On December 19, 2019 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok vs. standard-of-care antibiotic locks (Press release, Citius Pharmaceuticals, DEC 19, 2019, View Source [SID1234552538]). The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the prespecified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020. The market potential for an effective antibiotic lock therapy is estimated at $750 million per year in the U.S. and approximately $1.5 billion per year worldwide.

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"We are extremely happy and proud that the first independent expert review of the patient data in our Mino-Lok trial concludes that our study is on track. Enrollment has continued since finalizing the 40% level futility report, and we have now reached the midpoint of our study. The DMC will evaluate clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus standard-of-care antibiotic locks," said Myron Holubiak, the Chief Executive Officer of Citius. "We would also like to thank all of the patients, study investigators, and support personnel at the 32 clinical sites that are participating in our trial. Lastly, we also want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer Center in advancing this novel therapy."

On December 19, 2019 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the 38th Annual JP Morgan Health Care Conference on Monday, January 13, at the Westin St. Francis in San Francisco (Press release, Johnson & Johnson, DEC 19, 2019, View Source;johnson-to-participate-in-38th-annual-jp-morgan-health-care-conference-300977772.html [SID1234552537]). Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices and Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals will represent the Company in a session scheduled at 2:30 p.m. (Pacific Time)/5:30 p.m. (Eastern Time). A subsequent Question & Answer session is scheduled for 3:00 p.m. (Pacific Time)/6:00 p.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

On December 19, 2019 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it has closed the underwritten public offering of 32,343,750 shares of its common stock, including 4,218,750 shares sold as a result of the exercise by the underwriters of their option to purchase additional shares, at $1.60 per share for total gross proceeds, before underwriting commissions and estimated expenses, of approximately $51,750,000 (Press release, MEI Pharma, DEC 19, 2019, View Source [SID1234552536]).

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, as well as for working capital and other general corporate purposes.

Stifel and Wells Fargo Securities acted as joint book-running managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. Copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York NY 10152, by telephone at 800-326-5897 or by email at [email protected]. An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering is also available on the website of the SEC at www.sec.gov.

This release does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On December 19, 2019 Haemonetics Corporation (NYSE: HAE) reported that the Company intends to publish third quarter fiscal year 2020 financial results at 6:00 am EDT on Tuesday, February 4, 2020 (Press release, Haemonetics, DEC 19, 2019, View Source [SID1234552535]). The Company will hold a conference call with investors and analysts to discuss results and answer questions at 8:00 am EDT on February 4, 2020.

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The call can be accessed with the following information:

U.S. / Canada toll free (877) 848-8880; International (716) 335-9512
Conference ID required for access: 1906607

A live webcast of the call can be accessed on Haemonetics’ investor relations website. Webcast Link: View Source

Webcast replay will be available from February 4, 2020 after 11:00 am EDT.

On December 19, 2019 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan (rituximab) (Press release, Amgen, DEC 19, 2019, View Source [SID1234552534]). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA.

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"The U.S. filing for ABP 798 marks an important milestone for Amgen, as it affirms our commitment to providing high quality biosimilars that offer more life-altering biological treatment options and contribute to the sustainability of healthcare systems," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with the FDA to bring ABP 798 to market."

ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is a CD20-directed cytolytic antibody that has been approved in many regions for, among other things, the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids.

"We are excited about the progress that we’ve made to date through our partnership with Amgen, which includes the launch of the first two oncology therapeutic biosimilars in the U.S.," said David Nicholson, Ph.D., chief research and development officer at Allergan. "With ABP 798, we look forward to the opportunity to continue to provide additional treatment options to patients suffering from serious illnesses."

The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data generated in two clinical studies. The results of these studies confirmed no clinically meaningful differences between ABP 798 and Rituxan.

Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S. and three that are approved in the European Union (EU).

About ABP 798
ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is an anti-CD20 monoclonal antibody that has been approved in many regions for the treatment of, among other things, adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.

About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

About Amgen Biosimilars
Amgen is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.