On March 29, 2019 Celgene Corporation (NASDAQ:CELG) and Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook, LLC (collectively, Alvogen) reported the settlement of their litigation relating to patents for REVLIMID (lenalidomide) (Press release, Celgene, MAR 29, 2019, View Source [SID1234534755]).

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As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Alvogen from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Alvogen with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022 volume-limited license date that Celgene previously provided to Natco. For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Alvogen cannot exceed certain agreed-upon percentages. Although the agreed-upon percentages are confidential, they increase gradually each period to no more than a single-digit percentage in the final volume-limited period. In addition, Celgene has agreed to provide Alvogen with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026.

Alvogen’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

On March 29, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported the following statement regarding Celgene’s (NASDAQ:CELG) settlement with Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook, LLC (collectively, "Alvogen") relating to patents for Revlimid (Press release, Bristol-Myers Squibb, MAR 29, 2019, View Source [SID1234534780]):

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"We are pleased that Celgene has reached a settlement with Alvogen related to patents for Revlimid. This announcement is consistent with our assumptions during due diligence and provides further clarity and security around the patent estate for Revlimid. We are confident in the strength of our combination with Celgene and our ability to create a premier biopharma company with leading franchises and a deep and broad pipeline that will drive sustainable growth.

We look forward to continuing to work with Celgene to complete the transaction, and strongly urge all Bristol-Myers Squibb shareholders to vote ‘FOR’ the proposals relating to the proposed transaction with Celgene at the upcoming Special Meeting."

Additionally, the Company noted that in a March 29, 2019 report published prior to the disclosure of the settlement, Institutional Shareholder Services, an independent proxy advisory firm, concluded1:

"BMY’s perspective [about Revlimid] appears to be shared by a majority of the analyst community, and it has been strengthened since announcement of the deal by intervening events such as the PTAB’s recent IPR rulings in favor of Celgene."

Bristol-Myers Squibb and Celgene expect the transaction to close in the third quarter of 2019, subject to approval by Bristol-Myers Squibb and Celgene shareholders and the satisfaction of customary closing conditions and regulatory approvals. The Bristol-Myers Squibb Special Meeting of Stockholders to vote on matters relating to the proposed merger is scheduled to take place on April 12, 2019 at 10:00 a.m. Eastern Time. All shareholders of record of Bristol-Myers Squibb common stock as of the close of business on March 1, 2019 will be entitled to vote their shares either in person or by proxy at the stockholder meeting.

If Bristol-Myers Squibb shareholders have any questions or require assistance in voting their shares of Bristol-Myers Squibb stock, they should call MacKenzie Partners, Inc., Bristol-Myers Squibb’s proxy solicitor for its Special Meeting, toll-free at (800) 322-2885 or at (212) 929-5500.

On March 29, 2019, Immunomedics, Inc. (the "Company") reported that it entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") to issue and sell shares of the Company’s common stock, par value $0.01 per share (the "Common Stock"), having an aggregate offering price of up to $150,000,000 (the "Placement Shares"), from time to time during the term of the Sales Agreement, through an "at-the-market" equity offering program under which Cowen will act as the Company’s agent and/or principal (Filing, 8-K, Immunomedics, MAR 29, 2019, View Source [SID1234534781]).

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Under the Sales Agreement, the Company will set the parameters for the sale of the Placement Shares, including the number of Placement Shares to be issued, the time period during which sales are requested to be made, limitation on the number of Placement Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, Cowen may sell Placement Shares by any method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including, without limitation, sales made through The Nasdaq Global Market ("Nasdaq") or on any other existing trading market for the Common Stock. In conducting such sales activities, Cowen will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of Nasdaq. The Company is not obligated to make any sales of Common Stock under the Sales Agreement, and may at any time suspend solicitation and offers under the Sales Agreement. The Company or Cowen may suspend or terminate the offering of Placement Shares upon notice to the other party and subject to other conditions. Under the terms of the Sales Agreement, the Company may also sell Placement Shares to Cowen acting as principal for Cowen’s own account at prices agreed upon at the time of sale. The Sales Agreement provides that Cowen will be entitled to compensation for its services in an amount of up to 3.00% of the gross proceeds of any Placement Shares sold under the Sales Agreement.

