Orphan drug company Swedish Orphan International (SOI) will be moving to bespoke new offices in Cambridge this summer.

The company says that the new environment will provide an appropriate infrastructure to enable SOI to bring more orphan drugs to market and so improve the lives of many more patients with rare diseases.

Bruce Faulkner-Dunkley, the UK Managing Director, explains the difference this new location will make: “Although ‘orphan diseases’ affect no more than five in every 10,000 people, these illnesses are life-threatening and chronically debilitating. We at Swedish Orphan in the UK are committed to making a difference and ensuring that physicians are aware that the products are available, and working with the different patient organisations to ensure that patients gain access to these life-changing medications.

“Being in surroundings which are professional and designed for our purposes will enable the team at Swedish Orphan International to bring more drugs to market more efficiently in the UK.”

SOI aims to provide patients, healthcare professionals and the pharmaceutical industry with a global network specialising in the development, marketing and distribution of orphan drugs for the treatment of rare disorders, and products and services to satisfy unmet medical needs.

The company’s current portfolio includes Orfadin (nitisinone) for Hereditary Tyrosinaemia type 1 (HT-1), Ammonaps (sodium phenylbutyrate) for urea cycle disorders and

Ferriprox (deferiprone) for iron overload in patients with Thalassaemia major.

Pfizer has entered into an agreement with Private Access to create a new online community aimed at increasing clinical trial awareness and participation in the US.

Pfizer says its collaboration with Private Access, a provider of privacy-enhanced search technology, will help address patients’ and physicians’ key concerns regarding research and clinical trials and will encourage social networking on the clinical trial experience.

The companies hope to reduce the time needed to develop new and improved treatments by making it possible for researchers and investigators to conduct more focused searches for clinical trial candidates.

Private Access’ patented technology allows patients to control who has access to their personal health information. By granting “private access” only to researchers focused on the conditions that interest them, patients can be matched to appropriate clinical trials while protecting their confidential information.

Nearly 85% of patients in a recent survey stated they were unaware that clinical trials were a possible treatment option, and 31% of physicians surveyed did not refer patients to trials due to, among other things, lack of information.

According to a study commissioned by the Institute of Medicine, the number one reason why patients who were aware of trials were not willing to participate was fear that their health information would not remain confidential.

“Many patients who could benefit from participation in clinical trials don’t enroll in them because they are not aware that potentially relevant research is under way or they cannot find a specific trial to meet their needs; others worry that they will lose control of their health information,” said Freda Lewis-Hall, Pfizer’s Chief Medical Officer.

“By introducing technology that honors each patient’s privacy needs, we can leverage the efficiency of Internet-based search for clinical trial patients – speeding up the recruitment process and the discovery of new treatments,” added Robert Shelton, founder and CEO of Private Access.

Liver cancer cases have tripled in the last 30 years, according to statistics published by Cancer Research UK.

The dramatic increase has been in primary liver cancers, which is when the cancer actually starts in the organ, rather than spreading there.

Experts have said that hepatitis C infections, alcohol and obesity have increased the frequency of liver disease, which if left untreated can develop into cancer.

Commenting on the figures, Imogen Shillito, Director of Information and Education at the British Liver Trust, said: “We know liver cancer is caused by years of liver damage, often from infection with hepatitis B or C, or regular excessive drinking. But there are many interventions that can prevent liver cancer. In particular, if people at risk are screened for hepatitis B or C and are offered effective treatment before liver damage has set in, their risk of liver cancer drops dramatically.”

She added: “We need an integrated strategy to prevent liver disease, and diagnose and treat it effectively before patients progress to develop liver cancer. This needs dedicated action across the NHS, but could save lives and stem the rising tide of liver disease and death.”

Drug information provided by pharma companies is often too complex for patients to understand, argues a new report by Cutting Edge Information.

Despite heavy spending on patient education, adherence and disease management efforts, campaigns are often ineffective because the material is too complex for patients to understand.

The report is based on research in the US, where pharma companies are able to provide information about their drugs for patients. However, proposals are currently being reviewed in the EU to allow similar information provision in the UK.

According the report, Designing Patient Communications Programs, providing material that is overly dense or complicated causes pharmaceutical companies to miss their best opportunity to connect with their patients. For example, patients are less likely to recognise a symptom list as reflecting their own health problems and to ask their physician whether they might have an illness.

In addition, many educational materials highlight the importance of refilling prescriptions as they run out and of taking medication as prescribed by a doctor – these adherence messages will be overlooked or ignored if the patient cannot understand the potential consequences of skipping doses.

“Brand managers are sometimes more concerned with completeness than accessibility because of regulatory demands. As a result, many patients don’t make it past the first paragraph before they stop reading a brochure,” said Jason Richardson, President and CEO of Cutting Edge Information.

