizer a little more time after Lipitor’s patent expires, but the company really needs to start kicking out some new drugs,” said Miller Tabak analyst Les Funtleyder. “Otherwise, it will have to change direction, and move deeper into related areas of healthcare such as generics or consumer products.”

For its part, AstraZeneca separated the two stages of R&D by having a head of drug discovery and a head of drug development, leaving some investors uncertain about its focus.

Mackay’s appointment brings the two roles together as the company overhauls R&D to prepare for patent expiries on top drugs like Nexium, for acid reflux, and Seroquel, for schizophrenia.

AstraZeneca spokesman Neil McCrae said a unified head of R&D would speed up decision-making and help allocate resources between different projects at a time of major change.

“We set out our strategy for R&D in January, which calls for some significant changes as we seek to improve the productivity of our pipeline,” he said. “In addition, since the acquisition of MedImmune, it has become clear that we need a single point of accountability to manage the entire R&D portfolio.”

Mackay has extensive experience working on both sides of the Atlantic. Prior to joining Pfizer in 1995, he focused on research into central nervous system diseases at Ciba-Geigy, now part of Novartis AG. (Reporting by Ben Hirschler and Ransdell Pierson; additional reporting by Lewis Krauskopf; editing by Michele Gershberg and Gerald E. McCormick).

Source: FOREXPROS.com

Popularity: 7% [?]

AstraZeneca’s new licensing chief, Shaun Grady, traveled to Chicago to spread the word about the pharma company’s new partnering strategy at BIO. AstraZeneca has been reengineering its approach to drug development recently, moving away from an in-house approach to a new strategy that will look for external deals to drive 40 percent of its R&D.

The pharma company has already outlined plans to drop work in schizophrenia, bipolar disease, depression, anxiety, acid reflux, thrombosis, ovarian and bladder cancers, systemic scleroderma and hepatitis C.

“Historically, AstraZeneca was much more focused on organic growth,” Grady told Reuters. “We’re looking at internal and external in a consistent way, with the same quality of data, making judgments irrespective of where the origin was. It’s all about the quality of the products, which is quite a change.”

Dr. James Sabry, another new partnering chief at Genentech, told a standing-room-only crowd that he’s looking to make new neuroscience and immunology pacts that can offer the kind of blockbuster rewards the big biotech has found in cancer. According to Sabry, half of the molecules under consideration at Genentech today originated outside the company. And there’s a particular interest now in microbial pathogenesis.

Source: FierceBiotech

Popularity: 4% [?]

Dosing snafus during a pediatric trial of Geodon may end up costing Pfizer that coveted six extra months of U.S. exclusivity, consultants tell the Financial Times. And that loss would cut up to $500 million off the antipsychotic drug’s sales figures, the industry experts say.

The FDA sent a warning letter to Pfizer, citing the company for violations of good clinical practice during two Geodon trials in children. Those trials, which tested the drug in patients with bipolar disorder and schizophrenia, were designed to help Pfizer nab new pediatric indications for the drug–and to get the company the chance to sell Geodon without generic competition for six additional months. “It would be a big blow not to get this,” one of the consultants tells the FT.

Now that the FDA has raised questions about the conduct of these trials, the agency might not consider their data reliable, the consultants say. And the FDA tells the FT that, in general, pediatric exclusivity doesn’t depend on positive trial results, but on completion of studies “in a manner consistent with good scientific practices.” A flawed pediatric study could be grounds for denying exclusivity, the agency adds.

For its part, Pfizer says it’s evaluating the warning letter and plans to respond to the agency within two weeks. The company tells the FT that it believes in the clinical integrity of its Geodon testing in children. “We are responding to the FDA’s queries around the study and continue to plan to seek a pediatric indication for Geodon,” the company says.

Source: FiercePharma

Popularity: 2% [?]

Following its acquisition of Schering-Plough, Merck has released an updated pipeline that features 20 candidates in Phase III or under regulatory review, and more than 20 candidates in Phase II development. Its revamped pipeline is a mix of small molecules, vaccines and biologics.

Merck’s four near-term approvals include SCH 418131 for asthma; MK-6621 for atrial fibrillation; SCH 900121 for contraception; and asenapine for schizophrenia and bipolar I disorder. Other diseases targeted by the company’s projects include and thrombosis, cancer, diabetes, hepatitis C infection, insomnia and schizophrenia. Its deepest therapeutic areas are cardiovascular disease and infectious diseases, where the company boasts eight investigational therapies in each category.

