On July 19, 2019 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported the pricing of an underwritten public offering of 6,871,727 shares of its common stock at a price to the public of $15.28 per share (Press release, Atara Biotherapeutics, JUL 19, 2019, View Source [SID1234537614]). In addition, and in lieu of common stock, Atara Biotherapeutics is offering to certain investors pre-funded warrants to purchase 2,945,026 shares of its common stock at a purchase price of $15.2799 per pre-funded warrant, which represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant. The aggregate gross proceeds from the offering are expected to be approximately $150.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Atara Biotherapeutics. The offering is expected to close on or about July 23, 2019, subject to customary closing conditions. In connection with the offering, Atara Biotherapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,472,512 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Citigroup, Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the offering. Mizuho Securities and Canaccord Genuity are acting as co-managers.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Goldman Sachs & Co. LLC, by mail at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, or by email at [email protected]; or Cowen, by mail at Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at 1-631-592-5973, or by email at [email protected].

This press release shall 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 the registration or qualification under the securities laws of any such jurisdiction.

On July 19, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of an extension application to the European Medicines Agency (EMA) for subcutaneous (under the skin) use of DARZALEX (daratumumab) for the treatment of patients with multiple myeloma (Press release, Johnson & Johnson, JUL 19, 2019, View Source [SID1234537633]). This subcutaneous formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme’s ENHANZE drug delivery technology]. Daratumumab is currently only approved for intravenous (IV) use.

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"This new formulation is an example of our unwavering commitment to pursue innovative treatment options to support people living with multiple myeloma," said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. "Importantly, subcutaneous daratumumab demonstrated comparable efficacy with the existing IV formulation, reduced the rate of infusion-related reactions and significantly shortened the time it takes for patients to receive treatment, from several hours to approximately five minutes."

The submission is supported by two studies, the Phase 2 PLEIADES (MMY2040) study and the Phase 3 COLUMBA (MMY3012) study recently presented at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Congress, and at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting where the data were selected for the Best of ASCO (Free ASCO Whitepaper) 2019 Meetings, which highlight practice-changing science and leading research in oncology.1,2

"Janssen has an extensive heritage in multiple myeloma and we are committed to developing innovative approaches to minimise the treatment burden for patients with multiple myeloma," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We look forward to working with the EMA in its review of the data supporting this application."

Janssen has also submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the new daratumumab subcutaneous formulation.

In Europe, daratumumab is indicated:3

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
as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy
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.
#ENDS#

About the COLUMBA Trial (NCT03277105)4

The randomised, open-label, multicentre Phase 3 study included 522 patients with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an IMiD (median age of 67). In the arm that received the subcutaneously (SC) administered formulation of daratumumab (n=263), patients received a fixed dose of daratumumab 1,800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2,000 Units Per millilitre (U/mL), SC weekly for Cycles 1 – 2, every two weeks for Cycles 3 – 6, and every four weeks for Cycle 7 and thereafter. In the daratumumab IV arm (n=259), patients received daratumumab for intravenous infusion 16 milligrams per kilogram (mg/kg) weekly for Cycles 1 – 2, every two weeks for Cycles 3 – 6, and every four weeks for Cycle 7 and thereafter. Each cycle was 28 days. Patients in both treatment arms continued until disease progression or unacceptable toxicity. Co-primary endpoints were objective response rate (ORR) (analysed by Farrington-Manning test, with non-inferiority = 60 percent retention of ORR) and pre-dose C3D1 daratumumab Ctrough (non-inferiority = lower bound of 90 percent confidence interval (CI) for the ratio of the geometric means [GM] ≥80%).

About the PLEIADES Trial (MMY2040)2

The non-randomised, open-label, parallel assignment study Phase 2 PLEIADES trial included 240 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma were treated with 1,800 mg of the subcutaneous formulation in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan, prednisone and dexamethasone (D-VMPd). Patients with relapsed or refractory disease were treated with 1,800 mg of the subcutaneous formulation plus lenalidomide and dexamethasone (D-Rd). The primary endpoint for the D-VMPd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate. An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone was subsequently added to the study.

About daratumumab

Daratumumab is a first-in-class5 biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.6 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.3 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.3 Since launch, it is estimated that daratumumab has treated 90,000 patients worldwide.7 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.8,9,10,11,12,13,14,15 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.16,17 For more information, please see www.clinicaltrials.gov.

