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Roche suspends drug development

Tue, 09 Mar 2010 18:11:00 +0000

Swiss-based pharmaceutical giant Roche have confirmed that, along with their partner Biogen Idec, they are to suspend the development of their late-stage rheumatoid arthritis treatment ocrelizumab. The news comes after new data surfaced that points to serious infections that can cause death.

The recommendation to suspend development came following the results of an independent data and safety monitoring board that had been assessing the compound in four RA studies and two lupus trails. Roche reports that the board concluded the safety risk of ocrelizumab "outweighed the benefits observed in these specific patient populations at this time."

Fatalities

According to the Data Safety Monitoring Boards (DSMB) review, "serious and opportunistic infections, some of which were fatal", were detected. "Previously, a FILM study which had evaluated ocrelizumab, a humanise anti-CD20 therapy, in methotrexate-naive RA patients was placed on clinical hold, while the BELONG study in lupus nephritis patients was previously halted due to "serious and opportunistic infection signals," it said.

Suspension of the clinical trials was disclosed in Switzerland by Roche, the global pharmaceutical giant that has the larger stake in the success of the new drug than Biogen Idec. Neither Roche nor Biogen Idec would say how many patients have died from infections related to the experimental drug, or where they lived, but the companies suggested those breakdowns might be disclosed at a medical forum in the future.

Review

Roche added that ocrelizumab is still being evaluated for relapsing multiple sclerosis in an ongoing Phase II study.

The companies' partnership was originally struck in the mid-1990s by California biotechs Genentech Inc. and Idec Pharmaceuticals Corp., which developed Rituxan. Idec was acquired by Biogen in 2003, forming Biogen Idec, while Genentech was purchased by Roche last year.

Biogen Idec and Genentech extended their partnership in 2003 to cover ocrelizumab, a second-generation molecule that targets the same disease pathways as Rituxan. But unlike Rituxan, which is made using mice cells, the new drug is derived from human cells. Both treat rheumatoid arthritis, an autoimmune disease that leads to inflammation of the joints, and lupus, another chronic inflammatory disease. However, now that fatalities have been disclosed, the likelihood of approval has been significantly diminished.

Matthew Buttell

Matt Buttell graduated from Bath Spa University in 2006. Since then he has written for several publications, before moving to the web. He now writes solely for the internet, continuing to cover key business issues while managing his own personal blog.

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EU research sequences human gut microbe genome | AstraZeneca reveals cutback details | Homeopathy: hard to swallow?

EU research sequences human gut microbe genome

Mon, 08 Mar 2010 07:50:00 +0000

A new study by EU-funded researchers sheds new light on the influence that microbes in our guts have on our health and could lead to the development of new treatments and diagnostic tests for a variety of diseases.

According to news reports today, EU-funded researchers have now sequenced the genome of the community of microbes that live in our guts - and the findings of the study, which are published in the journal Nature, represents the first major outcome of the METAHIT (Metagenomics of the human intestinal tract) project, which is funded by 11.4 million euros from the Health theme of the Seventh Framework Programme (FP7).

"A vital contribution"

Scientists say that are bodies house some 100 trillion microbes, most of which live in our intestines where they make a vital contribution to our health by breaking down toxins, making vitamins and amino acids and boosting our immune system. However, despite their seemingly significant importance to our wellbeing, little is known about this community of 'friendly bacteria' in our guts.

As such, the METAHIT researchers have analysed the microbial DNA found in faecal samples taken from 124 adult Europeans. The study participants came from Denmark and Spain and included people of healthy weight as well as overweight and obese individuals. Some also suffered from inflammatory bowel disease (IBD).

Over the course of their research, the team sequenced 576.7 gigabases of genetic material, more than any other similar study to date. This microbial gene set comprises 3.3 million genes, making it 150 times bigger than the human genome.

Ninety-nine percent of the microbial species in the samples turned out to be bacteria; 1,150 species were identified, many of them new to science. Each individual harboured at least 160 microbe species in their guts, and the researchers were surprised to find that the gut microbe communities found in the samples were fairly similar to one another.

Global view

"Beyond providing the global view of the human gut microbiome, the extensive gene catalogue we have established enables future studies of association of the microbial genes with human phenotypes and, even more broadly, human living habits," said Peer Bork of the European Molceular Biology Laboratory (EMBL) in Germanty. "We anticipate that these studies will lead to a much more complete understanding of human biology than the one we presently have."

The aim of the METAHIT project is to characterise the genes and the functions of the microbes that live in our gut and investigate how they affect human health. The 4-year project began in 2008 and brings together 14 partners from China, Denmark, France, Germany, Italy, the Netherlands, Spain, and the UK.

Matthew Buttell

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AstraZeneca reveals cutback details | Homeopathy: hard to swallow? | Experts advise WHO, 'pandemic yet to peak'

AstraZeneca reveals cutback details

Thu, 04 Mar 2010 15:54:00 +0000

This week has seen AstraZeneca make good on previously-announced plans to cuts as many as 8000 jobs worldwide by confirming the closure of a plant in Leicestershire, UK. The move, which comes as part of an ambitious restructuring of the firm's R&D efforts, also includes withdrawal from research in as many as 10 disease areas.

