B-MS gets approval for two sNDAs and an analyst upgrade
Bristol-Myers Squibb and partner Otsuka Pharmaceutical of Japan have been boosted by a new approval from US regulators for their schizophrenia drug Abilify.The US Food and Drug Administration has given the green light to the firms’ supplemental New Drug Application for Abilify (aripiprazole) as adjunctive treatment to antidepressant therapy for adults who are suffering from major depressive disorder. It is the first medication approved by the agency as an add-on treatment for MDD.The approval is based on two six-week studies of 743 patients, both of which demonstrated significant improvement in depressive symptoms in patients experienced an inadequate response to monotherapy with one or more antidepressants in the current episode and then added Abilify to their treatment regimens.
Merck halts trials of leukaemia drug over heart safety issue
Merck & Co has told partner Vertex Pharmaceuticals that it has halted enrolment in clinical trials of the firms’ investigational drug for leukaemia over a cardiovascular safety issue in one patient.The companies said they suspended studies involving MK-0457, which is also known as VX-680, “pending a full analysis of efficacy and safety data” after preliminary findings revealed that one patient experienced QTc prolongation, an irregularity of the electrical activity of the heart that places patients at risk for ventricular arrhythmias. MK-0457 is the lead drug in Vertex and Merck’s collaboration to develop Aurora kinase inhibitors. It is being investigated in a Phase II trial in patients with treatment-resistant chronic myelogenous leukaemia, or Philadelphia chromosome-positive acute lymphoblastic leukaemia containing the T315I mutation, as well as an ongoing Phase I study in patients with advanced leukaemias.
Novartis withdraws application for new Zometa use in EU
Switzerland’s Novartis has pulled its application to extend the use of Zometa in Europe , says the continent’s regulator.The European Medicines Agency noted that it has been formally notified by Novartis Pharma AG of its decision to withdraw the application to extend the marketing authorisation to include a new indication for Zometa (zoledronic acid), which was approved in March 2001 for the prevention of advanced bone cancer, as well as for the treatment of tumour-induced hypercalcaemia. Last December, the company applied to extend the use to include preventing fractures and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.
Schering-Plough completes acquisition of Organon from Akzo
Schering-Plough has completed its 11 billion-euro acquisition of Organon BioSciences from the Dutch firm Akzo Nobel, some eight months after the deal was announced.The US firm has been able to sign off the purchase having received approval for the transaction earlier this week from the US Federal Trade Commission. The deal was given the green light by the European Commission in October and for its money S-P also gets Intervet, an animal health business, Nobilon, a human vaccine development unit, and Diosynth, a third-party manufacturing operation.
Germany and UK take Novartis’ Prexige off the market
Novartis’ problems with its COX-2 inhibitor Prexige took a turn for the worse yesterday, when regulators in the UK and Germany suspended marketing licences on safety concerns about the drug, following in the footsteps of Australia , Turkey and Canada .The Medicines and Healthcare products Regulatory Agency says it has informed health professionals in the UK to stop prescribing Prexige (lumiracoxib) for osteoarthritic pain on fears of possible liver damage, following a review by the Commission on Human Medicines which showed an increase in serious liver reactions occurring with the licensed 100mg dose which, in some cases, developed in under a month.
Altana integration nearly complete as Nycomed profits climb
Nycomed, which is now ensconced in its new headquarters in Zurich , Switzerland , has posted a strong set of results for the first nine months of the year, boosted by the contribution of Altana Pharma which it acquired last December for 4.22 billion euros.Turnover increased 4.9% to 873.5 million euros, driven by an 11.4% increase in sales of the gastrointestinal drug pantoprazole. Nycomed’s adjusted earnings before interest, taxes, depreciation and amortisation reached 940.8 million euros, an increase of 29.4% over the same period in 2006, helped by reduced expenses, “more efficient cost control as well as the fast and largely completed integration of Altana”, the company added. Back to the products and pantoprazole sold well in the USA and Germany but parallel imports hit sales from the UK and the Netherlands . Geographically, some of the Scandinavian markets, except Norway , were under significant pressure from generic competition, the privately-owned company said, while Russia , Argentina , Brazil , Canada , Mexico and South Africa all performed well.
Roche’s Avastin recommended for approval for kidney cancer
Roche has moved a giant step closer to getting a fourth approval for Avastin after receiving a recommendation in Europe to market the drug as a treatment for advanced kidney cancer. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Avastin (bevacizumab) for the first-line treatment of patients with renal cell carcinoma (RCC), the most common form of advanced kidney cancer. The recommendation is based on data from the Phase III AVOREN trial, which showed that adding Avastin to interferon gave patients with advanced RCC the chance to live twice as long without their disease progressing.
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FDA gives go-ahead to Bayer’s Nexavar for liver cancer
Bayer and partner Onyx Pharmaceuticals are celebrating again following the news that the firm’s Nexavar has received the blessing of US regulators as a treatment for liver cancer.The US Food and Drug Administration has approved a supplemental New Drug Application for Nexavar (sorafenib) for the treatment of patients with unresectable hepatocellular carcinoma. The only therapy shown to significantly improve overall survival in patients with liver cancer, it was approved in Europe for the treatment of HCC last month. Nexavar first hit the market in 2005 when it became the first new drug in more than a decade for advanced kidney cancer and it is currently approved in more than 60 countries for that indication