Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

Pfizer has discontinued a Phase III trial evaluating Sutent (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer following disappointing results. According to a 

, the combination was “unlikely to improve overall survival” compared with prednisone alone. The full dataset are being analyzed and will be presented soon.

This isn’t the first setback that Sutent has seen; 

, the drug failed another late-stage trial for advanced colon cancer when it was deemed no more effective than standard chemotherapy. Further disappointments also followed when the drug failed trials for advanced breast cancer, lung cancer and advanced liver cancer.

Currently, the treatment is approved for both gastrointestinal stromal tumor after disease progression and advanced/metastatic renal cell carcinoma. Pfizer is also evaluating the drug’s potential for the adjuvant treatment of renal cell carcinoma in a Phase III trial.  

Shortly after issuing the statement regarding the drug’s latest failure, Pfizer also released an 

, which the company claims focuses on value and unmet medical needs. The development pipeline includes 118 programs from Phase I through registration, compared with 133 programs in its last pipeline update issued in January 2010. The latest pipeline reflects 25 programs that are new or that have advanced along the pipeline and 31 programs that have been discontinued since the last update. 

Articles

Pfizer has discontinued a Phase III trial evaluating Sutent (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer following disappointing results.

Pfizer scraps cancer clinical trial

An external review has cleared Elan Corp (Ireland) of any wrongdoing following “a number of matters” brought to the Board’s attention by some directors concerning corporate governance practices. The review, conducted by US law firm McKenna Long & Aldridge, found “no legal breaches or other wrongdoings of any nature” by Elan management, members of its Board of Directors or its advisors. According to a company 

, Elan’s Board of Directors has unanimously adopted the final report.

With it, the Elan Board has also accepted the report’s recommendations, including “considering the feasibility of voluntarily complying with US domestic reporting requirements notwithstanding Elan’s status as a foreign private issuer and adopting a US ‘best practices’ conflicts policy”. Elan added that the close of the investigation will bring “renewed” focus to the company.

Although the press statement provides no details about the matters investigated, a number of other sources (

) have been discussing the background of the case. The sources claim that two Directors on the Elan Board, Vaughn Bryson and Jack Schuler, had challenged the company over transparency issues and its corporate governance, and even initiated High Court Proceedings. Many of the sources also make reference to a 

 established by one of Elan’s shareholders, who is leading an investor-driven campaign to “bring accountability to the company’s Board of Directors”.

According to the Elan statement, Bryson and Schuler have “expressed their satisfaction with the outcome of the McKenna process” and have agreed to suspend the Irish High Court Proceedings. They will also resign from the Board within 90 days.

An external review has cleared Elan Corp (Ireland) of any wrongdoing following "a number of matters" brought to the Board?s attention by some directors concerning corporate governance practices.

Elan Management Cleared Of Wrongdoing

The EMA and the FDA have extended their confidentiality arrangements for human and veterinary medicinal products following the “positive experience” gained since the initial arrangements were signed in 2003. Previously, the arrangements had been renewed in 2005 until 2010, but the latest development will see the cooperation continue indefinitely without the need for further renewal, according to a 

The arrangements allow both agencies to exchange confidential information as part of their regulatory and scientific processes. The types of information covered relate to scientific advice, orphan drug designation, pediatric development, GMP and GCP, inspection planning and reports, marketing authorization procedures and subsequent changes to the marketing authorizations, together with post-marketing surveillance.

The types of medicines covered are those subject to evaluation or authorized under the centralized procedure, as well as medicines that are authorized at national level by EU member states and that are subject to official European Community arbitrations and referrals.

Cooperation between the two agencies has been increasing significantly during the past few years. Only last month, the agencies issued a 

 for candidates to take part in a joint GMP inspection pilot programme. In March, the agencies also 

 to accept a single orphan drug designation annual report.

The EMA and the FDA have extended their confidentiality arrangements for human and veterinary medicinal products following the "positive experience" gained since the initial arrangements were signed in 2003.

EMA and FDA extend confidentiality arrangements indefinitely

The European Medicines Agency (EMA) and the US Food and Drug Administration have 

 their confidentiality arrangements for human and veterinary medicinal products following the “positive experience” gained since the initial arrangements were signed in 2003. Previously, the arrangements had been renewed in 2005 until 2010, but the latest development will see the cooperation continue indefinitely without the need for further renewal, according to an EMA press statement. 

The arrangements allow both agencies to exchange confidential information as part of their regulatory and scientific processes. The types of information covered relate to scientific advice, orphan drug designation, pediatric development, good manufacturing practice (GMP) and good clinical practice, inspection planning and reports, marketing authorization procedures and subsequent changes to the marketing authorizations, together with post-marketing surveillance. 

The types of medicines covered are those subject to evaluation or authorized under the centralized procedure, as well as medicines that are authorized at a national level by EU member states and that are subject to official European Community arbitrations and referrals.

