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.

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.

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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Eagle Pharmaceuticals’ Pemetrexed NDA Submitted for Review

On January 3, 2016 Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) ("Eagle" or "the Company") reported that the 505(b)(2) New Drug Application (NDA) for its novel pemetrexed drug product has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Eagle Pharmaceuticals, JAN 3, 2017, View Source [SID1234517249]).

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This 505(b)(2) NDA requests FDA approval of Eagle’s ready-to-dilute (RTD) Pemetrexed Injection product for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma (in combination with cisplatin).

"We look forward to the FDA’s decision on this NDA this year, and to continuing to work closely with the FDA through the review process. We believe our RTD liquid formulation will be well received, adding to Eagle’s growing commercial portfolio of improved formulations, benefiting patients and shareholders alike," said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Eagle’s RTD Pemetrexed Injection product is administered as an IV infusion.

Apollo Endosurgery Completes Merger with Lpath; Initiates Trading on NASDAQ as ‘APEN’

On December 29, 2016 Apollo Endosurgery, Inc. ("Apollo"), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported that it has completed its merger transaction with Lpath, Inc. ("Lpath", Nasdaq: LPTN) (Filing, 8-K, Lpath, DEC 30, 2016, View Source [SID1234517278]).

With the completion of the merger today, Lpath was renamed Apollo Endosurgery, Inc. and will begin trading on the NASDAQ Global Market under the symbol ‘APEN’ on December 30, 2016.

Following the closing of the merger and a 1-for-5.5 reverse stock split, the combined company has approximately 10.7 million shares of common stock outstanding. The stockholders of Apollo received common stock representing approximately 95.9% of the outstanding shares and the stockholders of Lpath retained approximately 4.1% of the combined company. Concurrent with the closing of the merger, certain stockholders of Apollo invested $29 million of new equity in the combined company, which is included in the 95.9% ownership of previous Apollo stockholders.

"Apollo has an exciting product and technology portfolio from which to advance the interventional treatment of obesity through less invasive procedures. We are grateful for the continued confidence and support of Apollo’s stockholders as we take this next step in the development of our company," commented Todd Newton, Chief Executive Officer of Apollo.

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