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.

Novartis is expected to overtake Pfizer and become the biggest manufacturer of prescription medicines by 2018, according to new consensus data.

Research by EvaluatePharma estimates Novartis will record sales of more than $50bn in six years’ time, with its eye care business Alcon and generic unit Sandoz driving growth.

But the outlook is not good for US-based companies with only Pfizer remaining in the top five by 2018 and Sanofi, GSK and Roche maintaining a strong presence.

Data found that despite generic competition on Diovan and Glivec and disappointment from key projects such as Gilenya and its new respiratory franchise, Novartis is expected to record annual growth between 2011 and 2018 of 1.2%.

This is in contrast with AstraZeneca whose annual sales are expected to drop from $32.4bn in 2011 to $22.1bn in 2018 representing a negative growth of 5.3%.

Gilead Sciences is expected to experience the biggest increase in annual growth of the top fifteen companies with data showing sales will rise from $8.1bn to $15.7bn at a rate of 9.9% per year.

Novo Nordisk is also forecast to enter the top 15 ranked companies for the first time due to an increasing demand for its diabetes medicines. Annual growth is expected to be 7% until 2018 with sales totalling nearly $20bn.

One of the biggest casualties, data found, will be Eli Lilly. The Indianapolis research-based company currently claims to be the 10th biggest pharmaceutical company in the world. But Lilly fails to make the top 15 companies after research found a drop in sales will see it fall to 17th place by 2018. But researchers did note that Lilly’s Alzheimer’s candidate, solanezumab, could reverse the trend if it successfully enters the lucrative market.

Lilly will be replaced in the list by German healthcare giant Bayer, which also enters the top 15 global companies for the first time, with annual sales of around $16.5bn by 2018 boosted by Xarelto.

NICE has recommended Novartis’ Tasigna (nilotinib) and Glivec (imatinib) for the first line treatment of chronic myeloid leukaemia (CML), but failed to recommend BMS’ Sprycel (dasatinib) in final guidance.

Despite evidence demonstrating Sprycel and Tasigna to be more clinically effective than standard dose Glivec, Sprycel’s cost swayed NICE’s decision after Novartis agreed to supply Tasigna at a reduced price.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, says the cost reduction “enabled” the independent Appraisal Committee to recommend its use on the NHS.

The appraisal incorporates a partial review of guidance published in October 2003 which recommended standard dose Glivec for first line treatment of CML.

NICE’s independent Appraisal Committee considered results of clinical trials that showed statistically more people receiving Sprycel and Glivec had a complete cytogenetic response and a major molecular response compared with people using Glivec after a 12 month review.

The Committee also noted the opinions of clinical specialists and patient experts who suggested that Tasigna and Sprycel were more effective than standard dose Glivec – despite it being a “very effective” option for the majority of patients.

Sprycel and Tasigna both cost more than £30,000 per patient, per year. Standard dose Glivec costs in the region of £20,000. However, after Novartis had agreed a Patient Access Scheme with the Department of Health for Tasigna, NICE deemed it was a cost effective use of NHS resources.

“The recommendations reaffirm the use of imatinib as an effective treatment for the majority of patients and a cost effective use of NHS resources, and we are also very pleased to be able to add a further treatment option for these patients by recommending nilotinib,” said Professor Longson.

“Although no trials directly comparing dasatinib and nilotinib were available, the committee concluded from indirect comparisons that dasatinib and nilotinib could be considered equally as effective in treating CML.

“However, the manufacturer of nilotinib has already agreed with the Department of Health to provide the drug to the NHS at a discounted price.”

CML is a rare condition that affects around 560 people in the UK each year.

NICE has recommended the use of Tasigna (nilotinib) and Glivec (imatinib) for the first-line treatment of chronic myeloid leukaemia (CML), but failed to recommend Sprycel (dasatinib) in final draft guidance.

The guidance reaffirms the use of standard dose Glivec and recommends the use of Tasigna after Novartis agreed a Patient Access Scheme with the DH to lower its cost.

Sir Andrew Dillon, NICE Chief Executive, says the Institute is “very pleased to be able to add a further treatment option” for patients.

CML is a rare condition that affects around 560 people in the UK each year.

NICE’s independent Appraisal Committee considered the results of clinical trials and noted the views of clinical specialists and patient experts when conducting the appraisal.

It found that more patients receiving Tasigna and Sprycel had a complete cytogenetic response and a major molecular response than people receiving Glivec at 12-month follow-up.

Also, experts said that Tasigna and Sprycel are more effective than standard-dose Glivece with a theoretically superior mechanism of action, although this option remains very effective.

