A new method has been developed by the scientists at the Oxford University in UK for delivering the complex drugs directly to the brain.
Researchers in a study said that the new method is a necessary step for treating Alzheimer’s, Parkinson’s, motor neurone diseases and muscular dystrophy.

In an experiment involving mice, scientists switched off the BACE1 gene present in Alzheimer’s disease by intravenously injecting exosomes, which are able to ferry a drug across the normally impermeable blood-brain barrier to the brain.
This has resulted a 60% decrease in the gene’s activity.

At the University of Oxford Dr Matthew Wood of the Department of Physiology, Anatomy and Genetics said, “These are dramatic and exciting results. It’s the first time new ‘biological’ medicines have been delivered effectively across the blood-brain barrier to the brain.”
One of the medical challenges with diseases of the brain is getting any treatment to cross the blood-brain barrier, which protects the brain by preventing bacteria from crossing over from the blood, while letting oxygen through.
This has however proved a problem for medicine, as drugs can also be blocked by the barrier.

“The major barrier for these drugs is delivery,” added Dr Wood. “This problem becomes even greater when you want to reach the brain.”
Neurosurgery is to be involved in delivering any such type of therapy to the brain.

Abbott (NYSE: ABT) has received U.S. Food and Drug Administration (FDA) approval for the next-generation XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. With the introduction of XIENCE PRIME in the United States, Abbott, the worldwide leader in drug eluting stent technology, now offers physicians an expanded range of drug eluting stents supported by the clinical results from the SPIRIT family of trials. XIENCE PRIME, which uses the same drug and biocompatible polymer as the XIENCE V® Everolimus Eluting Coronary Stent System, features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement.

“Drug eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease,” said Marco Costa, M.D., Ph.D., professor of medicine, director of the Interventional Cardiovascular Center and director of the Research and Innovation Center, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals, Case Western Reserve University in Cleveland, Ohio, and principal investigator of the global SPIRIT PRIME trial. “With XIENCE PRIME, for the first time in the U.S., physicians have a 38 mm everolimus-eluting stent for the treatment of long lesions. The enhanced deliverability and wide range of sizes, including a small-vessel 2.25 mm-diameter stent, will improve our ability to access challenging, complex lesions, and thereby improve care for our patients.”

XIENCE PRIME is based on the stent design of the MULTI-LINK family. It utilizes cobalt chromium technology and features a “peak-to-valley” mechanical design that imparts longitudinal strength and stability to the stent. To date, the stents based on the MULTI-LINK design – including VISION®, XIENCE V, PROMUS® and XIENCE PRIME – represent more than 300 million implant months, which is a measure of the clinical experience that supports this stent design. In addition, XIENCE PRIME features one of the thinnest drug eluting stent struts available while maintaining radial strength to support the vessel, and it provides excellent visibility under X-ray during stent implantation procedures. XIENCE PRIME is offered in long lengths up to 38 mm.

“Abbott is the worldwide leader in drug eluting stent technology, and U.S. approval of XIENCE PRIME will further advance our number-one position in the global drug eluting stent market,” said Robert B. Hance, senior vice president, vascular, Abbott. “XIENCE PRIME and XIENCE V are the only drug eluting stents that are directly supported by the robust body of clinical evidence from the SPIRIT family of trials. Together, these two stent platforms expand the range of treatment options that we offer physicians for the benefit of their patients with coronary artery disease.”

FDA approval of XIENCE PRIME was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated XIENCE PRIME in 500 patients with coronary artery disease. The trial met its primary endpoint, with low rates of target lesion failure (TLF) at one year. Stent thrombosis rates at one year also were very low. The full results from the SPIRIT PRIME study will be presented by Dr. Costa on Tuesday, Nov. 8, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.

About the SPIRIT PRIME Clinical Trial
SPIRIT PRIME is a prospective, two-arm, open-label, multi-center registry designed to evaluate XIENCE PRIME in 500 patients with coronary artery disease. The trial was conducted at more than 60 centers in the U.S. and Australia. Two registry arms were evaluated: the Core Size arm and the Long Lesion arm. The Core Size arm utilized XIENCE PRIME stents measuring 2.25 mm to 4.0 mm in diameter and from 8 mm to 28 mm in length. The Long Lesion arm utilized XIENCE PRIME stents measuring 2.5 mm to 4.0 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint was TLF at one year, which was a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.

