Cubist Joining the Fight Against Antibiotic Resistance in the United Kingdom

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Tuesday, November 18th marked European Antibiotic Awareness Day. Public health experts, hospitals, and physicians in the United Kingdom gathered to raise awareness of what can be done to fight what the World Health Organization (WHO) calls one of the top three threats to human health. The issue of rising antibiotic resistance and the lack of treatment options is causing increasing concern worldwide, including in the UK.

To address the urgent need for new antibiotics, Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), the global leader in the discovery, development, and commercialization of novel antibiotics, is investing significantly in global antibiotic R&D and is focusing its late-stage pipeline on addressing serious and potentially life-threatening healthcare-acquired bacterial infections. To fight the global battle against antibiotic resistance and to support the potential launch of two new antibiotics in Europe in 2015, Cubist is expanding its presence in Europe and has recently begun operations in the UK.

“This year’s awareness day comes at a critical juncture,” said Sebastian Stachowiak, Country Manager, United Kingdom, Ireland and Nordics, Cubist Pharmaceuticals. “With resistant bacterial infections resulting in an estimated 25,000 deaths in the European Union, solutions are needed today to address growing resistance in the United Kingdom and throughout Europe.”

Twenty percent of all deaths due to antibiotic resistance infections in Europe occur in the United Kingdom.

The World Health Organization (WHO) issued its first ever report on antibiotic resistance earlier this year and their characterization of the problem was stark. Less than a century after widely available antibiotics ushered in an era of increasing life expectancy thanks to the ability to fight infection, mankind is now at risk of entering a “post antibiotic era” where doctors no longer have medications to treat serious infections.

As a company at the forefront of antibiotic development, Cubist is a founding member of a recently announced public-private consortium called DRIVE-AB (Driving Reinvestment in R&D and Responsible Antibiotic Use). DRIVE-AB is a €9.4 million public-private consortium, funded by the EU Innovative Medicines Initiative (IMI), with the goal of improving standards for responsible antibiotic use and development of new models for research and development of new treatments. Visit http://drive-ab.eu/about/ to learn more.

About Cubist’s Commitment to Antibiotic R&D

For more than 20 years, Cubist has had an unwavering focus on antibiotics. The Company is committed to global public health through the discovery, development, and supply of antibiotics to treat serious and potentially life-threatening infections caused by a broad range of increasingly drug-resistant bacteria. With one of the strongest antibiotics pipelines in the industry, Cubist expects to invest approximately $400M USD in 2014 on antibacterial R&D and hopes to deliver at least four new antibiotics in support of the Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics by 2020. To learn more about superbugs, the threat of resistance, and the global response visit: http://www.cubist.com/superbugs

Reckitt finalises pharmaceutical demerger plans

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Reckitt Benckiser has confirmed its plans to spin-off its pharmaceutical portfolio from its core consumer products business.

Final details of the proposed separation were outlined earlier this week with the demerged RB Pharmaceuticals (RBP) being renamed as Indivior, and the process should be reach completion before Christmas.

“The demerger will allow the Indivior Group to allocate resources and deploy capital in a manner consistent with the priorities of the Indivior business,” the company says.

The split was first recommended in July after a strategic review by the company. Reckitt Benckiser is best known publicly in the UK as the maker of domestic goods such a Cillit Bang, Vanish and Nurofen, products ­– at odds with its pharmaceutical division’s focus on addiction treatments.

The firm hopes that separating its pharmaceutical business from its consumer side will allow both companies to focus more on core products.

RBP only has one marketed drug – the heroin addiction treatment Suboxone (buprenorphine and naloxone). The business has been lucrative for the company in the past, bringing in sales of $1.2 billion (£767m) last year, but revenues have slid by 8% for the first half of this year as generic competition takes its toll.

Other treatments in its pipeline include its once-a-month injectable version of Suboxone, which it hopes to bring to market in 2017, and a drug overdose rescue nasal spray for use in emergencies that could come to market in the US in 2016.

By George Underwood – Pharmafile online

GSK tops pharma league for access

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GlaxoSmithKline is basking in some good news after topping the league table of pharma companies which do the most to improve access to drugs in developing countries.

The Access to Medicine Index 2014 has put GSK first – for the fourth consecutive year – with Novo Nordisk close behind in second place.

