Home > News > featured news > Hikma and FAES Farma enter into exclusive licensing agreement for the commercialisation of Bilastine tablets in the US

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Hikma and FAES Farma enter into exclusive licensing agreement for the commercialisation of Bilastine tablets in the US

Hikma Pharmaceuticals PLC | September 21, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, announces the signing of an exclusive US license agreement with FAES Farma S.A. to commercialise Bilastine tablets, a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria.

Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US following approval. Hikma will provide FAES with an upfront payment, regulatory approval and commercial milestone payments as well as royalties. The agreement builds upon Hikma and FAES Farma's existing partnership on Bilastine in the Middle East and North Africa, where Hikma is the exclusive licensee for Bilastine in 15 countries.

We are pleased to form this partnership with FAES Farma for Bilastine, which builds on our growing position in the allergy market and further advances our objective of strengthening our specialty business in the US. Since its first launch in Europe in 2011, Bilastine has been successfully commercialised as a leading allergy brand in more than 100 countries. By introducing Bilastine in the US, Hikma is further solidifying its presence in the allergy market, and we will leverage our existing salesforce promoting our specialty portfolio, including our partnership with Eyevance Pharmaceuticals for the co-promotion of ZERVIATE® and our forthcoming branded seasonal allergic rhinitis nasal spray Ryaltris™. We look forward to bringing this new treatment option to US patients.

- Brian Hoffmann, President of Hikma Generics.

About Bilastine
Bilastine is a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria. Bilastine is currently approved in more than 120 countries and achieved more than €290 million in worldwide sales in 2020. If approved by the FDA, Bilastine would be the first New Chemical Entity antihistamine approved in the US since 2007.

About Hikma
Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world.

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Globenewswire | March 28, 2023

EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. 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The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.” “We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. 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Businesswire | May 29, 2023

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Hovione and H&T Presspart extend partnership to advance high efficiency device technology for Dry Powder Inhalation formulation delivery

PRNewswire | May 04, 2023

Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and H&T Presspart have entered in a strategic partnership to advance the development of Presspart's Sunriser© Capsule-based Dry Powder Inhaler platform. The demand for inhalable drugs that require higher drug loads and the delivery of cohesive materials has increased, making it necessary to develop more efficient solutions. To meet this demand, the two companies will work together to develop the Sunriser© Dry Powder Inhaler. This innovative and best-in-class capsule-based platform is flexible enough to address both the challenges of classic carrier-based and spray-dried engineered formulations. This partnership is an extension of a successful collaboration that has spanned several years on developing and commercializing innovative dry powder inhalation devices. As part of the joint development agreement, Hovione will exclusively partner with Presspart to exploit the Sunriser© device in the field of engineered formulations for dry powder inhalation. Presspart will remain responsible for the manufacturing of the Sunriser© device. To provide further insights into the benefits of this partnership for the industry, a joint workshop will be held today, May 3rd, at the Respiratory Drug Delivery (RDD) Europe 2023. "New inhalable therapies are often requiring delivery of higher doses of cohesive and sensitive powders. Our priority is to ensure maximum efficiency in delivering these drugs to the right locations in the lung," says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds: "We are thrilled to expand our current partnership with Presspart and combine our expertise in the fields of engineered particles and inhalers for the benefit of our customers and patients." Christian Kraetzig, President of H&T Presspart, commented "Following our successful collaboration with Hovione on the PowdAir Plus DPI device development, we are once again extremely pleased to be working with Hovione in developing this next generation high performance DPI device. As the market leader in respiratory components and devices, this strategic partnership will allow H&T Presspart to expand its portfolio within the growing field of dry powder technology." Pharmaceutical companies partnering with Hovione to develop their new inhalable drugs using the Sunriser© device can leverage Hovione´s unparalleled expertise in inhalable APIs, formulation, filling, and analytical characterization. Additionally, with H&T Presspart's state-of-the-art device manufacturing and supply, from lab to commercial cGMP scale, companies can benefit from a comprehensive approach to drug development. This partnership enables pharmaceutical companies to access top-notch expertise and cutting-edge technology, ensuring the successful development and commercialization of innovative inhalable drugs. About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. 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, formulation development and devices.

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Globenewswire | March 28, 2023

EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. 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The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.” “We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety. “Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert® E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.” About EYP-1901 EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. 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