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

Boehringer and Roche IPF drugs win FDA approval

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The FDA has approved both Roche’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of the fatal lung disease Idiopathic Pulmonary Fibrosis (IPF).

These new drugs are the first treatments for IPF available in the US. Esbriet previously became the first marketed drug for IPF globally when it was approved in Europe in 2011, and has since been shown the green light in Norway, Iceland and Canada.

“Today’s approval expands the available treatment options for patients with idiopathic pulmonary fibrosis,” says Mary Parks, deputy director of the Office of Drug Evaluation at the FDA. “Providing healthcare professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need.”

Esbriet was developed by InterMune who were then acquired by Roche in September. It is believed to work by interfering with proteins involved in inflammation and cell growth, and was initially rebuffed by the FDA who asked for more trial data. The regulator eventually granted it breakthrough designation earlier this year.

Ofev, meanwhile, works by blocking growth factor receptors involved in IPF and also previously received breakthrough designation from the FDA.

In trials both drugs have been shown to significantly reduce the decline in forced vital capacity – the amount of air that can be forcibly exhaled from the lungs – and have been racing each other to be first to market in the US. Both gained orphan product, fast-track and priority review designations on their route to approval.

The simultaneous go-aheads arrive well ahead of the FDA’s intended decision dates of 2 January 2015 for Ofev, and 23 November this year for Esbriet, and so they will now be pitted against each other earlier in the marketplace.

The drugs are likely to be expensive, however, but both companies have apparently set up financial assistance programmes in response to this – namely ‘CareConnect’ from Roche and ‘Open Doors’ from Boehringer.

IPF is characterised by scarring of the lung tissue, but its exact cause is still unknown. Patients have a poor prognosis, typically living only three to five years after diagnosis. This has led to it being a disease area of much interest for pharma firms, and it was a key focus of the European Respiratory Society Annual Congress last month.

The symptoms of IPF – including shortness of breath and coughing – mean that it is often misdiagnosed. The disease affects slightly more men than women and predominantly occurs in older adults over the age of 50, especially those with a history of smoking.

There is still no known cure however, and these new drugs can only slow the progression of the disease. Other current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplants.

Ofev has also recently received a positive opinion from the EMA for the treatment of non-small cell lung cancer after trial results suggested it could increase overall survival rates to more than a year when combined with docetaxel.

By George Underwood – Pharmafile online

Pharma and transparency: actions speak louder than words

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As an industry we continue to deliver innovative, life changing medicines and rewrite the story of many diseases, yet our social contract remains the subject of debate, commentary and challenge.

The conventional focus on prescriber relationships, though still important, has been increasingly superseded by the outcomes of health technology assessment (HTA) decision-making processes, guideline content and formulary inclusion. Fewer individuals are having a far greater impact on the use of a medicine.

It is in this context that our data, our actions and our relationships are the subject of unparalleled analysis and external scrutiny.

Transparency, particularly regarding financial relationships with the healthcare professionals (HCPs) that patients and the public know and trust, is no longer a ‘nice to have’, it is a societal expectation and part of our licence to operate. This is an area where the pharmaceutical industry must take the lead.

So what action is the pharmaceutical industry taking to make relationships with HCPs more transparent for the benefits of patients?

Actions speak louder than words

It is absolutely essential that patients have confidence that the relationship between their HCPs, who prescribe their medicine, and the industry that makes the medicines they rely on, are open and transparent. It is not just about transparency. We have a long established commitment to ensure that our relationships are appropriate.

There is already a clear framework for the pharmaceutical industry, which is administered at arm’s-length of the ABPI by the Prescription Medicines Code of Practice Authority (PMCPA). The ABPI Code of Practice for the Pharmaceutical Industry sets standards of ethical interactions in the UK between the industry and HCPs and has developed its guidance in this area over the years.

It is also important to note that doctors, pharmacists and pharmacy technicians, and nurses and midwives each have their own code of conduct, which each cover the areas such as making prescribing decisions on clinical grounds, conflicts of interest,  transparency and gifts and hospitality, and this is also backed up by UK law (the Human Medicines Regulation 2012).

In the boundaries of these regulations, it is entirely appropriate that HCPs are fairly compensated for their time and expertise when providing services to the pharmaceutical industry, and we have made a transformational step in the work we have done to be more transparent about payments.

