VIEWS AND ANALYSIS
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 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.
Telix Pharmaceuticals Limited | November 23, 2022
Telix Pharmaceuticals Limited announces Illuccix® with up to 50mCi for radiolabeling is available for use on 100mCi gallium generators, an important development in radioisotope production.
High activity generators from Eckert & Ziegler Strahlen- und Medizintechnik AG increase activity from 50mCi to 100mCi and will be integral to expanding patient access to gallium-based radiopharmaceuticals as demand for PSMA-PET imaging in the United States continues to grow. This technology increases the number of daily elutions and activity in each elution, enabling hospitals and radiopharmacies to increase the number of daily doses produced, expand their service area and gain greater production efficiency.
"As the only commercially available kit that can take advantage of high activity generators for up to 50mCi radiolabeling, Illuccix gives hospitals, pharmacies, and physicians added confidence that their dose scheduling needs – and the needs of their patients – can be met today and in the future as the potential of 68Ga PSMA-11 is realized in the diagnostic market. We are pleased to continue our collaborative relationships with IRE ELiT and EZAG to continue to make 68Ga PSMA-11 accessible and convenient to use for customers across the United States."
Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix
Jay Simon, Managing Director of Eckert and Ziegler North America said, "The high activity GalliaPharm® generator may allow for broader availability and expanded service areas. It is about delivering doses when and where they are needed, whether you're a remotely located clinic, a busy metropolitan hospital or a pharmacy. We are pleased to be working with Telix to harness this innovation to maximize the efficiency for our customers and ultimately, their patients."
Jean Bonnet, Head of Sales, Strategy and Marketing at IRE Group said, "While current generator technology is sufficient to meet today's demands, the rollout of the higher activity 100mCi generators are future-proofing the ability to meet demand in a market which is growing exponentially. The use of high activity generators has the potential to increase daily elutions and increase the activity in each elution. When radiolabeled up to 50mCi with Illuccix, the result could potentially provide more flexibilitty in meeting the growing demand for 68Ga radiopharmaceuticals while giving customers the benefit of greater dose scheduling flexibility and efficient production."
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.
Astellas Pharma Inc. | September 05, 2022
Astellas Pharma Inc. announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.
MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study's primary endpoint is the frequency and severity of adverse events which were generally consistent with previous Phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future.
"The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant. We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS."
Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas
Fezolinetant is an investigational selective neurokinin-3 receptor antagonist and is not approved anywhere in the world. In the U.S., a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™.
About the MOONLIGHT Phase 3 Clinical Trials
MOONLIGHT 1™ is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. A total of 302 women with moderate to severe VMS associated with menopause were enrolled at nearly 60 sites in mainland China, Korea and Taiwan. MOONLIGHT 3™ is a 52-week single-arm Phase 3 clinical trial designed to investigate the long-term safety and tolerability of fezolinetant in women in mainland China with VMS associated with menopause. A total of 150 women were enrolled at 34 sites in mainland China.
About the BRIGHT SKY™ Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1™ and SKYLIGHT 2™ enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe.
About VMS Associated with Menopause
VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than 50% of women 40 to 64 years of age experience VMS and, in East Asia, the prevalence of VMS has been estimated to be around 80% of women 40 to 65 years of age, with 55% having moderate to severe VMS.3,4 VMS can have a disruptive impact on women's daily activities and overall quality of life.1
Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.5,6,7 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.
LOVE Pharma | September 09, 2022
Love Pharma Inc. an international mental health and sexual wellness company, remains extremely active in shaping itself into a real competitor in the biotech/pharmaceutical space. The company’s growth and development plan took a major leap forward this week with the announcement that Love Pharma is establishing a “strategic alliance” with Starton Therapeutics a leading clinical-stage biotechnology company in the United States.
It’s a relationship that finds Starton ideally aligned with Love Pharma’s mission of improving “quality of life” for its customers. And the benefit to Love Pharma is that Starton is well on its way to transforming standard of care therapies with its proprietary dermal drug delivery technology that allows cancer patients to receive continuous treatment so they can live better, longer.
Love Pharma’s investment in Starton Therapeutics is primarily based upon “the company’s interest in innovative drug delivery technology, such as transdermal patches that can reduce side effects, transforming patient outcomes with established, approved medicines allowing for streamlined market entry with long-term IP protections.”
