Alcon has entered into a five-year research agreement with AstraZeneca that gives Alcon exclusive ophthalmic drug discovery and potential development rights to AstraZeneca’s compound library.

The two companies are targeting the development of drugs to treat sight-threatening conditions such as glaucoma, wet and dry age-related macular degeneration and other retinal diseases, as well as ocular allergy, dry eye and other inflammatory eye conditions.

“Alcon and AstraZeneca share a common goal: to use leading-edge science to deliver medicines that will benefit patients,” said Jan Lundberg, AstraZeneca’s Executive Vice President of Global Discovery Research. “We are constantly looking for new opportunities to maximise our strong early pipeline, and this collaboration is proof of its value beyond the therapy areas for which AstraZeneca is renowned.”

Under the terms of the agreement, Alcon obtains immediate access to thousands of AstraZeneca compounds in a variety of drug classes. AstraZeneca will hand over development and regulatory documentation associated with each compound as relevant to ophthalmology.

Alcon will perform and fund all R&D activities to move selected compounds forward. Individual licence agreements will be negotiated on a case-by-case basis for any compound that moves into clinical development, including regulatory milestone payments and royalties on product sales.

“This strategic partnership represents an extraordinary opportunity to bring Alcon’s global leadership in the field of ophthalmology together with AstraZeneca’s world-class basic research capability to advance treatments in eye care,” said Kevin Buehler, Alcon’s President and Chief Executive Officer. “I believe this partnership will not only benefit both parties, but will also lead to new therapies that reduce the incidence of blindness around the world.”

Geoffrey Francis, Chief Scientist at Novozymes Biopharma, has been named one of the 100 most inspiring people by PharmaVOICE magazine in recognition of his influence on the life sciences industry.

The PharmaVOICE 100 were nominated by PharmaVoice readers, who identified the individuals they believe have the greatest influence and positive impact on corporate leadership, research and development, technology, creativity, marketing and business strategies.

“It’s a great honor to have been recognised by my peers and to be profiled alongside such an esteemed group of industry leaders,” commented Geoffrey Francis. “I am delighted that this honor validates Novozymes Biopharma’s mission and is a real testament to the outstanding team we have here.”

Geoffrey Francis’ nomination and selection to the PharmaVOICE 100 was based on his exceptional 30-year career in the life sciences and biotechnology industries and his ability to inspire and motivate those around him.

With specific expertise in drug discovery, protein expression, cell biology, animal physiology and protein biochemistry, Geoffrey has a long and successful career in senior management and research within government, academia and industry.

Geoffrey used his expertise as part of the team to found the Cooperative Research Centre for Tissue Growth and Repair, Adelaide in 1991 and held senior scientist positions at CSIRO Human Nutrition and GroPep Ltd before joining Novozymes Biopharma in 2006.

Editor-in-chief and co-founder of PharmaVOICE Taren Grom said: “The PharmaVoice 100 are individuals who think outside the box, pioneer new paths to success, and inspire their colleagues in the industry; they translate industry issues into opportunities and take the time to mentor the next generation of leaders in the life sciences arena.”

The 2009 Cancer Congress Update has been hailed a success by clinicians from the worlds of breast, colorectal, lung, prostate and haematological cancer.

Created by medical education agency Succinct Healthcare Communications, the event was designed to provide a UK-focused digest of highlights from the past year’s international oncology meetings, and to act as a forum for discussion to facilitate translation of the data into clinical practice.

The unusual cross-sector audience allowed clinicians to share their experiences and research with professionals treating other cancers.

Dr Mark Verrill of the North East Cancer Network said: “The Cancer Congress Update has been a great meeting. We all usually talk to people who treat the same cancers as ourselves, and it has been fascinating to see the amount of commonality between different tumours. The congress has brought us into one big cancer family.”

Sponsored by AstraZeneca, Novartis, Roche, sanofi-aventis and Teva Hospitals, the Cancer Congress Update acted as a comprehensive resource for those unable to attend meetings such as ASCO 2009 and SABCS 2008.

The Managing Director of Succinct Healthcare Communications, Sean McGrath, added: “This was a fantastic opportunity for specialists to exchange ideas on emerging trends with a panel of experts. We are already planning next year’s event and hope that it will help to deliver the right cancer drugs to the patients who need them faster than ever before.”