The British-Swedish firm first announced plans to make cuts at the beginning of February in what was described as "one of the biggest shake-ups in the [pharmaceutical] industry's history." Now, it seems, the radical plans are underway.

According to reports from earlier this week, AstraZeneca says that while it will continue to invest in "R&D in all of [our] current therapy areas" - namely cardiovascular, gastrointestinal, oncology, respiratory, inflammation, neuroscience and infection - "within those areas, [we] will cease discovery efforts in thrombosis, acid reflux, ovarian and bladder cancers, systemic scleroderma, schizophrenia, bipolar disorder, depression and anxiety hepatitis C and vaccines other than respiratory syncytial virus and influenza."

Time for change

The changes, say the firm, will also inevitably bring about the closure of the some of AstraZeneca's major R&D centres around the globe. There are currently 17 in all.

The first closure, in Charnwood in Leicestershire, will see the loss of 1200 jobs and will be followed by the closure of smaller facility in Cambridge. Across the rest of the UK, pharmaceutical development work at the Avlon facility near Bristol will also cease, while the number of people working in R&D at Alderley Park - the firm's largest UK facility - will increase as employees transfer from other sites.

Elsewhere, in Sweden, the first site to go will be a research site in Lund, while it has been confirmed that early-stage discovery work will also be halted at the firm's facility in Wilmington, USA.

Speaking about the changes, head of development Anders Ekblom said, "We have made real strides in improving our efficiency in recent years, but there is a continuing need to adapt our organisation in anticipation of future challenges."

Ekblom added that the changes, "will help us create a more focused, innovative and productive company."

Matthew Buttell

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Homeopathy: hard to swallow?

Wed, 03 Mar 2010 15:10:00 +0000

MPs have argued that spending money on homeopathy is a waste of NHS money and that the money should go to other areas. The House of Commons Science and Technology Committee have said using public money on the highly-diluted remedies could not be justified.

Homeopathy is a 200-year-old system of treatment that uses highly diluted substances - sometimes so none of the original product is left - that are given orally in the belief that it will stimulate the body's self-healing mechanism.

The cross-party group said there was no evidence beyond a placebo effect, when a patient gets better because of their belief that the treatment works.

The homeopathy industry is worth around GBP£40 million in the UK, and around €400million in both France and Germany. While this may seem small compared to the mammoth size of the pharmaceutical industry, real drugs have to be proven to be effective before being licensed in the UK - something the homeopathy industry does not have to prove, and something they would be entirely unable to prove.

Homeopathic pills are being sold at a cost of around GBP£4.95 for less than 20g of sugar pills.

In the UK, the NHS spends around GBP£4 million every year on homeopathy and the British government supports four NHS Homeopathic Hospitals - Bristol, Glasgow, Liverpool and London. While over 400 GPs in the UK regularly refer patients to homeopathic clinics.

Arguments

Supporters believe the remedies help relieve a range of minor ailments from bruising and swelling to constipation and insomnia., but the MPs said homeopathy was basically sugar pills that only worked because of faith.

In medicine it is recognised that some people will get better because they believe the treatment they take is going to work. TheMPs said the NHS should not fund treatments on this basis. They argued the effectiveness was often unpredictable and involved a deception by the medical establishment.

There has been previous warnings from the World Health Organization, who said last year that people with conditions such as HIV, TB and malaria should not rely on homeopathic treatments.

Dr. Nick Beeching, a specialist in infectious diseases at the Royal Liverpool University Hospital, said at the time to the BBC: "Infections such as malaria, HIV and tuberculosis all have a high mortality rate but can usually be controlled or cured by a variety of proven treatments, for which there is ample experience and scientific trial data.

"There is no objective evidence that homeopathy has any effect on these infections, and I think it is irresponsible for a healthcare worker to promote the use of homeopathy in place of proven treatment for any life-threatening illness."

A survey done by Bristol Homeopathic Hospital found that 70 percent of patients said their health improved after treatment. However, while the MPs said that patient satisfaction is important, they concluded that it isn't proof that a treatment works, the British paper The Guardian reports.

Jodie Humphries

Jodie Humphries graduated from Bath Spa University with a BA Hons in Creative Writing in 2008. She has worked for GDS Publishing for the digital group since July 2009. She has previous experience with writing for the web, running her own website since April 2007.

Experts advise WHO, 'pandemic yet to peak'

Wed, 24 Feb 2010 13:28:00 +0000

The director-general of the World Health Organisation has today said that it is too early to declare that the peak of the global swine flu pandemic is over. WHO chief Margaret Chan has decided that it was "appropriate not to make any changes in the current pandemic phases right now".

The decision comes a day after the WHO's emergency committee of experts recommended against the UN health agency declaring that the peak of the pandemic is over. A committee of experts had warned that the pandemic of H1N1 flu is yet to peak, advising that it would be premature to suggest otherwise.

The warning came despite recent reports speculating that WHO's ties with the pharmaceutical industry meant the threat of H1N1 had been exaggerated.

Last June, the World Health Organization (WHO) declared the new virus had caused the first influenza in more than 40 years, after it spread around the world from Mexico and the US in less than six weeks. Since then, however, the impact of the influenza pandemic has failed to reach the levels expected by experts.

