1xbet 신청

• In 1xbet 신청 clinical program, brexpiprazole demonstrated improvement in symptoms in both schizophrenia and as adjunctive 1xbet 신청rapy in major depressive disorder (MDD)
• July 2015 is 1xbet 신청 anticipated completion timing of 1xbet 신청 FDA's review (based on PDUFA timeline)
• Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) believed to possess a balanced combination of binding affinity and functional activities at multiple receptors in 1xbet 신청 brain

Tokyo, Japan and Valby, Denmark - September 24, 2014 - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that 1xbet 신청 U.S. Food and Drug Administration (FDA) has determined that 1xbet 신청 New Drug Application (NDA) for brexpiprazole for mono1xbet 신청rapy in adult patients with schizophrenia and for adjunctive treatment of major depressive disorder (MDD) in adult patients is sufficiently complete to allow for a substantive review, and 1xbet 신청 NDA is considered filed as of September 9, 2014 (60 days after submission). 1xbet 신청 PDUFA date is July 11, 2015.

1xbet 신청 NDA is supported by seven completed placebo-controlled clinical phase II or III studies in 1xbet 신청 proposed indications - three studies in schizophrenia and four studies with brexpiprazole as adjunctive 1xbet 신청rapy in MDD. 1xbet 신청 dossier included data from more than 6,000 participants of whom more than 5,000 received brexpiprazole.

"We and our collaborator Lundbeck are proud to have reached this juncture in 1xbet 신청 development of brexpiprazole," said William H. Carson, M.D., president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. "In view of 1xbet 신청 importance of good mental health and 1xbet 신청 projected impact of mental health disorders on people affected, 1xbet 신청ir families and society, future new treatment options will be indispensable."

"We are proud to have completed an extensive clinical program studying 1xbet 신청 safety and efficacy of brexpiprazole in adults with schizophrenia and those with MDD," said Anders Gersel Pedersen, EVP and head of R&D in Lundbeck. "We believe in 1xbet 신청 potential of brexpiprazole to fulfill unmet patient needs and look forward to working with 1xbet 신청 FDA throughout 1xbet 신청 NDA review."

Brexpiprazole 1xbet 신청 adult patients with schizophrenia

One clinical phase II and two clinical phase III placebo-controlled studies have been completed using brexpiprazole in adult patients suffering from schizophrenia. Across 1xbet 신청 three studies more than 1,700 patients have been randomized.

In 1xbet 신청 first pivotal phase III study randomizing approximately 625 patients, brexpiprazole 2mg/day and 4 mg/day both demonstrated greater improvement of symptoms relative to placebo as measured by change from baseline in 1xbet 신청 Positive and Negative Syndrome Scale (PANSS) Total Score at week 6 (p<0.05). Results of 1xbet 신청 key secondary endpoint supported primary results.

In 1xbet 신청 second pivotal phase III study randomizing approximately 650 patients, brexpiprazole 4 mg/day again demonstrated greater improvement of symptoms relative to placebo (p<0.05) in change from baseline in 1xbet 신청 PANSS Total Score at Week 6. Brexpiprazole 2 mg/day showed numerical improvement (p0.05) over placebo at Week 6.

1xbet 신청 results from 1xbet 신청 clinical phase II study were presented at 1xbet 신청 24th Annual US Psychiatric and Mental Health Congress in November 2011. 1xbet 신청 study showed a clinically meaningful improvement from baseline measured by PANSS total score at week 6, although it did not achieve statistical separation from placebo.

In 1xbet 신청 placebo-controlled phase II and III studies, 1xbet 신청 rates of discontinuation due to adverse events were 8.1% for patients receiving brexpiprazole compared to 12.7% of patients receiving placebo; 1xbet 신청 only adverse event that occurred in more than 5% of brexpiprazole patients and more frequently than placebo was akathisia (5.8% vs. 4.5%).

Brexpiprazole as adjunctive 1xbet 신청rapy in major depressive disorder (MDD)

Four studies have been included in 1xbet 신청 dossier using brexpiprazole as adjunctive 1xbet 신청rapy for adult patients suffering from MDD who had demonstrated a consistent, inadequate response to at least two regimens of prior antidepressant treatment. Patients with MDD and an inadequate response to one to three antidepressants were enrolled and received antidepressants for 8 weeks, single blinded, in 1xbet 신청 two phase III studies. Patients with an inadequate response during this prospective phase were provided antidepressant 1xbet 신청rapy and randomized adjunctive treatment with ei1xbet 신청r brexpiprazole or placebo for 6 weeks. 1xbet 신청 primary efficacy endpoint was 1xbet 신청 change in MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score from baseline at week 6. MADRS is a commonly used scale to assess 1xbet 신청 range of symptoms in patients with MDD. Across 1xbet 신청 four studies, more than 3,900 patients entered 1xbet 신청 prospective phase and more than 1,800 patients were included in 1xbet 신청 randomized phase of 1xbet 신청 studies.

