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: 1% [?]

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: 2% [?]

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: 3% [?]

Dainippon Sumitomo has filed for FDA approval of its prospective blockbuster schizophrenia drug lurasidone, beating its own timetable as the Japanese pharma giant stays on course toward an expected 2011 market launch.

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Dainippon was willing to spend $2.6 billion for Sepracor last fall, at least in part because it plans to deploy its 1,200 sales people in a national campaign to sell the drug. “This NDA marks a significant milestone for our company as we accelerated the global clinical development of lurasidone and achieved an earlier than anticipated submission to the FDA,” said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma.

Analysts expect the drug’s safety profile will allow it to break the billion-dollar barrier in the U.S. if it is approved. But it won’t be easy. The antipsychotic market in the U.S. is intensely competitive. Lurasidone is designed to work much like Zyprexa, Risperdal or Seroquel, without the weight gain that many patients experience. And the Japanese company is also testing the therapy as a treatment for bipolar disorder.

Source: FierceBiotech

Popularity: 2% [?]

Merck & Co. has decided to continue its research collaboration with Addex Pharmaceuticals for an additional year. The partnership is focused on developing positive allosteric modulators (PAM) of the metabotropic glutamate receptor 4 (mGluR4) for the treatment of Parkinson disease and other undisclosed indications.

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The decision follows a report earlier this year from Addex that a preclinical study with an orally available mGluR4 PAM showed efficacy in an animal model of Parkinson. With the extension, Addex will recognize $1.8 million in research funding over the next 12 months in addition to the original financial terms.

As per the exclusive collaboration and license agreement announced in December 2007, Addex received $3 million up front. Since then the company has been paid two preclinical milestones of $250,000 and $500,000. Addex is eligible to receive up to $106.5 million in research, development, and regulatory milestones for the first product developed for multiple indications.

Additional milestones of up to $61 million would be payable if a second and third product are developed. Addex will also receive royalties on sales of any products resulting from this collaboration.

Glutamate, like dopamine and serotonin, is a key neurotransmitter in the human brain, an important signaling molecule involved in control of multiple brain functions ranging from motor control to mood. In Parkinson the death of dopamine-producing neurons leads to excess glutamate signaling.

Current treatments focus on dopamine-replacement strategies. Yet, most patients reach a stage where dopaminergic treatments are no longer effective. There can also be debilitating side effects with dopaminergic treatments. It is believed that selective activation of mGluR4 is one way to bypass the dopamine pathway and could correct the circuitry that modulates motor excitability via a nondopaminergic mechanism.

Research shows that mGluR4 activators could work via two distinct mechanisms to alleviate symptoms of the disease and, potentially, even slow the progression of the disease, according to Addex and Merck. mGluR4 activation triggers a compensatory mechanism that may spare or potentiate the use of dopamine-receptor activators. And mGluR4 activation may have a neuroprotective effect that helps to preserve the brain’s dopaminergic neurons.

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Addex has an mGluR5 NAM candidate called ADX10059 in Phase IIb testing for GERD and migraine prevention. The mGluR5 NAM ADX48621 has completed Phase I for levodopa-induced dyskinesia related to Parkinson. Also, Addex’ partner, Ortho-McNeil-Janssen Pharmaceuticals, is performing a Phase I study of another mGluR2 PAM, ADX71149, which has potential in anxiety and schizophrenia.

Source: GEN News

Popularity: 2% [?]

Scanning technology has helped researchers pinpoint the part of the brain that appears to be where psychotic disorders such as schizophrenia begin, a new study says.

The research could help doctors diagnose these types of disorders in their early stages and help scientists develop more effective drugs, according to the report in the Sept. 7 issue of the Archives of Psychiatry.

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In the study, researchers at Columbia University in New York City scanned the brains of 18 people at high risk for psychosis, using a novel high-resolution application of functional MRI technology, an imaging method that tracks which parts of the brain are most active.

Seventy percent of the participants who went on to develop disorders such as schizophrenia had very high activity in a region of the hippocampus known as the CA1 subfield, the study authors found.

