Bioprojet
The Bioprojet company was founded in 1982 under the impetus of Jeanne-Marie Lecomte and Jean-Charles Schwartz, doctors of pharmacy and sciences. From very different backgrounds, Jeanne-Marie Lecomte made her career in the pharmaceutical industry, whereas Jean-Charles Schwartz continued down the university pathway. They decided to bring together academic research and industrial pharmaceutical development, an uncommon practice at that time. With Bioprojet, they are following an objective based on novel fundamental research work in order to design and develop drugs destined to be forerunners in new therapeutic groups. To achieve this ambition, Bioprojet has partnered with Inserm, where Jean-Charles Schwartz leads a research unit, and with various Medicinal Chemistry university laboratories.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Globally (various continents)
- Year Founded:
- 1982
- Employees:
- 11-100
Welcome
BIOPROJET PHARMA, A PHARMACEUTICAL COMPANY
After the discovery, in 1992, of a new molecule in gastroenterology, Bioprojet has created a new company: Bioprojet Pharma, allowing to put this molecule on the market. This is the beginning of a big success.
BIOPROJET BIOTECH, AT THE HEART OF THE RESEARCH
Near Rennes, the research centre Bioprojet Biotech brings together some fifty collaborators which ensure the R&D of the group. Spread in four unities, the Biotech teams are in charged to create new molecules and to realize the preclinical evaluation of these candidate’s drugs.
BIOPROJET, AN INTERNATIONAL GROUP
Since the beginning of the 2000s, Biotech has extended its international presence with the creation of several subsidiaries. Except France, Bioprojet is currently operational in 9 Europeans countries (Benelux, Italy, United Kingdom, Germany, Spain) and also in Tunis.
Our Story
Today, Bioprojet is divided into two entities, bringing together 87 employees in charge of drug development and marketing:
- Bioprojet PHARMA, created in 1992, brings together 42 employees in charge of drug development and marketing.
- Bioprojet BIOTECH, created in 2001, brings together 45 employees managing the Group’s R&D. There are four units: biochemistry / molecular biology, therapeutic chemistry, pharmacology and pharmacokinetics.
The first joint research project between Bioprojet and Inserm covers neurotransmitters, endogenous opioids, the discovery of a new enzyme responsible for their inactivation, and in 1993 it led to the launch of Tiorfan®/Hidrasec®, the first pure intestinal anti-secretory drug for the treatment of diarrhoea.
With a mechanism of action affecting the core water and electrolyte regulation system of the digestive tract, the drug met with clear worldwide success in 2000 with the marketing of its paediatric version. Distributed in 70 countries in Europe, Africa, Asia and Latin America, racecadotril (scientific name) is used by over 10 million patients each year. To date, more than one hundred million patients have already benefited from it, whereas several development program are under way, including an oral suspension.
A fundamental discovery related to another histamine receptor resulted in the development of pitolisant. Marketed under the name Wakix®, the drug is indicated in adults for the treatment of narcolepsy, with or without cataplexy. Wakix® has been authorized for registration in the 28 European Union countries since 2016, and should be registered with the American FDA.
In 2001, Bioprojet acquired the GSK research centre in Saint-Grégoire near Rennes, housed its researchers as well as local researchers, and reorganized it. The objective was to create new molecules and to conduct the preclinical development of these candidate drugs. A thousand molecules are designed and studied there each year.
The Group is also continuing its development by purchasing marketing licenses or international rights for drugs, the active substances of which fall into their areas of expertise: Remodulin® in 2006, Clastoban® in 2012 and Anapen® in 2013. Bioprojet is continuing to develop them to create new formulations, combinations and to extend their indications.
In 2013 Bioprojet acquired the UK company Lincoln, owner of the worldwide rights for Anapen®.
Finally, since the early 2000s, the Group has been setting several subsidiaries up on an international scale. Bioprojet is currently operating in nine countries (France, Benelux, Italy, United Kingdom, Germany, Spain, and Tunisia). The Group intends to reinforce its targeted research strategy model and to increase its international importance, either directly or through partnerships.
Our Values
CODE OF ETHICS
The Bioprojet Collaborators follow a path drawn by the Founders and are guided in their mission by values such as :
Inovation, integrity, excellence, passion and commitment. All of these values are used towards science and health.
As Louis Pasteur once said :
« To wonder is the first step towards discovery ».
INNOVATION
Our laboratory stands out thanks to it inovative force and fundamental research center.
INTEGRITY
Our code of ethics develops the commitment of Bioprojet and its collaborators to the observance of all rules and Good Practices inherent to our activities and profession.
EXCELLENCE
Our success is the result of excellent and commited collaborators.
PASSION & COMMITMENT
Bioprojet is a company on human scale which encourages autonomy and the sense of responsability allowing every collaborator to truly thrive.
Research Center
BIOPROJET BIOTECH, A MULTI-DISCIPLINARY, MODERN RESEARCH CENTRE ORGANIZED ON A HUMAN SCALE
In September 2001, Bioprojet acquired the Glaxo SmithKline research centre in Saint-Grégoire near Rennes. On this occasion, it brought together researchers from GSK and those from Bioprojet previously housed in university laboratories. Renamed Bioprojet Biotech, the research centre welcomes 45 scientists and technicians skilled in all preclinical research business lines from the designing of novel chemical molecules up to the stages closest to clinical development.
