Medicine shortages reach ‘tragic point’ in Greece

by JoelLane 1. March 2013 12:30

greece Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

Watson Pharmaceuticals changes name to Actavis

by JoelLane 28. January 2013 16:01

ACTAVIS, INC. LOGO US generic drug company Watson Pharmaceuticals has taken the name of its recently acquired subsidiary, Actavis.

The company, which is now the world’s third largest manufacturer of generic drugs, has launched a new global website.

Actavis now has two business strands: Actavis Pharma makes and sells generic and biosimilar medicines while Actavis Specialty Brands makes and sells branded drugs in specialist areas.

The company, which has operations in 60 countries worldwide, achieved $8bn revenue in 2012.

Paul Bisaro, President and CEO of Actavis, said: “Today marks an historic day for Actavis and a milestone in our evolution into a global pharmaceutical leader. While we have been operating as one company since last year, today we unite all of our 17,000 employees under a single name.”

The new Actavis logo was designed by Lippincott, a leading brand development agency. The company’s press release explains that its green colour “reflects growth – a fundamental foundation for Actavis and its future – and a commitment to be an environmentally responsible company.”

Actavis is based in New Jersey, USA, with international headquarters in Zug, Switzerland. Its UK operation is based in Barnstaple, Devon.

The company’s Actavis Pharma business manufactures and sells generic, branded generic and legacy brands and OTC products, and is ranked in the top 10 in 33 global markets.

Its Actavis Specialty Brands business manufactures and sells a portfolio of about 40 products with applications in urology and women’s health.

AZ fined for cunning plan to delay generics

by JoelLane 11. December 2012 14:40

losec AstraZeneca has lost its appeal to the European Court of Justice against a €52.5m fine for its tactics to delay generic versions of Losec (omeprazole).

The company was fined by the European Commission in 2005 for manipulating regulatory approval in order to block generics.

According to the Commission, AZ launched a tablet version of the ulcer drug in 2001 and asked for the capsule’s authorisation to be withdrawn.

As a result, generic companies planning to launch their own capsule versions of omeprazole were blocked.

The Commission also claimed that AZ had deceived patent offices, courts and lawyers in several EU states over the date of Losec’s authorisation.

Losec, a proton pump inhibitor, was the world’s best-selling drug in 2000, but its European patent expired in 2001.

The European Commission commented that the appeal decision would prevent other companies from misusing drug regulatory procedures in order to protect their drug patents.

According to Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit, “This case exposed some of the strategems that pharma companies have used to delay the launch of cheaper generic versions of their drugs.

“By upholding the ruling, the court confirmed that pharma companies have to stamp out these practices or risk a substantial fine.”

Jonas Koponen of London law firm Linklaters commented that the decision was representative of “the European Commission’s policy of removing obstacles to competition from generics”.

J&J welcomes generic versions of HIV drug

by JoelLane 30. November 2012 13:26

prezista-packshot web Johnson & Johnson has said it will not enforce patents on its HIV drug Prezista (darunavir) in Africa and other poor regions of the world.

The decision will ensure that many patients have access to cheaper generic versions of the drug.

However, J&J insists that generic darunavir must be of high quality, and reserves the right to enforce its patents if this is not the case.

The company has declined to join the new Medicines Patent Pool, which aims to accelerate generic drug production.

J&J came second in the Access to Medicine Index 2012, which scores major pharmaceutical companies on the access to their drugs in poorer countries – seven places higher than its 2010 placing.

Multiple generic manufacturers will now be able to produce generic darunavir for sale in sub-Saharan Africa and other ‘least developed countries’.

The drug is a second-line therapy for patients who have developed resistance to the standard antiretroviral drugs. Demand for it in Africa is increasing rapidly.

Paul Stoffels, J&J’s Head of Pharmaceuticals, said that competition between generic manufacturers would drive down the price of darunavir.

Indian pharmaceutical companies would be particularly quick to bring out generic versions of the drug, he predicted.

Stoffels defended the decision to stay out of the Medicines Patent Pool: “We want to reserve the right to reinforce patents if people are not providing the right quality of product, for example by bringing products to market that under-dose.”

India bans drug brand names

by JoelLane 17. October 2012 11:42

india-flag India’s Health Ministry has ordered states to stop licensing branded medicines, aiming to restrict the country’s drug market to generics.

