NICE has recommended Remicade (infliximab) and Humira (adalimumab) as treatment options for some people with severe Crohn’s disease whose condition has not responded to conventional therapy.

The draft guidance recommends the drugs for adults with non-fistulising, severe Crohn’s disease that has not responded to conventional treatment.

The Institute also ruled that treatment should normally be started with the less expensive drug, taking into account drug administration costs, required dose and price per dose.

Infliximab was also recommended for adults with severe, fistulising Crohn’s disease, and for children and young people aged 6-17 years old with severe Crohn’s disease.

Dr Carole Longson, Health Technology Evaluation Centre Director, said: “These treatments are not suitable for all people with Crohn’s disease. However, it is clear that infliximab and adalimumab may provide benefit to some severely ill patients; hence our draft guidance is targeted at people who have the most severe forms of Crohn’s disease. It is also clear that these drugs should only be prescribed by specialists experienced in treating people with Crohn’s disease.”

Crohn’s disease is a chronic inflammatory condition of unknown cause affecting the gastrointestinal tract (gut). It is estimated that around 60,000 people in the UK have the disease, of whom approximately 3,000 (5%) have the most severe forms of the condition.

Sometimes Crohn’s disease causes the formation of abnormal passageways (‘fistulas’) between parts of the intestine or between the intestine and the skin. It can also affect other parts of the body, such as the eyes or the joints. People with Crohn’s disease have recurrent attacks, i.e. periods of flares and ‘remission’.

The draft guidance is available for public consultation on the NICE website until 10 December 2009 and final guidance is expected in spring 2010. Until this time, NHS bodies have been encouraged to make local funding decisions on the treatments.

Sanofi-aventis’ Multaq has become the first new anti-arrhythmic drug to be approved in the European Union in the last 10 years.

The European Commission has granted marketing authorisation for Multaq (dronedarone – 400mg Tablets) in all 27 European member states. The approval follows the CHMP’s positive opinion issued on September 25, 2009.

The drug is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

It is the first anti-arrhythmic drug approved in the EU that has shown a clinical benefit to reduce cardiovascular hospitalisations or death from any cause in patients with AF/AFL.

“The approval of Multaq in the European Union is important news for atrial fibrillation patients who will now have access to a new treatment approach,” said Marc Cluzel, Executive Vice President, Research and Development, sanofi-aventis. “The approval of Multaq is the result of more than 15 years of research and development conducted by sanofi-aventis and supported by the commitment of the experts involved in the clinical development program and AF patients participating in the trials.”

The marketing authorisation was based on a clinical data package that included seven international clinical trials involving more than 7000 patients, with almost 4000 patients receiving dronedarone during the program.

“This European approval is good news for doctors and patients since atrial fibrillation affects about 4.5 million people in Europe and represents one-third of hospitalisations for arrhythmia in the European Union,” said Dr Stefan H. Hohnloser, Goethe University’s Division of Clinical Electrophysiology, Frankfurt, Germany.

He added: “Multaq is a significant step forward which could change the way we approach the management of atrial fibrillation and offers a new treatment option to physicians in a field where there has been no significant anti-arrhythmic drug innovation for almost 20 years.”

The first launches of Multaq are expected to take place in the United Kingdom and Germany in January 2010.

A pilot to help patients get innovative new drugs not currently available on the NHS has been launched for consultation by Health Minister Mike O’Brien and Science and Innovation Minister Lord Drayson.

During the three-year pilot, an ‘Innovation Pass’ will allow patients with rarer diseases access to innovative new drugs and enable valuable data to be collected on their impact and cost effectiveness, contributing towards a future NICE appraisal.

The Office for Life Sciences (OLS) Blueprint, published in July, detailed the Government’s commitment to create the ‘Innovation Pass’ to allow access to drugs for rare diseases that are not yet appraised by NICE, and where there is limited data on their effectiveness.

As the number of patients using these drugs is small, the lack of current evidence available means that NICE are not able to conduct a full assessment for their use on the NHS.

Health Minister Mike O’Brien said: “I am extremely pleased to launch this consultation that will help patients with the greatest need to benefit from and get access to exciting new innovative drugs. The Innovation Pass pilot will help collect the essential data needed to demonstrate that such drugs, which would not otherwise be available to patients, are making a big difference to their lives.”

The Innovation Pass pilot is being run in partnership with NICE and has involved significant input from a range of stakeholders including the NHS and the life sciences industries. In 2010/11 it will be funded from a £25m budget set aside exclusively for the Innovation Pass. Funding for future years is discussed in the consultation.

Drugs included on the scheme will be licensed and NICE is to play a key role in developing and applying the drug eligibility criteria for the Innovation Pass. All drugs included on the pilot will be submitted for NICE appraisal at the end of the three years.

NICE Chief Executive Andrew Dillon added: “We recognise that for a small number of very promising new treatments, the evidence available may not reveal their full potential benefits for patients. Where there is a high risk that a NICE appraisal of a new treatment at the point of its first use in the NHS might underestimate its benefits, providing the opportunity to gather more evidence and making the treatment available before undertaking an appraisal is the right thing to do.”

