Otsuka and Lundbeck Initiate the Regulatory Process for Aripiprazole (Once-Monthly) Depot Formulation in Europe

• Aripiprazole depot formulation is the first partial dopamine agonist in development for maintenance treatment of schizophrenia as extended-release injectable suspension
• New data presented at the 51^st Annual Meeting of the American College of Neuropsychopharmacology (ACNP) support efficacy of aripiprazole depot formulation, thus further supporting the data package for the European filing

• It is estimated that schizophrenia affects approximately 1% of the adult population in Europe and the U.S., and approximately 24 million people worldwide^1,2

TOKYO & COPENHAGEN, Denmark -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced the European Medicines Agency's (EMA) acceptance of the submission of a marketing authorisation application (MAA) for the approval of aripiprazole depot formulation. The application of aripiprazole depot formulation is for the maintenance treatment of adult patients with schizophrenia.

“Long-acting therapies are moving to the forefront of treatment for psychiatric disorders, and I am very excited that we now also have submitted this product in Europe”

"Our efforts to bring the aripiprazole depot formulation to market demonstrate our long-term commitment to discover, develop and champion treatments for the most challenging psychiatric diseases," said William H. Carson, M.D., President and CEO, Otsuka Pharmaceutical Development & Commercialization, Inc.  " Buy Fansidar (Sulfadoxine-Pyrimethamine) pills online without prescription If approved, more patients with schizophrenia will have access to the efficacy and safety profile of aripiprazole in a once-monthly formulation."
"Long-acting therapies are moving to the forefront of treatment for psychiatric disorders, and I am very excited that we now also have submitted this product in Europe," says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and continues: "If approved, aripiprazole depot formulation will offer the clinical properties of oral aripiprazole, including its safety and efficacy profile, in a form that is suited to patients who may have difficulties consistently taking their medication."
Aripiprazole depot formulation is the first dopamine D₂ partial agonist submitted in Europe as a once-monthly injection. If approved, it will be a new treatment option to address the need for relapse prevention in patients with schizophrenia, a chronic and debilitating disease.
Results from the first clinical trial of aripiprazole depot formulation were presented in four poster presentations at the 2012 American Psychiatric Association (APA) Annual Meeting in May 2012 and have subsequently been published in the Journal of Clinical Psychiatry (Kane et al J Clin Psych, 2012). In December 2012, data from the second pivotal trial were presented at the 51^st Annual Meeting at the American College of Neuropsychopharmacology (ACNP) in Hollywood, Florida.
On 11 November 2011, Otsuka and Lundbeck announced an alliance to collaborate on the development and commercialisation of up to five early and late stage compounds in development. The two companies will co-commercialise aripiprazole depot formulation in the U.S. and will collaborate on the development and commercialisation of aripiprazole depot formulation in other markets worldwide. Aripiprazole depot formulation remains under review by the U.S. Food and Drug Administration (FDA).
About schizophrenia and disease relapse
Schizophrenia is a disease characterized by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood, and the condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of the adult population in the U.S. and Europe, and approximately 24 million people worldwide^1,2. In the U.S., there are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders^3,4. While there is no cure for the disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, when the disease is not managed, patients are at increased risk of disease relapse, which can cause the re-emergence or worsening of psychotic symptoms.
Relapses can occur during the natural course of schizophrenia⁵, but the major driver of recurrent episodes is medication non-adherence^6,7, which may be as high as 50%. There are many reasons patients stop taking their medication and they include: poor insight about their illness, side effects from their current treatment, complicated medication regimens or lack of support from their family.
Recurrent relapses can result in function decline that may never return to pre-morbid levels^6,8,9. The goals of long-term therapy in schizophrenia are therefor to prevent relapse, and to reduce the severity of side effects and residual symptoms^10,11.
About aripiprazole depot formulation
Aripiprazole depot formulation for extended-release injectable suspension, an intramuscular (IM) depot formulation of aripiprazole, is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly.
After an initial injection of aripiprazole depot formulation along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of aripiprazole depot formulation provide uninterrupted medication coverage for a month. Depot formulations of antipsychotic agents provide patients with stable concentrations of active drug that remain at a therapeutic range for an extended period of time and also allow psychiatrists to know when a patient does not return for a scheduled injection^12,13.
About Otsuka Pharmaceutical Co. Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 24 countries and regions around the world, with consolidated sales of approximately EUR 10.5 billion (JPY 1.15 trillion or USD 14.0 billion) for fiscal year 2011.
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with brain disorders. In 2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.1 billion or USD 3.0 billion).

