Imprimis to launch compounded Restasis alternative
SAN DIEGO — Opthalmology-focused company Imprimis Pharmaceuticals will be offering a compounded cyclosporine-based formulation to treat dry eye disease, the company announced Thursday. The products will be packaged in multi-use bottles and include Klarity Drops, a formulation developed by ophthalmologist Dr. Richard Lindstrom.
“We believe dry eye disease patients can benefit from unique customized medications that are not commercially available,” Imprimis CEO Mark Baum said. “While physicians who use compounded cyclosporine formulations have anecdotally known this for many years, there is now published data that demonstrates the clinical value of topical Cyclosporine formulations at concentrations greater than those currently available in commercially available medications. We are pleased to be able to offer affordable customized cyclosporine formulations that are designed for patients' individual needs.”
The company said the initial prescription will cost 99 cents for a one-month supply, with refills starting at $79 per month, including shipping.
“Imprimis has long championed issues of access, affordability and competition. While there are an estimated 30 million Americans suffering from dry eye disease, only a small fraction of these patients receive therapy,” Baum said. “We believe that affordability can affect access to needed medications, and it is our hope that our formulations will allow more patients to gain access to a high quality customized cyclosporine treatment option.”
On Tuesday, a Texas judge invalidated Allergan’s patent claims on Restasis — and in the wake of the ruling, Allergan has said it will work to protect its intellectual property.
“Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients,“ Allergan chief legal officer Robert Bailey said Tuesday.
FDA approves Yescarta from Gilead’s Kite
FOSTER CITY, Calif. — The Food and Drug Administration has approved the first chimeric antigen receptor T cell, or CAR T, therapy for patients with certain types of lymphoma. Yescarta, from Gilead’s recently acquired company Kite, was approved to treat relapsed or refractory large B-cell lymphoma following two or more lines of systemic therapy.
“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” Kite founder Dr. Arie Belldegrun said. “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR T therapies.”
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma, representing 1-in-3 of the roughly 72,000 new cases diagnosed every year in the United States. Each dose of Yescarta is customized based on a patient’s immune system to help fight the immune system. A patient’s T-cells are collected and genetically modified to include a new gene that targets and kill lymphoma cells. The list price of Yescarta, according to Gilead, is $373,000.
The approval comes as the FDA is set to offer more guidance to manufacturers on the development of gene therapies similar to Yescarta.
"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer," FDA commissioner Dr. Scott Gottlieb said. "This approval demonstrates the continued momentum of this promising new area of medicine and we're committed to supporting and helping expedite the development of these products. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies.”
National digestive brands see mixed sales results
The upper gastrointestinal proton pump inhibitors segment saw a 9% decrease — national brands only — in sales in multi-outlets for the latest 12 months compared with the previous year, with losses primarily driven down by large decreases at Procter & Gamble’s Prilosec OTC (-13%) and for GSK Consumer Heathcare’s Prevacid (-15%). Among the H2 segment — which was up 2% versus the previous year, national brands only — McNeil’s Pepcid brand showed strong growth versus the prior year with a 6% increase, while Chattem’s Zantac decreased 1% (Figure 1).
For leading manufacturers in the PPI segment, Pfizer’s Nexium 24HR saw the highest percentage of sales on promotion at 40%. Bayer’s Zegerid saw the lowest percentage of sales on promotion at just 13%. In the H2 segment, both Chattem and McNeil saw similar per-
centages of sales on promotion at 20% and 21% respectively (Figure 2).
Average PPI retailer margins were consistently the highest in the mass, food and drug channels for Bayer, while GSK Consumer Healthcare saw the lowest average margins. In the H2 segment, McNeil saw the highest margins across all channels while Chattem saw the lowest (Figure 3).
For upper GI PPI segment, P&G saw the largest amount of ad support across all three channels. For the H2 segment, Chattem saw the largest number of print circular ads for both food and drug channels, while mass focused primarily on price only (Figure 4).
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