PANTHERx® Rare Pharmacy Selected by Alnylam Pharmaceuticals to Distribute GIVLAARI™ (givosiran)

PR Newswire | December 12, 2019

PANTHERx® Rare Pharmacy announces that it has been selected by Alnylam Pharmaceuticals as a very limited distribution partner for the novel drug GIVLAARI™ (givosiran). GIVLAARI is the first and only FDA-approved medicine indicated for the treatment of adults with Acute Hepatic Porphyria (AHP). GIVLAARI becomes the second RNAi therapeutic from Alnylam approved by the FDA in the last 16 months and the first-ever approved GalNAc-Conjugate RNA therapeutic, a landmark in the advancement of precision genetic medicines. The FDA approval of GIVLAARI was received less than four months after the New Drug Application (NDA) filing acceptance and was based on positive results from the ENVISION Phase 3 study, a randomized, double-blind, placebo-controlled,

Spotlight

Siemens http://www.siemens.com/pharma invited to a User forum on “Paperless Manufacturing”. Experts discussed benefits and challenges of this key topic. Result: the integration of automation and MES plays a key role. Lower cost, improved quality and streamlined processes can be realized by paperless manufacturing.

Spotlight

Siemens http://www.siemens.com/pharma invited to a User forum on “Paperless Manufacturing”. Experts discussed benefits and challenges of this key topic. Result: the integration of automation and MES plays a key role. Lower cost, improved quality and streamlined processes can be realized by paperless manufacturing.

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BUSINESS INSIGHTS

Indivior To Acquire Opiant Pharmaceuticals

Indivior | November 21, 2022

Indivior PLC and Opiant Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Indivior will acquire Opiant for an upfront consideration of $20.00 per share, in cash plus up to $8.00 per share in contingent value rights that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. The transaction has been unanimously approved by the boards of directors of each company. "Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1," said Mark Crossley, Chief Executive Officer of Indivior. "Opiant's portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior's strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant's talented team as we undertake our shared mission of changing patients' lives through access to life-transforming treatment for substance use disorders." Acquisition Strengthens and Extends Indivior's Position as a Leader in Addiction Treatment "We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines. This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior's global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose." Roger Crystal, M.D., Opiant's President and Chief Executive Officer Opiant is a biopharmaceutical company developing treatments for addiction and drug overdose leveraging intranasal and injectable delivery technologies. Opiant contributed to the development of the formulation of NARCAN® Nasal Spray, a treatment to reverse opioid overdose. In addition to OPNT003, nasal nalmefene, the pipeline includes OPNT002, nasal naltrexone, which is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings, and OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose ("ACO"). OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl. These powerful drugs are responsible for the surge of overdose deaths in the United States (103,000-plus overdose deaths reported in the latest annual period, of which over 75% were driven by opioids, mainly fentanyl and synthetic opioids1). OPNT003 is designed to be used by non-healthcare individuals and delivered intranasally. Observations from multiple clinical studies reinforce its potential rapid onset and long duration of action. Opiant received FDA Fast Track Designation for OPNT003 in November 2021 and is expected to complete its New Drug Application submission for OPNT003 with the FDA in the fourth quarter of 2022. Subject to approval by the FDA, anticipated approval for a fast-track application is third quarter 2023, with launch in the United States expected in the ensuing months. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

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PHARMA TECH

Apollomics Inc., a Late-Stage Clinical Biopharmaceutical Company to be Listed on Nasdaq Through Business Combination