But according to reports from yesterday, the expert committee has now advised WHO that it would be too soon to suggest that all parts of the world have experienced peak transmission of the H1N1 virus - adding that additional time and information was needed to provide expert advice on the "status of the pandemic."

The ruling by the committee, which was addressed in an email from WHO spokesman Gregory Hartl, is of particular significance as it comes from a committee comprised of 15 experts which makes confidential recommendations to WHO director-general Dr. Margaret Chan.

From here, Chan is then required to inform the health ministries of WHO's 192 member states and the Vatican of her decision.

WHO has already confirmed the virus has killed 16,000 people, though stresses that this is a gross underestimate as patients often go undiagnosed or untested. In fact, according to WHO, it may take a year or two after the pandemic is over before the truth can really be established about the death toll.

Vested interests

Ultimately though the message coming out of WHO's camp seems to be a complex one. The mixed messages, which have been highlighted by the fact that - as a direct result of the H1N1 pandemic and the resulting demand for vaccines - the pharmaceutical industry has seen a massive rise in profits, have also been maintained by the so-called "unpredictability" of the influenza.

According to Dr. Nancy Cox of the U.S. Centers for Disease Control and Prevention (CDC) and a member of WHO's emergency committee, the group has long been struggling to make sure it gets the issue across correctly. "It is very, very difficult to get the wording exactly right," Cox said in a telephone interview yesterday. "We expect the 2009 H1N1 virus to be around for a long time. It is a complex kind of message."

As such, analysts are anticipating that WHO and other public health agencies will be keen to make clear that the influenza has a ferocious and uncertain future.

Race for vaccines

What's more, doubts remain over the reliability of vaccines, largely associated to the fact that drug makers rushed to get vaccines to market as the pandemic spread. In fact, following the outbreak last June the pharmaceutical industry's biggest players literally raced to develop new vaccines, with drug makers GlaxoSmithKiline (GSK) and Roche leading the way - but, as the pandemic appeared to be less severe than anticipated, nations who purchased the vaccines are now being left with a surplus of the drugs.

Switzerland, Spain and Britain, for instance, are now considering giving away or selling the millions of doses that they have received or have on order, while the US - which so far has only distributed 160 million of the 251 million doses it purchased to doctors, hospitals and other healthcare providers - is yet to make a decision on whether it will have an overflow and what it will do with any surplus.

Dr. Keiji Fukuda, WHO's flu expert, formally announced WHO's final decision earlier today, and the outlook appears pretty clear. Last week, Fukuda aready told reporters that younger people - especially those with chronic medical conditions - and pregnant women continue to be at a higher risk of infection and viral pneumonia from the H1N1 virus. In addition the WHO has cautioned that the H1N1 virus could still mutate or mix with the more deadly bird flu virus, which remains endemic in poultry in many Asian countries.

Merck post earnings, shares fall

Tue, 23 Feb 2010 16:15:00 +0000

Despite posting a decent set of figures for the fourth quarter of 2009 this morning, Merck KGaA have missed analysts estimates, and, as such, have seen a slump in shares.

The group, which is based in Darmstadt, Germany, saw net income come in at 56.7 million euros for the period, with revenues up 5.9 percent to 2.03 billion euros. This put Merck's full year net income at 366.3 million euros, while turnover was up 2.1 percent to 7.75 billion euros. The mediocre earnings meant that the group not only missed analysts earnings estimates but also means they are paying a much lower dividend than last year.

Satisfied

According to Chairman Karl-Ludwig Kley the group is satisfied with the results, given the "overall circumstances of last year." He noted that for 2010, Merck can anticipate revenue growth of between three and seven percent and an operating profit of between 20 and 30 percent. Kley did add, however, "it will be crucial for the economic recovery trend to remain stable."

Last year, reports Pharma Times, the Merck Serono unit contributed 5.35 billion euros, an increase of 6.6 percent. Driving that growth were sales of the multiple sclerosis drug Rebif (interferon beta-1a) which rose 15 percent to 1.54 billion euros, while the colorectal/head and neck cancer drug Erbitux (cetuximab) climbed 23 percent to 697 million euros.

Moving forward, the company hopes that its multiple sclerosis drug cladribine will be the first oral product for the disease to hit the market - though this plan has been rocked by moves by the US Food and Drug Administration (FDA), who issued a "refuse to file" letter stating that the application for cladribine remained incomplete.

In the meantime, Merck have proposed a dividend for 2009 of one euro per share, compared with 1.50 euros in 2008, which - coupled with the earnings post - hasleft a sour taste in many investors' mouths this morning.

Share are now down 6.7 percent (09:40 GMT).

Matthew Buttell

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Weekend round-up | Sanofi-aventis strikes research deal | Job cuts for GSK

Weekend round-up

Mon, 22 Feb 2010 13:10:00 +0000

Debates over data reliability, US regulatory concerns for GSK's asthma drug Advair and news of a potential vaccine for diabetes have rocked the pharmaceutical industry in what has proven to be a busy weekend for the sector.

On Friday, Swiss-based research and development company Basilea experienced a drop in shares after regulators in Europe announced they would be unable to recommend approval for the antibiotic ceftobiprole, having previously backed the drug.

