Report on the Pharmaceutical Sector from the National Federation of Workers in Pharmaceutical Industries of Greece -OEFSEE-

Global Pharmaceuticals

■ The “golden” top 10 pharma companies in 2018 

The list of the top ten pharmaceutical companies of the year is presented in IgeaHub’s analysis, evaluating a series of parameters and returns for 2017, on a total of 7 criteria, thus forming the “golden” 10th. The value of the global pharmaceutical market is estimated to be $ 1.11 trillion in 2017 and is expected to reach $ 1.43 trillion by 2020. Last year, the North American, Asian Pacific and Western Europe pharmaceutical market accounted for 37%, 22% and 20%, respectively. According to data analysis, in 2017, the top 10 pharmaceutical companies worldwide reported sales of $ 437.257 billion, accounting for about 40% of the global market share. Moreover, the top 15 pharmaceutical companies worldwide achieved sales of $ 568,617 billion. An amount corresponding to 51% of the global market share.

7-criteria assessment 

The classification model comprised seven criteria in each organization, with emphasis on sales revenues for pharmaceuticals and growth rates between 2016 and 2017. Specifically, the criteria include revenue, the rate of change in annual revenue growth, expenditure on Research and Development (R & D), total expenses and revenues, revenue from the first three pharmaceutical products of each company and revenues per employee. In Igea Hub’s analysis, a statistical basis for assessing these criteria was created. Each company was rated for each criterion while the weighted value was used to derive the final statistical result. Revenue from drug sales accounted for the highest rating (45%), while revenue from the 3 best products received the lowest (5%).

1st place: F. Hoffmann-La Roche Ltd (Switzerland).

Hoffmann-La Roche (Roche) focuses on research into the development and production of innovative medicines. Roche has a wide portfolio of drugs in oncology, diabetes, ophthalmology, neurosciences, immunology and infectious diseases.

2nd place: Pfizer (USA).

Pfizer has a wide range of therapeutic areas with several innovative medicines. Pfizer specializes in the fields of cardiology, oncology and immunology.

3rd place: AbbVie (USA).

The biopharmaceutical company AbbVie has advanced therapies in the category of rheumatology, gastroenterology, dermatology, oncology and neurological disorders.

4th position: Johnson & Johnson (J & J).

Johnson & Johnson is active in the production of pharmaceuticals and consumer goods, with its affiliates active in the research, development, production and sale of pharmaceuticals, medical devices and health products. It has in its portfolio medicines for hepatitis C, HIV / AIDS and arthritis.

5th place: Sanofi (France).

The French pharmaceutical company Sanofi has in its portfolio prescription drugs and OTC, specializing in the the central nervous system, cardiovascular system, oncology, diabetes and vaccines.

6th place: Merck & Co. (USA).

Merck, known as MSD outside of the United States and Canada, offers healthcare solutions via prescription drugs, vaccines, and biological treatments. Merck has medicines in the therapeutic area of oncology, infertility, neurodegenerative diseases and endocrinology.

7th place: Novartis (Switzerland)

Novartis, based in Basel, Switzerland has in its portfolio innovative therapies and pharmaceuticals in a wide range of therapeutic categories, such as oncology, cardiology, neurology, immunology, eye care, and bio-similar drugs.

8th position: Gilead Sciences (USA).

Gilead Sciences has focused on virological, hepatological, haematological, oncological, cardiovascular, as well as on respiratory diseases.

9th place: GlaxoSmithKline (United Kingdom)

GlaxoSmithKline’s portfolio includes medicines for cardiovascular diseases, gynecology, diabetes, dermatology and respiratory diseases.

10th position: Amgen (USA).

The US pharmaceutical company Amgen Inc., based in California, is developing innovative treatments for both biologicals and small molecule drugs.

■ THE TOP 10 PHARMA COMPANIES UNTIL 2024.