About XIENCE PRIME and XIENCE V
XIENCE PRIME received CE Mark in 2009. With FDA approval, XIENCE PRIME is now available in the U.S., Europe, the Middle East and most of Asia.

XIENCE PRIME is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 32 mm) with reference vessel diameters of greater than or equal to 2.25 mm to less than or equal to 4.25 mm.

Abbott’s market-leading XIENCE V drug eluting stent is marketed in the U.S., Europe, Japan and other international markets.

XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

From the Phase II study of a selective FLT3 inhibitor AC220, Ambit Biosciences and Astellas Pharma have reported positive clinical results which is used to treat acute myeloid leukaemia.

The open-label, single-arm and multi-centre study evaluated AC220 as an oral, once-a-day, monotherapy treatment in 240 patients with FLT3-ITD activating mutations who had relapsed or are refractory to second-line chemotherapy.

The findings from the study demonstrated improvement in complete remission rate, clinical response and safety profile in patients treated with the drug candidate.

Common treatment-related adverse events observed included nausea, vomiting, fatigue and febrile neutropenia.

SAN DIEGO, Nov 07, 2011 (BUSINESS WIRE) — ACADIA Pharmaceuticals Inc. ACAD +0.84%, a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that the U.S. Food and Drug Administration has completed its review of ACADIA’s Investigational New Drug application to begin Phase I clinical studies with AM-831, an innovative small molecule for the treatment of schizophrenia. AM-831 was discovered by ACADIA and is being developed in collaboration with Meiji Seika Pharma Co., Ltd. The parties plan to proceed with a Phase I study to assess the safety, tolerability and pharmacokinetics of AM-831 in healthy volunteers and to help inform the design of future studies in patients with schizophrenia.

“We are pleased to enter clinical development with AM-831 in collaboration with ACADIA,” said Yasushi Murai, Ph.D., Senior Vice President, Research and Development of Meiji Seika Pharma. “This important progress reinforces our mutual belief in the potential of a drug with the novel profile of AM-831 and our commitment to improve the lives of patients suffering from schizophrenia.”

“We are excited to initiate clinical studies with AM-831,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “Our preclinical studies have shown that AM-831 has the potential to be the first antipsychotic drug to combine pro-cognitive and antipsychotic effects in patients with schizophrenia, thereby addressing an area of major unmet medical need.”

AM-831 is a novel and orally available small molecule that combines muscarinic m1 partial agonism with both dopamine D2 and serotonin 5-HT2A antagonism. AM-831 has demonstrated a unique combination of robust antipsychotic effects in traditional preclinical models of psychosis and pro-cognitive effects in preclinical behavioral models. In contrast, currently prescribed treatments do not effectively address or may exacerbate cognitive dysfunction associated with schizophrenia.

About the ACADIA Pharmaceuticals/Meiji Seika Pharma Collaboration

ACADIA and Meiji Seika Pharma are collaborating to develop AM-831 through completion of proof-of-concept clinical studies as a treatment for patients with schizophrenia and related disorders. Meiji Seika Pharma has exclusive rights to develop and commercialize AM-831 in the Asian territory while ACADIA has retained rights to AM-831 in the rest of the world, including the U.S. and Europe. ACADIA received initial licensing fees and is eligible to receive development and regulatory milestones and royalties on product sales in the Asian territory. Meiji Seika Pharma is responsible for funding the initial development expenses of AM-831 up to a specified level and the parties will share remaining expenses through clinical proof-of-concept, subject to possible adjustment. Meiji Seika Pharma is responsible for all costs associated with the development and commercialization of AM-831 in the Asian territory.

