Nephron expanding again in Columbia, SC see more
With promising news about a COVID-19 vaccine making headlines, Lou Kennedy had reason for optimism during a beam-raising ceremony marking a milestone for a $215.8 million expansion at Nephron Pharmaceutical Corp.’s Saxe-Gotha Industrial Park campus.
Part of the expansion is a 110,000-square-foot vaccine production, chemotherapy and antibiotic wing that Kennedy, Nephron owner and CEO, expects to be operational around March 2021. She said Nephron is actively looking for a vaccine production partner to provide the ammunition for the pre-filled sterile syringes that make up the booming 503B Outsourcing Facility arm of the company.
“It’s a Chamber of Commerce day,” Kennedy said after signing the final beam of the 240,000-square-foot Kennedy Innovation Center’s steel skeleton on Tuesday morning. “This marks a milestone in 2020. This is good news. This is giving us the space to continue to grow.”
Moderna vaccine results looking very good early see more
The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.
Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.
Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.
Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.
South Carolina life sciences is booming, with new organizations growing and moving here see more
Comprised of 650 life sciences firms, with wages nearly double state averages and an annual economic impact over $12 billion, South Carolina life sciences employs 43,000 professionals in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. It’s a powerful force in today’s Palmetto State economy.
The fastest growing segment of the state’s innovation economy, life sciences shows no signs of slowing — despite a global pandemic that has advanced public awareness of the vital sector.
Life sciences’ 6 major segments include pharmaceuticals/biotech (including such state organizations as Nephron Pharmaceuticals, Thorne and Thermo Fisher Scientific), medical devices/medtech (Abbott, Arthrex and AVX), Health IT/digital health (ChartSpan), research-testing-diagnostics-labs (Greenwood Genetics Center, Precision Genetics and Vikor Scientific), bioscience distribution (SoftBox Systems), and Bio-Ag. Every sector is well-represented across South Carolina, with life sciences active in at least 43 of our 46 counties.
What makes the industry even more compelling is that it averages triple the R&D spend of all other industries and is highly recession resistant due to its connectivity with healthcare. An $8 trillion annual global healthcare spend is supported by a $1.5 trillion global life sciences industry – with the United States responsible for almost half of the world’s innovations.
To help the Palmetto State become a significant player in life sciences, SCBIO was refocused 3 years ago – with economic development as the focal point. Providing support for existing industry, working with economic development organizations to recruit global life sciences companies, and developing strategies to grow our own companies has had a seismic impact on SCBIO and its stakeholders — and ushered in a new era ripe with opportunity.
Aligning with the SC Department of Commerce in 2017 helped SCBIO to triple revenue in 3 years, more than quintuple membership, develop a full-time multi-disciplinary team, and cultivate an extraordinary board of directors from industry, academia, healthcare, core service providers, and economic development partners.
SCBIO has become a catalyst for and voice of South Carolina life sciences. From offices in Greenville, Columbia, and Charleston, SCBIO represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members and allies include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
Working with allies and partners, SCBIO created the state’s first ever SC Life Sciences Strategic Plan – now in its third iteration — to build a nationally competitive and sustainable ecosystem focused on building, advancing, innovating and growing the industry.
And innovation is the lifeblood of progress. For the state to become an innovation destination for life sciences, the effort requires relentless pursuit – of talent, of transformational ideas, of organizations bringing operations and R&D to our state, and of an enhanced ecosystem that supports existing industry while growing our own companies.
Life sciences innovation has a rich legacy in South Carolina, drawing on the notable talents and creativity of the research universities of Clemson, University of South Carolina, and MUSC… a Top 25 national health system in Prisma Health… plus South Carolina Research Authority, Greenwood Genetics Center and others whose ground-breaking work has earned South Carolina a deserved reputation as a life sciences up-and-comer.
