Biocept Announces Validation and Availability of its Liquid Biopsy Platform for the Detection of Actionable Cancer Biomarkers in Cerebrospinal Fluid

On January 14, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that its Target Selector assays are now available to physicians in order to evaluate the cerebrospinal fluid (CSF) of their patients for the presence of circulating tumor cells (CTCs) and biomarkers for patients with breast or lung cancer suspected of brain or central nervous system (CNS) metastases (Press release, Biocept, JAN 14, 2020, View Source [SID1234553201]). The presence of tumor cells in CSF may be an indicator of brain metastases, which occurs when cancer has spread into the CNS. Up to 30% and 36% of patients diagnosed with breast and lung cancer, respectively, will develop brain metastases.

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"Testing the CSF for cancer biomarkers in patients suspected to have brain metastases can be important, as the rapid confirmation and characterization of CNS involvement enables appropriate treatment selection in a timely manner," stated Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, Director of Neuro-oncology at the Pacific Neuroscience Institute and John Wayne Cancer Institute. "Liquid biopsy tests offer the ability to analyze an additional specimen type, beyond blood, to help physicians identify biomarkers and hence inform clinical decision making."

"We are very pleased to make our Target Selector platform available for testing CSF, as a more rapid identification of molecular alterations in brain metastases can aid physicians in choosing the best treatment options for their patients with breast or lung cancer," said Michael W. Nall, Biocept’s President and CEO. "Among the significant capabilities of our technology is its versatility, which enables applications in a variety of clinical situations and for use with multiple types of biofluids."

About CSF Testing

A medical procedure known as a spinal tap or lumbar puncture is typically done to collect CSF when cancer patients present with CNS symptoms, for example confusion or dementia. Over 200,000 of these procedures are performed annually in the U.S. Biocept’s Target Selector testing provides an alternative and potentially more accurate means compared to cytology to evaluate CSF. For more information about Biocept’s Target Selector testing, please contact Biocept Customer Services at 888.332.7729.

The United States Patent and Trademark Office has registered the LIDDS trademark NANOZOLID in the US

On January 14, 2020 LIDDS AB (publ) reported that the United States Patent and Trademark Office has registered the trademark NanoZolid (Press release, Lidds, JAN 14, 2020, View Source [SID1234555898]). LIDDS thereby has exclusive rights to the trademark for products and services in the USA and in the EU, where NanoZolid has been registered since 2016.

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The registered Trademark NanoZolid, without any claim to particular font, size or color, has registration no. 5,830,505 and includes International Classes 5 and 42.

-This is an essential, although expected, step in establishing the concept of LIDDS proprietary drug delivery technology NanoZolid for local depots and adds to our already strong IP portfolio, confirms LIDDS CEO Monica Wallter.

Takeda to Outline Progress on Business Transformation and Priorities at the 38th Annual J.P. Morgan Healthcare Conference

On January 14, 2020 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported that it will provide an update on the progress of its business transformation and priorities today at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Takeda, JAN 14, 2020, View Source [SID1234553185]). President and Chief Executive Officer, Christophe Weber, will share details on Takeda’s portfolio and pipeline strategy, financial outlook, and ongoing sustainability efforts, including its newly established commitment to carbon neutrality across its value chain.

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"Last year was an important and successful year for Takeda as we accelerated our transformation to become a leading global biopharmaceutical company," said Mr. Weber. "Our commitment to bringing better health and a brighter future to patients worldwide continues as we expand our global brands and advance our next-generation pipeline, driving sustainable growth. We also recognize that supporting our patients means we must commit to work on behalf of the broader global community – and one way to do this is by accelerating our environmental efforts."

Commercial Strategy and Innovative Pipeline

As highlighted at its recent R&D Investor Day event in November 2019, Takeda continues to generate significant opportunities through new indications and geographic expansion of its 14 global brands. By cultivating the best science through its research and development engine, comprised of internal capabilities and external partnerships, Takeda is quickly advancing a steady stream of next-generation therapies designed to provide transformative or curative potential for targeted populations with high unmet medical needs in its core therapeutic areas of oncology, rare diseases, neuroscience and gastroenterology.

Over the next several years, Takeda’s pipeline is projected to deliver value with a focus on the potential launches of 12 unique new molecular entities (NMEs) in 14 indications, which represent best-in-class or first-in-class therapies to advance patient standard of care, and that have the potential to deliver more than $10 billion (USD) in aggregate peak sales.

Takeda is confident in its ability to execute in the near-term and achieve sustainable growth through 2024 and beyond, with its portfolio of 14 global brands and additional anticipated product launches intended to fuel its growth trajectory while its next-generation platforms mature.

Additional Highlights include:

~40 NME clinical stage assets; 17 NMEs in Phase 2 and Phase 3
≥15 potential new launches within the next five years in China
8 potential best-in-class/first-in-class NMEs in pivotal studies
~50% of pipeline with orphan drug designation
Diversified modalities in research, including cell and gene therapies, small molecules and biologics
Financial Strength

Takeda is committed to maintaining investment grade credit ratings and remains on track towards its target of 2x Net Debt/adjusted EBITDA ratio within the fiscal years ending March 2022 to March 2024, with rapid de-leveraging driven by strong cash flow and proceeds from non-core asset divestitures. In the first six months of FY19, Takeda reduced its Net Debt/adjusted EBITDA ratio from 4.7x to 3.9x. In addition, four non-core asset divestitures were announced that, together with other potential divestments, are expected to reach $10 billion (USD).