The Committee concluded that available evidence suggests Tasigna and Sprycel provide superior clinical benefit as measured by surrogate outcome measures to standard-dose Glivec in people with chronic phase CML – despite no direct head-to-head data being available.

“Although no trials directly comparing dasatinib and nilotinib were available, the Committee concluded from indirect comparisons that dasatinib and nilotinib could be considered equally as effective in treating CML,” said Sir Andrew Dillon.

“However, the Department of Health and the manufacturer of nilotinib have already agreed to provide the drug to the NHS at a discounted price. This reduction in cost enabled the independent Committee to approve nilotinib for use on the NHS.”

Oral cancer drugs such as Glivec and Tarceva are negatively affected by other medications including steroids and antibiotics, according to a new US study.

The Medco Research Institute (MRI) has claimed that medications taken by as many as 75% of cancer patients interfere with the effects of oral kinase inhibitors, a major class of adjunctive cancer therapy.

The effect of the medication interference is to weaken the effectiveness of the anti-cancer treatment and/or increase its toxicity, the study found.

Oral kinase inhibitors, which suppress tumour cell metabolism, are widely prescribed for their ability to increase the effectiveness (and reduce effective dosage levels) of chemotherapy.

The MRI study, which looked at 4,617 cancer patients, found that 23–74% of them were being prescribed a medication that interfered with their oral cancer drug. Of these, 43% showed a reduction in the efficacy of the cancer drug and 68% showed an increase in its toxicity.

Oral kinase inhibitors include (UK trade names): Glivec (imatinib), Tarceva (erlotinib), Sprycel (dasatinib), Afinitor (everolimus), Tyverb (lapatinib), Tasigna (nilotinib), Votrient (pazopanib), Nexavar (sorafenib) and Sutent (sunitinib).

The medications that interfere with them, according to the study, are calcium channel blockers, antifungal agents, steroids, proton pump inhibitors and some antibiotics.

Dr Steve Bowlin, Senior Director at the MRI and co-author of the study, said: “Since these are drugs launched in the past decade for fairly small patient populations, we are learning more about how they are used in real-world settings as compared to traditional clinical trials that test safety and efficacy in a tightly-controlled environment.

“Oncologists are not always aware of other medications prescribed by other doctors and vice-versa, which can pose a real hazard for their patients on oral cancer therapies.”

The European Commission (EC) has approved a label update for Novartis’ cancer drug Glivec (imatinib), extending its use to three years in certain patients.

The drug has been approved for use as an adjuvant therapy for 36 months in patients with KIT (CD117)-positive gastrointestinal stromal tumours (GIST).

Glivec is the only treatment available in the EU for the treatment of this life-threatening type of post-surgical tumour.

GIST are rare (affecting an estimated 5,000 new patients in the EU each year), but are difficult to diagnose and treat. Patients with KIT+ GIST are at risk of metastasis after surgery, and their survival prospects following tumour recurrence are poor.

An international phase III trial showed that three years’ treatment with Glivec significantly improved recurrence-free and overall survival rates in adults with post-surgical KIT+ GIST relative to one year’s treatment.

The recurrence-free and absolute survival rates for patients taking Glivec for three years were 66% and 92%; those for patients taking Glivec for one year were 48% and 82%.

The new label also states that treatment with Glivec beyond three years may improve progression-free survival but its effect on overall survival is not known.

Hervé Hoppenot, President, Novartis Oncology, said: “This approval marks a key milestone in advancing the post-surgical treatment of GIST for certain patients in Europe, where Glivec is the only available therapy in this setting.

“Physicians now have a strong basis for recommending three years of treatment for these patients with KIT+ GIST after surgery.”

NICE has recommended Novartis’ Tasigna (nilotinib) for the treatment of chronic myeloid leukaemia (CML) but failed to recommend Sprycel (dasatinib) and high dose Glivec (imatinib) in final guidance.

The Appraisal Committee concluded all three treatments provided clinical benefit for people with Glivec-resistant CML but opted for Tasigna when provided under the terms of a patient access scheme.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says that although Tasigna is “expensive” the discount enabled the Committee to approve its use.

NICE estimates that Tasigna costs more than £30,000 per patient, per year.

The Institute received two appeals on its final draft guidance not to recommend Bristol-Myers Squibb’s Sprycel and Novartis’ Glivec, but both of these were dismissed on all accounts.

When completing the FAD, it found that patients with Glivec intolerance generally had a higher response rate to Tasigna and Sprycel than those with Glivec-resistant CML. But a lack of evidence base meant the magnitude of the benefit was uncertain.

