On December 3, 2020 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that shared an update from its partner, Elevar Therapeutics, on the development plan for Apealea (paclitaxel micellar), a non-Cremophor based formulation of paclitaxel, in ovarian cancer (Press release, Oasmia, DEC 3, 2020, View Source [SID1234572131]). Since acquiring rights to Apealea at the end of March 2020, Elevar has had interactions with the FDA and received guidance for further advancing the development program for Apealea. Following these interactions, Elevar has decided to complete two new studies with Apealea, which will both be initiated in the first half of 2021 before filing a new drug application (NDA) with the U.S. Food and Drug Administration (FDA).

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The first study planned by Elevar is a pharmacokinetics study, which Elevar aims to initiate in the first half of 2021. The study is expected to take approximately 12 months to complete.
Elevar is also planning to initiate a pivotal superiority study to investigate the safety and efficacy of Apealea in epithelial ovarian cancer. Elevar is working closely with The GOG Foundation (GOG-F) through its GOG Partners program in the U.S. to plan and execute this global study in the first half of 2021. This study is expected to take approximately 24-36 months to complete.
"Despite the global pandemic, Elevar has made great strides advancing the ovarian cancer development program for Apealea. We have designed a clinical program for Apealea with advice from the FDA as well as advisory boards consisting of global thought leaders," said Alex Kim, Chief Executive Officer of Elevar Therapeutics. "Paclitaxel is a well-known chemotherapy agent that has been proven effective to treat ovarian cancer, yet in the U.S. the approved formulations use Cremophor-EL, which may induce serious side effects, require longer infusion times, and may not be suitable for patients who have certain co-morbidities or cannot tolerate steroids pre-treatment. Elevar is dedicated to making Apealea available to patients with epithelial ovarian cancer worldwide, and we expect that it will be the first non-cremophor formulation approved in this indication by the U.S. FDA."

"The clinical benefit of paclitaxel has been well-established in oncology," said David M. O’Malley, M.D., Professor and Director, Division of Gynecologic Oncology, Co-Director, Gyn Oncology Phase I Program, The Ohio State University and the James Cancer Center. "Having a non-Cremophor formulation of paclitaxel micellar has the potential to contribute to improved clinical outcomes and treatment experiences for epithelial ovarian cancer patients."

In addition, Elevar is exploring the potential utility of Apealea in other indications beyond ovarian cancer.

Apealea received market authorization from the European Commission in 2018, which was the first approval in Europe for a non-Cremophor EL paclitaxel in epithelial ovarian cancer. Apealea has received Orphan Drug Designation from the FDA for the treatment of epithelial ovarian cancer, which could lead to potential benefits including seven years of market exclusivity.

"These two new studies of Apealea may potentially help to secure a successful registration in the U.S. and provide new data to support a strong product label – critical for commercial success. Through our partnership with Elevar, Oasmia will, as previously stated, receive double digit royalties on all sales and milestones associated with any indication successfully approved," commented François Martelet, M.D., Chief Executive Officer of Oasmia.

Since March, Elevar has also made significant progress to enable patients to access Apealea outside of the U.S.:

Elevar and Tanner Pharma launched a global named patient program to provide access to Apealea in areas outside of the U.S. where Apealea is not commercially available.
Elevar signed an agreement with Taiba Middle East FZ LLC for the commercialization of Apealea in the Middle East and North Africa Region.
Elevar is in active discussion with a number of other potential commercial partners for Apealea in regions around the world, including Europe.

Conference Call Details
Elevar and Oasmia will host an audiocast and telephone conference on December 3, 2020, at 16:00 CET, with the following participants:

Francois Martelet, CEO of Oasmia Pharmaceutical AB
Alex Kim, CEO of Elevar Therapeutics Inc.
Mark Gelder, MD, Head of Medical Affairs at Elevar Therapeutics Inc.
Weblink: View Source

About Apealea (paclitaxel micellar)
Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Cremophor EL, is a formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received market authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer.

