On April 15, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that it has expanded its existing BENDEKA (bendamustine hydrochloride) licensing agreement with Teva Pharmaceuticals International GmbH ("Teva") (Press release, Eagle Pharmaceuticals, APR 15, 2019, View Source [SID1234535127]). Under the terms of the revised licensing agreement, beginning on October 1, 2019, Eagle’s royalty payment will increase from 25% to 30% of BENDEKA net U.S. sales, provided that BENDEKA’s orphan drug exclusivity has not been rescinded, withdrawn or waived by such date. The royalty rate will increase by one percentage point on each anniversary of October 1, 2019 until it reaches 32%, and it will remain at 32% thereafter.

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The revised agreement, effective April 13, 2019, also extends the U.S. BENDEKA royalty term until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025. The extended term recognizes the strength of the bendamustine patents with expiries through 2033, and the value of the product beyond the original ten-year period. As part of the agreement restructuring, Eagle will continue to manufacture BENDEKA for the U.S. market for so long as it is sold in the United States and has agreed to assume a portion of the BENDEKA-related patent litigation expenses.

"We are very pleased to deepen our relationship with Teva by extending and expanding our licensing agreement for BENDEKA. This agreement recognizes the long-term value of the product, which is supported by orphan drug exclusivity through December 7, 2022 and an extensive patent portfolio through 2033. Teva has been a strong commercial partner, and we look forward to exploring additional areas of cooperation," stated Scott Tarriff, Chief Executive Officer of Eagle.

BENDEKA was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

On April 15, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported three oral presentations at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), taking place April 29-May 2, 2019, in Washington, D.C (Press release, Intellia Therapeutics, APR 15, 2019, View Source [SID1234535128]).

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Intellia’s data includes important updates from the company’s programs and platform development activities:

"CRISPR/Cas9-Mediated Targeted Insertion of Human F9 Achieves Therapeutic Circulating Protein Levels in Mice and Non-Human Primates"

Intellia will present data showing that its targeted gene insertion platform achieved therapeutic levels of Factor IX protein in non-human primates (NHP). The company employs a proprietary hybrid delivery system, comprised of both lipid nanoparticles (LNPs) and adeno-associated virus (AAV), to insert the desired gene sequence. Factor 9 (F9) is a gene that encodes Factor IX (FIX), a blood-clotting protein that is missing or defective in hemophilia B patients.

The data showing therapeutic levels of FIX achieved in NHPs is from an ongoing research collaboration between Intellia and Regeneron Pharmaceuticals, Inc.

Presenter: Hon-Ren Huang, Ph.D., associate director, Vector Biology, Intellia
Abstract number: 11
Session: Advances in Genome Editing and Hemophilia Gene Therapies
Presentation date/time: Mon., April 29, 2019, 9-9:15 a.m. ET
Location: Heights Courtyard 2
"Exploiting Clonal Tracking of WT1-Specific T Cells to Generate a Library of Tumor-Specific T Cell Receptors (TCR) for TCR Gene Editing of Acute Leukemia"

This presentation will focus on Intellia’s ongoing research collaboration with IRCCS Ospedale San Raffaele in Italy to develop CRISPR-edited T cell therapies to address intractable cancers, such as acute myeloid leukemia (AML). Researchers generated and tested a library of TCRs with different epitope specificities and human leukocyte antigen (HLA) restrictions.

Presenter: Eliana Ruggiero, Ph.D., Experimental Hematology Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS Ospedale San Raffaele, Italy
Abstract number: 123
Session: Cancer Adoptive Immunotherapy
Presentation date/time: Mon., April 29, 2019, 5-5:15 p.m. ET
Location: Georgetown
"CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria"

Intellia will provide information demonstrating successful knockout of two targets of interest, lactate dehydrogenase A (LDHA) and hydroxyacid oxidase 1 (HAO1), to address primary hyperoxaluria type 1 (PH1) in a PH1 mouse model. The data shows the continued progression of the company’s modular platform capability using CRISPR to knock out liver gene targets. The data being presented includes results from an ongoing collaboration with researchers at the University of Alabama at Birmingham.

