PHARMACY MARKET

EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)

CureVac, EMA | February 18, 2021

The European Medicines Agency (EMA's) Committee for Human Medicinal Products (CHMP) has begun a moving audit of CureVac AG's COVID-19 antibodies, CVnCoV.

The survey was started on the grounds that starter research facility contemplates and early clinical preliminary outcomes recommend the immunization triggers the creation of antibodies and insusceptible cells that target SARS-CoV-2, the infection that causes COVID‑19.

The survey will successively audit information as it opens up, beginning with the preclinical and beginning stage proof presently submitted. As opposed to a customary advertising authorisation application, in which all information on a medication's or immunization's viability, security and quality and all necessary archives should be prepared toward the beginning of the assessment.

Continuous preliminaries are proceeding to assess the immunization's wellbeing, immunogenicity and viability against COVID-19. EMA will assess information from these and other clinical preliminaries as they become accessible.

The moving audit will proceed until the CHMP concludes that adequate information is accessible for a conventional showcasing authorisation application. Because of the work attempted in the moving audit, it should take less time than typical to assess such an application.

EMA will survey the immunization's consistence with the typical norms for adequacy, wellbeing and drug quality inside the moving audit measure.

About CVnCoV
CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly.
When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.

Spotlight

Gaps in dermatological research present potentially lucrative market opportunities for pharmaceutical companies. Patients that suffer from skin conditions and diseases also benefit. Effective treatments relieve irritating, chronic, and often painful symptoms, which improves their quality of life and lifts the psychological and social burden of a visible dermatological issue.

Spotlight

Gaps in dermatological research present potentially lucrative market opportunities for pharmaceutical companies. Patients that suffer from skin conditions and diseases also benefit. Effective treatments relieve irritating, chronic, and often painful symptoms, which improves their quality of life and lifts the psychological and social burden of a visible dermatological issue.

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BUSINESS INSIGHTS

Orsini Specialty Pharmacy Selected By Sanofi As A Limited Distribution Partner For Nexviazyme®

Orsini Specialty Pharmacy | September 28, 2021

Orsini Specialty Pharmacy, the leading independent specialty pharmacy focused on rare diseases and gene therapies, announced that Sanofi has selected it as a limited distribution partner for Nexviazyme® (avalglucosidase alfa-ngpt). Nexviazyme, an enzyme replacement therapy (ERT), is used for treating patients one year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). This progressive and debilitating muscle disorder impairs a person's ability to move and breathe. For more information about Nexviazyme, please see the Full Prescribing Information. Pompe disease affects an estimated 3,500 people in the United States. It can present as infantile-onset Pompe disease (IOPD), the most severe form of Pompe disease with rapid onset in infancy, and late-onset Pompe disease (LOPD), which progressively damages muscles over time. LOPD symptoms may present at any age. However, due to the broad spectrum of clinical presentations and progressive nature of the disease, it can take seven to nine years before patients receive an accurate diagnosis. As the disease progresses, people with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility. Orsini's dedicated Pompe Disease Care Team's number one priority is providing exceptional care and compassionate support to patients and their families, We are proud to expand our partnership with Sanofi and add Nexviazyme to the growing number of enzyme replacement therapies we dispense to patients with rare diseases. - Mike Fieri, Orsini's Founder and Chief Executive Officer. About Orsini Specialty Pharmacy Providing patients with comprehensive and compassionate care since 1987, Orsini is the leading independent specialty pharmacy focused on rare diseases, gene therapies, and complex conditions. Orsini's high-touch care model centers around experienced, therapy-specific care teams that provide personalized care to patients based on their specific conditions and treatments. The company's comprehensive solutions include medication adherence programs, data analytics, customized manufacturer programs, and nationwide nursing coverage for convenient in-home infusion services. Headquartered in Elk Grove Village, IL, Orsini Specialty Pharmacy holds accreditations with URAC, the Accreditation Commission for Health Care (ACHC), ACHC's Distinction in Rare Diseases and Orphan Drugs, The Joint Commission, and the National Association of Boards of Pharmacy (NABP).

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BUSINESS INSIGHTS

Dicerna Announces Expiration of Hart-Scott-Rodino Act Waiting Period for Novo Nordisk Tender Offer to Acquire Dicerna

Dicerna Pharmaceuticals, Inc. | December 27, 2021

Dicerna Pharmaceuticals, Inc. announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended in connection with Novo Nordisk’s cash tender offer for Dicerna expired at 11:59 p.m., Eastern Time, on December 24, 2021. As previously announced on November 18, 2021, Novo Nordisk commenced a cash tender offer to purchase all outstanding shares of Dicerna common stock for $38.25 per share in cash, without interest and subject to any withholding of taxes. The expiration of the HSR waiting period satisfies one of the conditions necessary for the consummation of the tender offer. Other conditions remain to be satisfied, including, among others, a minimum tender of shares representing one more share than 50% of the sum of the total number of Dicerna shares outstanding at the time of the expiration of the offer. Unless the tender offer is extended, the offer and withdrawal rights will expire at 5:00 p.m., Eastern Time, on December 27, 2021. About Dicerna Dicerna Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference to silence selectively genes that cause or contribute to disease. Using our proprietary GalXC™ and GalXC-Plus™ RNAi technologies, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities. Initially focused on disease-causing genes in the liver, Dicerna has continued to innovate and is exploring new applications of its RNAi technology with GalXC-Plus, which expands on the functionality and application of our flagship liver-targeted GalXC technology to tissues and cell types outside the liver, and has the potential to treat diseases across multiple therapeutic areas. In addition to our own pipeline of core discovery and clinical candidates, Dicerna has established collaborative relationships with some of the world’s leading pharmaceutical companies, including Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc.

