Archive for January, 2014

NICE recommends wider access to Astellas’ Xtandi

Posted on January 28th, 2014 by Valorem Life Sciences

Cost regulators for NHS treatments in England and Wales have opened a second consultation on the use of Astellas’ Xtandi (enzalutamide) in patients with prostate cancer, after widening the drug’s target population. The National Institute for Health and Care Excellence (NICE) has this morning (Tuesday) issued new draft guidance endorsing the use of Xtandi in adult patients with hormone relapsed metastatic prostate cancer.

The drug has a different mechanism of action from other anti androgens on the market; it works by blocking the binding of androgens to androgen receptors, prevents activated androgen receptors from migrating to the nucleus, and blocks the interaction of the activated androgen receptor with DNA in the nucleus to help prevent the spread of the disease. As it stands, NICE is advising that the drug is used in patients only when their disease has progressed during or after a docetaxel-containing chemotherapy regimen and they have not been treated with Johnson’s & Johnson’s prostate cancer drug Zytiga (abiraterone).

This marks a change from first draft guidance published last October, which specified that Xtandi should only be used for people whose disease has progressed during or after one docetaxel-containing chemotherapy, and not any number of such regimens, a limitation which has now been removed thus widening the drug’s potential scope.

Source: Pharma Times

Merck & Co stock climbs on melanoma and blood drugs

Posted on January 14th, 2014 by Valorem Life Sciences

Shares of Merck & Co have shot up on the back of an earlier-than-expected filing its much-touted investigational melanoma drug, positive news on its heart drug vorapaxar and confirmation that it is exploring options for its animal health and consumer care businesses.

Firstly, the US drugs giant has started a rolling submission to the US Food and Drug Administration for MK-3475 (lambrolizumab), its anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with Bristol-Myers Squibb’s Yervoy (ipilimumab). A rolling submission allows completed portions of the application to be filed and reviewed by the FDA on an ongoing basis and the company expects to complete the application in the first half of 2014.

MK-3475 is currently being studied in three trials for advanced melanoma including a Phase III study versus Yervoy. The drug received breakthrough therapy designation from the FDA last April and Merck believes it could be a major growth-driver.

Source: Pharma Times

AZ expands cancer pipeline with Probiodrug pact

Posted on January 7th, 2014 by Valorem Life Sciences

AstraZeneca has acquired a cyclin-dependent kinase 9 inhibitor programme, targeting cancer and inflammatory diseases, from Germany’s Probiodrug.

The deal will see the Anglo-Swedish drugmaker get hold of a lead molecule and back-up compounds, plus associated intellectual property. Susan Galbraith, head of the oncology iMed unit at AstraZeneca, added that “we are particularly interested in the development of targeted therapies [and] we believe that Probiodrug’s CDK9 inhibitor programme, while early stage, shows potential and we look forward to continuing its development”.

Hendrik Liebers, chief financial officer at privately-owned Probiodrug, said AstraZeneca is “an excellent party to take over” the CDK9 inhibitor programme. He added that the transaction, the financial details for which have not been disclosed, “is consistent with our strategy to focus our resources exclusively on Alzheimer’s disease.”

Source: Pharma Times