Hundreds of sales and R&D jobs cut at Sanofi

by emma 3. November 2011 11:15

Pharma Industry News

Sanofi plans to cut hundreds of jobs in its sales and R&D departments in the US over the coming months.

The job losses come as the company prepares to lose patent exclusivity on key products and fully absorbs Genzyme following its acquisition in February 2011.

The sales jobs cuts would be focused on Sanofi’s cardiovascular and oncology groups, aiming for cost savings of $2.9 billion per year, said CEO Christopher Viehbacher.

More than 9,000 jobs have been cut at the company over the last several years, including approximately 3,800 sales employees in the US.

The staff reductions in mature markets have been similar at many other pharmaceutical companies, adding vacancies in emerging markets.

According to Mr Viehbacher, Sanofi has added more than 3,700 pharmaceutical jobs in emerging markets since 2008.

New MD at Teva UK

by emma 2. November 2011 12:00

Pharma Industry News

Teva UK has appointed Richard Daniell as its new Managing Director.

The former commercial operations officer succeeds Dipankar Bhattacharjee, who has been promoted to a wider European role, after more than two decades working with the Teva group.

Mr Daniell says he is “excited about driving the future and vision of Teva in the UK”.

Before being appointed commercial operations officer in 2009, the new MD served as a senior director at Teva UK after serving as director of generics at IVAX Pharmaceuticals UK.

“We want to keep growing, and keep serving our customers well, and I’m confident we can do both of those things with the talented people we have in our team,” said Mr Daniell.

“I’m delighted to be leading such a forward-thinking organisation and I’m proud to be at the helm of one of the UK’s leading pharmaceutical companies.”

Multi-cancer drug in human trials

by emma 2. November 2011 11:33

Pharma Product News

A potential multi-cancer drug is to be tested in a human trial to see if it can treat a number of solid tumour cancers.

The drug, L-NNA could be used in the treatment of solid cancers such as those of the bowel, breast or lung.

Professor Peter Hoskin, from the Mount Vernon Cancer Centre in London, said: “Scientists across the world are looking for ways to prevent cancer cells from receiving the supplies they depend on to grow and divide. It's very exciting to launch this trial of a new drug which in future may provide a new approach to treat a wide range of cancers.”

The drug constricts blood vessels leading to tumours, cutting of blood supply by acting on the enzyme, nitric oxide synthase (NOS).

“All cancers rely on the delivery of vital nutrients and oxygen through blood vessels. Without a blood supply, a tumour can't grow beyond the size of a pin head,” added Professor Hoskin.

Scientists at the Mount Vernon Cancer Centre in London are in the process of recruiting 40 patients for the Phase I trial. The study will focus on establishing the correct dose of drug and will be funded and managed by Cancer Research UK’s drug development office.

Other medicines have already been developed that block tumours from forming their own networks of blood vessels, a process called angiogenesis.

Dr Nigel Blackburn, Director of Drug Development at the charity, said: “This is a promising area of research. We're looking forward to the early trial results of this new drug with great interest.”

ABPI backs MHRA safeguard proposals

by emma 1. November 2011 14:44

Pharma NHS News

The ABPI has backed proposals from the MHRA to repeal part of the Medicines Act which allows pharmacists to trade overseas without the need for a wholesalers licence.

Pharmacists can currently sell medicines intended for UK patients at an inflated rate to customers abroad and could potentially lead to a shortage for patients and the NHS.

Stephen Whitehead, CEO of the ABPI, says the current practice is “not acceptable” and the repeal of the legislation “is a good first step” for patients and the health service.

The proposal is expected to be approved and implemented in 2012.

The new legislation would mean that pharmacies will only be permitted to trade when there is a necessary public health need, when small quantities are required, the order is infrequent and deals are non-profit.

The UK has some of the lowest medicine prices in Europe. This has resulted, the ABPI says, in “flowing out of the UK” and having a direct effect on supplies.

