The FDA has approved Cell Therapeutics’ facility to manufacture Pixuvri (pixantrone), an experimental cancer drug that is currently under review. The NerPharMa facility, which belongs to Nerviano Medical Sciences, is based in Nerviano, Italy. “FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved,” says Craig Philips, president of CTIC.

Cell Therapeutics’ closely-watched pixantrone is a potential treatment for relapsed/refractory aggressive non-Hodgkin’s lymphoma. The FDA’s decision will be a make-or-break moment for the struggling developer, with many analysts expecting the FDA to rule against the drug. FDA staffers have raised questions about the treatment, expressing concerns about both the drug’s effectiveness, as well as its safety profile. An ODAC meeting is scheduled for March 22, and the FDA is expected to make a final decision on approval of the NDA for pixantrone by April 23.

Source: FierceBioteck

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Nerviano Medical Sciences (NMS) has secured Food and Drug Administration (FDA) approval to conduct for the first time clinical trials of a novel antitumoral agent. The drug blocks Cdc7, a protein that is responsible for the uncontrolled proliferation of cancer cells. The preclinical data, recently published on the prestigious journal Nature Chemical Biology, demonstrate that inhibition of Cdc7 induces tumor cell death and blocks the growth of various types of cancer in experimental animal models.

The FDA approval will allow to conduct clinical phase I trials in cancer patients. “The news that the FDA has approved the clinical experimentation of our Cdc7 inhibitor – explains Dr. Francesco Colotta, NMS Oncology VP – first of all represents an acknowledgment of the quality and innovation of Italian research in the field of oncology. The discovery of this new drug results exclusively from the efforts of our investigators at the NMS R&D Site in Nerviano; thanks to their competence and passion we will be the first in the world to explore this new antitumor mechanism”.

About Nerviano Medical Sciences (NMS)

Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe. Research activities in Nerviano generate on average two clinical candidate molecules per year. NMS takes advantage of strategic alliances with biotechnology as well as pharmaceutical companies to secure its long term business sustainability. The Company has already finalized partnerships with major companies such as Pfizer Inc., Bristol-Myers Squibb Co., Genentech Inc. as well as with several biotech companies and academic institutions.

Source: Nerviano Medical Sciences

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Nerviano Medical Sciences (NMS), the largest pharmaceutical R&D facility in Italy and one of the leading oncology-focused, integrated discovery and development companies in Europe, today announced a new multi-year agreement with Genentech, Inc.

This new research agreement is the second collaboration agreement signed between Genentech and NMS in less than twelve months.

The two Companies will collaborate in the discovery of antibody drug conjugates for the development of potential anticancer agents.

Genentech, which is a leading oncology company in the United States, will have the exclusive license to fully develop and commercialize licensed products that contain such antibody drug conjugates.

During the research program, NMS will be primarily responsible for synthesizing and manufacturing drug reagents, while Genentech will generate antibody drug conjugates with such drug reagents and further evaluate their potential therapeutic utility.

Terms of the multi-year collaboration include an initial one-time-license-fee, milestones and royalties for licensed products as well as milestones on a target-by-target basis. Further details and financial terms were not disclosed.

“This new agreement marks an additional achievement in our strategic alliances strategy and we are very excited about the prospect of expanding our collaboration with Genentech one of the world’s leading biotech companies”, said Umberto Rosa, President of Nerviano Medical Sciences. “We believe that by working together and applying our complementary world class research capabilities in biologics and in small molecules, we may develop innovative targeted products for patients suffering from cancer”.

“With this new collaboration we are very pleased to enhance our collaboration with Genentech and to extend it in the field of antibody drug conjugates, an area where biologics and small molecules meet to generate very potent targeted therapies”, added Giampiero Duglio, CEO of Nerviano Medical Sciences. “I believe that Nerviano’s expertise in the discovery of potent small molecules may contribute to innovative and valuable products for the oncology market.”

Source: Nerviano Medical Sciences

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