Digital Marketing Teams Solidify Their Staffing at Top 10 Pharma Companies

Most drug manufacturers have yet to define their eMarketing and digital pharma teams. But Top 10 drug makers have already invested significant manpower into digital marketing groups, averaging more than 23 FTEs dedicated to these new media activities, according to a study by Cutting Edge Information. Buy Lozol (Indapamide) pills online without prescription

“A number of companies already invest a great deal of staffing and budget resources into eMarketing.”

The study, “Pharmaceutical Digital Marketing and Social Media,” found one large pharmaceutical company has a staff of 37 FTEs dedicated to its digital marketing team. Most of the positions within these Top 10 pharma companies’ eMarketing groups are middle management jobs. Programmers and design personnel combine to make up 46% of teams on average. Senior management positions make up the smallest percentage of dedicated Top 10 companies’ digital marketing groups.
“The data reveal a clear trend of the pharmaceutical industry’s marketing shifting into digital channels and away from some of the more traditional marketing channels,” said Ryan McGuire, Research Team Leader at Cutting Edge Information. “A number of companies already invest a great deal of staffing and budget resources into eMarketing.”
Cutting Edge Information’s study found that pharmaceutical companies are rapidly solidifying their digital marketing resources. An overwhelming 91% of the companies surveyed maintain internal resources to perform or manage eMarketing activities. Furthermore, a majority of these companies – 58% – already manage digital activities through dedicated digital marketing groups. In general, emerging functions start out under-resourced, and digital marketing is no exception. The study reveals that one-third of surveyed pharmaceutical and biotechnology companies have only 1 FTE in place to manage their eMarketing activities. But that number is likely to rise in the near future.
“Pharmaceutical Digital Marketing and Social Media” helps marketing teams:

• Prioritize objectives with case studies that illustrate successful digital marketing goal-setting.
• Build a team structure to manage both internal and external relationships, emphasize compliance and mitigate regulatory risks.
• Create a team equipped to meet current digital marketing needs and adapt to future challenges.

Improved Peanut Allergy Diagnosis

Researchers from the Murdoch Childrens Research Institute and the University of Melbourne have identified a new way to accurately test for peanut allergy. Buy Claritin tabs online without prescription

It is hoped the test will be more cost effective and convenient than standard approaches and minimise over-diagnosis of peanut allergy in the community.

Currently, an oral food challenge is the standard for diagnosing peanut allergy, and while an oral food challenge is definitive in diagnosing patients, it is time-consuming, costly and patients risk severe reactions such as anaphylaxis.

The new test researchers have identified uses part of the peanut protein called 'Arah2' and involves a two-step screening process. Researchers found they could perform a blood test, followed by the Arah2 test, which was more accurate and highly predictive than using one of the tests alone. They found the two step testing process reduced the need for oral food challenges by four-fold.

Co-lead researcher, Thanh Dang, a University of Melbourne PhD student based at the Murdoch Childrens Research Institute, said the new test has many benefits.

"By reducing the number of oral food challenges, this helps prevent many peanut allergics undertaking the unnecessary risks involved."

Associate Professor Katie Allen said the new test could reduce the burden on clinicians and the health care system.

"Due to the rapid increase in rates of sensitisation to foods, allergy services are overwhelmed, and food challenge tests might be difficult to access. This method would help alleviate the current strain and demand on clinical allergy services, with the allergy patient waiting times in excess of 18 months in many centres in Australia," she said. 

Researchers say the test would also help minimise over-diagnosis, and would reduce the number of patients requiring referral to specialist services for confirmation of a food allergy, by using oral food challenges.

Patients would simply need to visit a GP rather than require a referral to a specialist allergy clinic.

"Due to the long wait times for specialist's clinics, many clinicians are faced with the difficult task of having to assess the presence of food allergy based solely on a positive skin prick test or other available tests and must err on the side of caution and accept a diagnosis of 'possible' food allergy in these situations," Dr Allen said

"This approach can lead to over diagnosis of peanut allergy in the community and a potentially unnecessary burden on the health care system," she said.

Diagnosis of peanut allergy is relatively straightforward when there is an obvious history of clinical reaction to peanut ingestion. However, diagnosis can be more complicated in cases in which the clinical history is not clear or in children who have not yet been exposed to a food.

Researchers say the 'Arah2' twostep process can be used in children with high risk of food allergy, such as those with eczema and other food allergies and for those who haven't eaten peanuts but have a strong family history of food allergy.