Monday, 26 October 2009

UK - GSK to Open £38 million Bioscience Park

GlaxoSmithKline (GSK) is collaborating with the government, the Wellcome Trust and the East of England Development Agency (EEDA) to create a new biotechnology science park at the company’s base in Stevenage, with total funding of £38 million.

GSK is contributing £11 million to the park in land and facilities. The Department for Business, Innovation and Skills will invest almost £12 million, the Technology Strategy Board £5 million, the Wellcome Trust almost £6 million and the EEDA £4 million.

The park will aim to attract small, early-stage biotechnology companies, which will have shared access to specialist skills, scientific equipment and expertise to stimulate innovation. It will initially house 25 companies, and it is estimated that 1,500 new jobs will be created. GSK also has plans to further expand capacity at the park in the future.

The new park has been conceived as a competitor to similar sites in Boston, California and North Carolina in the USA.

Building work will begin in early 2010 with companies moving onto the site in 2011.

Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on GSK, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)

UK - CQC Rates More NHS Trusts ‘Excellent’, but Concerns Remain

The Care Quality Commission (CQC) released a report on the performance of NHS trusts on 15th October 2009.

The report, carried out annually, revealed that the NHS is achieving higher standards overall, but that a significant number of trusts are failing to reach key targets.

More than half of Primary Care Trusts (PCTs) achieved scores of ‘excellent’ or ‘good’ for the first time, but fewer acute trusts were given a top rating, with more receiving a ‘fair’ judgement.

In total, 20 trusts were rated ‘weak’ and a further 27 have not reached a score above ‘fair’ on both quality and financial management indicators for the past four years. However, only one trust was judged to be ‘double-weak’ for its quality of care and financial management, compared to six in 2008. This was Barking, Havering and Redbridge Hospitals NHS Trust.

The CQC expressed concern that 63,000 operations were cancelled for non-clinical reasons, but a higher proportion of procedures are now being rearranged within 28 days of the original appointment.

A total of 48 acute trusts failed to meet at least one of the three standards for infection control according to the report, compared to 44 in 2008. However, progress has been made in rates of hospital-acquired infections, such as Clostridium difficile and MRSA, which have both fallen by around a third.

The report also found that 98% of the 19 million patients who visited A&E were seen within four hours of arrival, and more patients are receiving hospital treatment within 18 weeks of referral.

The CQC will soon gain new powers which will allow it to close down any under-achieving trusts. All trusts must be registered with the CQC from 1st April 2010, and must adhere to core standards or risk being refused a licence to operate. Currently, only half of trusts fully comply.

Further reading - An in-depth analysis of the UK pharmaceutical market, including more information on the NHS and the CQC, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)

UK - Seven Million at Risk from Diabetes

Seven million people in the UK are at risk of developing diabetes, according to a report from Diabetes UK in October 2009.

Diabetes UK warned that seven million people have prediabetes, also known as impaired glucose regulation. These people are 15 times more likely to develop diabetes, but prediabetes alone can cause long-term damage to the heart and circulatory system, among others.

However, prediabetes can be reversed and the risk can be reduced by 60% simply by adopting a healthier lifestyle.

In September, Diabetes UK revealed that there were 145,000 new cases of diabetes in 2008 alone (see UK - Diabetes Now Affects 5% of the Population).

Further reading - A detailed review of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)

USA - Senate Approves Health Reform Bill

The US Senate Finance Committee approved the health reform bill with a 14-9 majority on 13th October 2009.

The bill, drawn up by chairman Senator Max Baucus, proposes a ten-year US$829 billion plan to reduce health costs and provide affordable health insurance, but does not include a government-run, universal health insurance scheme.

The bill will now go through a compromise process with the bill approved by the Senate Health, Education, Labour and Pensions (HELP) Committee in July 2009, before receiving a full vote on the Senate floor.

The Finance panel is the last of five Congressional committees to put forward health reform proposals.

Further reading - An in-depth analysis of the US pharmaceutical market, including some background information on the healthcare system and reform plans, is available from Espicom: The Pharmaceutical Market: USA (published September 2009)

Russia - Ban on Promotion of Medicines to Doctors Proposed

Prime Minister Vladimir Putin has proposed that pharmaceutical companies be banned from sending representatives to visit doctors in order to promote the use of their medicines.

At a meeting on the development of the drugs industry on October 9th 2009, Mr. Putin said, “We should get rid of these so-called pharmaceuticals representatives working in medical institutions.” He claimed that Russia has seen the rise of an “abnormal” interaction between pharmaceutical companies, particularly foreign ones, and the medical community over the past ten years.