Presenter: Anette Hübner, Ph.D., associate director, Liver Biology, Intellia
Abstract number: 1000
Session: Use of New Technologies for Hepatic Therapy
Presentation date/time: Thur., May 2, 2019, 12-12:15 p.m. ET
Location: Heights Courtyard 3
"Delivering on the Therapeutic Promise of CRISPR/Cas9"

Intellia also will participate in the ASGCT (Free ASGCT Whitepaper) Gene Editing Workshop, which will provide an overview of current gene editing technologies and approaches, as well as emerging uses and applications.

Presenter: Sean Burns, M.D., senior director, Hematology and New Therapeutic Areas
Session: Corporate Review II
Session date/time: Sun., April 28, 2019, 5-6 p.m. ET
Location: Lincoln

On April 12, 2019 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the first quarter ended March 31, 2019 before the US financial markets open on April 25, 2019 (Press release, Alexion, APR 12, 2019, View Source [SID1234535112]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast at 8:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 1692605 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.

On April 12, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and, through our license to Santen Pharmaceutical Co. Ltd., wet age-related macular degeneration, reported that its Phase 3 TAPPAS trial evaluating TRC105 in combination with Votrient (pazopanib) in patients with advanced or metastatic angiosarcoma was terminated for futility based on the recommendation of the Independent Data Monitoring Committee (IDMC) following its review of interim unblinded safety and efficacy data from more than 120 patients enrolled in the trial at the time of the analysis (Press release, Tracon Pharmaceuticals, APR 12, 2019, View Source [SID1234535113]).

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TRACON will work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

"We are disappointed that TRC105 in combination with Votrient did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic angiosarcoma," said Charles Theuer, M.D. Ph.D., President and CEO of TRACON. "Given these data, we will terminate further enrollment in company sponsored trials of TRC105 in oncology. We will continue to support our partner, Santen, in their development of DE-122 in wet AMD, where the anti-angiogenic and anti-fibrotic properties of endoglin inhibition may be more relevant than in oncology. We will also continue to develop our other drug candidates, including TRC253 in partnership with Janssen and TJ004309 (also known as TJ-D5) in partnership with I-Mab, and, intend to advance candidates within I-Mab’s broad bispecific pipeline into the clinic in the US as early as the beginning of next year. We will also continue our business development efforts to source additional innovative products to fortify our pipeline through risk share and cost share arrangements. On a financial note, as a result of the expected savings to be generated from terminating TRACON sponsored trials of TRC105, we anticipate our current cash runway will now extend into the third quarter of 2020."

Investor Conference Call

The Company will hold a conference call today at 8:30 a.m. EDT / 5:30 a.m. PDT to provide further details on the TAPPAS trial and TRACON’s clinical stage pipeline. The dial-in numbers are (877) 407‑9039 for domestic callers and (201) 689-8470 for international callers. Please use passcode 13689814. A live webcast of the conference call will be available at View Source

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About the TAPPAS trial in Advanced or Metastatic Angiosarcoma

The TAPPAS trial was designed to compare treatment with TRC105 and Votrient to treatment with single agent Votrient in up to 340 patients with advanced or metastatic angiosarcoma. Patients were randomized in equal numbers and the primary endpoint was progression free survival by RECIST 1.1. Key secondary endpoints included objective response rate, overall survival, safety and tolerability.

About TRC105 (carotuximab)

TRC105, the oncology formulation of carotuximab, is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the US and EU. The ophthalmic formulation of TRC105, DE-122, is currently being studied in the randomized Phase 2 AVANTE trial in patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About DE-122 (carotuximab)

DE-122, a novel ophthalmic formulation of carotuximab, is active in preclinical choroidal neovascularization (CNV) models and expected to enhance the effect of approved VEGF inhibitors used to treat wet AMD. DE-122 is being investigated in the Phase 2 randomized AVANTE trial assessing the efficacy and safety of intravitreal injections in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD.

On April 12, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its first quarter 2019 financial results on Tuesday, April 30, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, APR 12, 2019, View Source [SID1234535114]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.