“The ABPI welcomes the MHRA proposal to end the trading of medicines by pharmacies that do not have a wholesale dealers licence, except in exceptional circumstances to meet a public health need,” said Mr Whitehead.

“To fully address this challenge it is now essential that pharmacies who serve NHS patients directly need to separate wholesaling activities from pharmacy dispensing activities.

“The ABPI looks forward to taking an active role in solving the on-going challenges.”

Pradaxa recommended after new data

by emma 1. November 2011 11:38

Pradaxa

NICE has recommended Boehringer Ingleheim’s Pradaxa (dabigatran) for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF) in final draft guidance.

The positive recommendation follows the disclosure of further information from Boehringer that had been requested on a number of areas, including its cost effectiveness and use in clinical practice.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says the medication “represents a significant potential benefit for many people with AF”.

Questions were initially raised by NICE’s Independent Appraisal Committee over the cost to the NHS and a “more plausible set of assumptions” on Pradaxa’s use were required from Boehringer.

But NICE says it is “pleased” the additional information and analysis it received has enabled the Committee to recommend the treatment as a cost-effective use of NHS resources.

“The Independent Appraisal Committee accepted evidence that showed dabigatran 150mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that dabigatran 110mg twice daily is as effective as warfarin. However, there were a number of uncertainties relating to the drug’s cost-effectiveness in the original evidence submission from the manufacturer which required clarification,” said Professor Longson.

Dr Charles de Wet, Medical Director at Boehringer Ingelheim, welcomed the revised decision by NICE. “Pradaxa is the first new oral anticoagulant in 50 years and we are committed to working closely with the NHS to ensure appropriate prescribing in suitable patients with AF who are at risk of stroke,” he said.

Pradaxa has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients aged 75 years with AF who have had a previous stroke, heart attack or systemic embolism.

It is also authorised for people with AF over 65 who have diabetes, coronary heart disease or hypertension.

Final guidance is now expected to be published next month.

Profits up 12% at Novo

by emma 31. October 2011 14:05

Victoza

Novo Nordisk has increased operating profits by 12% in the first nine months of the year after sales growth rose due to the performance of Victoza (pictured), NovoRapid and Levemir.

Sales of modern insulins increased by 11% after Victoza sales nearly DKK 3.9 billion which resulted in net profit jumping nearly a fifth (19%) to DDK 12.4 billion.

Lars Rebien Sørensen, President and CEO, says Novo is “pleased” to see its key products “drive strong underlying sales growth”.

The Danish-based company has now updated its outlook for the year and expect sales growth to be between 10%-11% and operating profits growth be in the region of 17%-19%.

In North America sales increased by 17% and in other International Operations by 16%. Gross margin improved by 0.2% which Novo says reflects a favourable product mix development due to an increase in sales of modern insulin versus lower human insulin sales.

Regulatory dossiers for the company’s new generation of insulins, Degludec and DegludecPlus, were also submitted to the European and US authorities in September. “The filing of our new-generation insulins, ultra-long-acting Degludec and DegludecPlus, in the US and Europe is a major milestone in the expansion of our leadership in diabetes care."

Novo has now adjusted its preliminary outlook for next year which indicates a high single-digit sales growth and an operating profit increase near 10%.

The company increased its operating profit by nearly a third in 2010.

Over 700 pharma jobs set for Nephron

by emma 31. October 2011 13:02

Pharma Industry News

Nephron Pharmaceuticals plans to build a $313 million plant in Cayce, South Carolina, creating 707 new pharmaceutical jobs.

The generic respiratory treatment specialist will build its new facility on a 60-acre site to help expand its market and develop a pipeline of products.

Nephron currently employs more than 400 people at its manufacturing and distribution facility in Orlando, Florida.

The state will contribute $4.5 million to the facility’s preparation and construction costs, which is set to be up and running within the next couple of years.

ViroPharma buys DuoCort

by emma 31. October 2011 11:32

Pharma Industry News

ViroPharma has signed a definitive agreement to acquire Swedish-based DuoCort Pharma AB for an initial $33.6 million – but only if Plenadren is approved by the European Commission (EC).