According to the European Medicine Agency's Committee for Medicinal Products for Human Use, they have not adopted a negative opinion on the market authorisation application for the drug, which is used for the treatment of complicated skin and soft tissue infections.

The application had been submitted by Basilea's partner Johnson & Johnson unit Janssen-Cilag as long ago as June 2007 and had initially received positive opinion. However, the EMEA now admits that it had taken the "unusual step" of halting the authorisation process on ceftobiprolec "pending completion and assessment of Good Clinical Practice inspections."

Now the Swiss firm says it is "reviewing all strategic options to protect the interests of the company and its shareholders."

Shares remain down this morning (22 February).

GSK battle US restrictions

In other news from Friday, London-based pharmaceutical giant GlaxoSmithKline (GSK) has been defending its blockbuster drug Advair after US regulators included the drug as one of four asthma treatments that they believe should be used less often by suffering patients.

The US Food and Drug Administration (FDA) announced on Friday that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults and ordered that manufacturers should include such a warning on product labels.

For GSK, the warning impacts them twice over, relating to both their Advair (fluticasone/salmeterol) and single agent Serevent (salmeterol) drugs. Now, say reports, the drug makers have just 30 days to agree to the label changes or provide evidence as to why they are not warranted. GSK has already spoken out.

"There is no evidence from more than 10 years of data from clinical trials, observational studies and worldwide clinical experience exceeding 30 million patient-years of use that Advair is associated with an increased risk of asthma-related death, hospitalisation or other serious respiratory-related outcomes in any age group," the group said in a statement at the weekend.

"It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma," the statement added.

The news is of particular concern to GSK given than Advair remains such a big earner for the firm. In fact, fourth-quarter sales for chronic obstructive pulmonary disease as well as asthma, reached GBP£1.37 billion compared with rival AstraZeneca's Symbicort sales for the same period reaching only GBP£666 million.

New report says diabetes vaccine is "on horizon"

A new report published by Kalorama Information announced this weekend that a diabetes vaccine could be on the market by the end of the decade as several candidates are now in the drug pipeline. According to the report, Swedish firm Diamyd Medical is leading the way.

The report claims that there are at least seven diabetes vaccine candidates in development and most are in Phase I and address type 1 diabetes. However, the report does add that one being developed by Diamyd is currently in a global Phase III study and first results are expected in the spring of 2011.

The news of a potential vaccine is being heralded as excellent news for patients who suffer from the condition. Type I diabetes affects 700,000 people worldwide each year, while a further 200 million suffer from type II.

Shire strategy "harvests" drugs from rivals

And today, UK-based pharmaceutical company Shire, which specialises in treatments for rare diseases and symptomatic illnesses, is looking to pioneer a "search and development" strategy where - rather than developing drugs from scratch - the company collects promising drugs from other companies and then refine them in-house.

According to reports in today's edition of UK newspaper The Telegraph, the model of "niche researching" at first provoked hilarity from industry professionals, but now, the strategy is stirring an interest from pharmaceutical peers.

Shire Chief Executive Angus Russell told the paper that "working in rare diseases allowed [the company] to focus on a specific group of patients and develop strong relationships with clinicians", which had helped them to develop this trusted "search and develop" method.

What's more, Paul Cuddon, an analyst at KBC Peel Hunt added that while Big Pharma remains good at "late stage development, biotech is good at discovery and quick decisions on whether a drug is good or not." He added that a combination of the two makes for an "excellent strategic fit."

Matthew Buttell

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Sanofi-aventis income jump | Sanofi-aventis strikes research deal | Sanofi to go after diabetes market

Sanofi-aventis research deal

Thu, 18 Feb 2010 17:24:00 +0000

Leading drug maker sanofi-aventis have reportedly joined forces with France's National Alliance for Life Sciences and Healthcare (AVIESAN) in an effort to boost research in areas such as aging, infectious diseases and regenerative medicine.

According to a press release on the sanofi-aventis website, the partnership - which marks the first of its kind - is aimed at enhancing scientific knowledge in the areas of life sciences and healthcare, to contribute to the excellence and strength of French research. It is hoped that the partnership will encourage creativity and mutual teams, laboratories, technological platforms and even research centres for sanofi-aventis and AVIESAN could also be considered.

Investment

The French drug maker, who has also entered a corporate sponsorship agreement to provide an annual allowance that supports researchers who set up their labs in France, has pledged to invest as much as 50 million euros in these partnerships over the next five years.

In addition, the National Alliance includes the French Atomic Energy Commission, the National Centre for Scientific Research and the National Institute of Health and Medical Research, among other agencies, suggesting that there may be multiple possibilities for collaboration.

As many Big Pharma companies turn to partnerships or acquisitions in recent years to help manage research costs, sanofi seem to be making great waves.

According to the press statement released yesterday, "These agreements are part of the goal set by the Strategic Committee for Healthcare Industries (CSIS) to bolster funding for partnerships between manufacturers and academic research laboratories in order to encourage innovation in healthcare [...] We are very pleased to have entered into this partnership with the National Alliance for Life Sciences and Healthcare, which is a major breakthrough in terms of public-private partnerships in France."

