The Scottish Medicines Consortium (SMC) has approved Buccolam (midazolam, oromucosal solution) from ViroPharma for emergency treatment of prolonged, acute epileptic seizures in children (aged over three months) and teenagers.

The decision will give youngsters in Scotland an alternative to the standard emergency grand mal treatment, rectally administered diazepam.

Buccolam will be marketed in Scotland by ViroPharma Ltd, a subsidiary of US company ViroPharma Inc.

The SMC considered that Buccolam was at least as effective clinically as rectal diazepam and was more cost-effective.

Buccolam, which has anti-convulsant, sedative and muscle-relaxant effects, can be administered by parents and carers of children with epilepsy.

The medication is administered from a prefilled oral syringe to the space between the cheek and gums, to be absorbed through the lining of the mouth.

While various unlicensed forms of midazolam have been used with children in the UK, Buccolam is the first to have received a Paediatric Use Marketing Authorisation licence (in September 2011).

The licensing of Buccolam follows the advice of MHRA in recent years that “specific children’s-only medicines” should be made available as an alternative to giving children “cut-down doses” of adult medicines.

“The SMC’s approval of Buccolam as an emergency medication is welcome news for hundreds of families and clinicians in Scotland,” commented Lesslie A. Young, Chief Executive of Epilepsy Scotland. “We are delighted that this licensed drug is now available to treat infants to teenagers with severe and prolonged epileptic seizures.”

Thierry Darcis, ViroPharma’s General Manager for Europe, commented: “We are committed to delivering solutions that address critical gaps in care for patients living with few, if any, clinical treatment options.”

Nearly a million children and adolescents in the EU suffer from active epilepsy, which causes life-threatening seizures.

Teva UK has launched generic versions of Eisai’s Aricept (Donepezil Hydrochloride) and Aricept Evess (Donepezil Hydrochloride) for the symptomatic treatment of mild to moderately severe Alzheimer’s.

Donepezil film-coated tablets and Donepezil Orodispersible (OD) tablets are now immediately available in the company’s award-winning Teva 360 livery.

Kim Innes, Commercial Director at Teva, says the launch continues the company’s aim to help the NHS save more than £9bn each year by using generic prescriptions.

The launch of Donepezil and Donepezil Orodispersible is the third generic in as many weeks for the treatment of Alzheimer’s after Teva released Galantamine, Zeebral XL following the loss of patent protection.

“As the leading generics company in the UK we have the widest portfolio of our competitors, with over 700 product lines,” said Kim Innes. “We also have a growing presence in branded areas such as respiratory and in the hospital sector.

"We’re continuing 2012 with strong product launches and patent expiries. We’ve launched five products in six weeks, including this launch of Donepezil and Donepezil OD tablets (Galantamine, Zeebral XL, Latanoprost and Latanoprost + Timolol).”

New guidelines for industry on pharmacogenetics – the application of genetics to drug development and use – have been published by the European Medicines Agency (EMA).

The guidance, which will come into effect on 1 August 2012, advises companies on how to take account of genetic variation between patients when evaluating drugs and applying for marketing authorisation.

It applies primarily to small-molecule drugs and to pharmacokinetic factors: variations in the way the body absorbs, distributes and metabolises medications.

These variations, which can be influenced by specific genetic factors, can affect the efficacy and safety of a drug.

Relevant genetic variations include abnormal DNA sequencing and abnormal numbers of a DNA sequence in body cells.

The guidelines state that a study of the pharmacogenetic aspects of the pharmacokinetics of a drug is required when the “magnitude of the inter-individual variation in drug exposure is so high as to likely influence the safety and/or efficacy of the drug in genetically variable populations”.

Examples would include drugs where a polymorphic enzyme or transporter gene is thought to be an important pathway in the drug’s metabolism, or where differences between individuals in the pharmacokinetics of the drug are likely to affect its safety or efficacy and cannot be explained by non-genetic factors.

The document also recommends pharmacogenetic studies in cases where major differences in pharmacokinetics are observed in different ethnic groups.

Advice is provided on designing and carrying out pharmacogenetic studies, evaluating the results, and adapting dosage or treatment recommendations and labels for genetic subpopulations.

Bristol-Myers Squibb has completed its $2.5 billion cash acquisition of biopharmaceutical company Inhibitex, Inc.

The deal includes Inhibitex’s lead compound nucleotide polymerase (NS5B) inhibitor INX-189 for the treatment of chronic hepatitis C and continues BMS’ approach to drug development.

Lamberto Andreotti, Chief Executive Officer, Bristol-Myers Squibb, said the deal “represents an important investment in the long-term growth of the company” when it was first announced last month.

The company’s ‘string of pearls’ strategy has seen it merge, partner or acquire a host of companies focusing on products in its core therapeutic areas since 2007.

Nucleotide polymerase (NS5B) inhibitor INX-189 is currently in Phase II trials in combination with pegylated interferon and ribavirin for chronic hepatitis C.

Analysts have predicted pharma companies will receive billion dollar sales for a number of hepatitis C therapies currently in development. The industry has also been given a much needed boost recently by the approval of new oral therapies including Merck & Co’s Victrelis (boceprevir) and J&J, Vertex Pharmaceuticals and Mitsubishi Tanabe’s Incivek/Incivo (telaprevir).

In December 2011, BMS entered into an alliance with Johnson & Johnson’s Tibotec for the development of an all-oral combination therapy based on BMS’ daclatasvir and Tibotec’s NS3 protease inhibitor TMC435. Phase II trials of the combination are planned to start later this year.

NICE has failed to recommend GSK’s Tyverb (lapatinib) or Roche’s Herceptin (trastuzumab) with aromatase inhibitors as first-line treatments for women with breast cancer in a second draft guidance.

