On March 29, 2014 Nordic Nanovector reported that the European Patent Office has granted patent no. 2528627, entitled "RADIOIMMUNOCONJUGATES AND USES THEREOF" (Press release Nordic Nanovector, MAR 19, 2014, View Source [SID:1234500624]). The issued claims cover Nordic Nanovector’s proprietary radioimmunotherapy technology including the company’s lead product candidate Betalutin. The expiry date for the patent is 2031.

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"The granting of this patent is an important step in securing market protection of our investment in Betalutin, which is currently being developed as a treatment for patients with relapsed B-cell Non-Hodgkin lymphoma," said Jan A. Alfheim, Chief Executive Officer. "We now have patent protection for Betalutin in the two most important geographical markets for radio-immunotherapies, the USA and Europe."

OXiGENE is moving forward with a Phase II development program for ZYBRESTAT in neuroendocrine tumors (Filing 8K, OXiGENE, MAR 18, 2014, View Source [SID:1234500304]).

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On March 17, 2014 Pierre Fabre Dermatologie has obtained marketing authorization from the FDA* for the pediatric drug HemangeolTM (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy" (Press release, Pierre Fabre, MAR 17, 2014, View Source [SID1234591858]). Hemangeol is an oral solution specially developed for safe and effective use in children. Hemangeol will be available June 2014. This marketing authorization comes after the new drug application for Hemangeol was submitted to the US FDA in May 2013. The application was also submitted to the European Medicines Agency, receiving positive opinion on February 21st, 2014 from the CHMP**, with marketing authorization expected for April 28th, 2014.The efficacy of propranolol in the treatment of infantile hemangioma (IH) was first discovered in 2007 by Dr. Christine Léauté-Labreze, a dermatologist at the Bordeaux University Hospital. Subsequently, the off-label use of this molecule became the first-line treatment for IH. While propranolol has long been known and used in cardiology, its use in infants with IH had never been properly studied and there was no pharmaceutical form approved for pediatric use. In 2009, Pierre Fabre Dermatologie undertook the pharmaceutical and clinical development required to make the Bordeaux University Hospital discovery accessible to infants with IH, with proven clinical safety and efficacy.
This collaboration has endowed pediatric dermatology with a new therapy that fulfills an unmet medical need and thousands of American children may now benefit from this new therapy each year, declared Dr. Jean-Jacques Voisard, Dermatologist, General Manager of Pierre Fabre Dermatologie.

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As Pierre Fabre US representatives we are proud to be part of a Group able to develop children dedicated medicines and to be the first Pierre Fabre subsidiary to obtain marketing approval for Hemangeol, underlined Laurent-Emmanuel Saffré, General Manager of Pierre Fabre Pharmaceuticals, Inc. (USA).

The marketing authorization granted by the FDA rewards a public–private partnership developed over the last six years by Pierre Fabre Laboratories and the Bordeaux University Hospital, with the support from Aquitaine Science Transfert, stated Eric Ducournau, CEO of Pierre Fabre Dermo-cosmetics SAS, parent company of Pierre Fabre Dermatologie.

Following the marketing authorization approved by the FDA in July last year for Fetzima (levomilnacipran extended-release capsules), a drug created by Pierre Fabre research and developed in partnership with Forest Laboratories, the Hemangeol marketing authorization is yet further recognition for our R&D on the world’s most demanding pharmaceutical market. This is a tremendous encouragement to pursue our R&D effort in oncology, dermatology and neuropsychiatry which are our prioritized therapeutic areas of innovation,commented Bertrand Parmentier, CEO of the Pierre Fabre Laboratories.

On March 17, 2014 Kyowa Hakko Kirin reported that it has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO Injection) from Japan’s Ministry of Health, Labour and Welfare (MHLW) (Press release Kyowa Hakko Kirin, MAR 17, 2014, View Source [SID:1234500287]).

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Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including PTCL and CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Mogamulizumab was also granted orphan drug designations for the treatment of PTCL and CTCL in March 2013 by the MHLW.
Mogamulizumab was launched in Japan with the brand name POTELIGIO Injection 20 mg on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.

On March 17, 2014 Bellicum Pharmaceuticals reported that the first clinical study is underway of a Chimeric Antigen Receptor (CAR) T Cell therapy that incorporates a safety switch to enable rapid elimination of the administered T cells if they threaten the life or health of the patient. Researchers from the National Cancer Institute (NCI) have begun treating pediatric patients with osteosarcoma and other non-neuroblastoma GD2-expressing solid tumors with a third generation CAR T cell therapy that incorporates Bellicum’s unique CaspaCIDe safety switch technology (Press release Bellicum Pharmaceuticals, MAR 17, 2014, View Source [SID:1234500805]).

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"CAR T cell therapy has recently shown dramatic results including apparent cures in some of the deadliest of cancers, but the treatment can also cause life-threatening toxicities, and has resulted in some patient deaths. Experts in the field have talked about the critical need for an effective safety mechanism to allow the development of more potent products within this new class of immunotherapy," said Kevin Slawin, M.D., Executive Chairman and Chief Medical Officer of Bellicum Pharmaceuticals. "We’re excited to make this a reality by incorporating our unique safety switch into this third generation CAR T cell therapy, thereby potentially giving these patients, and their families and physicians, an added layer of safety."

Bellicum’s CaspaCIDe technology consists of an inducible Caspase-9-based cell safety switch, and the small molecule activator, AP1903. CaspaCIDe is engineered into immunotherapy cells, in this case GD2-targeted third generation CAR T cells, before they are introduced to the patient. In the event of a serious or life-threatening toxicity caused by the administered T cells, AP1903 is infused to trigger rapid destruction and elimination of the CaspaCIDe-enabled cells.

CaspaCIDe technology has already demonstrated the ability to selectively eliminate harmful immune cells, resolving acute Graft versus Host Disease (GvHD) in stem cell transplant patients.1 Bellicum is currently evaluating its own lead CaspaCIDe-enabled product, BPX-501, together with AP1903, in clinical studies to improve transplant outcomes and reduce or eliminate GvHD following stem cell transplant in multiple indications, populations and transplant modalities. The collaboration with NCI represents Bellicum’s initial application of its expertise and technology to the clinical advancement of the CAR T cell field.