Apollomics, Inc. | September 15, 2022

Apollomics Inc. a late-stage clinical biopharmaceutical company, and Maxpro Capital Acquisition Corp. announced a definitive agreement for a business combination that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market. The business combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol “APLM.” Apollomics’ broad pipeline of drug candidates includes late-stage clinical assets for the treatment of patients with difficult-to-treat cancers. Apollomics’ mission is to develop assets in critically important areas of unmet need. The Company’s leading drug candidates address certain subpopulations within lung cancer and leukemia. Globally, both lung cancer and leukemia affect over 2 million people annually. The Company is dedicated to discovering and developing oncology therapies of different mechanisms of action to inhibit cancer. Its diverse portfolio of innovative drug candidates for treating difficult-to-treat cancers includes precision therapy targeting tumors with specific mutations, as well as assets addressing broader cancer conditions. The Company’s pipeline of nine clinical, preclinical and discovery drug candidates has the potential to improve treatment of a number of tumor types. Upon the closing of the transaction, Apollomics will continue to be led by current Chairman and CEO, Dr. Guo-Liang Yu, Ph.D., a serial entrepreneur, and his team. Dr. Yu is a pharmaceutical researcher with more than 300 patents. “Apollomics’ announcement represents the next major milestone on our journey to provide solutions for patients with difficult-to-treat cancers,” Dr. Yu said. “We anticipate that the funds available to us from this transaction will help us accelerate development of our oncology pipeline.” Apollomics expects results from its global Phase 2 multi-cohort clinical trial of vebreltinib in NSCLC and other solid tumors with cMET dysregulation in 2023, which the Company believes may support its first New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) while generating clinical data for different indications. In addition, the Company expects to complete patient recruitment of its uproleselan Phase 3 study in China in 2023. “Our goal was to find an exciting company with a growing pipeline of innovative product candidates that could positively affect the lives of millions of people. Our team is excited to combine with Apollomics as it has met and exceeded all our key selection criteria. Together with Apollomics, Maxpro will do everything we can to support the Company’s vision of treating patients with difficult-to-treat cancers.” Moses Chen, CEO of Maxpro About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics currently has a pipeline of nine drug candidates across multiple programs, six of which are currently in the clinical stage of development. Apollomics’ lead programs include investigating its core product, vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States, and developing an anti-cancer enhancer drug candidate, uproleselan (APL-106), a specific E-Selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. About Maxpro Capital Acquisition Corp. Maxpro is a blank check company formed for the purposes of effecting a merger, capital share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in the healthcare and technology industries. In October 2021, Maxpro consummated a $103.5 million initial public offering of 10.35 million units (including the underwriters’ full exercise of their over-allotment option), each unit consists of one share of Class A common stock and one redeemable warrant, each warrant entitles the holder to purchase one share of Class A common stock at a price of $11.50 per share. EF Hutton, division of Benchmark Investments LLC, served as the sole book-running manager of Maxpro’s initial public offering.

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PHARMA TECH

Asahi Kasei Pharma to Sponsor Research for Drug Discovery Research and Technology: Open Innovation 2023

Asahi Kasei | October 17, 2022

Asahi Kasei Pharma, subsidiary of diversified Japanese multinational company Asahi Kasei, is publicly calling for new proposals for drug development research as part of its efforts for open innovation to promote pharmaceutical research and development through enhanced cooperation with universities, research institutes and enterprises around the world. The application period begins at 5:00 a.m. GMT on January 5, 2023 and ends at 8:00 a.m. GMT on February 28, 2023. Asahi Kasei Pharma established its Open Innovation Department in October 2016 with the mission to further strengthen and enhance global licensing and alliance-building activities, and has since funded around 5 proposals per year on average with a total of over 20 funded proposals for state-of-the-art pharmaceutical drug developments as well as collected a wealth of creative new ideas. The Open Innovation team is seeking to fund innovative proposals from researchers around the world for up to US$200,000 per year, per project for this upcoming round in 2023. Asahi Kasei Pharma will then pursue joint research opportunities with the drug discovery researchers together with their parent institutions in hopes to create new innovative drugs for diseases that currently have unmet needs or pioneer new platform technologies for drug discovery. Asahi Kasei Pharma has demonstrated a successful track record in developing new drugs in the realms of autoimmune, renal, neurological, and bone disease, so the organization can provide the greatest contribution from correlating research areas and subjects. "Asahi Kasei Pharma believes that nobody should have to give up what they would like to do because of illness. We believe great science comes from working together, and we are excited for the opportunity to accomplish this mission with researchers all over the world.” Osamu Matsuzaki, Primary Executive Officer and Head of R&D and Business Development at Asahi Kasei Pharma Open Innovation works to establish research collaborations related to innovative drug targets and candidate drug compounds up to the preclinical stage as well as advanced drug discovery technologies. Advancements in exploring a new mechanism of action for treating refractory autoimmune disease is one of the most promising outcomes of the research so far, with many more on the horizon. Asahi Kasei believes that these continued efforts to advance drug discovery and research technology will further contribute to life and living for people around the world. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.

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