Hemispherx Biopharma, GP Pharm Sign Manufacturing Pact

The specialty pharmaceutical company Hemispherx Biopharma, Inc. has signed a preliminary stage agreement with GP Pharma, a pharmaceutical company headquartered in Barcelona, Spain, to manufacture Ampligen, an investigational  RNA nucleic acid being developed for various diseases affecting the immune system, in Argentina to serve Latin American markets should Ampligen be approved in Argentina.

The agreement is a step in Hemispherx’s marketing, distribution, and supply agreement for Ampligen with GP Pharm. The agreement is a prerequisite to starting the manufacture of stability lots, followed by stability testing, necessary to gain approval by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), the national regulatory agency in Argentina, to manufacture Ampligen, contingent upon ANMAT approval. The parties are also actively discussing establishing manufacturing capacity in Argentina for a second product, Alferon N, a natural interferon for treating refractory HPV genital warts.

In June 2010, the companies entered into a sales, marketing, distribution, and supply agreement for Ampligen in certain Latin American countries. In December 2010, the parties extended this agreement to cover Mexico. In August 2012, the parties announced they had filed for approval in Argentina for Ampligen for treating chronic fatigue syndrome. Additionally, in December 2010, the companies entered into a sales, marketing, distribution, and supply agreement with respect to Hemispherx's Alferon N Injection, an injectable formulation of natural alpha-interferon, which is now approved for use in the US and Argentina.

GP Pharm SA has headquarters in Barcelona with operations in each major country in Latin America either directly or through local partners. Its activities are focused on research, development ,and marketing of injectable products made by partners and by GP Pharm based on its proprietary drug-delivery systems, which includes microspheres and liposomes. GP Pharm's new production plant recently achieved EU GMP approval and started manufacturing operations, producing the first batches of own products and also for some contract manufacturing partners. GP Pharm also has a centralized free-zone distribution facility in Uruguay for its own products as well as its partners' products.

Source: Hemispherx Biopharma

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