When considering the updated analysis submitted during consultation on the first draft from Novartis, the Committee concluded that the ICER of £22,800 per QALY gained for Tasigna compared with hydroxycarbamide was optimistic. But, when provided at a discounted rate, it was regarded as a cost-effective use of NHS resources.

However, the ICER for Sprycel compared with hydroxycarbamide would be more than £43,800 and could rise further. The Committee also noted that high-dose Glivec was more expensive and less effective than the other treatments under evaluation.

“We are very pleased to be able to recommend nilotinib as a treatment option for the chronic and accelerated phases in people who are resistant or intolerant to standard dose imatinib,” said Professor Longson.

CML is a very rare condition that affects around 560 in the UK each year. If treatment with Glivec does not work, current options include interferon-alfa, hydroxycarbamide or a bone marrow transplant.

NICE has recommended the use of Novartis’ Tasigna (nilotinib) and Glivec (imatinib) for the first-line treatment of chronic myeloid leukaemia (CML) but not recommended Bristol-Myers Squibb’s Sprycel (dasatinib).

In new draft guidance, NICE reaffirms the use of Glivec as a cost effective option and Tasigna after Novartis agreed a Patient Access Scheme with the DH, but deemed Sprycel to be too expensive.

Sir Andrew Dillon, NICE Chief Executive, says the Institute is “very pleased to be able to add a further treatment option” for patients with the rare condition.

The appraisal incorporates a partial review of 2003 guidance which recommended standard-dose Glivec for the first-line treatment for CML. High-dose Glivec was only recommended in the context of clinical trials.

Tasigna and Sprycel both cost more than £30,000 per patient, per year, NICE calculates. Standard dose Glivec costs £20,000. The discount price between Novartis and the DH for Tasigna has been kept confidential.

NICE is also currently appraising the use of Sprycel, high-dose Glivec and Tasigna for the treatment of Glivec-resistant CML and Sprycel and Tasigna for those with CML for whom treatment with Glivec has failed due to intolerance.

CML affects around 560 people in the UK each year.

Global revenues from small-molecule targeted cancer therapies are expected to reach $27.3bn in 2015, a new report predicts.

visiongain’s Small-Molecule Targeted Cancer Therapies: World Market 2011-2021 found that the overall market generated $20.3bn last year but is set to grow as more patients are diagnosed with cancer.

Dr Syed Ahmed, a senior healthcare industry analyst, visiongain, says there is still “an under-met need for therapeutic agents” and the therapies “remain a crucial part of the pharmaceutical market from 2011 to 2021.”

The report found that there were more than 13 million patients worldwide diagnosed with cancer in 2009. But there may be as many as 20 million new cases by 2025, it says.

Targeted cancer therapies block the growth and spread of tumours by interfering with with molecules involved in tumour growth and progression. Most of these are either small-molecule drugs or monoclonal antibodies.

The market is currently dominated by Novartis’ Glivec/Gleevec (pictured), the report says, but ‘blockbuster’ brands are set to lose their patent protection in the next ten years paving the way for generic competition.

“A strong R&D pipeline for small-molecule cancer therapies makes this industry segment dynamic and promising for pharmaceutical companies," said a report analyst.

A quarter of the NHS drugs spending of £4.1 billion last year went on just ten medicines, according to a new report.

IMS Health found that total prescribing costs in England, including primary care and community prescriptions, reached a record £12.86 billion in 2010, an increase of 4.8% from the previous year.

This total in English hospitals has increased by 7.7%.

The report, commissioned by the NHS, says that this growth is likely to be related to the introduction of new, more expensive treatments.

The top 10 drugs (Figure 1) were mainly biologics used to treat either autoimmune diseases or cancers.

The most expensive were two arthritis drugs, Abbott’s Humira (adalimumab), with an increase of 19% to £180.5 million, and Pfizer and Amgen’s Enbrel (etanercept), costing £179.6 million.

Novartis’ Lucentis (ranibizumab) treatment for eye disease cost £128.9 million, overtaking Roche’s breast cancer medicine Herceptin.

The report noted the difficulty in biologics, as they are unlikely to be copied and manufactured into generics, consequently costing for the NHS more for branded medication. Manufacturers are likely to make more innovative forms of existing drugs, which would also push prices up.

However, the primary care drugs bill, which takes up 66% of the £12.9 billion spending of medicines in the English NHS, is expected to decrease by £1 billion over the next four years due to a series of patent expiry dates.