AZ given more time to settle Seroquel suits

Thursday, September 2nd, 2010

AstraZeneca has been given more time by judges to settle 6,000 outstanding Seroquel lawsuits.

The US Judicial Panel on Multidistrict Litigation said the return of thousands of consolidated cases to judges’ home courts would delay settlement negotiations. The cases are currently in federal court in Florida.

“A remand at this juncture would likely disrupt the settlement dialog,” US District Judge Anne Conway told the panel. Returning the cases would “stall negotiations altogether,” she added.

The pharma company still faces at least 8,000 cases in both state and federal courts alleging Seroquel causes diabetes. AZ has already agreed to pay nearly $200 million to 17,500 plaintiffs.

AstraZeneca officials said they were ‘committed’ to resolving the remaining lawsuits despite the multi-million payouts.

“We remain committed to a strong defence effort, but will continue to participate in the court-ordered mediation process,” said Tony Jewell, a US spokesperson for AZ.

Seroquel is the pharma company’s second-biggest seller.

AZ staff to strike over pensions

Monday, August 23rd, 2010

Staff at AstraZeneca (AZ) have voted to strike over cuts to pension benefits.

Seven out of ten employees at AZ’s site in Macclesfield decided to take strike action over what the GMB called ‘draconian proposals to, in effect, end its final salary pension scheme for 2,500 staff’.

The pharma giant insisted only a small percentage of workers called for action and said the benefit remained attractive compared to competitors.

Shop stewards are now set to announce the dates for industrial action unless a compromise can be reached.

In a statement, AZ said it remained “committed to providing a very competitive level of pension benefit and the changes made ensure all employees continue to have access to pension arrangements that compare favourably to other organisations in the UK.”

“We understand that 165 employees have voted in favour of action, which represents about a third of the GMB members and less than 2% of the UK employee population,” it continued.

But Alan Black, National Officer of GMB union, called for AstraZeneca to reassess its stance before walkouts take place.

“This clear mandate for a strike in the midst of the current economic circumstances ought to be a wake-up call to AstraZeneca to resume negotiations with GMB,” he said. “They have to understand that unless they take this opportunity then strike action will be the consequence.”

The Macclesfield site is AZ’s second largest in the world.

Sanofi appoints new Director of Communications

Thursday, August 5th, 2010

Dr Ian Weatherhead has been appointed UK Director of Communications at sanofi-aventis.

Dr Weatherhead brings a wealth of experience with him following senior external communication roles at UCB, AstraZeneca and Syngenta.

Steve Oldfield, sanofi’s General Manager, said of his appointment: “I’m delighted that Ian will be joining us later in the year to lead communications, a critical area in supporting our UK business and our transition to a global healthcare leader. He brings substantial experience of driving internal and external communication activities in other pharmaceutical and life science organisations.”

His new role will start in October.

New capsule offers pharma ‘huge potential’

Thursday, July 29th, 2010

A new capsule delivery system has been granted a patent in Europe.

DuoCap, manufactured by Encap Drug Delivery, is an oral unit that consists of a capsule inside another capsule which offers various therapeutic applications.

The capsules may contain the same active drug offering a multiple release unit or combine different actives that are incompatible.

Already used by GSK and AstraZeneca, it’s said to have ‘huge potential’ for pharmaceutical active agents requiring controlled release.

The inner capsule can contain liquid, semi-solid, powder or pellet formations. The outer shell can also house liquid or semi-solid formulations.

Further options are also available in the capsule’s lining. It can be coated either with enteric systems or with Encap’s colonic delivery system, ENCODE.

Protection for clients interested in the line-extension formulations for drugs coming to the end of their patent is also provided by DuoCap. The opportunity to license a patent-protected technology on a product-by-product basis is also available.

Sales & Marketing Director Dr Robbie Stewart welcomed the patent and highlighted its future capabilities.

“Encap is able to manufacture DuoCap for clinical or proof-of-concept studies right through to full-scale commercial volumes,” he said.

NICE backs cancer treatments

Wednesday, July 28th, 2010

NICE has recommended two new convenient cancer treatments in their final guidance.

Roche’s Xeloda (Capecitabine) has been recommended in combination with a platinum-based regimen for the first-line treatment of inoperable advanced gastric cancer. Iressa (gefitinib) has also been given the go-ahead for first-line treatment of locally advanced or metastatic non-small-cell lung cancer.

NICE said that Iressa, which has been proposed as a patient access scheme by AstraZeneca, offers patients added convenience in its oral form. It also noted the Xeloda tablet would allow patients less time in hospitals connected to infusion pumps.

Health Technology Evaluation Centre Director Dr. Carole Longson hoped the new treatments would help the thousands of people suffering from the conditions in the UK each year.

“Non-small-cell lung cancer and gastric cancer can both be devastating conditions, with gastric cancer affecting approximately 8,200 people in the UK every year and non-small-cell lung cancer approximately 38,000,” she said. “We are very pleased to be able to recommend both capecitabine and gefitinib for use on the NHS.”

AZ ‘abused position’ to prevent generic launch

Thursday, July 1st, 2010

The General Court has upheld the decision by EU antitrust regulators to fine AstraZeneca in 2005 for blocking cheaper generic medicines coming to the market.

The European Commission said that AZ had breached EU rules by blocking or delaying market access for generic versions of its ulcer pill Losec (omeprazole) from 1993 to 2000.

The original fine of 60 million euros was reduced to 52.5 million, however, following AZ’s appeal to the General Court, the EU’s second-highest court.

“The General Court essentially upholds the decision of the Commission which found that the AstraZeneca Group abused its dominant position by preventing the marketing of generic products replicating Losec,” the court said in a statement.

The fine was reduced as the Commission had not proved that the deregistration of marketing authorisations for the drug in Denmark and Norway affected parallel imports. But the court did back the Commission’s finding that the company had provided misleading information to patent offices in Belgium, Denmark, Germany, the Netherlands, Norway and Britain.

“We were disappointed that the court hasn’t confirmed our position. We will be reviewing it in detail and decide on any next step once we have a chance to go through it in more detail,” said AstraZeneca spokeswoman Sarah Lindgreen.

The British Generic Manufacturers Association (BGMA) has applauded the ruling. BGMA Director Warwick Smith said that the findings “are consistent with those of the European Commission’s inquiry into the pharmaceutical sector and our own experience that the research-based pharmaceutical industry uses a toolkit of devices to prevent generic launch when the patents on its drugs expire. This costs the NHS many millions of pounds and diverts the research-based industry from its true task of developing new medicines that patients need.”

AZ has two months to appeal against the ruling at the Court of Justice, the EU’s top court.