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.

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.

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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On December 29, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported an update on the development of APTO-253, its investigational compound for acute myeloid leukemia (AML) (Press release, Aptose Biosciences, DEC 29, 2016, View Source [SID1234539166]). The company has successfully manufactured multiple batches of a new drug product formulation for APTO-253, including a batch that has been stable and soluble for over six months. However, Aptose will have to repeat the production of the fourth batch, a 40L batch that was the intended clinical supply, because of a correctable engineering design incompatibility during the filling process. Aptose expects the batch records and release specifications from such a new batch, along with the stability and sterility data, to be provided to the FDA during the first quarter of 2017.

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The need to strengthen the filling process is not a reflection on the drug substance or new formulation, both of which continue to perform favorably. Indeed, the new formulation demonstrates an increase of three times plasma drug exposure as compared to the prior formulation and may have the potential to create additional intellectual property for the company. Aptose also demonstrated that APTO-253 acts by inhibiting expression of the c-Myc oncogene without toxicity to normal bone marrow and blood cells, thereby potentially increasing the likelihood of application to additional cancer indications.

"We remain committed to the development of APTO-253, a small molecule agent that may provide benefit to an important patient population," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "While we have encountered delays in manufacturing activities, we also have continued mechanistic and pharmacokinetic testing of APTO-253 which heighten its viability. In parallel, we also continue to advance the development of CG’806, an exciting preclinical compound for patients with FLT3-driven AML and certain B-cell malignancies."

In November of last year, Aptose’s phase 1b trial of APTO-253 was temporarily suspended because of the report of an operational difficulty with an IV infusion pump at a clinical site. The company has spent the year identifying the root cause of the clogging issue and actively evaluating multiple formulation and production methodologies in order to improve solubility and stability characteristics and select the best approach to optimizing the delivery of the product to patients with the goal of re-entering the clinic. Aptose is currently working on submitting information requested by the FDA as a result of the development of a new drug product that does not cause filter clogging or pump stoppage during simulated infusion studies.

On December 27, 2016 Seattle Genetics, Inc. (Nasdaq:SGEN), a global biotechnology company, reported that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML) (Press release, Seattle Genetics, DEC 27, 2016, View Source;p=RssLanding&cat=news&id=2232880 [SID1234517205]). The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings. Seattle Genetics is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials.

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The phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant AML patients has been placed on full clinical hold. Two phase 1 trials have been placed on partial clinical hold (no new enrollment, existing patients may continue treatment with re-consent). These studies are SGN-CD33A monotherapy, including a subset of older AML patients in combination with hypomethylating agents, and SGN-CD33A combination treatment with 7+3 chemotherapy in newly diagnosed younger AML patients. No new studies will be initiated until the clinical holds are lifted.

Seattle Genetics’ other ongoing trials of SGN-CD33A, including the phase 3 CASCADE trial in older AML patients and phase 1/2 trial in myelodysplastic syndrome, are proceeding with enrollment.

About Vadastuximab Talirine (SGN-CD33A)

Vadastuximab talirine (SGN-CD33A; 33A) is a novel investigational ADC targeted to CD33 utilizing Seattle Genetics’ proprietary ADC technology. CD33 is expressed on most AML and MDS blast cells. The CD33 engineered cysteine antibody is stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer via site-specific conjugation technology (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the EC-mAb technology allows uniform drug-loading onto an ADC. The ADC is designed to be stable in the bloodstream and to release its potent cell-killing PBD agent upon internalization into CD33-expressing cells.

33A was granted Orphan Drug Designation by both the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of AML. FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States.