First-in-class osteoporosis drug approved

The European Medicines Agency and the US FDA have both approved denosumab (Prolia; Amgen), a human monoclonal antibody for the treatment of bone disorders that is widely anticipated to be a blockbuster.

The lowdown: Denosumab, which modulates bone resorption by osteoclasts by blocking receptor activator of nuclear factor-κB ligand (RANKL), recently became the first drug that targets bone loss through a new mechanism of action to be approved since 2002. On 28 May, the European Commission granted marketing authorization for denosumab for two of the three indications for which Amgen had applied: treatment of post-menopausal osteoporosis (PMO) and treatment of bone loss in patients undergoing hormone ablation for prostate cancer (making it the first approved therapy for this indication), but did not approve the drug for an analogous indication in patients with breast cancer. Shortly after, on 1 June, the FDA approved denosumab for the treatment of PMO in women at increased risk of fractures or in those who have failed or are intolerant to other available osteoporosis therapies.

In the United States, Amgen had originally submitted a biologic license application (BLA) for denosumab to the FDA in December 2008, applying for its use in six indications: treatment and prevention of PMO, and treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer. In August 2009, an FDA advisory committee backed approval for two of the treatment indications — for bone loss in PMO and in patients with prostate cancer — but voted against the use of denosumab in patients with breast cancer, as well as in the three prevention indications (Nature Rev. Drug Discov. 8, 757–758; 2009). Following the committee meeting, Amgen received a complete response letter from the FDA that included requests for a new clinical programme for the prevention of PMO, updated safety data, and a risk evaluation and mitigation strategy. Amgen submitted further information for the PMO treatment indication in January this year, which was approved by the FDA ahead of the 25 July Prescription Drug User Fee Act date, and data related to other indications continues to be generated. A BLA for the use of denosumab to reduce skeletal-related events in cancer patients was submitted on 14 May 2010.

Failed Alzheimer's clinical trial data made public

The Coalition Against Major Diseases (CAMD), led by the FDA's Critical Path Institute, has released a new database that contains data on 4,000 patients with Alzheimer's disease who have participated in 11 failed industry-sponsored clinical trials.

The lowdown: Currently, there are no marketed drugs that have been proven to halt or prevent Alzheimer's disease, and many efforts to develop disease-modifying drugs have failed. To help address this, seven pharmaceutical companies have contributed data from failed trials of investigational Alzheimer's disease drugs to the CAMD, which has now been made available to qualified researchers. The Coalition hopes that by giving researchers access to this data they will be able to more accurately predict the true course of the disease and subsequently to design more efficient clinical trials. The CAMD has already developed a quantitative disease model of the natural progression of Alzheimer's disease using data from the Alzheimer's Disease Neuroimaging Initiative. They are now testing and improving this model with this larger regulatory-standard database, and plan to submit the model to the FDA and the European Medicines Agency for review later this year.

The CAMD is a public–private partnership of 12 pharmaceutical companies, 7 patient advocacy and voluntary health associations, and government research and regulatory agencies. It was launched in 2008 to create methods that could help identify patients with neurodegenerative diseases before symptoms are apparent and to develop tools, such as novel drugs, to prevent or slow disease progression. It is hoped that trial data on other neurodegenerative disorders, such as Huntingdon's disease and Parkinson's disease, will be voluntarily added to the new database.

Merck launches collaborative oncology trial network

In June, Merck announced the launch of the Merck Oncology Collaborative Trials Network to address deficiencies in trials of cancer therapies.

The lowdown: In the wake of a recent report from the US Institute of Medicine on the National Cancer Institute's Clinical Trials Cooperative Group Program, which noted that almost half of collaborative cancer studies are never completed owing to issues such as poor coordination and bureaucracy, Merck announced their own network to improve their approach to collaborative clinical research of anticancer drugs.

Currently, the network consists of 15 sites from North America, South America, Europe and Asia — including institutes such as The University of Texas MD Anderson Cancer Center in Houston, USA, and the National Cancer Institute of Brazil in Rio de Janeiro — and is anticipated to enrol ∼1,200 patients in 30–40 clinical trials (from Phase 0 to Phase IIa) of Merck's investigational oncology therapies each year. The network aims to accelerate research of the latest clinical hypotheses by developing the infrastructure to facilitate rapid implementation and decision-making for industry- and investigator-initiated trials conducted at the participating centres.

Abbott's billion dollar deal for branded generics

Abbott will become a leader in the Indian branded generics market by acquiring Piramal's Healthcare Solutions business for an upfront payment of US$2.1 billion, plus $400 million annually for the next 4 years.

The lowdown: For Abbott, the acquisition of Piramal's Healthcare Solutions business is the latest deal that aims to strengthen their position in the branded generics market. Piramal's Healthcare Solutions will become part of Abbott's newly created Established Products Division, which will focus on expanding the global markets for its branded generics portfolio. This also includes the branded generics that Abbott gained when it completed its $6.2 billion acquisition of Solvay Pharmaceuticals in February 2010.

Abbott is not the only pharmaceutical company that has been expanding its branded generics portfolio recently. For example, GlaxoSmithKline partnered with Dr Reddy's Laboratories in June 2009 to develop and market selected branded generics across an extensive number of emerging markets (Nature Rev. Drug Discov. 9, 417–420; 2010). And in May this year, Sanofi–Aventis announced a joint venture with the Japanese company Nichi-Iko Pharmaceutical to capture some of the growth in generic-drug use in Japan.