4SC’s pivotal RESMAIN study of resminostat in CTCL receives second positive safety review

On January 28, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the Data Safety Monitoring Board (DSMB), an independent committee of clinical and drug safety experts, again recommends continuation of the ongoing pivotal RESMAIN study without modification of the study protocol (Press release, 4SC, JAN 28, 2019, View Source [SID1234532918]). Per the protocol’s pre-specified DSMB charter, the second DSMB meeting was scheduled recently to review cumulative safety data after 100 patients have been enrolled and completed at least one treatment cycle.

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RESMAIN is conducted as a multi-center, double blind, randomized, placebo-controlled study. It evaluates resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at more than 50 clinical centers in 11 European countries and Japan. The study is progressing on track, recruitment is expected to complete in 2019 and top-line results are expected in the first half of 2020.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "We are encouraged by the positive outcome of the second independent DSMB safety review and aim to bring resminostat to patients as quickly as possible to achieve an improvement in their quality of life.

Advanced-stage CTCL patients usually respond to available treatment options but the duration of response is often short-lived and declines as the severity of the disease increases. The aim of a maintenance therapy and thus of our RESMAIN study is to make such remissions more durable, halting disease progression."

MorphoSys Announces That Its Patents Were Ruled Invalid in Patent Lawsuit Against Janssen and Genmab

On January 26, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware, based on a hearing held November 27, 2018, has ruled in a Court Order on January 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746, 9,200,061 and 9,758,590 are invalid (Press release, MorphoSys, JAN 26, 2019, View Source [SID1234532974]). The Court thus granted a motion for Summary Judgement of invalidity filed by Janssen Biotech and Genmab, A/S against the three patents held by MorphoSys. As a result of this decision, the jury trial scheduled for February 2019 to consider defendants’ alleged infringement and the validity of the MorphoSys patents will now not take place.

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MorphoSys’s management is disappointed with the decision and is considering all of its options. The company has the right to appeal this judgement to the Federal Circuit.

On April 4, 2016 MorphoSys had filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. In 2017, a second and a third patent with US Patent Numbers 9,200,061 and 9,758,590 were added to the lawsuit. MorphoSys sought redress for infringement by Janssen’s and Genmab’s daratumumab, a CD38-directed monoclonal antibody for the treatment of multiple myeloma.

This court decision has no bearing upon the composition of matter patent protection for MorphoSys’s own CD38 antibody MOR202 and thus MorphoSys’s ability to develop MOR202 in various indications.

Genmab Announces that the patents asserted against DARZALEX® in the United States have been declared invalid by summary judgment.

On January 26, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. District Court of Delaware has declared the three U.S. patents (Nos. 8,263,746, 9,200,061, and 9,758,590), asserted by MorphoSys AG against Genmab and Genmab’s collaboration partner Janssen Biotech, Inc. (Janssen) are invalid by summary judgment (Press release, Genmab, JAN 26, 2019, View Source [SID1234532904]). The patent infringement lawsuit was initiated by MorphoSys against Genmab and Janssen in April 2016 asserting that activities with DARZALEX (daratumumab) in the United States infringe its U.S. patents, and the case has been pending before the U.S. District Court of Delaware. The summary judgment order declared all three patents invalid due to lack of enablement. As a result of this decision, the jury trial scheduled for February 2019 will not take place. MorphoSys has the opportunity to appeal the district court decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). In addition, during the case a further claim by Janssen and Genmab was included in the case that the three MorphoSys patents were unenforceable due to inequitable conduct by MorphoSys. That issue remains to be decided

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Allergan Announces Increased Quarterly Dividend and Annual General Meeting of Shareholders Date

On January 25, 2019 Allergan plc (NYSE: AGN) reported that its Board of Directors has approved an increase in the Company’s quarterly cash dividend for 2019 to $0.74 per ordinary share (Press release, Allergan, JAN 25, 2019, View Source [SID1234532901]). The Board declared a cash dividend for the first quarter of 2019 to be paid on March 15, 2019 to shareholders of record at the close of business on February 15, 2019.

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"Allergan’s increased dividend for 2019 demonstrates our confidence in our long-term business strategy and our commitment to executing on our capital allocation priorities. We remain committed to increasing our dividend annually," said Brent Saunders, Chairman and CEO of Allergan.

Allergan also announced that its 2019 Annual General Meeting of Shareholders will be held on May 1, 2019 in Dublin, Ireland. The Company’s Board of Directors has set the close of business on March 5, 2019 as the record date for determining shareholders eligible to vote at the meeting.

Actinium Pharmaceuticals, Inc. to Present at Noble Capital Markets’ 15th Annual Investor Conference

On January 25, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it will present at NobleConXV – Noble Capital Markets’ Fifteenth Annual Investor Conference at the W Hotel, Fort Lauderdale, Florida on Tuesday, January 29th at 12:30 pm EST (Press release, Actinium Pharmaceuticals, JAN 25, 2019, View Source [SID1234532902]). Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning via its ARC or Antibody Radiation Conjugate Approach. Details of Actinium’s presentation are as follows:

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Date: Tuesday, January 29th
Time: 12:30 PM ET
Room: Studio 4
Venue: W Hotel, Fort Lauderdale, Florida

Members of Actinium’s Executive team will be available for 1-on-1 meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so through the conference’s system View Source or by contacting Steve O’Loughlin, Actinium’s Principal Financial Officer via email to [email protected].