COMPANY PROFILE

Lipogen is a top quality liposomal, pegilated and biotech product development organization, with a particular focus in oncology, providing integrated product development and technical support to the pharmaceutical industry.

BEGINNING

• üLipogen was founded in the year 1998 with the aim to generate Argentine technology of international quality.

• üWith the collaboration and the support of the Faculty Biochemistry of the University of Buenos Aires , the Center of Medical Education and Clinical Investigations(CEMIC) it has been achieved to make concrete a top project with a great added value.

• üThanks to this enormous intellectual and economic effort, Lipogen consolidates the presence of Argentina in the select club countries of that produces biotechnology to the world.

PRODUCTION PLANT

• üLipogen has the highest technology in equipment for the performance of productive processes and final quality control.

• üIts laboratory areas – 1200m2 aproximately- are fully equiped for scientific investigation, development and manufacture of biotechnological products at industrial scale.

• üThe products developed by genetic engineering are processed to reach a final product with the highest quality standards.

LIPOSOMAL PROCESS EXPERIENCE

• üThe productive processes start from a fermentation that will be purified to recover the product. This is performed with expression systems built by genetically modified bacteria.

• üThe proteins are produced in inclusion corps inside the bacteria. Then the bacterial lysis (rupture) is performed to extract the protein we are interested in.Once finished, the processes of purification takes place –including ultrafiltration, centrifugation and refolding to give the protein the apropiated structure.

• üThe process is ended by a five-steped liquid chromatography to eliminate the residues and to offer the product a proper liquid media for its later storage. The final product is packed under strict sterility conditions.

BIOTECH EXPERIENCE

DEVELOPEMENT OF INTERFERON

• üThe interferon is an artificial copy of a substance originated by some types of white blood cells.

• üThe efficiency of the interferon (alpha interferon) has decided in different clinical essays including three types of pathologies: solid tumors, viral infections and malignant hemophaties

• üThe interferon can be considered to be one of the most important physiological regulators that acts extending the expression of specific genes, disabling the cellular proliferation and increasing the effect of the immune cells.

RESEARCH AND DEVELOPMENT

Lipogen’s activities of R&D can be classified –basically into 6 lines of work:

1. Development of expresion systems for the production of recombinant proteins.
2. Obtaining of raw materials for human health.
3. Clinic investigation on recombinant proteins.
4. Peguilation of different molecules.
5. 5.Liposomal formulations. 6.Oncology medications.

Lipogen (R&D) is seeking for new products based on recombinant proteins, new therapeutic systems and biotransformation.

PHARMACEUTICAL TEAM

For the fulfillment of the technical and commercial aims, Lipogen possesses a qualified team of RRHH highly professionalized: Industrial Pharmacists, Biochemists, Chemists, specializing technical personnel and support equipment trained in the strict procedure of Good Manufacture Practices.

MANAGEMENT TEAM EXPERIENCE

• Development of international suppliers in India, China ,US y UE
• Start Up in Latin America about Pharmion UK´s Vidaza. (Nasdaq: PHRM)
• Founded and managed pharmaceutical R&D, production and marketing start-up, leveraged to grasp business opportunities triggered by new regulations in Argentina (13th WW largest market).
• Positioned DRIBURG as one of the fastest growing companies in the market. Prepared business plan and achieved regulatory approval by local FDA in record time. Developed 3 lines or products: MIGRAINE-ONCOLOGY-PHLEBOLOGY. Acquired license to market migraine drug Sumatriptan from BMS and others drugs
• High experience in review, development and follow – up of new regulation affairs, OTC or ethics. .Experience in manages in sanitary authorities in Latin America, France, Pakistan and India.
• Preparation and evaluation of Pharmaceutical investment Projects.
• Signing confidentialy agreements with over a dozen interested companies, including two top 5 pharmaceutical companies.
• Licensing drugs in Korea, China and Japan.

