Stallergenes
Encyclopedia
Stallergenes is a Europe
an biopharmaceutical
company specialized in the manufacture of immunotherapy
medicines for the prevention and treatment of allergic respiratory diseases such as rhinoconjunctivitis and allergic asthma
. It is Europe’s second largest maker of allergy medicines, conducts 85% of its business in Europe, and is the 7th largest French pharmaceutical firm. A world leader in sublingual immunotherapy, the group is present in 50 countries via 13 subsidiaries and numerous partnerships and distribution agreements. By 2010 more than 500,000 patients had been treated with their products.
, France
in 1962, within the Institut Mérieux. By 1974 the company had expanded its operations into the Benelux
countries and North Africa
. By the late 1980s, Stallergenes had developed and supplied some of the world's first orally administered anti-allergies vaccines. In 1989, Stallergenes and Institut Pasteur merged their manufacturing activities and begin a joint research programme on allergens. In 1998 it became a publicly listed company, and in 1999 it purchased DHS
, Bayer Schering Pharmas allergy division, to become the world’s "number 2" company in its specialist field.
In 2010, Stallergenes signed an exclusive partnership agreement with Japan
ese biopharmaceutical
company Shionogi & Co., Ltd.
to promote the development, registration, and distribution of the "Stalair Program" in Japan. Sublingual
allergen
immunotherapy
is not currently available in Japan, which has some 32 million sufferers of allergic respiratory diseases. House dust mites and Japanese cedar pollen
are the two main causes of respiratory allergies and the Japanese cedar allergy
is a major public health concern in the country. Allergic rhinitis affects 25% of the population in Japan, and asthma 6.7%. The agreement could see as much as 70 million euros in sales, development and regulatory milestones payments.
Having met with the US Food and Drug Administration
(FDA) in October 2010, Stallergenes is currently seeking to start a production and distribution partnership with an American company.
On October 30, 2010, Wendel Investissement, an investment company owned by the De Wendel family
, agreed to sell its 46.1% stake in Stallergenes to Ares Life Sciences, Ernesto Bertarelli
s health-care investment company for €
59 a share, a total of €
358.8 million. (US $489.1 million) This gives the company a market value
of €
778.3 million. (US $1.061 billion)
In November 2010, shareholders approved the Ares Life Sciences-Wendel Investissement deal. Ares Life Sciences has made a mandatory takeover offer for the remaining outstanding shares.
On January 20, 2011, Stallergenes announced the launch of a new manufacturing unit in Amilly, Loiret
. The increased production makes Stallergenes the world's leading producer of grass pollen immuno-allergology treatment.
In 2010 group sales grew 12% to €216m and Stallergenes devoted 19.1% of its turnover in gross revenue to research and development. Stallergenes is listed on Euronext Paris
(Compartment B) and is part of the sample composing the SBF 120
.
Break-down of capital in 2010:
directives issued in 2009, the programme gives immunotherapy tablets the same level of recognition as standard pharmaceutical products.
Altogether, the Stalair programme covers 80% of the epidemiology in all markets.
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
an biopharmaceutical
Biopharmaceutical
Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...
company specialized in the manufacture of immunotherapy
Immunotherapy
Immunotherapy is a medical term defined as the "treatment of disease by inducing, enhancing, or suppressing an immune response". Immunotherapies designed to elicit or amplify an immune response are classified as activation immunotherapies. While immunotherapies that reduce or suppress are...
medicines for the prevention and treatment of allergic respiratory diseases such as rhinoconjunctivitis and allergic asthma
Asthma
Asthma is the common chronic inflammatory disease of the airways characterized by variable and recurring symptoms, reversible airflow obstruction, and bronchospasm. Symptoms include wheezing, coughing, chest tightness, and shortness of breath...
. It is Europe’s second largest maker of allergy medicines, conducts 85% of its business in Europe, and is the 7th largest French pharmaceutical firm. A world leader in sublingual immunotherapy, the group is present in 50 countries via 13 subsidiaries and numerous partnerships and distribution agreements. By 2010 more than 500,000 patients had been treated with their products.
Corporate history
Stallergenes was created in LyonLyon
Lyon , is a city in east-central France in the Rhône-Alpes region, situated between Paris and Marseille. Lyon is located at from Paris, from Marseille, from Geneva, from Turin, and from Barcelona. The residents of the city are called Lyonnais....
