NHS drug shortages: why are we running out of some treatments in the UK?

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The NHS is facing shortages of some important drugs used to relieve pain and treat cancer

The NHS is running low on some key drugs used to treat cancer and other diseases. The alternatives can cost more money and provide less effective treatment. Last year nine out of 10 GPs said they had been forced to write prescriptions for “second choice” medicines because their preferred drug was out of stock.

Writing in the British Medical Journal, Margaret McCartney, a GP in Glasgow said shortages “harm patients directly” and put pressure on primary care.

Dr McCartney said: “Instability of basic drug supplies is an avoidable pressure, one being absorbed (as usual) by general practice.

“A combined total of 5% of my latest day on call was spent trying to fix prescription supply problems, one by tedious one.”

Bladder cancer

One drug that is in short supply is the BCG vaccine, used to treat bladder cancer. It can prevent cancer from returning and reduce the risk of it becoming invasive.

Since a Canadian factory stopped production in 2012, more patients have been forced to undergo a removal of the bladder because they cannot be treated with the drug.

Some such patients will go on to wear a urostomy bag, or plastic bladder, outside their bodies for the rest of their lives. Faced with the shortage, doctors are having to give patients just one third of the dose normally recommended. Bladder cancer is the seventh most common cancer in the UK, with 10,000 pepole diagnosed with the disease every year.

 Controlling pain

Another drug in short supply is clonazepam, which is used for both epilepsy treatment and to relieve pain in palliative care. The cost has risen since since manufacturer Roche discontinued supplies to the UK because of profitability and low demand. The drug now has to be imported from abroad at a higher cost.

Ashgate Hospice in Chesterfield told the BBC they have had to cut back on the use of the injectable drug by 80 per cent because the price has risen from 67p a vial to £33. The shortage is likely to mean more pain for patients struggling with terminal illnesses at the end of their life.

 What more could the Government do?

Some argue that the Department of Health’s emphasis on pushing down costs puts more pressure on drug availability. According to the British Generic Manufacturers Association, the Department of Health drives a hard bargain, meaning fewer companies choose to tender for contracts. As a result, supplies can run short if a problem occurs.

In some instances, the NHS could look to alternative treatments which could be licensed in the UK to fill the gap from an unavailable drug. The Department of Health said: “We work closely with the Medicines and Healthcare products Regulatory Agency, NHS England, the pharmaceutical industry and others in the supply chain to help prevent medicine shortages and to minimise the risk to patients on the rare occasions that issues do arise.”

By: Sophie Jamieson

Source: The Telegraph

Roche drug succeeds in hard-to-treat form of multiple sclerosis

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Switzerland’s Roche said on Monday its experimental drug ocrelizumab had proved effective against hard-to-treat primary progressive multiple sclerosis in a keenly awaited final-stage clinical trial.

The injectable antibody medicine is the first product to show positive study results in both the progressive form of the disease and more common relapsing forms, underscoring its multibillion-dollar sales potential.

Chief Executive Severin Schwan had told Reuters in an interview earlier this month that the drug’s success in relapsing MS already made it a “huge opportunity” and a positive result in primary progressive multiple sclerosis (PPMS) would be “pure upside”.

The drugmaker now plans to submit data to global regulatory authorities for approval of ocrelizumab in treating both forms of multiple sclerosis in early 2016, implying it could reach the market around a year later.

Results from a pivotal Phase III study of the drug in PPMS showed that treatment with ocrelizumab significantly reduced the progression of clinical disability and the effect was sustained for at least 12 weeks.

The incidence of serious adverse events associated with ocrelizumab, including serious infections, was also similar to placebo.

Safety is crucial to success. Because MS is caused by abnormal immune system attacks on the protective sheath surrounding nerve cells, treatments need to adjust the body’s immune response, which can lead to dangerous side effects.

Preliminary data from the clinical trial will be presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis on Oct. 10.

Shares in Roche gained 2.5 percent by 0715 GMT, also buoyed by encouraging results reported at the weekend for its new immune-system boosting drug atezolizumab in lung and bladder cancer, that the company hopes will help it win quick regulatory approval.

