On January 6, 2022 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biopharmaceutical company with a portfolio of innovative, late-stage product candidates, reported preliminary net product revenue of NURTEC ODT (rimegepant) for the fourth quarter of 2021 (Press release, Biohaven Pharmaceutical, JAN 6, 2022, View Source [SID1234598503]).

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Based on preliminary unaudited financial information, the Company reported approximately $190 million in net product revenue from sales of NURTEC ODT in the fourth quarter of 2021 and approximately $462 million in net product revenue for 2021. There were no material changes in channel inventory days over the course of the year.

The foregoing information reflects the Company’s estimate with respect to net product revenue for NURTEC ODT based on currently available information, which is preliminary and unaudited, is not a comprehensive statement of the Company’s financial results and is subject to completion of the Company’s financial closing procedures. The Company’s final results, which will be issued upon completion of its closing procedures, may vary from these preliminary estimates.

Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven commented, "NURTEC ODT has changed the treatment paradigm for migraine with its dual-acting, acute and preventive indications. NURTEC ODT established itself as the market leading novel migraine therapy in 2021 and generated an impressive $462 million in net product revenue for the year. The dual indications offer healthcare providers and their patients a single treatment they can customize to treat and prevent migraine attacks. We remain steadfast in our commitment to the migraine community to support programs that drive awareness of migraine and the importance of effective treatment to reduce disability."

Approximately 40 million people in the U.S. and more than one billion individuals worldwide suffer from migraine. Migraine is the third most prevalent illness in the world and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses.

BJ Jones, Chief Commercial Officer, Migraine & Common Disease, added, "Every day we hear from patients and healthcare providers about the benefits of using NURTEC ODT to help stop a migraine attack quickly and prevent the next one. The overwhelming number of patients that share the positive impact that NURTEC ODT has for them
continues to inspire our team to do more to help those suffering from migraine. Our team is dedicated to continuing to deliver NURTEC ODT to as many patients as possible, especially during times of stress in the pandemic."
NURTEC ODT 75 mg is the only migraine medication approved as a dual therapy for both acute and preventive treatment, and is the first oral CGRP receptor antagonist approved for the preventive treatment of migraine. NURTEC ODT targets a key driver of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. A single dose of NURTEC ODT can deliver fast pain relief with some patients returning to normal function by 60 minutes and has a lasting effect of up to 48 hours for many patients. NURTEC ODT can be taken up to once daily, up to 18 doses/month, as needed to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. NURTEC ODT does not have addiction potential and is not associated with medication overuse headache or rebound headache.

NURTEC ODT was approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021 with commercial launch commencing within weeks of the approvals.

On January 6, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it will participate in the 40th Annual J.P. Morgan Healthcare Conference on January 10-13, 2022 (Press release, Galapagos, JAN 6, 2022, View Source [SID1234598491]).

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Onno van de Stolpe, CEO, will present on Thursday, January 13 at 14.15 CET (8.15 a.m. ET). The presentation will be a live audio webcast and can be accessed via the following link. A replay of the webcast will be available on the Galapagos’ website at www.glpg.com.

On January 6, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate in a pre-recorded fireside chat at the H.C. Wainwright Bioconnect Virtual Conference (Press release, Xencor, JAN 6, 2022, View Source [SID1234598398]).

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The on-demand recording will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com beginning Monday, January 10, 2022 at 4:00 a.m. PT and will be available on the website for at least 30 days.

On January 6, 2022 The Global Liver Institute (GLI), the only patient-led liver health nonprofit operating internationally, in partnership with TriSalus Life Sciences, an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors, reported the launch of Liver Central, a comprehensive online guide for all things related to liver cancer (Press release, TriSalus Life Sciences, JAN 6, 2022, View Source [SID1234598397]).

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Liver Central provides a central location for those seeking educational materials about the liver and liver cancers, including treatment options and ongoing clinical trials. With founding support from TriSalus Life Sciences, GLI developed this new resource to fill a significant gap in the availability of educational resources and tools. Liver Central will be regularly updated with the latest information on the central role the liver plays in overall health, immunological pathways that impact liver tumor progression and resistance to therapies, as well as treatment approaches and guidelines for various types of liver cancer.

"The growing burden of liver cancer is deeply concerning as more patients hear the words ‘you have liver cancer’ and are left with few treatment options. LiverCentral.org is designed to raise awareness of this vital organ and provide answers for patients and clinicians looking for information and new approaches to treat this devastating disease," said Donna Cryer, founder and CEO of the Global Liver Institute, and a 27-year liver transplant recipient.

