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.

The European Medicines Agency has described its vision on openness towards stakeholders in a new draft transparency policy.

Since its inauguration in 1995, the Agency has worked continuously to improve the transparency of its operations, often extending the levels of transparency beyond the existing legal requirements.

The new policy brings all these initiatives together and describes, for the first time in one comprehensive document, the Agency’s vision on its level of transparency towards its stakeholders.

The policy proposes to focus on three main objectives for achieving a robust and consistent approach towards transparency in all areas of its activity.

The first of these is to make the daily operations of the Agency more transparent. This will include a re-assessment of the balance between transparency and the protection of commercially confidential information. It also aims to be more proactive in disclosing details about the scientific evaluation of medicines.

The second is to strengthen the Agency’s interaction with its stakeholders, in particular patients and healthcare professionals. The eventual aim is for patients and HCPs to be consulted on the evaluation of drugs at the same level as the Agency’s scientific committees.

The third objective is to work with authorities in the member states to promote a harmonised approach to transparency across the EU, including consistent implementation across Europe.

The EMEA is inviting comments on its draft transparency policy until 25 September 2009. The publication of the final document is currently planned for the end of 2009.

Experts are predicting a boost to European pharmaceutical and biotech market revenue later this summer, following an important decision from the Enlarged Board of the European Patent Office (EPO).

The next three years had been earmarked as a cliff edge for many pharmaceutical companies with a number of the world’s drug blockbusters, such as Pfizer’s Lipitor and Eli Lilly’s Zyprexa, due to see their patents expire, but national patent and trademark firm Mathys & Squire is more optimistic.

Following the EPO’s decision, the company expect that pharmaceutical and biotech patent claims directed at new administration regimens, for example a change to dosage recommendations for an existing drug, will be considered more favourably in Europe, giving the sector a new focus.

Martin MacLean, partner at Mathys & Squire, commented: “Historically, the EPO has generally refused to grant dosage regimen claims on the basis that any underlying technical effect constitutes a method step that a physician would typically perform. Such method steps fall within a statutory exclusion and are therefore unpatentable.

“This approach has had a negative impact on the industry as patents have been refused without the need for thorough assessment of their respective merits under the more conventional metrics of novelty and inventive step.”

The shortfalls of this approach were first acknowledged in October 2004, when the EPO granted a patent for a new dosage regimen based on the cyclical administration of Insulin-like Growth Factor (IGF-1). Since this landmark case, there have been signs of a more favourable approach by the EPO to this type of patent claim category, which has separately found support by the UK Court of Appeal in a case involving Actavis and Merck.

Martin MacLean added: “If the Enlarged Board affirms the Genentech approach, it will pave the way for second-generation patent claims and provide potential patent protection for key commercial products long after the first generation ‘master’ patents have expired. This, in turn, is likely to have a dramatic impact on the sector and its ongoing revenue.”

Sanofi-Aventis will donate 100 million doses of influenza vaccine to the World Health Organization (WHO) to help people in developing countries, the company has declared.

During the opening session of the Pacific Health Summit, Chief Executive of the company Christopher Viehbacher said the whole industry has a “collective responsibility to assist patients across the globe during the current pandemic”.

He added that the company’s flexible donation of preventative medication is to help the body address the needs of the most vulnerable populations.

Once production begins, 10% of the A(H1N1) vaccines will be put to one side to go to communities in developing locations.

Mr Viehbacher asserted that the future of the sector is linked to healthcare solutions that can be found for emerging countries. "By pooling our collective strengths, as well as our dedication and our motivation, we can save millions of lives," he added.

The life sciences industry has welcomed Lord Mandelson’s announcement of the creation of an Innovation Fund which will be corner-stoned by Government with investment from private investors.

ABPI Director General Richard Barker described the move as an important first step towards putting life sciences at the forefront of the UK’s economy.

He said: “The economy and NHS patients need our country to lead in life sciences. Many great discoveries begin in small companies, many of which face an urgent funding crisis. Meeting this need is an important signal of Government’s intent and a first step towards delivering against an ambitious strategy to put UK life sciences at the forefront of our country’s economic and health future.”

The UK Innovation Fund (UKIF) will be made up of £150 million cornerstone investment from the Government which will leverage significant investment from VCs, institutional investors and large pharmaceutical companies.

The UKIF will hope to raise £1 billion to invest over a ten year life span and will invest in life sciences, clean technology, advanced manufacturing and digital Britain.

Clive Dix, Chairman of the BioIndustry Association (BIA), commented: “The Government’s plan for an Innovation Fund will make a significant contribution to securing the long-term health of the life science sector in the UK, providing much needed follow-on investment to early-stage companies developing innovative technologies for the patients that need them.

“This is an excellent first step towards delivering an integrated strategy for life sciences and we look forward to the announcement of a full package of measures from the Office for Life Sciences expected in July.”

The CHMP of the European Medicines Agency (EMEA) has recommended the approval of a once-daily formulation for Mirapexin/Sifrol (pramipexole) throughout the EU.

The CHMP recommendation states that the new prolonged-release formulation is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.

