Otsuka Holdings Co. Ltd.OTCPK - Current
Wed, Nov. 30, 9:49 AM
- The FDA accepts for review Otsuka Pharmaceuticals' (OTCPK:OTSKF)(OTCPK:OTSKY) supplemental New Drug Application (sNDA) seeking approval of the use of ABILIFY MAINTENA (aripiprazole) for the maintenance treatment of adult patients with bipolar I disorder. The agency's action date (PDUFA) is July 28, 2017.
- ABILIFY MAINTENA is currently approved in the U.S. for the treatment of schizophrenia. It is being co-commercialized in America with Lundbeck (OTC:HLUKF)(OTCPK:HLUYY).
Thu, Oct. 13, 7:08 AM
Wed, Sep. 28, 8:00 AM
- ARIAD Pharmaceuticals (NASDAQ:ARIA) announces that partner Otsuka Pharmaceutical Company (OTCPK:OTSKF)(OTCPK:OTSKY) has received marketing approval in Japan for Iclusig (ponatinib) for the treatment of refractory chronic myeloid leukemia and relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.
- The approval triggers a $10M milestone payment to ARIAD from Otsuka pursuant to their December 2014 collaboration agreement.
- Ponatinib is a multi-targeted tyrosine kinase inhibitor. It was approved in the U.S. for the treatment of two types of leukemia in December 2012.
- ARIA shares are up 2% premarket on light volume.
Wed, Apr. 27, 9:09 AM
- The FDA issues a Complete Response Letter (CRL) to Otsuka Pharmaceutical (OTCPK:OTSKF)(OTCPK:OTSKY) regarding its New Drug Application (NDA) seeking approval of Digital Medicine, a drug/device combination product that combines the company's antipsychotic med ABILIFY (aripiprazole) with an ingestible sensor embedded in a single tablet that measures adherence to the medication. The sensor, developed by privately held Proteus Digital Health, is already approved for sale.
- The NDA was submitted as a system that measures medication adherence in patients with schizophrenia, as an acute treatment of manic and mixed episodes associated with Bipolar I Disorder and as an adjunctive treatment for Major Depressive Disorder. Adherence to medications is a major problem in these patients. The agency requested additional information including performance data of the product under the conditions in which it is likely to be used, in addition to more human factors studies.
- Otsuka and Proteus will work together to address the FDA's requests as soon as feasible.
Mon, Feb. 8, 11:55 AM
- The FDA accepts for review the supplemental New Drug Application (sNDA) from Otsuka (OTCPK:OTSKF)(OTCPK:OTSKY) seeking clearance for the use of REXULTI (brexpiprazole) for the maintenance treatment of adults with schizophrenia. The agency's action date (PDUFA) is September 23.
- The data supporting the application was generated in a 52-week randomized withdrawal study that showed schizophrenic patients receiving REXULTI experienced a statistically significantly longer time to relapse compared to placebo.
- REXULTI was approved by the FDA in July for the treatment of major depressive disorder and schizophrenia. It is the successor product to Otsuka's top seller ABILIFY (aripiprazole). It was co-developed with Lundbeck (OTC:HLUKF)(OTCPK:HLUYY) and will be co-marketed in the U.S. by the two firms.
- Previously: FDA clears Otsuka and Lundbeck's next generation antidepressant for MDD and schizophrenia (July 11, 2015)
Fri, Jan. 8, 8:15 AM
- ARIAD Pharmaceuticals (NASDAQ:ARIA) announces that commercialization partner Otsuka Pharmaceutical (OTCPK:OTSKF)(OTCPK:OTSKY) has submitted a new drug application to the Japanese Pharmaceuticals and Medical Devices Agency seeking clearance of Iclusig (ponatinib) for the treatment of patients with treatment-resistant chronic myeloid leukemia and Philadelphia chromosome-positive lymphoblastic leukemia. A decision should be made in the second half.
- The companies inked their Iclusig commercialization partnership covering 10 Asian countries in December 2014.
Oct. 6, 2015, 1:14 PM
- The FDA designates Astex Pharmaceuticals (OTCPK:OTSKF) (OTCPK:OTSKY) investigational drug, guadecitabine (SGI-110) an Orphan Drug for the treatment of acute myeloid leukemia.
- Guadecitabine, currently in Stage 3 development, is a small molecule DNA hypomethylating agent administered via subcutaneous injection. It is designed to deliver longer exposure to its active compound, decitabine, compared to intravenous decitabine. The estimated completion date of the late-stage trial is December 2017.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
- Astex was acquired by Tokyo-based The Otsuka Group in October 2013.
Sep. 22, 2015, 12:32 PM
- Results from a Phase 2 clinical trial assessing Avanir Pharmaceuticals' (OTCPK:OTSKF) (OTCPK:OTSKY) investigational AVP-923 for the treatment of moderate-to-severe agitation in patients with Alzheimer's disease (AD) successfully demonstrated a significant treatment effect across various metrics. Patients receiving AVP-923 capsules twice per day for 10 weeks showed a statistically significant improvement in Neuropsychiatric Inventory (NPI), the primary efficacy endpoint, versus placebo (p<0.001). Statistically significant effects were also observed across the majority of secondary endpoints, including NPI total score, clinical global impression of change-agitation, patient global impression of change and measures of caregiver burden. Adverse effects, occurring in less than 10% of patients, were most commonly falls, diarrhea and urinary tract infections. The results were published today in the Journal of the American Medical Association (JAMA).
- Agitation, which encompasses behaviors such as shouting, cursing, hitting, kicking and pacing, is very common in AD patients. It is the main reason for transitioning them from home to residential care.