1. Medtronic 2. Johnson & Johnson 3. Abbott Laboratories
2. Siemens Healthineers 5. Becton Dickinson 6. Philips
3. Stryker 8. Roche 9. Boston Scientific   10. General Electric 

25% of global drug sales will be lost by 2023. Top formulations will lose their patent, facilitating the introduction of generics.

The report, “World Preview 2018, Outlook for 2024,” estimates that the drug industry will lose 25 percent of its sales from $ 251 billion in 2023, with top formulations losing their patent, making facilitating the entrance of generics. We remind the cases of the cholesterol drug Atorvastatin, and the anticoagulant clopidogrel, whose sales before breaking of their patent were more than $ 1 billion a year, for each. A event that clearly affected the Pfizer and Bristol-Myers Squibb / Sanofi-Aventis pharmaceutical manufacturers, respectively.

At this stage, the drug that is expected to record the biggest losses as it loses its patent is adalimumab. AbbVie, who produces it, has announced sales of $ 18.4 billion for the autoimmune disease drug in 2017. Although the patent for adalimumab in the US expired in 2016, AbbVie also has other patents that protect the drug until 2022. Surely, adalimumab is going to face competition from bio-similars. It is already facing bio-similar competition in Europe, while Biocon and its partner Mylan are expected to benefit.

At the same time, Celgene’s chemotherapy drug Revlimid, for blood cancer, loses its European patent in 2022. It is the second largest drug on sales globaly, achieving 2017 revenue of $ 8.2 billion. To compensate for the losses ahead the multinational, has reached an agreement with Natco Pharma to produce generics that will be sold in the US in limited quantities starting in March 2022. Despite the break of many patents, however, EvaluatePharma estimates that sales of prescription drugs will reach 1.2 trillion. dollars in 2024 due to new and more expensive therapies but also because of the increasing access to medicines worldwide.

Although, according to the report, there will be growth in pharmaceutical sales by 2024, generic and bio-similars formulations will slow down the pace. They argues that Novartis will be the leading prescription drug company in 2024, with sales of $ 53.2 billion over Pfizer and Roche.

Worldwide pharmaceutical research and development spending, totaling $ 165 billion in 2017, an increase of 3.9% compared to 2016, is projected to increase at an average annual rate of 3.1% to in 2024. This is less than that of the period 2010-2017, which was 3.6%. 

Trends in the generic drug market 2016 and 2021 

An increase of 10.8% is expected to hit the generic market in 2016-2021, reaching $380.6 billion from $200.2 billion in 2015, according to global surveys. The main drivers of this market are the lower prices, compared to branded formulations, as they are not required to repeat costly clinical trials, and are not burdened with excessive marketing money for their advertising and promotion.

The generic market has been also favored by the fact that many drug patents have expired, by the choice of many governments to support them because of the lower cost in their budgets, as well as the increase of chronic diseases and the fact that emerging markets such as India and China will create opportunities for greater penetration of generic drugs. However, stronger competition, as well as the choice of doctors to prescribe mostly branded formulations, can limit market growth.

Based on their therapeutic application, the market is divided into the central nervous system, cardiovascular, dermatological, oncological, respiratory drugs etc. The central nervous system and the cardiovascular sector are the two largest market segments covered by the generic market. The cardiovascular area which is an emerging segment with a contribution of over 15% for the year 2015, covers more than 20% of the global market generic drugs because of the expiration of many patent cardiovascular drugs.

Geographically, North America dominates the market due to the high demand and increase of chronic diseases, while Asia-Pacific is expected to show remarkable growth.

FDA recommends global standards for generic development worldwide the increasing competition and expanding into new markets.

The US Food and Drug Administration, FDA, must face the high cost of medication and since June 2017 focuses on three main pillars: strengthening competition in generic medicines, increasing patient access and more cost-effective generic drug development.

In this context, the FDA has accelerating approval procedures for generics, while hindering the strategies of companies trying to keep their patent on drugs. However, there is still “a lot of work”, says FDA commissioner Scott Gottlieb, who announced the renewal of the Action Plan with new initiatives to be launched in 2019.