Sanofi to go after diabetes market

Fri, 12 Feb 2010 16:02:00 +0000

Sanofi-aventis, France's largest pharmaceutical company, is reportedly on track to secure the top spot in the diabetes area, stealing it from current leader, Danish firm Novo Nordisk.

Reports are surfacing which suggest that sanofi has identified diabetes as a top priority in pharmaceuticals and has now established a global division to help the firm achieve its aim of becoming the number one firm in the disease.

The move comes after the firm's best-selling drug for 2009 proved to be Lantus (insulin glargine), with full-year revenues reaching 3.08 billion euros, up 22.5 percent from the year previous. Sales of Apidra (insulin glulisine) were up 38.8 percent to 137 million euros, driven by the launch of Apidra Solostar, a prefilled disposable pen.

Success

Such success has lead the French drug maker to create a global diabetes division integrating "R&D, medical, commercial and device development activities". The plans were unveiled at sanofi's annual results meeting in Paris, where Chief Executive Chris Viehbacher expressed the urgency in focusing on such a massive market, noting that 285 million people worldwide have diabetes.

Ultimately though, analysts believe that the Paris-based firm has a long way to go, given that Novo Nordisk's diabetes sales are about 25 percent higher currently and the fact that the Danish drug maker has just got approval for the much-touted glucagon-like peptide-1 (GLP-1) analogue Victoza (liraglutide) in the USA; it has been available in Europe since last summer.

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Sanofi-aventis income jump

Wed, 10 Feb 2010 15:52:00 +0000

Reports are surfacing that suggest French pharmaceutical giant sanofi-aventis has
seen an income jump of as much as 13 percent for 2009, marking significant growth for the industry.

According to reports, the European drug maker has booked a 12.8 percent increase in net income (excluding certain items) to 8.4 billion euros for 2009, with fourth-quarter earnings up nearly 20 percent at 1.8 billion euros.

Initial reports suggest that the globally operating group saw its earnings per share leap 18.2 percent to 6.49 euros per share for the year, as net sales climbed 5.3 percent to 29.3 billion euros. Projected growth for the Paris-based pharma group is expected to be between two and five percent in 2010, barring major unforeseen events and despite expected generic competition, in particular to its anti-thrombotic Lovenox (enoxaparin).

More on the story is expected tomorrow.

The future of GSK

Mon, 08 Feb 2010 16:57:00 +0000

At the end of last week, GlaxoSmithKline's CEO Andrew Witty announced major job cuts for the company. He has now come forward to explain the details of the plan moving forward, highlighting how the job cuts - most notably within the R&D sector - will impact the future of the group.

According to reports from Friday, Witty outlined his new plan after GSK presented a solid set of financials for the fourth quarter and full-year 2009. Witty highlighted that this year is likely to see continued growth in GSK's consumer business and emerging markets, as well as the introduction of some new products as the "pharma pipeline starts to deliver more and more."

As such, Witty also highlighted how the firm has seen a return to sales growth for the first time since 2007, despite a lagging off-patent market in the US. In fact, GSK has seen its consumer business grow by seven percent in 2009, and Witty pointed to this "incredible performance" that had resulted in the pharmaceutical giant becoming the "fastest growth of any consumer company in the world."

Research

Ultimately though, most shareholders wanted to know what the future plans meant for the R&D sector, given that - much like AstraZeneca's proposal just days before - this is where much of the job cuts will come into force for GSK. In regard to this, Witty said that "if you want a shareholder to give you permission to spend GBP£3-GBP£3.5 billion on R&D, it's only reasonable that there should be some sense of what the return rate might be.

"As an industry [as a whole], over the last 10 or 15 years, the return rates from R&D spend hasn't been very good. That's why many companies have been facing a drought in their pipeline," he added.

"At GSK we're not suffering from that and we have a late-stage pipeline which, if it delivers what we expect it to over the next 10, 15, 20 years of sales, is capable of delivering around an 11 percent rate of return."

Analysts remain confident about GSK, however. Jeremy Batstone-Carr at Charles Stanley told Pharma Times that "we remain of the view that GSK can deliver on its ongoing restructuring programme going forward and that emerging markets will play an even greater role in the generation of stable and sustainable revenue in the future."

Interestingly, British newspaper The Guardian today announced that GSK is one of only five companies that investors remain "heavily dependent" upon - alongside BP, Shell, HSBC and Vodafone - giving the businesses a massive amount of weight in investment markets.

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Job cuts for GlaxoSmithKline

Job cuts for GSK

Tue, 02 Feb 2010 15:52:00 +0000

The threat of pharmamerging markets got another boost yesterday after it was revealed that drug-maker GlaxoSmithKline (GSK) is expected to announce thousands of job losses alongside its annual results this week.

The UK-based pharmaceutical giant is reportedly likely to follow in the footsteps of other drug companies, including key rival AstraZeneca - who announced similar cuts at the end of last week - by announcing cuts at the end of this week.

According to a report in yesterday's British newspaper The Guardian, GSK Chief Executive Andrew Witty is now finalising plans that will see the company "switch focus" and concentrate on fast-growing emerging markets, including China.

Patent protection

Like many Big Pharma companies, GSK is facing the harsh reality that several of its blockbuster drugs are either about to lose - or have already lost - their patent protection in western countries, and - as US and European governments continue to bear down on medical costs - Witty, like many of his peers, believes the best prospects for growth lie elsewhere.