The Innovation Pass pilot consultation will run for 10 weeks, closing on 8th February 2010.

Boehringer Ingelheim’s Micardis (telmisartan) has been approved by the European Commission to reduce the risk of cardiovascular (CV) morbidity in high CV risk patients.

The granting of a marketing authorisation for Micardis to reduce CV morbidity in patients with manifest atherothrombotic CV disease or type 2 diabetes with documented target organ damage follows recent FDA approval in the US.

The drug is the only treatment in its class that demonstrates proven cardiovascular (CV) protection in patients at high CV risk and that has been approved in this indication.

The new indication is based on a review of clinical trials, including results from the ONTARGET trial, which showed that Micardis may prevent one in five serious CV events.

Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine of the University of Milan, Bicocca, Italy, said: “This new indication of telmisartan is a significant development for physicians and their at-risk patients. Prevention of CV events is vital as these are the primary causes of pathological death in Europe, due to lack of proper control of treatable risk factors and disease. The approval of telmisartan offers patients a well-tolerated treatment option which also provides CV protection.”

Professor Klaus Dugi, Corporate Vice President, Medical Affairs, Boehringer Ingelheim, commented: “These approvals clearly demonstrate the unique treatment option that Micardis now provides to both physicians and patients as the only medication in the ARB class to provide proven CV protection.”

Cardiovascular disease (CVD) is responsible for nearly one in three deaths worldwide and is the number one cause of death.

Novartis has gained the rights to two oral targeted investigational therapies focusing on patients with life-threatening blood disorders and cancers.

Under a licensing agreement with Incyte Corporation, Novartis will have responsibility for the future development of Incyte’s investigational JAK inhibitor outside the US and for future development of an early-stage cMet inhibitor globally.

Novartis will make upfront payments of USD 150 million and a first milestone payment of USD 60 million; following this, Incyte will be eligible for milestone payments and royalties on future sales.

“A key Novartis priority is to bring innovative medicines to patients as quickly as possible,” said David Epstein, President and CEO, Novartis Oncology and Novartis Molecular Diagnostics. “This agreement leverages these two promising investigational drugs with Novartis Oncology’s global development and commercialisation expertise and our wide range of multi-targeted approaches to cancer treatment.”

The lead compound is a Janus kinase (JAK) inhibitor. This oral targeted therapy is in Phase III clinical trials for the treatment of myelofibrosis, a life-threatening neoplastic condition that currently has no effective medical treatment. It has the potential of becoming a first-in-class therapeutic agent for the treatment of this and other haematologic diseases.

The second compound covered in the deal, a mesenchymal-epithelial transition factor kinase (cMet) inhibitor, is entering Phase I development. Compounds in this class are envisioned to become effective cancer therapies through their ability to block molecular signals leading to tumor cell angiogenesis, proliferation, survival, invasion and metastasis.

Emerging evidence indicates that cMet inhibition may be useful in the treatment of certain cancers, including gastric and kidney cancer, and may help to overcome resistance to some targeted therapies, such as gefitinib in non-small cell lung cancer.

The European Medicines Agency has reaffirmed the efficacy and safety of H1N1 pandemic vaccines Celvapan, Focetria and Pandemrix.

The Agency has reviewed further data on the centrally-authorised pandemic vaccines and has reaffirmed their positive balance of benefits and risks in the context of the current H1N1 influenza pandemic.

The data on Focetria and Pandemrix indicate that a single dose is able to trigger an immune response that may be sufficient to give protection against the H1N1 pandemic influenza in some age groups.

For both vaccines, a single dose may be used in adults aged between 18 and 60 years and in children and adolescents (from the age of 9 years for Focetria, and from 10 years for Pandemrix). Pandemrix may also be used as a single dose in the elderly.

For certain groups, such as younger children and immunocompromised patients, the Agency’s recommendation remains that two doses should be given, to ensure that their immune system responds adequately to the vaccination.

Data on Celvapan are still being assessed.

The Agency also concluded that Focetria and Pandemrix can be co-administered with non-adjuvanted seasonal flu vaccines.

The Agency, together with other national authorities, is continuously monitoring the safety profile of H1N1 pandemic influenza vaccines. With vaccination campaigns ongoing in the EU, about 5 million people have been vaccinated so far.

The Agency has said that it will continue to evaluate all information that becomes available and make further recommendations as necessary.

In a bad week for Roche, cancer drug Avastin (bevacizumab) has received negative opinions from both NICE and the CHMP.

Preliminary recommendations published by NICE state that the use of bevacizumab for metastatic colorectal cancer is not a cost-effective use of NHS resources, while the CHMP has issued a negative opinion for the drug in glioblastoma (GBM), an aggressive type of brain cancer.

Commenting on the NICE draft guidance, Health Technology Evaluation Centre Director Dr Carole Longson said: “Before making these preliminary recommendations, the independent Advisory Committee considered the manufacturer’s cost-effectiveness estimates, the proposed patient access scheme and the published evidence on the effectiveness of bevacizumab in treating metastatic colorectal cancer.

