A business deal between GlaxoSmithKline and Archemix Corporation is set to pioneer the discovery, development and commercialization of synthetic oligonucleotide drug therapies for inflammation-associated diseases.
GlaxoSmithKline (GSK) has entered into an alliance with the biotechnology company Archemix Corporation with the aim of driving forward the discovery, development and commercialization of a group of therapeutic drug candidates known as aptamers that target a total of seven inflammatory disease-associated proteins. It is thought that these small, high-affinity/specificity oligonucleotide sequences could emerge as promising new treatments for rheumatoid arthritis and inflammatory bowel disease.
This alliance will couple Archemix’s intellectual property rights and expertise of aptamer therapeutics with GSK’s knowledge and experience in the field of inflammatory disease. Archemix will be responsible for the discovery and development of the aptamer products and GSK will be able to exercise their option of exclusive license over the resulting aptamer drug product candidates, with the ability to develop the drugs further and commercialize them on a worldwide scale. Archemix will retain the right to develop and commercialize themselves any drug product candidates not licensed by GSK.
President and Chief Executive Officer of Archemix, Errol DeSouza commented: “We are very excited about this collaboration with GSK. GSK is an outstanding partner with leadership and expertise in inflammation and we look forward to expanding our efforts in inflammation where aptamers could offer novel options to treat disease … This is another step forward in our strategy to leverage our intellectual property estate together with our significant internal capabilities in order to develop aptamers for a variety of therapeutic areas with key partners who are experts in their field.”
The financial terms of the agreement will see Archemix receive an upfront payment of US$27.5 million; a sum that includes a $6.5 million equity investment into the biotech company by GSK. Archemix could be eligible for a further $200 million in development, regulatory and sales milestone payments for each of the seven aptamer therapeutics that could potentially be discovered and developed under this alliance.
Jose Carlos Gutierrez-Ramos, the Senior Vice President and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery at GSK believes that “This innovative multi-target drug-discovery deal is an important extension of our externalization strategy and provides GSK with an outstanding opportunity to work with the world leader in aptamer discovery and development.” He added, “The application of aptamers with their unique properties is an exciting opportunity that holds enormous potential for the treatment of many devastating diseases of the immune system.”
Source: GlaxoSmithKline: www.gsk.com
New NICE rules could broaden range of life-extending drugs available on the UK National Health Service
Terminally ill patients may benefit as life-extending drugs not previously considered to be cost effective now have a better chance of being approved on the UK National Health Service (NHS) under new NICE rules.
These new rules issued by NICE follow a 5-week public consultation last December and have now come into effect for those living in England, Wales and Northern Ireland. The terms and conditions stipulate that for a drug to be approved under the new rules, it must be aimed at patients with a life expectancy of 24 months or below, who are suffering from a disease affecting a relatively small number of people. In addition, there must be evidence that the drug is able to extend life by at least 3 months in comparison with existing NHS treatments and the drugs must not have a cheaper, currently accessible treatment that offers similar benefits. The guideline change will affect drugs that have been deemed to have a cost–effectiveness ratio above the normal cut-off point of the GB£30,000 threshold normally used by NICE.
This guideline change follows public anger after patients with advanced kidney cancer were denied access to drugs capable of extending life expectancy by 5–6 months last year on the grounds of lack of cost–effectiveness. There were subsequent calls for more weight to be given to this class of drugs. NICE Chief Executive Andrew Dillon commented that NICE is “conscious of its responsibility to support the development of novel treatments for smaller patient groups that provide innovative benefits over and above existing NHS care.”
Although these new rules will only affect around one or two treatments a year, the charity Macmillan Cancer Support, which had been campaigning for a change, predicts that an estimated 10,000 cancer patients a year could benefit from the new rules. Rachel Rowson, Policy Manager for the charity hopes that “this will now mean that people with rarer cancers and those at the end-of-life stage get access to the drugs they need on the NHS.”
Although this news is considered a step in the right direction with regards to the treatment of terminally ill patients, many believe more could be done. Stella Pendleton, Executive Director of the Rarer Cancers Forum, believes “there are many treatments which can never be assessed by NICE in the first place because of the rarity of the cancers they treat … Ministers need to explain how these patients can receive the life-sustaining treatments they need without relying on top ups.”
Sources: BBC News: http://news.bbc.co.uk NICE: www.nice.org.uk
Study exposes extent of the financial impact of multiple sclerosis in the UK
Independent research carried out by Paul McCrone and colleagues at King’s College London, UK, and published in Pharmacoeconomics was one of the largest ever to look into the financial impact on society of people living with multiple sclerosis (MS). The new evidence has calculated that the total expense to the British economy of this disease amounts to a figure of GB£1.4 billion, placing it second only to tumors as Europe’s most costly brain condition.
The study analyzed the economic costs, quality of life and extent of disability associated with the disease and concluded that the societal cost of each person diagnosed to be an average of £17,000; the 85,000 sufferers in Britain explaining the £1.4 billion total. Of the 2000 Britons surveyed, half also had to give up their jobs owing to their illness meaning that the costs of each person diagnosed is pushed up to £25,000 when the burden of unemployment is considered.
Over 70% of the total costs were for informal care given by patients’ friends and families. With the costs of informal care equal to £1 billion alone, it is not surprising that Multiple Sclerosis Society grants for financial advice and assistance are in high demand.
