Sandoz, Gan & Lee ink deal to develop insulin biosimilars
Sandoz, a Novartis division, has entered into an agreement with Gan & Lee to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes.
The commercialization and supply agreement with Gan & Lee aims at bringing to market biosimilar versions of glargine, lispro and aspart — the three top insulin medicines by sales.
Gan & Lee is a leading insulin supplier headquartered in China with more than 20 years’ experience in insulins and production capacity with attractive cost of goods sold structures.
Under the terms of the agreement, Sandoz will be fully responsible for commercializing these medicines in the EU, United States, Switzerland, Japan, South Korea, Canada, Australia and New Zealand.
Gan & Lee will be responsible for manufacturing and development, with support from Sandoz, and shall adhere to the stringent manufacturing requirements established for Sandoz biosimilars. Other specific terms of the agreement are confidential.
“Across the world, people suffering from diabetes still face very real access challenges. In fact, U.S. patients have reported taking less insulin than recommended by their doctor because they couldn’t afford it — putting them at higher risk for serious complications,” Sandoz CEO, Richard Francis, said.”At Sandoz, we have significant experience disrupting and transforming marketplaces, and look forward to extending access for the more than 420 million people worldwide suffering from diabetes.”
Hikma launches generic Ampyra
Hikma Pharmaceuticals has launched dalfampridine extended-release tablets in a 10-mg dosage strength.
The product, which is the generic of Acorda Therapeutics’ Ampyra, is indicated to help improve walking in adult patients with multiple sclerosis as demonstrated by an increase in walking speed.
Ampyra had a market value of roughly $543 million in 2017, Hikma said.
“We are very pleased to be launching dalfampridine extended-release tablets, a life-enhancing medicine for people with multiple sclerosis. This product highlights our ability to successfully litigate patent-protected Paragraph IV products, improving patient access to high-quality, affordable medicines,” Hikma generics division, president Brian Hoffman, said.
Ananda Professional studies CBD’s effect on tapering opioid usage
Ananda Professional, a hemp-derived CBD grower and manufacturer, has announced their sponsorship of an ongoing opioid reduction study.
“The first step to successfully reducing a patient’s opioid intake, is the patient’s willingness to taper down,” says, Dr. James Murphy, co-director of the study, adding, “pain is a physical and psychological condition – believing that tapering down is possible is huge.”
Alongside James Murphy of New Albany, Indiana’s Murphy Pain Center is collecting data showcasing how incorporating hemp-derived CBD can affect a patient’s willingness to taper their opioid usage in a positive way, the Cynthiana, K.Y.-based company said.
“We are very excited with initial findings,” Alex Capano, Ananda Professional’s chief medical director and study co-director, said. “Industry research, including NIH studies, support CBD’s unique ability to exert analgesic effects across multiple pain conditions. Moreover, its safety profile is better than that of opioids and is extremely well tolerated as an adjunct therapy.”
The study, which is being conducted with guidance from the Institutional Review Board, or IRB, enrolled 140 participants over a two-month period. Participants with initial intake had to participate in follow-up visits and questionnaires at four and eight weeks. Participants also must have been stable for one year or longer or above 30 morphine equivalent, or MME, daily, the company said.
“Pain is a complicated diagnosis with many components,” Murphy said. “CBD offers several peripheral benefits including increased relaxation, increased sleep, and an increase in activity ability, all which affect pain and pain perception.”
“Independent pharmacists have strong relationships with their patients, understand their treatment regiments and are uniquely capable of recommending CBD formulations based on the patient’s history and underlying health issue,” Chuck Schneider, Ananda Professional’s chief revenue officer, said.
“It should be noted that public health records indicate that states with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate compared to states without medical cannabis access,” Capano said. “Medicare prescriptions for drugs to treat pain, depression, anxiety, nausea, psychoses, seizures and sleep were reduced in states with cannabinoids. We are extremely optimistic this study will provide data that can change lives.”