Under the terms of the agreement, the deal will be closed after the tablet’s approval, after the EC’s confirmation of Plenadren’s orphan drug designation, and an amended agreement with the product’s contract manufacturer.

Vincent Milano, ViroPharma's President and CEO, says the deal is in line with the company’s “objective of broadening our orphan drug portfolio”.

Further milestone patients of up to $131 million associated with manufacturing, sales thresholds and territory expansion have also been agreed as part of the acquisition.

Plenadren is a once daily dual-release oral glucocorticoid tablet with a release profile designed to closely mimic the body's natural secretion pattern of cortisol. ViroPharma now anticipates the commercial launch of the treatment – which it says will be the first “true innovation in over 50 years” – of adrenal insufficiency in the EU within a year. It estimates that peak annual sales for Plenadren could reach up to $50 million.

The Committee for Orphan Medicinal Products confirmed in September that Plenadren’s orphan designation would be maintained and protected for a decade of market exclusivity.

RoActemra recommended for JIA

by emma 27. October 2011 11:20

RoActemra

Roche’s RoActemra (tocilizumab) has been recommended in draft guidance for treating systemic juvenile idiopathic arthritis (JIA).

NICE recommended the treatment after Roche provided its Appraisal Committee with further requested clinical data and it agreed a revised Patient Access Scheme with the DH.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says the recommendation is “good news for children with systemic JIA and those caring for them.”

The draft recommendation is for the use of RoActemra in children aged 2 and over where specific previous treatments have not produced an adequate response.

However, in cases where those whose disease continues to respond to methotrexate or who have not been treated with methotrexate, RoActemra is not recommended as a treatment option.

“The discount agreed as part of the patient access scheme put forward by the manufacturer, in addition to the further information they provided at the Committee’s request, has enabled the Committee to recommend tocilizumab for systemic juvenile idiopathic arthritis in today’s draft guidance,” said Professor Longson.

“The draft guidance proposes that tocilizumab should be the treatment for children aged over 2 years and young people where their systemic JIA hasn’t responded well to other treatments.”

Bone cancer drug recommended

by emma 26. October 2011 15:26

Pharma NICE Update

The first advance in the treatment of bone cancer in children and young people in two decades has been recommended in final guidance by NICE.

Takeda’s Mepact (mifamurtide), in combination with postoperative multi-agent chemotherapy, has been made available to the NHS at a reduced cost under an agreed Patient Access Scheme (PAS).

Sir Andrew Dillon, NICE Chief Executive, says for those treated with Mepact “the health benefits continue over the rest of their lives, effectively being a cure”.

The appraisal saw NICE for only the second time in its history clarify its ‘methods guide’ for treatments which can restore health over a long period, and together with the PAS, reduced the cost per QALY of Mepact.

“Following a clarification from the NICE Board on this issue, and in addition to a revised patient access scheme from the manufacturer, the extra cost per unit of health gained that the NHS will pay for mifamurtide is now lower than previously determined, but still above the normal range that is usually accepted,” said Sir Andrew.

“After having looked again very carefully at a number of factors (such the curative potential of the drug for some people and the small patient population) and taking these factors into account, the Committee was able to recommend mifamurtide for osteosarcoma as a cost-effective use of NHS resources.

“Today’s recommendation of mifamurtide will help children and young people with this very painful and distressing disease, as well as providing some for hope for them, and the people caring for them.”

NICE initially failed to recommend the treatment in an FAD published in October last year. However, after the revision to its methods guide and the proposed PAS, Yasuhiro Fukutomi, Managing Director of Takeda UK, says the company is delighted with the outcome.

“We are grateful to all those who have been involved in this long process including those at NICE, the Department of Health, physicians and patient organisations,” he said. “It has taken everyone’s collaboration to lead us to this successful conclusion for osteosarcoma patients today.”

Mepact was recommended by NICE in draft guidance in September and was approved for use in Scotland in August 2011.

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