The innovation strategy shall seek to design original medications in classes which have as yet not resulted in therapeutic applications It is based upon a rational process to develop molecules interacting with well identified targets, mostly from the same class of heptahelical receptors. Drug candidates are part of the neurology, gastroenterology, and immunology areas.
The site covers over 10,000 m2, of which nearly half are dedicated to the laboratories. They are equipped with cutting-edge scientific instruments necessary to achieve a wide variety of research and drug preclinical development operations. To meet the regulatory requirement, operations are performed in strict compliance with Good Laboratory Practice, and are subject to periodic checks from the French Agency for the Safety of Health Products.
The research centre comprises four scientific units:
- Biochemistry/molecular biology unit, which develops new research targets by cloning, evaluates chemical synthesis molecules in vitro in multiple automated bioassays, verifies their selectivity, and develops systems to predict adverse effects, such as safety cardiac tests.
- Chemistry unit, which uses the molecular modeling of target proteins to design new molecules (about 5 to 10 per week) from rational synthesis and the activity and selectivity assessment. The unit also prepares industrial synthesis routes of drug candidates selected for development.
- Pharmacology unit, which evaluates the molecules on models to predict therapeutic effect, prepares and directs regulatory safety toxicology and pharmacology trials that are then conducted in specialist centres;
- Pharmacokinetics unit (in conformity with GLP), which monitors pharmacokinetics, tissue distribution, metabolism and potential interactions of drug candidates at the pre-clinical stage, especially in toxicology trials conducted with the help of subcontractors. Lastly, the unit has been developing methods and performs the bioanalytical process of clinical trials.
“Bioprojet only researches molecules that are first in a given pharmacological class, and which constitute a therapeutic innovation“, Jeanne-Marie Lecomte.
Clinical Research
BIOPROJET PHARMA, RESEARCH & DEVELOPEMENT
Most of the products developed by Bioprojet are “First in Class”, in other words, they are the leaders in a new class of drugs. These include Racecadotril, an enkephalinase inhibitor, and Pitolisant, antagonist/inverse agonist of histamine H3 presynaptic receptors, or BP1.4979, a partial agonist of the dopamine D3 receptor.
These products are new chemical entities, and most of them have original mechanisms of action. Obtaining a marketing authorisation (MA) entails completing a comprehensive pharmaceutical, preclinical and clinical development process.
The Clinical Development Department in Paris takes charge of the drug candidates from the Bioprojet Biotech research centre to conduct the pharmaceutical development and therapeutic trials in humans from phase I to phase III and to obtain product regulatory registration in the selected indications.
PHARMACEUTICAL DEVELOPMENT
The development and preparation of pharmaceutical forms (tablets, sachets, i.v. solutions…) are performed according to Good Laboratory Practice by specialized subcontractors, on the initiative and under the supervision of Bioprojet pharmacists who provide regulatory approval for use.
PHASE I
Phase I studies are the first time a substance is administered to healthy volunteer humans (“First In Human”). The products are first administered in gradually increasing single doses, then in repeated doses, to assess PK parameters and tolerability. This method is used to determine the maximum tolerated dose and to define the dosage level to be tested for efficacy under phases II and III.
Other phase I studies are carried out on specific populations (young or elderly subjects, paediatric populations, kidney or liver failures, the effect of food intake, subjects from different racial groups etc.), and on the metabolism, in particular with a radio-labelled product, or on cardiovascular safety.
These clinical trials are conducted in specialized centres, following protocols provided by Bioprojet physicians who are monitoring their execution, while bioassays are carried out by Bioprojet Biotech.
PHASE II
These “proof of concept” studies assess the product efficacy and safety, and lay down active doses in a limited number of patients for the target indications set out on the basis of their mechanism of action. They are particularly important to identify the therapeutic indications of the new classes of agents created by Bioprojet.
PHASE III
These double blind, randomized studies against placebo or a reference product confirm the efficacy and safety of medicines. Conducted on wider cohorts of patients with a disease previously identified during phase II, they also allow for product comparison among existing therapies.
Phase II or III studies are usually multicenter trials conducted in the hospitals of several European countries. Bioprojet clinicians and clinical research associates write out the protocol, and ensure follow-up according to Good Clinical Practice and international harmonization requirements (ICH), with the participation of assistants working for companies under contract in the countries of enforcement. European scientific committees participate in the elaboration of protocols and check their implementation throughout the development, periodically assessing the risk benefit ratio for patients.
The study results are evaluated by methodologists and statisticians outside Bioprojet, which drafts the report to be submitted to the Medicines Agencies.
BIOPROJET THERAPEUTIC AREAS
Pitolisant, the first histamine H3 receptor (H3R) antagonist, was developed for its awakening effect in the treatment of narcolepsy with or without cataplexy. A European MA was obtained for this indication in March 2016 (Wakix®). A paediatric investigation plan is underway and studies are being carried out in narcoleptic children.
Pitolisant has also been developed for treating excessive daytime sleepiness (EDS) related to sleep apnoea and Parkinson’s disease. It is the subject of several international multicentre phase III studies.