The first and main initiative, proposed to the ICH International Council, is the harmonization of scientific and technical specifications for the development of generic medicines worldwide. This means that manufacturers will be able to apply a single global drug development program and submit common data to applications for authorization in many markets at the same time.

This allows manufacturers, which have not been able to apply for marketing authorizations both in America and Europe, due to different costly processes and tests to have access to other markets. According to Gottlieb, harmonization of these standards is fundamental to achieve global adoption of generic, high-quality medicines.

After a preliminary survey by the FDA, comparing data from the US, Japanese, Canadian, Australian, Swiss and 5 European Union countries (France, Germany, Greece, Poland and the United Kingdom), found that a large part of the medicines in the US do not exist in other countries.

Therefore, there are opportunities for countries to access generic medicines that are not currently available, increasing price and market competition, which can only be achieved by harmonizing their production. Harmonization of scientific and technical specifications can bring even the following significant benefits:

1. Reduce the cost of generic growth, e.g. reducing the number of tests, as the same studies will meet the criteria of many regulators.
2. By applying common standards that meet the requirements of many regulators at the same time, the quality of generic medicines will be common worldwide
3. Increase in the efficiency of oversight (and cost reduction) of regulators by providing more opportunities for exchange of information between organizations.
4. Increase of the global market of generic medicines and attracting competition from different manufacturers, leading to a reduction in production costs.

In order to promote these goals, the FDA submitted a proposal to ICH, to develop internationally harmonized guidelines for human medicines but has so far focused on novel drugs.

Biosimilar drugs 

Dynamic entry for biosimilar drugs into the European market. It is indicative that the biosimilars of Roche’s well-known oncology Herceptin have already gained 6% of the market in just 4 months. These drugs by Celltrion, Samsung Bioepis and Amgen, expect their sales to grow further as their penetration accelerates to the two largest markets in Europe, United Kingdom and Germany. Roche, which has the original Herceptin, Rituxan, and Avastin biologic drugs, is expected to be hit by biosimilar drug release.

In addition to Roche, Abbvie is expected to accept pressure, awaiting competition from Humira biosimilar. This drug is the first in the world, with an annual turnover of about $17 billion. Humira refers to conditions such as rheumatoid arthritis, psoriasis, psoriatic arthritis, etc. Similarly, biological drugs such as Remicade and Enbrel have already suffered from their biosimilars.

The release of biosimilar products intensifies price competition. Prices fell by 70% on the Remicade market in less than 3 years and by 46% on the Enbrel market in about two years. Analysts estimate that, in 2019, there is to be a significant increase in biosimilar sales especially in the US.

J & J knew that their talc was carcinogenic for 47 years.

For decades, the American giant Johnson & Johnson knew that the Baby Powder talc contained asbestos, a “guilty” carcinogen, as reported by Reuters news agency. Johnson insists that Baby Powder does not contain asbestos and added that  they will continue to defend the safety of its product

According to extensive agency research, based on memos, internal reports and other confidential documents, Johnson & Johnson executives knew at least since 1971 that their products contained a small amount of asbestos.

The company had even ordered and paid for studies on Baby Powder and paid someone to rephrase the article that presented the findings in a scientific journal. Johnson & Johnson, responding to an agency survey, issued a statement stating that “any suspicion” of knowing or hiding information on talc safety is “false.”

The company denies …

“This is a deliberate attempt to forget the fact that thousands of independent tests prove that our talc does not contain asbestos nor cause cancer,” the vice-president said in an e-mail. The company insists that Baby Powder does not contain asbestos and added that it will continue to defend the safety of their product. According to Reuters, in 1976 Johnson & Johnson assured the US Food and Drug Administration (FDA) that no “asbestos” was found in the talc produced from December 1972 to October 1973. However, at least three tests from three different laboratories, between 1972-75, found asbestos in the talc.