About Schizophrenia

Schizophrenia is a chronic and debilitating mental illness characterized by disturbances in thinking, emotional reaction and behavior, and affects about one percent of the population. Symptoms associated with schizophrenia may include positive symptoms, such as hallucinations and delusions, a range of negative symptoms, including loss of interest and emotional withdrawal, and cognitive dysfunction. This cognitive impairment frequently prevents patients with schizophrenia from integrating into society. Unlike psychosis, cognitive dysfunction is typically unremitting and lacks the episodic exacerbations associated with other symptoms of schizophrenia. As a result, patients with schizophrenia are normally required to be under medical care for their entire lives.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA has four product candidates in clinical development including pimavanserin, which is in Phase III development as a potential first-in-class treatment for Parkinson’s disease psychosis. ACADIA also has a product candidate in Phase II development for chronic pain and a product candidate in Phase I development for glaucoma, both in collaboration with Allergan, Inc., and AM-831 in Phase I development for schizophrenia in collaboration with Meiji Seika Pharma Co., Ltd. All of the product candidates in ACADIA’s pipeline emanate from discoveries made using its proprietary drug discovery platform. ACADIA maintains a website at www.acadia-pharm.com to which ACADIA regularly posts copies of its press releases as well as additional information and through which interested parties can subscribe to receive email alerts.

About Meiji Seika Pharma Co., Ltd.

Meiji Holdings Co., Ltd., the parent company of Meiji Seika Pharma, reorganized its operating companies, which resulted in the establishment of Meiji Seika Pharma on April 1, 2011. Meiji Seika Pharma, which inherited the pharmaceuticals business of Meiji Seika Kaisha, Ltd., is a “Specialty and Generic Pharmaceuticals Company” with a focus on the infectious disease field, the central nervous system disorders field, and the generic drugs business. For details on Meiji Seika Pharma, see http://www.meiji-seika-pharma.co.jp/english/index.html .

Actavis Group CEO Claudio Albrecht announced a major sales expansion into Latin America, among the world’s fastest-growing markets for generic drugs.

Albrecht outlined the company’s growth strategy at a meeting in South Florida with Actavis’ new Latin American business unit. The Latin America team, based in Sunrise, Florida, will target Brazil, Argentina, Colombia, Mexico, Venezuela and other key markets in the region.

With generic drugs not as widely used in South and Central America as in the United States and Europe, Albrecht said that Actavis’ portfolio of nearly 900 lower-cost alternatives to brand medications represents a potential healthcare solution for millions. “This is not only a tremendous opportunity for Actavis to grow as a company, but also to bring great value to consumers while supporting better health,” he said.

According to IMS Health, generic sales in Latin America grew by 14 percent from 2009 to 2010, compared to 4.4 percent worldwide. Generic sales in Latin America totalled $53.4 billion last year. Actavis Group, the world’s fourth largest generic pharmaceutical company, already operates in more than 40 countries, and plans another major expansion in Japan.

The Latin America unit, headed by Ricardo Quirch, also includes specialists in regulatory affairs, portfolio and business development, supply-chain management and business administration. Quirch joined Actavis from Sandoz, the generics division of Novartis, most recently leading cross-divisional Asia-Pacific sourcing for the company.

“The decisions we are making now will have long-term benefits for health consumers in these countries,” said Quirch. “We began with two products that we acquired several years ago and are now reviewing more than 20 products to potentially add to our portfolio, and in the process of receiving regulatory approval to begin marketing others.”

The Latin America unit is part of Actavis Inc., the global company’s New Jersey-based U.S. subsidiary headed by U.S. CEO Doug Boothe.

The global fight against the tuberculosis epidemic receives a boost today as Aeras and the China National Biotec Group (CNBG) announce that they have reached final agreement to jointly develop new tuberculosis (TB) vaccines. The agreement between the leading non-profit developer of TB vaccine candidates and the largest biotechnology corporation in China signals a commitment by both to engage and strengthen the role of China in the fight against one of the world’s deadliest infectious disease killers.

Xiaoming Yang, President of CNBG, said of the agreement: “CNBG has a great deal of expertise and energy to invest in this partnership. Not only is TB a public health crisis of the developing world, it is also a priority health issue here in China. We look forward to working with our counterparts at Aeras to develop new TB vaccines that will help stop tuberculosis in all corners of the world.”

