On October 28, 2021 PharmaMar Group (MSE: PHM) reported that recurring revenues, comprising net sales plus royalties received from sales by our partners, increased by 31% year-on-year to €119 million for the first 9 months of the year (Press release, PharmaMar, OCT 28, 2021, View Source [SID1234596672]).

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As in previous quarters, the increase in recurring revenues was mainly driven by the good performance of our oncology business unit. Oncology sales revenues reached €88.7 million year-to-date in 2021, an increase of 21% compared with the same period last year.

It is worth highlighting the growth in revenues from Zepzelca (lurbinectedin) in Europe under the compassionate use authorization program, which amounted to €23.3 million through September 30th. This represents an increase of 77.7% when compared with the same period last year. Yondelis (trabectedin) sales remained stable in 9M 2021, €56.5 million compared to €57.1 million in 9M 2020.

Royalty revenues amounted to €27.2 million in 9M 2021, compared to €7.4 million over the same period in 2020. This significant increase was mainly driven by royalties received from our partner Jazz Pharmaceuticals, which accounted for €25.2 million and have been entirely generated as a result of sales of lurbinectedin in the US. As our partner Jazz Pharmaceuticals has not reported its 3Q 2021 results yet, our recorded 3Q 2021 royalties are an estimate based on our conservative, best available information.

Revenues from licensing agreements refer, both in 2020 and in 2021, to the licensing agreement signed with Jazz Pharmaceuticals in 2019, reaching €24.4 million in 3Q 2021, and €130.4 million in 3Q 2020. This difference is due to the recording as revenue of the upfront payment for the license agreement, as well as the milestone for the approval of lurbinectedin in the US. Both events occurred in the first half of 2020 and are being recognized on the income statement, based on the degree of progress of the contractual commitments.

PharmaMar plans to commence a confirmatory trial with lurbinectedin in second-line recurrent Small-Cell Lung Cancer at the end of 2021. This will be a three-arm clinical trial comparing lurbinectedin in monotherapy or in combination with irinotecan, versus the investigators’ choice of irinotecan or topotecan. If positive, this trial will be used with the US FDA to confirm the benefit of lurbinectedin in the treatment of Small-Cell Lung Cancer when patients progress after first-line treatment with a platinum-based regimen, as well as with the European Medicine Agency as a registration trial in Europe.

GENOMICA, PharmaMar Group’s molecular diagnostics company, reported net revenues of €3.5 million up to September 30th, 2021, compared to €10.5 million in the same period of 2020. This difference was mainly due to increased competition in the market for COVID-19 tests, both PCR, lateral flow and antibody tests, which led to lower prices. Similarly, the decrease in the incidence of COVID-19 has considerably reduced the use of these tests.

As a result, PharmaMar Group’s total revenues for the first 9 months of 2021 amounted to €143.9 million, compared to €222.2 million over the same period of 2020, which, as mentioned above, included the upfront payment for the licensing agreement with Jazz Pharmaceuticals and the milestone payment for the approval of
lurbinectedin in the US.

The Group’s R&D expenditure increased by 21.2% to €47.4 million during the first nine months of 2021, compared with €39.1 million in the same period last year.

As a result, PharmaMar Group posted a net profit of €54.7 million on September 30th, 2021.

As of September 30th, 2021, the PharmaMar Group had cash, and cash equivalents, plus financial investments of €222.0 million and a total debt of €50.7 million. As a result, total net cash amounted to €171.3 million.

Earnings conference call for analysts and investors

PharmaMar will hold a conference call with analysts and investors on Friday, October 29th at 1:00 pm (CEST). The numbers to connect to the teleconference are +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participant access code: 296923.

The teleconference and recording will be available on PharmaMar’s website, by visiting the Events Calendar section of the company’s website at www.pharmamar.com.