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.18

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.19 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.20 Almost 60 percent of patients with MM do not survive more than five years after diagnosis.21

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.22 Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.23,24 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.25 While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.26 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.27

On July 19, 2019 Genmab A/S (CSE:GEN, Nasdaq:GMAB) reported that its licensing partner, Janssen Biotech, Inc., has submitted an application for the extension of the DARZALEX marketing authorization to the European Medicines Agency (EMA) (Press release, Genmab, JUL 19, 2019, View Source [SID1234537615]). This application seeks approval for the use of the subcutaneous (SubQ) formulation of daratumumab in multiple myeloma indications where the intravenous formulation of daratumumab is currently approved. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"Janssen has now submitted applications for approval of the subcutaneous formulation of daratumumab in both the U.S. and in Europe and we are looking forward to the possibility of multiple myeloma patients in both regions having access to this more convenient formulation of DARZALEX, which allows for both faster dosing and fewer infusion-related reactions according to recently presented data from the COLUMBA study," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission is based on data from two ongoing studies: the Phase III non-inferiority COLUMBA study, which is comparing the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma and preliminary non-public data from the Phase II PLEIADES study, which is evaluating daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA data were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress.

About the COLUMBA (MMY3012) study
The Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that includes 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SubQ daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) study
The Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 240 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg subcutaneous daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg subcutaneous daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: 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 is indicated in Europe 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 therapy. 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 is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan.

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

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 July 19, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson is reported with the recent announcement from the World Health Organisation (WHO) to include abiraterone acetate (ZYTIGA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in the updated Essential Medicines List, published on 9th July 2019.1,2 (Press release, Johnson & Johnson, JUL 19, 2019, View Source [SID1234537634])

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The WHO’s Essential Medicines List is a core guidance document that helps countries prioritise critical health products that are recommended to be widely available and affordable throughout health systems.1

"The inclusion of abiraterone acetate in the WHO Essential Medicines List highlights the critical role that this treatment can play in improving the lives of patients living with mCRPC and their families," said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "I am proud that we are working hard to impact survival and quality of life by developing and providing innovative medicines which are supported by the highest quality scientific evidence."

The foundation of Janssen’s scientific understanding in prostate cancer is based on the knowledge acquired through the development of innovative treatment options for mCRPC. Abiraterone acetate is an oral androgen biosynthesis inhibitor that is approved for the treatment of both mCRPC and metastatic hormone-sensitive prostate cancer, in Europe.3,4

"The addition of abiraterone acetate to the Essential Medicines List is a significant milestone for Janssen Oncology, reflecting the tireless efforts in recent years to bring optimal treatment options to patients with mCRPC," said Biljana Naumovic, Vice President Commercial Strategy Lead Oncology for Europe, Middle East & Africa, Cilag GmbH International. "This direction from the WHO further emphasises that our work is not yet over. It is critical that patients with prostate cancer have access to treatments that their clinicians feel can benefit them and that we continue to support the prostate cancer community in our common goal of making cancer a manageable and potentially one day, a curable condition."

On July 19, 2019 Genmab A/S (CSE: GEN, Nasdaq: GMAB) reported the exercise in full by the underwriters of their over-allotment option in connection with its initial public offering of American Depositary Shares ("ADSs") in the United States (the "Offering") and the listing of the ADSs on the Nasdaq Global Select Market (Press release, Genmab, JUL 19, 2019, View Source [SID1234537616]). On July 18, 2019, BofA Merrill Lynch, Morgan Stanley and Jefferies, on behalf of the underwriters, notified Genmab of the underwriters’ exercise in full of their previously announced option to purchase up to 4,275,000 additional ADSs, representing 427,500 ordinary shares, to cover any over-allotments (the "Option") at a price of $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per underlying ordinary share at an exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of 10 to 1.

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The exercise of the Option will increase the total gross proceeds of the Offering to $581,756,250 (DKK 3,873.3 million) and will result in a total issuance of 32,775,000 ADSs, representing 3,277,500 ordinary shares.

The 427,500 additional shares will be delivered by Genmab in the form of new shares with a nominal value of DKK 1 each (the "New Shares").

Following the registration of the New Shares with the Danish Business Authority, which is expected to take place on July 23, 2019 or early thereafter (and presuming that the 2,850,000 new ordinary shares of a nominal value of DKK 1 that were offered during the Offering will be registered with the Danish Business Authority on July 22, 2019) Genmab’s share capital will amount to DKK 64,967,643 divided into 64,967,643 shares with a nominal value of DKK 1 each.

The New Shares will rank pari passu with Genmab’s existing shares and carry the same dividend and other rights.

The New Shares are expected to be issued and registered with the Danish Business Authority on July 23, 2019 (or early thereafter) and are expected to be admitted to trading and official listing on Nasdaq Copenhagen on July 24, 2019 (or early thereafter), with the permanent ISIN code DK0010272202.

BofA Merrill Lynch, Morgan Stanley and Jefferies are acting as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets are acting as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen are acting as co-managers for the Offering. A copy of the preliminary prospectus and, when available, the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the preliminary prospectus and, when available, the final prospectus related to the Offering are also available, or will be available, at www.sec.gov. No Danish prospectus will be issued or offered.
This Company Announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.