New Chair of ABPI Innovation Board

by JoelLane 10. May 2012 14:48

WeirMAY12-12 web The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Neil Weir as the Chair of its Innovation Board.

Dr Weir will lead the Board’s work in developing the ABPI’s long-term vision for pharmaceutical innovation and increased international competitiveness.

He replaces John Stageman, who retired in April.

A leading expert on antibody-based medicine, Dr Weir currently leads UCB’s drug discovery programme. In this role he has led a team responsible for developing 20 new products.

He was formerly Head of Discovery at Celltech R&D.

Stephen Whitehead, ABPI Chief Executive, said: “With Neil’s introduction the ABPI is taking the opportunity to strengthen the link between our Innovation Board and our Board of Management. Supporting and encouraging innovation is the key role of our Innovation Board, but it is also a key consideration for the ABPI as a whole.”

“As the shape of our industry continues to rapidly change our fate lies in the ability to continually innovate,” said Dr Weir. “Our ambition must be to offer innovative new medicines and ground-breaking solutions that go beyond the drug.

“We must remain committed to enabling cutting-edge scientific research that is driven by the patients’ needs, but above all we should continue to focus on our core strength and offering, namely: innovation.”

Biogen submits US and EU marketing applications

by IainBate 10. May 2012 14:39

Pharma Product News The FDA and the EMA are to review Biogen Idec’s marketing application for BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).

BG-12 is the only known investigational compound for the treatment of MS that has experimentally demonstrated activation of the Nrf-2 pathway.

It has demonstrated significant reductions in MS disease activity, coupled with favourable safety and tolerability in two separate Phase III clinical trials.

Last year, Biogen published data from the DEFINE and CONFIRM global clinical trials that demonstrated BG-12’s effectiveness in patients taking the treatment either twice or three times a day over a period of two years.

As a result, the FDA has now accepted Biogen’s New Drug Application and granted the company a standard review timeline. In addition, the EMA has validated a similar application for review.

Cancer combinations expected to increase

by IainBate 10. May 2012 14:17

Pharma Industry News The use of combination therapies in the treatment of cancer patients is set to increase in the future, according to a new report.

Analysis found that oncological treatments are evolving to include biologic medication, which, in combination with cytotoxic drugs, is rapidly becoming the top pharmaceutical therapy.

GBI Research’s report found the effective capabilities of biologics in controlling and treating complications has led to their widespread use and popularity amongst patients and prescribers.

The cytotoxic therapies markets has eight major indications and brands include Taxotere (docetaxel), Alimta (pemetrexed) and Xeloda (capecitabine) – all of which have exceeded sales of $1 billion.

However, these drugs are set to be exposed to generic competition in coming years which will reduce the cost of combinational treatments.

The popularity of such treatments is also expected to convince pharmaceutical companies to apply for label extensions on their existing biologics portfolio for multiple oncology complications.

This, the report said, will support the continued development of cytotoxic drugs in the future, despite significant safety hurdles that have previously led to weak pipelines.

The cytotoxic therapies market accounted for $6.5 billion in revenue ten years ago. It grew at an annual rate of 5.8% to reach $10.1 billion in 2010. The report now expects generic competition to reduce revenues in the market by 2017 to $7.6 billion – despite predicted uptake.

Primary care needs new strategies, report says

by JoelLane 10. May 2012 13:29

Pf NHS News GPs need a new care model to deal with growing demand and their own falling numbers, a new report has said.

According to the Deloitte UK Centre for Health Solutions, primary care is facing the retirement of many GPs combined with increasing numbers of elderly and chronically ill patients.

To deal with these challenges, the report argues, primary care needs to focus on community healthcare, patient self-management and new technology.

The demand challenge is well understood: the ageing population and the growing prevalence of long-term health conditions.

However, the report highlights a supply challenge: 10,000 GPs intend to retire within five years, while increasing numbers work part-time. Practice nurses, who are increasingly relied on, show a similar demographic.

