Table 1
From the following article
Brazilian health biotech—fostering crosstalk between public and private sectors
Rahim Rezaie, Sarah E Frew, Stephen M Sammut, Maya R Maliakkal, Abdallah S Daar & Peter A Singer
Nature Biotechnology 26, 627 - 644 (2008)
doi:10.1038/nbt0608-627
Table 1. Brazilian health biotech firms interviewed and their product portfolios and pipelines
| Company or organization | Products on the market | Products in development | Domestic/international quality certification |
|---|---|---|---|
cGCP, current good clinical practices, cGLP, current good laboratory practices, cGMP, current good manufacturing practices. FDA, US Food and Drug Administration; ISO, International Organization for Standardization; OHSAS, Occupation Health and Safety Assessment Series. | |||
| Innovative SMEs | |||
| Aché Laboratórios Farmacêuticos | 240 formulations for various therapeutic areas, including cardiology, the respiratory system, digestive system, central nervous system, obstetrics and gynecology, musculoskeletal system, dermatology and others. Main products include: Acheflan (an extract of the plant Cordia verbenacea used as topical anti-inflammatory), Tandrilax (muscle relaxant made of paracetamol, carisoprodol, diclofenac sodium and caffeine), Sinergen (an antihypertensive formulation of amlodipine besylate and enalapril maleate). | Six products, including drug candidates for treatment of hypertension, anxiety, diarrhea and fungal infections. | ANVISA-BPF (GMP), ISO 14001, OHSAS 18001, BS8800 certification and US Occupational Health and Safety Act standards. GMP-compliant plant opened in 2007. |
| Biogene | ELISA test for visceral leishmaniasis in animal hosts to prevent transmission to humans. | ELISA-based tests for diagnosis of leishmaniasis in dogs (allowing infected and vaccinated animals to be distinguished) and toxoplasmosis, a serodiagnostic test for brucellosis, which uses a recombinant antigen. Co-development of a test for human visceral leishmaniasis with FK Biotech. | National Technical Biosafety Commission (CTNBio) monitors research and production. |
| Biolab Sanus Farmacêutica | Approximately 60 products for various indications, including Aradois (potassic losartan, for hypertension), Pressat (amlodipine besilate, for hypertension), Quinoflox (ciprofloxacine, antimicrobial) and Lovell (levonorgestrel and ethynilestradiol, a vaginal contraceptive). | Nanoparticle-based products for dermatologic and cosmetic usage and mucus-adhesive products for vaginal treatment. | GMP according to ANVISA. |
| COINFAR | No products on the market yet. | Antihypertensive protein (from Bothrops jararaca snake venom), a peptide-based analgesic (isolated from snake venom and acts through  and some  opioid receptors), an anticancer recombinant protein derived from tick saliva showing activity against melanoma. | N/A |
| Eurofarma Laboratórios | Approximately 260 drug formulations for various indications, including: oncology, antifungals, bronchodilators, antidepressants, benzodiazepines, antihypertensives, anticonvulsives, antihistamines, analgesics, a veterinary line of drugs and a line of drugs targeted to hospitals. | Products for treatment of meningitis, Helicobacter pylori infections, hypertension, nosocomial infections and an analgesic. A project is also underway to develop a neutropenia treatment. | REBLAS (Brazilian Network of Analytical Health Laboratories) and ANVISA GMP certified, implementing ISO 9001 version 2000 and ISO 14001 version 2000. New facilities meet FDA standards. |
| FK Biotecnologia | Over 70 different hybridoma lines producing different monoclonal antibodies for diagnostics tests and other applications. Immunodiagnostic kits for flow cytometry (for HIV follow up), point-of-care testing platform (for dengue, leishmaniasis, leptospirosis, Chagas disease, hepatitis B, HIV I/II and pregnancy). | Whole-cell autologous anticancer vaccine in clinical trials for prostate cancer (phase 1/2 completed) and myeloma, ovarian, breast, pancreatic and renal cancers (phase 1). Automated ELISA-based diagnostic tests (for PSA, HIV I/II strains and others). | ANVISA certified. |
| Hebron Farmacêutica Pesquisa, Desenvolvimento e Inovação Tecnológica (Recife) | Approximately 135 pharmaceutical products in 13 medical specialties, including pediatrics, internal medicine, gynecology and cardiology. Main products developed with universities include Giamebil (extract from the plant Mentha crispa with antigiardia and amoebicide properties) and Prostokos (mesoprostol formulations, used as a labor stimulant). | A few plant-derived natural products in development but details not disclosed. | Not indicated. |
| KATAL Biotecnológica | Forty-three products, including ELISA tests for: glycohemoglobin, PSA (with a visual readout for prostate cancer), toxoplasmosis, hormones (for example, human choriogonadotropin (hCG), luteinizing hormone, prolactin, triiodothyrionine, thyroxine and estradiol), ferritin and IgE. | PCR-based test for Mycobacterium tuberculosis, ELISA test kits for Chagas disease, TB-drug sensitivity, rubella IgG/IgM, herpes simplex viruses 1/2 and cytomegalovirus. | Not indicated. |
