Two merge to form Jazz Pharmaceuticals

by emma 21. September 2011 15:30

Pharma Field industry news

Jazz Pharmaceuticals and Irish-based Azur Pharma Limited have combined to create a new speciality company.

The combined company – which will continue as Jazz Pharmaceuticals plc– will be incorporated in Ireland and has several products currently marketed in the US.

Seamus Mulligan, Chairman and CEO, Azur Pharma, says the merger creates a company that has “greater operational and financial resources” to enable its strategy of acquiring and developing speciality products.

The company markets ten products in the US within the central nervous system (CNS) and women’s health areas. Including Xyrem, Luvox CR, Prialt, FazaClo and Elestrin, revenues are now expected to reach more than $475 million in the first 12 months following the completion of the deal.

The combined company would also have a number of pipeline of lower-risk development programmes, including line extensions for the clozapine franchise and various other branded women’s health products.

"This significant transaction represents a compelling strategic fit, given our companies' closely aligned missions of identifying and developing products that address unmet patient needs and can be efficiently marketed through a specialty commercial infrastructure," said Bruce Cozadd, who will become the Chairman and CEO of Jazz Pharmaceuticals plc.

Sanofi in R&D deal for acne vaccine

by emma 21. September 2011 15:04

Pharma Field industry news

Sanofi Pasteur has signed a research and development agreement with the University of California, San Diego, for its experimental acne vaccine and treatment.

The R&D pact includes a two-year collaboration with Chun-Ming Huang and team at UC San Diego School of Medicine.

The team’s immunological approach to acne prevention and treatment targets the neutralisation of Propionibacterium inflammation.

Elias Zerhouni, President of Global Research and Development at Sanofi, said that the vaccine and treatment could address an unmet medical need.

“This investigational vaccine and treatment may lead to a better solution for the many who suffer from this skin disease,” said Mr Zerhouni.

According to the vaccine division of Sanofi, the annual market for acne therapeutics is in excess of $3 billion.

Trajenta now available for T2DM

by emma 20. September 2011 16:58

Trajwhite

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”

Experienced Brinsmead joins Proteus

by emma 16. September 2011 15:30

Chris Brinsmead small

The current Life Sciences Business Advisor to the UK Government, Chris Brinsmead, has joined Proteus Biomedical Europe as its new Chairman.

Mr Brinsmead will develop the organisation in Europe and use his wealth of experience in guiding the commercial launch of Proteus’s first product, Helius.

Andrew Thompson, CEO, Proteus, says the company is pleased somebody with as “distinguished a career” as the new Chairman has assumed such an “important leadership role”.

Prior to his role within the Coalition Government, the former Chairman and President of AstraZeneca UK, was appointed as a Business Ambassador to promote UK life science abroad. He also served as the President of the ABPI.

Helius provides assurance and peace of mind to individuals struggling with complex medication regimens and health issues, the company says.

“I believe that Proteus is developing a potential game changer for the way in which consumers take their medicines, understand their chronic conditions and manage their health and wellness,” said Mr Brinsmead.

“With the launch of Helius, first in the UK and then across Europe, we will be building the foundation for a new kind of twenty-first century medical business—one that is as shaped, personalized and embraced by consumers as are the mobile phones, social media sites and other digital products that increasingly populate and define our daily lives.”

Report says cancer patients in England access more drugs

by emma 6. September 2011 11:54

Pf NHS News

Major inequalities in the numbers of patients approved to access certain cancer drugs have appeared across the UK, health campaigners have said.

Patients living in England are three times more likely to access key cancer drugs from their doctors than those in Scotland, and five times as likely as those in Wales, according to data presented by the Rarer Cancers Foundation (RCF).

Andrew Wilson, Chief Executive of the RCF, said: “A devastating divide has opened up with Scotland and Wales. A cancer drug does not become any less effective simply because it is prescribed on the other side of a border.”

Through the Freedom of Information Act, the RCF gathered data from health trusts across the country on the types of drugs approved by the Government’s cancer drugs fund.

Worth £200 million a year, the fund was established in England to access drugs approved by doctors, but is not currently available on the NHS.

Mr Wilson added: “The NHS should be there when you need it the most, regardless of where you live.

“People in Scotland and Wales will want to know why their chances of accessing a life-extending cancer drug are so much lower than their neighbours in England.”

The Scottish Government stated that it would carefully consider the report.

“Scotland has robust, equitable and transparent arrangements for the introduction of newly-licensed clinically and cost-effective medicines through the Scottish Medicines Consortium and Healthcare Improvement Scotland which operate independently from the Scottish government,” said a spokeswoman for the Scottish Government.

“These arrangements include flexibility for additional factors to be taken into account in prescribing decisions”.

NICE rejects three colorectal cancer drugs

by emma 5. September 2011 16:25

Pf NICE update

NICE has failed to recommend three treatments for patients with metastatic colorectal cancer that has progressed following first-line chemotherapy.

According to the new draft guidance, Merck Serono’s Erbitux (cetuximab), Roche’s Avastin (bevacizumab) and Amgen’s Vectibix (panitumumab) failed to prove to NICE’s Independent Appraisal Committee that the treatment options were cost-effective.

Andrew Dillon, Chief Executive of NICE, said that six treatments for various stages of colorectal cancer are already recommended by NICE and at present, the Committee “does not feel it has enough clear evidence, especially in the case of bevacizumab, to be able to recommend these drugs for use on the NHS.”

The preliminary recommendations are now available for public consultation.