From pioneering medical grade electrolytic capacitors that made thoracic implantable defibrillators possible at St. Jude Medical (now Abbott)… to the recent invention and introduction by MUSC, ZIAN and Rhythmlink of a novel safety electrode that has the potential to reduce needle sticks in surgical settings around the globe, South Carolina life sciences innovation is on the move.
Even facing a global pandemic, SC’s life science companies are on the front lines and performing at a high level. Entrepreneurs and academic institutions have deftly shifted focus or pivoted production to address needs resulting from the crisis. Providing everything from COVID-19 PCR test kits to antibody tests, from respiratory therapies to face shields, and from developing specialty garments for frontline workers to being selected to conduct Phase III vaccine trials in the hunt for a COVID cure, South Carolina is now a part of the global solution team.
A prime example is Columbia’s ZVerse, a digital manufacturer. Seeing desperate need for protective shields for healthcare workers, the early-stage company quickly pivoted to become one of America’s largest manufacturers of reusable face shields. ZVerse then devised a new, proprietary shield that is more comfortable to wear over long periods of time. Sales have soared.
The booming ecosystem includes technology incubators and accelerators across the state, providing entrepreneurs with guidance and opportunity to collaborate with peers. A recent SCRA initiative—the creation of the South Carolina Business Incubator Association — is an important step in helping organizations share best practices and stimulate innovation.
Along with Southeastern partners Global Center for Medical Innovation and Health Connect South, SCBIO is championing a unique innovation partnership: The Southeast HealthTech Collaboration. Leveraging complementary strengths, resources and networks, the group will identify pressing health needs in our region without requiring major new investment in infrastructure or capital.
Now a finalist for a major grant in the EDA 2020 Build to Scale Venture Challenge, the Southeast HealthTech Collaboration will launch a three-year program to:
- Convene healthcare leaders to identify top healthcare challenges and innovators working on technology-based solutions to address them;
- Accelerate best solutions through development and into commercialization; and
- Scale startups and networks to drive investment and job creation across South Carolina and Georgia.
With a focus on minority and underserved populations, the initiative will accelerate development and commercialization of technological solutions to address unmet clinical and health needs, leading to scaling of startup growth and a sustainable economic engine.
As American poet Robert Frost penned:
“The woods are lovely, dark and deep, but I have promises to keep,
And miles to go before I sleep.”
Despite miles to go, there is plentiful evidence that our state is “punching above our weight class”, given our relative size and resources. With innovation blossoming and a surging passion for improving prosperity, the promise of South Carolina and its future has never been brighter.
Market is currently valued at $770 million see more
Upsher-Smith Laboratories, LLC (Upsher-Smith) and AmbioPharm, Inc. (AmbioPharm) today announced that the companies have entered into a partnership agreement to develop and market Corticotropin Injection in the U.S. The market for adrenocorticotropic hormone or ACTH (brand Acthar® Gel*) is currently valued at $770 million (IQVIA, 12 months ending June 2020).
Under the terms of the agreement, Upsher-Smith will submit the New Drug Application for Corticotropin Injection to the U.S. Food and Drug Administration (FDA) and market and distribute it under its own label in the U.S. upon FDA approval. AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States. Financial terms related to the deal have not been disclosed.
“We are excited to partner with AmbioPharm, a leader in the field of peptide development and manufacturing, to bring Corticotropin Injection to the U.S. market,” said Rusty Field, President and CEO of Upsher-Smith. “This agreement represents another step in Upsher-Smith’s and Sawai’s strategy to co-invest in highly complex generics and 505(b)(2) products that can drive long-term growth.”
Added Chris Bai, CEO of AmbioPharm, “We are pleased to bring our unsurpassed technical capabilities and peptide manufacturing capacity to our partnership with Upsher-Smith, a company with a long-standing tradition of bringing high-quality products to the patients who rely upon them.”
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.
As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.
