09/12/2014 17h37

Orygen’s plant for the production of biosimilars will be located in São Carlos

Joint venture between Biolab and Eurofarma expects to invest R$ 500 million in the construction of the factory that will nationalize the production of drugs for diseases such as cancer and arthritis

Investe São Paulo

Orygen, a joint venture between the national laboratories Biolab and Eurofarma, announced on Friday, September 5, the construction of its national plant for the production of monoclonal antibodies in the city of São Carlos, 250 km from the state capital, on a area covering 200,000 square meters.

For the project to be made possible, however, the municipality of São Carlos, along with the City Council, must arrange the change of the area chosen from rural to industrial. The municipality must submit a bill for this change next week. The approval by the city council is expected to occur until October.

Monoclonal antibodies are produced by living cells and the clinical and commercial success of these biological agents has been transforming the global pharmaceutical industry. As the patents of these drugs expire, substantial opportunities emerge allowing the development of highly similar versions of these biologics, called biosimilars. The interest in developing biologics and biosimilars in Brazil has been incremented by the possibilities offered with the expiration of the patents in the coming years.

After the construction of the production plant of Orygen, the company plans to start operating with 110 professionals in total, 50 of which will be directly involved with the technical processes, 28 in the production lines, 20 in control and quality assurance and 12 in operational support activities. It is estimated that over one third of all professionals wll be Masters and PhDs.

Investe São Paulo, the investment promotion agency linked to the Secretariat of Economic Development, Science, Technology and Innovation, provided support to Orygen especially in the dialogue with state institutions and public utilities. The projects related to health are handled with priority by the Agency.

“This is a historic moment not only for the state but for the country, since the nationalization of biosimilars will reduce the deficit of our trade balance in this sector and facilitate the availability of key drugs in the SUS (Unified Health System). We have been in contact with Orygen since November 2012 and bringing this project to the State makes us very proud,” said the president of Investe SP, Luciano Almeida.” Orygen has chosen São Carlos because the city has technology parks, research centers, universities and qualified labor for the pharmaceutical industry,” he added.

For the implementation of the project, Orygen entered into a strategic partnership with Pfizer Inc. whose collaboration agreement is under analysis by the Administrative Council of Economic Defense (Cade). After the approval of the agreement and execution of ancillary agreements, Pfizer will begin the process of technology transfer for the production of up to five monoclonal antibodies to Orygen, which include the biosimilars Adalimumab, Bevacizumab, Infliximab, Rituximab and Trastuzumab used to fight diseases such as cancer and autoimmune illnesses.

For the construction of the plant, Orygen relies on the support from the National Bank for Economic and Social Development (BNDES) and the Financier of Studies and Projects (FINEP). The plant is expected to start operating in 2017, with the first drugs coming out in 2018.

According to the scientific director of Orygen, the English biochemist Andrew Simpson, Pfizer is already at a very advanced stage regarding the development of these drugs. ”The availability of the antibodies from Pfizer in Brazil to be distributed by SUS will bring a huge benefit to patients with diseases that can be treated with these medicines,” he said.

According to the city’s mayor, Paulo Altomani, “the investment made by Orygen will be very important for the economy and health of the city, in addition to generating several job opportunities. This is a high technology company that, with the authorization of Pfizer, will produce antibodies for the treatment of cancer and arthritis. São Carlos is a developed city in the medical area ,” he said.

Altomani and Simpson gathered last Thursday, August 28, with the general manager of Investe SP, Wanius Ribeiro, and representatives of CPFL Energia, the Department of Water and Energy (DAEE), Companhia Gás Brasiliano and Serviço Autônomo de Água e Esgoto São Carlos (SAAE). The purpose of the meeting was to evaluate the provision of energy, water, electricity and waste treatment services. The institutions guaranteed the availability of the services for the implementation of the company in the city.

Strategy

It has been two years since Orygen has been willing to build a drug plant in Brazil, and the partnership with Pfizer was key for the completion of this project.

The production of biosimilars is strategic for the Brazilian government, which currently imports the drugs to be distributed in the Unified Health System (SUS). Since 2012, the Ministry of Health has been discussing agreements with several companies for the nationalization of these products with support from BNDES.

The idea would be to reduce the deficit of the trade balance of medical equipment and medicines, which totals approximately R$ 25 billion a year.

Biolab and Eurofarma

Orygen is a joint venture integrated by the founding partners, Biolab Sanus Farmacêutica Ltda. and Eurofarma Laboratórios S.A., each one holding 50% of stakes.

Biolab has two manufacturing units in the state of São Paulo, in Jandira and Taboão da Serra, with production lines for oral solids, semi-solids and injectables, hormonal and nonhormonal, packaging lines, areas of utilities and wastewater treatment. The administrative center is located in the city of São Paulo, with a unit of RD&I (Research, Development and Innovation) in Itapecirica da Serra, São Paulo, and another in the Center for Innovation, Entrepreneurship and Technology (CIETEC) of the Energy Research Institute at USP, where it models and synthesizes new molecules (radicals and semi-radicals).

The company has approximately 1,900 employees, 1,000 of which in the sales force and commercial area according to data from December/2012. The company is focused on prescription drugs in the specialties of cardiology, gynecology, rheumatology, orthopedics, internal medicine, pediatrics, endocrinology, geriatrics and dermatology. Following a global trend, the company also invests in skin care products, developing products considering the different types of climate in the country, the skin type of Brazilians and the natural resources of the local biodiversity.

Eurofarma is today among the largest pharmaceutical companies of 100% national capital, operating in the main pharmaceutical segments of prescription, generic, OTC, hospital, oncology, veterinary drugs and services to third parties. Eurofarma is the second most prescribed brand in the country. The company has over 5,700 employees and is present in Brazil and in 14 Latin American countries (Argentina, Uruguay, Chile, Bolivia, Colombia, Peru, Guatemala, Panama, Honduras, Nicaragua, El Salvador, Costa Rica, Belize and the Republic Dominican). The company’s vision is to cover 90% of the Latin American market by 2015. 

Eurofarma reported growth in 2012 and 2013. The company’s consolidated gross revenue reached the milestone of R$ 1.9 billion, which corresponds to 15.1% increase compared to the previous year. The consolidated EBITDA increased 47.9% compared to 2011, totaling R$ 325.1 million, or 19.8% of the value creation, measured on net revenue. This was a result of the intense work, not yet completed, improvements in the cost structure in the division of hospital serum, maintenance of fixed expenses and improvement in the performance of subsidiaries.