By Ben Hirschler

Source: Reuters

(Editing by Louise Heavens and David Holmes)

Researchers find key cellular enzyme that could be effective drug target for urologic cancer cells

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Researchers at the SUNY Upstate Medical University have found that a key cellular enzyme, c-Abl, could be an effective drug target in cancer cells for urologic cancers, such as prostate and kidney.

Ongoing research into treatments for kidney cancer is especially important since kidney cancer is known to be resistant to current chemotherapy and radiation.

In this study, researchers uncovered a mechanism whereby the Heat Shock Protein 90, or Hsp90, could be disrupted or disengaged from its role as chaperone of cancer cells. By acting as a guardian of cancer cells, Hsp90′s role is to help cancer cells grow and thrive. This disruption is essential to halt the growth and kill the cancer cells.

Previous research showed that the disruption of Hsp90 from its activator, Aha1, sensitizes cancer cells to Hsp90 drugs. The Upstate researchers used specific compounds aimed at the regulator of Aha1, known as c-Abl1, to successfully disconnect Aha1 from Hsp90. With the regulator Aha1 disrupted, researchers were able to show that Hsp90 drugs can be used more effectively in inhibiting kidney cancer cells growth. Hsp90 drugs have been tested successfully in clinical trials for breast cancer, lung cancer, leukemia (multiple myeloma) and gastric cancer.

Upstate’s research was led by Mehdi Mollapour, Ph.D., an assistant professor of urology and biochemistry and molecular biology; Diana Dunn, a graduate student in the laboratory; and Mark Woodford, a research assistant; and was completed in collaboration with Dimitra Bourboulia, Ph.D., an assistant professor; and Gennady Bratslavsky, M.D., professor and chair of urology, all at Upstate Medical University.

According to Mollapour, the findings of this study will not only “help enhance the efficacy of Hsp90 drugs in the clinic, but also lay a foundation for future studies aiming to understand combination therapy with Hsp90 drugs.”

The scientific community is working with measured enthusiasm studying and testing ways to disrupt Hsp90′s role as a guardian of cancer cells, thereby enabling cancer survival. The research was conducted at Upstate and used kidney tumors from patients that were treated by urologic surgeons at Upstate Urology.

About 61,000 new cases of kidney cancer are diagnosed each year, with about 14,000 people dying from the disease.

The most common form of kidney care is renal cell carcinoma, which is resistant to chemotherapy. Mollapour says, “this type of study brings Hsp90 drugs closer to a clinical trial testing in kidney cancer patients.”

Source: SUNY Upstate Medical University / news-medical.net

Doctors ‘face jail over pharma payments’

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Jeremy Hunt says pharma sales reps have been ‘ripping the NHS off’

Healthcare professionals who have inappropriate financial links with pharma companies will face prosecution and up to 10 years in jail, under Government plans for a major crackdown on industry transparency.

From next year Health Secretary Jeremy Hunt plans to bring in new rules to force all NHS hospitals and GP clinical commissioning groups to keep a registers of all payments accepted from pharma companies – to weed out corruption in the NHS.

Mr Hunt is acting in the wake of allegations made in the national press. Prescribing staff were recorded discussing payments with a fictitious pharma company, who offered to pay to arrange meetings about NHS formularies, switching drugs and influencing doctors’ prescribing decisions.

Under the new transparency rules, any member of staff who fails to declare full details of payments they receive will face disciplinary action. If they are found guilty of wrongdoing they could be prosecuted under the Bribery Act, which can result in unlimited fines and up to 10 years in jail. It is not clear if there will be any sanctions for pharma companies above investigated by the Prescriptions Medicines Code of Practice Authority.

Writing in The Daily Telegraph, Mr Hunt says the plans for a UK ‘Sunshine Act’ – similar legislation to that in place in the US which requires mandatory disclosure of all payments made by pharma companies to doctors – will promote greater transparency in the industry.

Mr Hunt said the revelations made in the investigation were “disturbing evidence of NHS staff and professionals, alleged to have received payment or hospitality from pharmaceutical firms and medical device manufacturers to influence NHS purchasing decisions.”

“Even worse, the investigation suggested that some NHS staff and professionals making these decisions may have been influenced by extravagant hospitality,” Mr Hunt says. “It’s hard not to conclude that some sales reps have been ripping the NHS off, and diverting taxpayers’ money away from patient care.”