Its not a new train of thought either. In fact, GSK's emerging markets business has reportedly been expanding at close to 20 percent a year for the last two years, and reports from the end of 2009 suggest that as many as seven emerging nations - Brazil, Russia, India, China, Korea, Mexico and Turkey - could soon account for 70 percent of total pharma growth.

As such, yesterday's announcement is likely to continue the push by GSK to reduce the workforce in the US and Europe, while continuing to expand in Asia.

And who can blame Witty? The pharmaceutical industry at large has long been battling against the tide as it tries to source alternative ways to generate the lost revenue that will inevitably come from patent expiries. And GSK - who in early 2009 moved to broaden its product range by agreeing a US$3.6 billion deal to buy skincare specialist Stiefel Laboratories - have long been thinking that diversifying the company's portfolio away from conventional blockbuster drugs is the answer to future growth.

Profits

Nonetheless, the job cut issue for GSK remains multi-faceted. First is the well publicised issue that the firm has seen huge profits as a result of the swine flu pandemic, as governments stocked up on the company's vaccine Pandemix, and the drug Relenze, which helps relieve the symptoms of the disease.

However, that factor, coupled with the grave reality that key rival AstraZeneca will shed as many as 8000 staff, is likely raise fears about the future for the pharmaceuticals sector - historically an area of strength for British business.

Currently, GSK employs 99,000 people in more than 100 countries, but already, in 2007, the firm had announced a major restructuring plan that was aimed at reducing its costs by GBP£1.7 billion a year.

It seems then that, as cost-cutting takes priority alongside emerging market growth, like AstraZeneca, job losses for GSK are nothing short of inevitable.

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AstraZeneca looks to outsourcing

Mon, 01 Feb 2010 09:12:00 +0000

Drug info pledge | AstraZeneca settles generics problem

Leading British-Swedish pharmaceutical company AstraZeneca has announced that it is to cut 8000 jobs worldwide as it embarks on one of the biggest shake-ups seen in the industry's history.

According to analysts, the job cuts - which were announced at the end of last week - are likely to result in the loss of 1500 job in the UK, where AstraZeneca has research and development (R&D) operations in several locations. Analysts have also speculated that the pharmaceutical giant will shed as many as 3500 posts from its R&D facilities across the globe as it tries to cut costs.

Outsourcing

The reason behind the cuts are simple: saving money. The overall plan, according to the firm's (the UK’s second-largest pharmaceutical company) chief executive David Brennan, is to outsource more of AstraZeneca's research and development function - a division largely defined as the heart of any pharmaceutical company. However, AstraZeneca's plan is to outsource much of that work to pharmamerging markets such as China. In fact, Brenna reportedly told the UK press last week that, "As the majority of our employees are in the UK, the US and Europe, you could expect more job cuts there."

He added, "Let's be clear - 2010 is going to be a challenging year."

Patent protection

Its a difficult time for the pharmaceutical industry at large. Patent expiries and the rise in the generics drug market, are calling for a greater and renewed focus on R&D and drug development. For AstraZeneca in particular, two of their key drugs, the asthma medication Pulmicort and the breast cancer drug Arimidex, face the loss of patent protection this year, and there are no new drugs to replace those sales.

In addition, the group is also facing more than 10,000 lawsuits in the US involving 22,099 plaintiff groups who claim that AstraZeneca did not fully publicise the side effects of its antipsychotic drug Seroquel. Reports suggest that the lawsuits have cost about US$656 million to defend so far, although the company hopes most of this will be covered by an insurance policy. As such, Brennan told UK newspaper The Times, that he "believed the company acted ethically and vowed to defend the lawsuits vigorously."

Nonetheless, the firm has also seen shares fall 140p to 2905p, wiping GBP£2 billion from its market capitalisation and making it the biggest faller in the FTSE 100. For the organization, 2009 saw revenues rise by seven percent to US$32,804 million at constant exchange rates. Now, suggest analysts, in an effort to deal with sales declines, the company has earmarked US$2 billion for restructuring charges between 2010 and 2013.

Evidence shows that as 60 percent of that will be spent this year, most of the job cuts may be this year. In terms of the move to China, Brennan admitted that the nation was "one of those countries where the development of drugs could be outsourced to," although he does stress how AstraZeneca would concentrate on outsourcing within Europe and the US.

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Fake obesity drug sales found online

Tue, 26 Jan 2010 15:14:00 +0000

Counterfeits of weight-loss drug Alli have reportedly been found on sale on US-based websites, including renowned auction site eBay.

The genuine article, which is manufactured by leading UK-based pharmaceutical company GlaxoSmithKline (GSK) is currently available over the counter in Britain and claims to help users lose more weight than dieting alone. However, the counterfeit version has been found not to contain orlistat as it should have done and instead contains sibutramine, a substance which last week was removed from use by the European Medicines Agency, after early data showed it may increase the risk of heart attacks and stroke.

