On December 20, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission has granted marketing authorisation to provide healthcare professionals with the option to split the first infusion of Darzalex (daratumumab) over two consecutive days (Press release, Johnson & Johnson, DEC 20, 2018, View Source [SID1234532197]).

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"We are committed to the development of new treatments, combinations, and formulations that will support people living with multiple myeloma across the full disease spectrum," said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. "This is an important decision for healthcare professionals and patients, as it provides flexibility in administration that may help address individual patient needs."

The decision was based on data from the Phase 1b EQUULEUS (MMY1001) clinical trial, which demonstrated daratumumab pharmacokinetics concentrations were comparable regardless of whether the first dose was administered as a split infusion or single first infusion in patients with multiple myeloma.1 The safety profile of daratumumab was comparable when administered initially as a split or single dose.1

The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 19 November 2018.2

#ENDS#

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.3 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.4 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.4 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.5,6,7,8,9,10,11,12 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.13,14 For more information, please see www.clinicaltrials.gov.

In Europe, daratumumab is indicated for use 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, and 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.4 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.15

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.16 More than 45,000 people were diagnosed with multiple myeloma in Europe in 2016, and more than 29,000 patients died.17 Up to half of newly diagnosed patients do not reach five-year survival,18 and almost 29% of patients with multiple myeloma will die within one year of diagnosis.19

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.20 Refractory multiple myeloma is when a patient’s disease progresses within 60 days of their last therapy.21,22 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.23 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.24 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.25

On December 20, 2018 Novartis reported that Susanne Schaffert, Ph.D., currently President, Advanced Accelerator Applications (AAA), a Novartis company, has been appointed CEO Novartis Oncology (Press release, Novartis, DEC 20, 2018, View Source [SID1234532213]). She will report to Vas Narasimhan, CEO, Novartis, and will join the Executive Committee on January 1, 2019. Liz Barrett will be stepping down as CEO of Novartis Oncology effective December 31, 2018.

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Vas Narasimhan, CEO, Novartis, said: "I would like to thank Liz for her leadership and her contributions to our business and our patients this past year. She made a significant positive impact on the organization in a relatively short time and I wish her the very best in her future endeavors. As testament to our pipeline of talent, I am delighted that Susanne Schaffert, current president of AAA and a long-time Oncology and Novartis executive, has accepted the role of CEO, Oncology. Susanne is a successful business leader with very deep expertise in Oncology, an unwavering commitment to patients, and a strong track record of inspiring talent and building empowered, high performing organizations. She has our full support and confidence as we continue to invest in both our internal pipeline as well as external assets to strengthen our presence."

Regarding her appointment, Susanne Schaffert said: "Becoming CEO of Novartis Oncology is a great honor and I am humbled to be given the opportunity to lead one of the top-tier oncology businesses in the world. There is still much work to be done to help people with cancer live longer and better lives and I am excited to reimagine medicine together with my colleagues at Novartis."

Susanne Schaffert joined Novartis more than 20 years ago and has spent the last six years in the Oncology business in leadership roles, including Region Head, Novartis Oncology Europe, where she led that organization through 5 years of sustained growth (excluding Glivec which lost exclusivity during this period). Earlier this year she was appointed President, AAA, launching Lutathera, a radioligand therapy for the treatment of certain cancers, in the U.S. and E.U. Also during her tenure in Oncology, she was instrumental in the GSK Oncology integration and served on the Board of Directors of the Consumer Health joint venture between Novartis and GSK until early 2018. In addition, Susanne was Head of Investor Relations, Novartis, from 2010-2013. She transitioned back to Oncology in 2013, and has been a member of the Global Novartis Oncology Leadership Team since then. Prior to 2010, Susanne worked in Sales and Marketing in both the pharmaceuticals and oncology business units. She received her master’s degree and PhD in chemistry from University Erlangen, Germany.

Liz Barrett said: "After much personal reflection, it became clear that my family would be unable to relocate to Basel where the Oncology headquarters is based. Therefore, I decided to accept a new role as CEO of a U.S. based biotech. I want to thank Vas for the opportunity to work at this great company and to everyone in Oncology for their commitment to transforming cancer for patients and their families. I am confident that under Susanne’s leadership, Novartis will continue to expand its impact in Oncology."

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "will," "commitment," "continue," "pipeline," or similar expressions, or by express or implied discussions regarding potential future sales or earnings of the Novartis Group. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying

assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that Novartis will be commercially successful in the future, or achieve any particular financial results. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant acquisitions, divestments and reorganizations of recent years may not be realized or may take longer to realize than expected; the uncertainties inherent in the research and development of new healthcare products; our ability to obtain or maintain proprietary intellectual property protection on key products; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; uncertainties regarding actual or potential legal proceedings; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise

On December 19, 2018 Varian (NYSE: VAR) reported that Dow Wilson, chief executive officer, and Chris Toth, president of Oncology Systems, will present at the J.P. Morgan Healthcare Conference in San Francisco, scheduled for 9:30 a.m. Pacific Time on January 7, 2019 (Press release, Varian Medical Systems, DEC 19, 2018, View Source [SID1234532163]).

