Monthly Archives: June 2020

Orthocell adds to quality of board through appointment of new executive director – Proactive Investors UK

Posted: June 10, 2020 at 8:47 am

With a leading regenerative medicine portfolio and experienced senior advisory team, Orthocell is well-positioned to drive its products into the US, EU and AU markets.

() has enhanced the quality of its board through the appointment ofexperienced medical technology executive Leslie Wise, JD, as an executive director.

A point of strength for the Perth-based regenerative medicine company is the quality of advisors on its board and the key opinion leaders with whom they are closely connected, who are central to the way they innovate and do business.

As such,Wise, who has more than 20 years of specialist experience working in US reimbursement, life scienceand medtech fields, willstrengthen the company's strategy.

Orthocell managing director Paul Anderson said Wise was ideally suited to support the next phase of the companys development.

He said: We are delighted to welcome Leslie to the Orthocell board.

"Leslie has extensive experience in securing US market access and reimbursement for medical devices as well as serving in various senior management positions across large US medical device and pharmaceutical companies.

Leslies depth of knowledge and expertise is ideally suited to our product range and the next phase of growth for Orthocell.

Wise said: I am very excited to be joining Orthocell at this pivotal stage in the companys development.

Orthocell has one of the most advanced musculoskeletal regenerative medicine portfolios globally and is poised to leverage its impressive clinical evidence to drive towards the US, EU and AUS markets.

The timing could not be better for Orthocell as the broader Orthopaedic sector moves towards biologics and minimally invasive surgeries to deliver higher quality, more efficient and cost-effective solutions.

Leslie Wise, JD,has more than 20 years of specialist experience working in US reimbursement, life scienceand medtech fields

Wise has worked for both medical device and pharmaceutical companies, including Bristol Myers-Squib, Sanofi, Biomet Orthopedics and AngioDynamics, and is currently principal of EvidenceMatters, a Global Market Access consultancy.

Her skill set includes reimbursement, value evidence generation, clinical research strategy and frontline regulatory and payer experience, she has demonstrated experience in strategically integrating outcomes research, health policy analysis, payer insight, patient preference, along with stakeholder engagement and has been instrumental in creating new standards for reimbursement in the medtech space.

In recognition of her expertise, Wise was re-appointed to the Medicare Evidence Development Coverage and Advisory Committee (MEDCAC) for 2018-2020 and She also partnered with Advamed to facilitate the MedTech Value Summit inaugural event in Minneapolis in 2019.

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Orthocell adds to quality of board through appointment of new executive director - Proactive Investors UK

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SANUWAVE Health Enters Into Exclusive Letter of Intent to Acquire Celularity’s UltraMIST and Exclusive Partnership Rights for Wound Care Biologic…

Posted: June 10, 2020 at 8:47 am

Contemplated Transaction Would Create a Leading Provider of Advanced Wound Care Solutions that Improve Clinical Outcomes Across the Continuum of Care

SUWANEE, GA, June 10, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc.(OTCQB: SNWV)today announced that it has entered into an exclusive, non-binding letter of intent to acquire Celularitys UltraMIST Ultrasound Healing Therapy asset as well as exclusive partnership rights for Celularitys wound care biologic products. Celularity is a privately held, clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies, engineered from the postpartum human placenta, in cancer, infectious disease, and degenerative disease. SANUWAVE will conduct an investor teleconference at 9:00 a.m. EDT today to discuss how the contemplated acquisition is expected to broaden its wound care portfolio and enhance its financial profile.

UltraMISTand the Celularity wound care biologic products, Biovance and Interyl, are excellent complements to our dermaPACE System, said Kevin Richardson, SANUWAVE Chief Executive Officer. The contemplated acquisition would bolster our advance wound care portfolio and support our growth strategy to offer comprehensive advanced wound care solutions to improve clinical outcomes across the care pathway. The UltraMIST device is already established in over 900 wound care clinics and SANUWAVE will leverage their sales team to accelerate the penetration of dermaPACE into those facilities.

We are excited about the prospect to bring Celularitys wound care technologies and 25 dedicated wound care professionals to our team, Mr. Richardson continued. Together, we will apply shockwave and ultrasound science to bring differentiated offerings to key wound care solutions worldwide.