This is a journey that began back in 2010, when members of the ABPI voted to introduce disclosure of aggregate totals paid to health professionals and the number of HCPs they work with. In April, we disclosed aggregate payments to HCPs in the region of £38.5m for payments made in 2013.

This was a first step towards increasing transparency about  the relationships we have with HCPs and has helped pave the way for the next step when, from 2016, pharmaceutical companies will publish details of certain payments made to individual HCPs in 2015 for the first time in the UK.

As far as healthcare organisations (HCOs) are concerned, benefits in kind, fees for services, contributions towards events and joint working will have to be disclosed, in addition to the current requirements to disclose grants and donations. The aggregate spend on certain research and development (R&D) will also be disclosed.

These commitments are incorporated in the ABPI Code of Practice 2014 and are in line with the European Federation of Pharmaceutical Industries and Association’s (EFPIA) Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations Disclosure Code (2013), which sets out requirements for public disclosure of certain payments to HCPs in 2016 for 33 countries covered by the EFPIA Codes.

We should be proud of the relationship between the pharmaceutical industry and HCPs in the UK. It is a relationship that has helped develop many lifesaving medicines and has long been a positive driver for advancements in patient care and the progression of research. In fact, one eighth of world’s most popular prescription medicines were developed in the UK as a result of collaboration with HCPs.

There are benefits for HCPs, industry and, most importantly, patients. HCPs need to stay informed about current and new medicines to provide patients with the best possible care, including treatment options, and the pharmaceutical industry has a duty to provide HCPs with the latest information on its medicines to help ensure that they are able to make the best treatment recommendations to their patients.

Views from the HCP community

There is a strong shared determination among leading HCP organisations, patient groups and commercial organisations to ensure that relationships are based on transparency.

In 2013, a consultation was conducted to identify in principle whether there would be support from the HCP community for a centrally-hosted, single, searchable database, with a proactive role for HCPs in validating and submitting financial information.

The overwhelming majority of respondents, including representatives of the leading HCP bodies and over 1,000 individual HCPs, agreed that payments should be transparent and publicly declared (90%), and that HCPs should have a role to play in making this happen (77 per cent).

83% of respondents supported disclosure on a single, searchable database and 88% felt that public disclosure of payments should include payments from commercial organisations from other sectors such as medical devices and diagnostics.

In April this year we brought together senior stakeholders from across the medical community to discuss plans for disclosure of payments to HCPs, and to look at how we can co-ordinate efforts to develop disclosure in a way that meets the expectations and needs of HCPs and industry.

The meeting has resulted in a number of follow-up conference sessions and publications from participating organisations to inform and update HCPs on plans for disclosure. There is good awareness of public disclosure of payments happening in 2016 in medical leadership and across professional bodies and medical royal colleges, and we are continuously striving to enhance the levels of awareness among HCPs.

Building awareness and understanding of the disclosure project in the HCP community is of paramount importance, and the first wave of communications materials to support that process will be launched soon.

Transparency beyond borders

The drive to increase transparency of relationships with HCPs and HCOs is a Europe-wide initiative. EFPIA agreed the EFPIA Disclosure Code in June 2013. The EFPIA Disclosure Code includes requirements for public disclosure of certain payments to individual HCPs and HCOs from 2016 for payments made in 2015.

The central platform to disclose being considered by the ABPI, together with the proposed changes to the 2014 ABPI Code, finalise the implementation of the EFPIA Disclosure Code in the UK. Several other EFPIA member associations have declared an intention to disclose payments via a central platform or portal.

In the US, The Physician Payments Sunshine Act, or ‘Sunshine Act’, was passed as part of the Patient Protection and Affordable Care Act (healthcare reform) in 2010. The law is designed to bring transparency to financial relationships between clinicians, teaching hospitals and the pharmaceutical industry.

The Sunshine Act requires manufacturers of pharmaceutical drugs and devices, as well as group purchasing organisations (GPOs), to report payments or transfers of value (such as meals, honoraria or travel reimbursements) made to US doctors and teaching hospitals.

The law also requires manufacturers and GPOs to report doctors who have an ownership interest in the company.