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Information about the webcast of the company’s presentation will be available through a link on the company website at www.varian.com/inv­estors.

On December 19, 2018 Applied DNA Sciences, Inc. (Nasdaq: APDN) ("Applied DNA" or the "Company"), a leader in large-scale PCR-based DNA manufacturing, reported that it intends to offer for sale a combination of shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering (Press release, Applied DNA Sciences, DEC 19, 2018, View Source [SID1234532183]). The Company intends to use the net proceeds from this offering for working capital, capital expenditures, business development and research and development expenditures. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Maxim Group LLC is acting as sole underwriter and book-running manager for the offering.

The securities described above are being offered under the Company’s shelf registration statement on Form S-3 (No. 333-218158), previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). The securities will be offered by means of a prospectus supplement and accompanying prospectus, forming a part of the effective registration statement. The prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the website of the SEC at View Source Electronic copies of the prospectus supplement and accompanying prospectus also may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at 212-895-3745. Before you invest, you should read the prospectus supplement and the accompanying prospectus in the registration statement and other documents Applied DNA has filed or will file with the SEC for more complete information about Applied DNA and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer or 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 December 19, 2018 Eli Lilly and Company (NYSE: LLY) reported its 2019 financial guidance, updated certain elements of its 2018 guidance and 2020 minimum financial expectations, reviewed the performance of recently launched medicines and highlighted numerous potential new medicines in its clinical pipeline (Press release, Eli Lilly, DEC 19, 2018, View Source [SID1234532147]).

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David A. Ricks, Lilly’s chairman and chief executive officer, confirmed that the company is executing well against the company’s priorities to launch with excellence, replenish the pipeline, improve productivity and develop talent.

"Over the past five years, Lilly has successfully launched 10 new medicines, bolstered our pipeline with new candidate medicines from our own labs and from external partners, reshaped the company to be more productive, and attracted world-class scientific talent to our labs," said Ricks. "Our actions over the past several years have positioned Lilly to deliver significant value to our key stakeholders. Most importantly, they have benefited patients, many of whose lives are better because of new Lilly medicines."

Ricks acknowledged Lilly’s current strong performance, and expressed optimism for the company’s future growth. "We are proud of what we have achieved at Lilly over the past several years, but we are determined to raise the bar higher. We see incredible scientific opportunities to address some of the most significant health challenges of an aging society. We aim to create new medicines over the next decade that will transform the care of serious illnesses, and provide valuable new treatment options for doctors and patients."

R&D Transformation is Leading to Impressive Pipeline Productivity
At today’s meeting, Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, highlighted recent advancements that the company has made to improve R&D productivity and create new medicines that are either first-in-class or best-in-class.

The company is reshaping its drug discovery engine, with the dual goal of decreasing the time from target identification to clinical testing to approximately three years, while also increasing the use of externally-derived innovation to access novel targets, modalities and discovery tools.
Lilly has significantly improved the speed of its development activities and reduced the average time from first human dose of a potential new medicine to commercial launch by over two years.
There has been a steady improvement in the success rate of Phase 3 molecules in Lilly’s clinical pipeline due to a greater emphasis on target validation, patient population, molecule optimization, more robust Phase 2 data, and better Phase 3 design.
Skovronsky discussed the development plans and therapeutic potential for a number of promising late-stage pipeline opportunities and new indications for approved medicines in the company’s five therapeutic areas of focus:

Oncology – Verzenio, pegilodecakin
Pain – Emgality, lasmiditan, tanezumab
Neurodegeneration – N3pG antibody, tau antibody, D1PAM
Immunology – Olumiant, mirikizumab
Diabetes – Insulins and Connected Care, Trulicity, tirzepatide
"Lilly has created an industry-leading late-stage development organization and now we are focused on transforming our drug discovery engine," said Skovronsky. "With an attractive clinical pipeline, two new molecules achieving regulatory submissions and three entering Phase 3 in 2018, we are continuing an impressive period of productivity for Lilly Research Labs, and are on pace to deliver on the company’s goal to launch 20 new medicines in 10 years."

New Medicines Are Driving Volume-Based Revenue Growth and Positive Financial Outlook
Joshua Smiley, Lilly senior vice president and chief financial officer, highlighted the performance of several recently launched medicines and reviewed the company’s 2018 and 2019 financial guidance, as well as certain minimum financial expectations for 2020.