Hunt says he does not want to stop ‘sensible collaboration between private firms and the health service “but we must not tolerate abuse,” he adds.

The ABPI says it welcomes the move, as “a positive addition to the existing industry-led drive for disclosure and transparency around industry relationships with healthcare professionals.” The trade body has its own plans for a publicly accessible database to record payments made by companies to named doctors, although this will not be mandatory.

In response to the article, Dr Virginia Acha, the ABPI’s executive director of research, medical and innovation, says: “We would welcome the opportunity to work with the Department of Health and NHS England as plans for the ‘Sunshine Rule’ develop, to ensure that we maximise our combined efforts on disclosure for the benefit of patients and the public.

“It appears that whilst declarations of gifts and hospitality made under the proposed Sunshine Rule signal a common ambition for greater transparency in our relationships, it will cover just a small proportion of the important interaction between industry and HCPs in comparison to our own disclosure requirements.

“For that common ambition for greater transparency to really improve relationships between healthcare professionals and industry, we also need to align on the great value of those relationships to deliver advances in science and treatment for patients, including research.  We have always maintained these interactions are a critical part of advancing improved healthcare outcomes for patients within appropriate and transparent governance frameworks.”

Source: Pharmafile online - By Lilian Anekwe

Female Viagra approved by health regulators

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The first prescription drug designed to boost sexual desire in women has been approved by regulators in the US. The move by the Food and Drug Administration (FDA) was a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.

But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the 1990s.

The drug’s label will bear a boxed warning – the most serious type – alerting doctors and patients to the risks of dangerously low blood pressure and fainting, especially when the pill is combined with alcohol.

The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.

“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr Janet Woodcock, director of the FDA’s drug centre.

Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counselling patients about Addyi’s risks.

Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.

Opponents of the drug say it is not worth the side effects, which also include nausea, drowsiness and dizziness. They point out that the FDA rejected the drug twice, in 2010 and 2013, due to these risks.

“This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” said Leonore Tiefer, a psychologist and sex therapist who organised a petition last month calling on the FDA to reject the drug.

Patients should stop taking the drug after eight weeks if they do not see any improvement, notes the FDA release.

Sprout Pharmaceutical’s drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a U-turn by the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects.

The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.

On one side, Sprout and its supporters have argued that women need FDA-approved medicines to treat sexual problems. But safety advocates and pharmaceutical critics warn Addyi is a problem-prone drug for a questionable medical condition.

Beginning with the drug’s launch in October, doctors who see patients complaining about a loss of sexual appetite will have a new option.

 “Women are grasping, and I feel like we need to offer them something that acknowledges that, and that we can feel safe and comfortable with,” said Dr Cheryl Iglesia, a surgeon and official with the American Congress of Obstetricians and Gynecologists.

 The search for a pill to treat women’s sexual difficulties has been something of a holy grail for the pharmaceutical industry. It was pursued and later abandoned by Pfizer, Bayer and Procter & Gamble, among others. But drugs that act on blood flow, hormones and other biological functions all proved ineffective.

 Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite. Women and their doctors will have to decide whether the drug’s modest benefits warrant taking a psychiatric pill on a daily basis.

 Company trials showed women taking the drug generally reported one extra “sexually satisfying event” per month, and scored higher on questionnaires measuring desire.

 Ms Tiefer and other critics said the FDA was pressured into approving the drug by a feminist-themed lobbying campaign funded by Sprout and other drugmakers. For now, executives at Sprout, based in Raleigh, North Carolina, are setting modest expectations for Addyi, their first and only product. The company will focus its 200 sales representatives on promoting the drug to medical specialists.

Women with insurance can expect to pay between 30 dollars (£19) and 75 dollars (£47.86) per month for Addyi.

 The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, a lack of sexual appetite that causes distress. Surveys estimate that 8 to 14% of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million US women.

 Because so many factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship issues, medical problems, depression and mood disorders. The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.


Source: Western Morning News

Authour: WMNA Greenwood 


Spiolto Respimat provides meaningful quality of life improvements in COPD

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New data from the Phase IIIb OTEMTO® 1&2 trials show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with chronic obstructive pulmonary disease (COPD).

The data is published online in the journal Respiratory Medicine.

