The lack of new antibiotics is exposing the UK population to serious risk from untreatable gonorrhoea, the Health Protection Agency (HPA) has warned.

The Agency’s Gonorrhoea Resistance Action Plan aims to maximise the effectiveness of existing treatments after a year in which new diagnoses rose by 25%.

The increasing prevalence of antibiotic-resistant strains draws attention to the lack of new therapies, a problem highlighted by GSK’s Andrew Witty in 2012.

The action plan, developed by the HPA’s Gonococcal Resistance to Antimicrobials Surveillance Programme (GRASP), places emphasis on data collection, rapid detection of treatment failures, and actions to reduce infection rates.

The GRASP data show that new gonorrhoea diagnoses rose by 25% in 2011 to nearly 21,000. Men who have sex with men made up a third of new infections, compared to a quarter in 2010.

With treatment failures occurring worldwide and no new antibiotics in the pipeline, England’s Chief Medical Officer recently argued that antibiotic resistance should be considered a civil emergency on a par with terrorism.

Professor Cathy Ison, lead author of the action plan, said: “Ensuring treatment-resistant gonorrhoea strains do not persist and spread remains a major public health concern. The GRASP Action Plan sets out practical, measurable actions to extend the useful life of the current recommended therapies in England and Wales.”

Current fears that the transfer of sexual health services to the council-funded public health system will see cuts in these services has intensified concern about the likely spread of untreatable gonorrhoea.

Andrew Witty, CEO of GSK, commented in 2012 that by the time a viable commercial model for new antibiotics existed, it would be too late to avert a serious pandemic. “The market has failed,” he concluded.

Antibiotic Action, a new UK-led initiative to encourage global investment in the development of new antibiotics, is working to establish an all-party Parliamentary Group that can address the issue.

Professor Laura Piddock, Director of Antibiotic Action, commented: “The GRASP Action Plan is a good example of why we need new drugs, and begs the question why they are not being developed for this infection. Government must act now to avert this and similar crises that threaten the health of our nation.”

The number of new drugs becoming available to NHS patients is not in decline, contrary to widespread industry rumours.

Researchers analysing the British National Formulary found that the average number of drugs introduced per year is marginally higher than in the 1970s.

There was a dip in the number of new drugs becoming available between 1998 and 2006, but the pipeline has since become stronger.

A team at Birmingham University looked at drugs introduced to the Formulary from 1971 to 2011.

The average number of drugs introduced per year was just under 23, with the current level 0.16 above the level of the 1970s.

The report noted that short-term fluctuations have given rise to impressions in the past that pharmaceutical innovation, or NHS uptake of it, is in decline.

According to author Dr Derek Ward, “We started this research because there was a great deal of pessimism within the industry and among pharmaceutical companies about the number of new drugs that were getting to the market.

“We found that looking at the data over the longer term there was a slight increase. This is obviously a good thing for patients.”

ABPI Chief Executive Stephen Whitehead commented: “It is a common myth that our industry has struggled to develop new medicines, when in reality the research pipelines of companies are healthy.”

The report noted that the time and cost of drug development are increasing and the innovation model is becoming more complex.

Dr Phil L’Huillier of Cancer Research UK noted: “The landscape is shifting, with pharmaceutical companies increasingly collaborating with academia for discovery and development of drugs.”

The global market in statins, once the pharmaceutical industry’s lead blockbuster products, is predicted to decline by 40% in the next five years.

The forecast by GBI Research of a negative CAGR of 7.2% up to 2013 for the cholesterol-lowering drugs is based on prospects of generic erosion, weak pipelines and failing prescriber confidence.

The decline in the statins market shows that the shift of healthcare towards prevention and management of long-term conditions is not without pitfalls for the pharma industry.

Statins, which lower cholesterol levels by targeting an enzyme in the liver, have been hailed as ‘wonder drugs’ that could radically reduce the global incidence of cardiovascular events.

Routinely prescribed for ‘high-risk’ patients such as people with high blood pressure or diabetes, statins have also been linked to reduced risk of bowel cancer and reduced death rate from influenza.

However, their global market declined from $23.7 billion in 2004 to $20.5 billion in 2011 (a negative CAGR of 2.5%), due largely to patent expiry.

The report predicts a much steeper decline in the statins market over the next five years, for four reasons:

• Patent expiry – the generic share of the statins market is predicted to grow from 11% in 2011 to 34% in 2018.

• Austerity health budgets – spending on prevention is likely to be cut back.

• Weak product pipelines – the ‘me-too’ nature of most statins betrays a lack of potential for innovation.

• Increased use of alternative drugs.

Medical writer Ben Goldacre has argued that the marketing of statins in terms of relative risk reduction glossed over the low absolute risk reduction they offer, and left the products open to a backlash over side-effects.

Statins are associated with both symptomatic side-effects (including digestive disorders) and potential ones (including increased risk of type 2 diabetes).

