Year: 2017

Flamel Technologies Completes Cross-Border Merger and Becomes Avadel Pharmaceuticals plc

On January 3, 2016 Flamel Technologies SA, reported that it has completed its previously announced cross-border merger with and into its wholly-owned Irish subsidiary, Avadel Pharmaceuticals plc (NASDAQ: AVDL) (Avadel), effective January 1, 2017, with Avadel surviving the merger as the public holding company (Filing, 8-K, Flamel Technologies, JAN 3, 2017, View Source [SID1234517292]). As a result of the merger, all of Flamel’s outstanding ordinary and American Depository Shares (ADSs) were canceled and exchanged on a one-for-one basis for Avadel ordinary shares and ADSs, respectively. Avadel ADSs will begin trading on the NASDAQ Global Market under trading symbol "AVDL" on January 3, 2017.

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Michael Anderson, Avadel’s Chief Executive Officer, remarked, "We are excited to enter 2017 as Avadel. The completion of the cross-border merger from France to Ireland serves as a way to unify our subsidiaries under a shared corporate identity, and provides the company with a new set of corporate governance policies that will allow us greater flexibility as we continue to grow our business and commercialize products."

Mr. Anderson continued, "Our new name, Avadel, which stands for ‘advanced delivery,’ was born out of our company’s strong history in drug delivery and serves as a constant reminder of a key piece of our company’s growth strategy – to develop differentiated pharmaceutical products utilizing our proprietary and innovative technologies."

"We are excited to begin 2017 with a new name, an ongoing Phase III trial and a strong financial position," finished Mr. Anderson.

Marina Biotech Granted European Claims Covering Bacteria Mediated Gene Silencing

On January 3, 2017 Marina Biotech, Inc. (OTCQB: MRNA), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer, reported that the European Patent Office intends to grant the company a patent for Bacteria Mediated Gene Silencing (EP 08768475.9, European Patent 2173875) (Filing, 8-K, Marina Biotech, JAN 3, 2017, View Source [SID1234517265]).

The granted claims relate to the company’s tkRNAi technology being utilized in its CEQ508 program that is being developed to treat familial adenomatous polyposis (FAP). Marina’s patent portfolio around tkRNAi and its CEQ508 program includes 14 issued patents worldwide. The claims are broad, and cover a prokaryotic vector comprising a promoter for generating siRNAs. Targets for the siRNA include beta-catenin. The vector can include an invasion factor, and a lysis regulator. An invasive bacterium including the vector is also encompassed. Marina Biotech will continue to expand its development of tkRNAi to cover other therapeutic targets as permitted by the granted patent- including Ras, APC, HER-2, MDR-I, MDR-2, FATP4, SGLUT-1, GLUT-2, GLUT-5, apobec-1, MTP, IL-6, IL-6R, IL-7, IL-12, IL-13, Ra-I, IL-18, p38/JNK MAP kinase, p65/NK-kB, CCL20, Claudin-2, Chitinase 3-like 1, apoA-IV, MHC class I and MHC class II.

"We are excited by the recent positive developments from the CEQ-508 program and looking forward to expand bacteria mediated gene silencing to other therapeutic areas protected by our patent portfolio, including oncology, diabetes, and hyperlipidemia", stated Dr. Vuong Trieu, Chairman of the Board at Marina Biotech. "This unique ability to orally deliver oligo therapeutics across different species and kingdoms will open up applications not possible with any other delivery platforms".

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Flamel Technologies Completes Cross-Border Merger and Becomes Avadel Pharmaceuticals plc

On August 12, 2016 Flamel Technologies (NASDAQ: FLML) reported that it received shareholder approval to reincorporate its country of domicile to Ireland from France via a cross-border merger (Press release, Avadel Pharmaceuticals, AUG 12, 2016, View Source;item=o8hHt16027g9XhJTr8+weNRYaV9bFc2rMd0Q/AXw4zvZ/USJmYQCtLIQG2aEdNsmFxHqxmm39PDt+LydB4tmozzAmW9nBdXvb3mR+p/DbTIWkJzh8LD8LGxkQnP3b9aywxrvUjWJ9oubudnn9pG8ZA==&cb=636204461836502476 [SID1234521917]). Shareholders voted in favor of the reincorporation by proxy at the Company’s Extraordinary General Meeting, held at the Company’s headquarters in Lyon, France on August 10, 2016.

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Under the terms of the Company’s reincorporation, Flamel will merge with and into its wholly owned subsidiary, Avadel Pharmaceuticals Limited. In connection with the merger, Avadel Pharmaceuticals Limited will re-register as an Irish public limited company and will be known as "Avadel Pharmaceuticals plc," which will be the name under which the Company will conduct its business from and after the merger, effective on January 1, 2017.

Mike Anderson, Chief Executive Officer of Flamel, remarked, "Flamel’s vision has transformed over the last few years from a pure play drug delivery company, to that of a diversified specialty pharmaceutical company capable of independently developing and marketing its own proprietary products. Ireland is an ideal location to execute this vision as it is quickly becoming a global pharma hub, and offers corporate governance policies more akin to those in the U.S. Our board and senior management both feel strongly that this move will allow the Company to operate in a manner that will return maximum value to shareholders once we begin to launch products utilizing our proprietary technologies, such as Micropump sodium oxybate, for which we expect to initiate a Phase III pivotal trial imminently."

More information regarding the Company’s reincorporation to Ireland can be found in its proxy to shareholders, filed with the Securities and Exchange Commission on July 5, 2016.