From now, pharmaceutical companies applying for a licence to market or manufacture drugs in India will have to submit the generic name – over which they have no exclusivity.

The policy is a response to a threefold increase in healthcare costs over a decade, and will radically affect the pharmaceutical industry’s footprint in one of the world’s fastest-growing markets.

According to the Drug Controller General, Dr G.N. Singh, “We want to gradually move towards a future where we will not issue any brand or trade names. We are going all out to push generic drugs solely for the benefit of the public.”

The Government is also seeking to increase the availability of free medicines through public health clinics, reducing the private sector market – which currently dominates drug purchasing in India.

A WHO study found that 20–40% of India’s public health clinics had adequate stocks of generic medicines, compared to 40–60% of private clinics.

About 72% of healthcare expenditure in India is money paid by individual patients for drugs.

Healthcare expenditure tripled between 1994 and 2006, while individual income rose only by two-thirds.

Drug prices rose by 40% between 1996 and 2006, with increased drug consumption having more economic impact than price rises.

Sun Pharma appoints Makov as Chairman

by JoelLane 30. May 2012 13:42

Pf industry news India’s leading pharmaceutical company, Sun Pharma, has appointed former Teva CEO Israel Makov as Chairman.

Makov takes over the role from Sun Pharma founder Dilip Shanghvi, who will continue as Managing Director.

Having led Teva to become a world leader in generic drugs, Makov aims to help Sun Pharma expand its own major international generics business.

Israel Makov is currently Chairman of life science companies Given Imaging (endoscopy) and Micromedic Technologies (cancer diagnostics), as well as life sciences investment company BIOLIGHT.

As CEO of Teva from 2002 to 2007, Makov led the company’s meteoric rise in the global generics market and managed over 12 acquisitions.

Dilip Shanghvi said Makov was “an exceptional leader with deep knowledge and experience in globalising businesses” whose experience would help Sun Pharma “to rapidly expand its presence worldwide”.

“Sun Pharma is an exciting company poised for substantial global expansion and I look forward to working together with Dilip and his team in realising their visionary goals,” commented Makov.

Like Teva, Sun Pharma is an international generics leader that uses branded medicines to spearhead its market presence, relying on its diverse generics portfolio to soften the impact of patent expiry.

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Teva shake-up strengthens US generics operation

by JoelLane 28. May 2012 13:38

Jeremy Levin, Teva (resized) Jeremy Levin, the new Teva CEO, has announced “an augmentation of the US generics team” to restore the company’s position in that market sector.

Allan Oberman will shift from leading Teva’s EMIA division to leading its US generics division – replacing Tim Crew, who will move to another role.

Teva has long dominated the US generics market, but its annual generic drugs revenue in the US fell by 32% to $4bn in 2011.

Based in Israel, Teva divides its global business into four units: Europe, the Americas, EMIA (Eastern Europe, the Middle East, Israel and Africa).

Speaking at a press conference, Levin (pictured) said: “We have instituted an augmentation of the US generics team, and that was an important step for us to bring in the greater depth of management and greater capability there, to assist in what I believe we can do here, which is to rebuild that market share.”

Teva’s new distribution centre in Northeast Philadelphia, due to be completed in mid-2013, will further strengthen its US presence.

Levin, who joined Teva in February, replaced Shlomo Yanai as CEO on May 10.

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ABPI launches new health partnership team

by JoelLane 27. April 2012 11:58

Stephen Whitehead 2 The Association of the British Pharmaceutical Industry (ABPI) has launched a new regional partnership team to build relationships with the NHS.

The team of five industry professionals will work with the SHA clusters to develop regional partnership projects and promote patient access to innovative medicines.

At the ABPI’s annual conference in London, where the new team was announced, ABPI Chief Executive Stephen Whitehead placed emphasis on the role of partnership in supporting medical innovation.

The role of the partnership team builds on the recommendations of the Government’s Innovation Health and Wealth report to improve the adoption and diffusion of innovative medical products and services.

The team will consist of five experienced industry professionals: one for each of the four SHA clusters in England and a fifth to provide strategic oversight. They will work to promote innovation and healthcare improvement at a regional level, not specific companies or products.

Stephen Whitehead said the partnership team would “make an invaluable contribution to the work of the NHS and the pharmaceutical industry”.

He added that “I firmly believe partnership working is the future of healthcare in the UK,” and predicted the new initiative would “signal the beginning of many more projects” in which the industry and the NHS would work together to improve healthcare.