The number of entrants to the primary care sector has fallen, while changes in employment regulations mean that recruiting qualified practitioners from overseas will be impossible.

The new commissioning role of GPs will increase strain on primary care, the report notes, with GPs facing unfamiliar responsibilities and performance management systems as well as severe financial constraints.

Karen Taylor, Research Director at the Deloitte Centre, commented: “GPs need to adopt new models of care, using new technology and other practice staff more effectively, working closely with patients to provide more care in the community, with an emphasis on shared decision-making and self-management.

“GPs will still need to act as gatekeepers, but also, increasingly, as care navigators.”

Experienced Clarke swaps Pfizer for Novo

by IainBate 10. May 2012 11:26

Pharma Appointment Pfizer’s Robert Clarke will leave his role as US regulatory strategy head to join Novo Nordisk in a similar position.

Mr Clarke will join Novo on 14 May to lead the Danish-based pharma company’s US regulatory team.

Anne Philips, Corporate Vice President of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, said the new recruit’s “know-how” is required by the diabetes specialist.

He will be tasked with maintaining relationships with key stakeholders and agencies that play a specific role in the FDA’s review and approval process.

“Bob is bringing 27 years of experience and knowledge of the global and US regulatory environment, and it’s that know-how we require for an increasingly complex pharmaceutical marketplace,” said Anne Philips.

“Novo Nordisk has one of the most promising diabetes pipelines in the industry, and having a respected leader known to regulatory authorities will help us achieve our ongoing mission to bring new therapies to patients.”

Pfizer gives up marketing Lipitor

by JoelLane 10. May 2012 11:00

lipitor web Pfizer has dropped attempts to market its cholesterol-lowering drug Lipitor (atorvastatin) in the US, nearly five months after its patent expiry.

The company said its post-expiry marketing campaign had been successful, but generic erosion of the Lipitor brand would soon escalate.

The decision is a milestone in the history of the world’s best-selling drug, used to help prevent cardiovascular events in high-risk patient groups.

Pfizer has ceased negotiating new contracts to sell Lipitor to health providers in the US or promoting it through sales representatives or advertising.

Following its US patent expiry on 30 November 2011, Pfizer invested $87m in sustaining the brand through doctor marketing, advertisements and price rebates. The strategy succeeded in retaining 33% of market share, bringing in $383m in the first quarter of 2012.

However, the second wave of generic atorvastatin following Lipitor’s patent expiry in the EU in May has prompted Pfizer to give up on the brand that at one time accounted for a quarter of its revenue.

The company will continue to promote the drug in emerging markets, including China, where it could still earn billions of dollars.

NICE gives Tarceva green light

by IainBate 10. May 2012 10:57

Tarceva (resized) Roche’s Tarceva (erlotinib) has been recommended in final draft guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

The decision comes after Roche provided NICE with additional data on the clinical and cost effectiveness of Tarceva when supplied under an agreed Patient Access Scheme (PAS).

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the health regulator is “pleased to recommend another treatment” for NSCLC.

NICE recently recommended Iressa (gefitinib) as a first-line treatment for NSCLC. Roche were unable to provide any clinical data comparing Tarceva with Iressa, but specialists confirmed the two were similar and equally effective.

Tarceva and Iressa work differently to chemotherapy. The oral treatments are known as “target agents” due to the way they block certain processes in the cancer cells.

Data supplied by Roche showed Tarceva showed longer progression-free survival and similar overall survival compared with current treatment options. It expects that NICE’s recommendation will benefit approximately 11% of patients with NSCLC.

The PAS agreed between Roche and the DH may mean that Tarceva is supplied to the NHS free of charge in certain circumstances. Tarceva will be made available at a single cost of £12,200 per patient irrespective of the duration of treatment. However, Roche will only invoice the health service after the third monthly pack of Tarceva is supplied. Any patients who receive only one or two months of treatment will receive the drug without the NHS being charged.

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