, France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
in 1962, within the Institut Mérieux. By 1974 the company had expanded its operations into the Benelux
Benelux
The Benelux is an economic union in Western Europe comprising three neighbouring countries, Belgium, the Netherlands, and Luxembourg. These countries are located in northwestern Europe between France and Germany...
countries and North Africa
North Africa
North Africa or Northern Africa is the northernmost region of the African continent, linked by the Sahara to Sub-Saharan Africa. Geopolitically, the United Nations definition of Northern Africa includes eight countries or territories; Algeria, Egypt, Libya, Morocco, South Sudan, Sudan, Tunisia, and...
. By the late 1980s, Stallergenes had developed and supplied some of the world's first orally administered anti-allergies vaccines. In 1989, Stallergenes and Institut Pasteur merged their manufacturing activities and begin a joint research programme on allergens. In 1998 it became a publicly listed company, and in 1999 it purchased DHS
DHS (disambiguation)
DHS is an initialism that can refer to:*United States Department of Homeland Security, a Cabinet department of the U.S. federal government*DHS Logistics, a company that maintains the Deployable rapid assembly shelter...
, Bayer Schering Pharmas allergy division, to become the world’s "number 2" company in its specialist field.
In 2010, Stallergenes signed an exclusive partnership agreement with Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
ese biopharmaceutical
Biopharmaceutical
Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...
company Shionogi & Co., Ltd.
Shionogi
is a Japanese pharmaceutical company best known for developing Crestor. Medical supply and brand name also uses Shionogi .Shionogi has business roots that date back to 1878, and was incorporated in 1919. Among the medicines produced are for hyperlipidaemia, antibiotics, and cancer medicines.In...
to promote the development, registration, and distribution of the "Stalair Program" in Japan. Sublingual
Sublingual
Sublingual, literally 'under the tongue', from Latin, refers to the pharmacological route of administration by which drugs diffuse into the blood through tissues under the tongue...
allergen
Allergen
An allergen is any substance that can cause an allergy. In technical terms, an allergen is a non-parasitic antigen capable of stimulating a type-I hypersensitivity reaction in atopic individuals....
immunotherapy
Immunotherapy
Immunotherapy is a medical term defined as the "treatment of disease by inducing, enhancing, or suppressing an immune response". Immunotherapies designed to elicit or amplify an immune response are classified as activation immunotherapies. While immunotherapies that reduce or suppress are...
is not currently available in Japan, which has some 32 million sufferers of allergic respiratory diseases. House dust mites and Japanese cedar pollen
Pollen
Pollen is a fine to coarse powder containing the microgametophytes of seed plants, which produce the male gametes . Pollen grains have a hard coat that protects the sperm cells during the process of their movement from the stamens to the pistil of flowering plants or from the male cone to the...
are the two main causes of respiratory allergies and the Japanese cedar allergy
Allergy
An Allergy is a hypersensitivity disorder of the immune system. Allergic reactions occur when a person's immune system reacts to normally harmless substances in the environment. A substance that causes a reaction is called an allergen. These reactions are acquired, predictable, and rapid...
is a major public health concern in the country. Allergic rhinitis affects 25% of the population in Japan, and asthma 6.7%. The agreement could see as much as 70 million euros in sales, development and regulatory milestones payments.
Having met with the US Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) in October 2010, Stallergenes is currently seeking to start a production and distribution partnership with an American company.
On October 30, 2010, Wendel Investissement, an investment company owned by the De Wendel family
De Wendel family
The de Wendel Family is an industrialist family from Lorraine, France.In the 19th and 20th centuries the family gained might both industrial and political...
, agreed to sell its 46.1% stake in Stallergenes to Ares Life Sciences, Ernesto Bertarelli
Ernesto Bertarelli
Ernesto Bertarelli is a Swiss-Italian billionaire and entrepreneur.Together with his extended family, Bertarelli was ranked 81st in the 2011 annual ranking of the world's wealthiest people compiled and published by Forbes magazine, The family's wealth was estimated at US$10.0...
s health-care investment company for €
Euro
The euro is the official currency of the eurozone: 17 of the 27 member states of the European Union. It is also the currency used by the Institutions of the European Union. The eurozone consists of Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,...
