On December 5, 2019 Novartis AG (NYSE: NVS) ("Novartis") reported that its indirect wholly-owned subsidiary, Medusa Merger Corporation, a Delaware corporation ("Purchaser"), has commenced a cash tender offer to purchase all of the outstanding shares of common stock, par value USD 0.001 per share, of The Medicines Company (NASDAQ: MDCO) for a price of USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding (the "Offer") (Press release, Novartis, DEC 5, 2019, View Source [SID1234551952]). The Offer is being made upon the terms and subject to the conditions set forth in the Offer to Purchase, dated December 5, 2019, and the related Letter of Transmittal and pursuant to the terms of the previously announced Agreement and Plan of Merger, dated as of November 23, 2019 (the "Merger Agreement"), among Novartis, Purchaser and The Medicines Company.

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The Offer will expire at 12:00 midnight, New York City time, at the end of the day on January 3, 2020, unless extended (the latest time and date at which the Offer will expire, the "Expiration Date"). Any extension of the Offer will be followed by public announcement of the extension by press release or other public announcement before 9:00 a.m., New York City time, on the next business day after the Expiration Date.

Novartis will file today a Tender Offer Statement on Schedule TO with the United States Securities and Exchange Commission (the "SEC"). The Offer to Purchase contained within the Schedule TO sets out the full terms and conditions of the Offer.

The Medicines Company will file today a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC, which includes, among other things, the recommendation of The Medicines Company board of directors that The Medicines Company’s stockholders accept the Offer and tender their shares of The Medicines Company common stock pursuant to the Offer.

The Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of The Medicines Company common stock and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The Offer is subject to other important conditions set forth in the Offer to Purchase. The Offer is not subject to a financing condition.

Innisfree M&A Incorporated is acting as information agent for Purchaser in the Offer. American Stock Transfer & Trust Company, LLC is acting as the depositary and paying agent in the Offer. Requests for documents and questions by stockholders relating to the Offer may be directed to Innisfree M&A Incorporated by telephone at 1 (888) 750-5834 (toll free).

On December 5, 2019 Genmab A/S (Nasdaq: GMAB) reported that it has achieved a USD 100 million sales volume milestone in its DARZALEX (daratumumab) collaboration with Janssen Biotech, Inc (Press release, Genmab, DEC 5, 2019, View Source [SID1234551951]). The milestone was triggered by confirmation from Janssen that sales of DARZALEX reached USD 2.5 billion in a calendar year. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

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"We remain very pleased with the robust uptake seen with DARZALEX since its initial launch and with new approvals this year and potential approvals in 2020, we hope that it becomes even more widely available for the many multiple myeloma patients in need," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The milestone was included in the original financial guidance issued by Genmab on February 20, 2019, and in the improved financial guidance issued on November 6, 2019, as such there is no change to the company’s financial guidance for 2019.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On December 4, 2019 BioHybrid Solutions, LLC (BHS), a Pittsburgh-based protein engineering company, reported that it was awarded a contract worth up to $30 million from the United States Department of Defense to develop a next-generation prophylactic medical countermeasure (Press release, Myris Therapeutics, DEC 4, 2019, View Source [SID1234650500]). The project was sponsored by the U.S. Government through the Medical CBRN Defense Consortium (MCDC).

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The U.S. Defense Threat Reduction Agency (DTRA) selected BHS through a request for prototype proposal under the MCDC to apply its proprietary NanoArmored protein engineering technology to improve pharmacokinetics of the prophylactic while reducing the potential for immunogenic side effects. Over the five-year program, BHS will develop NanoArmored drug candidates, conduct studies to demonstrate functionality, scale manufacturing, and complete regulatory activities towards approval of the countermeasure by the U.S. Food and Drug Administration (FDA). BHS is leading the program in collaboration with FLIR Systems, Battelle, Ology Bioservices, the Allegheny Health Network, BTG PLC (now part of Boston Scientific) and the US Army.

"We have developed a unique way to protect against the toxic effects of chemical warfare agents and are honored to have been selected by DTRA to lead this very important program," said Alan Russell, Co-Founder and CEO of BioHybrid Solutions.

In order to expedite development, BHS will utilize its specialized high-throughput discovery technology to rapidly select the NanoArmor needed and then manufacture that drug candidate. "Our technology allows us to rationally tune protein performance through precision modification of proteins with a wide variety of synthetic polymers," noted Krzysztof Matyjaszewski, BHS Co-Founder and CSO. "To date, we have created thousands of different NanoArmored proteins for a variety of industrial and therapeutic indications. We are well positioned to apply our technology to this important national security and public health application."

On December 4, 2019 Omeros Corporation (Nasdaq: OMER) ("Omeros"), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported that it has commenced a registered underwritten public offering of its common stock (Press release, Omeros, DEC 4, 2019, View Source [SID1234551970]). In addition, Omeros has granted the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering.

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Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

Omeros intends to use the net proceeds of the offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization. Omeros may also use the net proceeds for working capital, the repayment of debt obligations, acquisitions or investments in businesses, products or technologies that are complementary to its own, and other capital expenditures.

A registration statement on Form S-3 relating to the securities was filed with the Securities and Exchange Commission (the "SEC") on December 4, 2019 and became automatically effective upon filing. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the offering will be filed with the SEC on December 4, 2019 and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected].

On December 4, 2019 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported the appointment of Rafael Bejar, M.D., Ph.D., to the position of Senior Vice President, Chief Medical Officer, effective January 1, 2020 (Press release, Aptose Biosciences, DEC 4, 2019, View Source [SID1234551957]). In his role as a member of the executive leadership team, Dr. Bejar will oversee global clinical development and regulatory initiatives for Aptose, as well as other research activities.

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"Rafael is a physician-scientist whose depth of experience both in the research setting and in treating patients with hematologic malignancies brings a unique and important perspective as we accelerate the clinical development of our hematologic product candidates," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We are very fortunate and excited to have him join Aptose and welcome him as a senior member of the management team."

Dr. Bejar is trained in internal medicine and board certified in oncology and hematology, with a special interest in hematologic malignancies and myelodysplastic syndrome (MDS). Prior to joining Aptose, he served as Associate Professor of Clinical Medicine in the Division of Hematology and Oncology at University of California San Diego in the Moores Cancer Center, where he established an MDS Center of Excellence, which provides state of the art care, clinical trials and medical expertise in one center. Dr. Bejar has authored numerous research articles published in leading journals such as The New England Journal of Medicine, Journal of Clinical Oncology, Blood and more; has served as an invited speaker and chair at multiple scientific/clinical conferences; has served in teaching capacities and has been honored extensively.

Dr. Bejar completed his internal medicine residency at the Brigham and Women’s Hospital in Boston, where he later served as a Chief Medical Resident. He then received his fellowship training in hematology and oncology at the Dana-Farber Cancer Institute. He earned his medical degree and Ph.D. at UC San Diego School of Medicine, and his bachelor’s degree in Physics at the Massachusetts Institute of Technology.

"As a physician and researcher who has dedicated my professional life to understanding the development and progression of hematologic malignancies such as AML and MDS, I’m excited join Aptose at such a pivotal moment and to have the opportunity to bring CG-806 and APTO-253 to patients in need of new therapies," said Dr. Bejar. "Our goal is to translate these discoveries into clinically meaningful improvements for these patient populations and I very much look forward to being an integral part of that endeavor."