A New Post Hoc Analysis Indicates asenapine has Effect on Both Manic and Depressive S

ECNP, VIENNA /PRNewswire/ —
Post hoc analyses presented at the 25th European College of Neuropsychopharmacology (ECNP) congress show asenapine achieves significant control of mixed episodes in bipolar I disorder compared to placebo.
– For media outside China, Japan, UK, USA only.
Lundbeck today announced results from post hoc analyses in bipolar I disorder patients experiencing mixed episodes, which found asenapine has a significant effect on both manic and depressive symptoms versus placebo. The analyses used pooled data from two identically designed 3-week, randomised, double-blind flexible dose, placebo- and olanzapine-controlled trials and a 9-week, double-blind olanzapine-controlled extension study.
“One of the most challenging treatment goals in bipolar I disorder is to address mixed episodes, where both manic and depressive symptoms are present,” said Professor Jean-Michel Azorin, Professor of Psychiatry at the Mediterranean University School of Medicine. “Mixed episodes are experienced by more than 40% of patients and are considered a severe presentation of bipolar I disorder. Further investigation into the potential to manage both depressive and manic symptoms simultaneously with one treatment is warranted.”
Asenapine is a tetracyclic antipsychotic therapy for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The efficacy of asenapine was studied using two scales; for manic symptoms the Young Mania Rating Scale (YMRS) and the Montgomery- Åsberg Depression Rating Scale (MADRS) for depressive symptoms.[1]
The changes in YMRS score from baseline to week 3 were:
Significantly greater with asenapine (-15.0 ± 0.9) compared to placebo (-11.5 ± 1.2; p=0.015)
The difference between olanzapine and placebo was not statistically significant
(-13.3 ± 0.9; p=0.169)
Asenapine was also significantly superior to placebo in change from baseline in MADRS total score at week 3 (-8.2 ± 0.9 versus -4.5 ± 1.2, respectively; p=0.009). The difference between olanzapine and placebo was not statistically significant (-6.5 ± 0.8; p=0.181).[2]
The composite response of both manic and depressive measures (classified as ≥ 50% reduction in YMRS and MADRS scores) rate at week 3 was:
Significantly greater with asenapine (46.3%) than with placebo (24.4%; p=0.023)
The difference between olanzapine and placebo was not statistically significant (37.5%; p=0.141)
The composite remission (YMRS ≤ 12 and MADRS ≤ 10) rate was significantly greater with asenapine (44.8%) than placebo (24.4%; p=0.033) at week 3; the difference with olanzapine was not significant (35.2%; p=0.218).[2]
Bipolar disorder affects 30 million people worldwide including over four million people in Europe.[2] It is the sixth leading cause of disability worldwide.[3] People with bipolar disorder are part of a medically-burdened population that often experience multiple complications. It is estimated that approximately two thirds of patients will suffer a mixed episode at some point in their illness.[4]
Editor notesAbout the post hoc analyses
The efficacy of asenapine in the treatment of mixed episodes was assessed using post hoc analyses on pooled data from two identically designed 3-week, randomised, double blind, flexible dose, placebo- and olanzapine-controlled trials and a 9-week, double-blind olanzapine-controlled extension study.[2]
In the intent-to-treat population, 295 patients has a DSM-IV-TR mixed episode (placebo: 66; olanzapine: 122; asenapine: 107) in the 3-weeks trials. Of these, 102 patients (olanzapine: 56; asenapine: 46) entered the 9-week extension study.[2]
These post hoc analyses were conducted on the pooled 3-week data of the subset of patients diagnosed with a mixed episode according to DSM-IV-TR, and complemented by the data collected during the 9-week extension trial.[2]
About bipolar I disorder
Bipolar disorder (also known as manic-depressive disorder) is a chronic, episodic illness so named because sufferers alternate between two poles of extreme moods – mania and depression.[5] Bipolar I disorder is characterised by mania (episodes of elevated moods, extreme irritability, decreased sleep and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both.[5]
About asenapine
Asenapine is a sublingual tablet indicated for the treatment of moderate to severe manic episodes of bipolar I disorder in adults. Approximately 4,500 subjects, including more than 3,150 patients in phase II/III studies (including trials in schizophrenia), have contributed to asenapine safety and tolerability data and the clinical trial programme for asenapine has included nearly 1,300 patients with manic or mixed episodes of bipolar I disorder.[6],[7],[8]
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) 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 2.2 billion or USD 3.0 billion). For more information, please visit http://www.lundbeck.com/.
References
1. Azorin, et al. Remission of Manic and Depressive Symptoms with Asenapine in Patients with Mixed Episodes. Presented at the 25th European College of Neuropsychopharmacology (ECNP) Congress, Vienna, October 2012, Poster 2.e.019
2. World Health Organization. Disease incidence, prevalence and disability. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_part3.pdf. Accessed August 24, 2012.
3. Kleinman, L et al. Costs of bipolar disorder. Pharmacoeconomics. 2003;21:601-622.
4. Mackin, P. & Young, A.H. (2005) Bipolar disorders. Core Psychiatry (eds P. Wright, J. Stern, M. Phelan). Edinburgh. Elsevier Saunders.
5. National Institute of Mental Health. Bipolar Disorder 2009. Available at: http://www.nimh.nih.gov/health/publications/bipolar-disorder/nimh-bipolar-adults.pdf. Accessed August 24, 2012.
6. Asenapine Summary of Product Characteristics, 2012.
7. McIntyre, R et al. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disorders. 2009:11:673-686.
8. McIntyre, R et al. Treatment of Mania in Bipolar I Disorder: Placebo and Olanzapine Controlled trials of Asenapine. Congress of European College of Neuropsychopharmacology, October 13-17, 2007, Vienna, Austria.
Source: Lundbeck