Such legislative requirements are not confined to the US. A number of European countries have varying requirements either under legislation, regulatory body requirements or through a multi-stakeholder agreement.

How will UK payment disclosure work?

Whilst proposals to build on the EFPIA requirements and create a single, searchable database in the UK are still out to consultation and its potential functionality still under development, we are excited about the prospect of what it will achieve. The aim is to ensure that the data that companies have invested time and resource collecting is presented in a way that is transparent, accessible and meaningful for stakeholders.

Accessed through the ABPI website, users will be able to search the database by a variety of fields such as first name, last name, HCO, place of work, city of principal practice or company. In developing the system we have prioritised accessibility, company workload and consistency with the pan-European approach.

Companies will upload data to the system in a standard template using a secure login.

Data from the templates will be matched, consolidated and a unique ID assigned to each record to facilitate accurate search capability. In addition to individual payment data, the disclosure pages of the ABPI website will also publish payments to HCOs, aggregate totals of company R&D spend and a total figure for R&D in the UK.

The UK template, currently part of the PMCPA public consultation, is as close to the EFPIA produced template as possible whilst recognising the additional reporting requirements under the UK Code such as joint working and changes needed to facilitate the development of a central platform.

The finalised template and changes to the Code mandating use of the central platform will be published if agreed in November.

The disclosure of payments to HCPs is about bringing further transparency to the relationship between industry and the people it works with. It is a relationship that is critical to the future of medical innovation and patient care and as such, should meet the high expectations of patients and wider stakeholders.

As an industry, our responsibility to patients and to society extends beyond the sale and purchase of new medicines. It is about playing our part in meeting the challenges faced by healthcare systems the world over. Taking on that role means working collaboratively with HCPs, so the addition of disclosure requirements on top of existing frameworks should allow us to move forward in confidence.

By Andrew Powrie-Smith, ABPI director (Pharmafile online)

Cancer drug destroys tumours in pre-clinical trials

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Scientists at QIMR Berghofer Medical Research Institute have used an experimental drug produced from the seeds of a rain forest plant to cure solid cancer tumors in pre-clinical trials.

The study led by Dr Glen Boyle at QIMR Berghofer’s Cancer Drug Mechanisms group found a single injection of the drug EBC-46 led to rapid breakdown of tumors in a range of human tumor models.

Dr Boyle says the findings of the pre-clinical trials at QIMR Berghofer suggest the drug could be effective in human patients.

“We were able to achieve very strong results injecting EBC-46 directly into melanoma models, as well as cancers of the head, neck and colon,” Dr Boyle said.

“In most cases the single injection treatment caused the loss of viability of cancer cells within four hours, and ultimately destroyed the tumors.”

Dr Boyle says EBC-46 works in part by triggering a cellular response which effectively cuts off the blood supply to the tumor.

“In more than 70 per cent of pre-clinical cases, the response and cure was long-term and enduring, with very little relapse over a period of 12 months.”

EBC-46 is a compound extracted from the fruit of the Blushwood tree which is found in north Queensland rain forests.

EBC-46 was discovered by the Queensland biotechnology company EcoBiotics.

The  is being developed as a human and veterinary pharmaceutical through EcoBiotics’ subsidiary company QBiotics.

The experimental drug has been used by practicing veterinarians to successfully destroy or shrink tumors in pets – including dogs, cats and horses.

QBiotics is currently undertaking formal veterinary clinical trials with EBC-46 in Australia and the USA.

A final regulatory approval is still required for a human Phase I clinical trial.

Dr Boyle says QIMR Berghofer is keen to pursue further research to determine if EBC-46 could be made more effective.

“We must stress at this point that EBC-46 will only be trialled in the short-term for tumours which can be accessed by direct injection or topical application,” Dr Boyle said.

“There is no evidence to suggest EBC-46 would be effective against metastatic cancers.”

The pre-clinical trials at QIMR Berghofer have been largely funded by QBiotics with additional support from the NHMRC.

