SmPC approval for Viramune

Wednesday, July 15th, 2009

Boehringer Ingelheim has received approval for an update of the summary of product characteristics (SmPC) for Viramune (nevirapine) as a treatment for patients with HIV.

The company said that the European Commission’s decision came after a positive recommendation from the CHMP.

Viramune’s SmPC has been updated to show that clinical studies have indicated the treatment is linked to an increase in HDL cholesterol, as well as an overall improvement in the total proportion of HDL cholesterol within the body.

Dr Manfred Haehl, Senior Vice President of Medicine at Boehringer Ingelheim, stated that the firm is “very satisfied” with the Commission’s decision.

“Physicians treating patients with HIV need to have a range of treatment options available so they can tailor the therapy to the individual patient’s need and response,” he added.

Cancer death toll lowest for 40 years

Wednesday, July 15th, 2009

The number of deaths from three of the most common cancers in the UK has dropped to its lowest level for nearly 40 years.

Cancer Research UK figures have revealed that the mortality rates for breast, bowel and male lung cancer are at their lowest since 1971.

Harpal Kumar, Chief Executive of Cancer Research UK, said: "Years of research are behind the dramatic progress being made in the fight against Britain’s common cancers.

"Survival rates have doubled in the last thirty years and the work of Cancer Research UK has been at the heart of that progress.”

The figures show that breast cancer deaths peaked in 1989, when 15,625 women died from the disease. The latest figures (from 2007) showed the figure having dropped to 11,990.

For bowel cancer the mortality rate peaked in 1992 at 19,598 deaths, but was down by 31% in 2007.

The number of men dying from lung cancer was down by 53% in 2007 from the number in 1979.

Government commits to support health innovation

Wednesday, July 15th, 2009

A new Blueprint to put innovation at the heart of healthcare delivery has been launched by the Office for Life Sciences (OLS).

The Blueprint aims to transform the UK environment for life sciences companies and ensure faster patient access to cutting-edge medicines and technologies.

NICE has supported the new Blueprint and announced changes to its own interactions with the pharmaceutical industry to create a better working relationship.

As part of the new agreement, the Government and NICE will introduce an ‘Innovation Pass’, a three-year initiative that will make selected innovative medicines available on the NHS for a time-limited period. The Pass will be piloted in 2010/2011, with a budget of £25 million.

Lord Darzi, Health Minister for Quality and Innovation, said: “Establishing a culture of innovation is essential for the NHS to meet any current economic challenges, and the Life Sciences Blueprint will help us continue to support this country’s knowledge industries and ensure that we benefit from the competitive edge which they provide.”

In welcoming the Blueprint, NICE emphasised the importance of the life sciences industry both to patients and to the UK’s economy. Chief Executive Andrew Dillon went on to explain how NICE will be changing how it works with companies to increase confidence in its product evaluations.

“Later this year, we will begin asking pharmaceutical and other life sciences companies whose products we are evaluating to make technical staff available to engage with our advisory Appraisal Committees,” he said. “They will be able to respond to requests from committee chairs to clarify the data they have submitted and to point out any error of fact in the presentation of their data.”

Other features of the Blueprint include a review of system incentives to accelerate the uptake of medical technologies, a greater emphasis on research and clinical trials in the next NHS Operating Framework, the formation of a UK Life Sciences Super Cluster to co-ordinate work across industry, Higher Education and the NHS, and the investment of an extra £1 million to promote the UK and NHS brands at flagship life sciences events.

In addition, the Technology Strategy Board will launch an £18 million ‘RegenMed’ programme of investment to support commercial R&D with additional funding from the Medical Research Council, the Engineering and Physical Sciences Research Council, and the Biotechnology and Biological Sciences Research Council.

Further treatment use for Aclasta

Wednesday, July 15th, 2009

Once-yearly Aclasta (zoledronic acid 5 mg) has been approved in the European Union to treat men and postmenopausal women with osteoporosis caused by long-term use of glucocorticoids (steroids).

Glucocorticoids are widely used to treat inflammatory conditions such as asthma and rheumatoid arthritis, but also cause bone loss and can increase the risk of fracture in up to 50% of patients on long-term glucocorticoid therapy.