The transaction is expected to close in July 2020. The funding for the acquisition will consist of a mix of funded term debt and equity. Existing SANUWAVE shareholders, directors and officers have committed over $5 million at $0.25 per share to assist in completing the transaction.

SANUWAVE has engaged William Blair for investment banking services to arrange, negotiate and assist in the placement of debt capital for the proposed acquisition. William Blair is in advanced discussions with lenders for the debt capital.

The contemplated acquisition is expected to be a transformative event for SANUWAVE and to represent a strategically and financially compelling growth opportunity for the Company. The contemplated transaction would broaden SANUWAVEs addressable market and combines two highly complementary energy transfer technologies with two biologic skin substitute products to create a platform of scale with an end-to-end product offering in the advanced wound care market. Furthermore, it would uniquely position SANUWAVE to address the entire advanced wound care patient pathway from the initial stages of treatment to closure. The treatment combination of UltraMIST and the dermaPACE System would create a significant opportunity to demonstrate improved patient outcomes over the current standard of care, initially for diabetic foot ulcers and across all wound indications in the future.

SANUWAVE will conduct an investor teleconference at 9:00 a.m. EDT today. Investors can access this conference via the following:

Live webcast athttps://www.webcaster4.com/Webcast/Page/2249/35268

Live telephone:

Call 844-602-0380 within the U.S. or +1 862-298-0970 outside the U.S. Please join the call at least 10 minutes before the start time.

Webcast replay:

Go tohttps://www.webcaster4.com/Webcast/Page/2249/35268. The webcast replay will be available until Thursday, September 10, 2020.

Telephone replay:

Call 877-481-4010 within the U.S. or +1 919-882-2331 (for both U.S. and outside U.S., the access code is 35268). The telephone replay will be available until Wednesday, June 17, 2020.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVEs portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the bodys normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTrondevice, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotronand orthoPACEdevices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVEs shockwave technology for non-medical uses, including energy, water, food and industrial markets.

About Celularity Inc.

Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative, highly scalable off-the-shelf treatments for patients with cancer, infectious diseases, and degenerative diseases. To learn more, please visitwww.celularity.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companys ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Companys product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companys ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companys periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visitwww.sanuwave.com.

Contact:

Millennium Park Capital LLCChristopher Wynne312-724-7845cwynne@mparkcm.com

SANUWAVE Health, Inc.Kevin Richardson IICEO and Chairman of the Board978-922-2447investorrelations@sanuwave.com

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Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market 2019 Break Down by Top Companies, Countries, Applications, Challenges,…

Posted: June 10, 2020 at 8:46 am

A new market report by Market Research Intellect on the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

The research study includes the latest updates about the COVID-19 impact on the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) sector. The outbreak has broadly influenced the global economic landscape. The report contains a complete breakdown of the current situation in the ever-evolving business sector and estimates the aftereffects of the outbreak on the overall economy.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=235171&utm_source=COD&utm_medium=888

The report also emphasizes the initiatives undertaken by the companies operating in the market including product innovation, product launches, and technological development to help their organization offer more effective products in the market. It also studies notable business events, including corporate deals, mergers and acquisitions, joint ventures, partnerships, product launches, and brand promotions.

Leading Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) manufacturers/companies operating at both regional and global levels:

Sales and sales broken down by Product:

Sales and sales divided by Applications:

The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.

The report also focuses on the global industry trends, development patterns of industries, governing factors, growth rate, and competitive analysis of the market, growth opportunities, challenges, investment strategies, and forecasts till 2026. The Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market was estimated at USD XX Million/Billion in 2016 and is estimated to reach USD XX Million/Billion by 2026, expanding at a rate of XX% over the forecast period. To calculate the market size, the report provides a thorough analysis of the market by accumulating, studying, and synthesizing primary and secondary data from multiple sources.

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The market is predicted to witness significant growth over the forecast period, owing to the growing consumer awareness about the benefits of Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs). The increase in disposable income across the key geographies has also impacted the market positively. Moreover, factors like urbanization, high population growth, and a growing middle-class population with higher disposable income are also forecasted to drive market growth.

According to the research report, one of the key challenges that might hinder the market growth is the presence of counter fit products. The market is witnessing the entry of a surging number of alternative products that use inferior ingredients.