Through expected cost synergies from the acquisition of Shire that are expected to reach a run rate of approximately $2 billion (USD) annually and operating expenditure efficiencies, Takeda is also driving towards its target of a mid-30% underlying core operating profit margin within the fiscal years ending March 2022 through March 2024. Takeda remains committed to shareholder returns with a well-established dividend policy of 180 yen per share annually.

Values-Driven Commitment to ESG (Environment, Social, Governance)

Recognizing that climate change poses a risk to human health, including the spread of infectious diseases, Takeda has made environmental efforts a priority. To date, Takeda has met and exceeded its previously established 2020 environmental goals ahead of schedule, including reducing its CO2 emissions by 33.7% compared to 2005 levels. Furthering the Company’s commitment to the environment, today Takeda will unveil its new 2040 targets to achieve carbon neutrality across its value chain. Takeda intends to do this by eliminating all greenhouse gas (GHG) emissions from its operations (Scopes 1 and 2), working with its suppliers to significantly reduce their emissions (Scope 3), and addressing remaining Scope 3 emissions through verified carbon offsets. Beginning with FY19 GHG emissions, the Company commits to carbon neutrality (Scopes 1, 2, and 3) through the purchase of renewable energy and verified carbon offsets, while simultaneously working to reduce emissions from its operations and suppliers.

In addition to Takeda’s environmental efforts, its overall commitment to ESG – including the Access to Medicines Strategy and Global Corporate Social Responsibility (CSR) Program – has been recognized by multiple benchmark ESG indices. Since 2014, Takeda has risen 15 spots to No. 5 in the latest Access to Medicines Index, which measures commitment and achievements in the field of patient access to medicine and treatment globally. Takeda is proud to have provided access to innovative and potentially life-saving treatments to more than 125,000 patients. In addition, its CSR Program has committed over $100 million (USD) to organizations that work to prevent diseases and improve health outcomes around the world. Takeda is proud that employees are engaged and select the organizations that the CSR Program supports. Takeda’s 2019 Sustainable Value Report provides additional details on the its commitment to ESG.

Nevro Announces Preliminary Unaudited Fourth Quarter and Full Year 2019 Revenue

On January 14, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported its preliminary unaudited revenue for the fourth quarter and year ended December 31, 2019 (Press release, Nevro, JAN 14, 2020, View Source [SID1234553202]). In addition, the Company is providing its worldwide revenue guidance for the full year 2020.

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Fourth Quarter 2019
Preliminary unaudited fourth quarter 2019 worldwide revenue is expected to be $114.4 million, compared to $107.9 million in the fourth quarter in the prior year period. Preliminary unaudited fourth quarter 2019 U.S. revenue is expected to be $97.9 million, compared to $91.6 million in the prior year period. Preliminary unaudited fourth quarter 2019 international revenue is expected to be $16.5 million, compared to $16.3 million in the prior year period. Fourth quarter U.S. trial procedure growth was 17% and permanent implant procedure growth was 20%.

Full Year 2019
Nevro’s preliminary unaudited full year 2019 worldwide revenue is expected to be $390.3 million, compared to $387.3 million in the prior year period. Preliminary unaudited full year U.S. revenue is expected to be $326.0 million, compared to $321.8 million in the prior year period. Preliminary unaudited full year international revenue is expected to be $64.3 million, compared to $65.5 million in the prior year period.

Worldwide Revenue Guidance for Full Year 2020
Nevro currently expects full year 2020 worldwide revenue to be in the range of $435 to $440 million. The Company plans to provide additional guidance metrics for 2020 when it reports its fourth quarter and full year 2019 results in February.

Celsee and Kindstar Global Collaborate to Bring Advanced Tools for Monitoring Circulating Tumor Cells to Scientists in China

On January 14, 2020 Celsee, Inc., a leading provider of single-cell isolation technology, and Kindstar Global, the largest medical esoteric testing service group in China, reported a purchase agreement to provide scientists at the Kindstar Laboratory System in China with Celsee’s Genesis System for monitoring circulating tumor cells (CTCs) in lung, breast, and bladder cancers as well as single-cell research (Press release, Celsee, JAN 14, 2020, View Source [SID1234553186]). In addition, Kindstar will become a distributor of Celsee’s products in China.

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For this cancer research, Kindstar scientists will use the BioINK kit, which was developed by IncellDx for CTC enumeration in therapeutic monitoring and is performed on Celsee’s Genesis System utilizing the Celselect Technology. Now, researchers will gain access to Celsee’s Genesis System, which has better capture efficiency and detection of CTCs compared to other CTC enumeration platforms.

"Kindstar Global is leading the way for oncology research and testing in China, and we are committed to implementing the most advanced tools for that work," said Dr. Shiang Huang, Founder and CEO of Kindstar. "We are truly impressed by the capabilities of Celsee’s single-cell isolation and enumeration technology and are eager to use it in our own laboratories as well as to make it available to scientists throughout China."

John Stark, Chief Executive Officer of Celsee, commented: "We are very excited to announce the partnership with Kindstar and the opportunity to bring Celsee technology to the clinical research market in China. Our team has worked closely with IncellDx to develop workflows that combine our single-cell tools with their flow cytometry classification assays and BioINK assays for CTC enumeration to assess disease progression and response to therapy."

Celsee’s technology enables high-throughput analysis of single cells with industry-leading capture rates. The Genesis System supports two slide technologies. Celselect slides enrich and enumerate CTCs with high capture efficiency and detection rates. Celsingle slides use a gentle, gravity-based method to capture and isolate thousands of individual cells while maintaining viability and structural integrity for robust downstream analysis in both genomic and proteomic applications and improved sensitivity compared to other single-cell technologies.