Compiled by the Access to Medicine Foundation, the methodology has been developed with support from academics, NGOs, investors and governments, and pharma companies have been “more transparent with their data and more open about their challenges than ever before”, the Netherlands-based organisation says.

While GSK leads the overall table, data is broken down into seven different areas such as pricing, where Gilead Sciences comes first for implementing equitable pricing strategies more closely targeted toward poor population groups within countries.

One key issue on which pharma needs to do better is public policy and market influence. “Scores are generally low in this area,” the report warns. “There is a clear gap between companies’ stated commitments to ethical behaviour and what actually happens in practice.”

Apart from Gilead and AbbVie, all companies have been the subject of settlements or decisions relating to corruption, ethical marketing or competition this year, “despite almost all having codes of conduct to govern employee behaviour”.

GSK does well on R&D, as does Johnson & Johnson, and the report praises the top five companies in that section for developing many of their products on access-oriented terms.

Access to Medicine Foundation founder and chief executive Wim Leereveld points to pharma’s improving record generally on tackling TB, hepatitis C and neglected tropical diseases.

“These developments show us how much we need the entrepreneurial power of pharmaceutical companies to address access to medicine,” he insists. “But while it is clear that companies have a role to play, there is still no sustainable model for ensuring the poorest patients have access to the medicine they need.”

GSK chief executive Sir Andrew Witty says: “People rightly expect us to do all we can to discover, develop and price our medicines and vaccines so they are accessible to those who need them, wherever they are in the world.”

He points to the company’s work on a new Ebola vaccine and agreements with Save the Children to develop child-friendly medicines as proof of GSK’s commitment.

Praising the Index, Sir Andrew adds: “It challenges us to think harder about how we drive innovation and enable access to our products.”

By Adam Hill – Pharmafile online

Cost of NHS medicines rises

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Hospitals in England are taking an increasing share of the NHS’s bill for drugs approved by NICE, according to a new report.

The NHS spent £14.4 billion on medicines in 2013-14 and hospital use represented 40.1% of that total – up from 37.5% in 2012-13.

The figures from the Health and Social Care Information Centre (HSCIC)’s ‘Hospital Prescribing: England 2013-14’ also show the cost of medicines rose 7.6% overall year-on-year – but by 15.1% in hospitals.

The world’s biggest-selling drug, AbbVie’s Humira (adalimumab), represented the biggest individual product cost to the NHS at £311 million, a rise of 12.5% on 2012-13.

When it comes to spend on the next biggest brands, Novartis’ Lucentis (ranibizumab) rose 20.7% year-on-year to £244 million, while Amgen’s Enbrel (etanercept) was up just 2% to £233 million.

Breaking the figures down further, the greatest cost to the NHS in primary care came from insulin glargine, at £78.3 million, while Humira represented the biggest cost in secondary care.

Interferon beta (1A & 1B) was the most costly of those NICE-approved products prescribed in hospital but dispensed in the community.

Earlier this year the UK government received a £74 million refund from the pharma industry after it was deemed to have spent too much on patented medicines.

The repayment was the first under an onerous new drug pricing arrangement for the industry known as the Pharmaceutical Price Regulation Scheme (PPRS), which from 1 January this year mandates that pharma can only grow by a certain amount.

UK pharma firms must keep NHS spend on branded medicines flat for two years, and keep the growth rate below 2% for a further three years.

The payments are based on the difference between the allowed percentage growth (which for 2014 is flat) and the actual percentage growth in how much the NHS spends on branded medicines.

By Adam Hill – Pharmafile online

Allergan eyeing Actavis buyout

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Allergan is attempting to block a recent Valeant hostile takeover bid by seeking the rumoured alternative merger deal with Actavis, according to media reports.

The two companies apparently disagree on the value of the deal though, with Actavis offering $200 per share but Allergan wanting more than $210 per share – a total gap of around $3 billion. Talks are currently focussed on reducing this gap, according to Reuters.

Actavis was first rumoured as a potential merger for botox maker Allergan after the latter company rejected the latest, $54 billion takeover bid from Valeant – although the Canadian firm has now said that it is prepared to raise its offer to $200 per share.

This was the latest of several bids from Valeant over the year.

