Palatin Technologies, Inc | December 29, 2021
Palatin Technologies, Inc. a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced the initiation of the pivotal Phase 3 MELODY-1 clinical study of PL9643 in patients with dry eye disease. The study is designed to enroll up to 400 patients at multiple U.S. sites, and top-line results are currently expected second half calendar 2022.
"We are excited to initiate the MELODY-1 study of PL9643 in patients suffering from dry eye disease. This is the second melanocortin peptide Palatin has advanced into Phase 3, demonstrating Palatin's expertise and efficiency in melanocortin peptide development for indications with unmet medical need."
Carl Spana, Ph.D., CEO and President of Palatin
The pivotal Phase 3 MELODY-1 clinical study is a multi-center, randomized, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in subjects with dry eye disease . The study design is based on positive Phase 2 results of PL9643 for the treatment of dry eye disease, and an end-of-phase 2 meeting with the with the U.S. Food and Drug Administration, reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, to support a New Drug Application filing, a second phase 3 study and long-term safety study will be required. If the program progresses as planned, top-line results from MELODY-1 would be available second half calendar 2022, MELODY-2 data read out second half calendar 2023, with a potential NDA submission first half calendar 2024.
"Progressing PL9643 into Phase 3 is a significant milestone for the Company and patients with DED," said Michael Raizman, MD, Chief Medical Officer of Palatin. "PL9643, with its differentiating factors, could provide a more tolerable and effective treatment option for patients suffering from dry eye disease."
About Dry Eye Disease
Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires week or months to demonstrate activity.
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
Many tissues and immune cells located in the eye express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential.
CELL AND GENE THERAPY
BOSTON LABS | September 23, 2021
Clinical logistics and life science manufacturing leaders Boston Labs and Germfree Laboratories Inc. announced their partnership to launch a new network of mobile CGT manufacturing facilities. The two companies are combining deep logistics, CGT manufacturing expertise and mobile cleanroom technology to deliver CGT point-of-care contract manufacturing services.
The CGT mobile manufacturing platform will launch in Boston, MA in the fourth quarter of 2021 and will scale to a network of global point-of-care mobile contract manufacturing centers.
Boston Labs is embedded within the Boston/Cambridge life science community which is home to more than 1000 biotech companies. 18 of the top 20 biopharmas have a major presence in the area, including Biogen, Novartis, Sanofi and Takeda and other leading companies such as Moderna, Crispr Therapeutics, bluebird bio and Avrobio.
As the cell and gene therapy industry continues to grow, easier on-site access to cleanroom manufacturing facilities will likely be highly valued. Our pivotal partnership with Germfree Laboratories, Inc. enables Boston Labs to readily deploy mobile manufacturing platforms to any clinical site globally where CGT trials are enrolling, eliminating logistical risks associated with transporting patient material under a critical timeline. This is the Future of Point-of-Care Cell and Gene Therapy Delivery.
- Jon Mason, CEO of Boston Labs
This groundbreaking collaboration with Boston Labs should deliver much needed process space and opportunities to showcase how next-generation cleanrooms and manufacturing facilities can accelerate the processes needed for the future.
- Kevin Kyle, CEO of Germfree
This partnership, designed to reduce client CGT manufacturing costs and complexities, delivers secure access to mobile GMP-compliant manufacturing facilities wherever they are needed.
About Boston Labs:
Founded in 2003, Boston Labs is a leading clinical logistics company, working with clients to streamline the complexities of biotech and pharmaceutical logistics and manufacturing.
Germfree Laboratories Inc. creates environments that serve life science innovation and advance global health. They design and manufacture flexible cGMP-compliant cleanroom buildings and high containment facilities which are process or containment ready upon deployment.
CELL AND GENE THERAPY
Sartorius | July 05, 2021
Sartorius Stedim Biotech, a leading international biopharmaceutical partner, has acquired a majority stake in CellGenix GmbH, a reagent manufacturer. The company, headquartered in Freiburg, Germany, and with a sales subsidiary near the biotechnology center in Boston, Massachusetts, USA, manufactures and distributes cell culture components in GMP grade for the manufacture of cell and gene therapy products.
Sartorius Stedim Biotech originally purchased 51% of this company, which was previously privately held, for about 100 million euros in cash. Sartorius Stedim Biotech plans to purchase the remaining CellGenix shares in 2023 and 2026. CellGenix, founded in 1994 at the University Medical Center of Freiburg, employs about 70 employees and aims to produce revenues of more than 20 million euros in 2020, with a very high double-digit EBITDA margin.
Sartorius Stedim Biotech intends to significantly expand the Freiburg facility and establish it as a center of excellence within the company to develop and produce high-quality critical raw materials for the cell and gene therapy markets.
This press release includes forward-looking statements regarding the Sartorius Stedim Biotech Group's future development. Forward-looking statements include known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or indicated by such statements. Sartorius Stedim Biotech disclaims all obligation for revising such statements in light of new information or future events. The following is a translation of the original French news release. Sartorius Stedim Biotech accepts no responsibility for the accuracy of this translation. The legally binding version is the original French news release.
Sartorius Stedim Biotech's profile
Sartorius Stedim Biotech is a leading international biopharmaceutical industry partner. As a complete solutions provider, the business helps its clients produce biotech medications in a safe, timely, and cost-effective manner. Sartorius Stedim Biotech, headquartered in Aubagne, France, is listed on the Eurolist of Euronext Paris. Sartorius Stedim Biotech has a worldwide reach thanks to its production and R&D facilities in Europe, North America, Asia, and an international network of sales companies. The Group's yearly growth rate has been in the double digits on average, and it has constantly been extending its portfolio via acquisitions of related technology. In 2020, the business had about 7,500 employees and a sales revenue of 1,910 million euros.