By Kim Lyell, Medical Press

More information: Boyle GM, D’Souza MMA, Pierce CJ, Adams RA, Cantor AS, et al. (2014) “Intra-Lesional Injection of the Novel PKC Activator EBC-46 Rapidly Ablates Tumors in Mouse Models.” PLoS ONE 9(10): e108887. DOI: 10.1371/journal.pone.0108887

Journal reference: PLoS ONE

Provided by QIMR Berghofer Medical Research Institute

BMS therapeutic cancer vaccine given swift FDA appraisal

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Bristol-Myers Squibb has been granted a speedy review for its new cancer immunotherapy drug Opdivo by the FDA for patients with the deadliest form of skin cancer.

The drug is one of a new class of cancer medicines called PD-1 inhibitors that can help the body’s immune system fight certain tumours, and may be worth around $30 billion by the next decade.

It was first approved in Japan in the summer but lost out to Merck’s Keytruda (pembrolizumab) when it became the first PD-1inhibitor to gain an FDA approval earlier this month, where it too gained a licence for melanoma.

Bristol-Myers Squibb will now be second to market, should its drug gain approval, which could be as early as 30 March next year.

BMS should still see blockbuster sales at its peak for Opdivo (nivolumab) with Keytruda also expected to make around $1.7 billion at its height, although Merck’s medicine may make more given its first-to-market status.

New trial data

But BMS will hope its new data for the vaccine published this week may help shore up its defences against Merck’s new medicine.

The company touted new data at the ESMO European cancer congress today, which showed that in patients with advanced melanoma, 32% saw their tumours shrink when given Opdivo against 11% of those treated with conventional chemotherapy drugs.

The duration of response was also much longer as patients on chemotherapy typically responded for 3.6 months, whereas 95% of those who responded to Opdivo were still benefiting after six months and the median duration of response was not reached.

There was not any head-to-head between Opdivo and Keytruda however, although analysts were still impressed by the duration of response rates, which are important in real-world terms.


But things have become ugly between Merck and BMS after the latter firm began legal action against its fierce US rival the day it received FDA approval for Keytruda.

In its lawsuit filed in the US District Court of Delaware, BMS said that Merck was planning to ‘exploit its invention’ of its new immunotherapy drug nivolumab with Keytruda, arguing that it is violating the company’s 20 May patent.

The alleged infringement relates to BMS’s patent that allows its drug to treat cancer with anti-PD-1 antibodies. Specifically, this is its 474 patent relating to how its antibody binds to the PD-1 and blocks the checkpoint pathway.

Merck has dismissed the claims however, and says it will still roll-out its drug in the US as planned.

By Ben Adams – Pharmafile

Boehringer’s lung cancer drug gets EMA nod

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The EMA has issued a positive opinion for the approval of Boehringer Ingelheim’s nintedanib in combination with docetaxel for the treatment of lung cancer, following trials suggesting they can increase overall survival by more than a year.

The Phase III LUME-Lung 1 trial tested the two drugs combined for the treatment of patients with an advanced form of the non-small cell lung cancer (NSCLC) adenocarcinoma after first-line chemotherapy.

Adenocarcinoma is the most common type of lung cancer and accounts for nearly half of all NSCLC cases. The majority of advanced adenocarcinoma patients will experience disease progression after first-line chemotherapy.

The trial showed that adding nintedanib to docetaxel extended the median overall survival from 10.3 to 12.6 months in patients, compared to docetaxel alone. Although this is only an improvement of two months, it makes nintedanib the first lung cancer treatment to demonstrate an overall survival rate of more than a year for patients with advanced adenocarcinoma.

Dr Martin Reck, head of department of thoracic oncology at Lung Clinic Grosshansdorf in Germany, says: “Patients with advanced adenocarcinoma NSCLC after first-line chemotherapy typically have a very poor prognosis. Therefore, providing an extension of overall survival while maintaining quality of life remains the ultimate goal. Nintedanib has shown promise in achieving this.”

In a statement Boehringer adds: “There is still a significant unmet need for new, effective second-line treatments for these patients who have a poor prognosis.”

Drug in other settings

Nintedanib is also tipped to potentially make a big splash in the emerging idiopathic pulmonary fibrosis (IPF) market. There is currently only one drug on the market in Europe for this fatal lung disease – InterMune’s Esbriet (pirfenidone) – but the drug has recently been accepted for accelerated review for its treatment by both the EMA and the FDA. It could be on the market from early 2015.