“The Committee recognised that bevacizumab may provide benefits in terms of clinical effectiveness. However, the uncertainties in the economic analysis provided by the manufacturer and, in particular, the proposed patient access scheme led the Committee to conclude that the high cost of bevacizumab relative to the benefits it brings means that it is not a cost-effective use of NHS resources for the treatment of metastatic colorectal cancer.“

She added that the proposed patient access scheme was too complex, did not reflect routine clinical practice and would have high administration costs.

The CHMP’s negative opinion related to the approval of Avastin alone or in combination with irinotecan chemotherapy for the treatment of relapsed or progressive GBM.

The major objection from the CHMP was the lack of a comparator arm without Avastin in the BRAIN study, an investigational Phase II trial. Although the CHMP usually bases its approval decisions on Phase III studies only, Roche chose to submit this data set based on what it felt was remarkable clinical activity on the part of Avastin.

“We are very disappointed with the CHMP opinion, which will result in a delay to patients receiving an important new treatment option. We strongly believe that Avastin is a new treatment option for physicians within the EU which would bring hope to GBM patients and their families as it is today in the US and other countries,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division.

“Relapsed glioblastoma is a rare condition and represents a very high unmet medical need. These patients deserve effective additional therapies to manage this devastating disease,” he continued.

NICE’s draft guidance on bevacizumab is now out for consultation.

NICE is to publish final guidance that recommends the use of topotecan as a second line treatment for relapsed lung cancer.

The final guidance on use of topotecan recommends the oral form of the drug as an option for people with relapsed small-cell lung cancer for whom retreatment with their previous medication is not considered suitable and who cannot take the combination of cyclophosphamide, doxorubicin and vincristine (CAV).

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “Under the arrangements introduced by NICE for appraising life-extending, end-of-life treatments, the independent Appraisal Committee has concluded that oral topotecan should be recommended for use.

“Without treatment, small-cell lung cancer has an aggressive clinical course leaving patients with a life expectancy of approximately 3.5 months for limited-stage disease and 6 weeks for extensive-stage disease. We are pleased to be able to recommend topotecan as an alternative treatment for relapsed lung cancer patients who cannot receive CAV.”

The guidance does not recommend intravenous topotecan for people with relapsed small-cell lung cancer.

This final guidance brings the total number of cancer drugs appraised by NICE to 79, of which 59 (75%) have recommended the use of the drug.

Erbitux has been recognised by the American Society of Clinical Oncology (ASCO) for the second year running as a major advance in cancer treatment.

Merck Serono’s cancer drug Erbitux (cetuximab) was selected by ASCO for providing the first significant increase in survival for 30 years in the treatment of patients with first line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The acknowledgment coincides with the Lancet Oncology publication of long-term survival data for Erbitux in locally advanced SCCHN, demonstrating that half of patients were alive at five years.

The ASCO report ‘Clinical Cancer Advances 2009: Major Research Advances in Cancer Treatment, Prevention and Screening’, published in the Journal of Clinical Oncology, is an independent assessment of the most significant clinical cancer research studies of the past year.

Erbitux was singled out for the SCCHN study, EXTREME, the first randomised trial in 30 years to identify a regimen that increases survival for patients with recurrent and/or metastatic SCCHN.

The report commented: “The ability to improve overall survival with chemotherapy has proven elusive over the last 30 years in several randomized trials comparing different chemotherapy regimens in this setting. Thus, the results of this [EXTREME] trial are particularly noteworthy and are changing clinical practice.”

In 2008, Erbitux was recognised for extending survival in the first line treatment of NSCLC and for the role of K-RAS tumour status in predicting whether patients with newly diagnosed metastatic colorectal cancer will respond to Erbitux.

“Merck Serono is honored that Erbitux is recognised by ASCO two years in a row, and across three different disease areas – colorectal cancer, lung cancer and now head and neck cancer – as a major clinical advance,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. “This latest acknowledgement from ASCO is a tribute to the role Erbitux now plays as a gold standard therapy in first line recurrent and/or metastatic SCCHN.”

Merck (MSD in the UK) has received a positive opinion from the CHMP for its new fertility treatment, Elonva.

The CHMP has recommended approval of Elonva (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.

Elonva is the first in the class of sustained follicle stimulants (SFS). Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of Elonva may replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.

“ELONVA will reduce the burden of injections for women experiencing difficulty conceiving, and the positive opinion is an important step toward a European approval,” said Mirjam Mol-Arts, Senior Vice President, Merck Research Laboratories. “Elonva demonstrates Merck’s commitment to providing effective patient-focused fertility treatments and extends the company’s leadership in this therapy area.”

The Phase III development program for Elonva included the Engage trial, the largest double-blind fertility agent trial ever performed. The trial showed that the ongoing pregnancy rate with Elonva (38.9% per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH for seven days (38.1% per started cycle).