AmbioPharm, Inc. is a full-service peptide manufacturing company headquartered at its North Augusta, South Carolina, USA cGMP production site. Its second cGMP facility in Shanghai, China, performs process development and optimization and manufactures building blocks, raw materials, and custom peptides at a very large scale. Both of its cGMP facilities are capable of handling any manufacturing scale required to produce bulk peptides to custom specifications using a wide range of skill sets in both solid and solution-phase chemistry. Its management team has over 120 years of cumulative experience running a pilot to commercial-scale production. The Company also performs organic conjugations to small molecules, proteins, toxoids, antifungals, KLH, and PEG. For more information, visit www.ambiopharm.com.
Partnership Reduces Barriers to Testing, Provides Top Quality to Customers see more
Compliments of MidlandsBiz
Partnership Reduces Barriers to Testing, Provides Top Quality to Customers
Nephron Pharmaceuticals Corporation, one of the fastest-growing pharmaceuticals companies in the country, announced a new collaboration with Methapharm.
As a part of this collaboration, Nephron will produce kits of methacholine chloride sterile inhalation solution in ready-to-administer concentrations for bronchoprovocation challenge testing, when diagnosing respiratory illnesses, such as asthma.
“Methapharm will be a fantastic partner,” said Nephron CEO Lou Kennedy. “Patients deserve access to the very best respiratory tests available, that’s what this collaboration will offer, and that’s why we are looking forward to working with Methapharm.”
Working together with Methapharm, Nephron will be able to supply stable room temperature solution kits, ensuring that testing facilities can continue to rely on the quality and reliability of Provocholine for their bronchoprovocation testing needs.
“Through this partnership with Nephron, Methapharm continues its mission to help reduce barriers to testing, provide the level of quality our customers expect, and contribute to better healthcare outcomes for our patients,” said Craig Baxter CEO of Methapharm. “We’ve been impressed by Nephron’s capabilities and professionalism.”
Provocholine® is the only FDA-approved methacholine chloride powder for use in humans. Methapharm, the manufacturer of Provocholine, has always tried to be responsive to needs of our testing partners. For example, in response to the revised ERS technical standard, Methapharm initiated a comprehensive nebulizer characterization study to support the recommendation of PD20 as a clinical endpoint. This was published in a technical bulletin earlier this year.
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.
New leadership named at helm of BIO see more
The Executive Committee of the Biotechnology Innovation Organization (BIO) and its Board of Directors have announced the appointment of Dr. Michelle McMurry-Heath to lead BIO at this pivotal moment in our organization’s history, effective June 1, 2020.
"With her background as a scientist and physician, her health policy and experience in federal government, her leadership within industry as a champion of scientific progress, her commitment as an advocate for patients, and her gifts as a communicator, Dr. McMurry-Heath is the right person at the right time to lead us into the future," the official announcement released today stated.
Dr. McMurry-Heath is a coalition-builder and change agent who comes to BIO from Johnson & Johnson (J&J). She served in numerous senior leadership roles at J&J since 2014, most recently serving as Vice President of External Innovation, Global Leader for Regulatory Science and Executive Director of Scientific Partnerships for JLABS @ Washington, D.C. There, she led a large global team charting the evidence generation and regulatory strategy across J&J’s medical device companies. And she worked to knock down regulatory barriers that were hindering the ability of small innovators to partner and grow.
Prior to her work at J&J, Dr. McMurry-Heath served in scientific leadership roles at the FDA from 2010 to 2014. Her driving purpose at the FDA was to devise strategies to incorporate the patient point of view into FDA decision-making and develop new ways for patients to collaborate with innovators.
BIO’s incoming leader is a clinician-scientist with experience working at the bench in molecular immunology. She is the first African-American to graduate from Duke’s Medical Scientist Training Program, receiving an MD/PhD in immunology along the way. While Harvard-educated, she was raised in the San Francisco Bay Area – one of the great epicenters of biotechnology.
Throughout her impressive career, Dr. McMurry-Heath has been focused on the social impact of medicine so that more people in our society can benefit from its transformative potential. She led health and science policy on Capitol Hill for Senator Joe Lieberman, where she drafted legislation to protect the country from biological attacks, and then went on to sharpen her policy skills at the Robert Wood Foundation.
