Bioprojet Pharma

What Bioprojet Pharma does

Bioprojet Pharma is a privately held French pharmaceutical laboratory founded in 1982 by Jeanne-Marie Lecomte and Jean-Charles Schwartz, operating through two divisions: Bioprojet Pharma (commercialization, established 1992) and Bioprojet Biotech (preclinical R&D, established 2001). The company discovers, develops, and commercializes first-in-class drugs with novel mechanisms of action, primarily in neuroscience and immunology, built on proprietary discoveries of the histamine H3 receptor and orexin receptor pathways. Its flagship asset is WAKIX (pitolisant), a first-in-class histamine H3 receptor antagonist/inverse agonist and the only FDA-approved non-scheduled treatment for narcolepsy with or without cataplexy across both adult and pediatric populations (ages 6+). OZAWADE extends the pitolisant franchise to excessive daytime sleepiness in OSA patients. The pipeline includes BP1.15205 (orexin-2 receptor agonist in Phase 1), BP1.4979 (D3 partial agonist), and BP1.7881 (H4/H1 mixed antagonist), alongside five ongoing Phase 3 trials.

The company maintains an integrated drug discovery model anchored by its Saint-Grégoire research center near Rennes, which evaluates approximately 1,000 molecules annually across four specialized units (biochemistry, medicinal chemistry, pharmacology, and pharmacokinetics with BPL ANSM level A certification). A new €25 million, 7,000 m² research facility under construction will double capacity to over 100 researchers by 2027. Bioprojet distributes through direct commercial operations in 17 countries (primarily Europe plus Tunisia) and licensing partnerships with Harmony Biosciences (US, generating ~$868M in WAKIX sales in 2025 with $1.0–1.04B guidance for 2026), CR Sanjiu (China), and Acino (Middle East). Additional marketed products include Tiorfan/Tiorfanor (racecadotril, 70 countries), Anapen (adrenaline auto-injector), Remodulin (pulmonary arterial hypertension), Kengrexal, Cleviprex, Amglidia, and Clastoban. The company operates a self-financed model reinvesting 40% of annual revenue into R&D.

Name

Bioprojet Pharma

Legal name

BIOPROJET PHARMA

Website

https://bioprojet.com

Company type

Private

Founded year

1982

Operating status

Operating

Headcount range

101–250 employees

Short description

Bioprojet Pharma is a French specialty pharmaceutical laboratory founded in 1982 that discovers and commercializes first-in-class drugs in sleep disorders (WAKIX/OZAWADE for narcolepsy), gastroenterology, and immunology, distributing through direct operations in 17 countries and licensing partnerships globally.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Specialty pharmaceuticals
• Sleep disorder therapeutics
• Narcolepsy treatment drugs
• Acute diarrhea medication
• First-in-class drug discovery

Headquarters

HQ city

Paris

HQ country

France

HQ region

Europe

Offices18 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Supply Chain, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Bioprojet generates revenue through the sale of proprietary and licensed pharmaceutical products globally. Key products include WAKIX (pitolisant) for narcolepsy, Tiorfan (racecadotril) for diarrhea, and various other medications across therapeutic areas. The company distributes through direct commercial presence in 17 countries and licensing partnerships globally.
2. Licensing Royalties: Revenue generated from licensing agreements with partners such as Harmony Biosciences (US market for WAKIX), CR Sanjiu (China for WAKIX), and Acino (Middle East for pitolisant). Harmony Biosciences reported approximately $868 million in WAKIX revenue for 2025, with guidance of $1.0-1.04 billion for 2026.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Bioprojet Pharma is a French pharmaceutical laboratory that discovers, develops, manufactures, and commercializes proprietary first-in-class prescription drugs primarily for sleep disorders (narcolepsy, idiopathic hypersomnia, excessive daytime sleepiness in OSA), gastroenterology (acute diarrhea), allergology (anaphylaxis), and cardiology. Its core proprietary asset is pitolisant (marketed as WAKIX and OZAWADE), the first-in-class histamine H3 receptor antagonist, complemented by an integrated pipeline targeting orexin-2 receptor agonists and D3 dopamine receptor partial agonists. The company sells these medications through direct commercial operations in 17 countries plus licensing partnerships covering the US, China, and the Middle East.

Product overview

Bioprojet Pharma is a French pharmaceutical laboratory developing and commercializing innovative medications primarily in three therapeutic areas: sleep disorders (narcolepsy, hypersomnia, excessive daytime sleepiness), gastroenterology (acute diarrhea), and allergology. The company operates two divisions: Bioprojet Pharma (established 1992) handles development and commercialization, while Bioprojet Biotech (established 2001) manages pre-clinical research. Core products include WAKIX® and OZAWADE® (pitolisant for narcolepsy and OSA-related sleepiness), TIORFAN®/TIORFANOR® (racecadotril for acute diarrhea), ANAPEN® (adrenaline for anaphylaxis), and multiple other specialty medications. The company maintains an integrated drug discovery model, reinvesting 40% of annual revenue into R&D.