59 a share, a total of €
Euro
The euro is the official currency of the eurozone: 17 of the 27 member states of the European Union. It is also the currency used by the Institutions of the European Union. The eurozone consists of Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,...
358.8 million. (US $489.1 million) This gives the company a market value
Market value
Market value is the price at which an asset would trade in a competitive auction setting. Market value is often used interchangeably with open market value, fair value or fair market value, although these terms have distinct definitions in different standards, and may differ in some...
of €
Euro
The euro is the official currency of the eurozone: 17 of the 27 member states of the European Union. It is also the currency used by the Institutions of the European Union. The eurozone consists of Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,...
778.3 million. (US $1.061 billion)
In November 2010, shareholders approved the Ares Life Sciences-Wendel Investissement deal. Ares Life Sciences has made a mandatory takeover offer for the remaining outstanding shares.
On January 20, 2011, Stallergenes announced the launch of a new manufacturing unit in Amilly, Loiret
Amilly, Loiret
Amilly is a commune and town in the Loiret department in north-central France.-Main sights:*Church of St. Martin *Castles of Varenne and of the Bourgoins *Bardin Watermill*Museum of Folk Art-See also:...
. The increased production makes Stallergenes the world's leading producer of grass pollen immuno-allergology treatment.
In 2010 group sales grew 12% to €216m and Stallergenes devoted 19.1% of its turnover in gross revenue to research and development. Stallergenes is listed on Euronext Paris
Euronext Paris
Euronext Paris is France's securities market, formerly known as the Paris Bourse, which merged with the Amsterdam, Lisbon and Brussels exchanges in September 2000 to form Euronext NV, which is the second largest exchange in Europe behind the UK's London Stock Exchange...
(Compartment B) and is part of the sample composing the SBF 120
SBF 120
The SBF 120 is a French stock market index. The index is based on the 120 most actively traded stocks listed in Paris. It includes all 40 stocks in the CAC 40 index plus a selection of 80 additional stocks listed on the Premier Marché and Second Marché under Euronext Paris....
.
Stock market information
Company listed on the second marché of the Paris stock exchange since 1998Break-down of capital in 2010:
- 73.18% Ares Life Sciences
- 26.82% Float
Executive committee
On 28 November 2011:- Albert Saporta: Chief Executive Officer
- Roberto Gradnik: Managing Director
- Anne-Marie Pommier: Industrial Director
- Charles Ruban: Director of Product Development
- Christian Thiry: Director of Finance and Administration
- Philippe Verez: Director of International Operations
Stalair programme
Stalair is the pharmaceutical and clinical development programme for immunotherapy tablets being implemented by Stallergenes with a view to obtaining marketing authorisations for pharmaceutical products in Europe and on other strategic markets. Launched in 2003 in line with the European Medicines AgencyEuropean Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
directives issued in 2009, the programme gives immunotherapy tablets the same level of recognition as standard pharmaceutical products.
- Oralair is the first product originating from this programme. Oralair is a grass pollen immunotherapy tablet has demonstrated efficacyEfficacyEfficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
after 3 years of treatment. Launched in Germany in October 2008, it was recently launched in the Netherlands, the Czech Republic, Slovakia, Austria, Italy and Spain. In France, however, Oralair was refused submission from the Commission of Transparency, as an initial review by the board found that the medical benefit of Oralair was of category (SMR) low. A Mutual Recognition Procedure has been completed in Europe.
- The second project in this programme is the Actair house dust mite immunotherapy tablet. Stallergenes is conducting a phase III pediatric clinical trial. After consulting with the PEI (German biological product regulatory agency), Stallergenes will submit a registration file for Actair to the German health authorities in 2011. Stallergenes plans to market Actair in Germany in late 2012 before roll-out to the rest of Europe.
- The Stalair rBet v 1 tablet (birch pollen recombinant allergen) has been the subject of a phase IIb/III clinical trial conducted in allergic rhinitis caused by birch pollen. Additional trials are necessary.
- Ragweed pollen immunotherapy tablets (mainly aimed at the United States market) and Japan cedar pollen tablets (mainly aimed at the Japanese market) are in the early stages of development.
Altogether, the Stalair programme covers 80% of the epidemiology in all markets.
External links
- Stallergenes' website
- The French Wikipedia page for Stallergenes