About Flamel Technologies:
Flamel Technologies SA (NASDAQ: FLML) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs. Flamel currently markets three previously Unapproved Marketed Drugs ("UMDs") in the United States, Bloxiverz (neostigmine methylsulfate injection), Vazculep (phenylephrine hydrochloride injection), and Akovaz (ephedrine sulfate injection). The Company also develops products utilizing its proprietary drug delivery platforms, Micropump (oral sustained release microparticles platform), along with its tangent technologies, LiquiTime (a Micropump-derivative platform for liquid oral products) and Trigger Lock (a Micropump-derivative platform for abuse-resistant opioids). Additionally, the Company has developed a long acting injectable platform, Medusa, a hydrogel depot technology, particularly suited to the development of subcutaneously administered formulations. Current applications of Flamel’s drug delivery products include sodium oxybate (Micropump), extended-release of liquid medicines such as ibuprofen and guaifenesin (LiquiTime, through a license arrangement with Elan Pharma International Limited for the U.S. Over-the-Counter market) and a current study of the delivery of exenatide utilizing the Medusa technology. In February 2016, Flamel acquired FSC Pediatrics, a company that markets three pediatric pharmaceutical products – Cefaclor for oral suspension, indicated for infection, Karbinal ER, indicated for allergic rhinitis and AcipHex Sprinkle (rabeprazole sodium) indicated for the treatment of gastroesophageal disease (GERD). FSC also received 510(k) clearance from the FDA in October 2014 for Flexichamber, a collapsible holding chamber for used in the administration of aerosolized medication using pressurized Metered Dose Inhalers (pMDIs) for the treatment of asthma. The Company is headquartered in Lyon, France and has operations in Dublin, Ireland and St. Louis, Missouri.

Prima Announces New Product Candidate IMP761 – A LAG-3 Agonist Antibody

On January 3, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) (“Prima”, the “Company”) reported that it has developed a new early stage product candidate, a humanised IgG4 monoclonal antibody to be known as IMP761 (Press release, Prima Biomed, JAN 3, 2017, View Source [SID1234517263]). This antibody, developed at the Company’s laboratory in Châtenay-Malabry south of Paris, is believed to be the first agonist antibody of LAG-3.

The IMP761 agonist antibody is an exciting new addition to the Prima pipeline of product candidates. It is mechanistically distinct from any of the known LAG-3 antibodies. Prima continues to lead the way in researching and developing novel LAG-3 targeting technologies.

Dr. Frédéric Triebel said “Even though IMP761 is an early stage product, we are very excited to have developed what we believe is the first ever agonist of LAG-3. Until now, therapeutic antibodies with agonistic properties have not been described for any of the three major immune checkpoints, CTLA-4, PD-1 or LAG-3. IMP761 promises the first opportunity for fine tuning of the immune response to an immune checkpoint target. This singular biological activity of IMP761 could benefit sufferers of certain autoimmune diseases by temporarily switching off activated LAG-3+ T cells that are damaging tissue or creating inflammatory responses.”

Prima CEO, Mr Marc Voigt commented “Our ongoing research efforts in the Paris laboratory are further consolidating our leading position in the development of LAG-3 product candidates. With development of IMP761, Prima is harnessing even more of the therapeutic potential of the LAG-3 target. Our antagonist and agonist antibodies can respectively increase immune responses (for cancer indications) or decrease such responses (for auto-immune diseases), suggesting exciting options for novel immunotherapies. As IMP761 is early stage, in 2017 we will focus on pre-clinical development, including in vivo efficacy model studies, to better understand its potential applications.”

About IMP761
IMP761 is a humanised IgG4 monoclonal antibody that has been developed by staff in Prima’s laboratory in Paris. A new patent has been filed to provide protection for this antibody.

Inflammatory and autoimmune diseases are characterised by activated T cells that react against the patients’ own tissues. They fail to switch off when they should and therefore cause tissue destruction or inflammatory responses. Using an agonist antibody that targets the LAG-3 receptor on the surface of activated T cells is expected to result in an inhibitory signal being delivered directly into the T cell to stop it from continuing to proliferate and react against a patient’s own tissues.

Cellectis Submits IND Application for UCART123, an Allogeneic Gene Edited CAR T-Cell Product Candidate, in AML and BPDCN

On January 3, 2017 Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate Phase 1 clinical trials of UCART123 the Company’s most advanced, wholly owned TALEN gene edited product candidate in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Cellectis, JAN 3, 2017, View Source [SID1234517253]).

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Pending regulatory clearance, Cellectis plans to initiate Phase 1 clinical trials in the first half of 2017. This is the first IND filing for human clinical applications of a gene edited allogeneic "off-the-shelf" product candidate in the U.S. UCART123 is a gene edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML, as well as on leukemic and other tumoral cells in BPDCN.

The UCART123 program was subject to a public hearing by the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) in December 2016, where it received the unanimous approval of the RAC committee members.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

The clinical research at Weill Cornell will be led by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine. BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is a disease of bone marrow and blood cells but also often affects skin and lymph nodes.

The UCART123 clinical program at MD Anderson will be led by Dr Naveen Pemmaraju, MD, Assistant Professor, and Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production can be industrialized and standardized with defined pharmaceutical release criteria.

"Following a Pre-IND meeting with the FDA in August 2016 and a NIH-RAC public hearing in December 2016, filing this IND is an important regulatory milestone for the Company. It represents many years of research and development by a dedicated team focused on developing highly innovative UCART products for the benefit of patients", stated Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis.

Chief Medical Officer, Dr. Loan Hoang-Sayag, commented: "UCART123 represents a unique therapeutic approach for patients with unmet medical needs such as relapsed or refractory AML, high risk AML and BPDCN and we are excited to move this experimental product into clinical development. We have designed robust Phase 1 clinical trials to better understand the potential of UCART123 to address the needs of different patient populations."

Information about ongoing clinical trials are publically available on dedicated websites such as:

www.clinicaltrials.gov in the U.S.

www.clinicaltrialsregister.eu in Europe