The biggest concern is that, though the websites selling the counterfeit drug are based in America, the counterfeit packets may be available to British patients online. As such, the UK Medicines and Healthcare products Regulatory Agency (MHRA) have warned against the "trend of self-diagnosing and self-prescribing", calling this practice "dangerous". Their warnings suggest that, unless the website has a physical address clearly displayed, and the green cross logo of the Royal Pharmaceutical Society of Great Britain (RPSGB) is displayed, then the likelihood of obtaining a counterfeit product is greatly increased.

Risk

"Unregulated websites offer nothing more than a dangerous option to consumers," Mick Deats, MHRA Head of Enforcement, said in a statement. "This is because you often don't know what you're taking and your condition is not being monitored by a healthcare professional. It's just not worth taking that type of risk."

There is some good news, however: reports suggest that the counterfeit Alli can be distinguished from the genuine article thanks to two distinctive flaws. The first is that there is an absence of a lot code on the end flap of the outer packaging and the foil inner safety seal remains plain on the counterfeit version, lacking the otherwise appropriated printed words that autheticate the genuine product.

Markings

In addition, while the legitimate capsule is clearly marked 'Alli' in the UK and 'Orlistat' in the US, counterfeit versions largely remain unmarked, GlaxoSmithKline - which have been working with American regulators over the findings - added that they have identified a small quantity of fake weight loss products, falsely packaged and labelled as alli® on US sites.

According to a statement by GSK: "We fully supports the MHRA warning concerning purchasing medicines from unregistered websites. All retail pharmacies in Great Britain, including those providing internet services, must be registered with the Royal Pharmaceutical Society of Great Britain."

The statement added a warning that said: "Purchasing medicines from websites that are not connected to registered pharmacies can present a number of risks."

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Compassionate-use opinion for Tamiflu

Mon, 25 Jan 2010 15:27:00 +0000

According to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the first opinion on the compassionate use of a medicine has now been issued.

Compassionate-use programmes seek to give patients with a life-threatening, long-lasting or seriously disabling disease who have no available treatment options, access to treatments that are still under development and that have not yet been authorised.

The opinion, says reports, is based on a request from Finland and relates to an intravenous formulation of Roche's flu prevention and treatment product Tamiflu IV (oseltamivir).

No option

Reports on Pharma Times detail that, in its opinion, the CHMP states that compassionate-use Tamiflu IV should be considered only to treat critically-ill adults and children older than one year of age having a life-threatening condition due to suspected or confirmed pandemic (H1N1) infection or infection due to seasonal influenza A or B virus.

In addition, patients should also only receive compassionate-use if they fall under the following criteria:

Patients are not responding to either oral or inhaled authorised antiviral medicinal products;
Patients for whom drug delivery by a route other than IV (eg, oral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible.

However, the recommendation has come under fire because the CHMP has thus far been unable to qualify advice for infants below one year of age because of the absence of pharmacokinetic and safety data on the use of Tamiflu IV in this very young population. The organisation argues that if a physician decides to treat an infant aged less than one year, the decision should be taken based on the assessment of the benefit and risk for the individual.

In addition, in alignment with the recommendation, the EMA has emphasized that these opinions are optional and complement national legislation - they do not replace it, nor do they create any legal framework within the EU member states.

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Drug info pledge from EU health chief

Tue, 19 Jan 2010 13:10:00 +0000

A call for new initiatives to complete Commission proposals that would liberalise controls on the provision of prescription drug information to patients have come courtesy of Europe's new Health Commissioner-designate today.

John Dalli, who is the Commissioner-designate for Health and Consumer Policy (SANCO) in President Jose Manuel Barroso's new Commission, has told ministers that the current draft directive needs to be reassessed in order to "bring more patients' perspective in the proposal."

His advice came in front of a three-hour hearing, held late last week by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI). He also noted that there may also be a need for a "harder demarcation between industry and advertising" - an issue that continues to stall the proposal within the Council of Ministers. Dalli's warnings were well-received by the MEPs, who were there to consider his nomination.

Right to information

According to Dalli, a member of Malta's National Party, "Patients have the right to have access to proper information on prescribed medicines. We have to reassess the proposal and put a better one on the table."

If successful in his nomination, Dalli would also be taking on responsibility for the European Medicines Agency, and in his written answers to the ENVI panel he says he is looking forward to the upcoming evaluation report on the Agency's functions "and, in this context, to evaluating whether there is scope for measures whereby we can optimize the bringing of new medicines to the market as quickly as possible."

Less enthusiastic

However it wasn't all good news for Dalli last week, who learned that MEPs were less enthusiastic about his call for the pharmaceutical legislation package to be "unbundled" to allow its non-controversial aspects - initiatives to tackle counterfeit medicines and improve pharmacovigilence - to proceed speedily.

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H1N1 sales boost GSK - again

Mon, 18 Jan 2010 13:39:00 +0000

GlaxoSmithKline (GSK) have seen a record boost to sales after revealing that sales of its influenza A (H1N1) vaccine reached GBP£835 million in the fourth quarter of 2009.

According to the UK-based pharmaceutical company, around 130 million doses of the vaccine were delivered to governments in the closing quarter of the last decade, which, along with pandemic vaccine products supplied to the US and other governments, amounted to unaudited sales of GBP£835 million. The drugs giant added that a donation of 60 million vaccines to the World Health Organisation (WHO) will be charged as a selling, general and administrative cost for the fourth quarter of 2009.