Key factors influencing market growth:

Reasons for purchasing this Report from Market Research Intellect

Customized Research Report Using Corporate Email Id @ https://www.marketresearchintellect.com/need-customization/?rid=235171&utm_source=COD&utm_medium=888

Customization of the Report:

Market Research Intellect also provides customization options to tailor the reports as per client requirements. This report can be personalized to cater to your research needs. Feel free to get in touch with our sales team, who will ensure that you get a report as per your needs.

Thank you for reading this article. You can also get chapter-wise sections or region-wise report coverage for North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

To summarize, the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

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Stem Cells Market 2019 Break Down by Top Companies, Countries, Applications, Challenges, Opportunities and Forecast 2026 – Cole of Duty

Posted: June 10, 2020 at 8:46 am

A new market report by Market Research Intellect on the Stem Cells Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

The research study includes the latest updates about the COVID-19 impact on the Stem Cells sector. The outbreak has broadly influenced the global economic landscape. The report contains a complete breakdown of the current situation in the ever-evolving business sector and estimates the aftereffects of the outbreak on the overall economy.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=207801&utm_source=COD&utm_medium=888

Leading Stem Cells manufacturers/companies operating at both regional and global levels:

Sales and sales broken down by Product:

Sales and sales divided by Applications:

The report also focuses on the global industry trends, development patterns of industries, governing factors, growth rate, and competitive analysis of the market, growth opportunities, challenges, investment strategies, and forecasts till 2026. The Stem Cells Market was estimated at USD XX Million/Billion in 2016 and is estimated to reach USD XX Million/Billion by 2026, expanding at a rate of XX% over the forecast period. To calculate the market size, the report provides a thorough analysis of the market by accumulating, studying, and synthesizing primary and secondary data from multiple sources.

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=207801&utm_source=COD&utm_medium=888

The market is predicted to witness significant growth over the forecast period, owing to the growing consumer awareness about the benefits of Stem Cells. The increase in disposable income across the key geographies has also impacted the market positively. Moreover, factors like urbanization, high population growth, and a growing middle-class population with higher disposable income are also forecasted to drive market growth.

Key factors influencing market growth:

Reasons for purchasing this Report from Market Research Intellect

Customized Research Report Using Corporate Email Id @ https://www.marketresearchintellect.com/need-customization/?rid=207801&utm_source=COD&utm_medium=888

Customization of the Report:

Thank you for reading this article. You can also get chapter-wise sections or region-wise report coverage for North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

To summarize, the Stem Cells market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

About Us:

Mr. Steven Fernandes

Market Research Intellect

New Jersey ( USA )

Tel: +1-650-781-4080

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Stem Cells Market 2019 Break Down by Top Companies, Countries, Applications, Challenges, Opportunities and Forecast 2026 - Cole of Duty

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Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with…

Posted: June 10, 2020 at 8:46 am

Company Announcement

Copenhagen, Denmark; June 4, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours. Patients currently on daratumumab IV will have the choice to switch to the SC formulation. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab. With consistent efficacy, and greater convenience for patients and health care providers with dosing time reduced from hours to just minutes and fewer infusion-related reactions, this formulation provides significant benefits for patients, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

About the COLUMBA (MMY3012) studyThe Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SC daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 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 Cycles 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) studyThe Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC 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 SC 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 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 is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: 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 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. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. 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 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 relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients 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.3 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

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 persons 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).1,4,5,6,7

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 and T-cell acute lymphocytic leukemia (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.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), has been approved in the U.S. for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 DARZALEX Prescribing information, April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf Last accessed April 20202 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed October 20193 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20204 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.5Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.6 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.7 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Company Announcement no. 24CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with...

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Insights on Global Regenerative Medicine Partnering Terms and Agreements (2014 to 2020) – ResearchAndMarkets.com – Business Wire

Posted: June 9, 2020 at 3:47 am

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Partnering Terms and Agreements 2014 to 2020" report has been added to ResearchAndMarkets.com's offering.

The Global Regenerative Medicine Partnering Terms and Agreements 2014-2020 report provides comprehensive understanding and unprecedented access to the regenerative medicine including cell therapy, organ regeneration, stem cells and tissue regeneration partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter Regenerative Medicine partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes.

