Purveyors of black-market pharmaceuticals target immigrants

Medical News | September 16, 2019

The bootleg medications were smuggled across the border and sold to mostly Latino immigrants in public spaces throughout Los Angeles at swap meets, parks, beauty salons and makeshift stands outside mom-and-pop grocery stores. The drugs were cheap, and the customers mostly from Mexico and Central America did not need prescriptions to buy them. Some of the products featured brand names and colorful packaging that immigrants knew well from their home countries including Ciprofloxacina, a potent antibiotic, and Dolo Nervi Doce translated as "Pain Nerve 12" an injectable B-complex vitamin taken for fatigue. Many were sheer counterfeits. Others, though legal south of the border, were not approved for sale in the United States. Some had expired. Still others would have been legal if sold by people licensed to do so but none of the sellers held pharmacist licenses or any other medical credential. L.A. County authorities seized the drugs last month in an operation that led to the arrest of eight people. Their haul included 100,000 foreign-made pills, compounds and injectable medicines they said could have caused serious harm or even death to consumers.

Spotlight

As any senior executive within an organisation knows, the reduction of waste and, more importantly, the cost associated with that waste can have a major effect on any business. Whilst some waste is unavoidable, an executive can begin to implement principals to eliminate this additional “cost of poor quality” (COPQ) by considering which costs would be eliminated if every system, process and product in the business were run at maximum optimisation. In the pharmaceutical industry, it is not uncommon for such costs to range between 25 and 40 percent of total sales revenue1 and yet reducing the COPQ is not a well understood or implemented practice.


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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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VIEWS AND ANALYSIS

Enteris BioPharma Publishes White Paper Examining Factors to Consider While Evaluating Oral Administration of Peptides

Enteris BioPharma | September 13, 2022

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation announced the publication of a new white paper in Drug Development & Delivery entitled, "Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration." The paper, authored by John Vrettos, PhD, Director of Formulation Development for Enteris BioPharma, and Kalpana Ramakrishnan, PhD, Manager of Business Development for Enteris BioPharma, explores the barriers to developing oral delivery of peptides and how pharmaceutical companies can overcome them. Oral administration of peptides offers several advantages while treating chronic conditions such as diabetes and obesity as they are less invasive and more cost effective compared to injections. "Molecule size, potency, and solubility are some of the key physicochemical properties that determine a peptide's suitability for oral delivery. The healthcare industry is in need of enabling drug delivery technologies with the capability to overcome barriers in oral delivery of peptides. Importantly, orally delivered medications may encourage patient compliance compared with more invasive approaches to administering drugs. Approximately 75% of peptides are delivered by injective routes, including subcutaneous injections which can be painful and difficult to incorporate into a daily routine." Dr. Vrettos Dr. Vrettos continued, "Enteris' Peptelligence® platform offers a 'triple-action' solution comprised of our enteric coating, protease inhibitor, and permeation enhancer. When combined, these technologies have demonstrated an ability to improve the solubility and permeation of orally delivered peptides. These properties can potentially enable oral delivery of some peptide drugs for the first time, and we are excited to share our knowledge on oral delivery of peptides through this informative whitepaper." Peptelligence is a novel formulation technology designed to enhance the oral delivery and bioavailability of selected drugs by enhancing the permeation of such compounds that are typically injected, including peptides and BCS class III and IV small molecules, and preventing their breakdown in the digestive tract. About Enteris BioPharma Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation offering total integrated contract development and manufacturing services for innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®, and contract manufacturing (CMO) services using non-proprietary technologies. The company's proprietary technologies have been the subject of numerous feasibility studies and active development programs, some of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option.

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BUSINESS INSIGHTS

Hovione expands drug product offering with a new manufacturing line dedicated to Continuous Tableting

Hovione | September 07, 2022

Hovione, the leader in spray drying and particle engineering, announced that it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is now coming online at the Loures site in Portugal. In addition, to support Hovione's commitment to providing access and services for continuous tableting, Hovione has further strengthened its capabilities by establishing a highly experienced multi-disciplinary global team in continuous tableting and upgrading its labs with the tools needed to support the drug product lifecycle, thereby further guaranteeing competency and capacity from research & development to production. Continuous manufacturing is expected to change the landscape of drug product development and commercial production. The Food and Drug Administration (FDA) is partnering with the International Council for Harmonization and leading a global initiative to advance continuous manufacturing of small molecules and other pharmaceutical modalities. Hovione is offering customers a commercial continuous tableting platform prepared to support key control needs and deliver on operational excellence, mechanistic modeling, and appropriate process analytical technology (PAT). Additionally, Hovione´s quality system has been designed to support the release of continuous tableting products through automated in-process controls, deployment of real time release, and compliant digital infrastructure. This cutting-edge technology offers a distinct set of features and advantages including faster development of simpler processes, agile manufacturing for variable demand, robust control strategies and high process quality standards. "Hovione has been historically focused on innovative technologies that benefit our customers and patients. With this investment in continuous tableting, our customers can rely on our support to bring much needed medicines to the market as fast as possible with the highest quality and manufacturing standards. We are investing to accelerate the adoption of this technology as we continue to innovate and enhance our offering around our areas of expertise." Jean-Luc Herbeaux, Hovione´s CEO "This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering and responds to the growing customer interest." says Filipe Neves, Hovione´s Strategic Business Director. This latest investment in Continuous Tableting is part of Hovione´s broader strategy to build differentiated and enabling capabilities and assets to meet customers unique needs for oral dosage forms manufacturing. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API and formulation development to devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

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BUSINESS INSIGHTS

Glaukos Licenses Iveena’s Investigational Keratoconus Therapy

iVeena and Glaukos | August 25, 2022

iVeena Delivery Systems Inc. a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, has entered into a strategic licensing agreement with Glaukos Corporation that grants Glaukos an exclusive global license to develop and commercialize IVMED-80, a pharmacologic treatment for keratoconus. Keratoconus, a rare corneal disorder, is the leading cause of primary full-thickness corneal transplantation in the United States. IVMED-80 is a proprietary disease modifying topical eye drop with orphan drug designation that upregulates lysyl oxidase and induces pharmacologic corneal crosslinking to strengthen the cornea and treat keratoconus. In a 6-month phase 1/2a clinical study, IVMED-80 met its primary endpoint of a statistically significant reduction in baseline-adjusted Kmax of 1.0 D relative to placebo. “We are pleased to complete this agreement with Glaukos. This deal validates the technology we have developed at iVeena to induce corneal crosslinking pharmacologically via eyedrops. Glaukos is a strong partner to complete development of this product where, if approved, patients will have an additional keratoconus treatment option.” iVeena CEO Jerry Simmons As part of the agreement Glaukos paid $10 Million upfront and will assume all costs associated with development and regulatory activities on IVMED-80. In addition, deal terms include the potential for both development and sales milestone payments as well as royalties on sales to iVeena. About iVeena iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has licensed its lead asset to Glaukos Corporation, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first in class, investigational eyedrop formulation for pediatric myopia where it plans to initiate a first in human clinical trial early 2023. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and has since developed a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

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Spotlight

As any senior executive within an organisation knows, the reduction of waste and, more importantly, the cost associated with that waste can have a major effect on any business. Whilst some waste is unavoidable, an executive can begin to implement principals to eliminate this additional “cost of poor quality” (COPQ) by considering which costs would be eliminated if every system, process and product in the business were run at maximum optimisation. In the pharmaceutical industry, it is not uncommon for such costs to range between 25 and 40 percent of total sales revenue1 and yet reducing the COPQ is not a well understood or implemented practice.

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