TECHNICAL TEAM EXPERIENCE

• Liposomal molecules developement and recombinant proteins peguilation.
• 15 years experience where were developed over 800 pharmaceutical products.
• More tha 10 years of experince in develop pharmaceutical liposomal techniques and development own peguilated and clonation techniques and international patents.
• Long experience in auditories of validation process and ISO 9000 quality system.
• Experience in registration and regulation in oncology and biotechnology.
• Experience in building an oncology facility under GMP regulations.
• High capacity in development of analytic techniques for antiviral oncology drugs
• Experienced Pharmacist & Biochemist professional with broad experience in the pharmaceutical industry both in the technical and regulatory areas including national and international regulations: ANMAT /FDA / ICH / EMEA in Biosidus Laboratories.
• Experience in quality control of oncology drugs.
• Experience in Standard Operating Procedures (SOPs)
• Audits about fulfillment of procedures and Lay outs.
• Realization of continuous improvements guidelines .
• Control, closing and approval of documentation of production.
• Design of Pharmaceutical Plants.

MARKETS

• üLipogen has been positioned as an agile and innovative company that seeks to launch to the market the first alternative copy of the biotechnological and liposomal products developed by multinational laboratories.

• üIn the last 5 years the company has been contacted by Brazilian laboratories, and others from India, Pakistan, Mexico, Canada, Israel, Argentina and EU with the objetive to collaborate in the process of transfer our pharmaceutical technologies like licensers or partners.

• üThe technical teams of Lipogen have travelled to the India, Mexico and Brazil to develop successfully the transfers of mentioned technologies.

MARKETS AND CUSTOMER

ARGENTINA

• Activa Pharma
• Adox
• All Pro Salud
• Altana Pharma
• Andrómaco
• Arcano
• Ariston
• Asprius
• Avic
• Buxton
• Cevallos Salud
• Defuen
• Delta Biotech
• Deltafarma
• Diffucap Eurand
• Drawer
• Dupomar
• Epicaris
• Fada Pharma
• Bagó
• Fecofar
• Filaxis
• Forbenton
• Gemepe
• Gobbi Novag
• Hexal
• Infinity
• Kampel Martian
• Kilab
• Lanpharm
• LBA Pharma
• Medac
• Monserrat Éclair
• Neuropharma
• Omedir
• Panalab
• Permatec
• Pharmadorf
• Prosint
• Qpharma
• Química Estrella ACA
• Raymos
• Richmond
• Ronnet
• Scott Pharma
• Sidus
• Veinfar
• Walker

BOLIVIA

• Sanovet

BRAZIL

• Biochimico

VENEZUELA

• Biocontrolled-Leti

URUGUAY

• Celsius
• Szabo

PAKISTAN

• Feroz Sons

INDIA

• Khandelwal Laboratories PVT
• Alkem Laboratories LTD

EXPERIENCE BASED IN CTD DOSSIER

MODULE 1: ADMINISTRATIVE AND PRESCRIBING INFORMATION
MODULE 2: COMMON TECHNICAL DOCUMENT SUMMARIES
MODULE 3: QUALITY:

3.S DRUG SUBSTANCE

• nomenclature
• structure
• general properties
• description of manufacturing process and process controls
• control of materials
• controls of critical stops and intermediates
• process validation and/or evaluation
• manufacturing process development
• characterization
• control of drug substance
• referente standards or materials
• container closure system
• stability

3.P DRUG PRODUCT

• description and composition of the drug product
• pharmaceutical development
• manufacture
• control of excipients
• control of drug product
• reference standards or materials
• container closure system
• stability

MODULE 4: NONCLINICAL STUDY REPORTS
MODULE 5: CLINICAL STUDY REPORTS

PIPELINE

• Current products:
• Anfotericin B liposomal: Free Certificate Argentina, Brazil, Rep Dominican, Pakistan.-
• Doxorubicin B liposomal: Free Certificate in India.

ACTUAL PRODUCTS