“Valeant’s revised proposal substantially undervalues Allergan, creates significant risks and uncertainties for Allergan’s stockholders and does not reflect the company’s financial strength, future revenue and earnings growth or industry-leading R&D,” the firm’s chief executive David Pyott said of the $54 billion bid.

Allergan’s board claims that Valeant’s strategy of slashing costs after acquiring business would damage the value it has built and threaten the future of a number of promising pipeline projects.

Fighting back

The talks between Allergan and Actavis are just one of several ways the company is trying to fend off Valeant.

Earlier this month Allergan attempted to block shareholder Pershing Square, who is a key supporter of Valeant’s bid, from voting at a meeting next month. However, a judge ruled that they would still be allowed to use their block vote in an attempt to replace several of Allergan’s directors with candidates who will support the merger.

The company has also posted an open letter from eye surgeons on its website expressing fears that the takeover would decrease R&D funding and negatively impact its practices – many of which are centered on eye care. Other clinicians were invited to sign.

Valeant itself has also been trying to court healthcare professionals in another of Allergan’s major franchises – cosmetic care. The firm says it had met with 45 influential cosmetic surgeons and dermatologists who use Allergan’s Botox to try and win them over.

The company reportedly paid for the clinicians’ flights, hotels and meals and agreed to pay consulting fees of up to $30,000.

Speaking to the Wall Street Journal, several of these doctors even said that they had indeed been won over by Valeant’s Allergan plans.

By George Underwood – Pharmafile online

EU and drug industry set aside €280m for Ebola

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The EU’s Innovative Medicines Initiative (IMI) has unveiled a new programme to find vaccines, drugs and diagnostics for Ebola, funded to the tune of €280 million.

The IMI – which operates as a partnership between the European Commission and the pharmaceutical industry – says it is now seeking proposals for projects that “will help make a difference in the current and future outbreaks”.

The money brings the total investment by the EU into tackling Ebola to €805 million, with DG Sanco pledging €525 million to the cause earlier this year.

The investment programme – called Ebola+ – comes as the number of Ebola cases around the world has risen above 13,000, with more than 4,800 deaths, according to figures released this week by the World Health Organization (WHO).

It also follows damning remarks by WHO director general Margaret Chan at a meeting in Africa, who asks why – given that Ebola emerged nearly four decades ago – clinicians are “still empty-handed, with no vaccines and no cure?”

She blames a ‘profit-driven’ pharmaceutical industry that “does not invest in products for markets that cannot pay”. She continues: “WHO has been trying to make this issue visible for ages, continued Chan. “Now people can see for themselves.”

While critics will argue that the IMI’s initiative comes too late to have an impact on the current outbreak, the hope is that it will lay the foundations to tackle future epidemics.

A primary focus of the programme will be the development, manufacture, transport, and storage of vaccines; ensuring compliance with vaccine regimens; and the development of rapid diagnostic tests for the virus, said the IMI. The first projects are expected to begin in early 2015.

Stopping the spread of Ebola, now and for future generations, is a key priority for the pharmaceutical industry, which has a long history in fighting pervasive infectious disease,” says Richard Bergstrom, director general of the European Federation of Pharmaceutical Manufacturers and Associations (EFPIA) at the launch of Ebola+ initiative.

Of the total €280m pot, half will be funded directly by the IMI, and the remainder will be provided by big pharma companies in the form of ‘in-kind’ contributions, such as their researchers’ time and access to resources.

New vaccine trials

There was some more encouraging news on the vaccine front this week, when Switzerland’s drugs regulator Swissmedic showed a green light to a clinical trial of the experimental VSV-ZEBOV vaccine developed by scientists at the Public Health Agency of Canada. Swiss research teams have already started a trial of GlaxoSmithKline’s ChAd3 candidate, with the first patients recruited at the end of last month.

VSV-ZEBOV is also being tested on healthy volunteers in the US and additional trials are planned to start very soon in Germany, Gabon and Kenya, according to the WHO.

Johnson & Johnson announced last month that its vaccine will be fast-tracked and human trials will now start in early 2015, a year earlier than originally planned.

By Phil Taylor – Pharmafile online

Lundbeck sales slide as generic competition bites

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Lundbeck’s sales fell dramatically in the third quarter of 2014 as it struggles with expiring patents, although several of its new products did see strong growth.

