UK charity sues UCB for patent breach

Tuesday, August 17th, 2010

A UK charitable trust is taking Cimzia’s manufacturer UCB to court for promoting the drug in combination with methotrexate.

The Mathilda and Terence Kennedy Institute of Rheumatology Trust filed the case against Belgian company UCB for infringing its 2001 patent on combining drugs like Cimzia with methotrexate.

The trust’s patent relates to treating arthritis by co-administering methotrexate and drugs that block receptors to an inflammation-causing protein called tumor necrosis factor alpha (anti-TNFa), such as Cimzia.

Amgen and Wyeth were sued by the trust for infringing the same patent with their arthritis drug Enbrel last year. The case was withdrawn, but the lawsuit for the current case claims that Amgen and Wyeth, as well as Abbott Laboratories and Centocor, have paid “tens of millions of dollars” to the trust in loyalties.

Cimzia is one of UCB’s three key hopes for growth after patents expire on some of its big-selling drugs. The company has said annual Cimzia sales could top €1.5 billion in the coming years.

The lawsuit, demanding royalties and damages from UCB, was filed earlier this month in US federal court in Delaware.

The Mathilda and Terence Kennedy Institute of Rheumatology Trust (the KIR Trust) was founded in 1965/66 and was the first research institute dedicated to Rheumatology.

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Amgen reveals ‘disappointing’ Vectibix results

Monday, August 16th, 2010

Amgen has concluded trials into Vectibix (panitumumab) for head and neck cancer after the drug failed to meet its primary endpoint.

The company has revealed top-line results from a Phase 3 trial evaluating Vectibix as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer which showed that Vectibix did not improve overall survival in.

The data showed that the drug’s addition to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival compared to chemotherapy alone (median 11.1 months versus 9.0 months).

“The outcome of this study is disappointing. However, Vectibix remains an important monotherapy treatment option for patients with metastatic colorectal cancer whose disease has progressed on other therapies,” said Roger M. Perlmutter, Executive Vice President of Research and Development at Amgen.

The SPECTRUM study enrolled 658 patients who were randomised to receive a standard platinum-based chemotherapy with or without Vectibix every three weeks. The primary endpoint was overall survival. The secondary endpoints included progression-free survival, objective response rate, duration of response, time to progression, time to response, patient reported outcomes and safety.

Detailed results from the study will be presented at the 35th European Society for Medical Oncology (ESMO) Congress on October 8-12 in Milan, Italy.

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Amgen fails to provide Prolia data

Wednesday, July 28th, 2010

NICE has closed an appraisal of Amgen’s Prolia (denosumab) due to a lack of information about the drug’s cost effectiveness.

The appraisal into whether Prolia is a suitable treatment for therapy-induced bone loss in patients with non-metastatic prostate cancer was terminated after manufacturer Amgen declined to provide any clinical or cost effectiveness data.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “When an appraisal is terminated, we issue advice to the NHS stating that ‘NICE is unable to recommend the use of the technology’. This advice sets out an explanation provided by the manufacturer as to why they did not submit evidence and will offer advice on what to do next. NHS organisations should take into account the reasons why no evidence of denosumab’s clinical and cost-effectiveness was submitted when considering their local use of the drug.”

“Of course, if the manufacturer decides to submit the evidence in the future, NICE will then take the opportunity to review our advice to the NHS,” she added.

Another NICE appraisal of Prolia, evaluating the drug as a treatment for therapy-induced bone loss in non-metastatic breast cancer, has been removed from the Institute’s work programme, because the drug has not received a separate marketing authorisation for this indication.

NICE issued draft guidance last month recommending Prolia as a treatment for the prevention of osteoporotic fractures in post-menopausal women, and is also currently assessing the drug for bone metastases treatment in cancer.

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First virtual community for ITP patients

Thursday, June 17th, 2010

Amgen has launched ITPvillage.com, a dedicated website that aims to bring together patients, healthcare professionals and carers for people affected by Immune Thrombocytopaenia (ITP).

The new website was officially launched at the 15th Congress of European Haematology Congress in Barcelona, Spain.

It is hoped that ITPvillage.com will provide an online community for European healthcare professionals and patients, where they can share information and experiences about the condition.

“Amgen are committed to improving the lives of patients, not just in terms of the products that we develop, but also in the way we support our patients and those who care for them,” said Georg Kreuzbauer, Medical Director International Development at Amgen International. “With ITPvillage.com, we have developed a centralised resource that provides information to everyone impacted by ITP.

“The website content is validated by leading ITP experts from around the globe and will be updated regularly, based on the requirements of its users.”

Affecting an estimated 50,000 adult patients in the EU, ITP is a serious autoimmune disorder characterised by low platelet counts in the blood (thrombocytopaenia), which can lead to serious bleeding events and has a devastating impact on patients’ lives.

Features of the website include:

  • The Village Library, which provides comprehensive background information, publications and support relevant to living with or managing ITP.
  • The Village Cinema, which presents a choice of short films for healthcare professionals and for the general public to expand their understanding of ITP.
  • The Community Post Office, which allows users to post any questions they may have about ITP, as well as providing important information about the disease.
  • The ITP Village Council, which consists of leading consultants from Europe who specialise in ITP and can help provide useful information and advice.

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