Dr. McMurry-Heath will become just the third leader of BIO since our organization’s founding in 1993. She will succeed a towering figure in our industry, the Honorable Jim Greenwood, who for 16 years has built the most consequential biotechnology advocacy organization in the world. Mr. Greenwood was a champion of the cause even before he was BIO's leader, reforming the FDA and fighting for broad acceptance of stem-cell science during his 12 years of principled, pragmatic leadership in the United States Congress.
As BIO’s leader, Mr. Greenwood has brought incomparable political and policy acumen to bear on the needs of our industry. During his tenure at BIO and as the United States built an innovation ecosystem that is the envy of the world, he played a pivotal role. After he hands over the reins on June 1st to Dr. McMurry-Heath, he has committed to work with her and will stay on in a strategic advisory role. The industry and BIO are grateful for his outstanding leadership, professionalism and continued contribution.
Softbox Systems honored with national recognition see more
Tempcell® ECO, the latest sustainable innovation from Softbox Systems, a global provider of temperature control packaging for the life science industry, has been recognized by Fast Company’s 2020 World Changing Ideas Awards—honoring companies, products and ideas that are making the world a better place.
According to John Hammes, General Manager of the America’s for Softbox Systems, Tempcell ECO’s innovative design addresses the challenges the pharmaceutical sector and the world face around plastics while offering the ease of curbside recycling for the end user.
“In the temperature-controlled shipping container space, we continue to push towards a more sustainable future - Tempcell® ECO is an innovative corrugated cardboard packaging system that protects temperature-sensitive life-science products and the planet,” he said. “It’s good for the pharmaceutical industry, great for the environment, and an even more sustainable solution for the world.”
Launched in the US in January 2020, Tempcell® ECO offers the pharmaceutical sector a 100 percent curbside-recyclable temperature control packaging system to support a more sustainable future for customers, consumers and the planet.
Made of the most reusable material on the planet, Tempcell® ECO is made from 100 percent recycled corrugated cardboard, and capable of being repurposed seven times over. This innovative packaging system saves end users from costly or unsustainable disposal, and drastically helps reduce pharmaceutical companies’ carbon footprint.
Using its own innovative corrugated cardboard insulating technology, Softbox Systems created Thermaflute™, a patent-pending design that is qualified against industry accepted test profiles. It is able to control temperature sensitive products with wide stability data in different temperatures ranges between +2°C to +25°C.
In combination with a number of temperature-regulating cool packs, layers of cardboard fluting are engineered to create an insulating barrier to protect life-enhancing, temperature-sensitive pharmaceutical products during shipping. The fit-for-purpose design maintains a shipment’s internal temperature for up to 72 hours and is light, strong and versatile, ideal for all parcel delivery networks.
In partnership with American Forests, Softbox Systems pledges to plant one tree for every 10 Tempcell® ECOs sold in the United States. This equates to three trees being planted for each one used in production. Through the sale of Tempcell® ECO in the first quarter of 2020, Softbox Systems has already enabled American Forests to plant more than 20,000 trees.
The World Changing Ideas Awards entries were judged on the key ingredients of innovation: functionality, originality, beauty, sustainability, user insight, cultural impact, and business impact.
“There seems no better time to recognize organizations that are using their ingenuity, resources, and, in some cases, their scale to tackle society’s biggest problems,” says Stephanie Mehta, editor-in-chief of Fast Company. “Our journalists, under the leadership of senior editor Morgan Clendaniel, have uncovered some of the smartest and most inspiring projects of the year.”
Now in its fourth year, the World Changing Ideas Awards showcase 26 winners, more than 200 finalists, and more than 500 honorable mentions—with Health and Wellness, Corporate Social Responsibility, and AI and Data among the most popular categories. A panel of eminent judges selected winners and finalists from a pool of more than 3,000 entries across transportation, education, food, politics, technology, and more. The 2020 awards feature entries from across the globe, from Vancouver to Singapore to Tel Aviv.