"Lilly has dramatically upgraded the quality of its revenue base over the past five years through the launch and uptake of 10 new medicines, which together are expected to account for over 45 percent of human pharmaceutical sales in 2019," noted Smiley. "These 10 medicines are launching in some of the fastest growing categories and continue to deliver growth through increased volume, not price, meaning more and more people around the world are benefitting from Lilly medicines."

At today’s meeting, Mr. Smiley highlighted the strong U.S. performance and market share gains of several of these medicines, including Trulicity, Jardiance, Taltz and Verzenio, as well as the early progress for Emgality and international growth opportunities across the portfolio.

"We are encouraged by the commercial execution across our new launches, and are excited about their prospects for future growth," added Smiley. "The success of these medicines gives us confidence that we will continue to deliver strong results and generate significant cash balances in 2019 and beyond. Based on these growth prospects, we are pleased to today announce a 15 percent increase in our dividend."

2018 Financial Guidance
The company has revised certain elements of its 2018 financial guidance on a reported basis. Earnings per share on a reported basis are now expected to be in the range of $2.80 to $2.85, while non-GAAP earnings per share for 2018 are still expected to be in the range of $5.55 to $5.60.

Numbers may not add due to rounding

* 2018 Expectations are pending finalization of estimates, accounting policy elections, and guidance issued for tax reform.

(a) Relates to adjustments to the 2017 Toll Tax for U.S. tax reform proposed regulations and tax expenses associated with the separation of the Elanco animal health business.

* Certain elements of 2018 guidance are pending finalization of estimates, accounting policy elections, and guidance issued for tax reform.

Non-GAAP adjustments are consistent with the earnings per share table above.

2019 Financial Guidance
Lilly today issued its 2019 financial guidance. The individual elements of the 2019 financial guidance outlined below include fully consolidated financial expectations for both the company’s human pharmaceutical business and Elanco Animal Health, with the exception of earnings per share, which excludes approximately $0.08 per share for the non-controlling interest in Elanco. Lilly expects to divest its remaining ownership in Elanco through a tax-efficient transaction within one year of Elanco’s initial public offering, and will restate 2019 financial guidance at that time to reflect Elanco as discontinued operations.

Earnings per share for 2019 are expected to be in the range of $5.52 to $5.62 on a reported basis and $5.90 to $6.00 on a non-GAAP basis.

Numbers may not add due to rounding

* 2019 Expectations are pending finalization of estimates, accounting policy elections, and guidance issued for tax reform.

The company anticipates 2019 revenue between $25.3 billion and $25.8 billion. Revenue growth is expected to be driven by volume from newer medicines including Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant and Lartruvo. Revenue growth is also expected to benefit from the recent launch of Emgality, and could benefit from the potential approval and launch of nasal glucagon and lasmiditan. Revenue growth is expected to be partially offset by lower revenue for Cialis and other products that have lost patent exclusivity. Revenue growth is also expected to be partially offset by the negative impact of foreign exchange rates, as well as continued price pressures in the U.S and some international markets.

Gross margin as a percent of revenue rate is expected to be approximately 75.0 percent on a reported basis and 76.5 percent on a non-GAAP basis.

Marketing, selling and administrative expenses are expected to be in the range of $6.4 billion to $6.7 billion. Research and development expenses are expected to be in the range of $5.6 billion to $5.8 billion.

Other income (expense) is expected to be expense between $75 million and $225 million.

The 2019 effective tax rate is expected to be approximately 16 percent on both a reported basis and on a non-GAAP basis, pending finalization of estimates, accounting policy elections, and guidance issued for tax reform.

* Certain elements of 2019 guidance are pending finalization of estimates, accounting policy elections, and guidance issued for tax reform.

Non-GAAP adjustments are consistent with the earnings per share table above.

2020 Minimum Financial Expectations
The company has revised its 2020 minimum financial expectations and now expects at least 6 percent compound annual revenue growth from 2015 to 2020 for the full company, and at least 7 percent compound annual revenue growth for the human pharmaceutical business.

Certain financial guidance information for 2019 and 2018 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results are prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the periods. Non-GAAP measures exclude the items described in the reconciliation tables contained in this press release. The non-GAAP measures are presented to provide additional insights into the underlying trends in the company’s business. This press release does not constitute an offer of any securities for sale.

Webcast of Conference Call and Investor Materials
As previously announced, investors and the general public can access a live webcast of the 2018 investment community meeting conference call and investor materials through a link on Lilly’s website at www.investor.lilly.com. The conference call will be held today beginning at 9:00 a.m. Eastern time (ET) and will be available for replay via the website.