Akorn Pharmaceuticals | August 17, 2022
Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1
"We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics."
Akorn President and CEO Douglas Boothe
Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2
The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix.
According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million.
About Cetrorelix Acetate for Injection 0.25 mg
Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation.
Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.
WuXi AppTec | August 17, 2022
WuXi STA, a leading Contract Research, Development, and Manufacturing Organization is pleased to announce the groundbreaking for its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware. First announced in June 2021, this site will be WuXi STA's second facility in the United States, offering expanded capacity and greater flexibility to meet the needs of customers in the U.S. and around the world.
The WuXi STA Middletown site is located in the Middletown Business Center at 1091 Industrial Drive, and the new state-of-the-art facility will create approximately 500 full-time jobs by 2026. Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labeling, storage and distribution services for clinical trial materials and commercial drug products.
WuXi STA has 12 sites across the U.S., Europe and Asia that offer a range of services and meet or exceed all regulatory standards. Together with three other drug product manufacturing sites in Couvet Wuxi City (China) and Shanghai this new facility will further enhance the company's global drug production capacity and capabilities.
"The biopharmaceutical industry is part of Delaware's DNA. Over the next five years, WuXi STA plans to build a state-of-the-art pharmaceutical manufacturing campus in one of Delaware's fastest-growing communities, bringing with it good jobs and economic growth. This campus is only possible because of Delaware's world-class, innovative workforce. Thank you to WuXi STA, Middletown Mayor Kenny Branner and everyone who made this project possible."
Delaware Governor John Carney
"The First State continues to be a first-rate destination for businesses looking to innovate and grow," said Senator Tom Carper. "This investment by WuXi STA helps position Delaware as a continued global leader in biopharmaceuticals, further cementing the manufacturing might of one of our fastest growing communities. Delaware's workforce is ready to help build the future of our life-saving pharmaceuticals. This state-of-the-art campus will create good jobs and help fortify our supply chains here at home."
"This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region," said Senator Chris Coons. "I am excited about WuXi STA's decision to choose Middletown for one of their new manufacturing facilities. This isn't just the largest private-sector investment in Middletown's history – it's a defining moment that will bring many more good-paying jobs to Delaware and will further cement the First State as a world leader in biopharmaceutical research and manufacturing. Thanks are due to everyone from Middletown to Dover to Washington who helped us get to this point, whether by making continued investments in NIIMBL, improving our education system from kindergarten to our universities, or ensuring that Delaware workers have the skills manufacturers like WuXi AppTec are looking for."
"As the First State, Delaware has always had a spirit of innovation – constantly seeking new opportunities and ventures that will strengthen our economy and our state as a whole," said Rep. Lisa Blunt Rochester. "Today's groundbreaking of the WuXi STA pharmaceutical manufacturing plant represents another step in that spirit of innovation – bringing good-paying jobs to Middletown and strengthening communities throughout Delaware. The state-of-the-art facility will bring 500 full-time jobs over the next several years, growing our state's workforce and allowing us to manufacture more goods domestically - enhancing our economic competitiveness on the global stage."
"We are truly looking forward to our partnership with WuXi STA, as the groundbreaking today marks the kick-off to them making their new home in Middletown, Delaware. WuXi STA will be joining our bustling industrial area, just steps away from Clarios, Datwyler, Amazon and Breakthru Beverage, just some of the companies that have invested in Middletown. When asked by WuXi STA about our business-friendly attitude, these businesses expressed their wholehearted support for how we do business and we couldn't be more excited about WuXi STA wanting to join them, and the Town of Middletown, in our journey together," said Middletown Mayor Ken Branner. Branner added he was thankful for the support of Gov. John Carney and the Delaware Prosperity Partnership.
"I would like to thank our federal, state and local partners in Delaware for their continued support in the establishment of this site," said Dr. Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA. "WuXi STA continues to increase our capabilities and capacities to better serve our customers through a more robust and reliable supply chain. With our integrated Contract Research, Development, and Manufacturing Organization platform and proven quality system, we look forward to working with our customers to swiftly deliver their innovative therapies to market in order to save lives and improve healthcare for patients."
About WuXi STA
WuXi STA a subsidiary of WuXi AppTec is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Research, Development, and Manufacturing Organization WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.
About WuXi AppTec
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,850 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."
Novavax, Inc. | August 16, 2022
Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 and older.
"It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations. Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants."
Stanley C. Erck, President and Chief Executive Officer, Novavax
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
About the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373)
The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
About Matrix-M™ Adjuvant
Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 Vaccine, Adjuvanted, the company's COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including in the U.S., European Union and with the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines the Novavax COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.