globenewswire | August 28, 2023
Tarsus Pharmaceuticals, Inc. whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that XDEMVY™ (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The U.S. Food and Drug Administration (FDA) approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis.
“We are delighted that within weeks of FDA approval, XDEMVY is now available to millions of patients with Demodex blepharitis,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “The efforts of our team have created incredible interest in XDEMVY, the first and only approved solution for this highly prevalent disease. I’m so appreciative of our team and our partners who’ve worked diligently to bring this product to eye care providers and patients quickly and seamlessly following regulatory approval. We are proud to introduce XDEMVY to the eye care community and look forward to its potential to significantly change the way this disease is treated.”
XDEMVY is the only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes. XDEMVY is a prescription eye drop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks.
Tarsus is committed to ensuring that patients have affordable and broad access to XDEMVY and developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. More information about Tarsus Connect can be found on xdemvy.com or by calling: 1-866-846-3092.
About Demodex Blepharitis
Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at targeting the root cause of Demodex blepharitis.
XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease – Demodex mite infestation. The active ingredient in XDEMVY is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found XDEMVY to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Tarsus is studying three investigational medicines in clinical trials. In addition to XDEMVY (lotilaner ophthalmic solution) 0.25%, which is FDA approved in the United States for the treatment of Demodex blepharitis, Tarsus is also investigating TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, Tarsus is developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.
PHARMACY MARKET, PHARMA TECH
Businesswire | July 12, 2023
Kindeva Drug Delivery, a global leader in contract drug delivery development and manufacturing services and technology, and H&T Presspart (a division of the Heitkamp & Thumann Group), a market leader in respiratory drug delivery systems design, development, and manufacturing, are partnering with Chiesi Group, an international research-focused biopharmaceutical and healthcare group, for the installation of a production line for dose counter (DC) and dose indicator (DI) devices. Combining the specific expertise of each partner, H&T Presspart will manufacture Kindeva Drug Delivery’s dose counters under license for Chiesi Group for their pressurized metered-dose inhaler (pMDI) portfolio.
This partnership is a continuation of the agreement signed in 2014 between Kindeva Drug Delivery and H&T Presspart to accelerate the growth of Kindeva Drug Delivery’s dose counter technology. This technology enhances patient safety by providing real-time information on the remaining doses in inhalers, preventing unexpected shortages. H&T Presspart will expand the cleanroom facilities at their Marsberg, Germany, site to support the dose counter production. As part of this strategic partnership, Chiesi Group will use dose counters in their innovative carbon minimal pMDI portfolio, which uses a low Global Warming Potential (GWP) propellant to minimize the climate impact of the inhalers, while maintaining all the therapeutic options that patients suffering from respiratory diseases need.
David Stevens, global chief commercial officer of Kindeva Drug Delivery, stated: “Kindeva is pleased to extend this strategic partnership as it solidifies our core objective of improving the lives of patients around the world. Kindeva embraces the responsibility it has in ensuring that patients who depend upon our device technology are reliably supplied, and we believe that this innovative supply chain collaboration further underscores this commitment.”
Roberto Della Valle, head of global direct procurement of Chiesi Group, added: “Chiesi, with its patient-centric approach, is dedicated to delivering therapeutic solutions that enhance patients’ health and quality of life. Collaborating with Kindeva and H&T Presspart exemplifies this commitment, and we are thrilled to take this step forward. By providing an inhaler that reassures patients about the remaining dose count, we aim to enhance their safety and confidence.”
Christian Kraetzig, president of H&T Presspart, commented: “With our expertise in device industrialization and manufacturing, this agreement marks another step in our journey to becoming a leading development and contract manufacturing partner in drug delivery devices.”
About Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development manufacturing organization focused on drug-device combination products. Kindeva Drug Delivery develops and manufactures products across a broad range of complex drug-delivery formats, including injectables (autoinjector, intradermal, microneedle), pulmonary & nasal, and transdermal patches. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva Drug Delivery serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K.
About Chiesi Group
Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees.
VIEWS AND ANALYSIS, PHARMACY MARKET
PRNewswire | July 31, 2023
LSPedia, a leading SaaS provider specializing in product traceability solutions for the pharmaceutical industry, has partnered with Altro Pharmaceuticals, enabling Altro customers to easily comply with the Drug Supply Chain Security Act (DSCSA) ahead of the FDA's final deadline on November 27, 2023.
Altro provides expertise and services to pharmaceutical manufacturers and wholesale distributors, helping them expand their businesses, streamline supply chain operations, increase efficiency, and more. Now, its services include proven, worry-free turnkey DSCSA compliance, thanks to LSPedia's easy-to-use, comprehensive OneScan software suite.
Sandy Greco, President of Altro Pharmaceuticals, noted, "Getting DSCSA right is essential to the smooth flow of business in the pharma supply chain, so we take it incredibly seriously, and we absolutely want our customers to succeed with it. LSPedia has the industry's best track record for user experience, scalability, and success – we can say for sure we're offering the best service available."
LSPedia's OneScan Suite enables manufacturers and wholesalers to quickly achieve full compliance with all DSCSA requirements, including serialization, sending and receiving EPCIS data, verification, and interoperability. Further, the solution includes access to LSPedia's Investigator for Exceptions Management, the industry's gold standard for alerting, resolving, and preventing EPCIS transaction errors.
"Altro is a perfect partner for LSPedia," said LSPedia CEO Riya Cao. "With so little time left before the compliance deadline, access and convenience are essential. Altro supports its customers with a deep service portfolio, and there's every reason it should include easy, complete DSCSA compliance."
LSPedia is a leading provider of turnkey DSCSA compliance and SaaS solutions in the pharmaceutical industry. CMOs, manufacturers, 3PLs, wholesale distributors, dispensers, and healthcare providers use LSPedia's OneScan solution to make, move, track, verify, ship, and receive serialized products at every point in the supply chain.
As the largest processor of serialized data in the industry, LSPedia builds solutions with workflow, automation, and data security at their core. OneScan delivers flexible integrations, high-performance product verification, and state-of-the-art EPCIS data exchange; LSPedia's Investigator platform is the gold standard for serialization exceptions management, as the first collaborative platform to resolve EPCIS errors and supply chain issues in real time.