Europe catches up to the US on public–private partnerships in 2012

Europe disclosed 4% fewer public–private partnerships (PPPs) than did the United States in 2012, compared with a 13% lag in 2011.

The lowdown: An annual assessment of the PPP landscape by SciBx showed a relative uptick in European activity last year (go.nature.com/o27TWu). Although US companies and institutions continue to lead in the PPP space, and were involved in nearly two-thirds of disclosed projects, European organizations narrowed the gap. The shift was driven by a nearly 60% increase in participation in PPPs by UK-based companies and institutions, as well as increased activity from the European Commission's Seventh Framework Program and Europe's Innovative Medicines Initiative (IMI).

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Figure 1

The report also analysed PPPs and early-stage venture financing (seed and series A financing) by therapeutic area, and showed the focuses were comparable from 2011 to 2012 (see figure). Infectious diseases, the second most active PPP area in 2011, swapped spots with diagnostics and pharmacogenetics, the third most active area in 2011. The report highlighted an ongoing disconnect between the proportion of infectious diseases PPPs disclosed each year (14% in 2012) versus financings of infectious disease companies (6% in 2012).

The report looked at 387 PPPs disclosed in 2012, versus 241 disclosed in 2011. It assessed US$960 million in seed and series A financings in 2012, down 25% from the $1.3 billion raised the previous year.

Lilly's tabalumab takes a tumble

Lilly stopped developing its anti-BAFF (B cell-activating factor) tabalumab for rheumatoid arthritis after the monoclonal antibody (mAb) failed in a key Phase III trial.

The lowdown: Based on the massive success of anti-tumour necrosis factor (TNF) drugs in inflammatory diseases in general and rheumatoid arthritis in particular, drug developers have poured hundreds of millions of dollars into the development of antagonists of the TNF superfamily (Nature Rev. Drug Discov. 12, 147–168; 2013). BAFF (also known as B lymphocyte stimulator; BLYS), a member of this superfamily, controls the responsiveness of T and B lymphocytes. But although anti-BAFF drugs succeeded with regulators in 2011, when the US Food and Drug Administration (FDA) approved Human Genome Sciences (HGS) and GlaxoSmithKline (GSK)'s belimumab for the treatment of systemic lupus erythematosus (SLE), progress in the broader rheumatoid arthritis indication has remained elusive. HGS and GSK did not advance belimumab into Phase III rheumatoid arthritis trials after it achieved only mild efficacy in Phase II testing.

In the latest setback, Lilly has stopped developing tabalumab for rheumatoid arthritis. Flags first went up in December when a planned interim futility analysis showed that the drug was unlikely to succeed in a Phase III trial of patients with moderate to severe rheumatoid arthritis and an inadequate response to methotrexate therapy. Last month, a second negative futility analysis in patients with moderate to severe rheumatoid arthritis and an inadequate response to at least one TNF antagonist prompted Lilly to discontinue the entire rheumatoid arthritis programme.

The mAb is still in two ongoing Phase III trials for SLE that are due to be completed next year. It is also in ongoing Phase II trials for multiple myeloma.

Leerink Swann analyst Seamus Fernandez and colleagues call the programme discontinuation “marginally disappointing”, noting that they expected only a limited contribution of revenue from rheumatoid arthritis, an already highly competitive space. They lowered sales expectations for tabalumab to around US$150 million by 2018; prior to the news, consensus sales expectations for the drug were around $350 million in 2018.

FDA issues pharmacogenomics guidance

New guidance lays out how drug developers should evaluate whether variations in the human genome could affect a drug's pharmacokinetics, pharmacodynamics, efficacy or safety.

The lowdown: The FDA's newly issued 26-page pharmacogenomics guidance, available at go.nature.com/gmCN1w, updates a 2011 draft guidance with “clarifying changes”, new content on when pharmacogenomics studies are warranted, and elaborations on targeted sample collection, sample retention, genotyping approaches, pooled analyses, dedicated prospective pharmacogenomics studies, genetic substudies and safety pharmacogenomics. Regulators from the FDA, the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently provided a multiregional regulatory overview of the various pharmacogenomics guidelines and the differences between regions (Nature Rev. Drug Discov. 12, 103–115; 2013).