Court Issues Ruling in ZYTIGA® Patent Infringement Litigation

On October 26, 2018 Johnson & Johnson (NYSE: JNJ) reported that the United States District Court, District of New Jersey has issued a ruling invalidating all asserted claims of U.S. Patent No. 8,822,438 for ZYTIGA (abiraterone acetate) (Press release, Johnson & Johnson, OCT 26, 2018, View Source [SID1234530301]). The Court held that the patent claims would be infringed if the patent were valid. The patent infringement case was filed against several companies who have submitted Abbreviated New Drug Applications for 250 mg and/or 500 mg tablets.

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Janssen strongly disagrees with the court’s ruling and will continue to defend the patent. We plan to appeal the decision. The Court has ordered that the status quo be maintained through October 30, 2018, and no generic launch shall occur before October 31, 2018 so that Janssen’s preliminary injunction motion to enjoin defendants from launching their generic products pending the appeal process can be decided. Janssen has filed a motion for rehearing with the U.S. Patent & Trademark Office (USPTO) in connection with the prior Inter Partes Review decisions related to the ‘438 patent.

Commercial launch of generic abiraterone acetate prior to the outcome of the appeals would be considered an at-risk launch. In Europe, ZYTIGA is protected by regulatory exclusivity through September 2022.

Janssen will continue to defend intellectual property rights relating to its innovative medicines. The company reaffirms its guidance provided on October 16, 2018 for operational sales growth of 5.5% to 6.0% and its adjusted earnings per share guidance of $8.13 – $8.18 for the full-year 2018.

IntelGenx Announces Exercise of Over-Allotment Option

On October 26, 2018 IntelGenx Technologies Corp. (TSXV:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported that in connection with its previously announced public offering (the "Offering") of units of the Company (the "Units") for aggregate gross proceeds of approximately US$12 million, Echelon Wealth Partners Inc. ("Echelon"), who acted as the Company’s exclusive placement agent in Canada in connection with the Offering, has exercised its option to place a further 903,610 Units pursuant to its over-allotment option (the "Over-Allotment Option"), resulting in additional gross proceeds to the Company of US$632,527 (Press release, IntelGenx, OCT 26, 2018, View Source [SID1234530268]).

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Each Unit was issued at a price of US$0.70 and was comprised of one share of common stock (the "Offered Shares") and one half of one warrant (a "Warrant"), each whole Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of US$1.00 per share. The Warrants are exercisable immediately and will expire on October 22, 2021.

The Units were distributed under a final prospectus supplement to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement to the Canadian MJDS short-form base shelf dated October 18, 2018 filed by the Company in connection with the Offering.

Including the net proceeds from the exercise of the Over-Allotment Option, the Company expects the aggregate net proceeds of the Offering to be approximately US$11 million. The Company intends to use the net proceeds from the Offering for its 2a Montelukast Study, its Tadalafil 505(b)(2) submission to the U.S. Food and Drug Administration, and working capital

Actinium Pharmaceuticals to Hold Webinar Showcasing Actimab-A Post Phase 2 Trial Plans and Actimab-MDS Regulatory Update

On October 26, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it will host a conference call and webinar today at 11:00 AM ET to provide key updates on the advancement of its CD33 program that is based on the Antibody RadiationConjugate (ARC), Ac-225 – Lintuzumab (Press release, Actinium Pharmaceuticals, OCT 26, 2018, View Source [SID1234530265]). Actinium is developing its CD33 program for hematologic indications including Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM). Today’s call will highlight Actinium’s post-Phase 2 development plans following completion of its Actimab-A trial in patients newly diagnosed with AML who are over the age of 60 and unfit for intensive chemotherapy. In addition, management will provide an update on the regulatory pathway for Actimab-MDS following positive interactions with the U.S. Food and Drug Administration (FDA).

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Conference call and webcast Participation Information

Date: Friday, October 26, 2018
Time: 11:00 AM ET
Webcast Registration: View Source
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831

Fresenius Kabi launches IV Drug in the U.S.

Arsenic Trioxide Injection is the newest addition to the company’s oncology portfolio (Press release, Fresenius, OCT 26, 2018, View Source [SID1234530133]).

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Targovax ASA: Announcement of Third Quarter 2018 Financial Results

On Oct 26, 2018 Targovax ASA (OSE: TRVX, Targovax), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it will announce its third quarter 2018 results on Thursday, 1 November 2018 at 07:00 CET (Press release, Targovax, OCT 26, 2018, View Source [SID1234530221]).

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The results report, and the presentation will be available at www.targovax.com in the investors section from 07:00 CET.

Øystein Soug, Chief Executive Officer of Targovax, will host an online presentation for investors, analysts and the press at 08:45 CET. The presentation can be followed here, or at: View Source

For an elaborate presentation of the Targovax strategy, please visit targovax.com for a replay of the 15 October 2018 Capital Markets Day.

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47-922-61-624
Email: [email protected]

Media and IR enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47-9300-1773
Email: [email protected]

Simon Conway/Stephanie Cuthbert – FTI Consulting (International)
Phone: +44-20-3727-1000
Email: [email protected]

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