Spexis AG (SIX:SPEX) is a publicly-listed Swiss clinical-stage biopharmaceutical company developing rare disease and oncology treatments in indications where new therapeutic options are urgently needed. Spexis AG was launched in December 2021 by the reverse merger of EnBiotix, Inc. (Boston, MA, USA) and Polyphor AG (Allschwil, Switzerland), with EnBiotix shareholders resulting in the majority. Our focus is on chronic respiratory diseases (CRD), and our lead product candidate ColiFin® is P3 ready.
ColiFin® is an inhaled colistimethate sodium product in-licensed from PARI Pharma GmbH for ex-European rights. Approved and marketed in Europe as a front-line therapy in cystic fibrosis (“CF”) patients, ColiFin® already has a proven safety, efficacy, and commercial track record. In the U.S., ColiFin® has Orphan Drug and Qualified Infectious Disease Product (“QIDP”) designations, which together will provide a total of 12 years of market exclusivity from NDA approval. We also have a “Study May Proceed” letter from the FDA regarding a single phase 3 study evaluating ColiFin® in CF patients being sufficient to support a future New Drug Application (“NDA”). The trial design has been endorsed by the Cystic Fibrosis Foundation (CFF) Therapeutic Development Network (TDN), the clinical development arm of the CFF. Of note, the CFF also invested in the pre-merger financing launching Spexis.
Company Details
- Employees
- 19
- Founded
- -
- Address
- Hegenheimermattweg 125, Allschwil,4123,switzerland
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://spexisbio.com/
- HQ
- Allschwil
Spexis Ag Questions
Spexis Ag's website is https://spexisbio.com/
Spexis Ag's LinkedIn profile is https://www.linkedin.com/company/spexis-ltd
Spexis Ag has
19 employees.
View email and phone details for 19
employees at Spexis Ag.
Spexis Ag's industry is
Pharmaceutical Manufacturing
Spexis Ag's top competitors are
Bioversys Ag,
Santhera Pharmaceuticals,
Idorsia Pharmaceuticals Ltd,
Actelion (Now Janssen Pulmonary Hypertension),
Bright Peak Therapeutics,
Basilea Pharmaceutica,
Tillotts Pharma Ag,
Alentis Therapeutics,
Bachem,
Solvias.
Spexis Ag's categories are Pharmaceutical Manufacturing
Spexis Ag's founding year is 1996