As the overall statins market declines, the report says, individual products will struggle to gain or keep a place within it: “The global statins market has reached the competitive stage of its lifecycle, with many branded and generic drugs competing with each other on price.”

The ‘empty’ antibiotic pipeline threatens a future of mass death from antibiotic-resistant infections, the UK Chief Medical Officer has said.

Professor Dame Sally Davies told a Parliamentary committee that the pharmaceutical industry has no solutions to the growing problem of antibiotic resistance.

Overuse of antibiotics, especially in the developing world, and the combined impact of sex tourism and medical tourism were globalising the most serious health threats, the committee heard.

Antibiotic resistance has been recognised as a problem in Europe for decades, with the power of the standard antibiotics to fight disease steadily waning.

However, the massive current use of antibiotics in countries such as India, where private drug supply is deregulated, has caused a proliferation of drug-resistant infections that are spreading through the developed world.

Professor Davies warned: “The apocalyptic scenario is that when I need a new hip in 20 years I’ll die from a routine infection because we’ve run out of antibiotics.”

Antibiotic-resistant strains of tuberculosis and gonorrhoea are spreading globally, she said. Meanwhile, the pharmaceutical industry is failing to develop new antibiotics because there is no urgent need for them – but when there is, it may be too late to prevent a lethal pandemic.

GSK’s CEO, Andrew Witty, made the same point last year and warned that “the market has failed” to address the danger. He called for global collaboration between health systems and industry.

“There is a broken market model for making new antibiotics, so it's an empty pipeline, so as they become resistant, these bugs... there will not be new antibiotics to come,” said Professor Davies.

Novartis expects its pharmaceutical division to have at least 14 ‘blockbuster’ products within the next five years.

The Group claims to lead the industry with the number of new approvals it has had globally since 2007 and expects the release of new products to be equally successful.

Joseph Jimenez, CEO of Novartis, said its “leading pipeline... positions us well for continued future growth.”

So far this year the company has received nine approvals or positive recommendations. It aims to build on this within the next 13 to 24 months with a further 11 pivotal trials, 11 filings and 10 regulatory decisions with various health authorities.

In addition, Novartis claims its pipeline boasts 139 projects in clinical development, including more than 73 New Molecular Entities across a multitude of disease areas.

It has highlighted compounds AIN457 from its oncology pipeline and LCZ696 and RLX030 for heart failure to create “significant newsflow” in the future. Also, Novartis claims compound QVA149 has the potential to become the “new standard of care for COPD”.

But within its oncology business is where the greatest growth is expected within the next five years. Novartis points towards its robust late-stage pipeline, which includes 13 new chemical entities and 19 new indications, to combat the upcoming patent expiry on Glivec.

These late-stage products are expected to contribute more than $1bn in sales by 2017, with Afinitor predicted to earn revenues of around $2bn in sales in advanced breast cancer alone in the same period.

GlaxoSmithKline (GSK) has reported modest global sales growth and significant pipeline development in the first quarter of 2012.

The UK’s largest pharmaceutical company achieved 2% sales growth worldwide despite a 6% drop in European sales.

The company also highlighted positive phase III data for five assets in treatment of major diseases, pointing the way to future growth.

CEO Andrew Witty said that GSK had “returned to reported sales growth, delivered additional R&D pipeline output and maintained our focus on returns to shareholders” in Q1.

GSK’s performance “reflects the resilience of our business and the investments we have made to increase the breadth and mix of the Group,” he commented.

The company’s pharmaceuticals and vaccines business grew by 2% overall – due largely to 9% growth in the US, where a co-promotion deal for overactive bladder treatment Vesicare combined with successful product launches in oncology.

However, Witty noted that pharmaceuticals and vaccines sales fell by 6% in Europe due to “the continued implementation of government austerity measures”.

The EMAP market saw 2% growth in this product area, with pharmaceuticals up 6% but vaccines down 9%, and strong sales in China and Latin America compensating for the impact of political turmoil in Africa and the Middle East.

Witty emphasised that GSK’s future lies in its pipeline, echoing the recent words of Lilly CEO John Lechleiter. He pointed to positive results for five drug candidates:

• The first of three phase III studies for HIV drug dolutegravir, showing non-inferiority to raltegravir.

• Successful phase III studies for melanoma drugs BRAK and MEK, which are ready to be filed for approval (and to be trialled in combination).

• Ongoing successful phase III data for type 2 diabetes drug albiglutide.

• Completion of phase III studies of asthma and COPD treatment Relovair, which will be filed for both indications this summer.

These new products, Witty said, “together with the progress we have made with the broader late-stage pipeline since the beginning of 2011, underpins our growing confidence in our ability to grow sales on a sustainable basis.”

For a video interview with GSK’s CFO, Simon Dingemans, click here.