“We are pleased to support this new initiative and we look forward to working with our partners in the pharmaceutical industry to encourage the adoption and diffusion of new medicines that help improve the lives of patients,” commented Mike Farrar, Chief Executive of the NHS Confederation and a longtime champion of joint working.

“In our ongoing work with the ABPI and ABHI, I have witnessed first-hand how working as a team can deliver significant patient benefits above and beyond what can be delivered by any party in isolation. That is why I am firmly behind greater partnership working.”

Whitehead also placed the new partnership in the context of a drive to ensure that the NHS embraces innovative medicines as part of the solution to the crisis of increasing need and shrinking budgets.

In a memorable statement, he told the conference: “Generic medicines do save us money, but it is innovation that saves lives. We have to be careful not to focus on cost saving when we should be focusing on patients. The effective use of innovative new medicines can often reduce costs elsewhere in the healthcare system by reducing the need for expensive primary and secondary care.

“In fact, with diseases like Alzheimer’s placing an increasing burden on NHS resources, the development of new medicines by the pharmaceutical industry will be pivotal in not only fighting disease but ensuring the financial burden they impose doesn’t cripple the healthcare system.”

Recent figures, he said, show that NHS spending on new medicines is rising at a much slower rate than its spending on generics. The NHS will save £3bn from 2010 to 2014 due to patent expiry – but if those savings are not reinvested in innovative medicines, both the industry and medical care will be held back.

He concluded: “If we do not create the right environment for innovation in the UK, we will run the very real risk of failing to develop treatments which address the challenging disease burdens we face in the future.”

Whitehead’s statement strongly backs up the industry strategy of beating the recession through pipeline development (recently voiced by the leaders of GSK and Eli Lilly), calling on the NHS and other health provider systems to look beyond cost-cutting to the value of better healthcare.

Watson to buy Actavis for $4.25bn

by IainBate 26. April 2012 15:34

Pharma Industry News Watson Pharmaceuticals has entered into a definitive agreement to acquire Actavis for around €4.25 billion to create the third largest global generics company.

The combined company will have commercial operations in more than 40 countries and increase Watson’s international generic net revenues from 16% to 40% to reach around $8bn.

Paul M. Bisaro, President and CEO of Watson, said the acquisition “dramatically enhances” Watson’s commercial positioning and “brings complementary products and capabilities” in the US.

Actavis has more than 10,000 global employees and had revenues last year of around $2.5bn. It markets more than 1,000 products and has approximately 300 products in its pipeline.

“In a single, commercially compelling transaction, we more than double Watson’s international access and strengthen our commercial position in key established European markets as well as exciting emerging growth markets, including Central and Eastern Europe and Russia,” said Paul Bisaro. 

“The transaction achieves Watson’s stated strategic objective of expanding and diversifying our business into a truly global company.  Once the transaction is completed, approximately 40% of our generic revenues will come from markets outside of the US.”

The CEO added that the deal is “financially compelling” and will accelerate Watson’s growth profile for the “foreseeable future”.

When completed, Watson will have more than 17,000 staff around the globe and have around 20 manufacturing facilities and more than a dozen R&D centres. Watson says its enhanced scale will allow it to capitalise on new commercial, R&D, manufacturing and customer service capabilities.

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Novartis profits drop 18%

by JoelLane 24. April 2012 13:51

Pf industry news Novartis has reported an 18% drop in its profits for the first quarter of 2012, due to generic competition and manufacturing problems.

The Swiss company’s net profit fell to $2.33bn from $2.82bn in the same period last year, while its sales revenue fell by 2%.

“We expected a challenging quarter in Q1, and we delivered in line with our expectations,” said Novartis CEO Joe Jiminez.

He highlighted the impact of the temporary closure of the company’s factory in Nebraska, USA, which cost Novartis £200m in quarter 1.

Novartis’ generics business suffered from further production problems, which combined with growing competition to reduce its sales by 10%.

Jimenez said the company would restart production at its Nebraska site, but expected its full-year profits to be below the 2011 figure.

However, he said that Novartis expected sales of over $1bn this year from its nine leading drugs, including Galvus (for diabetes), Tasigna (for leukaemia) and Lucentis (for wet AMD).

In addition, he said, the company’s oral MS drug Gilenya was set to achieve ‘blockbuster’ status, despite safety concerns that have led to label changes.

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