The cancer-blocking pill is also undergoing Phase III studies for the treatment of forms of colon cancer and ovrarian cancer, as well as Phase II studies in mesothelioma, kidney cancer and liver cancer.

By George Underwood – Pharmafile online

Gilead’s blood cancer pill approved in Europe

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Gilead has gained European Commission approval for its new blood cancer pill Zydelig (idelalisib) as it looks to expand further into oncology.

Zydelig is a first-in-class oral treatment for two incurable blood cancers, namely: chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL).

For the treatment of CLL, Zydelig has been approved for use in combination with Roche’s arthritis and cancer drug MabThera (rituximab) for patients who have received at least one prior therapy.

It can also be used as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. For the treatment of FL, Zydelig has been approved as a monotherapy in patients who are refractory to two prior lines of treatment.

Zydelig inhibits PI3K delta, a protein that is overexpressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells.

CLL and FL are slow-growing incurable blood cancers that can lead to life-threatening complications such as anaemia, serious infection and bone marrow failure requiring treatment. The goal of therapy for patients with these cancers is to improve overall survival and quality of life.

“Although chemo-immunotherapy is initially used to treat both CLL and FL, relapse is common and many patients run out of treatment options to treat the disease as it progresses,” explains Peter Hillmen, Professor of experimental haematology and honorary consultant haematologist at Leeds Teaching Hospitals NHS Trust.

“Further, CLL patients with the 17p deletion or TP53 mutation are not suitable for chemo-immunotherapy, requiring alternative first-line treatment options. Thus, Zydelig is a welcomed treatment option that offers a new approach in the management of these cancers.”

Competition and costs

Gilead’s drug has already been approved in the US where its price is believed to be $7,200 (£4,400) per month, although this rises to around $12,000 when added to MabThera, which its licence warrants.

In the US Zydelig also comes with a black-box warning that highlights such side effects as colitis, lung inflammation and potential fatal liver problems, which may dampen its sales prospects.

And Gilead is not alone in this market as the firm faces competition in the form of Janssen’s Imbruvica (ibrutinib), a treatment that doesn’t have a black box in the US, but costs $8,200 per month.

The price of the drug in Europe has not yet been announced but MabThera’s price tag for CLL is £1,397 for the first cycle of treatment, and £1,746 for subsequent cycles on the NHS – and this was deemed cost-effective by England’s drug pricing watchdog NICE.

Zydelig will most likely be launched in the UK in the coming weeks and be appraised by NICE early next year, although it will be a tough ride for Gilead given NICE’s history in rejecting high-priced cancer medicines.

Blows and slow downs

Overall however, this approval will be good news for the firm as it looks to expand its portfolio outside of virology and into other areas like oncology.

But this month has seen mixed fortunes for the firm as its cancer pipeline took a blow last week, when a Phase II study showed its investigational treatment simtuzumab didn’t provide a clinical benefit in advanced pancreatic cancer patients.

There have been few advances in pancreatic cancer over the past decade so this was not too surprising for analysts, and Gilead also points out that it has ongoing clinical trials with the drug in colorectal cancer, myelofibrosis and serious fibrotic lung and liver diseases.

But the firm will still be disappointed that the medicine failed at a key point in its development, and would hope to gain entry into the potentially lucrative market for pancreatic cancer – given that it is an unmet medical need.

Zydelig is expected to bring in blockbuster sales of $1.2 billion a year by 2020, although this is much less than the exceptional sales seen by its lead drug Sovaldi (sofosbuvir).

The hep C treatment is on course to become the biggest-selling medicine in the world, making nearly $6 billion in its first two quarters this year.

But this trajectory is expected to slow down in the coming months as its competitors line up to launch their new hep C pills (that can also be used in conjunction with Sovaldi) to match or better the 90% success rate Gilead’s drug currently enjoys.

The competition may also lower their prices to better compete with Sovaldi, which costs $84,000 for a full course of treatment in the US.

By Ben Adams – Pharmafile online

FDA panel backs Victoza for obesity

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An FDA panel has voted 14-1 to allow Novo Nordisk’s type 2 diabetes treatment Victoza to help obese patients lose weight.

If it gains final FDA approval (and the regulator usually follows the advice of its specialist panels) Novo says the new treatment will be called Saxenda. According to analysts it could generate an extra $1 billion in revenue for the company.