NICE has agreed to delay its Final Appraisal Determination for Nexavar (sorafenib) for the treatment of advanced hepatocellular carcinoma (HCC), in order to consider a patient access scheme.

The drug’s manufacturer, Bayer Schering Pharma, has already agreed the access scheme with the DH.

“Bayer Schering Pharma is encouraged that NICE has delayed its decision to issue final guidance for Nexavar in HCC,” a company spokesperson commented. “We hope that NICE takes this opportunity to evaluate and fully understand the benefit of our proposed patient access scheme and to listen to leading healthcare professionals in the field who were unanimous in their condemnation of the initial negative proposal.”

Liver cancer causes more than 3,000 deaths every year in the UK and HCC accounts for 80–90% of all primary liver tumours.

Nexavar (sorafenib) is the first systemic therapy to show a survival advantage for patients with HCC in over 30 years of trials. It has been proven to extend overall survival by 44% compared to best supportive care alone, and is currently available to patients in other European countries and in other parts of the world.

The company added: “Bayer Schering Pharma will continue to work with NICE and the Department of Health through this delay, to secure access to Nexavar for NHS patients with advanced hepatocellular cancer. We hope a favourable decision for patients waiting for access to this treatment is reached.”

The EC has approved the first intranasal spray for breakthrough cancer pain, representing a new approach to the treatment of pain in cancer patients.

Instanyl, manufactured by Nycomed, is a first-in-class intranasal fentanyl spray designed to closely match the typical episodes of breakthrough cancer pain.

“We have had a great unmet need in the management of breakthrough cancer pain. With Instanyl, however, we now have a treatment designed to better meet the needs of a patient suffering from breakthrough cancer pain. Instanyl has a fast onset, a short duration, is well tolerated and is easy to use, allowing the patients effective control of the pain episodes with minor adverse effects,” said Professor Stein Kaasa, Chairman of the Research Network of the European Association for Palliative Care (EAPC-RN).

Instanyl is the first fast-acting intranasal fentanyl spray approved for the management of breakthrough cancer pain in adults already receiving maintenance opioid therapy for chronic cancer pain.

Phase III data on Instanyl has shown clinically substantial pain relief at 10 minutes after administration in 58% of Instanyl-treated pain episodes.

“The intranasal drug administration is an innovation within treatment of breakthrough cancer pain,” added Professor Kaasa.

“The rapid uptake via the nose translates into fast onset of action, enabling the patients to be in control of their pain. Instanyl data presented at the 11th Congress of the European Association for Palliative Care (EAPC) demonstrated an onset of pain relief as early as 5 minutes, underlining the clinical benefit this treatment represents to the patients.”

The European Medicines Agency has started to receive and review data on H1N1 pandemic vaccines.

The Committee for Medicinal Products for Human Use (CHMP) is committed to fast-tracking the review of data as vaccine manufacturers make them available.

Given the public health threat posed by the current pandemic, the Agency’s goal is to ensure that data are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September.

The CHMP is currently reviewing data relating to manufacture of vaccines. The results of additional clinical trials in adults and children will be reviewed in the coming months as they become available. Approval of the H1N1 vaccine is expected to be given after satisfactory review of these data.

Initial results on the efficacy, immunogenicity and safety of the vaccine from these trials are expected from September 2009 onwards, and will also be reviewed as soon as they become available.

Four ‘mock-up’ vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the EU, based on earlier data generated with the H5N1 virus strain (which is similar to H1N1), tested in 8,000 subjects.

These vaccines were developed in the knowledge that the virus strain would be changed to include the strain causing the pandemic. Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain should not substantially affect the safety or level of protection offered.

In addition to the mock-up vaccines, a number of other pandemic influenza vaccines are currently under development, and data from GSK and Sanofi Pasteur are also being assessed by the CHMP.

NICE has issued a positive Final Appraisal Determination recommending the use of Basilea’s Toctino on the NHS.

Toctino (alitretinoin) has been recommended as a treatment option for adults with severe chronic hand eczema that has not responded to potent topical corticosteroids.

“The positive Final Appraisal Determination is an important milestone for Basilea and is confirmation of the value Toctino brings to patients and the healthcare community,” said Dr. Anthony Man, Chief Executive Officer, Basilea Pharmaceutica Ltd. “The NICE recommendation should provide patients in England and Wales who suffer from severe chronic hand eczema a real chance to obtain hands cleared of eczema and the possibility to resume normal activities.”