The Danish firm says that revenue was five million Danish kroner ($840,000) down from 267 million in the same period last year.

“Lundbeck is investing significantly in product launches and in the late stage development pipeline while being in the midst of a transition period,” the firm says in a statement.

“This is a period with an unusual number of variables which elevates the uncertainties for the company. These variables include market access processes in various countries for Lundbeck’s new products, launch uptake, timing of generic erosion as well as slope of erosion curves and development in exchange rates.”

Revenues fell by 8% to 3.18 billion kroner ($534 million), down from 3.44 billion, partly due to the loss of patents on Lundbeck’s biggest selling-drug, antidepressant Cipralex (escitalopram). Cipralex saw a 33% decline in sales from 1,464 million kroner to 983 million kroner.

Alzheimer’s treatment Ebixa (memantine) also saw its sales eroded by generic competition in Europe, falling by 60% to 136 million kroner in sales in the region.

This loss was partly offset by a 40% growth in the firm’s large range of new products. Key drivers included: Sabril (vigabatrin), up 42% in sales to 186 million kroner; Onfi (clobazam), up 40% to 219 million kroner; and Xenazine (tetrabenazine), up 27% to 440 million kroner.

However, Lundbeck notes that the increased launch costs of these new products also drove the decline in earnings. The firm’s president and chief executive Ulf Wiinberg, says: “In the period we have focused on successful execution of our new product launches in the US, Europe and in International Markets.

“We are in the middle of our most extensive launch efforts in the history of Lundbeck, and have until now had 25 launches of new products, and expect to have more than 50 launches during the next 12 months.”

The company is confident that its new schizophrenia drug brexpiprazole, co-developed with Otsuka and currently under review by the FDA, will be approved for sale in 2015. It is also hoping to launch Abilify Maintena (aripiprazole) and Carbella (Intravenous carbamazepine) next year.

Lundbeck says that it still expects full-year revenues to be around 13.5 billion kroner ($2.2 billion) for 2014, with new products continuing to offset generic erosion – although this will still be down from last year’s revenues of 15.3 billion kroner.

By George Underwood – Pharmafile online

AstraZeneca completes respiratory deal with Almirall

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AstraZeneca has finally completed its takeover of Almirall’s respiratory drug portfolio in a deal worth $875 million.

As reported by Pharmafile earlier in the year, the agreement will give AZ ownership of the rights for the development and commercialisation of Almirall’s respiratory business.

AZ, who originally announced the pact back in July, will also pay up to $1.22 billion in development, launch and sales-related milestones.

Pascal Soriot, chief executive officer, AstraZeneca, says: “I am delighted to welcome our Almirall colleagues to AstraZeneca. Respiratory disease is one of our company’s key therapeutic areas, and the combination of these exciting portfolios reinforces our long-term commitment to patients with asthma and COPD.”

AZ now has the rights to drugs in various stages of development, including COPD offering Duaklir Genuair (aclidinium bromide/fomoterol fumarate dehydrate; plus Eklira (aclidinium), a treatment for smoking-related diseases which recorded $112 million in sales last year.

Jorge Gallardo, president of Almirall says: “This global collaboration will allow us to maximize the potential value of our exciting respiratory franchise and AstraZeneca is the perfect partner to do this.

“Moreover, the deal has given us a strong financial baseline to accelerate our strategy and to start focusing our resources in becoming a top dermatology global player with an additional interest in other specialist driven areas.”

This isn’t the only agreement AZ completed in 2014; the pharma giant also signed a contract with its US rival Lilly to develop a new and experimental pill for the treatment of Alzheimer’s in September.

AZ expects to receive $50 million in the first half of 2015 in a deal worth up to $500 million in developments and regulatory milestones payments for the medicine. Furthermore the ongoing possibility of a Pfizer merger is still on the cards – but is looking a little cloudy of late in the wake of its $118 billion bid rejection back in May.

It remains to be seen if Pfizer will make another swoop for the firm on 26 November, which is the next date available to do so due to British merger laws.

It appears the UK’s second largest pharma firm behind GlaxoSmithKline will be entering the New Year on the back of a busy 2014, rife with potential big money deals and portfolio advances.