The Placement Shares sold under the Sales Agreement will be issued pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333- 225550) and the base prospectus included therein. On the date hereof, the Company filed a prospectus supplement with the SEC in connection with the offer and sale of the Placement Shares pursuant to the Sales Agreement.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K. The legal opinion of DLA Piper LLP (US) relating to the shares of common stock being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 29, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, reported that interim data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial to be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting has an updated embargo date and time of Monday, April 1, 2019 at 8:30am ET (Press release, TG Therapeutics, MAR 29, 2019, View Source [SID1234534782]). At that time, the abstract will be available via the AACR (Free AACR Whitepaper) meeting website at www.aacr.org, and the data which will be presented during an oral session later that day (details below) will be available on the Company’s website at www.tgtherapeutics.com/publications.cfm.

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The Company will also host a conference call with Dr. Nathan Fowler of the MD Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort at 12:00pm (noon) ET on Monday April 1, 2019 to review the UNITY-NHL MZL interim data.

Details are provided below outlining the Company’s schedule of events for April 1, 2019.

CONFERENCE CALL INFORMATION
The Company will host a conference call on Monday April 1, 2019, 12:00pm (noon) ET. Michael S. Weiss, Chief Executive Officer of TG Therapeutics, will host the call, and Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, will review the UNITY-NHL interim MZL data.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics AACR (Free AACR Whitepaper) Update Call.

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

2019 AACR (Free AACR Whitepaper) ORAL PRESENTATION DETAILS

Title: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study
– Session Date and Time: Monday April 1, 20193:00 PM – 5:00 PM ET
– Presentation Time:4:20 PM ET
– Session Title: The Next Generation of Clinical Trials in Molecularly-driven Therapy
– Session Location: Marcus Auditorium- Bldg A-GWCC
– Presenter: Nathan Fowler, MD, Associate Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
– Abstract Number: 7821
ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort
The multicenter, open-label, UNITY-NHL Phase 2b study – Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.

The MZL cohort completed enrollment in August 2018 with a total of 69 patients enrolled and receiving at least one dose of umbralisib. In February of 2019, the Company announced that the MZL cohort met its primary endpoint of ORR as determined by central IRC for all treated patients (n=69). While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted later this year once all treated patients have had at least 9 cycles (Cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

ABOUT BREAKTHROUGH THERAPY DESIGNATION

The Company announced in January of 2019 that the U. S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20 regimen.

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies

On March 28, 2019 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Dr. Cornelis Melief will give an oral presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, on March 31, 2019 (Press release, ISA Pharmaceuticals, MAR 28, 2019, View Source [SID1234534689]).

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The presentation titled "A strong HPV-specific T-cell response after chemo-immunotherapy for advanced cervical cancer is associated with prolonged survival"is scheduled for Sunday, March 31, 2019, as part of the session "Predictive Biomarkers for Immunotherapy" (12:45-2:45pm, Marcus Auditorium- Bldg A-GWCC).

The data will outline the effects of vaccination with ISA Pharmaceuticals´ therapeutic vaccine ISA101 during chemotherapy in 77 patients with advanced, recurrent or metastatic cervical cancer in a dose assessment study.

ISA101 is directed against the HPV16 oncoproteins E6/E7 and is the Company´s clinical-stage lead compound. It is being developed to treat HPV16-induced cancers such as cervical cancer and head-and-neck cancer. Clinical efficacy of ISA101 in combination with Regeneron’s PD-1 inhibitor cemiplimab is currently being tested in a randomized controlled Phase 2 trial in platinum refractory, HPV16-positive oropharyngeal cancer patients (NCT03669718). The results to be presented at AACR (Free AACR Whitepaper) form the basis for a planned Phase 3 trial, in which the clinical benefit of the combination of ISA101 plus cemiplimab on top of standard-of-care chemotherapy will be studied in patients with advanced HPV16-positive cervical cancer.