This approval in glucocorticoid-induced osteoporosis (GIO) represents a fifth indication for Aclasta, which is already approved to treat osteoporosis in men and postmenopausal women, including those who have experienced a low-trauma hip fracture.

The new indication is based on study data published in the Lancet, which showed that Aclasta, given once a year as a 15-minute infusion, is more effective at treating bone loss than daily oral risedronate, a currently established therapy.

"Oral bisphosphonates have been used for many years for the treatment of GIO, but they are associated with poor compliance as patients frequently fail to take them as prescribed," said Professor David Reid, Head of the Division of Applied Medicine at the University of Aberdeen. "Available data show that patients who remember to take their medicines only half of the time receive little or no protection."

He added: "The approval of Aclasta is a significant step forward, as it is more effective and faster-acting than a current established therapy for the treatment of GIO and has the advantage of year-long compliance and sustained osteoprotection."

Aclasta is the only bisphosphonate approved in the EU and US to reduce the risk of fractures at all key osteoporotic fracture sites. It is also approved to treat Paget’s disease of the bone.

"This European approval marks another important achievement for Aclasta by adding to the broad spectrum of patients who can now be treated with this therapy," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Since its launch in 2007, Aclasta has been used in more than 500,000 patients, demonstrating that an annual infusion has become a valuable treatment option."

EC approves first advanced therapy product

Wednesday, July 15th, 2009

The European Medicines Agency has recommended the first marketing authorisation for an advanced therapy medicinal product.

The decision followed a positive opinion from the new Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP).

ChondroCelect, from TiGenix NV, is a cell-based medicine that is used to repair defects in the cartilage of the femoral condyle (the end of the thighbone) in the knee.

The treatment consists of chondrocytes (cartilage-forming cells) that are taken from a healthy region of the patient’s cartilage, grown outside the body, and then re-implanted during surgery.

ChondroCelect is the first product to benefit from the new legal and regulatory framework for advanced therapy medicinal products, which was designed to ensure these treatments gain access to the EU market and to encourage competitiveness between pharma companies in the field.

The CAT assessed the scientific data provided to support the marketing authorisation application for ChondroCelect. On the basis of their positive opinion, the CHMP also recommended the therapy be granted marketing authorisation.

As part of the application, the company has been asked to submit a risk management plan with a series of measures, including further studies to ensure that the medicine’s efficacy and safety are followed up in a robust manner once it is on the market.

Scientists receive £4.3 million for allergy research

Wednesday, July 15th, 2009

Researchers at St George’s, University of London have been awarded £4.3 million by the Wellcome Trust for the development of a unique new class of drugs to target the root cause of asthma and allergies.

The research team, led by Professor Clive Robinson, has identified novel, drug-like chemical compounds that combat asthma and allergic diseases of the nose, eyes and skin.

Asthma and allergic conditions such as rhinitis, conjunctivitis and dermatitis are an escalating problem expected to affect more than 100 million people globally by 2011.

In the UK, 5.2 million adults and 1.1 million children currently receive treatment for asthma, creating a significant social and healthcare burden for the NHS.

The Allergen Delivery Inhibitors being developed by Professor Robinson and his team target allergens excreted by dust mites, tiny creatures that live in the carpets and soft furnishings of homes, offices, trains, planes and cars.

The team at St George’s will work with pharmaceutical research and development contractors worldwide to develop a drug for clinical trials in the next few years.

This latest award comes from the Seeding Drug Discovery initiative, and follows more than £1 million of Wellcome Trust support for the programme since 2005.

CHMP approves orphan product

Wednesday, July 15th, 2009

The Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional EU marketing authorisation for Gilead’s orphan medicinal product Cayston.

The recommendation is for the product in powder and solvent solution, intended for the suppression of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 18 years and older.

Cayston, when given as a 28-day three times daily course of treatment, is shown to improve pulmonary function in adult CF patients suffering from chronic pulmonary infection due to Pseudomonas aeruginosa.

A conditional marketing authorisation is granted to a product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required.

It is likely that Gilead will be required to provide comprehensive clinical data at a later stage.