About the World Changing Ideas Awards
World Changing Ideas is one of Fast Company’s major annual awards programs and is focused on social good, seeking to elevate finished products and brave concepts that make the world better. A panel of judges from across sectors choose winners, finalists, and honorable mentions based on feasibility and the potential for impact. With a goal of awarding ingenuity and fostering innovation, Fast Company draws attention to ideas with great potential and helps them expand their reach to inspire more people to start working on solving the problems that affect us all.
About Softbox Systems
Softbox Systems is an award-winning temperature control packaging innovator that has been designing and producing high performance passive temperature control packaging solutions for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout North America, Latin America, Europe, India and Asia Pacific.
Softbox Systems has formed long standing partnerships with the world’s leading pharmaceutical, clinical research, biotech and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive clinical trial and commercialized products.
SCRA added three advisory groups for biomedical sciences, cybersecurity and industry see more
Summerville, S.C.—South Carolina Research Authority (SCRA) announces the formation of three Business and Science Advisory Boards (BSABs). The purpose of the BSABs is to advise SCRA’s Board of Trustees when requested by it. The boards include representatives from South Carolina research universities, the venture capital/angel investment community, South Carolina Department of Commerce, and industry leaders in the following areas:
Each board provides key business and technical expertise, acts as an independent/ unbiased sounding board for input on SCRA’s program implementation and performance and provides guidance to SCRA regarding funding opportunities. One upcoming funding opportunity on which the BSABs will advise is the SCRA-Academia Collaboration Team (SACT) Collaborative Research Grants. These grants will be available for multi-institutional, collaborative research teams that seek to advance commercially relevant research and address key industry challenges to foster technology-enabled growth of the state’s innovation economy. The solicitation will be released in June.
“SCRA serves as a bridge between industry and academia. It is imperative that the applied research SCRA funds benefits not only its academic stakeholders, but also South Carolina’s industrial base. The development of the BSABs ensures that the new SACT program achieves those objectives for both stakeholder groups,” said Christine Dixon Thiesing, SCRA Director of Academic Innovations.
The SCRA fuels South Carolina’s innovation economy by accelerating technology-enabled growth in academia, entrepreneurship and industry. SCRA works with public and private sectors, including industry, to identify market trends and validate the commercial relevance of academic research that SCRA funds. SCRA’s programs and operations had an almost $700 million impact on the state’s economy during the last fiscal year.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, SCRA fuels South Carolina’s Innovation Economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry.
BMS steps up to help newly uninsured patients see more
PRINCETON, N.J. – April 7, 2020 – Bristol Myers Squibb (NYSE: BMY) today announced an expansion of its existing patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic.
The expanded program offers access to any branded Bristol Myers Squibb medicine for free, including some of its most widely prescribed products, as well as those prescribed via telehealth services. The program features:
- Immediate access for patients who have lost their employment and health insurance;
- A simple, single point of entry;
- Streamlined enrollment process; and
- Vouchers to assist with continuity of care for several self-administered BMS medicines, for eligible patients
All Bristol Myers Squibb patient support programs, as well as, additional eligibility requirements, can be reached by calling (800) 721-8909 or by visiting BMS.com.
“The COVID-19 pandemic has created unprecedented financial challenges for patients and families, adding considerable new stress to the millions of Americans who have lost their jobs and health insurance,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. “As more patients face difficult decisions in their daily lives, it is important to continue their treatments.”
Bristol Myers Squibb’s Response to COVID-19
Bristol Myers Squibb recognizes this is a challenging time for everyone. The company will continue to take all necessary actions to promote public health and carry out its mission of providing life-saving medicines to the patients who depend on us. Please visit BMS.com to learn more about our actions to date.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
Nephron, Ritedose to the rescue with respiratory drugs see more
Two South Carolina companies that make drugs used to treat respiratory illnesses and symptoms, like those experienced by people infected with the coronavirus, have upped their production amid increased demand.
