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.”


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.”


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.


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.


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

‘Game changing’ new lung cancer drug is available from today

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Vaccine trains the body to single out diseased cells that experts say will double survival rates

Lung cancer patients are to be offered a ‘game-changing’ treatment that trains the body to single out and attack diseased cells. It is being made available under a Government policy that enables life-saving treatments to be fast-tracked through the licensing process that usually takes years. Administered in a vaccine every two weeks, the drug nivolumab works by teaching the body’s immune system to attack cancerous cells.

Evidence shows the effect continues for several years after the treatment has stopped. Experts have hailed such immunotherapy as a ‘new era’ in the fight against cancer. Early trials have suggested it doubles survival rates. From today, doctors will be able to offer nivolumab free to patients with advanced lung cancer, for whom surgery is no longer an option. The costs will be footed by the manufacturer, Bristol-Myers Squibb. The therapy differs from ‘blanket’ treatments such as chemotherapy and radiotherapy which kill all cells including healthy ones.

This means there are fewer debilitating side effects such as fatigue, sickness, hair loss and infections caused by healthy cells being destroyed. Some skin cancer patients previously diagnosed as terminal have been able to return to work following immunotherapy. They only need to top up jabs every few months. Lung cancer is one of the deadliest forms of the illness. Only 5 per cent of patients are still alive ten years after diagnosis. It is also the second most common – after breast in women and prostate in men – with 43,000 new cases each year. Nivolumab is the third treatment made available through the Early Access To Medicines Scheme which bypasses red tape that can last up to a decade. Manufacturers submit data on new drugs to experts at the Medicines and Healthcare Products Regulatory Agency for assessment.

If the watchdog is satisfied the treatment can be beneficial without causing harm, it is made available to patients. Costs are covered by the manufacturer until the drug is formally licensed in the usual way. The scheme means patients are effectively guinea pigs testing out new drugs and possible side effects, but the Government hopes it will save hundreds of lives. George Freeman, Life Sciences Minister, said: ‘The positive scientific opinion of nivolumab offers real hope to those who need it most… I hope this is just one of many drugs that will be made available.’

A trial involving 272 patients found 42 per cent taking nivolumab were alive a year later, compared with just 24 per cent who had chemotherapy. Some of those on the drug are still living two years on. Dr Tom Newsom-Davis, consultant cancer specialist at Chelsea and Westminster Hospital, said: ‘Lung cancer is one of the most difficult to treat … early access to nivolumab is therefore very positive … patients have the potential to access a new medicine which has shown in clinical studies to offer significant extension of survival.’ Manufacturers say 10,000 UK patients could benefit from the jab. Last month experts said immunotherapy was a ‘game-changer’ and the biggest breakthrough since chemotherapy.

By Sophie Borland Health Correspondent

FDA provides safety update about Essure Birth Control Implant

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The FDA first announced their intention to provide a safety update about Essure late yesterday evening. Today’s much anticipated report comes on the heals of a private citizen petition that raised serious concerns about the Essure Birth Control Implant and resulted in the launch of an FDA investigation into the birth control device.

This afternoon the U.S. Food and Drug Administration (FDA) added a page to their website informing the public of increased risks associated with the Essure Permanent Birth Control Implant. The new page acknowledges the 5,093 adverse events that have been reported to the agency about Essure and provides new information about serious risks associated with the device including: pelvic pain, migration of Essure coils, perforation of the uterus or fallopian tubes, and rash and itching. The page also advises physicians to warn patients about complications that have resulted in women with nickel allergies who have received the Essure Birth Control Implant.

One section of the webpage recognizes reports of miscarriage and ectopic pregnancy following the non-surgical sterilization procedure, stating, “The FDA will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks,” and “While scientific evidence shows that Essure is a highly effective means of sterilization when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100% effective.”

The FDA announced today that there will be a public meeting of their Obstetrics and Gynecology Devices Panel later this year on September 24, 2015, to discuss the safety and efficacy of the device.

Source: Arentz Law Group

China rejects patent linked to Gilead hepatitis C drug

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China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

Gilead has drawn fire for the cost of its top-selling drug Sovaldi, priced at $1,000 per pill in the United States or $84,000 for a typical 12-week course and its patents have been challenged in the U.S., India and Europe.

The application China has rejected was for a so-called prodrug, the inactive form of the drug which then converts into the chemically active compound once in the body, the New York-based Initiative for Medicines, Access & Knowledge (I-MAK) said.

Gilead, however, holds the China patent to the base compound in the drug, also known by its generic name sofosbuvir and China’s rejection of the prodrug patent does not open the way for copycat drugs to be made in the world’s No. 2 drug market.

China-based officials for Gilead were not immediately available for comment. Emails and calls to Gilead’s U.S. offices outside office hours went unanswered.

Officials at China’s State Intellectual Property Office did not confirm the decision when contacted by Reuters, but a notice posted on the body’s website said Gilead’s application for “nucleoside phosphramidates”, a kind of prodrug, had recently been rejected.

China’s move follows a decision by India’s patent office in January to reject Gilead’s patent application for Sovaldi, finding it was not inventive enough. Gilead is appealing the ruling.

Under pressure to cut prices, the California-based firm agreed last year to make the drug available for lower prices in 91 developing countries.

I-MAK has brought legal challenges against Gilead’s patents or patent applications in five countries not covered by the agreement: China, Argentina, Brazil, Russia and Ukraine.

Charities in Europe have also challenged Gilead’s patent over its prices.

The World Health Organization says as many as 150 million people worldwide live with chronic hepatitis C infection, most of them in low and middle-income countries. It recently added Sovaldi to its essential medicines list and urged lower prices, especially in middle income countries.

By Brendan Pierson and Adam Jourdan, Reuters

(Editing by David Gregorio and Edwina Gibbs), Reuters