Questions were again raised about the cost and effectiveness of both treatments when compared against existing options to delay the growth of advanced breast cancer that has already spread to other parts of the body, and for patients whose tumour cells react with oestrogen or progesterone and have high levels of HER2.

Sir Andrew Dillon, Chief Executive of NICE said that independent analyses indicate that both treatments “do not appear to be cost effective for the NHS” due to “uncertain clinical benefits”.

The second draft guidance follows an appeal from Roche against NICE’s independent Appraisal Committee and its initial findings published in July 2011. The Committee concluded that Herceptin did fulfil the small population criterion within NICE’s “end of life criteria”. This decision was subject to appeal, but upheld by an independent panel in November 2011.

Experts estimate that between 50 and 2,000 postmenopausal women are diagnosed with this type and stage of breast cancer each year. It is believed that the majority of these women are likely to be offered Herceptin as a first-line treatment option.

Tyverb and Herceptin would only usually be considered as first-line options alongside aromatase inhibitors when chemotherapy is deemed unsuitable – but it is unclear how many patients this would be relevant to.

“Having reviewed the available evidence, our committee of experts has found that while both lapatinib and trastuzumab can reduce the growth and further spread of metastatic breast cancer tumours when taken alongside the aromatase inhibitors letrozole and anastrozole, the extent that these treatments can improve overall survival appears to be small or undefined,” said Sir Andrew.

The Scottish Medicines Consortium (SMC) also failed to recommend the use of Tyverb or Herceptin for use on the NHS in Scotland for this particular type and stage of breast cancer when it recently published advice.

NICE’s draft guidance has now been issued for consultation. The deadline for comments to be received is Tuesday 6^th March. The independent Appraisal Committee will then meet to review any submissions.

According to the BMJ, GPs are standing “baffled in the wreckage” of the NHS. Qualified blog provider Maxine Vaccine tries to make sense of the ‘clinician-led’ NHS reform that clinicians overwhelmingly reject.

The Government’s NHS reform policy will empower clinicians. It will improve the productivity of a service that has declined severely over the last decade and is performing badly by European standards. It will ensure that healthcare in England remains free. It will reduce bureaucracy, empower patients and ensure better outcomes.

All the above claims, made by Health Secretary Andrew Lansley over the last 18 months, have now been challenged by the major organisations of health professionals and by independent health experts such as the King’s Fund. As the ‘listening exercise’ delivered only minor changes and the NHS reform proceeded according to schedule despite the delays to legislation, the mood of health professionals and the public has soured. The impression has been not of representative democracy but of business deals sewn up behind closed doors, with ‘proposals’ magically becoming a fait accompli.

Here (summarised from a number of sources) is the reality as it is currently understood by the majority of health professionals and health experts:

The Government’s NHS reform policy will force clinicians to accept the control of private healthcare corporations. It will destroy the capability of the NHS as a health service and make it basically the UK equivalent of Medicare. It will severely reduce the availability and reliability of services – following a decade in which the performance of the NHS improved and took steps towards catching up with most of Europe. It will increase bureaucracy and take away the entitlement of patients to free comprehensive healthcare.

What’s not to love, right?

The NHS has been subjected to what Naomi Klein called the ‘shock doctrine’: a sudden and traumatic lesson in the ethos of the free market. All that means is that the Government is behaving like a corporation. For the pharma industry, therefore, the NHS reform programme feels like coming home.

Last month, a doctor and health lecturer writing in the BMJ asked how he could explain to his students how the Health Bill being mostly enacted before it has become law, and that state of affairs being used to railroad the Lords into letting it pass without delay, is not “contempt of Parliament”.

This week, the former vice chair of the Local Commissioning Group in Cambridge, also writing in the BMJ, said that he and his colleagues were now standing “baffled in the wreckage” of a system the Government had promised it would improve.

And the fact that the 2010 Conservative Party manifesto explicitly promised not to impose major structural change on the NHS is such a distant memory that these days, it barely rates a mention.

So what has the Government done? It made a promise it had the clear intention of breaking. It declared a consultation period that was purely for show. It said one thing to its business friends and another to the public. It tried to persuade its employees that massive layoffs were in their best interests.

To put it bluntly, it did everything that a good corporate management team would be expected to do.

Somebody should give them a bonus.

Maxine’s views are not necessarily those of Pharmaceutical Field.

Vernalis, a UK development-stage pharmaceutical company, has partnered with US specialist company Tris Pharma to develop and commercialise new therapies for the US prescription cough/cold market.

Under the terms of the exclusive licensing agreement, Tris will develop up to six new drug applications (NDAs) which Vernalis will then acquire and commercialise in the US.

Vernalis will pay development milestones to Tris on each product, as well as paying a royalty on sales.

Tris specialises in the R&D of products using drug delivery technologies to provide sustained-release dosage forms.

“This transaction is fundamental in transitioning Vernalis into a diversified and self-sustaining pharmaceutical company,” said Ian Garland, CEO of Vernalis.

“The US cough/cold prescription market is a market that we know extremely well and Tris is a uniquely positioned development partner, with proven capabilities validated by multiple NDA approvals.”

Ketan Mehta, CEO of Tris, commented: “The US cough and cold market has been ripe for innovation and when you consider that market research shows most adults prefer long-lasting relief in the form of a liquid, rather than solid dose, our technology is well positioned to address this market.”

Based near Reading, Vernalis is a revenue-generating development-stage pharmaceutical company that seeks to commercialise product candidates. Its partners include Endo, Genentech, GSK, Lundbeck, Menarini, Novartis and Servier.