GlaxoSmithKline (GSK) has reported modest global sales growth and significant pipeline development in the first quarter of 2012. CFO Simon Dingemans answers questions about GSK’s current position and expectations for the future.

To read the whole story, click here.
 

Pipeline or P45? Blogger Maxine Vaccine asks whether the pharma industry is willing to put its money where its mouth is regarding its strategy for surviving the recession.

As the global recession spirals further out of control and the UK looks set to follow Greece, Spain and Ireland into deeper crisis, the online Pf readers’ poll asked: What’s the best way forward for the pharma industry?

The response has been impressive: 84 % ticked ‘Collaboration to enter specialist areas’, 16% ticked ‘Cheap generics and biosimilars’, and nobody agreed with ‘Cutting back to survive austerity’.

To be honest, the second answer was just us being sarcastic. We didn’t expect anyone to say that was a good thing. And the third answer, though bleak, so clearly reflects the realpolitik of the industry in 2012 that we expected it to be a strong contender – though we hoped confidence in the collaboration model would outweigh it.

So it’s quite striking to see that none of our respondents thought austerity measures were the answer. But is their view supported by the leaders of the industry?

On the face of it, yes. John Lechleiter, CEO of Eli Lilly, said recently: “I don’t think we can save our way out of the enormous challenge we face. The best course is to maintain our focus on advancing our pipeline.”

But in 2012 Lilly has announced a global salary freeze for most of its employees, including the CEO (whose bonus package remains at a tidy $16.4 million), after a quarter in which its ‘blockbuster’ antipsychotic Zyprexa lost 44% of its former market due to generic competition.

Pfizer is similarly talking a ‘pipeline’ game, but is reducing its employees’ redundancy terms from 12 to 8 weeks as a prelude to further layoffs, and may split into branded and generic drug businesses. The Lipitor patent cliff may have been seen from a long way off, but the parachute didn’t open.

Dashiell Hammett – author of that immortal satire on the commercial mentality, The Maltese Falcon – said that he took up drinking when he realised that what people say has nothing to do with what they do. Some of us may wonder what took him so long.

In recent years, the pharma industry has taken steps to repair its reputation with the public – who have never exactly seen pharma as the place where you go to learn integrity and honesty. In particular, much attention has been given to industry codes of practice on dealings with customers. From luxury flights to biros and biscuits, the industry is cultivating a new image as the Puritans of the commercial world.

But has trust between management and staff in the pharma industry improved? Are companies treating their employees better? Is the representation of staff within the industry stronger? You tell me. And wait for the Pf Survey 2012 results to find out how your peers feel.

Meanwhile, if – like us – you are genuinely impressed by the emerging culture of cross-sector collaboration and partnership, it may be worth just keeping two words in mind. Hostile takeover.

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

Covidien, a global supplier of healthcare products based in Ireland, plans to spin off its pharmaceuticals business into a standalone US company.

The spin-off is expected to give the new company better opportunities to commercialise its pipeline and pursue its global growth plans.

Covidien’s medical devices and products business will remain within the existing company.

The company’s pharmaceutical business is a leading supplier of generics, opioid pain medications and bulk paracetamol, as well as such diagnostic products as medical isotopes and contrast media.

The growing pain management drug market is expected to be a major focus for the new company.

“We’ve evaluated whether to separate these businesses for several years, due to the major differences between the medical products and pharmaceutical industries,” said José E. Almeida, President and CEO of Covidien. “We believe that now is the right time to do so because we have significantly improved the operations, performance and pipeline of our pharmaceuticals business.

“While both businesses hold industry-leading positions, they have distinctly different business models, sales channels, customers, capital requirements and talent bases. In addition, their respective innovation pipelines differ substantially in length, regulatory approval requirements, possible risks and potential returns.

“This transaction would give both businesses greater flexibility to focus on and pursue their respective growth strategies, while potentially providing shareholders with greater value over the longer term.”

Covidien plans to distribute shares in the new pharmaceutical company to its US shareholders. The transaction is expected to be completed within 18 months.

Cubist Pharmaceuticals has appointed Dr Jennifer Jackson as its new Senior Vice President of Regulatory Affairs.

Dr Jackson will oversee all aspects of Cubist’s Regulatory Affairs, providing oversight for all regulatory matters, reporting to Dr Steve Gilman, the company’s Executive Vice President of R&D and CSO.

Dr Gilman said: “Jennifer’s extensive international experience, collaborative nature, and focus on disciplined execution will help us as we advance our exciting pipeline in the years ahead.”

Dr Jackson joins Cubist from Biogen Idec Hemophilia, where she worked as vice president of Regulatory Affairs and Clinical Compliance. She has also worked at Vertex Pharmaceuticals and Bristol-Myers Squibb.

Cubist Pharmaceuticals is a biopharmaceutical company focused on the research, development and commercialisation of pharmaceutical products that address the unmet medical needs in acute care.