Nephron Pharmaceuticals in West Columbia and Ritedose Corp. make generic versions of almost all the respiratory drugs used in the United States, including albuterol sulfate and ipratropium bromide, according to the CEOs of the two companies.
Business at Nephron spiked last week, CEO Lou Kennedy said, with orders up 48 percent. The CEO of Ritedose, Jody Chastain, said his company has received a slight increase in demand. Click to read full story, courtesy of The Post and Courier...
VA Portland Health Care System Joins KIYATEC Clinical Study of Test to Predict Response to Glioblastoma DrugsTest to Predict Pre-Treatment, Patient-Specific Responses see more
GREENVILLE, S.C. – March 2, 2020 – KIYATEC, Inc. today announced that VA Portland Health Care System (VAPORHCS) has joined the growing roster of institutions participating in its 3D-PREDICT clinical study to validate the company’s test as a patient-specific predictor of response to cancer therapies for patients with glioblastoma, an aggressive form of brain cancer.
“Glioblastoma, one of the most common and deadly forms of brain cancer, is notoriously difficult to treat. Patients and clinicians do not have the luxury of time to experiment with drug therapies they don’t know will work, so we developed our investigational glioblastoma drug response profile to help clinicians optimize therapeutic decision-making for their patients over the course of their disease,” said Matthew Gevaert, CEO of KIYATEC. “We are honored to welcome VAPORHCS to the 3D-PREDICT study and salute the important commitment to cancer clinical studies demonstrated by all VA hospitals.”
3D-PREDICT is a prospective, open-label, non-interventional study to validate KIYATEC’s glioblastoma drug response profile, which leverages the company’s ex vivo 3D cell culture technology platform to assess pre-treatment, patient-specific response to a panel of 12 drugs most commonly used to treat patients with newly diagnosed or recurrent glioblastoma. Details on the study can be found at https://clinicaltrials.gov/ct2/show/NCT03561207.
About KIYATEC, Inc.
KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.
HOTH THERAPEUTICS SIGNS TERM SHEET WITH ZYLÖ THERAPEUTICS TO ACQUIRE A LICENSE AND JOINTLY DEVELOP A PRODUCT TO TREAT LUPUSSouth Carolina's Zylo Therapeutics partners with Hoth on lupus treatment see more
NEW YORK, May 14, 2019 /PRNewswire/ -- Hoth Therapeutics, Inc. (Nasdaq: HOTH) a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced that the company has signed a term sheet with Zylö Therapeutics Inc (Zylö) to co-develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus (CLE). CLE is a chronic autoimmune disease that affects the skin.
Zylö, dedicated to bringing innovative technologies to multiple facets of medicine, has an innovative sustained-release drug-delivery system that was developed by Joel Friedman MD PhD, Adam Friedman MD FAAD, and Andrew Draganski PhD. The delivery system uses patented xerogel-derived nanoparticles, called Z-pods™, to deliver—in a sustained and controlled manner—notoriously hard-to-deliver therapeutic agents through topical administration. For more information, please visit; http://www.zylotherapeutics.com/
Scientists at Einstein College of Medicine recently demonstrated that topical administration with AEA-loaded nanoparticles significantly prevents the development of CLE in an established animal model of lupus. This work reinforces and highlights the utility of targeting the endocannabinoid system for autoimmune rheumatic diseases.
The work at Einstein supports the thesis that AEA loaded into Z-pods™ improves drug skin penetration, reduces the expected inflammatory cytokine secretion by keratinocytes when exposed to ultraviolet radiation, prevents the development of CLE skin lesions, improves skin histopathology, prevents inflammation and structural damage on histology and reduces macrophages and C3 accumulation.