On October 28, 2021 Amgen (NASDAQ: AMGN) reported that it will report its third quarter financial results on Tuesday, November 2, 2021, after the close of the U.S. financial markets (Press release, Amgen, OCT 28, 2021, View Source [SID1234592090]). The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On October 28, 2021 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported that it has appointed Jan D. De Witte as its next President and Chief Executive Officer (Press release, Integra LifeSciences, OCT 28, 2021, View Source [SID1234592107]). Mr. De Witte succeeds Peter J. Arduini, who previously announced he will step down as Chief Executive Officer to accept the role of President and Chief Executive Officer of GE Healthcare. Mr. De Witte will join Integra prior to the end of the year, at which time he will also be appointed to Integra’s board of directors.

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With over two decades in the healthcare industry, De Witte brings global public company leadership experience as well as deep technological, operational and commercial expertise to Integra. For the past five years, De Witte served as Chief Executive Officer of Barco N.V. (Euronext: BAR), where he created shareholder value through digital innovation and new product development, commercial acceleration, international market growth and operational excellence while effectively leading the company through the COVID-19 pandemic. In addition, De Witte spent 17 years in senior-level leadership roles at GE, including serving as President and CEO of GE Global Healthcare IT, where he had full global P&L

responsibility for product management, technology and software development, commercialization, services and solutions delivery. Prior to GE, De Witte spent five years in strategic consulting at McKinsey and three years in operations at Procter & Gamble (NYSE: PG). De Witte currently serves on the Board of Directors of ResMed (NYSE: RMD, ASX: RMD), a global leader in digital health technologies and cloud-connected medical devices that transform care for people with sleep apnea, COPD and other chronic diseases.

Integra’s special board committee on CEO succession partnered with Heidrick & Struggles to conduct a comprehensive search that included interviewing and evaluating a talented slate of internal and external candidates.

"We are thrilled to have Jan join Integra at this exciting time in the company’s history. Jan is a proven global business leader with extensive C-level experience at internationally-recognized companies. His deep experience in healthcare and technology, commitment to advancing sustainability and proven ability to develop and commercialize innovative new products led the board to select Jan as Integra’s next CEO. His values around inclusivity, integrity and accountability are highly aligned with Integra’s people-first culture. We look forward to Jan’s start later this year and his many future contributions to Integra," said Stuart Essig, Chairman of Integra’s board of directors.

"I would like to express my genuine appreciation to Pete for his 11 years of leadership. Pete shaped Integra into the company it is today, and we wish him all the best in his next endeavor," concluded Essig.

Mr. De Witte stated, "I am honored and excited to be joining Integra and a very talented and dedicated team. The company has a rich history of global leadership in neurosurgery with some of the most recognized brands in plastic and reconstructive surgery. I look forward to building on an already strong foundation to drive value for all our stakeholders. To the 3,700 employees around the world, I am delighted to join such an engaged and entrepreneurial culture and look forward to working with you to further elevate Integra’s impact around the world."

Mr. De Witte holds a master’s of science degree in electromechanical engineering with greatest distinction from the KU Leuven in Belgium and a master’s degree in business administration from Harvard University. He has lived and worked in seven countries, with much of his career spent in the U.S., and is fluent in three languages. He is also a dedicated community leader.

On October 28, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported its EsoGuard Esophageal DNA Test has been selected as winner of the "Diagnostics Innovation of the Year" award in the inaugural awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe (Press release, Lucid Diagnostics, OCT 28, 2021, View Source [SID1234592140]).

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"Lucid Diagnostics is empowering clinicians to save lives by accurately detecting esophageal precancer in an office setting at a stage when it can be effectively managed or treated to prevent progression to highly lethal esophageal cancer"

"We are honored to have Lucid’s EsoGuard recognized as BioTech Breakthrough’s inaugural ‘Diagnostics Innovation of the Year’," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "This award adds to a growing list of accolades and recognition for Lucid’s products, including a prestigious 2020 Edison Best New Product Award, a National Cancer Institute highlight as one of the year’s significant advances in cancer prevention in its 2020 report to Congress, and FDA Breakthrough Device Designation indicating the potential to offer more effective diagnosis or treatment of life-threatening diseases."