Multiple research institutes operating under the umbrella of CNBG will engage with Aeras on a strategy focused on the joint development, manufacturing and distribution of affordable new TB vaccines for use globally. The agreement spans all aspects of TB vaccine development – from vaccine discovery to pre-clinical research to clinical research to manufacturing – and positions CNBG as a major emerging player in the TB vaccine field.

Bacille Calmette-Guerin (BCG), the only currently-licensed TB vaccine, does not prevent pulmonary TB, the most common form of the disease. As part of this collaboration, Aeras will license its recombinant BCG (rBCG) platform – which aims to improve upon the current TB vaccine – and other technologies to CNBG. The groups will jointly develop novel TB vaccines using the rBCG platform and other technologies provided by Aeras or CNBG’s research institutes. A variety of candidate booster vaccines will be engineered to match the new constructs with a goal to create more efficacious and longer-lasting protection against TB disease.

A keystone of this broad collaboration is the implementation of joint product development teams to develop and execute comprehensive plans for both the research and clinical development of TB vaccines and the design, construction and validation of a vaccine process development and manufacturing facility in China, which will receive financial support and technical expertise provided by Aeras.

“The synergy created by bringing together our scientific and manufacturing expertise could have a substantial impact on efforts to advance innovative candidates in TB vaccine development,” said Jim Connolly, President and CEO of Aeras. “We look forward to working with the largest biotech corporation in a country with the skills, resources and TB disease burden to play a major role in overcoming the complex challenges of TB vaccine R&D.”

TB is a major public health priority in China, where there are more than one million new TB cases every year. Globally, the TB epidemic is responsible for the deaths of 1.4 million people annually.

About AerasAeras (www.aeras.org) is a non-profit product development organization dedicated to the development of effective TB vaccines and biologics to prevent TB across all age groups in an affordable and sustainable manner. Aeras utilizes its broad capabilities and technologies in collaboration with numerous partners and stakeholders to support the development of vaccines and other biopharmaceuticals to address TB and other significant public health needs of underserved populations. Aeras has invented or supported the development of six TB vaccine candidates to date, five of which are currently undergoing Phase I and Phase II clinical testing in Africa, Asia and North America. Aeras receives funding from the Bill & Melinda Gates Foundation, other private foundations and various governments. Aeras is based in Rockville, Maryland, USA – where it operates a state-of-the-art manufacturing and laboratory facility – and Cape Town, South Africa.

About CNBG CNBG (www.cnbg.com.cn) is a company limited by shares, the controlling shareholder of which is China’s National Pharmaceutical Corporation (Sinopharm). CNBG has 10 subsidiaries and is the largest biotech corporation in China engaged in the research and development, manufacturing and marketing of biological products. CNBG manufactures more than 200 kinds of biological products (with approximately 100 GMP product lines) for prophylactic, therapeutic and diagnostic use, including all the vaccines in China’s EPI programme, and maintains an 80% share of the public sector in China. In 2010, the annual output of CNBG reached 730 million doses, and it maintains one of the broadest portfolios of vaccine products in the world.

Aetna, one of the leading diversified health care benefits companies, and the Centre for Biomedical Informatics at Harvard Medical School (HMS) has signed a research agreement aimed at analysing health care data in new ways to further clinical research and improve the quality and affordability of health care.

The research will be conducted by members of the Center for Biomedical Informatics at Harvard Medical School and Aetna clinicians and informatics specialists. It will be supervised by Isaac (Zak) Kohane, MD, PhD, Henderson Professor of Paediatrics and Health Sciences and Technology at Harvard Medical School (HMS) and co-director of the HMS Centre for Biomedical Informatics, and Brian Kelly, MD, head of Informatics and Strategic Alignment at Aetna.

“If our health care system is going to become a ‘learning’ health care system, we need to better use the enormous amount of information we derive from health care to develop tools to understand what is happening today —such as which drugs are not working as safely as we thought, which therapies have unexpected benefits, what are the predictors of effective diabetes management and which genetic tests are likely to usefully guide therapy,” said Dr Kohane. “Major advances in research and clinical care can be made by applying new bioinformatics techniques to large, aggregated clinical databases. We are excited about the opportunity to work with Aetna to rapidly develop and deploy algorithms and applications that can make a real impact on biomedical discovery and patient care,” he said.