According to estimates by the Lupus Foundation of America (LFA), 1.5 Million Americans currently suffer from lupus, with 16,000 new cases reported annually. Tragically, lupus strikes mostly women of child-bearing age. Worldwide, the LFA estimates that at least five million people may have some form of the disease. Of the people diagnosed, approximately two-thirds will develop CLE. The annual average cost to provide medical treatment for a person with lupus: $6,000 to $10,000, with some treatment costing several thousand dollars a month.
"Management is extremely pleased to partner with Zylö Therapeutics, enhancing our portfolio of unique treatments for patients suffering from various dermatological related ailments," stated, Mr. Robb Knie, CEO of Hoth Therapeutics. "Zylö's initial work shows significant promise in combating Cutaneous Lupus Erythematosus, and we look forward to working with them in order to bring this treatment to market."
"We are thrilled to partner with Hoth, a company that is committed to innovative solutions and partnerships to develop treatments for diseases with a high unmet clinical need, such as lupus," said Scott Pancoast, CEO of Zylö. "As we work with the Hoth team to advance AEA-loaded Z-pods through the next stages of development, we expect to further demonstrate the important role that our patented Z-pod delivery system plays in improving treatment outcomes."
The term sheet is non-binding and neither party thereto shall have any obligation to consummate a transaction of any kind until such time as the parties have entered into a mutually agreeable definitive agreement. There can be no assurance that any such definitive agreement will be entered into or that the transaction will be completed on the terms set forth in the term sheet, or at all.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth's current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Hoth's Form 10K for the period ending December 31, 2018, and Hoth's other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
EUROPEAN MARKETING CLEARANCE RECEIVED FOR MACIMORELIN see more
CHARLESTON, S.C., Jan. 16, 2019 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX: AEZS) announced that the European Medicines Agency (EMA) has granted marketing authorization for macimorelin, an orally available ghrelin agonist, for diagnosis of adult growth hormone deficiency (AGHD). The approval came following the Committee for Medicinal Products for Human Use (CHMP) positive opinion of macimorelin on November 15, 2018.
“Clinical studies have demonstrated that macimorelin is safer and much simpler to administer than the current methods of testing for insulin-induced hypoglycemia, and is well-tolerated by patients and reliable in diagnosing the condition,” said Dr. Christian Strasburger, the Head of Clinical Endocrinology at Charité Unversitaetsmedizin Berlin and the principal investigator for macimorelin. “Both patients and healthcare-providers will undoubtedly welcome the general availability of macimorelin and I believe that macimorelin will become the generally accepted new reference procedure for diagnosing adult growth hormone deficiency.”
AGHD may occur in an adult subject who has a history of childhood onset growth hormone deficiency (GHD) or may occur during adulthood as an acquired condition. Considering a population of 510 million for the European Community, research based on incidence prevalence suggests that at least 35,000 adults could be afflicted with GHD.
“The EMA approval of macimorelin further validates the value of the product and will assist in our efforts to create value for our shareholders from macimorelin,” said Michael V. Ward, Chief Executive Officer, Aeterna Zentaris.
Macimorelin stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty biopharmaceutical company focused on developing and commercializing, principally through out-licensing arrangements, Macrilen™ (macimorelin), an oral ghrelin receptor agonist, to be administered in the diagnosis of patients with adult growth hormone deficiency. Aeterna Zentaris is a party to a license and assignment agreement with a subsidiary of Novo Nordisk A/S to carry out development, manufacturing, registration and commercialization of Macrilen™ (macimorelin) in the United States and Canada. For more information, visit www.zentaris.com.
This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates," and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully launch the product, the ability of Aeterna Zentaris to enter into out-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, reliance on third parties for the manufacturing and commercialization of our product candidates, potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, and, more generally, uncertainties related to the regulatory process, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our products, the impact of securities class action litigation or other litigation on our cash flow, results of operations and financial position, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
Michael V. Ward
Chief Executive Officer
Aeterna Zentaris Inc.