Differentiator

Problem solved

Functional benefit

Products and services

• WAKIX® (pitolisant) Antagonist/inverse agonist of the histamine H3 receptor indicated for the treatment of narcolepsy with or without cataplexy in adults, adolescents, and children over 6 years of age. It is the first and only FDA-approved non-scheduled treatment for narcolepsy, distributed in 28 EU countries, the US, Canada, China, the UK, Switzerland, Israel, Taiwan, and Hong Kong.
• OZAWADE® (pitolisant) Pitolisant tablets (4.5 mg, 18 mg) indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) whose sleepiness has not been adequately treated by primary CPAP therapy or who do not tolerate it.
• TIORFAN® (racecadotril) Racecadotril antisecretory intestinal medication available in multiple formulations (4 mg/ml oral suspension, 10 mg infant sachets, 30 mg child sachets, 100 mg capsules) for acute diarrhea management in infants, children, and adults. Distributed in 70 countries in Europe, Africa, Asia, and Latin America.
• TIORFANOR® (racecadotril) Racecadotril film-coated tablets indicated for the treatment of acute diarrhea in adults.
• FANOLYTE® Oral rehydration solution containing tripotassium citrate monohydrate and anhydrous citric acid, used for compensation of water and electrolyte losses in acute diarrhea or gastroenteritis.
• ANAPEN® Adrenaline solution for injection in pre-filled syringe (150 µg/0.3 ml, 300 µg/0.3 ml, 500 µg/0.3 ml) for the emergency treatment of anaphylactic shock symptoms triggered by peanuts, other foods, medications, insect stings, or idiopathic/exercise-induced anaphylaxis.
• KENGREXAL® (cangrelor) Cangrelor powder for solution for injection/perfusion, co-administered with acetylsalicylic acid for the reduction of cardiovascular thrombotic events in adult patients undergoing percutaneous coronary intervention who have not received oral P2Y12 inhibitors prior to intervention.
• CLEVIPREX® (clevidipine) Clevidipine 0.5 mg/ml injectable emulsion for the rapid reduction of blood pressure in perioperative settings in adults.
• CLASTOBAN® (anhydrous clodronate sodium) Anhydrous clodronate sodium film-coated tablets for the treatment of malignant hypercalcemia and palliative treatment of malignant osteolytic lesions with or without hypercalcemia.
• REMODULIN® (treprostinil) Treprostinil solution for perfusion (1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml) for the treatment of idiopathic or hereditary pulmonary arterial hypertension to improve exercise tolerance and symptoms of NYHA class III patients.
• AMGLIDIA® (glibenclamide) Glibenclamide oral suspension (0.6 mg/ml and 6 mg/ml) for the treatment of neonatal diabetes mellitus in newborns, infants, and children.
• HELICOBACTER TEST INFAI 13C-urea crystalline powder for oral solution (45 mg for children 3-11 years, 75 mg for ages 12 and above), an in vivo diagnostic test for gastroduodenal Helicobacter pylori infection in children, adolescents, and adults.

Quantifiable outcome

• Tiorfan distributed in 70 countries, benefiting hundreds of millions of patients
• +4 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators11 records

Recent moves10 records

Expansion highlights6 records

Direct peers

• Avadel Pharmaceuticals: Specialty pharma developing Lumryz (sodium oxybate) for narcolepsy, a direct therapeutic competitor to WAKIX in the same sleep-disorder category, with comparable single-asset commercial focus.
• Idorsia Pharmaceuticals: Swiss CNS-focused specialty pharma with QUVIVIQ (daridorexant) for sleep disorders; comparable European-headquartered, science-driven, mid-sized specialty pharma pursuing differentiated sleep mechanisms.
• Jazz Pharmaceuticals: Direct competitor in narcolepsy with Xyrem/Xywav (sodium oxybate) and Epidiolex; closely comparable CNS specialty pharma with a sleep-disorder franchise of similar scale and a focus on rare/neurological conditions.
• Harmony Biosciences: US licensee for WAKIX; while a commercial partner, Harmony effectively operates the same pitolisant asset in the US market and competes head-to-head with sodium oxybate franchises, making it the closest operational and financial peer.

Emerging players

• Crossject: French specialty pharma developing emergency injectable therapeutics; comparable French specialty-pharma origin with first-in-class device-drug combination products, though at a smaller scale.
• Theranexus: French biotech developing treatments for narcolepsy and rare neurological disorders; comparable in geography and therapeutic focus, though at a much earlier stage of development and scale.

Regional players

• Biocodex: French independent specialty pharma of comparable size and family/founder-controlled governance; comparable in scale, geographic roots, and independent specialty-pharma operating model, though with a different therapeutic focus.

Broad incumbents

• Lundbeck: Specialty pharma historically focused on CNS and neurology; comparable European specialty-pharma model with branded neurology products and similar self-funded R&D culture.
• UCB: European specialty pharma with a strong neurology/CNS franchise; comparable Belgium-headquartered, science-led mid-cap with similar emphasis on differentiated mechanisms and rare-disease CNS indications.
• Takeda Pharmaceutical: Global pharma with the historic narcolepsy leader Provigil/Nuvigil (modafinil); broader portfolio but overlapping presence in sleep-wake therapeutics and CNS specialty pharmacy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bioprojet-pharma

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Bioprojet Pharma