This report provides details of the latest Regenerative Medicine agreements announced in the life sciences since 2014.

The report takes the reader through a comprehensive review Regenerative Medicine deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Regenerative Medicine partnering deals.

The report presents financial deal term values for Regenerative Medicine deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals.

The middle section of the report explores the leading dealmakers in the Regenerative Medicine partnering field; both the leading deal values and most active Regenerative Medicine dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market.

One of the key highlights of the report is that over 1100 online deal records of actual Regenerative Medicine deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal.

In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

Key benefits

Key Topics Covered:

Chapter 1 - Introduction

Chapter 2 - Trends in Regenerative Medicine dealmaking

2.1. Introduction

2.2. Regenerative Medicine partnering over the years

2.3. Most active Regenerative Medicine dealmakers

2.4. Regenerative Medicine partnering by deal type

2.5. Regenerative Medicine partnering by therapy area

2.6. Deal terms for Regenerative Medicine partnering

2.6.1 Regenerative Medicine partnering headline values

2.6.2 Regenerative Medicine deal upfront payments7

2.6.3 Regenerative Medicine deal milestone payments

2.6.4 Regenerative Medicine royalty rates

Chapter 3 - Leading Regenerative Medicine deals

3.1. Introduction

3.2. Top Regenerative Medicine deals by value

Chapter 4 - Most active Regenerative Medicine dealmakers

4.1. Introduction

4.2. Most active Regenerative Medicine dealmakers

4.3. Most active Regenerative Medicine partnering company profiles

Chapter 5 - Regenerative Medicine contracts dealmaking directory

5.1. Introduction

5.2. Regenerative Medicine contracts dealmaking directory

Chapter 6 - Regenerative Medicine dealmaking by technology type

Chapter 7 - Partnering resource center

7.1. Online partnering

7.2. Partnering events

7.3. Further reading on dealmaking

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/damlsx

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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COVID-19 Impact and Recovery Analysis- Regenerative Medicine Market 2020-2024 | Increasing Prevalence of Chronic Diseases to Boost Growth | Technavio…

Posted: June 9, 2020 at 3:47 am

Technavio has been monitoring the regenerative medicine market and it is poised to grow by USD 9.55 billion during 2020-2024, progressing at a CAGR of over 20% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200604005336/en/

Technavio has announced its latest market research report titled Global Regenerative Medicine Market 2020-2024 (Graphic: Business Wire)

Technavio suggests three forecast scenarios (optimistic, probable, and pessimistic) considering the impact of COVID-19. Request for Technavio's latest reports on directly and indirectly impacted markets. Market estimates include pre- and post-COVID-19 impact on the Regenerative Medicine Market Download free sample report

The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Allergan Plc, Amgen Inc., Hitachi Chemical Co. Ltd., Integra LifeSciences Holdings Corp., Medtronic Plc, MiMedx Group Inc., Organogenesis Holdings Inc., Smith & Nephew Plc, Takeda Pharmaceutical Co. Ltd., and Zimmer Biomet Holdings Inc. are some of the major market participants. The increasing prevalence of chronic diseases will offer immense growth opportunities. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

View market snapshot before purchasing

The increasing prevalence of chronic diseases has been instrumental in driving the growth of the market. However, uncertainties in regulatory approval might hamper market growth.

Technavio's custom research reports offer detailed insights on the impact of COVID-19 at an industry level, a regional level, and subsequent supply chain operations. This customized report will also help clients keep up with new product launches in direct & indirect COVID-19 related markets, upcoming vaccines and pipeline analysis, and significant developments in vendor operations and government regulations. https://www.technavio.com/report/regenerative-medicine-market-industry-analysis

Regenerative Medicine Market 2020-2024: Segmentation

Regenerative Medicine Market is segmented as below:

To learn more about the global trends impacting the future of market research, download a free sample: https://www.technavio.com/talk-to-us?report=IRTNTR41171

Regenerative Medicine Market 2020-2024: Scope

Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. Our regenerative medicine market report covers the following areas:

This study identifies the increasing number of clinical trials as one of the prime reasons driving the regenerative medicine market growth during the next few years.