Pharma Manufacturing & Quality Management China 2012 Talks to GMP Experts in China

SHANGHAI /PRNewswire/ — Pharma Manufacturing & Quality Management China 2012, organized by CPhI Conferences, will be held on 6th-7th November in Suzhou, China. The event will gather 120+ decision makers from both government institutions and pharmaceutical companies to discuss hot topics including quality management systems, API manufacturing, solid dosage form production and sterile drug products. It will provide an interactive communication platform for professionals in the pharmaceutical industry to benchmark their business and technology against ‘best in class’ and ensure that they have the tools they need to form a coherent and logical strategy.
High-level Speakers Including:

Deng Haigen
Deng Haigen, Senior Engineer /2010 version of GMP Drafting Expert, Sino-Swed Pharmaceutical Corp. Ltd.
Intro: Mr. Deng had been Senior Director of Quality Assurance (QA) for Sino-Swed Pharmaceutical Co., Ltd. for 1 8years. China Pharmaceutical Association of Plant Engineering Senior Professor / Advisor, GMP Editor / translator of the book titled “Guidelines of European GMP”- 2008; “Guidelines of validation on pharmaceutical processing, 2nd revision”- 2003. and “Guidance of GMP Application for Pharmaceutical Industry.” Invited by SFDA as a member of working group for Revision of China GMP.

An Guohong
An Guohong, Quality Director, North China Pharmaceutical Group Corporation
Intro: Ms. An has over 20 years experience in QA, QC, pharmaceutical manufacturing management, quality management in the field of free drying, oral solid dosage, API, sterile drug, etc. She has lead 11 GMP certifications in North China Pharmaceutical Group Corporation.