By Tom Robinson – Pharmafile online

Cancer drug discovery system ‘broken’

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The global system for discovering new cancer drugs is ‘broken’ and failing to turn scientific advances into enough innovative new medicines.

This is according to Professor Paul Workman, the interim chief executive of The Institute of Cancer Research in London.

Speaking at the World Oncology Forum hosted today, Workman said that big leaps forward in cancer treatment are now possible – but only with major changes to the model for discovering and developing drugs.

In his keynote lecture, Workman – one of the world’s leading experts in cancer drug discovery – adds that concerted action was needed by governments, pharma companies, regulators and academic institutions to fix a system that was failing to take the risks needed to deliver exciting new treatments.

He told the summit in Lugano, Switzerland, that drugs were only available for 5% of the 500 known cancer drug targets – and that far more were needed to deliver the combination treatments that are essential to overcome the major problem of cancer evolution and drug resistance.

The World Oncology Forum – only the second to have been organised – brings together 50 global leaders in cancer research and treatment in order to come up with policy recommendations designed to improve treatments across the world.

Workman said that the overall ‘ecosystem’ of pharmaceutical companies, academic institutions, government and regulators was far too risk averse, mostly tending to work in the same areas of research and producing ‘me too’ drugs, similar to others on the market – rather than genuinely new and innovative medicines.

He argued: “There have been some impressive advances in the personalised treatment of cancer, but overall progress has failed to keep pace with the dramatic advances over the last 20 years in our knowledge about cancer biology and genetics. We could, and should, be doing much better.”

He adds: “It is my contention that the whole model of cancer drug discovery – in which private companies and academia should be working together to take the most exciting, innovative new drugs to patients – is broken and in need of help.

“We need to be looking beyond low-hanging fruit when it comes to drug discovery and to focus our efforts on more novel drug targets to produce really innovative drugs that tackle major unmet needs in cancer. I see our broken model of drug discovery and development as the biggest challenge in our efforts to get exciting and game-changing new drugs to patients.

“Until we fix it, we will not see the number of really innovative treatments – capable of making a big impact on the lives of patients – that we should be expecting.”

He believes the key to driving faster progress in cancer treatment is by incentivising private companies, and the academic organisations that work with them, to take the risks they need to take to discover the truly innovative treatments of the future.

“In return, pharmaceutical companies will need to accept that they are receiving help from governments, regulators and health services, and they can’t expect to set prices that squeeze every penny of possible profit from those same public institutions,” he explains.

By Ben Adams – Pharmafile online

New cancer drugs escalate Roche earnings

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Roche’s sales saw solid growth in the first nine months of the year, increased by the firm’s new cancer medicines.

Sales climbed 5% from 34.75 billion Swiss francs ($36.79 billion) to to 34.87 billion, at constant exchange rates, for the first nine months of 2014. Its pharma divsion also saw sales rise by 4%, up to 26.96 billion Swiss francs.

It was unsurprisingly Roche’s oncology portfolio that was the biggest growth driver, with the Swiss firm’s treatments for HER2-positive breast cancer – Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine) – being among its biggest selling drugs.

Roche reported that Perjeta’s sales figures nearly tripled to 633 million francs whilst Kadclya’s jumped 148% to 371 million francs for the first three quarters.

In fact Herceptin, Perjeta and Kadcyla, all helped Roche’s pharma division grow overall, as together they saw sales increase by 21 per cent.

This has helped offset lower sales of chemotherapy drug Xeloda (capecitabine), which went off-patent last year, and hepatitis medicine Pegasys (peginterferon alfa-2a), which faces increased competition from a new generation of hepatitis C pills, such as Gilead’s Sovaldi.

Commenting on the results, Roche chief executive Severin Schwan says: “Demand for our products is strong in both divisions and we are well on track to reach our full-year targets.”

Roche also completed its acquisition of US firm InterMune in September, gaining with it the breakthrough idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone), which has also been approved by the FDA in October.

But it wasn’t all good news as sales of its new melanoma drug Zelboraf fell 13% in the third quarter alone as it faces fierce competition from GlaxoSmithKline’s new skin cancer treatments Tafinlar (dabrafenib) and Mekinist (trametinib).

Roche says that it expects low- to mid-single digit growth at constant exchange rates for the full year 2014.

By George Underwood – Pharmafile online