The company is faced with more than 10,000 lawsuits by consumers who claim that Baby Powder and Shower products cause ovarian cancer. The company is faced with more than 10,000 lawsuits by consumers who claim that Baby Powder and Shower products cause ovarian cancer. These products are also accused of causing a rare and fatal type of cancer that often starts from the pleura or peritoneum. Although J & J has been on the talk market for more than 100 years, revenue from the sale of these products was just 0.5% of the 76.5 billion gained last year. From all the lawsuits against the company for causing personal injuries, the talc-related cases account for less than 10%.

 Εconomics of multinational companies ·       

• Merck is expected to return to profit next year. The pharmaceutical company is “fully unfolding” the portfolio’s dynamics in its core business (healthcare sector). On 30 July 2018, Merck announced that the US Food and Drug Administration (FDA) had accepted a request for review of cladribine tablets as a possible treatment for patients with relapsing MS. Cladribine is the first oral therapy that provides efficacy at all key points of Multiple Sclerosis activity. The company acknowledged that 2018 was a difficult year and confirmed development prospects for 2019. 
• Johnson & Johnson’s earnings increased by 4.5% due to increased sales of anti-cancer medicines helping to counterbalance the fall in sales of anti-arthritis medicine, Remicade.

Greek pharmaceutical companies

• A cooperation agreement was signed between the pharmaceutical company Menarini Hellas SA and Marvifarm SA to promote and distribute the pioneering product MO-FREE MOSQUITO-SHIELD for Greece and Cyprus since January 2019.

• Famar has achieved a restructuring of 174 million by Pillarstone, who has invested for the reduction of its existing financial obligations from 234 million to 118 million euros and the extension of repayment time in six years. Pillarstone committed new funds of 57.6 million euros to finance the long-term development plan and to meet the needs of the company. It is an important milestone for the management team who has managed to make critical improvements and has designed a compact long-term business plan to stimulate the international presence of the company in the markets of Europe and North America. At the same time, Famar has made significant investments to improve its packaging and information systems based on international standards of serialization. Famar is reported to have lost 10% of his pharmaceutical contracts, making it crucial from now on to be able to recover lost ground.

• A gradual reduction of + 25% rebate for new drugs is anticipated at 2019 with 5% and then 4%, 3%, 2%, 1% over the next 5 years. Therefore, the viability of companies ia still uncertain about the due to claw back. Clarification of pricing measures is expected from the pharmaceutical industry. Significant increase in non-prescription drug sales and nutritional supplements is anticipated.

Greek government in support of the Greek pharmaceuticals

The Minister of Health once again supported the domestically produced medicines. Speaking at a meeting of EOF (National Organization of Medicine), he mentioned the need the old, effective and inexpensive medicines to stay on the market, He stated “the majority of which (the medicines) are produced domestically, maintain jobs in the country and produce added value”.

The conference was organized by EOF on December 4, 2018, with the topic “EOF and Access to Medicine. Focusing on the patient”. The Health Minister emphasized that the goal of the Ministry of Health is to ensure that citizens of the country, like any European citizen, have access to modern pharmaceutical innovation that has, with no doubt, added therapeutic value and measurable clinical benefit for the patient, for the quality of his life.

He referred to the fact that for the first time in the country a mechanism for the evaluation of innovation and a mechanism for negotiating the compensation prices was created, especially for expensive drugs and the new institution of the family doctor. In conclusion, he endorsed the role of EOF regarding the medicine, the achievements of the administration of EOF, as well as the entire staff mechanism, the excellent scientists and other employees who work in this critical service for the public good and public health.

Patients’ associations were invited and participated in the conference by representatives, representatives of health care organizations namely the Ministry of Health, EOPYY, EDIKA, Health Technology Assessment Committee (HTA), Negotiating Committee, IFET, Pharmaceutical Industry, ie SFEE and PEF as well as representatives of the Federation of Cooperatives of Pharmacists of Greece (OSFE).