For COPD patients, breathlessness, among other symptoms, limits their ability to keep active and has a negative impact on their daily lives. As there is no cure for COPD, improving quality of life is a major goal of treatment. In COPD, quality of life is measured using the St George’s Respiratory Questionnaire (SGRQ); a reduction in SGRQ score of 4 points or more is deemed clinically meaningful. The OTEMTO trials show Spiolto Respimat provides a reduction in SGRQ total score of 4.67 versus placebo.

Data shows Spiolto Respimat regimen helped COPD patients maintain a more independent life

“The improvement in quality of life provided by Spiolto Respimat in these trials could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life,” said Dave Singh, Professor of clinical pharmacology and respiratory medicine, University of Manchester and lead investigator of the OTEMTO trials. “For example, this could mean that patients are able to walk up stairs without stopping, go out to socialise with friends or find it easier to wash and dress. Essentially, the data show that patients feel much better.”

Source: europeanpharmaceuticalreview.com

Author: Victoria White

CSL acquires Novartis global influenza vaccine business for $275m

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Australia’s biotechnology firm CSL has completed the acquisition of global influenza vaccine business from Novartis for around $275m.

The deal was first announced by both firms in October 2014.

CSL will incorporate the acquired business in its subsidiary bioCSL, as the transaction concluded.

The combined business is claimed to be the second largest influenza vaccine business in the $4bn global industry.

With manufacturing facilities in the US, UK, Germany and Australia, the business includes differentiated product portfolio and strong pandemic and pre-pandemic franchises in around 20 countries.

According to CSL, the combined business will complete all clinical programmes underway and market all bioCSL and Novartis influenza vaccine brands in various markets.

The combined business will continue to in-licence and supply a wide range of vaccines and specialty pharmaceuticals, as well as produce blood typing reagents for local use in Australia.

It will also continue to produce anti-venoms and Q fever vaccine, claimed to be the world’s only supplier of these Australian medicines.

At the time of acquisition, bioCSL general manager Dr John Anderson said: “This will transform bioCSL’s existing influenza vaccine business, giving us first class facilities, global scale and product and geographical diversity.

“bioCSL is absolutely focused on its critical role as Australia’s onshore supplier of influenza vaccine, which underpins its pivotal position in both the nation’s influenza pandemic preparedness and swift seasonal responses to influenza.”

Source: Pharmaceutical-technology.com

Sanofi and Regeneron partner to develop new antibody cancer treatments

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Sanofi has partnered with Regeneron Pharmaceuticals to discover, develop and commercialise new antibody cancer treatments in the field of immuno-oncology.

Under the deal, both firms will jointly develop a programmed cell death protein 1 (PD-1) inhibitor that is currently in Phase I testing and intends to start clinical trials in 2016 with new therapeutic candidates based on ongoing and innovative preclinical programmes.

The new deal will cover both monoclonal antibodies and new bi-specific antibodies. Regeneron will take the responsibility for discovery, antibody generation and development through proof-of-concept (PoC), while Sanofi will take care of further development and commercialisation.

With an ability to extend the collaboration for selected ongoing programmes for an additional three years, the exclusive collaboration to discover and develop potential monotherapy or novel combination immuno-oncology antibody candidates through PoC will be for five years.

Regeneron chief scientific officer and Regeneron Laboratories president Dr George Yancopoulos said: “The efficiency and power of our suite of technologies, such as VelocImmune and VelociGene, combined with our human genetics capabilities, uniquely positions the alliance to accelerate the development of potential new immuno-oncology treatment options for cancer patients.”

As part of the deal, Regeneron will receive an upfront payment of around $640m from Sanofi and the firms will invest $1bn in discovery through PoC development (Phase II a study) of monotherapy and novel combinations of immuno-oncology antibody candidates to be funded 25% by Regeneron ($250m) and 75% by Sanofi ($750m).

The firms have also agreed to equally invest an additional $650m to develop PD-1 inhibitor REGN2810.

Regeneron will also receive a one-time milestone of $375m from Sanofi in the event that sales of a PD-1 product and any other collaboration antibody sold for use in combination with a PD-1 product exceed, in the aggregate, $2bn in any consecutive 12-month period.

The firms also have agreed to re-allocate $75m over three years for immuno-oncology antibodies from Sanofi’s $160m annual contribution to their existing antibody collaboration, which was announced in November 2009.

