BioCryst Announces Acceptance and Accelerated Review of the ORLADEYO™ (berotralstat) Marketing Application by the Israeli Ministry of Health

On June 16, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the Israeli Ministry of Health has accepted the regulatory submission of ORLADEYO for the prevention of recurrent attacks in patients with hereditary angioedema (HAE) 12 years and older(Press release, BioCryst Pharmaceuticals, JUN 16, 2021, View Source [SID1234584041]). The Israeli Ministry of Health also has granted an accelerated review. In addition, BioCryst has entered into a distribution and supply agreement granting Neopharm Ltd., a corporation organized under the laws of the State of Israel, the exclusive rights to commercialize ORLADEYO in Israel.

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"Neopharm is the right partner to help us commercialize in Israel as we continue to bring oral, once-daily ORLADEYO to HAE patients around the world. They have extensive rare disease experience and proven commercial success in Israel, and they understand the local regulatory environment," said Charlie Gayer, chief commercial officer of BioCryst.

"We are proud of our partnership with BioCryst and excited to deliver a new and innovative treatment option to HAE patients in Israel. The momentum gained from recent approvals of ORLADEYO across the globe will support our commercialization efforts to provide access to this important treatment," said Efi Shnaidman, general manager of Neopharm Israel.

Founded in 1941, Neopharm Israel is one of the leading pharmaceutical companies in Israel, providing the Israeli market with a wide range of products and integrated services for patients in need, with a proven track record of successful market access and launches. In addition to exclusive rights to commercialize ORLADEYO in Israel, Neopharm Israel has exclusive rights to commercialize in the Palestinian Authority.

Astellas Transfers Five Legacy Products in Europe, Russia, CIS and Asia to Cheplapharm

On June 16, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that Astellas and Cheplapharm Arzneimittel GmbH ("Cheplapharm") have enterd into an Asset Purchase Agreement, under which Astellas will transfer the Products Rights for five legacy products (the "Products") in certain countries of Europe, Russia, Commonwealth of Independent States (CIS)1 and Asia(Press release, Astellas, JUN 16, 2021, View Source [SID1234584040]).

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Once the transaction closes, Cheplapharm will take over the Products Rights from Astellas and sell them in certain countries of Europe, Russia, CIS and Asia. Astellas will work closely with Cheplapharm to enable a smooth transition.

(1) Purpose of Asset Purchase Agreement
The agreement is a part of Astellas’ ongoing efforts to improve the quality and efficiency of operations so as to accommodate the rapidly changing business environment and achieve sustainable growth. Astellas will continue to strengthen our business presence in Europe, Russia, CIS, and Asia through optimization of resource allocation.

(2) Financial Terms of Asset Purchase Agreement
€95 million

(3) Schedule of Asset Purchase Agreement
June 15, 2021: Signing of the Asset Purchase Agreement
September 2021 or later: Closing of the transaction(tentative)

After closing of the transaction, the Products Rights for the Products will be transferred in each country.

(4) List of the Products

Products Name Indication
FLEMOXIN Acute respiratory infections, Helicobacter pylori associated diseases, such as gastritis and gastric ulcer, urogenital infections and others
DE-NOL Gastro protector with antibacterial effect on H. pylori
SUPRAX Chronic and recurrent respiratory infections with the highest activity towards H. influenzae. Infections caused by susceptible bacteria, such as urinary tract infections and others, e.g. skin, secondary infection in trauma, burn or surgical wound, cholangitis
UNIDOX Infections, such as mild community acquired pneumonia, acute exacerbations of chronic bronchitis, lymphogranuloma venereum, acne vulgaris, chlamydia trachomatis infections, prostatitis, cervicitis and pelvic inflammatory diseases
ORBENINE Infections caused by gram-positive organisms (except MRSA and MRSE), including infections caused by beta-lactamase producing staphylococci

(5) Sales of the Products
€81.5 million(fiscal year ended March 31, 2021)

Astellas has already reflected the impact from this transaction in its financial forecast of the current fiscal year ending March 31, 2022.

Acorda Therapeutics Announces Repayment of Convertible Senior Notes

On June 15, 2021 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that on June 15, 2021, it repaid in full its 1.75% Convertible Senior Notes due 2021(Press release, Acorda Therapeutics, JUN 16, 2021, View Source [SID1234584039]). Prior to their maturity and repayment, there were $69.0 million aggregate principal amount of 2021 notes outstanding. The 2021 notes were repaid using cash on hand.

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"The repayment of the 2021 notes removes an overhang on the company and is another important milestone in our strategy, following the sale of our manufacturing operations earlier this year. We are focused on accelerating the growth of INBRIJA, continuing to maintain the strength of AMPYRA, and optimizing the company’s financial structure," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We have maintained cost discipline since our restructuring announcement in February and are continuing to drive toward cash flow breakeven.

Innate Pharma to Host Virtual Investor Event to Highlight Progress Against Company Strategy

On June 16, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will host a virtual investor event on Wednesday, June 23, 2021, at 2 p.m. CEST / 8 a.m. EDT(Press release, Innate Pharma, JUN 16, 2021, View Source [SID1234584032]).

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The event will feature presentations and an interactive Q&A session from the Company’s executive leadership team as well as Martine Bagot, M.D., Ph.D., Professor and Head of the Dermatology Department at the Saint-Louis Hospital, University of Paris, France.

Pr. Bagot will present preliminary mycosis fungoides data from the Company’s Phase 2 TELLOMAK trial evaluating its lead product, lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody in development for T-cell lymphomas. This preliminary data will be presented as an oral presentation at the 16th International Conference on Malignant Lymphoma (16-ICML) on June 22.

Additionally, the Company’s Chief Scientific Officer, Pr. Eric Vivier, DVM, Ph.D., will present preclinical data from ANKETTM (Antibody-based NK cell Engager Therapeutics), Innate’s proprietary platform for developing next-generation, multi-functional NK cell engagers. These new data were presented at the Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting on June 10.

VBL Therapeutics Provides Update on OVAL, a Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer

On June 15, 2021 VBL Therapeutics (Nasdaq: VBLT) reported an update on its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer(Press release, VBL Therapeutics, JUN 15, 2021, View Source [SID1234584038]).

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The Company was notified by the U.S Food and Drug Administration (FDA) that clearance of new VB-111 batches for use in the U.S. is currently pending the completion of a technical review by the Chemistry, Manufacturing, and Controls (CMC) group, which is evaluating the comparability of VB-111 manufacturing between different source sites. Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S. Accordingly, recruitment of new patients in the U.S. will be temporarily paused. Treatment will continue as usual for all U.S. patients currently enrolled. To-date, the study has enrolled approximately 75% of the planned 400-patients.

"Our team is working to provide the requested information to the FDA as quickly as possible," said Dror Harats, M.D., CEO of VBL Therapeutics. "Since receipt of the notification, we have submitted some of the requested information, and are preparing the remaining documentation, which we believe can be completed and submitted to the agency in the next two to three months. We do not expect a material change to our data readout timelines. We are in regular contact with the FDA and taking the steps necessary to minimize disruption to the trial in the U.S."

VBL recently amended the primary endpoint of OVAL based upon requested changes by the Company that were reviewed by the FDA. OVAL now includes a second, separate primary endpoint, of progression free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS). Successfully meeting either primary endpoint is expected to be sufficient to support BLA submission.

About the OVAL study (NCT03398655)

OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies

About VB-111 (ofranergene obadenovec)

VB-111 is an investigational anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that is designed to use a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).