David Chen
David Chen, VP, Quality and Regulatory Affair, Shanghai Desano Chemical Pharmaceutical Co., Ltd
Intro: Dr. David Chen has more than 20 years of pharmaceutical development experience in the areas of process analytical technology, spectroscopy, solid state characterization, chemical process development and GLP/GMP compliance. Dr. Chen served as Manager for Schering-Plough Global Quality and as a Research Leader for Roche Pharmaceuticals in USA before joining Desano.
Xu Hefeng, Senior Document Manager, Northeast Pharmaceutical Group Import and Export Company
Intro: Mr. Xu has over 20 years experience in international pharmaceutical registration and certification and has in-depth insight of EU/USA regulatory, GMP compliance, labrotary management, verification, risk analysis, etc. He has been involved in compiling and publishing GMP Training tutorials, ICH API Quality Control and The Implementation of APIC-Q7, API Process Verification, etc.
For more information, please visit: http://www.pharma-manufacturing-china.com/Index.asp or send an email to askconference@ubm.com.
Media Contact
Ms. Tracy Cui
Tel: +86-21-6157 3919
Fax: +86-21-6157 7299
Email: tracy.cui@ubm.com
Source: CPhI Conferences

Alliance Boots to Form a Strategic Alliance with Nanjing Pharmaceutical Company Limited

NANJING, China /PRNewswire/ — Alliance Boots, under the terms of a strategic alliance agreement signed today, announces that it will acquire a 12% stake in Nanjing Pharmaceutical Company Limited, through a private placement, for a total consideration of approximately EUR56 million (RMB560 million). On completion of the transaction, which is subject to various regulatory approvals, Alliance Boots will be the second largest shareholder in Nanjing Pharmaceutical Company Limited with Board and operational management representation.

Stefano Pessina, Executive Chairman of Alliance Boots, and Zhou Yaoping, Chairman of Nanjing Pharmaceutical, at the signing ceremony of Alliance Boots’ RMB 550 million investment

Stefano Pessina, Executive Chairman of Alliance Boots, and Zhou Yaoping, Chairman of Nanjing Pharmaceutical, at the signing ceremony of Alliance Boots’ RMB 550 million investment

Stefano Pessina, Executive Chairman of Alliance Boots, and Zhou Yaoping, Chairman of Nanjing Pharmaceutical, at the signing ceremony of Alliance Boots’ RMB 550 million investment
Nanjing Pharmaceutical Company Limited, which is listed on the Shanghai Stock Exchange, is the fifth largest pharmaceutical wholesaler in China with sales of around EUR2 billion (RMB20 billion) in 2011. It has a strong market position in its home province of Jiangsu operating distribution centres in 12 cities across eight provinces and one autonomous region. Its largest shareholder is Nanjing Pharmaceutical Group Limited.
The strategic alliance agreement was signed by Stefano Pessina, Executive Chairman, Alliance Boots, and Zhou Yaoping, Chairman, Nanjing Pharmaceutical Company Limited, after being greeted by Yang Weize, Secretary of Nanjing Municipal CPC Committee. The official ceremony, which took place in the city of Nanjing, was held in the presence of Ji Jianye, Mayor of the Nanjing Municipal Government.
Alliance Boots first entered the Chinese pharmaceutical distribution market in 2008 through its Guangzhou Pharmaceuticals Corporation joint venture, which operates in complementary geographies and continues its successful development.
Stefano Pessina commented: “We are delighted to be partnering with such an established player in the Chinese pharmaceutical market and believe there is huge potential in working together to create a great healthcare distribution network. This agreement builds on the success we have already had in China and further strengthens our commitment to the country as well as our willingness to play an active role in the evolution of the market in partnership with the authorities and key players. We believe that this strategic investment marks an important step in our long term development in Asia. ”
Zhou Yaoping, Chairman of Nanjing Pharmaceutical, said: “The cooperation with Alliance Boots is of great significance in the context of the slowing global economy and China’s medical and healthcare reforms. By introducing Alliance Boots advanced supply chain management technology and experience, Nanjing Pharmaceutical will be able to improve its management practices, achieve greater performance, and help China’s medical industry reach global standards, as well as support the pharmaceutical sector in establishing a vibrant social responsibility.”
Editor’s notes:
Alliance Boots is a leading international, pharmacy-led health and beauty group delivering a range of products and services to customers. Working in close partnership with manufacturers and pharmacists, we are committed to improving health in the local communities we serve and helping our customers and patients to look and feel their best. Our focus is on growing our two core businesses: pharmacy-led health and beauty retailing and pharmaceutical wholesaling and distribution.
Alliance Boots has a presence in more than 25* countries and employs over 116,000* people. Alliance Boots has pharmacy-led health and beauty retail businesses in 11* countries and operates more than 3,330* health and beauty retail stores, of which just over 3,200* have a pharmacy. In addition, Alliance Boots has around 625* optical practices, of which around 185* operate on a franchise basis. Our pharmaceutical wholesale businesses supply medicines, other healthcare products and related services to more than 170,000* pharmacies, doctors, health centres and hospitals from over 370* distribution centres in 21* countries. In June 2012, Alliance Boots announced that it had entered into a strategic partnership with Walgreen Co., the largest drug store chain in the US, to create the first global pharmacy-led, health and wellbeing enterprise.
* Figures are approximations as at 31 March 2012 and include associates and joint ventures.
For further information, please contact:
Group Communications, Alliance Boots
Yves Romestan / Laura Vergani / Katie Johnson / Julie Longton: Tel: +44 (0) 207 980 8585
RLM Finsbury (UK media contacts)
Katie Lang / Claire Scicluna: Tel: +44 (0) 207 251 3801
Kreab Gavin Anderson (Asia / China media contacts)
Richard Barton (Tel: +852 9301 2056) / Yang Yang (Tel: +135 0127 4482)
Source: Alliance Boots　