Source: pharmaceutical-technology.com

Novartis and Genmab seek FDA approval for ofatumumab to treat relapsed CLL

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Novartis and Genmab are seeking approval from the US Food and Drug Administration (FDA) for their ofatumumab (Arzerra) as maintenance therapy for patients with relapsed chronic lymphocytic leukaemia (CLL).

Ofatumumab is a human monoclonal antibody, which is developed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.

Under Genmab’s ofatumumab collaboration, Novartis has submitted a supplemental biologics licence application (sBLA) to the FDA for the uses of ofatumumab as maintenance therapy of patients with CLL.

The sBLA was submitted based on interim results from a Phase III study, Prolong (OMB112517), which assessed ofatumumab maintenance therapy against no further treatment in patients with a complete or partial response after second or third line treatment for CLL.

Genmab CEO Dr Jan van de Winkel said: “The submission of the application to expand the label to use ofatumumab as a maintenance therapy for patients with relapsed CLL in the US follows closely behind the marketing application for this indication in Europe.

“We are looking forward to the response from both the US and European regulatory authorities, and hope that ofatumumab will soon become available for maintenance therapy of patients with relapsed CLL.”

In the US, Arzerra received approval for use in combination with chlorambucil to treat previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.

In the EU, Arzerra obtained approval for use in combination with chlorambucil or bendamustine to treat patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.

Arzerra is also indicated as monotherapy to treat patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab, in around 50 countries worldwide.

Under the co-development and collaboration agreement, Genmab and Novartis, as successor in interest to GSK, markets Arzerra in different countries.

Source: Pharmaceutical-Technology.com

Recently-developed drug holds great promise for children with acute lymphoblastic leukaemia

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A new Australian study shows that a recently-developed drug, already used safely in adult leukaemia clinical trials, holds great promise for some children with an aggressive form of cancer known as acute lymphoblastic leukaemia (ALL).

Each year, around 150 Australian children and almost as many adults are diagnosed with ALL, which is the most common childhood cancer. Around 15% will have an aggressive subtype of ALL (known as T-ALL) that is generally less responsive to therapy and more likely to relapse.

Professor Richard Lock and Dr Donya Moradi Manesh from Children’s Cancer Institute have shown that a drug known as PR-104 is effective against laboratory models of aggressive T-ALL.

Their findings are now published online in the prestigious journal Blood.

The research team tested PR-104 through the Pediatric Preclinical Testing Program, a consortium funded by the US National Cancer Institute (NCI) to prioritise and fast track new drugs into clinical trials in children with aggressive cancers. Children’s Cancer Institute is the only testing site located outside of the US, and conducts all of the consortium testing against childhood ALL.

“During the 10 years we’ve been funded under the NCI program, we’ve tested over 70 drugs and combinations, and PR-104 is one of the most exciting yet – with the potential to be fast-tracked into clinical trials for children,” said Professor Richard Lock.

“We were so encouraged by our first results with PR-104 that we undertook additional studies which showed the drug to be preferentially active against T-ALL, a subtype of ALL affecting white blood cells known as ‘T cells’.

“Around 15% of acute lymphoblastic leukaemia patients have T-ALL, while 85% have a disease that affects their ‘B cells’, another white blood cell type. PR-104 is much less effective against these B cell leukaemias.

“We believe that PR-104 might be an effective drug for patients who have initially benefited from conventional treatment for T-ALL, but who have subsequently relapsed.”

At first baffled by why T-ALL responded to PR-104, the researchers realised that only the T cell subtype expressed high levels of AKR1C3, an enzyme that activates PR-104.

The research team is in the process of examining the molecular biology behind AKR1C3, and trying to understand why T-ALL cells express very high levels of the enzyme.

“If we can work out what activates this enzyme in T cells, we might find a way of activating it in B cells, making the B cell disease sensitive to the drug as well,” said Professor Lock.

“Obviously it would be ideal if we could extend this drug’s reach to include all acute lymphoblastic leukaemia patients.

“In the meantime, we can envisage using PR-104 to target highly aggressive T-ALLs that express high levels of AKR1C3.

“We are actively pursuing opportunities to conduct a clinical trial to treat childhood T-ALL with PR-104.”


Children’s Cancer Institute Australia