"Our hope is that Liver Central will serve as an enduring educational resource to support patients, clinicians and researchers along the cancer care continuum," said Steven C. Katz, MD, FACS, chief medical officer at TriSalus. "We want to raise awareness as to how unique the liver is in general, and with respect to how liver immune function creates therapeutic challenges for cancer patients. As we work to bring multi-modality approaches to better address these challenges and ensure more patients can benefit from the promise of immunotherapy, we are grateful for the opportunity to partner with GLI to develop this resource and advance care for patients living with liver tumors."

In a recent discussion on GLI LIVE, GLI’s weekly educational program that provides tailored information for patients living with liver diseases on a variety of timely topics, Dr. Katz and Ms. Cryer highlighted Liver Central’s functionality for experienced and new patients alike. During their discussion, they spoke at length about the critical need to reinvent liver cancer education, tailor therapeutic approaches based on the unique biology of the liver, and how a central hub of information can bring about positive change in a patient’s experience with liver cancer.

Over the last several decades the percentage of Americans who develop liver cancer has grown.[1] Liver cancer is among the leading causes of cancer death worldwide with more than 800,000 people diagnosed annually.1 Additionally, the liver is one of the most common sites of metastatic cancer. Liver metastases – not the primary cancer – are often the cause of mortality. In fact, for colorectal cancer patients whose cancer has metastasized to the liver, the 5-year survival rate is only 11%.[2]

Today, patients urgently need new treatment options that are designed to address the unique challenges specific to liver tumors. Despite progress made in cancer treatment, patients with primary or metastatic liver tumors still experience poor outcomes, as these tumors remain stubbornly difficult to treat. Two of the most significant barriers that prevent optimal delivery and performance of therapeutics for liver and pancreatic tumors include immune response suppression and ineffective drug delivery due to high intratumoral pressure. The high intratumoral pressure prevents medicine from entering the tumor, meaning patients often receive little benefit from new immunotherapy drugs such as checkpoint inhibitors and CAR T-cell therapies. While these treatments may help reduce symptoms, there is no cure for liver metastases.

On January 6, 2022 SHINE Technologies LLC (SHINE), a next-generation nuclear technology company, and the Department of Energy’s National Nuclear Security Administration (NNSA) and Office of Environmental Management (DOE-EM) reported that signing of the first-ever contracts as part of the Department’s Uranium Lease and Take-back Program (Press release, Shine Medical Technologies, JAN 6, 2022, View Source [SID1234598396]). The shared milestone for SHINE and the Department’s efforts will help increase domestic production of molybdenum-99 (Mo-99), a crucial medical radioisotope used in over 40,000 daily medical diagnostic procedures across the United States to assist in diagnosing life-threatening diseases, including heart disease and cancer.

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The NNSA’s lease contract will provide SHINE with the low-enriched uranium necessary to produce Mo-99, while SHINE’s contract with DOE-EM details requirements surrounding the return of any resulting radioactive waste without a commercial disposition path once Mo-99 production is complete.

"Signing these contracts with SHINE is a crucial step toward medical isotope autonomy for the United States," said Corey Hinderstein, NNSA Deputy Administrator for Defense Nuclear Nonproliferation. "Once SHINE begins production, our country will be that much closer to creating a reliable and sufficient supply of these life-saving materials right here at home, while also increasing nuclear security by reducing the use of highly enriched uranium."

The American Medical Isotopes Production Act of 2012 directed DOE/NNSA to establish a program to make uranium available to medical isotope producers in the United States. Although the Act also requires DOE to establish take-back contracts for spent nuclear fuel and radioactive waste resulting from medical isotope production without a disposal path, there is no spent fuel or radioactive waste involved in these contracts.

SHINE is steadily progressing toward Mo-99 production capability at its plant located in Janesville, Wis.

"We are incredibly proud to partner with the NNSA and DOE to be deploying an integrated irradiation and processing facility to manufacture U.S.-based, high-specific-activity (HSA) Mo-99 that millions of patients rely on every year throughout the U.S.," said SHINE CEO Greg Piefer. "We consider the ability to produce HSA Mo-99 without the need for highly enriched uranium to be a huge win for both patient access to essential medical diagnostic procedures, and for nuclear security."

SHINE is also one of the DOE/NNSA’s cooperative agreement partners. As announced in October 2021, NNSA awarded SHINE an additional $35 million to support their efforts to produce Mo-99 commercially by the end of 2023. This award is part of the DOE/NNSA financial assistance efforts to establish a reliable, U.S.-produced supply of Mo-99, without using highly enriched uranium. NNSA has implemented this effort by competitively awarding cost-shared cooperative agreements to commercial entities, as well as providing funds to DOE’s National Laboratories to support development of non-highly enriched uranium Mo-99 production technologies.