“Right now, the odds of knowing who will go on to develop schizophrenia from [early indications] is only a little better than a coin toss,” first author Dr. Scott A. Schobel, an assistant professor of clinical psychiatry at Columbia University and the New York State Psychiatric Institute, said in a news release. “We’re hoping that applying this imaging technique can enhance our knowledge of who might go on to develop schizophrenia and related disorders, since early diagnosis and early intervention are so important.”

More information
To learn more about schizophrenia, see the U.S. National Institute of Mental Health.

Source: Drug Information Online

Popularity: 5% [?]

Schizophrenia disease symptoms are triggered by a low level of a brain protein called kalirin, according to researchers from the Northwestern University Feinberg School of Medicine. Kalirin is needed to build the dense network of dendritic spines that allow information to flow from one neuron to another. Without an adequate amount, the frontal cortex of the brain of a person with schizophrenia only has a few narrow paths.

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“Without enough pathways, the information takes much longer to travel between neurons, and much of it will never arrive,” says Peter Penzes, M.D., Ph.D., assistant professor of physiology at the Feinberg School. He is also the senior author of the paper, published in a recent issue of the Proceedings of the National Academy of Science, called “Kalirin regulates cortical spine morphogenesis and disease-related behavioral phenotypes.”

Previously in postmortem examinations of schizophrenic human brains, scientists found fewer connections between the brain cells in the frontal cortex and lower levels of kalirin. But they couldn’t show whether one condition led to the other.

Dr. Penzes thus developed a mouse model that had low levels of Kalirin. He was able to demonstrate that the low level of this protein resulted in fewer dendritic spines in the frontal cortex. Other areas of the brain had a normal number of the dendritic spines.

These mice also developed symptoms of schizophrenia at two months, equivalent to reaching adolescence in humans. This mimics the delayed onset of the disease in humans. In normal development, the brain ramps up the production of kalirin as it begins to mature in adolescence.

Additionally, the new schizophrenic mouse model also exhibited more symptoms than other models, Dr. Penzes states. They had a poor working memory and were antisocial and hyperactive.

Source: GEN News

Popularity: 4% [?]

Johnson & Johnson announced that the FDA granted expanded approval for Invega (paliperidone) as an acute treatment of schizoaffective disorder, either alone or in combination with mood stabilisers and/or antidepressants. The drugmaker said the product is the only antipsychotic approved for this indication.

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The FDA’s decision was based on results from two studies of patients with the condition, Johnson & Johnson stated. Data showed that at certain doses, Invega was superior to placebo on a scale measuring positive and negative symptoms, disorganised thoughts, uncontrolled hostility or excitement, as well as anxiety and depression.

The drug is approved in the US and in Europe for patients with schizophrenia.

Source: FirstWord

Popularity: 4% [?]

Lundbeck and Solvay said it would be “futile” to continue studies of Solvay’s bifeprunox as a maintenance treatment for schizophrenia and have decided to halt all joint R&D activities for the experimental compound, the Danish drugmaker announced Thursday.

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“Efficacy data did not support pursuing the existing development strategy of stabilisation of non-acute patients with schizophrenia,” Lundbeck explained. The companies made the decision after considering recent results from an interim analysis of pooled data intended to support the possible extension of the drug’s ongoing late-stage programme.

Source: FirstWord

Popularity: 4% [?]

Schering-Plough reported on Thursday an FDA advisory committee voted in favour of recommending approval for Saphris (asenapine) as a treatment for adults with schizophrenia and bipolar disorder.

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Panellists voted unanimously in favour of the overall balance of safety and efficacy for Saphris in treating patients with manic or mixed episodes associated with bipolar I disorder, and they voted 9-1, with two abstentions, in favour of the drug’s benefit-risk profile for treating patients with schizophrenia. Committee members indicated that Saphris, which is a dissolvable tablet, would be useful for patients who cannot swallow their medication, or who experience side effects such as weight gain when using other drugs.

The drugmaker said it believes the drug could potentially address an unmet need in these indications for patients who are starting therapy and for those who require different options when switching or re-starting treatment.

Source: FirstWord

Popularity: 4% [?]