Taking another look at alliance failure rates

We take a fresh look at the issue of the expect rate of failure of strategic alliances here.

Cancer collaboration between Eisai and Anaeropharma Science

On September 29 2010 Eisai Co Ltd and Shinshu University venture company Anaeropharma Science Inc concluded an option agreement concerning APS001, a novel anticancer agent currently under development at Anaeropharma Science that utilises characteristic features of Bifidobacterium longum, as well as an agreement concerning the discovery of novel anticancer agents that utilise Bifidobacterium as a drug delivery system. The two contracts cover the development of drugs that utilise obligate anaerobes and nonpathogenic bacteria, traits which are characteristic of Bifidobacterium, a human intestinal tract bacterium.

Under the terms of the agreement, Eisai acquires the right of first review concerning the results of the Phase I clinical trials for the novel anticancer agent APS001, which are scheduled to be conducted in the United States by Anaeropharma Science, and the right of first refusal concerning the licensing of the compound under development. Eisai shall compensate Anaeropharma Science for these two priority rights.

The two companies shall also conduct joint research regarding specific substances in order to discover novel anticancer agent candidates that utilise Bifidobacterium as a drug delivery system. Eisai shall bear the research expenses for the joint research and shall acquire the right of first refusal regarding the exclusive licensing necessary for commercialisation based on the results of this joint research. Furthermore, regarding research that is not covered by this agreement, the agreement shall not constrain any research into delivery systems using Bifidobacterium that Anaeropharma Science conducts independently.

Galapagos and Chiesi expand collaboration

On October 14 2010 Galapagos NV announced that its BioFocus service division has expanded a collaboration with Chiesi Farmaceutici, a privately held Italian pharmaceutical company. The total value for the collaboration with Chiesi has now reached €2.5 million.

BioFocus and Chiesi began their collaboration in December 2009 and recently extended it for one year. Under the terms of the extended collaboration agreement, BioFocus will provide medicinal chemistry and biology services, with an additional option for ADME services, for an undisclosed Chiesi therapeutic programme.

FDA approves Bio-Rad and Axis-Shield’s test for rheumatoid arthritis

In October 2010 the U.S. Food and Drug Administration approved for licensing Bio-Rad’s BioPlex® 2200 Anti-CCP test for the early detection of rheumatoid arthritis. The test was developed through a collaboration between Bio-Rad Laboratories Inc and Axis-Shield plc.

The assay, which runs on Bio-Rad’s BioPlex® 2200 system, measures anti-CCP (anti-cyclic citrullinated peptide antibodies), a novel marker shown to have specificity in the diagnosis of rheumatoid arthritis. The BioPlex 2200 Anti-CCP assay is based on Axis-Shield’s proprietary anti-CCP technology and was launched in territories outside the U.S. earlier in 2010.

Partnership between Fate Therapeutics and Becton, Dickinson and Company

On October 14 2010 Fate Therapeutics Inc entered a collaboration and license agreement with BD (Becton, Dickinson and Company) for the joint development and worldwide commercialization of induced pluripotent stem cell (iPSC) tools and technologies for drug discovery and development.

Under the three-year collaboration, Fate and BD will endeavor to co-develop certain stem cell products using Fate’s iPSC technology platform, and BD will commercialise these stem cell products on a worldwide basis. The goal of the collaboration is to provide life science researchers and the pharmaceutical community with reliable access to advanced iPSC tools and technologies for use in human disease research, drug discovery and development, and the manufacture of cell-based therapies.

Collaboration between GE Healthcare and Hamilton Robotics

On October 15 2010 GE Healthcare and Hamilton Robotics entered into a licensing and collaboration agreement to develop a fully automated workflow for sample handling and processing from FTA® substrates. Financial terms were not disclosed.

BMS and AstraZeneca announce positive trial results for dapagliflozin

On September 24 2010 Bristol-Myers Squibb Company and AstraZeneca announced positive results from a randomized, double-blind Phase 3 clinical study for their collaborative drug dapagliflozin aimed at treating adults with type 2 diabetes. The two companies entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.

The Phase 3 study demonstrated dapagliflozin was non-inferior compared to glipizide (sulphonylurea) in improving glycosylated hemoglobin levels (HbA1c) when added to existing metformin therapy during a 52-week treatment period. The study also demonstrated that dapagliflozin plus metformin achieved significant reductions in key efficacy secondary endpoints: reduction in total body weight from baseline, compared with a weight gain on glipizide plus metformin therapy and a reduced number of patients reporting one or more hypoglycemic events. Overall, the frequencies of adverse events, serious adverse events and study discontinuations were comparable across the two treatment groups; although signs, symptoms and other reports suggestive of urinary tract or genital infections were more common in dapagliflozin treated subjects.

Dapagliflozin, an investigational compound, is a first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor and is currently in Phase 3 trials under joint development by Bristol-Myers Squibb and AstraZeneca as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes. SGLT2 inhibitors, which act independently of insulin mechanisms, facilitate the excretion of glucose and associated calories in the urine, thereby lowering blood glucose levels.

AstraZeneca and Rigel’s drug improves outcome for rheumatoid arthritis

On September 23 2010 AstraZeneca announced in an article in the New England Journal of Medicine that a new oral syk inhibitor, fostamatinib (R788), it in-licensed from Rigel Pharmaceuticals Inc in February 2010 significantly improved outcomes of patients with rheumatoid arthritis who responded inadequately to ongoing treatment with methotrexate (MTX). The results come from a phase II study. AstraZeneca plans to commence the phase III clinical trial programme for fostamatinib shortly.

Under the original worldwide licensing agreement AstraZeneca and Rigel Pharmaceuticals AstraZeneca is to develop and commercialise fostamatinib.

Positive phase 2 results for GlaxoSmithKline and Theravance drug

On September 22 2010 GlaxoSmithKline and Theravance announced positive results from a Phase II safety and efficacy study for developmental combination treatment Relovair in chronic obstructive pulmonary disorder (COPD). Relovair is an investigational drug which combines fluticasone furoate (an inhaled corticosteroid or ICS) and vilanterol trifenatate (a newly developed long-acting beta agonist or LABA) in a once-daily treatment for patients with COPD or asthma.

The Phase 2 combination study is part of an ongoing collaboration between the two companies which includes the Phase III programmes in both COPD and asthma, which are already underway for Relovair and its components.

Dendreon inks supply deal with GlaxoSmithKline

On September 21 2010 Dendreon Corporation signed a development and supply agreement with GlaxoSmithKline for its novel prostate cancer vaccine, alleviating investors’ concerns about the biotech firm’s ability to provide an adequate supply of the vaccine.The initial order is worth US$8.3 million.