“The combination of two complementary pipelines has yielded a robust and diversified portfolio to fuel Merck’s future growth,” said Peter Kim, Ph.D., president, Merck Research Laboratories. “Many of the more than 40 Phase II and Phase III investigational medicines and vaccines have the potential to have a major impact on human health.”

Merck has already won kudos for its handling of the massive merger. Analysts have predicted solid growth for the new Merck and anticipate the company will do everything it can to make its combined operations as efficient as possible.

Source: FierceBiotech

Popularity: 3% [?]

Questioning the theory that prenatal exposure to the flu virus might be a risk factor for schizophrenia, a new study finds no link between the flu pandemic of 1957 and later schizophrenia rates.

In an analysis of studies from Europe, Australia, Japan and the U.S., researchers found no higher-than-normal risk of schizophrenia among people born in the nine months after the 1957 flu pandemic.

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The findings, reported in the Schizophrenia Bulletin, conflict with those from some earlier studies linking the same pandemic to a heightened schizophrenia rate.

While the exact causes of schizophrenia are not clear, it is considered a disorder of disrupted brain development, and researchers have long believed that schizophrenia arises from a combination of genetic susceptibility and environmental factors.

Among the suspected environmental factors is fetal exposure to a mother’s infection during pregnancy, with the influenza virus being one of the potential culprits.

The first evidence came from a 1988 Finnish study that found an increased rate of schizophrenia among people who were in the womb at the time of the 1957-58 Asian flu pandemic that killed about 2 million people worldwide.

Since then, studies have come to conflicting findings as to whether prenatal flu exposure might contribute to schizophrenia. However, some smaller studies that have used mothers’ blood samples to measure flu exposure during pregnancy have supported a link.

One theory is that inflammatory substances released in the mother’s blood in response to the infection may cross the placenta and affect fetal brain development in a way that makes the child more vulnerable to developing schizophrenia later in life.

These latest findings, however, “do not support this hypothesis,” report the researchers, led by Dr. Jean-Paul Selten of the University Medical Center Utrecht in the Netherlands.

The results are based on 11 international studies that compared rates of schizophrenia among people who were in the womb during the 1957-58 pandemic with those of people born within the few years before and after the outbreak.

The researchers also analyzed two studies that included women who were pregnant and reported having the flu during the pandemic.

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Overall, Selten’s team found no increased schizophrenia risk among people who were in the womb during the flu pandemic, at any trimester of pregnancy.

According to the researchers, the original Finnish study that focused on the 1957 pandemic used an “inappropriate statistical method” to arrive at its conclusions. Their re-analysis of that data, they add, uncovered no increased risk of schizophrenia.

“We conclude that the evidence to support the maternal influenza hypothesis is insufficient,” the researchers write.

SOURCE: Schizophrenia Bulletin, online December 3, 2009.

Popularity: 3% [?]

Here’s a quick drug-news roundup:

More than two-thirds of patients who took an experimental impotence drug were able to have sex within 15 minutes, according to Vivus, the company that’s developing the drug. (Among patients who took a placebo, the success rate within 15 minutes was less than one third, by the way.) Impotence drugs such as Pfizer’s Viagra and Eli Lilly’s Cialis can take hours to work, so faster onset could be a selling point, Dow Jones Newswires notes. Still, the company has yet to file for FDA approval of the drug, avanafil, and a decision from the FDA isn’t likely until next year. And Viagra will lose patent protection in 2012, which will bring generic competition to the field.

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The FDA approved Actemra for rheumatoid arthritis patients who need more treatment after trying a drug like J&J’s Remicade or Abbott’s Humira. Those drugs block something called tumor necrosis factor; Actemra, sold by Roche, blocks another substance, interleukin-6.

Novartis started selling a new antipsychotic drug called Fanapt in the U.S. While this isn’t particularly surprising — the FDA approved the drug last year to treat schizophrenia — the backstory is interesting. According to the Washington Post, Novartis actually sold the rights to the drug a while back, to a company called Vanda that was founded by an MD — who used to work for Novartis. Last year, Novartis acquired the rights to sell Fanapt in the U.S. and Canada.

Source: The Wall Street Journal

Popularity: 6% [?]