Pharmacy Market
PRNewswire | July 21, 2023
Catalyst Clinical Research an industry-leading provider of specialized clinical development solutions, announced today it has acquired Genpro Research ("Genpro"), a Massachusetts-based global clinical research organization with staff in the US, India, and Ireland.
Genpro is a next generation services and technology partner for the pharmaceutical, biotechnology, and medical devices industry with expertise in biometrics, medical writing, RWE, and AI enabled automation product development. Genpro will continue to be led by Dr. Sachin Marulkar and the existing management team.
Commenting on the announcement, Catalyst CEO Nick Dyer said, "We are hugely enthusiastic about the addition of Genpro to our family. We share the opportunity to expand our global footprint, broaden and deepen our services, and to use the AI platform to create value for ourselves and customers in a range of labor-intensive document creation processes. In addition, our approach to prioritizing culture and treating our teams like family are similar and will act as a critical foundation for our combined company as we move forward."
Genpro CEO Dr. Sachin Marulkar added, "By joining Catalyst, we will continue to expand our biometrics, scientific reporting and technology offerings, have access to more opportunities globally, and provide our clients with additional products and services. We are excited to utilize the synergies in advancing our AI/ML technology platform to create beneficial new tools and improve the efficiency of clinical research. Catalyst is highly aligned with our purpose, values, and our relationship-driven focus. We look forward to stepping into these opportunities while still acting with the speed and flexibility our customers value and maintaining the collaborative culture that is so important to our employees."
This acquisition adds more than 120 team members in India with expertise in biometrics and medical writing further bolstering Catalyst's robust functional service offerings. This further enables biopharma, MedTech and CRO clients (current and future) to access Catalyst's specialized clinical research services, along with broader expertise in global time zones, new solutions, and early access to innovative automation platforms.
Melissa Church, Senior Vice President, Strategy at Catalyst, expressed the strategic significance of the acquisition, emphasizing its importance in advancing Catalyst's commitment to providing top-notch specialized clinical development solutions. She stated, "Catalyst is extremely intentional in its acquisition approach, ensuring we choose organizations that are additive to our capabilities and match well with our people-first culture. In Genpro we are gaining a very talented team delivering function specific biometrics and medical writing services which fits squarely in our strategic growth plan supporting both our Catalyst Flex and Catalyst Oncology solutions. This creates more value for our customers, collaborators, partners and investors long term."
Highlighting scientific and innovation focus of the deal, Kapil Khambholja, Genpro's CSO and Practice Head of Medical Writing, Real-World Evidence, and Health Economics and Outcomes Research (RWE & HEOR) emphasised both company's shared commitment for advancing therapies beyond milestones to transforming lives. Dr Kapil stated, "This partnership will propel Genpro's automation roadmap forward, aligning strategically with Catalyst's interests. We are also thrilled to see Genpro's scientific initiatives gaining momentum, and we eagerly anticipate collaborating with Catalyst's dedicated team to inspire advancements of breakthrough therapies touching lives."
About Catalyst Clinical Research
Catalyst is a clinical research organization (CRO) that provides highly customizable solutions to the global biopharmaceutical industry through two established, branded solutions: Catalyst Oncology and Catalyst Flex. The company provides full-service oncology CRO offerings through Catalyst Oncology and multi-therapeutic Client- or Catalyst-managed functional services through Catalyst Flex. With around 1000 staff and offices in the United States, Europe, and Asia-Pacific regions, Catalyst's flexible service model is built from more than a decade of listening to customers, devising customer-centric solutions, and helping customers drive breakthrough clinical studies by leveraging expert teams and innovative technologies.
Catalyst is a portfolio company of QHP Capital, a leading healthcare and life sciences investment firm.
About Genpro Research
Genpro Research is a technology and services partner dedicated to serving the pharmaceutical, biotechnology, and medical devices industries. By providing expertise in biostatistics, data sciences, medical writing & evidence synthesis, the focus has been on thoughtful service execution on clinical studies. And, as an experienced technology provider, Genpro uses Artificial Intelligence, Machine Learning, and Natural Language Processing algorithms for clinical development and post-launch activities, Genpro's central commercial platform called MaiA is used for Evidence Generation and Study Report Automation that brings depth and clarity to enable informed decision making.
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Views and Analysis
PRNewswire | August 21, 2023
Everest Medicines announced that U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for Nefecon® from its partner Calliditas Therapeutics AB and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is Dec. 20, 2023.
"We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-disease therapy to all IgAN patients at risk of progression. It is another testament to Nefecon® as an important, disease-modifying medicine with significant eGFR treatment benefit observed across the entire study population that can substantially delay onset of dialysis for patients at risk," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As IgAN prevalence in Asia is much higher than the rest of the world, we look forward to receiving NDA decision for Nefecon® in mainland China in the second half year and filing NDAs in other Asian territories as soon as possible."
The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The full data from the NeflgArd Phase 3 trial was published in The Lancet in August 2023.
The trial demonstrated a statistically significant benefit of Nefecon® over placebo (p-value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year study period, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off the study drug. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline, and showed a difference between TARPEYO and placebo in 2-year eGFR total slope of approximately 3mL/min per year using a robust regression method of analysis.
The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon® for the treatment of IgAN in November 2022, with a decision expected in the second half year of 2023. The NMPA has also granted Nefecon® break-through therapy designation and NDA priority review. Nefecon® was the first non-oncology drug to receive break-through therapy designation in China.
About Nefecon®
Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
Nefecon® was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon® over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include renal diseases, infectious diseases, mRNA platform and autoimmune disorders.
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Pharmacy Market
Businesswire | August 01, 2023
Harrow a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The U.S. commercial rights to VIGAMOX werepurchasedby Harrow in January of 2023, and VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name.
“Having now completed the NDA transfer of VIGAMOX, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow. “With an exceptional record of safety and efficacy, VIGAMOX is a well-known, reliable, and trusted product by U.S. eyecare professionals, many of whom regard VIGAMOX as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.”
Product orders for VIGAMOX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%:
INDICATIONS AND USAGE
VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis.
Efficacy for this organism was studied in fewer than 10 infections.
IMPORTANT SAFETY INFORMATION
Contraindications
VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Warnings and Precautions
Hypersensitivity Reactions –Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.
Prolonged Use –May result in overgrowth of non-susceptible organisms, including fungi.
Avoid Contact Lens Wear –Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients.
Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
About Harrow
Harrow Health, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.
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