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Regenerative Medicine Market 2020-2024: Key Highlights

Table of Contents:

Story continues

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Technology

Customer Landscape

Geographic Landscape

Drivers, Challenges, and Trends

Vendor Landscape

Vendor Analysis

Appendix

About Us

Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005336/en/

Contacts

Technavio ResearchJesse MaidaMedia & Marketing ExecutiveUS: +1 844 364 1100UK: +44 203 893 3200Email: media@technavio.com Website: http://www.technavio.com/

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COVID-19 Impact and Recovery Analysis- Regenerative Medicine Market 2020-2024 | Increasing Prevalence of Chronic Diseases to Boost Growth | Technavio...

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Stem Cell Therapy Designed To Treat Severely Ill Coronavirus Patients Being Tested In Maryland – CBS Baltimore

Posted: June 9, 2020 at 3:47 am

BALTIMORE (WJZ) A stem cell therapy trial for the most critically ill coronavirus patients is underway in Maryland.

Researchers at the University of Maryland School of Medicine are trying to save the maximum number of patients who are significantly sickened by the virus and reduce the mortality rate.

Thanks to a sponsorship by Australian regenerative medicine company Mesoblast, the stem cell therapy trial is underway at several sites across the U.S., including in Maryland.

The therapy involves 300 people hospitalized with COVID-19 with moderate to severe acute respiratory distress syndrome.

These are patients that are intubated, requiring great support for their lung function, Dr. Sunjay Kaushal with the University of Maryland said.

CORONAVIRUS RESOURCES:

COVID-19 patients often become very ill from an escalated immune response referred to as a cytokine storm, which creates high levels of inflammation that can be fatal. The experimental stem cell therapy called remestemcel-L, which has been developed for various inflammatory conditions like what is being seen with the coronavirus, aims to block or mitigate that response, Kaushal said.

Were trying to extrapolate from what they have been shown to be efficacious in trying to treat before and trying to use that type of therapy now for COVID-19 patients, he said.

Once the final results from the trial are available, which could take between six and eight months, researchers hope to reach even more patients.

Were excited, weve seen some early signs that these cells may be efficacious, Kaushal said.

Ultimately, their hope is to provide a new treatment for those suffering from the worst cases of COVID-19.

Were hoping we can save a lot of patients lives, Kaushal said.

For the latest information on coronavirus go to the Maryland Health Departments website or call 211. You can find all of WJZs coverage on coronavirus in Maryland here.

Excerpt from:
Stem Cell Therapy Designed To Treat Severely Ill Coronavirus Patients Being Tested In Maryland - CBS Baltimore

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Akouos Aims for an IPO to Advance Hearing Loss Gene Therapy to Clinic – Xconomy

Posted: June 9, 2020 at 3:47 am

XconomyBoston

Hearing loss can stem from a variety of reasons, but in rare cases its caused by genetic defects. Akouos is developing a gene therapy to address these problems and its planning an IPO to finance the first tests of its approach in humans.

In paperwork filed with regulators late Friday, Boston-based Akouos set a preliminary $100 million goal for its IPO.

The first target for Akouos is hearing loss due to mutations in the OTOF gene, which encodes a protein called otoferlin. Hearing happens when tiny hair cells in the inner ear pick up vibrations and turn them into signals that the brain interprets as sound. Otoferlin is key to this process, as it enables the sensory cells of the ear to release tiny membranes carrying neurotransmitters, Akouos says in its filing. These neurotransmitters activate auditory neurons, which in turn relay the information to the brain where it is recognized as sound.

Those who have OTOF gene mutations are typically born deaf. There are currently no FDA-approved therapies for this form of hearing loss. The experimental Akouos gene therapy, AK-OTOF, is intended to deliver a functioning version of the OTOF gene with the goal of restoring proper otoferlin expression.

The Akouos therapy is delivered using an engineered version of adeno-associated virus (AAV), an approach used by some FDA-approved gene therapies marketed by other companies for other diseases, as well as for some gene therapies still in development. But the anatomy of the inner ear presents challenges for AAV gene therapy delivery, the company says in its filing. Also, AAV has a limited capacity for carrying a genetic payload.