Reports by leading authority Pharma Times say that the company, which both continues to deliver shipments of the vaccine throughout the first quarter of 2010 and remains in "ongoing discussions with governments as their needs evolve", is already looking at renegotiation's of existing contracts to continue delivery beyond the first quarter.

A statement from the company suggests that it is "therefore too early to say what the final number of doses supplied and the value of these orders will be."

Similar discussions

Interestingly, these figures have been released just days after GSK reached an agreement with the German Ministry of Health to amend its existing contract to receive 34 million doses rather than 50 million. Reports also note that the firm is involved in several similar discussions with governments in the UK, France, Spain, the Netherlands and Belgium.

Analysts at Credit Suisse had downgraded GSK shares to under-perform from outperform, saying that "emerging concerns that pandemic flu potential has been overstated could ultimately limit earnings growth."

Teva hits 15-year high

Mon, 11 Jan 2010 14:14:00 +0000

Teva Pharmaceutical Industries Ltd, the world's largest generic maker of drugs, have announced that trading has hit a 15-year high and than annual revenue will double to $31 billion by 2015.

As the company has reduced its dependency on Copaxone multiple sclerosis treatment, its biggest selling drug, it has seen its more profitable branded business more than double.

The company's growth has also been attributed to more opportunities in countries where generics account for a small amount of drug sales, as well as greater government reforms emphasizing cost savings. It also hasn't hurt that $150 billion worth of brand name drugs will be losing their patent protection in the next five years.

High net projection

Teva also projected net income of $6.8 billion in 2015, with the company expected a net income for 2009 of nearly $3 billion.

During its investor event in New York, Teva projected the global market for generics would grow to $135 billion to $150 billion by 2015, from around $80 billion today.

Shlomo Yanai, chief of Teva Pharmaceutical Industries, has said the company will become more diversified, both product-wise and geography-wise, in order to achieve its goals.

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Lundbeck antitrust proceedings begin

Fri, 08 Jan 2010 16:32:00 +0000

Danish drug maker H Lundbeck yesterday became the victim of a formal antitrust investigation by the European Commission, as potential breaches of business practice rules set by the European Union (EU) came to light.

According to reports in today's Pharma Times, the Commission will now investigate the incident as a "matter of priority" after it appears that not only have business practice rules been breached, but the company has also reportedly abused its dominant market position.

The Commission claims that it will "probe unilateral behaviour and agreements" by Lundbeck related to delays in entry of generic versions of its antidepressant Celexa/Cipramil (citalopram) into European Economic Area (EEA) markets: Lundbeck’s patent on the drug, a selective serotonin re-uptake inhibitor (SSRI), expired in 2003.

Reports show that the ensuing investigation was opened after the Commission received certain information related to the breaches of the laws after it conducted an initial enquiry into the state of the pharmaceutical sector. Initially, the enquiry was meant to examine the ways originator firms obstruct the entry of generic drugs on to the market, but its specific findings allowed it to draw certain conclusions relating to competition law.

Formal proceedings

European Competition Commissioner Neelie Kroes first warned drug-makers that the Commission was "now capitalising" on its pharmaceutical sector inquiry with new cases last September. At the time, she added that they should "expect" and "look out for" new antitrust investigations over the coming months.

Lundbeck yesterday confirmed that formal EU proceedings had begun, with the investigation seemingly relating to an initial raid by the Commission on Lundbeck's premises - in Denmark, Italy and Hungary - back in 2005. At that time, the firm said the visit was probably related to citalopram.

"When it comes to generic entry, every week and month of delay costs money to patients and taxpayers. We will not hesitate to apply the antitrust rules where such delays result from anticompetitive practices," warned Kroes yesterday.

AstraZeneca's generics problem

Thu, 07 Jan 2010 17:03:00 +0000

At the end of 2009, one word summed up one of the biggest challenges set to face the pharmaceutical industry in the coming years: generics. Now, as more and more blockbuster drugs face patent expires, the generics market looks set to grow.

But today there is some good news facing Big Pharma: or, at least, AstraZeneca. That's because the leading pharmaceutical company has today announced it has successfully settled a patent dispute with Israeli group Teva Pharmaceutical Industries over the latter's proposed generic version of Nexium, Astra's best-selling blockbuster drug.

Teva, which is the world's biggest generic drug maker, is considered to be one of the biggest threats to Big Pharma - at least in terms of the generics market. However, according to reports on PharmaTimes.com, as part of the deal, Astra will grant a licence to Teva that prevents them from entering their generic equivalent to the US market until May 2014, when the first Nexium patent expires. As such, this holds back competition for another few years.

In addition, reports also show that the deal has settled litigation relating to a second drug, heartburn and ulcer treatment Prilosec, with the Israeli drug maker set to make a one-off payment for past infringements.

Reducing risk

The deal has also helped to put Astra's shares up, to GBP£29.07, and analysts are already heralding the settlement as a "welcomed move." Panmure Gordon analyst Savvas Neophytou, for instance, told British newspaper The Guardian, "AstraZeneca's announcement reduces risk to earnings in 2011 because Teva could have been prepared to launch generic Nexium at risk after a lower court case which was scheduled to start in January."

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