- AVP-923 is a combination of two well-characterized compounds, dextromethorphan hydrobromide, the active CNS ingredient, and quinidine sulfate, which increases the bioavailability of the other.
- Previously: Avanir presents AVP-923 Phase 2 data at neurology meeting (Oct. 13, 2014)
Sep. 22, 2015, 11:52 AM
- The FDA approves Lonsurf (trifluridine/tipiracil) for the treatment of patients with advanced colorectal cancer who no longer respond to other therapies.
- In a late-stage clinical trial, patients receiving Lonsurf lived an average of 7.1 months compared to 5.3 months for placebo. The average time to disease progression was two months for the Lonsurf cohort compared to 1.7 months for placebo. Side effects were numerous, including anemia, neutropenia (decrease in white blood cells), thrombocytopenia (decrease in blood platelets), weakness, extreme fatigue, nausea, decreased appetite, diarrhea, abdominal pain and fever.
- Lonsurf (formerly TAS-102) is made by Princeton, NJ-based Taiho Oncology, a subsidiary of Otsuka Holdings' (OTCPK:OTSKF) (OTCPK:OTSKY) Taiho Pharmaceutical.
Aug. 20, 2015, 3:49 PM
- The FDA's action date for its review of Alkermes' (ALKS -4%) New Drug Application (NDA) seeking approval for aripiprazole lauroxil for the treatment of schizophrenia is August 22. Since this is Saturday, an announcement from the agency should come tomorrow.
- Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and two-month formulations in development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, the active ingredient in Otsuka's (OTCPK:OTSKF) (OTCPK:OTSKY) ABILIFY, which is dosed daily. Alkermes' candidate is based on the company's proprietary LinkeRx technology which enables the compound to be released at a controlled rate over a specified length of time.
Jul. 30, 2015, 1:12 PM
- The FDA approves an expanded label for Otsuka America Pharmaceutical's (OTCPK:OTSKY) (OTCPK:OTSKF) antidepressant Abilify (aripiprazole) to include the new injection site of the deltoid (shoulder) muscle. Previously, the only approved site for intramuscular administration was the gluteal (rear end) muscle. Patients will, no doubt, be appreciative.
Jul. 11, 2015, 1:11 PM
- The FDA approves REXULTI (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and adults with schizophrenia. It will be available to patients in August.
- REXULTI, discovered by Otsuka (OTCPK:OTSKF) (OTCPK:OTSKY) and co-developed with Lundbeck (OTC:HLUKF) (OTCPK:HLUYY), will be co-marketed by the firms in the U.S. It is the successor product to Otsuka's top-selling Abilify (aripiprazole).
- MDD affects ~15M Americans while schizophrenia affects 2.4M.
May 27, 2015, 10:25 AM
- The European Commission approves Otsuka Pharmaceuticals' (OTCPK:OTSKY) (OTCPK:OTSKF) Jinarc (tolvaptan) for the treatment of adult patients with autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder that causes cysts to grow and proliferate in the kidneys. Complications include chronic and acute pain, hypertension and kidney failure. It affects ~200K Europeans.
- Jinarc is the first drug approved in the EU that treats the underlying pathophysiology of ADPKD. It decreases cyst cell proliferation and fluid secretion by blocking vasopressin from its V2 receptor. Vasopressin is a hormone that regulates the body's retention of water by increasing water reabsorption in the kidney's collecting ducts.
Feb. 27, 2015, 11:19 AM
- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Otsuka Pharmaceutical Co.'s (OTCPK:OTSKF) (OTCPK:OTSKY) Orphan Drug-designated Jinarc (tolvaptan) for the treatment of patients with autosomal dominant polycystic kidney disease (ADPKD).
- ADPKD is a chronic and progressive genetic disorder characterized by the growth of numerous cysts in both kidneys. The progressive expansion of the cysts slowly replaces the normal mass of the kidneys, reducing their function and leading to failure. It affects ~200K Europeans.
- In a Phase 3 trial, patients treated with tolvaptan showed a 49% reduction in the annual increase total kidney volume versus placebo and a reduction in the decline in kidney function by 30% compared to placebo.
- A final decision from the European Commission usually takes ~60 days. If approved, Jinarc will have a 10-year period of market exclusivity in the E.U. for this indication.
Dec. 2, 2014, 3:44 AM
- Deal values Avanir (NASDAQ:AVNR) at $3.5B.
- Otsuka (OTCPK:OTSKY) will launch a tender offer within ten business days to purchase all outstanding shares of Avanir and will end 20 days later.
- Expected to close in the first quarter of 2015.
- Management: "As we bring together Otsuka's experience and business track record in the area of mental illnesses with Avanir's strengths in neurologic diseases, we believe that we can evolve into a truly global CNS pharmaceutical company. Avanir's creativity and proven execution on drug discovery and development for largely unexplored medical indications, typified by PBA, represents a hand-in-glove fit with Otsuka's culture. We admire and respect Avanir's innovation, vision, and execution and want to continue to grow together."
- Avanir closed yesterday at $15.
- Previously: Avanir moves up on takeout speculation
- Previously: Avanir skyrockets premarket on trial results
Dec. 10, 2013, 9:33 AM
- Bristol-Myers Squibb (BMY) and Otsuka (OTSKF) announce four-year follow-up data from a Phase 3 study of Sprycel versus imatinib (NVS).
- At four years: MMRs in 76% of Sprycel patients and 63% of imatinib patients.
- 67% of Sprycel patients and 65% of imatinib patients remained on therapy.
- The companies say the results provide "further evidence of the sustained efficacy of Sprycel in the first-line [CML] setting." (PR)