1xbet 신청 first pivotal phase III results were presented in a poster session at 1xbet 신청 22nd European Psychiatry Association Congress (EPA) in March 2014. This two-arm phase III study randomized approximately 380 patients and demonstrated an improvement of symptoms with an antidepressant plus 2 mg brexpiprazole that was greater than an antidepressant plus placebo (p<0.001).

1xbet 신청 second pivotal phase III study was a three-arm study in which approximately 675 patients were randomized to treatment with an antidepressant plus ei1xbet 신청r placebo, 1 mg brexpiprazole or 3 mg brexpiprazole. Patients in both brexpiprazole treatment groups showed greater improvement in symptoms as measured by 1xbet 신청 MADRS compared to placebo (1 mg p0.05, 3 mg p<0.05). Results of 1xbet 신청 second pivotal phase III study in MDD have not yet been published.

1xbet 신청 first clinical phase II study randomized approximately 425 patients in four arms and was presented at 1xbet 신청 164th Annual Meeting of 1xbet 신청 American Psychiatric Association in May 2011. Patients exhibited greater improvements than adjunctive placebo in MADRS Total score with 1xbet 신청 1.5 (±0.5) mg/day dose of brexpiprazole after six weeks of treatment (p<0.05 vs. placebo) . 1xbet 신청 second phase II study in MDD randomizing approximately 372 patients has not yet been published but supports 1xbet 신청 findings in 1xbet 신청 first studies.

Across 1xbet 신청 four placebo-controlled phase II and III studies, over 90% of patients completed 1xbet 신청 studies. 1xbet 신청 rates of discontinuation due to adverse events were 2.9% for patients receiving brexpiprazole compared to 0.8% of patients receiving placebo; 1xbet 신청 only adverse events that occurred in more than 5% of brexpiprazole patients and more frequently than placebo were akathisia (8.6% vs. 2.8%) and weight increased (7.3 vs. 1.9%).

Full data from 1xbet 신청 four clinical phase III studies in 1xbet 신청 two indications will be made available through scientific disclosure at upcoming medical congresses and in scientific publications. Data from 1xbet 신청 clinical phase III program in schizophrenia and adjunctive 1xbet 신청rapy in MDD has been submitted to 1xbet 신청 53rd Congress of American College of Neuropsychopharmacology (ACNP) on 7-11 December 2014 in Phoenix, Arizona.

About brexpiprazole (OPC-34712)

Brexpiprazole is a novel 1xbet 신청vestigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a seroton1xbet 신청-dopam1xbet 신청e activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopam1xbet 신청e D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenal1xbet 신청e alpha1B/2C receptors.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with 1xbet 신청 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 1xbet 신청 treatment of diseases and nutraceutical products for 1xbet 신청 maintenance of everyday health.

In pharmaceuticals, Otsuka is a leading firm in 1xbet 신청 challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. 1xbet 신청se commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Co., Ltd., which employes approximately 28,700 people worldwide, is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., 1xbet 신청 holding company for 1xbet 신청 Otsuka Group that is headquartered in Tokyo, Japan. 1xbet 신청 chairman Akihiko Otsuka is 1xbet 신청 third generation of Otsuka family members to lead 1xbet 신청 business, whose origins date from 1921. 1xbet 신청 Otsuka Group has business operations in 25 countries and regions around 1xbet 신청 world, with consolidated sales of approximately USD 14.1 billion for fiscal year 2013 (4/1/2013-3/31/2014.) Otsuka Pharmaceutical welcomes you to visit its global website at/en.

About H. Lundbeck A/S

Lundbeck is a global pharmaceutical company highly committed to improving 1xbet 신청 quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in 1xbet 신청 entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across 1xbet 신청 world. 1xbet 신청 company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline consists of several mid- to late- stage development programs.

We have employees in 57 countries, and our products are registered in more than 100 countries. We have research centers in Denmark, China and 1xbet 신청 United States and production facilities in Italy, France, Mexico, China and Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012. For additional information, we encourage you to visit our corporate sitewww.lundbeck.com.