In Russia, this form of communication is one of the main ways that companies are able to promote their products, and Mr. Putin’s statement has prompted fears that doctors will have no way of finding out about new medicines on the market. Under the law, prescription drugs can only be advertised in certain publications, which not all doctors are able to access.

Pharmaceutical companies spend an estimated 10-15% of their revenue on representatives, which amounts to around the same as production costs. For foreign companies who do not manufacture in Russia, this proportion can rise to as much as 40-50% of revenue.

Many pharmaceutical companies have hit back at the suggestion, claiming that what they are doing is not unethical or illegal. The head of GlaxoSmithKline in Russia, Fabio Landazabal, commented that representatives are not allowed to give doctors presents or money, and cannot hold entertainment or sport events. The drugmakers also asserted that it is in only isolated cases that doctors are paid for such activity.

Further reading - A detailed analysis of the Russian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Russia (published September 2009)

Sweden - Anti-Counterfeiting System Trials Underway

The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced in October 2009 that trials of an anti-counterfeiting system are underway in Sweden, to try to combat the problem of counterfeit drugs entering the market.

A medicines verification system utilising a small data matrix is being trialled, which alerts the pharmacist immediately if a pack could be counterfeit. The data matrix allows each pack to be individually coded, providing information such as the product code, expiry date, batch number and a serial number which is unique to each pack.

The trial is taking place in conjunction with the retailer Apoteket AB and local wholesalers Tamro and Oriola, in 25 pharmacies in the Stockholm area. A total of 100,000 products will be verified.

The initiative is the response of EFPIA to the European Commission’s proposal for a mass serialisation of medicines as part of measures to better protect EU citizens from the serious threats posed by counterfeit drugs.

The trial will run until the end of November 2009.

Further reading - An in-depth analysis of the Swedish pharmaceutical market is available from Espicom: The Pharmaceutical Market: Sweden (published September 2009)

EU - EU Commission Raids Pharmaceutical Companies Suspected of Anti-Competitive Behaviour

The EU Commission carried out raids at several pharmaceutical companies on 6th October 2009, as part of its investigation into anti-competitive behaviour within the industry.

Surprise inspections were confirmed at sanofi-aventis, Teva, Novartis and Ranbaxy Laboratories.

This is the third time that the EU Commission has carried out raids. In January 2008, the EU Commission raided the offices of GlaxoSmithKline, AstraZeneca, sanofi-aventis and several generic competitors, and in November 2008, Teva, Servier and Krka Group were all raided.

In a statement the EU Commission said, “The Commission has reason to believe that the provisions of the EC Treaty prohibiting restrictive business practices and/or the abuse of a dominant market position... may have been infringed.”

However the regulators stressed, “The fact that the European Commission carries out such inspections does not mean that the companies are guilty of anti-competitive behaviour nor does it prejudge the outcome of the investigation itself.”

The raids follow an 18-month inquiry into anti-competitive practices within the pharmaceutical industry, the findings of which were released in July 2009 (see EU - Competition Inquiry Findings Released). The inquiry found that at least 200 settlement agreements between generic and originator companies were known, and that many of these were formed to restrict generic entry onto the market.

The European Commission is already investigating Servier and some generic firms on suspicion of blocking a generic copy of the cardiovascular drug perindopril from entering the market.

Further reading - Pharmaceutical market profiles for all European countries are available from Espicom: Pharmaceutical Market Reports; Europe

EU - European Court Sides with Drugmakers on Pricing Matter

The European Court of Justice ruled on 6th October 2009 that the EU Commission should reconsider whether efforts by drugmakers to prevent traders from exploiting price differences across Europe should be allowed.

Up until now, the EU Commission has opposed companies changing their prices to compensate for parallel trade. Pharmaceutical companies, however, have complained that this undermines their ability to recover the costs of developing new medicines.

The case involved GlaxoSmithKline, who introduced a policy in the late 1990s to put higher prices on a number of drugs sold in the Spanish market, which it had determined were going to be exported. The EU Commission said that the company was restricting competition within the European Union, having long favoured the creation of a single market for goods, including prescription drugs, with the aim of lowering prices.

Many governments buy medicines in bulk in southern European countries such as Spain, and sell surpluses in northern nations such as the UK, where drugs usually cost more. This type of parallel trade helps to cut the price of medicines for their health services.

The traders were disappointed by the verdict. Andreas Mohringer, the president of the European Association of Euro-Pharmaceutical Companies, which represents the traders, commented, “Allowing the system in Spain to stand would mean competition would suffer in Europe with the losers being national social security systems, taxpayers and patients.”

