Development

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The hormone testosterone stimulates the growth of prostate cancer cells. Abiraterone acetate is an orally active inhibitor of the steroidal enzyme complex 17 (hydroxylase/C17,20 lyase)which is involved in testosterone production.

In May 2011, the US Food and Drug Administration approved ZYTIGA^™ (abiraterone acetate) for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

In September 2011, Janssen-Cilag International NV announced that the European Commission approved ZYTIGA^™ (abiraterone acetate), in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

Additional ongoing studies are currently underway for abiraterone acetate including patient enrolment into a Phase I/II trial of abiraterone acetate in patients with advanced breast cancer.

J & J acquired Cougar Biotechnology Inc. in July 2009.

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Alemtuzumab is a monoclonal antibody which binds to the CD52 antigen, which is present on the surface of B and T lymphocytes and other cells.

Alemtuzumab is approved as a single agent for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL) and marketed under the name Campath^®. It is also in late-stage clinical development for multiple sclerosis and the programme has been granted Fast Track status by the FDA.

In July 2011, Genzyme announced positive top-line results from CARE-MS I, the first of two randomized, Phase III clinical trials comparing alemtuzumab to the approved multiple sclerosis therapy Rebif^® (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (RRMS). In the CARE-MS I trial, 2 annual cycles of alemtuzumab treatment resulted in a 55 percent reduction in relapse rate compared to Rebif^® over the two years of the study (p<0.0001), hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success.  Statistical significance was not achieved for the second primary endpoint, time to six month sustained accumulation of disability, as compared to Rebif^®. At the two year time point, 8 percent of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) as compared to 11 percent of those who received Rebif^® (Hazard Ratio=0.70, p=0.22).

In November 2011, Genzyme announced that the Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab (LEMTRADA^™) as compared with Rebif^® (44 mcg subcutaneous interferon beta-1a). CARE-MS II is the randomized Phase III clinical trial comparing the investigational drug alemtuzumab to interferon beta-1a in patients with relapsing-remitting multiple sclerosis (RRMS). Patients were required to have experienced a relapse while on a prior therapy to be eligible for CARE-MS II.

Following these Phase III results Genzyme is planning to file alemtuzumab with regulatory authorities in the US and Europe in early 2012.

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AZD9773 (tumour necrosis factor alpha (TNF-α) immune fab (ovine)) is a polyclonal antibody fragment (Fab) which neutralises TNF-α; an inflammatory mediator strongly implicated in sepsis.

Sepsis is an inflammatory condition, resulting from uncontrolled infection. As the condition progresses, patients require intensive care as their organs fail and the situation becomes life-threatening. With a staggering 30% mortality rate, up to three million lives a year are threatened by sepsis worldwide. Current treatment options for patients are extremely limited and there are very few products in late stage development.

AZD9773 is a first-in-class anti-TNF-alpha polyclonal antibody fragment (Fab) product. A multicentre, randomised, double-blind, placebo controlled Phase IIb trial in 300 patients is currently underway which will evaluate the efficacy of two intravenous dosing regimens of AZD9773. The primary outcome measure will be the number of ventilator-free days over 28 days following first dose. Secondary outcome measures include 7 and 28 day patient mortality and characterisation of the safety and tolerability of AZD9773. This Phase IIb study follows successful completion of a 74-patient Phase IIa study by AstraZeneca in 2009. In a previous Phase II clinical study in 81 patients with severe sepsis, D-CytoFab, a closely related product to AZD9773, was well tolerated and significantly reduced the number of days patients spent on a ventilator and in the intensive care unit compared with patients on placebo.

AZD9773 is licensed to AstraZeneca, who are responsible for the global development and commercialisation of the product with BTG responsible for the manufacture and supply, including current clinical trial supplies. The agreement has a potential total deal value, excluding royalties, of approximately £195 million. BTG (at the time Protherics) received an initial payment of £16.3 million and a £7.5 million equity investment by AstraZeneca, and will receive additional payments worth up to £171 million payable upon the achievement of milestones.

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Otelixizumab is a humanised monoclonal antibody that binds to the CD3 receptors on T cells and is designed to block the function of autoreactive T-effector cells that attack the body and cause autoimmune diseases. In October 2007, Tolerx and GSK established a worldwide alliance to develop and commercialize otelixizumab for a range of autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes and rheumatoid arthritis.

Tolerx, Inc., announced in March 2011that the first pivotal Phase III study of otelixizumab for type 1 diabetes, DEFEND-1, did not meet the primary efficacy endpoint. Recruitment in a second pivotal Phase III trial, DEFEND-2, has been temporarily halted.

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ABIO-0801 is in development for anxiety.

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Therapeutic formulation of the sugar mannose-6-phosphate designed for injection into newly formed wounds to promote healing with reduced scarring.

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Acadra^™ (acadesine) is a nucleoside analogue in development for the treatment of B-cell Chronic Lymphocytic Leukaemia (B-CLL) and it is designed to induce cell death in B-cells with little effect on T-cells.

In November 2009, BTG licensed its exclusive worldwide rights for acadesine back to Advancell S.A., in exchange for an undisclosed potential future milestone payment and a royalty on any future sales.

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Nexvax2 is a peptide-based vaccine in development to treat or prevent Coeliac disease. Coeliac disease is a life-long immune intolerance to specific components of wheat, rye, barley and oat gluten proteins.

Product Information

ONX 0801 is a novel thymidylate synthase (TS) inhibitor designed to work by combining two proven approaches to improving outcomes for cancer patients. These include receptor-mediated targeting of tumour cells and inhibition of thymidylate synthase, a key enzyme involved in cell growth and division.

Onyx initiated a Phase I clinical study of ONX 0801 in September 2009, the approval of which triggered a $7 million milestone payment to BTG.