AstraZeneca has lost its appeal to the European Court of Justice against a €52.5m fine for its tactics to delay generic versions of Losec (omeprazole).

The company was fined by the European Commission in 2005 for manipulating regulatory approval in order to block generics.

According to the Commission, AZ launched a tablet version of the ulcer drug in 2001 and asked for the capsule’s authorisation to be withdrawn.

As a result, generic companies planning to launch their own capsule versions of omeprazole were blocked.

The Commission also claimed that AZ had deceived patent offices, courts and lawyers in several EU states over the date of Losec’s authorisation.

Losec, a proton pump inhibitor, was the world’s best-selling drug in 2000, but its European patent expired in 2001.

The European Commission commented that the appeal decision would prevent other companies from misusing drug regulatory procedures in order to protect their drug patents.

According to Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit, “This case exposed some of the strategems that pharma companies have used to delay the launch of cheaper generic versions of their drugs.

“By upholding the ruling, the court confirmed that pharma companies have to stamp out these practices or risk a substantial fine.”

Jonas Koponen of London law firm Linklaters commented that the decision was representative of “the European Commission’s policy of removing obstacles to competition from generics”.

Eisai Europe has launched a child-friendly drinkable medicine to treat seizures associated with Lennox-Gastaut Syndrome (LGS), a rare form of epilepsy.

Inovelon (rufinamide) is indicated as an adjunctive therapy for seizures caused by Lennox-Gastaut syndrome in patients aged four and older.

The orange-flavoured liquid formulation is designed to aid treatment in children whose condition means they have difficulty in swallowing tablets.

LGS affects up to three in every 10,000 children in Europe, accounting for 10% of childhood epilepsy cases.

Medication compliance is crucial to LGS management, as the disease causes frequent seizures associated with mental retardation and regression.

Inovelon, which regulates electrical charges in the brain, was approved in tablet form for LGS treatment in 2007. The drinkable version gained EMA approval in November 2011.

The UK and the Netherlands follow Germany in the European launch of the liquid Inovelon, with other EU countries to follow this year.

Helen Cross, Head of Neuroscience Unit at the UCL Institute of Child Health, London, commented: “Many children (and in fact adults), particularly those with complex epilepsy and associated neurodevelopmental problems such as LGS, experience difficulties with swallowing tablets. A suspension formulation of new and targeted medication is always welcome therefore to widen the availability to the full population of affected individuals.”

“The availability of the oral suspension formulation will hopefully make treatment easier for children and young people with LGS,” said Mike Bee, Eisai Europe’s Epilepsy Business Unit Director for EU North. “Our efforts are now focused to ensure that this new formulation is made available at centres throughout the UK as soon as possible.”

The development of anti-epileptic drugs is a major strategic focus for Eisai in the European market, Inovelon being one of three medications it currently sells in this therapy area.

The European Commission (EC) has authorised DuoCort Pharma’s Plenadren (hydrocortisone) to be marketed in the EU for the treatment of adrenal insufficiency.

The dual release hormone replacement therapy is the first pharmaceutical innovation in over 50 years for adults suffering from adrenal insufficiency, or cortisol deficiency.

Professor Gudmundur Johannsson, Chief Medical Officer at DuoCort Pharma, said: “Plenadren offers a welcome new treatment option to help patients suffering from adrenal insufficiency. It can improve therapy for many of the almost 200,000 patients in Europe who suffer from this disease and who need lifelong cortisol replacement therapy for their survival.”

The once-daily tablet is designed to imitate the normal physiological cortisol profile, with an outer layer that releases hydrocortisone immediately into the bloodstream and an inner core releasing the rest of the medicine gradually throughout the day.

Although glucocorticoid replacement therapy for adrenal insufficiency has been available for decades, complications have been linked to the medication, including premature death, impaired quality of life, increased risk of cardiovascular diseases, and decreased bone mineral density.

Adrenal insufficiency (cortisol deficiency) is a rare, life-threatening disease that affects patients in their active years. Patients require lifelong replacement therapy with hydrocortisone, the synthetic form of cortisol, replacing or substituting the hormones that the patient's adrenal glands are not producing.

DuoCort Pharma provides drug development with a focus on improving glucocorticoid therapy. The company is currently being absorbed by ViroPharma, who acquired the pharmaceutical company for an upfront payment of $33 million dollars in October.

ViroPharma has signed a definitive agreement to acquire Swedish-based DuoCort Pharma AB for an initial $33.6 million – but only if Plenadren is approved by the European Commission (EC).

Under the terms of the agreement, the deal will be closed after the tablet’s approval, after the EC’s confirmation of Plenadren’s orphan drug designation, and an amended agreement with the product’s contract manufacturer.

Vincent Milano, ViroPharma's President and CEO, says the deal is in line with the company’s “objective of broadening our orphan drug portfolio”.

Further milestone patients of up to $131 million associated with manufacturing, sales thresholds and territory expansion have also been agreed as part of the acquisition.

Plenadren is a once daily dual-release oral glucocorticoid tablet with a release profile designed to closely mimic the body's natural secretion pattern of cortisol. ViroPharma now anticipates the commercial launch of the treatment – which it says will be the first “true innovation in over 50 years” – of adrenal insufficiency in the EU within a year. It estimates that peak annual sales for Plenadren could reach up to $50 million.

The Committee for Orphan Medicinal Products confirmed in September that Plenadren’s orphan designation would be maintained and protected for a decade of market exclusivity.

Boston Scientific has launched the first iPad app to help healthcare professionals educate patients and carers about cardiovascular diseases and their treatment.