While pharmaceutical companies design patient programmes to provide information to patients, patients are not the only beneficiaries.

“Doctors are not receiving pens and pads from physicians any more, but they do appreciate the informational brochures that pharmaceutical companies provide if the content is unbranded and objective,” said Jeremy Spivey, the report’s lead author.

“If the material leads to more questions than answers, however, physicians are unlikely to distribute it to patients, and drug companies will miss a key opportunity to improve their reputations among physicians.”

Pharma and healthcare market intelligence provider IMS Health has appointed a new General Manager to lead its divisions in the UK, Ireland and South Africa.

Seyed Mortazavi will be responsible for all aspects of the company’s local market business operations with effect from 13 July 2009.

Previously, Mortazavi led IMS’ sales and business line function in its Americas region. For 10 years prior to moving to the US, he held various positions of increasing responsibility in IMS’ UK and EMEA sales organisations – latterly as Vice President, Sales, EMEA.

Mortazavi succeeds Paul Johnson, who has been reassigned within the company.

Operating in more than 100 countries, IMS boasts more than 50 years of industry experience and offers product and portfolio management capabilities, commercial effectiveness innovations, managed care and consumer health offerings, and consulting and services solutions.

GlaxoSmithKline plc (GSK) has launched a unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil.

The agreement will establish a new research and development collaboration programme at Fiocruz to develop a vaccine for dengue fever, a mosquito-borne disease that globally places 2.5 billion people at risk of infection.

GSK will also provide Fiocruz with access to the technology behind its 10-valent conjugate vaccine for paediatric pneumococcal disease, internationally known as Synflorix. The Brazilian government will incorporate the vaccine into its national immunisation programme in the coming months.

“Brazil has excellent vaccine research facilities,” said Abbas Hussain, President of Emerging Markets at GSK. “This collaboration with Fiocruz is a key piece of our strategy to partner with emerging middle-income countries. Together, we will be able to develop and make available new vaccines to benefit public health in Brazil.”

Synflorix, which protects against life-threatening diseases such as pneumonia, meningitis and bacteraemia, was approved by Brazilian regulatory authorities in June 2009. The vaccine also protects against otitis media (middle ear infection), which has a considerable impact on Brazil in terms of individual suffering and associated public health costs.

GSK Biologicals and Fiocruz initiated their first collaboration with an agreement to supply oral polio vaccines in 1985. Since then, the companies have formed several strategic alliances to provide Brazilians with key vaccines, including vaccines against Haemophilus influenzae type b (Hib), MMR (measles, mumps and rubella) and rotavirus.

“This new agreement continues and expands Brazil’s groundbreaking commitment to innovation in public health,” said Dr Paulo Gadelha, President of Fiocruz. “The partnership will enhance Brazilian R&D capacity, improve the health of our citizens and cement Brazil’s role as a leading partner on vaccines.”

The number of authorised generics (AG) agreements will grow, in tandem with the increasing convergence between branded and generic drug companies, a new report by independent market analyst Datamonitor forecasts.

Competitive pressures in the US and Europe have radically altered the brand-generic dynamic, to the extent that the line between the two is beginning to blur, with AG agreements one outcome of these developments, the report says.

Authorised generic agreements, where companies market generic versions of their own branded drugs, provide innovators with a means of capitalising on the generic erosion of their own brands.

AG agreements involve a branded drug and generics partner, sometimes the company’s own generics subsidiary. Such ‘own-AGs’ allow the branded company to retain all revenues derived from AG sales, rather than just a fraction as is the case when the generics partner is external.

Datamonitor analysed 40 AG launches in the US between 2004 and 2008. Though only a third of the 14 branded companies under investigation could market an own-AG, these constituted 45% of all AG launches.

AG launches for branded cardiovascular, infectious disease, and central nervous system drugs were responsible for most (60%) of the AG launches under analysis. This supports the idea that companies will defend their most lucrative brands – the blockbusters – with the greatest vigour.

“Although the issue of AGs has come under scrutiny across the board, there have yet to be any definitive conclusions regarding their anticompetitive nature,” said Datamonitor healthcare strategy analyst Pam Narang.

“Moreover, the FTC’s recent AG report actually implies that AGs are pro-consumer, due to their impact on generic price. Notwithstanding the lobbying efforts of some of the larger generics companies, therefore, AGs look to remain a fixture in the battle between branded and generics pharma in the short term,” she added.