The chairman of EOF has preached the conference, highlighting that the theme of the conference was chosen in order to provide reliable information to the patients and develop a healthy dialogue with patients’ associations. Then, she briefly outlined the pre- authorization and post-authorization controls performed by EOF, ensuring the maximum effectiveness, safety of the medicines, accessibility of the patients to the pharmaceutical therapies, and the sufficiency of the products to meet the needs of patients. For example, she referred to the conference topics on clinical trials and clinical research, early access of patients to new drugs, control of the availability and adequacy of authorized medicines on the market, and biosimilar products, stating that the Department of Biological Medicines Evaluation organizes a conference on “Legislative Framework of Biosimilars in Europe” on Tuesday, December 11, 2018 at EOF.

Layoffs in multinationals

• The intention of removing 12,000 workforce out of a total of 118,200 worldwide by 2021, the German Bayer Group announced, cutting 10% of its staff, after the announcement of the acquisition of US Monsanto.

• Almost half of the roles to be dismantled concern administrative services, while 4,100 jobs will be eliminated in the agrochemicals sector, a direct consequence of the “marriage” with Monsanto. In addition, 1,250 jobs in the pharmaceutical sector will be eliminated and 1,100 in non-prescription medicines.

• English company Lonza plans 100 dismissals at a plant in Maryland.
• Pfizer, in the context of its reorganization, plans to cut 1800 jobs and 100 in San Francisco
• GSK’s decided to dismiss 100 workers in America and to cut 200 jobs in its UK plant.
• US Momenta dismisses 110 workers (50% of its staff).
• Bayer fired 227 workers at its factory in California.
• French company Sanofi plans to lay off 650 workers at its headquarters in France by 2020.
• Boehringer Ingelheim will lay off 327 workers in France.

Acquisitions-mergers 

• GlaxoSmithKline has proceeded with the agreement to acquire the Tesaro biopharmaceutical company.
• Unilever has finalized the acquisition of the GlaxoSmithKIine (GSK) Indian Horlicks food unit for a price of 3.3 billion euros.
• GSK and Pfizer have announced they are planning to unite consumer health care products, creating a new global joint venture worth over $ 10 billion.
• Νovartis enhances the battle against cancer by the acquisition of Endocyte.

The acquisition of Endocyte Inc., for $ 2.1 billion, is leading Novartis to boost research and development of new drugs to treat cancer through specialized biopharmaceuticals.

• Johnson & Johnson plans to purchase the Japanese Ci:z in a $ 2.1 billion deal.
• Cooperation of AstraZeneca and InnatePharma in the field of immunohistology. The pharmaceutical company AstraZeneca is stepping up its immunohistology therapy portfolio by extending its existing cooperation with French InnatePharma, buying 9.8% of its share capital.

Conclusion

It is obvious the effort of the Greek government to support the Greek pharmaceutical companies and at the same time try to make it look like this is for the good of the patients, trying to hide that in the period of the economic crisis the pharmaceutical sector were not affected that much (the majority seems to have significant profits and earnings) and at the same time patients spend more money for their medications as a result of the measures of the 3 memorandums that is followed and that the working condition on the pharmaceutical companies have been worse. Although supposedly on August 2018 Greece is officially out of the probation of the IMF this has not changed this situation.

Pharmaceuticals in Greece, multinational and Greek ones, continue to increase their profits not only by selling more drugs but also using layoffs and intensifying working conditions.

National Federation of Workers in Pharmaceutical Industries of Greece is continuing the fight for the enhancement of the class-oriented struggle, against the restrictions of the trade union actions and the right to strike, in order to sign a collective Agreement for the workers in the Sector of Pharma, participated in the General Strike on 28 November 2018 along with other trade unions and Federations.

Against the logic of social partnership and social dialogue, the only weapon workers have is class struggle.

-OEFSEE-

Affiliate of PAME and WFTU

OCT-DEC 2018