Lonza's $46 million investment expected to create new jobs in Greenwood, SC see more
Lonza, one of the world’s leading suppliers to the pharmaceutical, biotech and specialty ingredients markets, today announced plans to expand operations in Greenwood County. The company is investing $46 million over the next five years and is expected to generate 30 new jobs as a result.
Headquartered in Basel, Switzerland, Lonza harnesses science and technology to create products that enhance the overall quality of life for patients and consumers around the world. Through its acquisition of Capsugel in July 2017, Lonza now offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms.
Lonza’s Greenwood County operations, which are located at 535 North Emerald Road in Greenwood, S.C., produce empty capsules and finished dosage forms for the global biopharma and consumer health and nutrition markets. To expand, the company is adding approximately 50,000 square feet of new manufacturing space, which will enable the firm to produce key nutritional ingredients, among other projects.
With construction expected to be completed in the second quarter of 2019, hiring for the new positions will take place starting in mid-2018. Those interested in joining the Lonza team should visit the company’s careers page online(link is external).
The Coordinating Council for Economic Development has approved job development credits, as well as a $300,000 Set Aside grant to Greenwood County to assist with the costs of site work and infrastructure improvements.
“Lonza is making a significant investment in our operations in Greenwood, further demonstrating our commitment to providing high-quality products and services to our customers worldwide. Greenwood County is rich with talented, skilled individuals who will enhance our global and regional footprint, particularly in the area of consumer health and nutrition.” –Lonza Specialty Ingredients COO Sven Abend
“South Carolina’s workforce continues to demonstrate unmatched excellence; and, as a result, global companies like Lonza are growing and thriving here. I look forward to seeing all that these new positions will be able to produce and achieve in the years to come.” –Gov. Henry McMaster
“The Palmetto State’s life sciences industry continues to expand, showcasing South Carolina’s ability to produce a variety of advanced products. We congratulate Lonza and look forward to their continued success in Greenwood County.” –Secretary of Commerce Bobby Hitt
“Lonza has been an excellent job provider and a source of economic prosperity for Greenwood County. Their new expansion is exciting and encouraging, as it means their good work will continue to produce positive results for people locally and globally.” –Greenwood County Council Chairman Steve Brown
“We congratulate our friends at Lonza on today’s expansion announcement. Lonza’s continued growth within Greenwood County speaks to the company’s dedication and commitment to the area and the future of life sciences in South Carolina.” –Greenwood Partnership Alliance Chair Dr. Kristin Manske
FIVE FAST FACTS
- Lonza is expanding operations in Greenwood County.
- $46 million investment to create 30 new jobs.
- Lonza designs, develops and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health and nutrition industries.
- The company is adding 50,000 square feet to its Greenwood County facility, which is located at 535 North Emerald Road in Greenwood, S.C.
Mount Pleasant's FirstString Research completes $15MM Series B financing see more
FirstString Research, a clinical-stage biopharmaceutical company, announced today that it has completed a $15 Million Series B financing round. Led by Park West Asset Management LLC and Sophos Capital Management L.P., the Series B financing round brings FirstString’s total investor funding to over $27 Million.
In connection with the Series B financing, Tony Bartsh of Park West and Neal McConnell of Sophos have joined FirstString’s Board of Directors. “FirstString’s team has developed impressive data for Granexin® across a wide range of wound healing indications. We believe the Series B capital will allow FirstString to accelerate the development pipeline in several promising areas. We look forward to the initiation of two important studies in the first half of 2018” said Tony Bartsh.
“We are thrilled to have Tony and Neal join our Board,” said Dr. Gautam Ghatnekar, President & CEO and Co-Founder of FirstString Research. “They bring with them a wealth of biopharmaceutical experience and expertise. We believe that the Park West and Sophos investments provide significant credibility and validation to our innovative technology and clinical strategy. With this new funding, FirstString will be able to continue our extensive pipeline development and to advance our existing late-stage clinical programs toward approval. ”