CardioTeach, available free of charge, provides an overview of normal heart function and the therapy options for atrial and ventricular arrhythmias, coronary artery disease, heart failure, heart rhythm disorders and peripheral vascular disease.

The app’s accessible content and graphics (see picture) help the clinician to explain specific conditions and procedures used to treat them, helping patients and their families to make informed choices.

Healthcare providers can also use CardioTeach to mark up anatomical illustrations with cardiac devices, add notes to a page or attach graphics to an e-mail for the patient or carer.

The patient can receive personalised cardiovascular education anywhere, helping them to make decisions and understand compliance and adherence requirements.

“Most medical device apps are designed to educate physicians on a specific product or therapy, said Leslie Saxon, Chief of Cardiovascular Medicine at the University of Southern California. “CardioTeach is unique because it lets clinicians better educate patients about their overall heart and vascular health and available treatment options.”

He added that CardioTeach gives patients “something they can reference after they leave my office and when thinking about or explaining what went on during the office visit,” as well as helping patients and their families “educate themselves prior to and between visits.”

Kenneth Stein, Boston Scientific’s Chief Medical Officer for Cardiac Rhythm Management, commented: “A recent study shows that one in five physicians use a tablet computer in their practice. Creating an app that enables healthcare professionals to use this technology to enhance communication with patients and caregivers is a logical extension of our efforts to empower patients with information about Boston Scientific’s therapies.”

Based in Massachusetts, USA, Boston Scientific is a global supplier of interventional medical devices.

Krka, d.d., Novo mesto has formally withdrawn its marketing application for Desloratadine Krka (desloratadine) with the EMA.

The generic of Aerius was intended to be used for the relief of symptoms associated with allergic rhinitis and urticaria.

In its official letter, Krka, d.d., Novo mesto said the withdrawal was down to a change in marketing strategy.

At the time of withdrawal, the tablets were awaiting marketing authorisation by the European Commission.

The application for a centralised marketing application was submitted to the EMA in February after Aerius was authorised for use in the EU in January. Prior to its application being pulled, the CHMP issued a positive opinion at its September meeting.

Mobisante has launched its MobiUS SP1 in the US, the world’s first smartphone-based ultrasound imaging system.

The device joins other portable point-of-care diagnostics that have recently entered the mobile health sector, including GE’s handheld visualisation tool Vscan and Siemens' Acuson P10.

The £4,700 MobiUS SP1 is designed for use in foetal, cardiac, pelvic, paediatric, musculoskeletal, peripheral vessel and abdominal imaging, providing the potential for enhanced patient care in any location, even remote areas.

The mobile health technology uses both cellular and WiFi networks, and consists of a Windows Mobile 6.5-based Toshiba TG01 smartphone, an ultrasound probe and computer software.

The manufacturer claims that the system could also be more suitable for use in low-income regions than traditional ultrasound equipment due to its lower operating costs and the increased convenience it would provide for patients.

Mobisante actually received FDA clearance for the device in February 2011, but it took eight months to implement necessary FDA-mandated controls.

The company is exploring the option of making a version of the product for healthcare-specific tablet computers as well.

A new smart phone application is being developed, that can measure heart rate, heart rhythm, respiration rate and blood oxygen saturation from the patient’s fingertip.

The new app uses the phone’s integrated video camera, and is claimed to be as accurate as standard medical monitors currently in clinical use.

Authors of the study at Worcester Polytechnic Institute (WPI), Massachusetts, USA, stated: “This gives a patient the ability to carry an accurate physiological monitor anywhere, without additional hardware beyond what's already included in many consumer mobile phones.”

“One of the advantages of mobile phone monitoring is that it allows patients to make baseline measurements at any time, building a database that could allow for improved detection of disease states.”

The application, developed by Ki Chon, Professor and Head of Biomedical Engineering, and colleagues at WPI, analyses video clips recorded while the patient's fingertip is pressed against the lens of the phone's camera.

The camera's light penetrates the skin, reflecting off blood in the finger. The device’s technology is able to link subtle changes in colour with changes in the patient's vital signs.

Chon’s team of researchers is also developing a version of the mobile monitoring technology for use on video-equipped tablets.

“We believe there are many applications for this technology, to help patients monitor themselves, and to help clinicians care for their patients,” Chon said.

The UK Government’s Department of Health called for new healthcare app ideas in August 2011.

The CHMP has adopted a positive opinion for Novartis’ Rasitrio, recommended as replacement therapy for patients with high blood pressure.

The single-pill treatment combines calcium channel blocker amlodipine with the diuretic hydrochlorothiazide (HCT) and Rasilez, the only approved direct renin inhibitor in the world.

Professor Roland E. Schmieder at the University Hospital of the University Erlangen-Nuremberg, Germany, commented that the drug will provide patients with a “comprehensive and convenient high blood pressure treatment in one pill”.

The CHMP positive opinion of Rasitrio is based on a Phase III clinical trial involving more than 1,181 patients with high blood pressure. Data showed that Rasitrio significantly reduced blood pressure compared to dual combinations of each of its individual components.

David Epstein, Division Head of Novartis Pharmaceuticals, said: “This positive CHMP opinion is an important step towards approval and making this new triple combination therapy available for patients whose blood pressure is not under control and who may require multiple medications.”

Approximately 1 billion people have high blood pressure worldwide, with many remaining uncontrolled despite treatment, with up to 85% of patients requiring multiple medications to help control their blood pressure.

High blood pressure can cause damage to the heart, brain and kidneys and is also linked with other conditions such as diabetes.

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”