"This effective new treatment option combines the trusted clinical benefits of Mirapexin with the convenience of a single daily dose,” commented Dr. Manfred Haehl, Boehringer Ingelheim’s MD and Senior Vice-President, Medicine.

“In addition to benefiting from the high therapeutic value of Mirapexin, the reduced pill burden will mean added convenience for patients and their carers. It is important for physicians to have effective and flexible treatment regimens to choose from so that they can offer individualised treatments in line with the patient’s needs," Haehl added.

Pramipexole was first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson’s disease, as monotherapy or in combination with levodopa. It was also was approved in 2006 to treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome (RLS).

The Bone Cancer Research Trust (BCRT) is calling for new treatments for bone cancers affecting children and young people including osteosarcoma and Ewing’s sarcoma, the two most common forms of primary bone cancer.

A study funded by the Trust published this year shows that the survival of children and young adults with bone cancer in the UK has not improved for 20 years.

More research is urgently needed to find new treatments, says the Trust. It also urges that when new treatments are developed, they are introduced without delay to avoid any more young people dying of this disease.

On average, a young person cured of the disease would have another 60 years of life.

One new treatment for osteosarcoma that improves survival is currently being considered for funding by NICE. The BCRT has asked that this drug be made available as quickly as possible.

Michael Francis, Chairman of the BCRT, said: “Too many of the children and young people with bone cancer still die from their disease. We need to make bone cancer a priority and we urgently need more research to identify effective new treatments. The Government needs to play its part and streamline the process for introducing new treatments into the UK.”

An awareness week was held during June 2009, focusing on the need to improve survival for young people with this disease, and demanding greater priority, more research and new treatments. The week finished with a conference for patients and their supporters, which covered recent research and gave patients the opportunity to question experts in bone cancer.

Twenty-eight year-old Hannah Millington from Bromsgrove, who has been treated for osteosarcoma, said: "’Awareness Week and the Patients’ and Supporters’ Conference are key events for patients. They are an opportunity to raise awareness about this awful disease and to meet other people who are affected. Bone cancer is quite rare and it is easy for young people with the illness to feel extremely isolated."

The Awareness Week was supported by, the Teenage Cancer Trust, Sarcoma UK, Cancer 52 and the Rarer Cancers Forum.

Onglyza (saxagliptin) has received a CHMP positive opinion as add-on therapy to improve glycaemic control in adult patients with type 2 diabetes.

The decision was based on data from a comprehensive clinical development programme involving 4,148 patients that assessed the safety and efficacy of saxagliptin as a once-daily therapy.

Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body’s ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver’s production of glucose.

The recommended indication is as an add-on therapy in combination with metformin,

Sulphonylurea or a thiazolidinedione, when these treatments alone do not provide adequate glycaemic control.

Manufacturers Bristol-Myers Squibb and AstraZeneca expect the European Commission to issue its decision on a marketing authorisation for this investigational drug in the coming months.

Roche has decided not to review its membership of the ABPI in a controversial move that has led analysts to question the effectiveness of the UK’s regulation system.

The company says its decision does not alter its commitment to working within the Code of Practice and, to reiterate this, has recently strengthened its internal compliance procedures.

Roche was suspended from the Association in 2008 after making payments to clinics that prescribed its obesity drug Xenical.

In a statement, Roche said: “Our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs for the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being.”

The ABPI receives a six-figure annual subscription from Roche and it is rumoured that the Association is disputing the company’s right to leave. President Chris Brinsmead told the Financial Times: “Roche is thinking through the situation. There is an ongoing dialogue. Technically it is still a member. The ABPI doesn’t want to see any member walk away. A unified front makes sense.”

Roche has also announced plans to drop its membership of the Pharmaceutical Research and Manufacturers Association (PhRMA) in the US. Following its acquisition of biotech company Genentech, it has suggested that membership of the Biotech Industry Organisation (BIO) is a more logical choice.

US spokesperson Darian Wilson said: “Genentech and Roche believe BIO’s purpose is closely aligned with the direction of the new company and can therefore represent the company’s interest in Weshington.”

Merck Serono has launched the first global professional educational program in fertility, to be run by worldwide leading experts in this area.

The Global Fertility Academy has been developed for physicians active in treating infertility and aims to improve their knowledge of clinical standards in fertility and maximise the success rates of treatment by providing valuable educational tools and sharing best practices.

The newly launched website, www.GlobalFertilityAcademy.org, provides an online learning platform, covering topics ranging from the diagnosis of infertility to the business management of fertility clinics.

After the participants have passed a mandatory e-learning module test, they can register for one of five different practice sessions proposed by over 20 selected leading in vitro fertilization (IVF) centers in Europe, North and Latin America, Asia and Australia and last for one week.

"The goal of the Global Fertility Academy is to share the experience of practicing fertility specialists to train physicians, researchers and fertility center staff in the theory, application and implementation of state-of-the art methods in the treatment of infertility," said Dr. Antonio Pellicer, a Professor of Obstetrics and Gynaecology and one of the Academy’s faculty members.

"This will be a valuable tool to provide the next generation of fertility professionals with the skills and excellence required to meet the needs of our patients."