A partnership with Starton offers a host of advantages to Love Pharma and its shareholders, including a wealth of experience from industry leaders, proven clinical trials using its proprietary technology, and a “continuous drug delivery” platform that Love Pharma could exploit in the development of its own clinical portfolio—especially in the “addiction” space. The company’s strategic investment certainly makes a lot of sense for the future of this young global brand.
“This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which just reported positive data from a phase 1 clinical trial evaluating the pharmacokinetics and safety of the company’s continuous delivery lenalidomide program. Starton is also entering a phase 2 trial, which the U.S. Food and Drug Administration has already cleared an Investigational New Drug application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV).
Love Pharma’s Chief Executive Officer (CEO), Zachary Stadnyk, said of the relationship
“With this investment in Starton, we are building our relationship, forming an alliance, and look to Starton’s expert management team to reduce risk in our own portfolio of clinical pursuits and focus more on the addiction space.”
So, what made Starton Therapeutics an attractive investment now? Well, earlier this year, Love Pharma partnered with researchers at Johns Hopkins University. This research initiative aligns with key principles in Love Pharma’s strategy as it aims to develop innovative products that establish new consumer applications based upon science and efficacy. And to further its meticulous plan, the company likely sees a much smoother path forward by expanding its development strategy to include guidance from a vast selection of industry and clinical experts and a highly de-risked avenue into the clinic by way of this strategic alliance with Starton.
It's no secret that Love Pharma wants to develop its own clinical portfolio, and specifically, has its eye on developing therapeutic treatments for addiction. Pharmaceutical applications for addiction and recovery treatment are an unmet need and represent a growing market, including in the cannabis space where the Johns Hopkins research initiative is focused. With Starton’s mission of delivering meaningful patient outcomes by leveraging the untapped potential of continuous delivery and dermal technology, it’s obvious that Love Pharma sees this platform technology and its endless opportunities for expansion, as an ideal platform on which it can develop its own therapeutic treatment(s) for addiction.
The benefit to partnering with Starton and having access to its platform technology is that the “proof of concept” is complete, and the technology has proven it can address unmet medical needs using already FDA-approved drugs to transform patient outcomes. For Love Pharma and its shareholders, this means much of the hard work is already done.
Starton’s proprietary continuous delivery technology can increase efficacy of approved drugs, make them more tolerable, and expand their potential use. Starton uses three different delivery technologies to provide continuous, low-dose delivery as part of its strategic platform that provides a controlled, sustained release over multiple days. Starton uses proven transdermal and subcutaneous technologies to transform approved medicines–establishing superiority or new indications. It is the potential to establish a new indication/use for already approved drugs using the delivery technology, namely in the addiction space that is enticing to Love Pharma.
And Love Pharma isn’t stopping there. The company announced that “to further accelerate its planned strategic alliance with Starton, and to bolster the company’s own biotech initiatives in the area, Love Pharma is in discussions with TRPL Laboratory, the lab that develops and supports Starton’s transdermal drug delivery programs and is a global leader in transdermal delivery systems.”
Investors in Love Pharma couldn’t ask for a better way to reduce the risk associated with the company developing its own clinical portfolio than by surrounding itself with a plethora of industry and clinical leaders. That expertise begins with Pedro Lichtinger, the CEO and Chairman of the Board at Starton. Lichtinger has spent almost 40-years in the biotechnology arena, including 16 years at Pfizer as President of Global Primary Care and as Pfizer’s President of Europe.
Additionally, Love Pharma can draw from the experiences of the former Global Lead, Multiple Myeloma at Celgene, world-renowned scientific leaders in their field leading each program at Dana Farber/Harvard, Mayo Clinic, and Moffitt Cancer Center, and a breadth of operational expertise in regulatory, clinical development, manufacturing, and intellectual property.
The company stated that it is currently identifying and assessing disruptive opportunities within the transdermal biotechnology field, which it believes can be a superior delivery system in many cases for new and existing pharmaceutical therapeutic drugs. With its initial investment in Starton, the company believes it can leverage their expertise and proven success to credibly evaluate potential acquisitions in the transdermal field of advanced drug delivery systems. This news should be seen as extremely encouraging by the company’s investors as it could dramatically accelerate Love Pharma’s path to the clinic and the development of its own clinical portfolio. After all, it is these relationships in the biopharma industry that can lead to promising results and real shareholder value.
About Love Pharma Inc.
With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce, market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America.
About Starton Therapeutics
A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use.
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