Health In Your Hands Launches Innovative New iPhone App for Patients to Track Individual Progression of Scoliosis at Home

ScolioTrack technology for iPhones has been released on February 24, 2011

SINGAPORE, Feb. 24, 2011 /PRNewswire-Asia/ — Dr. Kevin Lau, D.C., author of “Your Plan for Natural Scoliosis Prevention and Treatment – Health In Your Hands” book and exercise DVD, announces the release of a Singapore made application called ScolioTrack, an innovative new iPhone application which places an instrument similar to a doctor’s scoliometer into the hands of scoliosis patients worldwide. The device proves much safer than x-ray technology and can be used in between doctor’s visits to track one’s individual condition.

“With ScolioTrack, the patient can track the curvature in the spine from month to month by using the iPhone accelerometer and camera function, just as a doctor would with a scoliometer,” said Dr. Lau. “A scoliometer is a device which objectively measures the severity of curvature, or more specifically the Angle of Trunk Rotation.”

The new ScolioTrack technology tracks the patient’s Angle of Trunk Rotation (ATR), a key measurement in screening and planning for the “Health In Your Hands” approach to treatment. ScolioTrack records a person’s height and weight, both beneficial for growing teenagers or health-conscious adults, and also uses the camera function on the iPhone to capture the person’s back to see changes in back deformity.

ScolioTrack saves the information in one convenient location and provides touch-of-the-finger retrieval for future checkups and comparison between tracks.﹛An easy-to-read display shows data output in graph format for ease of tracking variations, and can save the data of multiple users. With ScolioTrack’s access to the latest breaking news, and its user-friendly support guides, patients gain an effortless handle on their disorder.

For more information or to install ScolioTrack for iPhone, iPod or iPad go to http://appshopper.com/link/scoliotrack or http://scoliosis.com.sg/about-iphone-app.html

About Dr. Kevin Lau, D.C. and Health In Your Hands

Dr. Kevin Lau’s ScolioTrack is one element of his comprehensive “Health In Your Hands” series for a natural, non-surgical, highly effective and proven method for reversing scoliosis. The other elements include his in-depth book and a newly-released exercise DVD for scoliosis. He is a recipient of the “Best Health-care Provider Award” by the Straits Time and featured on Prime Time Channel News Asia.

Contact Information:

Dr. Kevin Lau D.C.
drkevinlau@gmail.com
Address: 302 Orchard Road #06-03, Singapore 238862
http://www.Scoliosis.com.sg
Tel: +65-6884-9820

SOURCE﹛Health In Your Hands Pte Ltd