Tarsier Pharma | August 28, 2021
Tarsier Pharma, a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced it raised capital to execute a phase-3 clinical trial of its TRS01 program in the US and Europe. Strategic and new investors alongside existing investors participated in this transaction.
Following a successful End of Phase II meeting with the FDA, the Company obtained all necessary regulatory approvals to execute phase 3 and has recruited leading uveitis experts as principal investigators. Tarsier plans to enroll the first patient in Q4 of 2021.
Tarsier's technology, TRS, is a novel immunomodulator molecule that showed, in a dose-ranging, randomized, double-masked phase I\II trial in the target indication, a prompt and statistically significant improvement in signs and symptoms of uveitis.
"We are excited to have the support of our existing and new investors, as we continue our clinical development of TRS01 in advanced stages," said Dr. Haim Langford, CEO of Tarsier. "Looking ahead, we are eager to bring our lead product to market and simultaneously progress our development of important pipeline projects for other back-of -the-eye blinding diseases, and plan to raise additional capital to realize these as well."
About Tarsier Pharma
Tarsier Pharma is a late clinical stage pharmaceutical company, phase-3 ready, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular blinding diseases. TRS is a breakthrough proprietary technology platform, based on a new bio-inspired chemical entity, with novel mechanism of action and demonstrated safety and efficacy in a rare debilitating and blinding indication.
Lead product candidate for uveitic glaucoma
Non-infectious uveitis is an autoimmune blinding ocular inflammation, considered the third leading cause of blindness in the developed world. Tarsier's TRS01 is a potent fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma – considered an end-stage condition of uveitis. Once a uveitis patient has also developed glaucoma (uveitic glaucoma), the only available treatments for active inflammation, which are steroids, should be avoided, due to their negative side effects in expediting glaucoma and vision loss. Thus, TRS01 has the potential to become the standard of care for uveitic glaucoma.
Antares Pharma, Inc. | February 04, 2022
Antares Pharma, Inc. a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO®, an oral treatment for testosterone replacement therapy. The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act.
TLANDO® was granted tentative approval from the FDA as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO® met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022.
“As we take this final step moving from tentative approval to potential final approval in late March, we will continue to prepare for the commercial launch of TLANDO. Our National Sales Meeting is set for the end of April and will serve as the venue to train and ready our sales professionals to start promoting TLANDO to the medical professionals who treat testosterone deficiency. We are excited to be able to complement our current offering of XYOSTED with an oral formulation to patients and physicians. We will leverage our strong physician relationships which we believe will accelerate the adoption of TLANDO, support our future revenue growth and drive our market share gains in the testosterone market,”
Robert F. Apple, President and Chief Executive Officer of Antares Pharma
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® in the U.S. and expects to commercially launch TLANDO® in the U.S. pending final FDA approval.
Prnewswire | October 01, 2020
Genuity Science, a genomics and data insights organization and Ionis Pharmaceuticals (NASDAQ: IONS), the leader in antisense therapeutics, today announced a broad, multi-year collaboration aimed at accelerating the discovery and development of innovative therapeutics across a range of up to 20 diseases. The collaboration is expected to play an important role in allowing Ionis to continue delivering transformational medicines to patients for many years to come. Genuity Science's approach combines high-quality, whole-genome sequence and deep phenotype data resulting in better definition of the underlying disease mechanisms. This approach, when coupled with Ionis' proprietary antisense technology, has the potential to significantly expedite the drug development process through a more direct translation of targets into therapeutics.