“It is also possible for the manufacturers to provide further comment on the committee’s interpretation of their products’ clinical effectiveness or consider reducing the price they are asking the NHS to pay through a patient access scheme,” Dillon said.

New UK HQ for Astellas

by emma 31. August 2011 12:47

Pf industry news

Astellas will move its base of UK operations from its premises in Stains, Middlesex, to a new facility in Chertsey, Surrey.

The pharma company is believed to have paid around £17 million for the 90,000 square foot building, which is currently occupied by software company EA Games.

The agreement will also include an adjacent 100,000 square foot office development and will house the workforce which currently stands at more than 250 employees.

The company has also sold a research centre in Tokyo for more than 10bn YEN, excluding tax, to improve asset efficiency through reduction and liquidation of assets, the company says.

Nurofen mix-up with anti-psychotic drug

by emma 26. August 2011 13:30

Pf industry news

Regulators have issued warnings that thousands of packets of Nurofen Plus could have been mixed up with anti-psychotic drug, Seroquel XL.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert after three packets of Nurofen Plus were found containing individual blister packs of Seroquel XL in branches of Boots in the Victoria, Beckenham and Bromley areas of London.

The MHRA decided not to recall thousands of batches of the 32-tablet packs, but to urge “extra vigilance” to consumers, as the affected packets could be in pharmacies across the UK.

Nurofen Plus’ manufacturer, Reckitt Benckiser said “serious investigations” were underway to establish how the mix-up occurred, as Seroquel XL is manufactured by another drug firm, AstraZeneca.

A number of theories have been offered, but the drug makers are not believed to be at fault. The first suggestion hinted a simple mix-up at a wholesaler, but neither company is ruling out sabotage at this time.

Siân Boisseau, Director of Virgo Health, a public relations firm which represents Reckitt Benckiser, told the Guardian that there has been a “suggestion that the packets were deliberately put in the wrong boxes”.

The two drugs are very different. Reckitt Benckiser’s Nurofen Plus is one of the most popular brands of painkiller, whereas Seroquel XL by AstraZeneca is a prescribed anti-psychotic medicine to treat several disorders, such as schizophrenia, mania and bipolar depression.

People who accidentally take Seroquel XL may experience drowsiness and are advised to not drive or operate any tools or machinery until they know how the tablets have affected them. Other side effects include dizziness and headache.

The large capsules of Seroquel XL 50mg have gold and black packaging while the Nurofen Plus tablets are smaller and have silver and black packaging.

Ian Holloway from the MHRA's Defective Medicines Report Centre (DMRC), said: “People should check to see if they have any affected packets of Nurofen Plus. If you do, return them to the pharmacy where you bought them from”.

“If you have taken a tablet and you have any questions, speak to your GP,” he added.

A statement from AstraZeneca said: “Patient safety is the primary concern of AstraZeneca and the company is taking this issue seriously. AstraZeneca is collaborating with the MHRA and Reckitt Benckiser to investigate the root cause.”

Pfizer site opportunities extend to Europe

by emma 25. August 2011 13:15

Sandwich_B530_15

MPs are campaigning to continue a pharmaceutical presence at Pfizer’s site in Sandwich, Kent (pictured), after receiving 'Enterprise Zone' status last week.

The aim is to maintain the site as a life sciences location when Pfizer leaves the plant next year. In June, Pfizer agreed to keep 350 employees working at the plant until the US firm exits the site next year, incurring the total loss of 2,500 jobs.

It is hoped that the incentives of the Enterprise Zone will help to attract 190 businesses providing 2,500 new jobs, ideally headed by young people and former Pfizer employees, claimed Kent MP Greg Clarke.

Mr Clarke said: “We hope to continue the tradition of scientific research at Sandwich and benefit from the skills the area already has”.

MP Laura Sandys said that there are opportunities in “renewables, pharmaceuticals, food science, even aerospace”.

Ms Sandys has travelled across the Channel to try to promote the Discovery Park to potential European businesses and investors, claiming that she “will sell east Kent”.

Science Minister David Willetts is also supporting the UK Trade & Investment (UKTI) and the Department for Business, Innovation and Skills (BIS). He confirmed that the “UKTI and BIS will work with Discovery Park to get overseas investment and business interest in the site.”

Mr Clarke added: “In ten years’ time we will be able to look here and not just think of Pfizer but see a world centre of excellence for scientific research”.

The next step is to obtain tourism funding and to hopefully be successful in a Regional Growth Fund (RGF) bid, says Dover District Council Leader Paul Watkins.

Details of successful bids are expected to be announced in late Autumn.

Orencia fails to get NICE backing for RA

by emma 24. August 2011 16:59

Pf NICE update

NICE has failed to recommend Orencia (abatacept) as a second-line treatment for people with rheumatoid arthritis in final guidance.

Both NICE and Orencia’s manufacturer Bristol-Myers Squibb agreed the treatment would not be cost-effective when compared with several other recommended options.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says other recommended treatments offer better value for money as second-line options.

No appeals where received against the Final Appraisal Document released last month.

BMS had asked that Orencia be compared against another recommended option Remicade (infliximab), the only other recommended intravenous treatment options.

But NICE’s independent Appraisal Committee did not consider this to be a relevant comparison since the route of administration rarely determines which drug to prescribe.

The Committee also considered whether Orencia could be a cost-effective treatment option for those with a TNF inhibitor was contraindicated because of congestive heart failure. However, it did not consider it appropriate to provide a second recommendation given there was no evidence of how much clinical benefit the drug may provide in this group of people.

Humira, Enbrel, Cimzia, plus Remicade, and most recently Simponi have all been recommended as treatment options for second-line use on the NHS.

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