"We believe EsoGuard, the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through early detection of precancer, could have as great an impact as widespread screening has had in preventing breast, colon, and cervical cancer deaths," Dr. Aklog added.

The mission of the annual BioTech Breakthrough Awards program is to conduct the industry’s most comprehensive analysis and evaluation of the top technology companies, solutions, and products in the life sciences and biotechnology industry today. This year’s program attracted more than 1,200 nominations from over 12 different countries throughout the world.

"Lucid Diagnostics is empowering clinicians to save lives by accurately detecting esophageal precancer in an office setting at a stage when it can be effectively managed or treated to prevent progression to highly lethal esophageal cancer," said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards. "Congratulations on being our choice for the ‘Diagnostics Innovation of the Year award."

Gastroesophageal reflux disease (GERD), also known as chronic heartburn, is ubiquitous and can lead to a highly lethal form of esophageal cancer (EAC). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease.

All EAC is believed to arise from esophageal precancer which occurs in up to 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored until it progresses to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer. Screening is already recommended by clinical practice guidelines in many millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, less than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment. The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard is that missing element.

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient multicenter case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer. EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at a CLIA/CAP-certified laboratory. At-risk GERD patients can undergo the EsoCheck procedure for EsoGuard testing at gastroenterology physician offices or at a growing network of Lucid Test Centers.

On October 28, 2021 GenesisCare — one of the leading oncology providers in the United States, Australia, Spain, and the United Kingdom — reported it will be expanding access to the novel fluorinated prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging capabilities in its Florida, South Carolina, and Texas centers (Press release, GenesisCare, OCT 28, 2021, View Source [SID1234592156]). They plan to rapidly accelerate PSMA PET access at all U.S. GenesisCare sites by Q2 2022.

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A PSMA PET scan uses a small amount of a radioactive tracer such as PYLARIFY (piflufolastat F 18), the first and only commercially available FDA-approved PSMA PET imaging agent for prostate cancer. PYLARIFY targets and binds to the PSMA protein, which is found on nearly all prostate cancer cells, and lights up on a scan to pinpoint where cancer is located.

Prostate cancer is the second leading cause of cancer-related death for men in the United States. Finding novel approaches and standards to treat prostate cancer is critical. PSMA PET scanning is instrumental in advancing novel approaches, precision medicine, and standard of care for prostate cancer treatment. This revolutionary approach makes smaller lesions visible with greater accuracy than traditional CT or Tc bone scans, enabling oncologists to determine disease progression and adjust treatment more easily.

GenesisCare patients, like retired attorney Leonard Bitterman of Boca Raton, who received the first injection of PYLARIFY in the U.S. on June 3, 2021, have experienced improved outcomes and quality of life. "This new process has taken the guesswork out of my prostate cancer journey," said Bitterman. "My wife and I now have greater peace of mind with this new treatment and feel comfortable living life to its fullest."

"PSMA PET is a revolutionary diagnostic tool we’re now offering nationwide that allows doctors to see metastatic or recurrent prostate cancer earlier – anywhere in the body. This is a game-changer that will have a tremendous impact for patients across the U.S.," said Dan Collins, Founder and CEO, GenesisCare. "Through continued collaborations with medical imaging and theranostics leaders like Lantheus, GE, Telix and Clarity, and our leading team of global theranostics experts, we are able to bring the latest breakthroughs in cancer diagnostics and treatment to more patients, much faster."

"Innovative diagnostic tools like PSMA PET provide more accurate and earlier detection of disease than conventional imaging so our clinicians, along with their patients and families, can make more informed treatment decisions that lead to improved outcomes," stated Neal D. Shore, M.D. FACS, GenesisCare Chief Medical Officer of Urology and Surgery and National Urology Research Director. "We are very excited to offer PSMA PET imaging with the first FDA-approved and commercially available PSMA PET prostate cancer imaging agent, PYLARIFY, to all of our patients throughout the U.S."