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Dainippon Sumitomo Pharma Co., Ltd (DSP) has reached an agreement to acquire Boston Biomedical Inc. DSP will make an upfront payment of $200 million to the shareholders of BBI on closing of the acquisition of its shares, and afterwards it will make development milestone payments up to $540 million related to BBI’s compounds (BBI608 and BBI503) currently under development. DSP will also make milestone payments up to $1.89 billion based on the achievement of various net sales targets with the last milestone being paid upon net sales of greater than $4 billion in any fiscal year. DSP aims to commercialise BBI608 and BBI503 in 2015 or later.
BBI is a biotechnology company focused on oncology. Its pipeline
H. Lundbeck A/S has presented the results of its clinical Phase 3 programme on Selincro (nalmefene), an investigational compound for the treatment of alcohol dependence. They include results from three placebo-controlled clinical Phase 3 studies supporting the efficacy and tolerability of Selincro in reducing alcohol consumption in patients with alcohol
dependence. All studies were multi-centre, randomised, double-blind, placebo-controlled, parallel group studies of 18 mg Selincro taken as needed in patients with alcohol dependence
products BBI608 and BBI503 are small-molecule oral drugs with the purpose of cause an anti- tumour effect in cancer stem cells. Anti-cancer drugs targeting cancer stem cells have potential as potent cancer therapies because they are considered to be effective against refractory, recurrent and metastatic cases, the main challenges in current cancer treatment. BBI608 is currently in the preparatory stage for a Phase 3 clinical trial for colorectal cancer in North America and is in Phase 1b and 2 clinical trials for various solid tumours. BBI503 is in a Phase 1 clinical trial for patients with various advanced solid tumours in North America.
DSP signed an exclusive Product Option Licence agreement with BBI in March,
according to DSM-IV criteria. In all studies a wide range of secondary endpoints were assessed, including the proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function, other laboratory tests and pharmaco- economic outcomes.
In the ESENSE 1 and ESENSE 2 trials, Selincro was superior to placebo in reducing the number of heavy drinking days (HDDs) and total alcohol consumption (TAC). In the SENSE trial, Selincro was more efficacious than placebo in reducing the number
EU approval for Roche skin cancer drug
The European Commission has approved Roche’s Zelboraf (vemurafenib) as a monotherapy for the treatment of adults with BRAF V600 mutation-positive unresectable or metastatic melanoma, the most aggressive form of skin cancer. Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma.
Roche stated that in pivotal 12 sp2 Inter-Active March/April 2012
clinical trials, Zelboraf was the only treatment to benefit patient survival in both previously untreated and previously treated people with advanced melanoma who tested positive for BRAF V600 mutations using the company’s cobas 4800 BRAF V600 Mutation Test.
In 2011, Zelboraf became the first and only FDA-approved personalised medicine that is shown to improve survival for
2011 for development and commercialisation rights for BBI608 in Japan for all indications of cancer. In its second Mid-term Business Plan, DSP is aiming to expand its pipeline for continuous new drug creation to provide innovative drugs for the areas of cancer and immune-related diseases, among others, and the acquisition of BBI is in support of that strategy.
After the acquisition, BBI will become a wholly owned subsidiary of DSP and continue its operations in the Boston, Massachusetts area. BBI holds exclusive rights for BBI608 and BBI503 in Japan and North America.
The boards of directors of both companies have approved the acquisition, which is expected to close in April.
Lundbeck presents promising Phase 3 results for alcohol dependency treatment
of HDDs and TAC at the majority of the time points and at the end of the study. Selincro is an opioid system modulator and its modulating effect on the cortico- mesolimbic system is thought to reduce the reinforcing effects of alcohol, helping the patient to reduce drinking. Lundbeck licensed the rights to Selincro from Finnish company Biotie Therapeutics Corporation. In total, Biotie is eligible for up to €84 million in upfront and milestone payments plus royalty on sales. Lundbeck will be responsible for manufacturing and registration of the product.
people with this melanoma. The cobas 4800 BRAF V600 Mutation Test, a diagnostic test co- developed by Roche to identify patients eligible for treatment, was approved simultaneously with Zelboraf in the USA, and is CE-marked and commercially available in the EU.
Zelboraf has also recently been approved in Switzerland, Brazil, Israel, Canada and New Zealand and marketing authorisation submissions are currently under review in other countries.
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