About Ovarian Cancer
Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs. It is the fifth most common cancer among women in the U.S., with a prevalence rate of nearly 230,000 women, and accounts for more deaths than any other cancer of the female reproductive system., About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis.iii,

On December 3, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of data presentations at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held virtually December 5 – 8, 2020 (Press release, TG Therapeutics, DEC 3, 2020, View Source [SID1234572130]).

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ASH 2020 PRESENTATION DETAILS:

Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study
Publication Number: 543
Oral Session: 642. CLL: Therapy, excluding Transplantation
Session Date and Time: Monday, December 7, 2020; 7:00 AM – 8:30 AM (Pacific Time)
Presentation Time: 7:15 AM (Pacific Time)
Presenter: John G. Gribben, MD, D.Sc., Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom;
Poster Presentation Title: Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global UNITY-NHL Trial
Publication Number: 2934
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
Presenter: Pier Luigi Zinzani, MD, PhD, Institute of Hematology, "L. e A. Seràgnoli", University of Bologna, Italy

Poster Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Publication Number: 3137
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, NY

Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies
Publication Number: 1130
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
Date and Time: Saturday, December 5, 2020; 7:00 AM – 3:30 PM (Pacific Time)
Presenter: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia
Following each presentation during ASH (Free ASH Whitepaper) 2020, the data presented will be available on TG’s corporate website at View Source TG abstracts are publicly available via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org or on the company’s corporate website.

On December 3, 2020, Bausch Health Companies Inc. (the "Company") reported that it completed its previously announced offering of $1,000,000,000 aggregate principal amount of its 5.000% Senior Notes due 2029 (the "2029 Notes") and $1,000,000,000 aggregate principal amount of its 5.250% Senior Notes due 2031 (the "2031 Notes" and, together with the 2029 Notes, the "Notes") (Filing, 8-K, Bausch Health, DEC 3, 2020, View Source [SID1234572129]).

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The Notes were offered in the United States and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be registered under the Securities Act or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements.

The proceeds of the Notes offering, along with cash on hand, will be used to fund the Company’s previously announced redemptions in full of its outstanding (i) 4.50% Senior Notes due 2023 and (ii) 5.50% Senior Notes due 2023, and to pay related fees and expenses.

The Notes Indenture

The Notes were issued pursuant to the indenture, dated as of December 3, 2020 (the "Indenture"), among the Company, the guarantors named therein and The Bank of New York Mellon, as trustee.

Interest and Maturity

Pursuant to the Indenture, the 2029 Notes will mature on February 15, 2029 and the 2031 Notes will mature on February 15, 2031. Interest on each series of the Notes will be payable semi-annually in arrears on each February 15 and August 15, beginning on August 15, 2021.

Guarantees

The Notes will initially be jointly and severally guaranteed on a senior unsecured basis by each of the Company’s subsidiaries that is a guarantor under the Company’s existing credit agreement (the "Credit Agreement"), the Company’s existing senior secured notes (the "Existing Senior Secured Notes") and the Company’s existing senior unsecured notes (together, the "Note Guarantors").

Ranking

The Notes and the guarantees related thereto will be:

senior unsecured obligations of the Company and the Note Guarantors, as applicable;

pari passu in right of payment with all existing and future unsubordinated indebtedness of the Company or the applicable Note Guarantor;

senior in right of payment to all existing and future indebtedness of the Company or the applicable Note Guarantor that expressly provides for its subordination to the Notes or the applicable guarantee;

structurally subordinated to all existing and future indebtedness and other liabilities of the Company’s subsidiaries that do not guarantee the Notes to the extent of the value of such subsidiaries’ assets; and

effectively subordinated to all existing and future secured indebtedness of the Company or the applicable Note Guarantor, including the Credit Agreement and the Existing Senior Secured Notes, to the extent of the value of the assets securing such indebtedness.

Redemption

The 2029 Notes will be redeemable at the option of the Company, in whole or in part, at any time on or after February 15, 2024, at the redemption prices as set forth in the Indenture. The 2031 Notes will be redeemable at the option of the Company, in whole or in part, at any time on or after February 15, 2026, at the redemption prices as set forth in the Indenture.