The active substance of Cayston is aztreonam, an antibacterial medicinal product for inhalation use only. Aztreonam binds to penicillin-binding proteins of susceptible bacteria, including P. aeruginosa, which leads to inhibition of bacterial cell wall synthesis, followed by cell lysis.

Ceuta backs school of enterprise

Wednesday, July 15th, 2009

Ceuta Healthcare, an outsourcing company in the health and beauty industry, is backing a training initiative by Dragon’s Den entrepreneur Peter Jones.

The Bournemouth-based company has become a partner in the Peter Jones Foundation, which aims to train a new generation of business leaders through the National Enterprise Academy (NEA).

The NEA, a brainchild of Peter Jones, will offer the UK’s first full-time accredited courses in Enterprise and Entrepreneurship, providing 16–19 year olds with an opportunity to develop the skills and knowledge necessary to succeed in the modern business world.

Ceuta will contribute a three-year package of support worth up to £300,000: mentoring and coaching, lecturing on various topics, training through its New Life training division, and offering work placements.

Edwin Bessant, CEO of Ceuta Healthcare, said: “We are living through difficult economic times at the moment, and this country needs strong, skilled and confident entrepreneurs coming through to help maximise recovery when it comes. There is a wealth of undiscovered talent in young people in this country, and whatever can be done to unearth that I am very proud to play a part in.”

CHMP Update

Wednesday, July 15th, 2009

This month the CHMP gave a positive opinion on six new drugs, adopted its first positive opinion for an advanced therapy medicinal product (see separate story) and reviewed 13 generics of Plavix.

The CHMP recommended the approval of EU marketing authorisations for the following:

· UCB’s Cimzia (certolizumab pegol) for rheumatoid arthritis

· Pierre Fabre’s Javlor (vinflunine ditartrate) for carcinoma of urothelial tract

· Bristol-Myers Squibb and AstraZeneca’s Onglyza (saxagliptin) for type 2 diabetes mellitus.

· Centocor’s Simponi (golimumab) for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Positive opinions were also adopted for the following generic medicines:

· Viagra generic Vizarsin (sildenafil), from Krka, d.d., Novo mesto

· Topotecan Teva (topotecan hydrochloride), a generic of Hycamtin, to treat ovary carcinoma, small cell lung cancer and carcinoma of the cervix

A total of 13 clopidogrel-containing medicines were also given positive opinions – these are all generics of Plavix and are intended for the prevention of atherothrombotic events.

The Committee reversed its previous negative opinion on Gilead’s Cayston (aztreonam lysine) for the suppressive therapy of chronic pulmonary infection caused by Pseudomonas aeruginosa bacteria in adults with cystic fibrosis.

Several extensions of indication were also approved:

· Roche’s Avastin (bevacizumab) – adding combination therapy with docetaxel chemotherapy to the first-line treatment of metastatic breast cancer

· Merck Sharpe and Dohme’s Januvia (sitagliptin), Tesavel (sitagliptin) and Xelevia (sitagliptin) – allowing the use of sitagliptin as monotherapy

· Novartis’ Xolair (omalizumab) – extending the existing indication to paediatric patients from 6 to less than 12 years of age.

No appeal against Alzheimer’s decision

Wednesday, July 15th, 2009

Eisai and Pfizer have decided not to appeal NICE’s decision on Alzheimer’s drugs and have called for an expedited review of guidance for the disease.

In June this year, NICE announced that the guidance remains unchanged despite recognising significant errors within their model. Eisai and Pfizer have decided not to appeal the decision, however, on the basis that NICE has promised to review the existing guidelines.

Nick Burgin, Managing Director of Eisai, commented: "While we shared the disappointment of many on hearing NICE’s decision, we have decided not to appeal. The fundamental reason for this is that on June 11th, Andrew Dillon, NICE Chief Executive, committed to commence a review of the existing guidance ‘as soon as possible’, as long as no appeals were received.

“It is therefore right that Eisai and Pfizer do all we can to allow NICE to honour its stated commitment and to take into account new data that have become available as well as advances in economic modelling techniques."

Eisai and Pfizer have stated that they are committed to working with NICE and call upon the Institute to provide a timeline for the review as a matter of urgency.