FLORENCE, Italy & PLANTATION, Fla.--(BUSINESS WIRE)--Goodwin Biotechnology, Inc. (GBI), of Plantation, Florida and Menarini Group, of Florence, Italy, have just announced the successful completion of a strategic co-operation for the manufacturing of the monoclonal antibody Abagovomab. This antibody is the active principle of the Menarini Group’s groundbreaking ovarian cancer vaccine, now in phase III clinical studies around the world.
The monoclonal antibody, produced by GBI to standards fully compliant with both US and European requirements, will be used to kick off the initial phase of a multicenter clinical trial, known around the world as MIMOSA (Monoclonal antibody Immunotherapy for Malignancies of the Ovary by Subcutaneous Abagovomab).
In this internationally important clinical trial, Abagovomab will be administered as a maintenance therapy, after surgery and first line platinum + taxane chemotherapy with the aim to prevent the reappearance of tumor and prolong survival. Around nine hundred women will be enrolled in the MIMOSA study throughout the world (USA, Germany, Italy, Poland, Czech Republic, Spain, Hungary and Belgium). They will be treated in more than 120 selected highly specialist clinical sites.
The important milestone of the production of the antibody for MIMOSA clinical lots supply represents, according to Stephanie Finnegan, CEO, Goodwin Biotechnology Inc., a significant milestone for GBI and Menarini. “We are extremely pleased to have manufactured this product.” She also commented, “It is always gratifying when our clients’ products are successful in the clinic, and we are especially proud that Menarini, from among the many partnering options they had, chose GBI to manufacture this important product for Phase III registrative trials.”
GBI, currently undergoing expansion to double its manufacturing capacity, is a subsidiary of one of India’s leading drug manufacturers, Wallace Pharmaceuticals India Pvt. Ltd. GBI’s expertise in biopharmaceutical process development and manufacturing has been extensively leveraged by clients in North America and Europe. GBI recently commissioned new laboratories in India, offering its global client base the ability to leverage the advantages that Asia offers towards their product development strategy.
Andrew Slade, Menarini Biotech Managing Director, also was delighted with the results obtained: “As Menarini Biotech (the Menarini Group’s biotech Company) we oversaw the production of the active principle. The two companies have worked hand in hand to achieve this outstanding result. We now hope Abagovomab will help the over 200 thousand women attacked by Ovarian cancer every year in the world.”
About Menarini Biotech
Menarini Biotech is a wholly owned subsidiary of the Menarini Group. We manage the development and cGMP manufacture of in-house biologic products, assist in the in-licensing of novel biologics with a focus on oncology, cardiovascular and other niche indications or markets and undertake strategic third party contracts.
Menarini Group is the biggest Italian pharmaceutical company in the world with a 3 billion euro turnover and 13 thousand employees all over the world. Research-oriented company, in the last 25 years, it has developed a major skill in cardiovascular, asthma, and general inflammations diseases. But it is on cancer, both in chemiotherapies and vaccines field, that Menarini has developed the highest and most valuable specialization over the years.
About Goodwin Biotechnology Inc.
GBI is one of the earliest biologics contract manufacturing organizations (CMO), specializing in process development and cGMP compliant mammalian cell culture of bio-therapeutics for pre-clinical through Phase III clinical trials. The company and its predecessor, The Goodwin Institute for Cancer Research, have been operating in the biologics CMO sector since the early 1980s. GBI's clients include small to midsized biotech companies, renowned cancer research institutes and various branches of the U.S. government