“We are delighted to be working with a thought leader in health care and bioinformatics like Harvard Medical School on this initiative. Aetna has been committed to using health care information technology to improve the quality and affordability of health care, and through this collaboration we believe we can together make an even greater impact,” said Dr Brian Kelly.

Bioinformatics is the application of computer science and information technology to the field of biology and medicine. Researchers on the project will benefit from the extensive clinical resources and expertise available through the HMS Centre for Biomedical Informatics and its affiliated institutions as they focus on:

evaluating the outcomes of various treatments for specific conditions based on quality and cost; determining factors that predict adherence to medical and drug treatments for chronic diseases; studying how claims data and clinical data available through electronic health records can best be used to predict disease and follow outcomes; and improving the ability to predict adverse events through the proactive study of claims and clinical data.

Harvard Medical School (HMS) has more than 7,500 full-time faculty working in 11 academic departments located at the School’s Boston campus or in one of 47 hospital-based clinical departments at 17 Harvard-affiliated teaching hospitals and research institutes namely: Beth Israel Deaconess Medical Centre, Brigham and Women’s Hospital, Cambridge Health Alliance, Children’s Hospital Boston, Dana-Farber Cancer Institute, Forsyth Institute, Harvard Pilgrim Health Care, Hebrew SeniorLife, Joslin Diabetes Centre etc.

The USFDA has granted fast-track designation to AiCuris’ Letermovir, an inhibitor of the human cytomegalovirus. iCuris CEO Helga Rübsamen-Schaeff said that the fast-track status will hopefully facilitate the regulatory process for the drug and support the company’s view that Letermovir has the potential to become the treatment of choice for patients at risk of human cytomegalovirus.

The US AIDS Drug Assistance Program has reacted angrily to the news that Merck has refused to lower the price of blockbuster HIV/AIDS drug Isentress, accusing the company of engaging in “unethical behaviour”.

Isentress, the generic of which is raltegravir, currently costs over $8,000 per patient per year, making it the most expensive first-line drug.

The news comes hot on the heels of Merck’s announcement that it has agreed to pay a $950m fine to settle criminal and civil charges that it misrepresented the safety of its anti-inflammatory drug Vioxx.

The US Justice Department alleged that Merck promoted the drug for treating rheumatoid arthritis before it had been approved for that indication by the US Food and Drug Administration.

AIDS-related deaths are down 21 percent from their peak in 2005, according to a report released today by UNAIDS, the joint United Nations program on HIV and AIDS. That’s the lowest level since 2005, the BBC reported. The number of new HIV infections is also down 21 percent from its peak in 1997.

“We have seen a massive scale up in access to HIV treatment which has had a dramatic effect on the lives of people everywhere,” UNAIDS Executive Director Michel Sidibe told BBC News.

About half of people eligible for treatment with antiretroviral drugs, or ARVs, globally are now receiving them, BBC News reported.

According to the Los Angeles Times:

Three African countries, Botswana, Nambia and Rwanda, achieved universal access, defined by UNAIDS as access for 80 percent or more of those eligible. Four African countries, Kenya, Ethiopia, Swaziland and Zambia, had coverage for between 60 percent and 80 percent of infected people.

Expanded access to ARVs has also decreased transmission, the LA Times reported.

“In addition to improving quality of life and reducing AIDS-related deaths, antiretroviral treatment is now recognized as preventing HIV transmission, by reducing viral load and hence the potential for transmission,” the UNAIDS report said, according to the LA Times. “Coupling treatment access with combination prevention options is pushing new HIV infections down to record levels.”

Officials from the humanitarian organization Doctors Without Borders warned that the financial crisis threatens such progress and called for increased funding to combat AIDS and HIV to sustain the momentum, USA Today reported. Donor funding for AIDS prevention decreased from $7.6 billion in 2009 to $6.9 billion in 2010, Doctors Without Borders reported, according to the LA Times.

“Just at the moment when we know how to manage HIV, we’re hitting the brakes,” Sharonann Lynch, an HIV policy adviser at Doctors Without Borders, told USA Today. “Without more investment, we’ll be squandering the best chance we have of getting ahead of the new wave of infections.”