To overcome those limitations, Akouos uses synthetic AAVs that recreate naturally occurring viruses called ancestral AAVs, which the company says can reach the target in the ear. Furthermore, the company uses a dual vector approach that employs two engineered viruses, each carrying a fragment of the OTOF gene. The Akouos approach to gene therapy is based on the research of Luk Vandenberge, director of the Grousbeck Gene Therapy Center in Boston and a professor at Harvard Medical School. In mouse studies, Akouos says AK-OTOF delivered its genetic payload to the inner ear hair cells, restoring auditory function. Now the company wants to test its technology in humans.

Paperwork seeking FDA permission to start a clinical trial is on track to be submitted in 2021, Akouos says in its filing. If all goes as planned, the company expects to report preliminary data from the clinical trial the following year.

Akouos isnt the only company developing new treatments for inherited forms of hearing loss.Decibel Therapeutics is also developing a gene therapy to address the same genetic protein deficiency that Akouos is targeting. The Boston-based companys experimental gene therapy, DB-OTO, is in preclinical development with partner Regeneron Pharmaceuticals (NASDAQ: REGN). Otonomy (NASDAQ: OTIC), in San Diego, is advancing a preclinical gene therapy program intended to address hearing loss caused by mutations in another key gene, GJB2. Frequency Therapeutics (NASDAQ: FREQ) is addressing hearing loss caused by the loss of hair cells in the inner ear. The Woburn, MA-based company is developing a regenerative medicine approach that coaxes the regrowth of these hairs.

Akouos was founded in 2016 and unveiled $50 million in financing two years later. In March, the company closed a $105 million Series B round of financing that added crossover investors. The biggest shareholders in Akouos prior to the IPO are 5AM Ventures and New Enterprise Associates, which own about 21.6 and 18.5 percent respectively, according to the filing.

Akouos has applied for a listing on the Nasdaq under the stock symbol AKUS. If the company successfully completes the IPO, it says it will apply the capital toward clinical development of AK-OTOF, as well as the preclinical development of other programs in its pipeline.

Image: iStock/iLexx

Frank Vinluan is an Xconomy editor based in Research Triangle Park. You can reach him at fvinluan@xconomy.com.

Originally posted here:
Akouos Aims for an IPO to Advance Hearing Loss Gene Therapy to Clinic - Xconomy

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Miracle cures and fast-track approval threatens medical advances, say scientists – The University of Manchester

Posted: June 9, 2020 at 3:47 am

Prof Volker ter Meulen, Co-chair of the EASAC-FEAM working group and past president of EASAC, said: Stem cell and gene-based therapies hold great medical promises. But we are alarmed over a trend to lower requirements of evidence. Also, we see an increasing problem of commercial clinics offering unregulated products and services.

The Academies say the idea of regenerative medicine is to tackle diseases which up to now are incurable. According to the report, cosmetic applications are inappropriate for the time being.

So far, regenerative medicine has proven itself only in few specific clinical indications, for example for skin disorders. Yet, we see an increasing number of unregulated clinics promising a wide range of benefits based on poorly characterised medicinal products with little evidence of effectiveness. They usually advertise their services via the internet with the primary intention of financial profit, explains EASAC Biosciences Programme Director, Dr Robin Fears.

The scientists urge the EU to resist the pressure and put patients first:When countries lower regulatory standards in their eagerness to support national economic interests, it is even more important for the EU as a major global player to defend the principles of international cooperation in health regulation, says Prof George Griffin, Co-chair of the working group and President of FEAM.

We all want cures to be available in the shortest time frame possible. But our analysis and recommendations aim at ensuring that regulatory procedures are robust, transparent and evidence-based, concludes Cossu. Scientific research and proof are more important than ever. The EU and national regulators should be wary of not undermining public trust in science.

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Miracle cures and fast-track approval threatens medical advances, say scientists - The University of Manchester

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Insights on Global Regenerative Medicine Partnering Terms and Agreements (2014 to 2020) – ResearchAndMarkets.com – Business Wire

COVID-19 Impact and Recovery Analysis- Regenerative Medicine Market 2020-2024 | Increasing Prevalence of Chronic Diseases to Boost Growth | Technavio…

Stem Cell Therapy Designed To Treat Severely Ill Coronavirus Patients Being Tested In Maryland – CBS Baltimore

Akouos Aims for an IPO to Advance Hearing Loss Gene Therapy to Clinic – Xconomy

Miracle cures and fast-track approval threatens medical advances, say scientists – The University of Manchester

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