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PHARMA TECH

Fareva and ApiJect sign a licensing agreement to create a France-based 500M unit annual capacity for single-dose prefilled vaccine injections

ApiJect Systems Corp. | December 10, 2021

Fareva and ApiJect Systems, Corp. announced a 10-year licensing agreement to install three Blow-Fill-Seal production lines that when operational will be able to fill-finish more than 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect's innovative prefilled injector technology. Fareva intends to invest more than €50M for these three manufacturing lines, with support from the Government of France, through the "France Relance" industry initiative and the Investments for the Future Program. The three manufacturing lines and ApiJect's technology utilize the Blow-Fill-Seal aseptic packaging process. BFS has demonstrated its ability to package certain vaccines and large molecule formulations, and ApiJect is helping to expand BFS's capabilities to additional drug products, including temperature sensitive pharmaceuticals. When cleared by regulators, ApiJect will provide the necessary needle hub and other attachable components to convert finished BFS single-dose containers from these lines into easy-to-assemble, ready-to-use prefilled injectors. COVID-19 has demonstrated the strategic importance of regional pharmaceutical manufacturing to ensure strong and reliable medical supply chains. By investing in these three BFS lines and installing ApiJect technology, Fareva is helping to increase Europe's high-speed, high-volume fill and finish capacity by potentially more than 500 million doses per year. And, the compact polyethylene-based supply chain of BFS helps establish and maintain dependable and resilient fill-finish capacity, even in the face of additional COVID-19 pandemic waves and their supply chain repercussions. "This commitment by Fareva, with the support of the French Government, to expand fill-finish capacity is the right step at the right time. We are proud to partner with Fareva in bringing the next generation of injection technology to global health." ApiJect CEO and Chair Jay Walker commented Mr. Walker continued: "Our mission at ApiJect is to support and execute a strategy of expanded distributed fill-finish capacity in the U.S. and regionally around the world. This is desperately needed in the battle against COVID, particularly as we continue to face emerging variants. Distributed fill-finish capacity will also yield huge dividends when future pandemics and other possible bio-emergencies threaten our populations. Fareva, along with its support from the French Government, is showing itself to be a vital leader in confronting and defeating the COVID threat." The new lines will be situated in Fareva Excelvision, located in Annonay, France, which has more than 50 years of experience manufacturing BFS containers and exporting products around the world. The BFS machines will be purchased from Rommelag in Germany. Clean rooms for these new lines will be operated in a Biosafety Level 2 (BSL2) environment, allowing them to handle most vaccines. The objective is to start the first validation batches in June 2022. In addition, this capacity expands ApiJect licensing of its BFS manufacturing and device technology to the USA and Europe. Olivier Dussopt. Minister Delegate for Public Accounts said: "I am very happy that Fareva, and their manufacturing site of Annonay in Ardeche, invests in such a development project, concerning 3 production lines for an amount of 50 million euros. The government will support those investments with a program of 36,9 million euros. This is an excellent news for the local territory as it will create 150 jobs and this is also an excellent news for France and Europe that will benefit from this high technology for the manufacturing of pharmaceutical drugs and more precisely of vaccines. " Agnès Pannier-Runacher, Minister Delegate for the Industry declared: "I welcome the project implemented by Fareva in collaboration with ApiJect, a world premiere that will enable the production up to 500 million of injectable pharmaceutical products from 2022. This ambitious 50 million euros project will strengthen our healthcare industry in France and shows that innovation is not only in the vaccines but also stands in the injection devices. It is also the reason why we have agreed to support it with the France Relance program." ABOUT APIJECT SYSTEMS, CORP. ApiJect Systems, Corp. is a public-benefit medical technology company working to bring prefilled, single-dose injections to more people in every market. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own ApiJect-licensed Blow-Fill-Seal packaging lines or at one of our world-class manufacturing partners. ABOUT FAREVA Fareva, a family-owned company, whose strength lies in its financial independence, is one of the world's leading CDMOs in the pharmaceuticals, cosmetics, make-up, and industrial and homecare fields. Fareva operates in 12 countries with 42 factories and employs more than 13 000 employees with annual revenues reaching € 1.8 billion in 2020. ABOUT "FRANCE RELANCE" France Relance is a €100 billion investment plan designed to support economic recovery in France in the wake of the COVID-19 pandemic. The program supports businesses, new production models, transformation of infrastructure, and training investment.

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