Daniel Berry, Head of Policy and Campaigns for the Multiple Sclerosis Society, the charity behind this independent research, remarks: “This research shows the shocking cost of living with MS … It has been proven to be economically viable to keep people with MS as healthy as possible and in work for as long as possible and this study shows how cutting corners in health and social care is counterproductive … these figures underline the enormous costs of inaction. Long-term investment in research and in support for carers would pay dividends for people living with MS and for the whole economy.”
Lead study author McCrone agrees that: “The costs associated with MS are substantial. Most of the service costs are hidden as they represent care provided by family members … It is crucial that evaluations of any new treatments or forms of care should assess their impact on carer costs as well as the costs of statutory services.”
Source: Medical News Today: www.medicalnewstoday.com
New license agreement enables EQ-5D data to be collected remotely
eClinical solutions provider Perceptive Informatics has entered into a license agreement with the EuroQOL group which will allow the company to be one of the first in the industry to provide the standardized instrument EQ-5D, which assesses health-related quality of life outcomes research, through its Electronic Patient Reported Outcomes (ePRO) solution in an Interactive Voice Response (IVR) format.
The agreement means that EQ-5D information will be able to be collected via the telephone. Since this instrument is not disease-specific and will be available in 83 official language versions, it will be applicable to a wide range of health conditions as well as worldwide clinical programs.
With easy instructions for study participants, this program has received praise for its user-friendliness. Patients are able to access ePRO through a free-of-charge number, where they can access an application in their own language. Rapid progression through questions is facilitated through single index values for particular health statuses and through numerical responses to questions that can be entered via the telephone keypad. Clinical trial study sponsors will have rapid access to the information collected in this way through the ability to view the data in real time through an online web reporting capability.
Stephen Joel Coons, Member of the EuroQoL Group and Professor of Pharmacy and Public Health at The University of Arizona, AZ, USA believes that the existence of a new IVR version of the EQ-5D is a “significant breakthrough for the biopharmaceutical industry”.
“As sponsors are now using ePRO for major therapeutic areas across phases of trials, our goal is to offer more value to clients in this important component of an overall eClinical platform”, comments Steve Kent, President of Perceptive Informatics. “We are pleased to incorporate EQ-5D into our ePRO solution, working with the EuroQoL Group to provide biopharmaceutical companies with this well-respected, widely used instrument and additional level of standardization.”
Source: Perceptive Informatics: www.perceptive.com
Study shows depression can add significantly to cardiovascular costs in women
Thomas Rutledge and colleagues from the Veterans Affairs San Diego Healthcare System, CA, USA, have found that depression is associated with higher 5-year cardiovascular costs in women with suspected myocardial ischemia; reporting their findings in the Journal of the American College of Cardiology.
In the study, depression was quantified in several ways; recent antidepressant usage, history of treated depression and the Beck Depression Inventory score. Rutledge’s group analyzed data from 868 women suspected of having myocardial ischemia who had been referred for a coronary angiogram. The group collected data on cardiovascular healthcare use of the study contingent annually.
The report indicated that, although patients with depression presented with less severe coronary artery disease initially, they were more likely to have cardiovascular events during follow-up. Depending on the type of definition used, depression was associated with a 15–53% increase in 5-year cardiovascular costs compared with the control group, with depression–cost associations more pronounced in women lacking significant coronary artery disease. This suggests that depression could play a larger role in the costs of treating women lacking traditional markers of cardiovascular disease.
The authors believe that: “The results reinforce the importance of assessing depression in clinical populations and support the hypothesis that improved management of depression in women with suspected myocardial ischemia could reduce medical costs.”
Source: Rutledge T, Vaccarino V, Johnson D et al. Depression and cardiovascular health care costs among women with suspected myocardial ischemia: prospective results from the WISE (Women’s Ischemia Syndrome Evaluation) study. J. Am. Coll. Cardiol. 53, 176–183 (2009).
US food chains offer no-cost generic medicines in effort to attract recession-conscious customers
US chain store Wegmans Food Markets are offering no-cost generic oral antibiotics, such as amoxicillin and cephalexin in all of their 72 stores nationwide in a deal that offers customers up to a 14-day free supply of a total of nine generic antibiotics that would otherwise cost between US$8.99 and $13.99 for the uninsured. Medications that treat common viral illnesses, such as the flu and the common cold, will not be included in this deal. Retail experts have claimed that pharmacy sales make up approximately 10% of revenue at grocery stores in the USA. Colleen Wegman, President of the company, estimated that the program could save consumers $1 million and that the deal may become a permanent fixture if the program is successful over the next 3 months. This offer follows news that rival food chains, including Giant Food stores and sister company Stop & Shop are now also offering free generic antibiotics to their customers for a 3-month period. Robin Michel, Executive Vice President for Giant Food, believes that this new and aggressive sales strategy will appeal to customers during the economic recession: “If this is the way that we can help most people, why not?”
However, some physicians are concerned that no-cost antibiotics could encourage excessive use of the drugs, some of which are already being excessively prescribed, and could add to the ever-increasing problem of antibiotic resistance. In light of these offers, Thomas Campbell, Highland Family Medicine Physician and Chair of Family Medicine at the University of Rochester Medical Center, NY, USA has commented: “While I think the intent to save people money is laudable, I think Wegmans chose the wrong class of medications to offer for free.”
Source: Medical News Today www.medicalnewstoday.com