This decision follows a positive recommendation by the SMC in March, making Toctino available to patients across the UK. Toctino is currently the only therapy approved for severe chronic hand eczema unresponsive to potent topical corticosteroids.

Hand eczema is a common inflammatory skin disease, affecting up to 10% of the population, and is often chronic and relapsing. The chronic form of the condition is thought to affect 5–7% of patients, causing impaired use of their hands and a considerable impact on their ability to perform everyday activities.

GSK has completed its acquisition of Stiefel, creating a new world-leading specialist dermatology business with revenues of approximately $1.5 billion.

GSK has acquired the company for a total price of $2.9 billion, as well as assuming $0.4 billion of net debt. The new unit will operate as Stiefel, a GSK company.

Under the terms of the agreement, GSK may be obligated to make additional cash payments of up to $0.3 billion depending on the future performance of the business.

Deirdre Connelly, President, North American Pharmaceuticals, GSK, said: “The Stiefel acquisition demonstrates how we are implementing our strategy to grow and diversify our business through targeted acquisitions. We now have established a new world-leading, specialist dermatology business that will immediately generate new revenue flows to GSK.”

Charles Stiefel, Chairman of Stiefel, added: “As part of GSK, we are stronger, more competitive and continue to be a driving force in dermatology around the world. Our combined portfolios, together with our specialty sales force and GSK’s global presence, positions GSK’s dermatology business for significant growth.”

The combined revenues of the two companies in 2008 total approximately $1.5 billion, and represent an 8% share of the global prescription dermatology market.

In acquiring Stiefel, GSK has gained a robust development pipeline with more than 15 projects in late-stage development across a wide variety of dermatological conditions, such as acne, dermatoses and fungal infections.

NICE should relax its rules on pricing for drugs that offer the most benefits to patients, an independent study has concluded.

The proposal forms part of Sir Ian Kennedy’s report into the value of new innovative health technologies, which was commissioned in February.

Sir Kennedy suggested that the ‘price ceiling’ should be raised for two or three years for the most innovative new treatments, although he also warned that this will mean a reduced budget for other drugs.

“We should consider offering an incentive to the industry and to others to say OK if you’re doing something which really brings cutting edge technology to patients you should have some financial incentive for a limited period of time so that you can make slightly more money which you can put back into research,” he said.

“You will have to drop the threshold – how much you are prepared to pay for other drugs. That is the quid for the quo that the industry will have to deal with.”

In reaching his conclusions, Sir Kennedy considered submissions from the pharma industry, patient groups and health service managers.

The ABPI has welcomed the suggestions. A spokesperson said: Sir Ian Kennedy has recognised the need for NICE to change – for it to be more transparent, to foster innovation, and to take greater account of wider health benefits.”

Similar proposals were made by the government last week, in its ‘innovation pass’ suggestion, whereby innovative treatments for small patient groups will be able to temporarily bypass NICE assessment.

NICE has said it will respond to the proposals in September, followed by a three-month public consultation.

Actelion’s Zavesca (miglustat), the only licensed treatment for Niemann-Pick type C (NP-C) disease, has been approved in the UK and the Republic of Ireland.

NP-C is a rare genetic disease with significant neurological deterioration that can be fatal and affects infants, children and adults. There is currently no cure for the disease, and patient management was previously restricted to symptom relief.

Neurological deterioration is the key feature of NP-C, which manifests in a variety of symptoms including eye movement disorders, balance disorders, difficulty in swallowing, slurred and irregular speech, seizures and a lack of muscle control.

Ed Wraith MD, Royal Manchester Children’s Hospital, commented: “For the first time we have an approved therapy for NP-C. The data on the effects of treatment with Zavesca obtained in a clinical trial and in a retrospective cohort study consistently showed a favourable clinical response. As a treating physician I am acutely aware of the importance of reducing progression of neurological symptoms.”

Jean-Paul Clozel, Chief Executive Officer of Actelion, added: "I am very proud that Actelion – together with the scientific community – has been able to demonstrate the role of Zavesca in reducing the progression of clinically relevant neurological symptoms in patients with NP-C. I would like to thank both the patients and their families who, over the years, have been involved in our clinical programme with so much dedication, as well as all the clinical experts for their continuous support.”

Zavesca, which was granted orphan drug status allowing for a faster approval process, is now approved in all EU countries for the treatment of patients with NP-C.