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 5, 2019 ARTIDIS reported a privately held healthtech company, announced today the successful closure of a CHF 8.8 million seed financing in two rounds, securing early clinical validation and the next development phase towards market entry in 2021 (Press release, ARTIDIS, DEC 5, 2019, View Source;raising-chf-8-8-million-in-seed-financing-300969365.html [SID1234551988]). The funding will be used to advance the company’s healthtech platform into a large multi-centre clinical study together with the University Hospital Tuebingen (Germany), University Hospital Barcelona (Spain), and Texas Medical Center (Houston, US). The study aims to further validate the value of ARTIDIS in diagnosing breast and lung cancer, as well as for personalizing and optimizing cancer treatment. The results will support the regulatory submissions to the FDA and the European Notified Body to gain approval for the ARTIDIS medical device and data platform. This is one of the major prerequisites for ARTIDIS to enter the diagnostic market world-wide in 2021 in order to improve the standard of care for cancer patients.

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Dr. Marija Plodinec, CEO of ARTIDIS commented: "The closure of this financing round and the successful recruitment of 545 patients in our first clinical study at the University Hospital Basel this year is a huge success. We are thankful for the support and trust of all our shareholders – together, we are opening a new chapter towards personalizing the patient journey."

The round was supported by family offices and private individuals from Switzerland and the EU, including BERNINA Bioinvest, Zurich and SMD MedicalTrade AG, Taegerwilen.

"We are extremely happy for the opportunity to invest in this promising company and support the great team of ARTIDIS on their mission to deliver fast diagnosis and personalized treatment to cancer patients," stated Philipp Looser from SMD Medical Trade AG.

The management of BERNINA BioInvest commented: "ARTIDIS brings the future of cancer diagnostics and treatment to the patients and clinicians. We support ARTIDIS because their approach will significantly optimize the diagnostics workflow and has the potential to revolutionize the way treatment decision-making is done, improving not only the personal patient journey but benefiting the whole healthcare ecosystem. We are confident that Marija Plodinec and her team have the expertise, the passion, and the drive needed to realize this vision."

Martin Gertsch, Chairman of the Board says: "We are very glad that we could also strengthen our Board of Directors during this year: Owing to their significant industry experience and diverse subject matter expertise, Ms Trudi Haemmerli, Board Member Innosuisse, and Dr. Reinhard Ambros, former Global Head of Novartis Venture Fund, were both elected as Board of Directors this year."

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 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported it will present interim efficacy, immunological and safety data from its ongoing KEYNOTE-890 study of TAVO in combination with KEYTRUDA in patients with late-stage, heavily pretreated, chemo-refractory metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held December 10-14, 2019 (Press release, OncoSec Medical, DEC 5, 2019, View Source [SID1234551971]).

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The poster, titled "Phase 2, open-label study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation in combination with intravenous pembrolizumab therapy in patients with inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) (KEYNOTE- 890/OMS-I141)," will be presented by lead author Melinda L. Telli, MD on Thursday, December 12th from 5:00 p.m. – 7:00 p.m. CST.

The SABCS abstracts are listed on the conference website under Abstracts at View Source!/7946 .

On December 5, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Medicines Agency ("EMA") has agreed to the Company’s proposed Pediatric Investigation Plan ("PIP") for omburtamab (Press release, Y-mAbs Therapeutics, DEC 5, 2019, View Source [SID1234551989]). The decision was made on the basis of a positive opinion from EMA’s Pediatric Committee ("PDCO"). Omburtamab is being developed by Y-mAbs for the treatment of CNS/leptomeningeal metastases from neuroblastoma which is the indication targeted by the PIP, as well as a number of additional cancer indications.

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As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application ("MAA") for any new medicinal product in Europe.

"We are pleased to announce this important regulatory milestone. The approval of the PIP provides Y-mAbs with a clear path for registration of omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. We look forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as soon as possible," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "We are preparing the European submission of the marketing authorization application for omburtamab, and plan for submission in the second half of 2020. This is a vital step forward in our efforts of bringing omburtamab to the market in Europe, and it demonstrates the close and constructive interactions established with the regulatory authorities in Europe.

Researchers at Memorial Sloan Kettering ("MSK") developed the therapeutic product referenced in this statement, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product and in Y-mAbs.