Goodwin Biotechnology Secures Significant Institutional Investment in New Round of Growth Capital Financing

benzinga | April 22, 2019

Goodwin Biotechnology, Inc. ("Goodwin") announced that it has completed its largest ever round of financing with growth capital which will help fund its next stage of expansion.  Goodwin is a full GMP, FDA-registered biopharmaceuticals Contract Development and Manufacturing Organization (CDMO) that offers a fully integrated Single Source Solution™ from Cell Line Development, Process Development including Bioconjugation, Scale-Up, cGMP Contract Manufacturing and Aseptic Fill/Finish of mammalian cell-culture derived life-saving monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs). The investment was made by Signet Healthcare Partners ("Signet"), a New York based growth equity firm specializing in healthcare investments. Concurrently, Nikhil Puri and Jerry Liao, investors at Signet, will join the board of directors of Goodwin Biotechnology. The growth capital will be used to support Goodwin's investments in doubling its space available for cGMP capacity as it readies for further expansion of its biopharmaceutical manufacturing, including support for commercial product manufacturing and developing various capabilities to better serve its growing customer base.

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BUSINESS INSIGHTS

AustinPx Names Elizabeth Hickman Chief Business Officer

AustinPx | September 28, 2022

AustinPx, Pharmaceutics and Manufacturing, a contract development and manufacturing organization announced the appointment of Elizabeth Hickman as Chief Business Officer. In this role, Ms. Hickman will be responsible for the Company’s CDMO business operations and strategy, including building capabilities and a team to deliver high-value solutions for pharmaceutical customers. Ms. Hickman is an accomplished business leader with over 15 years of experience with small and multi-billion-dollar CDMOs. Over her career, she has held business development and market strategy positions of increasing responsibility, most recently at West Pharmaceutical Services as Senior Director of Strategic Marketing, Services and Solutions where she was responsible for market expansion of the company’s contract development, testing and manufacturing services. Prior to joining West, Ms. Hickman led sales and marketing at Pharmatek Laboratories, where she helped grow the company’s services and revenues resulting in its successful acquisition by Catalent Pharma Solutions. Following Pharmatek’s acquisition, she continued to excel in market strategy and business development leadership roles with Catalent’s oral drug development business unit. Ms. Hickman has a BA in Microbiology from the University of Texas, Austin and an MBA from San Diego State University. "Elizabeth brings a sharp skillset and a wealth of CDMO experience to AustinPx," said Tim Scott, President and CEO for AustinPx. "She has a strong history of growing CDMOs as both a strategist and a team-builder. Elizabeth is unique in her ability to foster and create a culture that excels at providing client-centric services, and that is why she is such a tremendous asset for AustinPx. We are very fortunate to have her." As CBO at AustinPx, Ms. Hickman will focus on the strategic buildout of agile, best in class operations, systems, and teams. She will be responsible for all market strategy and communications, business development, project management, systems optimization, and data-driven processes that drive growth. "I am excited to be a part of AustinPx and join its impressive team of formulation and manufacturing scientists and operations staff. They are a true scientific powerhouse for our clients. My goal is to build on the Company’s strong foundation to develop a client-centric CDMO that consistently delivers exceptional service from initial engagement to product shipment. Ultimately, my passion is for the patients of our clients – if we can help get their drug candidates to the clinic faster, with better formulations and dosage forms, we can in turn impact more patients around the world." Elizabeth Hickman About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.

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BUSINESS INSIGHTS

Hyfe Joins Forces with Merck to Deploy Its Artificial Intelligence-Powered Cough Detection and Counting Technology