In addition, the Company may redeem some or all of the 2029 Notes prior to February 15, 2024 at a price equal to 100% of the principal amount thereof plus a "make-whole" premium. Prior to February 15, 2024, the Company may redeem up to 40% of the aggregate principal amount of the 2029 Notes using the net cash proceeds of certain equity offerings at the redemption price set forth in the Indenture.

In addition, the Company may redeem some or all of the 2031 Notes prior to February 15, 2026 at a price equal to 100% of the principal amount thereof plus a "make-whole" premium. Prior to February 15, 2024, the Company may redeem up to 40% of the aggregate principal amount of the 2031 Notes using the net cash proceeds of certain equity offerings at the redemption price set forth in the Indenture.

Upon the occurrence of a change of control (as defined in the Indenture), unless the Company has exercised its right to redeem all of the Notes of a series, as described above, holders of the Notes of such series may require the Company to repurchase such holder’s Notes, in whole or in part, at a purchase price equal to 101% of the principal amount of such Notes plus accrued and unpaid interest to, but excluding, the purchase date applicable to such Notes.

Certain Covenants

The Indenture contains covenants that limit the ability of the Company and any of its restricted subsidiaries (as such term is defined in the Indenture), to, among other things:

incur or guarantee additional indebtedness;

make certain investments and other restricted payments;

create liens;

enter into transactions with affiliates;

engage in mergers, consolidations or amalgamations; and

transfer and sell assets.

Events of Default

The Indenture also provides for customary events of default.

The foregoing summary of the Indenture is not complete and is qualified in its entirety by reference to the full and complete text of the Indenture, a copy of which is attached as Exhibit 4.1 to this Current Report on Form 8-K and incorporated herein by reference.

On December 3, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a webcast scheduled for investors to discuss the results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients.

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The data will be presented by Dr. Line Stensig Lynggaard at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. On the webcast, Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, and Principal Investigator of the trial, will comment on the data and be available for Q&A.

Oral Presentation Details (accessible only if registered for the ASH (Free ASH Whitepaper) annual meeting)

Abstract #467: NOR-GRASPALL 2016 (NCT03267030): Asparaginase encapsulated in Erythrocytes (eryaspase) – a promising alternative to PEG-asparaginase in case of hypersensitivity

The NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase. The trial was conducted at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. The study findings will be featured as an oral presentation at ASH (Free ASH Whitepaper) by Dr. Line Stensig Lynggaard, representing NOPHO, on 6th December 2020 2.45pm PST/ 5.45pm EST / 11.45pm CET. Final results from this trial will be presented at the meeting.

The abstract can be found on-line at: View Source

Webcast Details

ERYTECH will hold a webcast on Monday, December 7, at 4:00 pm CET / 10:00am ET.

Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, and Principal Investigator of the trial, Dr. Iman El-Hariry, Chief Medical Officier of ERYTECH Pharma, and Gil Beyen, Chief Executive Officer of ERYTECH Pharma, will comment on the data and be available for Q&A.

The webcast can be followed live online via the link: View Source

Conference ID#: 2272914#

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options. (Press release, ERYtech Pharma, DEC 3, 2020, View Source [SID1234572128])

On December 3, 2020 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that it will host a Virtual Lung Cancer R&D Day for investors and analysts on December 16, 2020, from 10:00 a.m. to 12:00 p.m. EST (Press release, Veracyte, DEC 3, 2020, View Source [SID1234572126]).

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The event will feature Veracyte senior management who will provide an overview of the company’s vision for transforming patient care in lung cancer, as well as leading pulmonologists who will discuss the challenges and opportunities in lung cancer diagnosis and treatment. Veracyte will also provide updates on its lung cancer product pipeline, including its Nasal Swab Test, for early diagnosis of lung cancer, and Percepta Atlas, for informing treatment decisions at the time of diagnosis. The company plans to launch both products in the second half of 2021.

A link to register for the event is available here and can also be accessed through Veracyte’s website at View Source A replay of the presentation will be available on the company’s website for approximately 90 days.