Cooperation between the two agencies has been increasing significantly during the past few years. Only last month, the agencies 

 for candidates to take part in a joint GMP inspection pilot program. In March, the agencies also 

 to accept a single orphan-drug designation annual report.


The European Medicines Agency (EMA) and the US Food and Drug Administration have extended their confidentiality arrangements for human and veterinary medicinal products.

EMA and FDA Extend Confidentiality Arrangements Indefinitely

The European Medicines Agency (EMA) has discussed the possibility of a global framework for clinical trials at an international workshop, given the fact that the majority of clinical trials for medicines approved in Europe are conducted outside of the EMA’s regulatory reach.

“Wherever in the world we stand, the majority of clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in different cultural settings. However, we all rely on the same trials to make decisions,” Fergus Sweeney, Head of Inspections at the EMA, explained in a

According to the EMA, only 38.8% of patients enrolled in pivotal clinical trials between 2005 and 2009 received their treatments in the EU and the EEA. These trials involved more than 44000 clinical trial sites in 89 countries, with the data being used to support almost 350 EMA marketing authorizations.

The workshop was held to discuss views on the EMA’s draft reflection paper on “ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorization applications to the EMA”. The reflection paper sets out a number of recommendations, and considers that EU regulators should only expect/require studies in support of an EU marketing authorization application that would also be ethically acceptable in the EU. “There should not be a different standard applied to trials conducted in the EU compared to those conducted elsewhere,” said the statement.

The workshop highlighted three main needs in order to meet the reality of safe, global clinical trials:

cooperation and networking between regulatory authorities and ethics committees involved in supervising clinical trials

greater transparency of clinical trials, including patient registers and the provision of information about ethical and good clinical practice aspects

involve patients early on in trial design to ensure adequate protection.

“What is needed is a robust framework for the oversight and conduct of clinical trials, no matter where in the world the clinical investigator’s sites are located and patients recruited. The Agency is committed to build and extend its relationship with regulators in all parts of the world and with international organisations to work to standards agreed and recognised by all,” said Thomas Lönngren, Executive Director of the EMA.

Consultation on the reflection paper is open until 30 September 2010. Comments should be sent to 

The European Medicines Agency (EMA) has discussed the possibility of a global framework for clinical trials at an international workshop, given the fact that the majority of clinical trials for medicines approved in Europe are conducted outside of the EMA's regulatory reach.

EMA recommends global trials framework

The European Commission (EC) has issued a last call for 

 (Registration, Evaluation, Authorisation and restriction of Chemicals) registration; a European Union (EU) initiative targeting companies that import or produce chemicals, which will ultimately impact a number of industries, including pharmaceuticals. The deadline for registration of the most widely used or most dangerous chemicals is 30 November this year.

, the EC reminded users of chemicals (which includes pharma companies) that they will also be affected by REACH because they depend on the availability of substances on the market. Any non-registered substances manufactured or placed on the market after the November deadline will be illegal. The registration process will also generate manufacturers and importers’ recommendations for the safe use of chemical substances, which will be passed on in the supply chain.

“Our chemical industry needs to be sustainable. Therefore, we appeal to all companies concerned to submit their dossiers in time and in full,” Antonio Tajani and Janez Potočnik from the EC explained in a 

. “These demands on companies are tough but they are also an investment that will pay off by fostering the leading role of Europe’s chemical industry.”

According to the EC, one of the main reasons for developing and adopting REACH is that there is insufficient information on a great number of chemicals, which are often imported into Europe in large amounts, and the hazards they pose to human health and the environment. “REACH aims to ensure that the risks from substances of very high concern are properly controlled, and to progressively replace these substances where there are suitable alternatives,” says the EC.

Companies submitting REACH dossiers have first had to gather data about the environmental and health properties of their chemical, and then share such data with other companies that produce or import the same substance using the 

  (SIEFs). As of 10 September 2010, about 4000 dossiers had been submitted to the European Chemicals Agency, and the rate is increasingly very rapidly, according to the EC.

REACH came into force in June 2007 and the November deadline marks an important milestone in the phasing-in process. The upcoming deadline will apply for:

substances produced or imported in volumes of 1000 tonnes* per year or more

substances that are carcinogenic, mutagenic or toxic to reproduction and produced or imported in volumes of 1 tonne per year or more

substances that are very toxic to the aquatic environment and produced or imported in volumes of 100 tonnes per year or more.

For other substances, the deadlines for registration are 2013 and 2018. More information about this is available on the 

*Note: 1 tonne is equal to a metric ton, or 2205 lb.

The European Commission has issued a last call for REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) registration; an EU initiative targeting companies that import or produce chemicals, which will ultimately impact a number of industries, including pharmaceuticals.