What PlumeSTARS does

PlumeSTARS (PlumeStars s.r.l.) is an Italian pharmaceutical SME founded in September 2013 in Parma as a spin-off from the Biopharmanet-TEC research center at the University of Parma. The company specializes in pharmaceutical particle engineering for dry powder inhalation, with a portfolio of micro- and nano-particle drug delivery technologies targeting rare respiratory and genetic diseases. Its core pipeline consists of orphan medicines: THALIDOMIDE (TALDO) for Hereditary Hemorrhagic Telangiectasia, CISPLATIN (HYALCIS) for pleural mesothelioma, and AMIKACIN/TOBRAMYCIN dry powders for cystic fibrosis — all of which have received EMA and/or FDA orphan drug designations. The technology platform also extends to nasal antiviral powders (Covinhale, targeting SARS-CoV-2 and influenza/RSV), excipient-free inhaled insulin, and peptide-loaded calcium phosphate nanoparticles for cardiovascular delivery via the lung (developed under the EU-funded CUPIDO project).

The company's business model is B2B and bifurcated. First, it develops orphan drug candidates intended for licensing to pharmaceutical partners for late-stage development, clinical trials, and commercialization. Second, it offers contract research and consulting services, including Quality by Design pharmaceutical development, formulation problem-solving, business development advice, and market access support, leveraging a validated network of academic experts. Pricing is not publicly disclosed as products are pre-commercial. Go-to-market relies on industry conference participation (AAPS PharmSci360, AFI Symposium, PLACE Conference), scientific publications, and academic collaborations with the Universities of Parma, Ferrara, Verona, and Trinity College Dublin.

Revenue is not publicly disclosed. Capitalization to date has come primarily from non-dilutive public funding, including approximately €173K in cumulative European Commission Horizon 2020 grants (CUPIDO, Hyalcis) and Emilia-Romagna regional grants, with one European Commission Seal of Excellence certification. The company employs 1–10 people and is led by Prof. Paolo Colombo (CEO, Professor Emeritus at University of Parma) and co-founder Dr. Francesca Buttini. The company is privately held, founder-controlled, and has not raised traditional venture equity.

Name

PlumeSTARS

Legal name

PlumeStars s.r.l.

Website

https://plumestars.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

PlumeSTARS is an Italian pharmaceutical SME that designs dry-powder inhalation and nanoparticle drug delivery technologies, developing orphan medicines for cystic fibrosis, mesothelioma, and Hereditary Hemorrhagic Telangiectasia for licensing to pharmaceutical partners.

Ownership category

akta.pro rank

Product category

Inhalation pharmaceutical drug development

NAICS

Medicinal and Botanical Manufacturing (325411), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Pulmonary Hypertension & Rare Pulmonary Disease Therapies (HLAIAIAG)

akta.pro secondary industries

Inhalers (MDI/DPI/SMI) (HLAHAIAI), Respiratory & Allergy Pharmaceuticals (HLAIAAAH), Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF)

Keywords

• Dry powder inhalation
• Orphan drug development
• Pharmaceutical particle engineering
• Targeted drug delivery
• Nanoparticle technology

Headquarters

HQ city

Parma

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Orphan Drug Development and Licensing: Development of orphan medicinal products with EMA and FDA designations. The company has received orphan designation for three medicines: Amikacin & Tobramycin powders for inhalations in cystic fibrosis, Cisplatin films for loco-regional delivery in pleura mesothelioma recurrences, and Thalidomide powder for oral and nasal delivery in Hereditary Hemorrhagic Telangiectasia.
2. Contract Research and Consulting Services: PlumeSTARS offers scientific services including Quality By Design (QbD) pharmaceutical development, consulting for development and manufacturing process problems, business development advice, and market access support. The company has a validated network of scientific experts for R&D support.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

PlumeSTARS designs, develops, and produces advanced dry powder inhalation medicines and drug delivery formulations using proprietary particle engineering, micro and nanoparticle technology. Its portfolio focuses on orphan medicines for rare respiratory and related diseases — including antibiotics (Amikacin, Tobramycin) for cystic fibrosis, a Cisplatin/hyaluronan film for mesothelioma, and Thalidomide for Hereditary Hemorrhagic Telangiectasia — alongside contract research, Quality by Design consulting, and licensing of its drug delivery platform.