However, the victory for the pharmaceutical industry could be significant at a time when companies face a great deal of price competition.

Further reading - Detailed reviews of the pharmaceutical markets in all European countries are available from Espicom: Pharmaceutical Market Reports; Europe

Friday, 23 October 2009

Japan, Mexico, Turkey, Belgium and Sweden - Takeda to Expand Operations

Takeda Pharmaceutical Co. is establishing four new commercial subsidiaries in Mexico, Turkey, Sweden and Belgium. The Swedish subsidiary will also encompass Norway and Denmark, and the Belgian one will include Luxembourg.

Alan Mackenzie, executive vice president of international operations at Takeda Pharmaceuticals International, said, “Takeda has a significant opportunity to expand our presence in Mexico, Europe and other priority markets. Executing our territory expansion strategy is an important step toward further globalising our operations.”

The Tokyo-headquartered firm has also set up operations in Spain, Portugal, Ireland and Canada in recent months.

Further reading - In-depth reviews of the pharmaceutical markets in Japan, Mexico, Turkey, Sweden and Belgium are available from Espicom: The Pharmaceutical Market: Japan; The Pharmaceutical Market: Mexico; The Pharmaceutical Market: Turkey; The Pharmaceutical Market: Belgium; and The Pharmaceutical Market: Sweden (all published September 2009)

India - Novo Nordisk to Hire More Staff

Novo Nordisk is planning to increase its workforce in India, as the staff are cheaper and the education level is high, it was reported on 26th September 2009.

The Danish company currently has 100 employees in India, and it is planning to increase this to around 500 staff in the next three to five years.

The wage level in India is around 20-40% of a salary in Denmark. However, Novo Nordisk will not reduce its Danish workforce to compensate for more employees in India; instead this will reflect the company’s overall growth.

Further reading - A detailed analysis of the Indian pharmaceutical market, including more information on domestic producers, is available from Espicom: The Pharmaceutical Market: India (published September 2009)

China - 2,300 Drug Prices to be cut in October 2009

The price of more than 2,300 medicines are to be cut by an average of 12%, the National Development and Reform Commission (NDRC) announced on 2nd October 2009.

Prices will be cut for around 45% of the essential drugs list. The prices of 49% of medicines on the list will stay the same, while the remaining 6% will have their prices increased to encourage production, as they are currently in short supply. The price changes will come into effect on 22nd October 2009.

The price cuts are being implemented to help people afford essential drugs, and this is part of China’s three-year US$124 billion healthcare reform plan, which aims to provide access to essential healthcare for the entire population by 2010.

The NDRC also announced that state-run basic medical and healthcare facilities will no longer be able to sell medicines at a 15% mark-up, which will reduce prices even more.

The essential medicines list was published in September 2009 (See China - Essential Medicines List Published as Part of Health Reforms).

Further reading - An in-depth analysis of the Chinese pharmaceutical market, including more detailed information on health reforms, is available from Espicom: The Pharmaceutical Market: China (published September 2009)

UK and China - GSK Invests in Joint Venture to Produce Paediatric Vaccines in China

GlaxoSmithKline has entered into a partnership with Jiangsu Walvax Biotech Company to develop and manufacture paediatric vaccines for use in China.

As part of the deal, GSK will provide the technology for its MMR jab Priorix to Walvax to enable local production and distribution of the vaccine. A manufacturing plant will built specifically so that the joint venture can eventually supply China’s public vaccine market.

The collaboration will be reached with a total investment of £41.2 million, of which GSK is providing £20.1 million to begin with and a further £7.3 million in 2015. Meanwhile, Walvax is investing £13.8 million into the partnership. From these investments, GSK has an equity share of 65% and Walvax 35%, although the companies noted that this can be revised in the future if necessary.

Further reading - Detailed reviews of the pharmaceutical markets in both the UK and China, including more information on pharmaceutical companies, are available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009) and The Pharmaceutical Market: China (published September 2009)

UK - NHS in Wales Scrap 22 Local Health Boards

On 1st October 2009, the 22 local health boards in Wales were scrapped, and integrated with NHS trusts to form seven new local health boards. These will control all hospital and community services, in addition to GP and dentist funding. The new boards will also be responsible for meeting hospital targets on waiting times.

The new local health boards are:
  • Betsi Cadwallader;
  • Hywel Dda;
  • Abertawe Bro Morganwg University;
  • Powys Teaching;
  • Cwm Taf;
  • Cardiff and Vale; and
  • Aneurin Bevan.