This month the CHMP adopted positive opinions for the following medicines:

• Regeneron’s Arcalyst (rilonacept) for the treatment of adults and children aged 12 years and older with severe symptoms of Cryopyrin-Associated Periodic Syndromes (CAPS)
• Novartis Europharm’s Exforge HCT (amlodipine besylate/valsartan/hydrochlorothiazide), Copalia HCT (amlodipine besylate/valsartan/hydrochlorothiazide), Imprida HCT (amlodipine besylate/valsartan/hydrochlorothiazide) and Dafiro HCT (amlodipine besylate/valsartan/hydrochlorothiazide), all for the treatment of essential hypertension
• Novartis Europharm’s Ilaris (canakinumab) for the treatment of adults, adolescents and children aged 4 years and older with Cryopyrin-Associated Periodic Syndromes (CAPS)
• Ratiopharm’s Ratioepo (epoetin theta) and Eporatio (epoetin theta), and CT Arzneimittel’s Biopoin (epoetin theta) for the treatment of symptomatic anaemia associated with chronic renal failure and in adult cancer patients with non-myeloid malignancies receiving chemotherapy
• Movetis’ Resolor (prucalopride) for chronic constipation in women.

The following generic medicines were also recommended for marketing authorisation:

• Enyglid (repaglinide) and Repaglinide Krka (repaglinide) from Krka DD Novo Mesto, generics of Novonorm, for type 2 diabetes
• Irbesartan Teva (irbesartan), a generic of Aprovel, for essential hypertension
• Lamivudine Teva (lamivudine), a generic of Zeffix, for chronic hepatitis B in adults
• Clopidogrel MYLAN Pharma (clopidogrel, as besilate), a generic of Plavix, for the prevention of atherothrombotic events in patients suffering from myocardial infarction or established peripheral arterial disease.

The Committee gave positive opinions for new treatment options for the following medicines:

• MSD’s Isentress (raltegravir), to extend the indication to include antiretroviral treatment naïve adult patients
• UCB’s Keppra (levetiracetam), to extend the use of the medicine to children and infants for the adjunctive treatment of partial seizures (fits) with or without secondary generalisation
• Roche’s Mabthera (rituximab), to include the treatment of relapsed/refractory chronic lymphocytic leukaemia
• Wyeth’s Torisel (temsirolimus), to include adult patients with relapsed and/or refractory mantle cell lymphoma.

Amgen has formed a partnership with GlaxoSmithKline to commercialize denosumab for the treatment of postmenopausal osteoporosis in Europe and emerging markets.

Denosumab is the first monoclonal antibody to be developed for osteoporosis and is currently being reviewed by regulators.

Under the terms of the deal, Amgen will retain full rights in the US and Canada and those for oncology indications in Europe. GlaxoSmithKline will be responsible for marketing the drug in several countries, including those in Europe, and will commercialise the drug for osteoporosis and oncology in the emerging markets.

Industry analysts Datamonitor have stated their belief that this is an ideal partnership to increase denosumab’s potential in the competitive European market, as Amgen has lacked the sales force and the knowledge to market denosumab in the EU.

Denosumab also provides a good opportunity for GlaxoSmithKline to grow its market presence while protecting future franchise revenues in anticipation of Bonviva’s patent expiry. However, Datamonitor believes the company will face a challenging market in Europe, due to the predicted high cost of the drug compared to the current therapy.

The FREEDOM trial, published in the New England Journal of Medicine this week, revealed that twice-yearly denosumab significantly increases bone mineral density and reduces the risk of suffering a vertebral fracture in women by 68%.

Datamonitor added: “Data released by Amgen have shown that denosumab is more effective than alendronate in increasing bone-mineral density, but is equivalent in terms of fracture prevention.”

The Royal Pharmaceutical Society of Great Britain (RPSGB) has called on the Prime Minister to introduce parity between nurses and pharmacists in the prescribing of controlled drugs.

The RPSGB is disputing the ability of nurses to prescribe controlled drugs in certain conditions as independent prescribers while pharmacist independent prescribers cannot do so, even in the case of controlled drugs that they sell as ingredients in over-the-counter medicines.

The Society believes that many patients are disadvantaged by the current disparity. In its submission the RPSGB has called for both nurse and pharmacist independent prescribers to prescribe an unrestricted range of controlled drugs for patients in their care.

“Pharmacists are experts in medicines and are a recognised resource for healthcare professionals and patients,” said Howard Duff, the RPSGB Director for England. “Allowing pharmacist independent prescribers the ability to prescribe controlled drugs will expand access to important medicines which improve quality of life by helping manage chronic conditions.

“At a time when pressure on the primary care team is increasing day by day, we see this extension of the pharmacists’ role as vital in its ability to further support community-based medicine. This is especially true for pharmacists working within palliative care teams and hospices, where they provide expertise in medicines but cannot prescribe many useful treatments.”