Hyfe, Inc. | July 20, 2022

Hyfe, Inc., the global leader in AI-powered cough detection, tracking and classification, has entered into an agreement with Merck, known as MSD outside the United States and Canada, to integrate its artificial intelligence-powered (AI) cough tracker technology into Merck’s consumer disease educational efforts.. Hyfe’s AI-powered technology passively and remotely monitors the number of times a person coughs and the sound of the cough through any smart device, such as a mobile phone. This data collected over time provides the user with helpful information by revealing patterns and potential triggers like seasonal allergies that may be causing the cough that would otherwise go unnoticed or unaddressed. “The overwhelming majority of people cannot even come close to accurately estimating the number of times they cough per day. In order to help diagnose and treat patients, cough frequency and sound should be monitored and measured with the same accuracy as blood pressure, temperature, heartbeat and other biomarkers that are essential for assessing health and medical conditions.” Peter Small, M.D., chief medical officer of Hyfe, Inc Users of the app will be able to determine when and how long to track their coughing. The AI-powered technology records cough-related sounds and allows the user to compare the frequency and quality of their coughs against their own benchmark. This personalized approach provides users with more detailed information and confidential data about their individual situations to share with their health care providers. Hyfe, Inc. is the global leader in AI-powered cough detection and classification that provides insight into cough patterns and correlations that can greatly improve treatment and prevention. With more than 280 million samples, Hyfe maintains the largest cough dataset in the world enabling the building of powerful models to track, manage and diagnose respiratory illnesses. Hyfe provides platforms and data for pharmaceutical companies, medical researchers, government agencies, health care providers and patients and has partnerships with leading academic institutions including Johns Hopkins University and the University of California at San Francisco. The company was founded in 2020 and is headquartered in Wilmington, Delaware.

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PHARMA TECH

Babson Diagnostics and Pharmacy Podcast Network Announce Partnership That Will Take Listeners Inside Largest Retail Pharmacy Trade Show

Babson Diagnostics | July 27, 2022

Babson Diagnostics, a science-first, health care technology company, announced a media partnership with the Pharmacy Podcast Network in connection with the 2022 National Association of Chain Drug Stores’ Total Store Expo, the largest gathering of retailers and suppliers in the health and wellness industry. As part of the partnership, the Pharmacy Podcast Network, the most popular and downloaded podcast about the pharmacy industry, will be integrated into Babson Diagnostics’ booth at the Total Store Expo. Todd Eury, founder and chief executive officer of the media company, will host podcasts from the booth featuring industry leaders attending the trade show. In addition, Babson will sponsor two podcasts that will be broadcast prior to the expo, which takes place Aug. 27 through Aug. 29 in Boston. The first of those shows, “Diagnostic Testing in Community Pharmacies,” went live today. “Babson is excited to be collaborating with one of the leading media outlets aimed at community pharmacists, who are the face of neighborhood healthcare. Babson is working with pharmacies to offer medically accurate blood testing that is easier, more convenient and less invasive than traditional methods.” David Stein, CEO of Babson Diagnostics Launched in 2009, the Pharmacy Podcast Network reaches more than 80,000 listeners per month with audio content focused on the critical role pharmacists play in the healthcare industry. “I look forward to bringing exciting new content to my audience through this partnership with Babson Diagnostics,” Eury said. “The Total Store Expo is a one-of-a-kind opportunity to bring insights to pharmacists about new and innovative products and services in health and wellness, such as Babson’s blood-testing ecosystem.” About Babson Diagnostics Babson Diagnostics is a science-first healthcare technology company bringing convenient, medically accurate diagnostic blood testing to the local pharmacy. We are the first and only company to do broad blood panels from a capillary microsample, collected from a finger, at a retail setting. Our core technology was incubated at Siemens Healthineers ​in 2015, and we became Babson Diagnostics in 2017. We have exclusive partnerships with Siemens Healthineers and BD (Becton, Dickinson and Company), two global leaders in healthcare innovation and medical technology. Together we are reimagining the entire blood testing process, helping people get the care they need, when they need it. Babson, based in Austin, Texas, is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built. About Pharmacy Podcast Network Pharmacy Podcast Nation is the flagship show hosting all of the Pharmacy Podcast Network 1400+ episodes. With more than 30 different podcast programs and some 40 different co-hosts helping to develop audio content about the pharmacy sector, its reach includes communities, hospitals, senior-care residences, military and public health settings that meet the information needs of 300,000 pharmacists with more than 100,000 monthly listeners. PPN also delivers a unique publication called Rx Influencer to all healthcare professionals with a specific focus on pharmacy.

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BUSINESS INSIGHTS

Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

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. About Akorn 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.

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