On January 4, 2013 GTC Biotherapeutics reported that it has changed its name to rEVO Biologics (Press release, rEVO Biologics, JAN 4, 2013, View Source [SID:1234510526]). The name change reflects the recent commercial growth of the company, and better aligns with the company’s business strategy of evolving recombinant medicine for the treatment of rare diseases.

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"Our company is taking a revolutionary approach to the development of recombinant therapies, as evidenced by our lead product ATryn Antithrombin (Recombinant) and its remarkable growth over the past year," stated rEVO Biologics President Yann Echelard, Ph.D. "With this change, our name now reflects that core strength. Our rPRO Technology enables us to maintain all of the advantages that recombinant science offers, but through an entirely different approach. The result is better efficiency, better scalability, better cost control and ultimately better patient access to these innovative therapies."

ATryn Antithrombin (Recombinant) is the first and only recombinant antithrombin concentrate, and is currently the fastest-growing antithrombin product with market share that has tripled in the last 12 months.

The original GTC Biotherapeutics name dates back to when the company was Genzyme Transgenics Corporation, and a spinoff of Genzyme Corporation. Today, the company is a subsidiary of LFB Biotechnologies S.A., a leading European-based biopharmaceutical group. rEVO Biologics corporate offices are in Framingham, MA, with protein production facilities in Charlton, MA.

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On January 2, 2013 Medical Need reported that it has entered into an exclusive distribution agreement with the Italian company ADIENNE Pharma & Biotech relating to their product Tepadina (Press release, Immedica Pharma, JAN 2, 2013, View Source [SID1234555255]).

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Tepadina was approved as an orphan drug in the EU through an EMA centralized procedure in March 2010. The product holds a broad indication as conditioning therapy, in combination with other products or radiotherapy, in connection with hematopoietic stem cell transplantations (HSCT) and in high dose chemotherapy with HSCT support for the treatment of solid tumors, in both adults and children.

Under the agreement, Medical Need is awarded the exclusive distribution rights to Tepadina in the five Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) and will be responsible for the distribution, marketing and sale of the product in this territory, starting on January 1, 2013.

Tepadina is already used at several clinics in the Nordic countries, both for hematological and solid malignancies. The collaboration between ADIENNE and Medical Need will improve the availability of the product as well as access to medical information and other support services in local language, aiming to make the product available to even more patients across the region.

"Tepadina is a highly valuable and well tolerated component in the treatment of hematological and cerebral malignancies in connection with stem cell transplantation", said Dr. Peder Walberg, CEO of Medical Need, and continued: "We are very happy about the possibility to provide Tepadina to the Nordic patients and look forward to a long-term partnership with ADIENNE"

About Hematopoietic Stem Cell Transplantation (HSCT)

Hematopoietic stem cells reside in the body’s bone marrow and are responsible for the formation of the different cells of the blood. Hematopoietic Stem Cell Transplantation (HSCT), sometimes also referred to as bone marrow transplantation, is a procedure in which hematopoietic stem cells are infused to restore bone marrow function in patients whose own bone marrow has stopped working or been destroyed, commonly because of administration of bone-marrow-toxic doses of cytotoxic drugs with or without whole body radiation therapy for treatment of a malignancy. The new stem cells can come from different sources, including the patient (autologous), a relative (allogeneic related) or an unrelated donor (allogeneic URD). HSCT is commonly performed in connection with treatment of hematological conditions and malignancies, but sometimes also for certain solid tumors, particularly in children. There are approximately 1 500 HSCTs performed in the Nordic countries each year.

About Tepadina

Tepadina (thiotepa) is an alkylating agent with both myeloablative and immunosuppressive properties. It passes the blood brain barrier and has a high degree of CNS penetration and activity. It is commonly used in the treatment of leukemia, lymphoma and CNS tumors. The product is well tolerated, and lacks cumulative toxicity and interactions with other agents commonly used in connection with HSCT.

Tepadina was approved as an orphan drug in the EU through an EMA centralized procedure in March 2010.

Tepadina is indicated, in combination with other chemotherapy medicinal products:

with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients
when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients
The product is available in 15mg and 100mg vials.

(Filing, 10-K, Arrowhead Research Corporation, DEC 28, 2012, View Source [SID:1234504646])

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On December 19, 2012 AIMM Therapeutics reported a strategic partnership with Cosmo Pharmaceuticals to develop oral diagnostic and therapeutic antibodies for gastrointestinal diseases including colon carcinoma (Press release, AIMM Therapeutics, DEC 19, 2012, View Source [SID:1234500902]). Under the agreement, Cosmo Pharmaceuticals will formulate novel human monoclonal antibodies generated by AIMM Therapeutics in an extended release form exploiting its proprietary MMX technology. No financial details were disclosed.

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Jan de Vries, CEO of AIMM Therapeutics, said, "The strong preclinical in vivo data generated by Cosmo using its MMX technology show the tremendous potential of oral antibody delivery for gastrointestinal diseases. We expect that the combination of Cosmo’s MMX technology with AIMM’s antibodies will allow us to build a unique portfolio of products with a compelling competitive advantage in gastrointestinal disease." Mauro Ajani, Chairman and CEO of Cosmo Pharmaceuticals, said, "Access to AIMM’s proprietary high quality antibodies through our partnership will enable us to rapidly advance the oral delivery of diagnostic and therapeutic antibodies into clinical studies.‘’

On December 18, 2012 Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") reported its U.S. subsidiary Eisai Inc. has entered into a definitive asset purchase agreement to divest U.S. rights for its Gliadel Wafer (carmustine intracranial implant wafer), an antineoplastic agent, to Arbor Pharmaceuticals, Inc. (Headquarters: Georgia, the United States; President & CEO: Ed Schutter; "Arbor") (Press release, Eisai, DEC 18, 2012, View Source [SID1234569108]). Under this agreement, Eisai Inc. will transfer the New Drug Application (NDA) (rights as the marketing authorization holder) for Gliadel to Arbor. The Eisai Group will retain all rights to Gliadel outside the United States and will continue to manufacture Gliadel at its facility in Baltimore, the United States as well as serve as the exclusive supplier of Gliadel for the global market, including in the United States and Japan.

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The Gliadel Wafer is a sustained-release formulation approved for intracranial implantation. Each wafer contains carmustine, a nitrosourea alkylating agent, distributed in a biodegradable copolymer matrix. Implanting the wafer into the brain following surgical removal of a malignant glioma allows direct delivery of chemotherapy to the tumor site. Therefore this agent can be used prior to initiating other standard therapies, such as radiation and chemotherapy.

Arbor is a pharmaceutical company with strengths in hospital-based marketing as well as promising development products in the field of neurosurgery. Eisai believes that this agreement, which enables Arbor to strengthen Gliadel-related information-provision and development activities aimed at indication expansion, will lead to maximization of Gliadel’s product and patient value. Meanwhile, Eisai will be able to strategically reallocate resources to other mid-to-long-term business growth areas so as to continue to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families.