| Labtest Diagnóstica | A line of clinical chemistry reagents and automatic analyzers, immunoassay-based rapid tests (for hCG, HIV, dengue, others), urinalysis strip test (for example, for glucose or leukocytes) and ELISA-based kits (for herpes simplex virus 2, cytomegalovirus, rubella, toxoplasmosis). | Liquid stable enzymatic assay for chloride, potassium and sodium. Liquid stable control and calibrators for clinical chemistry, and test kits for hemoglobin A1C for use in small laboratories. | ISO 9001 version 2000. Follows international GMP guidelines. ANVIAS GMP-certified for manufacturing in vitro devices. |
| Nortec Química | Forty-nine active pharmaceutical ingredients (APIs) for >70 medicines, including: antivirals, antiretrovirals, benzodiazepines, cardiovascular drugs and others. | APIs for new antiretrovirals and central nervous system drugs. | New production plant approved by ANVISA and compliant with US FDA guidelines. |
| Pele Nova Biotecnologia | BIOCURE (a natural latex biomembrane extracted from the plant Havea brasiliensis) used for treatment of skin lesions (diabetic ulcers, vascular insufficiency ulcers, pressure sores, wounds, others). | Testing the Biomembrane product for timpanoplasty surgery, treatment of second- and third-degree burns, and treatment of urinary incontinence in women. Active ingredient in the membrane product (a VEFG protein) is being developed for cosmetic applications. | Manufacturing according to ANVISA GMP. |
| Recepta Biopharma | No product on the market yet. | Four monoclonal antibodies at different stages of development for cancer treatment. | Not applicable (no in-house R&D or production facilities). |
| Silvestre Laboratories | Products include Dermazine (silver sulfadiazine) used as a broad spectrum antibiotic with wound healing activity, Dermacerium (formulation of cerium nitrate and silver sulfadiazine) for burns, diabetic foot, leg ulcers, surgical wound, and Extra Graft XG-13 (bovine collagen-hydroxyapatite composite scaffold for bone tissue regeneration). | Artezine (sodium arthensunate antimalarial rectal cap), Reage (an antiwrinkle cosmetic), HS (herpetic lesion treatment), and a Dermacerium-based leprosy lesion treatment. | ANVISA GMP certified. |
| União Química Farmacêutica Nacional (São Paulo) | Over 200 different drug formulations in various categories (for example, antibiotics, corticoids, neuroleptics, anticonvulsives and antidepressants), including \>20 over-the-counter products, 27 generic medicines, 17 ophthalmic products, 75 hospital-use products and 48 products for animal health. | Mucus adhesive and nanoparticle-based ophthalmic products. More details not available. | ANVISA GMP certification. |
| Service companies | |||
| BIOCANCER | Design, conduct and manage phase 1 through phase 4 clinical trials, including clinical trial planning, site and investigator identification, patient recruitment, medical writing, protocol design and review, data management activities, site monitoring, and conduct of cGCP, cGLP and cGMP audit and compliance activities. | Three products in clinical development: an autologous dendritic cell vaccine against metastatic melanoma, an intralymphonodal vaccine based on multi-peptides associated to GM-CSF in patients with melanoma, and a vaccine based on dendritic cells pulsed with specific peptides in hormone-resistant patients with prostate carcinoma (all were in phase 1 studies in mid-2007). | Not indicated. |
| BIOMM | Technology transfer and setup of fermentation and purification facilities for protein manufacturing. The company possesses a proprietary bacterial protein expression system. | The company aims to become a contract-manufacturing organization for recombinant proteins and is in the process of setting up a pilot manufacturing facility. | Not applicable. |
| Cryopraxis Criobiologia (Rio de Janeiro) | Brazil's largest private umbilical cord blood and stem cell bank (with  10,000 samples stored already). R&D focus on providing cell therapies in the future. | Clinical trials for development of cell therapy procedures for heart malfunction, type I diabetes and neonatal hypoxia. Preclinical tests on cellular differentiation. | ANVISA- cGMP, cGTP and GCP, ISO 9001: 2000, FDA registration. |
| Intrials Latin America Clinical Research (São Paulo) | A full range of services related to clinical research, including clinical trial design and monitoring, regulatory affairs and data management. Participated in 130 clinical studies thus far, including pivotal investigational new drug (IND) trials for submission to the US Food and Drug Administration (FDA). | Not applicable. | Adheres to ICH-GCP guidelines; phone audit by FDA in May 2007. |
| Scylla Bioinformatics | Writes software to assist companies analyze genomic data for a variety of applications. Most of the company's clients have been agricultural firms thus far. | Applications are tailored to client needs. | Not applicable |
