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."

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.

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.

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 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.”

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.

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.