The panel’s recommendation comes from one main study where half of obese patients given a daily 3mg injection of the drug lost at least 5% of body weight, while 22% lost more than 10 per cent.

The treatment is proposed for use in patients who also have at least one other weight-related condition, such as high blood pressure. Novo’s drug is already sold under the brand name Victoza (liraglutide) for certain type 2 diabetes patients who are not able to control their blood sugar levels.

It is usually taken as an add-on to metformin or sulphonylurea when these drugs are no longer helping patients to keep their blood sugar levels down, and is the step before needing to use insulin.

It made just over $2 billion in sales last year, a growth of 27% on 2012 sales, but has faced safety concerns from regulators, predominately over its potential to increase the risk of side effects on the pancreas.

Growing market

This comes in the same week that in the US the FDA approved the fourth such obesity pill in the form of Orexigen’s Contrave, and follows the 2012 approvals of Vivus’ Qsymia (phentermine/topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin).

These were the first new obesity treatments approved in the US since Roche’s Xenical (orlistat) in 1999.

But all of these medicines have suffered a difficult path on the road to approval, with a number of FDA rejections and concerns from doctors over safety, notably the effect of these medicines on the heart.

This has led to poor sales trajectories, despite the high rate of obesity in the US. Arena reported Belviq sales of just $5.7 million in 2013, with $5.3 million of that going to its partner Eisai.

Qsymia’s sales were higher at $23.7 million in the same period, but still weak given the market potential.

This means Saxenda, should it gain approval, would be fifth such medicine to market, but analysts still expect the drug to do well given that it has been used for four years by doctors for diabetes, and has not faced the same cardiovascular safety concerns as many of its rivals.

According to the US Centers for Disease Control and Prevention, two-thirds of American adults are overweight or obese.

Furthermore, the prevalence of obesity in the US more than doubled among adults from 1980 to 2010, meaning any new – and safe – obesity drugs could be highly lucrative, although no company has yet managed to bring their drug into the blockbuster range.

By Ben Adams – Pharmafile online

AbbVie and Infinity sign cancer deal

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AbbVie has partnered with US company Infinity Pharmaceuticals to develop and commercialise the latter firm’s blood cancer treatment duvelisib (IPI-145).

Infinity will receive an upfront payment of $275 million and could receive an additional $530 million for reaching certain milestones under the terms of the deal. This includes up to $405 million for successful development and regulatory approval.

The two companies will jointly commercialise and share profits of duvelisib in the US, while AbbVie alone will commercialise the drug in other markets – although Infinity will be eligible to receive double-digit royalties on net product sales outside the US.

Duvelisib, Infinity’s only clinical-stage asset, is an oral inhibitor of the PI3K-delta and PI3K-gamma enzymes. It has shown promising clinical activity across a range of blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukaemia (CLL).

AbbVie’s own lead blood cancer drug candidate, ABT-199, has been troubled by safety concerns, and this partnership offers a new avenue through which the firm can continue its drive towards an expanded cancer portfolio, despite duvelisib also having faced questions about its safety in the past.

The drug is currently undergoing three trials – the Phase II DYNAMO trial for iNHL, the Phase III DUO trial for CLL, and an additional Phase I trial for advanced blood cancers – to further evaluate its safety and efficacy. A Phase III study testing duvelisib in combination with rituximab for the treatment of patients with follicular lymphoma will begin later this year.

Michael Severino, AbbVie’s executive vice president and chief scientific officer, says: “We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers.

“The addition of duvelisib will complement AbbVie’s emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients.”

This ‘emerging oncology pipeline’ also includes the US firm’s recently-announced $1.5 billion collaboration with Google’s Calico to develop new treatments for age-related cancers (among other conditions), its in-development breast cancer treatment veliparib, and its prostate cancer drug Lupron – although Lupron has been performing poorly since coming on the market.

But AbbVie and Infinity will be facing stiff competition as they enter the blood cancer market, as several other CLL drugs have recently gained various levels of approval in the US and Europe – including Roche’s Gazyvaro (obinutuzumab), Janssen’s Imbruvica (ibrutinib) and Gilead’s Zydelig (idelalisib).

By George Underwood – PHARMAFILE, online