Product overview

PlumeSTARS is a pharmaceutical SME that designs and develops orphan medicines using dry powder for inhalation technology and advanced drug delivery systems. The company operates from the University of Parma and focuses on particle engineering to create innovative therapeutics. Its core product portfolio includes: THALIDOMIDE (TALDO) for oral/nasal delivery in Hereditary Hemorrhagic Telangiectasia, CISPLATIN (HYALCIS) for loco-regional chemotherapy in mesothelioma, AMIKACIN (AMIKA PS) and TOBRAMYCIN (TOBRA PS) for inhalation in cystic fibrosis, Covinhale antiviral nasal powder, and inhaled insulin powder. The company also offers contract research services including Quality By Design development, consulting, and training through its validated expert network.

Differentiator

Problem solved

Functional benefit

Products and services

• THALIDOMIDE (TALDO)

Quantifiable outcome

• Three orphan medicine designations obtained from EMA and FDA
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core and minor.

• University of ParmacoreStrategic or Co-development PartnerPlumeSTARS originated from Biopharmanet-TEC, Interdepartmental Centre for Innovation in Health Products at University of Parma. Ongoing collaboration on research including insulin powder development, CUPIDO project, and various drug delivery research. Prof. Paolo Colombo is Professor Emeritus at University of Parma.
• University of FerraracoreStrategic or Co-development PartnerOngoing research collaboration with Prof. Sabrina Banella and Prof. Gaia Colombo. Joint presentation at AAPS 2023 on Cisplatin/Hyaluronan film technology. Prof. Gaia Colombo is Associate Professor of Pharmaceutical Technology.
• University of VeronaminorStrategic or Co-development PartnerResearch collaboration with Dr. Georgeta Caraua from University of Verona, who participated in AAPS 2024 conference with PlumeSTARS team.
• Trinity College DublinminorStrategic or Co-development PartnerProf. Carstin Ehrhardt from Trinity College Dublin hosted the Special Poster Collection 'Advances in Pulmonary and Nasal Drug Delivery' at AAPS 2023 where PlumeSTARS research was presented orally.
• CUPIDO Project ConsortiumcoreStrategic or Co-development PartnerHorizon 2020 funded project (€110,099.65 total to PlumeSTARS) developing innovative inhalation therapy for cardiovascular diseases using respirable microparticles containing nanoparticles loaded with drugs for direct delivery to the diseased heart.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Chiesi Farmaceutici: Headquartered in Parma, Italy (same city as PlumeSTARS), Chiesi is a major privately-held pharmaceutical company with a substantial respiratory and rare-disease franchise including inhaled therapeutics. Highly comparable given the shared geography, inhalation focus, and rare-disease specialization, but at vastly larger scale.
• Vectura Group (Philip Morris): UK-based specialist in inhaled drug development with proprietary DPI device platforms and a broad portfolio of partnered programs. Comparable as an inhalation-focused drug delivery specialist, though substantially larger and now owned by Philip Morris.
• Zambon: Italian privately-held pharmaceutical company with a respiratory franchise (including Promixin inhaled colistin for CF) and rare-disease focus. Comparable as a fellow Italian pharma company working in respiratory and orphan disease therapeutics.
• Aptar Pharma: Global leader in drug delivery device solutions including inhalers and nasal spray systems for pharmaceutical partners. Comparable as a major supplier and developer in the inhalation drug delivery ecosystem where PlumeSTARS operates.
• Lonza Group: Global contract development and manufacturing organization with significant inhalation and nasal drug product capabilities across multiple sites. Comparable as a large CDMO serving pharmaceutical clients in inhaled drug development and manufacturing.

Direct peers

• Hovione: Portugal-based contract development and manufacturing organization with deep expertise in inhalation and dry powder inhaler formulation services. Directly comparable as a CDMO/development partner in the same DPI technology space PlumeSTARS operates in.
• Iconovo: Swedish company developing proprietary dry powder inhaler devices and formulation services for inhaled therapeutics. Directly comparable as a focused inhalation platform company working on DPI technology for pharmaceutical partners.
• Cirrus Pharmaceuticals: US-based contract development and manufacturing organization specializing in inhaled and nasal drug products including dry powder formulations. Comparable as a specialized inhalation CDMO serving pharmaceutical clients in the same technology space.
• Savara Pharmaceuticals: US clinical-stage pharmaceutical company developing inhaled therapies for rare respiratory diseases, including inhaled antibiotics for cystic fibrosis. Directly comparable as a developer of inhaled orphan respiratory drugs targeting the same patient populations as PlumeSTARS.

Emerging players

• TFF Pharmaceuticals: US clinical-stage pharmaceutical company developing inhaled dry-powder formulations of existing drugs using thin film freezing technology for respiratory and infectious diseases. Comparable as a small inhalation-focused formulation company pursuing similar licensing-based business model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/plumestars

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds1 record

Investors1 record

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 PlumeSTARS