On October 13, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, reported preliminary first quarter fiscal year 2023 Vyleesi product sales results (Press release, Palatin Technologies, OCT 13, 2022, View Source [SID1234621987]). Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

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"We are pleased with Vyleesi’s continued quarter over quarter growth on net product revenue and prescriptions dispensed for the quarter ended September 30, 2022," stated Carl Spana, Ph.D., President and CEO of Palatin. "We are especially pleased with our prescription refill rate, which now exceeds 50% of total prescriptions dispensed, and is the top indicator of patient satisfaction with Vyleesi."

Preliminary Vyleesi product sales results for the first fiscal quarter of 2023 ended September 30, 2022:
Net product revenue for prescriptions dispensed increased 20% to $856,000 over the prior quarter;
increased 400% over the comparable quarter in fiscal 2022.
Total prescriptions dispensed increased 17% over the prior quarter;
increased 108% over the comparable quarter in fiscal 2022.
Preliminary Financial Information
The Vyleesi related financial and operating data for the first fiscal quarter of 2023 is preliminary and may change. This preliminary data has been prepared by, and is the responsibility of, Palatin’s management and no independent accounting firm has audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial data. There can be no assurance that Palatin’s actual results for this quarterly period will not differ from the preliminary financial and operating data and such changes could be material. In addition, Palatin’s estimate of Vyleesi product sales for the quarter ended September 30, 2022 should not be viewed as a substitute for full financial statements prepared in accordance with U.S. generally accepted accounting standards. Additional information that will be material to investors will be provided in the financial statements for the three months ended September 30, 2022, and, accordingly, investors should not place undue reliance on the limited preliminary information being provided herein.

About Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD. Palatin is actively seeking Vyleesi collaborations for the United States and for territories outside the currently licensed territories of China and Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com.

On October 13, 2022 XBiotech (NASDAQ: XBIT) reported the enrollment of the first patient in a multicenter, randomized clinical study for Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer (Press release, XBiotech, OCT 13, 2022, View Source [SID1234621986]). The much anticipated clinical study for XBiotech’s candidate cancer treatment is being funded by the French National Cancer Institute (INCA). The study is headed by renown oncologists Dr. François Ghiringhelli and Dr. Come Lepage, Professor in Medical Oncology and Director of the INSERM research team at the Georges-Francois Leclerc Cancer Centre, and Professor at the Department of Gastroenterology and Digestive Oncology, University Hospital Dijon, Dijon, France, respectively.

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Investigators are combining XBiotech’s Natrunix with trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer. Subjects receiving the experimental therapy have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. Subjects are randomized to receive Natrunix plus trifluridine/tipiracil chemotherapy or placebo plus the chemotherapy. The study is designed to seamlessly proceed through Phase III development based on achievement of certain efficacy milestones in the Phase I/II portions.

Natrunix is a therapeutic monoclonal antibody discovered, manufactured, and undergoing clinical development by XBiotech. The antibody blocks the activity of substance produced by tumors and inflammatory cells that stimulates new blood vessel formation and breaks down connective tissue at the site of the tumor, allowing tumors to grow and spread. The same substance also activates blood vessels, making them sticky to enhance migration of circulating tumor cells to new sites of metastasis. Natrunix potently blocks the action of the substance, known as IL-1, which is also produced in response to chemotherapy.

Colorectal cancer is one of the most common forms of cancer in Europe and the United States, with the American Cancer Society’s estimating over 151,000 new cases and over 52,000 deaths annually in the United States alone.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On October 13, 2022 Celdara Medical, LLC reported that the National Cancer Institute (NCI) of the National Institutes of Health (NIH) has awarded a Phase II Small Business Innovation Research (SBIR) Fast-Track grant to fund company’s ongoing development of CM-CX1, a chimeric antigen receptor (CAR) T cell therapy for the treatment of ovarian clear cell and renal cell carcinomas (Press release, Celdara Medical, OCT 13, 2022, View Source [SID1234621985]).

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Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, remarked, "We’re very grateful to the NCI for their continued support of this program. As the field begins to see the potential of CAR-T in solid tumors realized, the fundamental importance of target selection comes once again into focus. We’re working hard to bring CM-CX1 to the clinical for the benefit of patients with renal cell or ovarian clear cell carcinomas, or indeed for any patient whose tumor expresses CM-CX1’s target."

"I have been working closely with our industry and academic partners to identify ideal targets for cellular therapies and we have created something unique with CM-CX1", said Dr. Joana Murad Mabaera, Executive Director of Research at Celdara Medical and lead Principal Investigator on the study. "We have made significant progress in Phase I towards the preclinical development of CM-CX1. The Phase II funding will enable the submission of our Investigational New Drug (IND) application to bring CM-CX1 to clinic. With CM-CX1, we have an exciting opportunity to translate our promising research and make this therapeutic option accessible to patients of ovarian and renal carcinomas."

Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under award number R44CA265424-02. The content is solely the responsibility of Celdara Medical and does not necessarily represent the official views of the National Institutes of Health.

On October 13, 2022 JSR Corporation (Representative Director, CEO: Eric Johnson, "JSR") reported that it has signed a Share Purchase Agreement to acquire the 60% of shares held by PERI Corporation ("PERI") and make JSR Electronic Materials Korea Co., Ltd. ("JEMK") a wholly owned subsidiary of JSR (Press release, JSR, OCT 13, 2022, View Source [SID1234621984]). JEMK is a joint venture between PERI and JSR, which is the sales agent/distributor of its Electronic Materials business in Korea.

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JEMK was established in 2014 and has contributed the growth and expansion of JSR’s electronic materials business in Korea. With the current progress, and full-fledged development of cutting-edge technologies at customers, including the metal oxide resist of Inpria Corporation acquired in October 2021, it becomes increasingly important for JSR to promote businesses in closer relationships with customers. Given this environment, JSR decided to make JEMK a wholly-owned subsidiary and promote greater customer satisfaction and faster service delivery through integrated group management. Going forward, JSR will collaborate with JSR Micro Korea Co., Ltd. to strengthen critical functions such as research and development.

By making JEMK a wholly owned subsidiary, JSR will further strengthen the global collaboration of its semiconductor materials business and build a system that enables solutions quickly and smoothly, which will lead to further customer and product portfolio expansion.

On October 13, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the certification of its leading in-vitro diagnostic (IVD) kit and its fully automated NeuMoDx platforms under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR) replacing the previous IVDD rules since May (Press release, Qiagen, OCT 13, 2022, View Source [SID1234621983]). The ipsogen JAK2 RGQ PCR Kit used for myeloproliferative neoplasms (MPN), a certain type of blood cancer, is now QIAGEN’s first IVD kit with IVDR CE-marking under Class C.

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The updated set of rules that became effective May 26, 2022, is now imposing higher and broader requirements on IVD manufacturers to receive CE-marking for their products. For example, the change includes a new risk-based classification system that ranks all IVDs from A for lowest to D for highest risk, as well as a stronger oversight by independent EU-designated organizations, so-called Notified Bodies. With its more stringent mandates, the European regulatory framework comes closer to the FDA IVD regulations in the US. The new EU regulation will ensure a higher level of protection further reinforcing patient safety. It will allow laboratories to work with high-end reagents, further increasing the quality of their results.

QIAGEN is committed to the highest standards of quality and has therefore pledged full compliance with the new rules, which apply to all manufacturers commercializing IVD medical devices on the EU market. Last year QIAGEN completed the required audit of its quality management system (QMS) through a notified body without major observation – also related to IVDR – marking a first key milestone towards the company’s IVDR compliance. Based on this result, QIAGEN will continue to submit technical documentation in order to receive certifications across the entire IVD portfolio.

With the certification of its leading IVD kit and NeuMoDx platform, the company has now reached another significant milestone in its preemptive and meticulous campaign to timely transition over 180 products that fall within the scope of IVDR. The IVD kit is now classified under Class C, according to the new regulation. The ipsogen JAK2 RGQ PCR Kit provides highly sensitive and accurate leukemia biomarker detection, supporting the evaluation of suspected MPN patients, as well as monitoring those already diagnosed. The NeuMoDx rapid, integrated PCR testing platforms for mid- and high throughput are now classified under Class A and currently offer 16 regulated assays for different infectious diseases in Europe.

"Building on our extensive regulatory experience, QIAGEN experts across our business areas are working tirelessly to ensure QIAGEN’s global quality management and products are IVDR-ready and compliant," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. "Our customers can expect to receive certified and approved products from QIAGEN, and will profit from improved clinical performance thanks to this enhanced, sustainable and transparent regulatory framework. In addition, they will benefit from our lab-developed test capabilities of our NeuMoDx offering that will not be impacted by the new regulatory framework."

The transition period for IVDs has ended on May 26, 2022, but has been extended under certain conditions. However, European labs and clinicians supplied by QIAGEN can approach the transition with confidence, as the company has been at the forefront of developing and implementing the new regulations.

Following this significant step in the transition to new EU standards, passing the QMS audit and obtaining the product’s declaration of conformity, QIAGEN will now commence implementation of the updated labelling for these products over the coming month and will announce the release of individual products accordingly.