The only NHS trusts to remain are the Welsh Ambulance Service and Velindre Hospital in Cardiff, which specialises in cancer treatment.

Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the NHS, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)

UK - Summary of NICE Appraisals in October 2009

NICE Rejects RoActemra for Rheumatoid Arthritis on the NHS

The National Institute for Health and Clinical Excellence (NICE) has issued preliminary guidance rejecting the use of RoActemra (tocilizumab) on the NHS to treat rheumatoid arthritis.

The drug, which is produced by Chugai Pharma and distributed by Roche, has demonstrated its potential benefits to patients in clinical trials. In studies including 4,000 patients, RoActemra, alone or in combination with a disease-modifying anti-rheumatic drug (DMARD), such as methotrexate, significantly reduced the symptoms of rheumatoid arthritis compared to DMARDs alone, regardless of previous therapies and the severity of the disease.

However, NICE has concluded that the drug is not cost-effective, costing £9,295 a year for a patient weighing around 70kg.

The National Rheumatoid Arthritis Society said the guidance means that sufferers’ only options now will be to retry therapies that have already failed or palliative care, which involves large doses of steroids which could cause side effects such as osteoporosis in the longer term.

NICE’s final guidance is due to be issued in February 2010.

NICE Approves Hycamtin for Small Cell Lung Cancer

NICE has approved Hycamtin (topotecan) for patients with small cell lung cancer on the NHS, under certain conditions.

The regulator’s Final Appraisal Determination recommends the use of the drug in patients suffering from a relapse of the disease, but only when treatment with the first-line therapy again is not appropriate, or the combination of cyclophosphamide, vincristine and doxorubicin chemotherapies is contraindicated.

In addition, the oral form of GlaxoSmithKline’s Hycamtin should be used, as the intravenous version is considered too expensive. The cost per cycle for the oral form of Hycamtin is £638, which is equal to an average cost per patient of £2,552, whereas the cost for the intravenous version is £1,495 and £5,980, respectively.

Lung cancer is one of the most common cancers in England, with over 33,000 new cases in England and Wales a year, of which between 10% and 20% are of the small cell type.

In September 2009, Hycamtin was approved by NICE to treat cervical cancer on the NHS (See NICE Approves NHS Use of Hycamtin for Cervical Cancer).

Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)

UK - Diabetes Now Affects 5% of the Population

Around one in twenty people in the UK has diabetes, with around 145,000 new cases diagnosed in the past year, according to figures published by Diabetes UK in October 2009.

The data was compiled from GP practices and reveals that 2.6 million people now suffer from the condition, and around 90% of these have diabetes type II, which is linked to obesity on many occasions.

Diabetes UK warned that the increasing number of cases is putting a strain on the NHS, as diabetes already costs the health service £1 million an hour to treat. Also, diabetes can lead to more serious conditions such as heart disease, stroke, kidney failure and blindness.

Furthermore, it is estimated that around half a million people in the UK have the condition but have not been diagnosed, as the condition can remain undetected for around 10 years. Therefore, many of these may already have complications by the time they are diagnosed.

The rise in cases of diabetes is known to be linked to rising levels of obesity, which is a factor in around 80% of cases of type II diabetes, according to the International Diabetes Federation.

Further reading - A detailed analysis of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published September 2009)

Wednesday, 7 October 2009

Brazil - The government aims to create a ‘super’ local producer able to compete internationally, but foreign producers are a big threat

Pfizer … is it acquiring Neo Química?

Generics sales continue to grow at a higher rate than the overall pharmacy sector, and they are expected to represent 20% of the sector by volume in 2010. Therefore, the sector is attracting foreign interest. In September 2009, it was rumoured that the local generic producer Neo Química was being acquired by Pfizer. This would be the second major acquisition in the generic sector in 2009, following sanofi-aventis’ acquisition of Medley. This wave of foreign acquisitions is a blow for the government which has been trying to create a leading local pharmaceutical group with the help of the National Bank for Economic & Social Development (BNDES). Other leading producers such as EMS, Aché and Eurofarma remain local.

How are foreign producers assessing the market?

Leading foreign pharmaceutical companies are strengthening their operations in the country. Brazil is the most important BRIC market for sanofi-aventis; the company is acquiring Medley. Daiichi-Sankyo, the only Japanese company with manufacturing operations in Brazil, is expanding its plant. GlaxoSmithKline has announced an alliance with Fiocruz’s Bio-Manguinhos to develop vaccines. Novartis is setting up a vaccines plant. Pfizer is strengthening its operations via a rumoured local acquisition. In the wholesaling sector, Celesio, the largest European wholesaler, has acquired a majority state in the Panpharma group. Other companies are re-assessing their operations. Boehringer Ingelheim, for instance, has signed a third-party manufacturing agreement with Zambon, whilst Roche has announced plans to sell its manufacturing plant in Brazil.

How are local producers responding?

Local manufacturing investments continue in order to increase market positioning locally and internationally. Cristália, for instance, has inaugurated a new R&D centre; the company claims to be the local producer with the highest R&D portfolio and investments. EMS is investing in a new Drug Delivery Systems (DDS) platform. Eurofarma continues to invest in its animal health division in the local market, whiltst it has acquired an Argentine pharmaceutical producer in order to develop its international operations. Hipolabor is building a second manufacturing plant for the production of antibiotics. Even public producers follow the same trend. Fundação para o Remédio Popular (FURP), for example, has inaugurated a new manufacturing plant for the production of generic medicines, the first of its type.

Further reading - An in-depth analysis of the Brazilian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Brazil (published September 2009)

Friday, 2 October 2009

South Africa - Government Pledges Quicker Access to New Medicines

The South African government pledged to clear the backlog of drug approvals and develop a recovery strategy for the pharmaceutical industry, in September 2009.

The Medicines Control Council (MCC) attributed the backlog to an unexpected increase in submissions for the registration of medicines during the last three years.

Since Mr Motsoaledi took over as Health Minister on 11th May 2009, he has voiced his commitment to healthcare reform, including making changes to the MCC to speed up access to new medicines and expand the availability of generic medicines.

The MCC is undertaking a 12 million rand (£990,000) backlog clearance project, with funding from the UK’s Department for International Development (DFID). The industry association, Innovative Medicines SA (IMSA), has welcomed the project as it said the current approval process can take up to four years and more than 2,000 applications are now stuck in the pipeline.

Further reading - A detailed analysis of the South African pharmaceutical market, including some background information on the drug approval process, is available from Espicom: The Pharmaceutical Market: South Africa (published June 2009)

India - Doctors Working in Rural Areas to be Given More Money

Doctors who work in rural areas will be compensated with extra money and assistance when they apply for higher study, Health Minister Ghulam Nabi Azad announced on 17th September 2009.

The Indian government is also planning to set up more medical colleges, as there is expected to be a lack of medical personnel in the coming years. According to a Planning Commission report, India is facing a shortage of around 600,000 doctors, one million nurses and 200,000 dental surgeons.

Further reading - An in-depth review of the Indian pharmaceutical market, including some background information on healthcare personnel, is available from Espicom: The Pharmaceutical Market: India (published June 2009)

Russia - Nycomed to Build Production Plant Near Moscow

In September 2009, Nycomed announced plans to build a production plant in Russia, with a total investment of between 65 million and 75 million euros (US$96 million and US$110 million).

The new site will be located in Yaroslavl, around 280 kilometres from Moscow, and construction will start there in 2010. The factory will have a total of 150 employees when production begins in 2014.

The new facility will manufacture medicines for the Russian and neighbouring markets of the Commonwealth of Independent States (CIS), which together account for 10% of Nycomed’s turnover.

Production taking place at the plant will include liquid sterile products such as ampoules and vials, as well as tablets. It will also manufacture products which are important for the local market, such as Cardiomagnyl (acetylsalicyclic acid and magnesium hydroxide) for pain relief, the bovine blood derivative Actovegin and the anticoagulant warfarin.

Further reading - An in-depth review of the Russian pharmaceutical market, including some background information on local manufacturers, is available from Espicom: The Pharmaceutical Market: Russia (published June 2009)

UK - Renovo to Cut Jobs

UK-based Renovo is to cut the jobs of a third of its workforce as part of restructuring, the company revealed in September 2009.

The restructure comes after talks of a takeover with an unnamed company failed.

Renovo, which specialises in scar-reduction technology, hopes to reduce costs by around 20-30% by axing around 50 of its 160 employees.

In addition to job cuts, the company will freeze directors’ salaries in order to retain cash for the Phase III trials of Juvista.

Further reading - A detailed review of the UK pharmaceutical market, including some more information on domestic producers, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)

UK - Pharmacies to Receive Increased Funding

Pharmacy funding is to increase by 3.9% in 2010, following negotiations between the Department of Health and the Pharmaceutical Services Negotiating Committee (PSNC) in September 2009.

The extra £87 million will bring total funding for primary care pharmaceuticals services to £2.3 billion.

The government has also agreed to make additional provisions to help pharmacy contractors cope with one-off costs, such as the implementation of the second stage of an electronic prescription service.

Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)