Liletta from Actavis, Medicines360 now available in the U.S.
BY Ryan Chavis
DUBLIN and SAN FRANCISCO — Actavis and Medicines360, a nonprofit women’s health pharmaceutical company, on Monday announced that Liletta (levonorgestrel-releasing intrauterine system) in 52 mg is now available in the United States. Liletta is used by women to prevent pregnancy for up to three years, according to the companies.
Liletta was granted Food and Drug Administration approval in February. It’s placed in the uterus by a healthcare professional and provides a continuous release of levonorgestrel to prevent pregnancy, the companies stated.
"The availability of Liletta marks another significant achievement in women's health," said Carolyn Westhoff, MD, M.Sc, professor, division director, Family Planning and Preventive Services, Columbia University Medical Center. "It's critical that women have choices when it comes to their preferred contraception and I am pleased that I can offer my appropriate patients this new safe and effective option."
Liletta is now commercially available in doctor’s offices. Through the Actavis-Medicine360 partnership, it’s priced lower for public health clinics enrolled in the 340B Drug Pricing Program.
"The commercial availability of Liletta represents a remarkable next step for women's health in the U.S., providing IUD-appropriate women, regardless of income and insurance coverage, with a safe and effective contraceptive option," said Pamela Weir, COO of Medicines360. "Through this truly innovative partnership, women will now have an accessible, affordable option for effective, long-term contraception."
Sunny Pharmtech, Vitruvias Therapeutics to co-develop portfolio of generics
BY Ryan Chavis
MONTGOMERY, Ala. and TAIPEI, Taiwan — Taiwan-based drug development company Sunny Pharmtech and Vitruvias Therapeutics, a generic drug development company, on Tuesday announced that they will team up to co-develop a portfolio of generic drug products.
According to the companies, the partnership will allow them to “develop and commercialize generic products in markets that currently exceed $400 million.” Each company will have a 50% stake in the portfolio of products and the first abbreviated new drug application is expected to be filed in fourth-quarter 2015.
“We are fortunate to have the opportunity to partner with a company as technologically sophisticated as Sunny Pharmtech given their expertise in the development of API and finished dose formulations,” said Carl Whatley, general manager of Vitruvias. “Sunny Pharmtech provides us with the know-how to develop difficult products in under-served U.S. markets and we look forward to addressing the needs of those markets as soon as we possibly can.”
Dr. Yon-Lian Wu, Sunny Pharmaceutical CEO and chairperson, added: “I am delighted to announce this strategic partnership between Sunny Pharmtech and Vitruvias. It will leverage both companies’ respective strengths to meet the needs of patients for high quality and cost-effective generic pharmaceuticals. For Sunny Pharmtech, this agreement will enhance our efforts to establish a world-class platform to support our efforts in the generic pharmaceutical products area. By combining our respective capabilities in this joint effort, Sunny Pharmtech and Vitruvias are creating a global business model and a robust base in the generic pharmaceuticals market.”
Diplomat Pharmacy to distribute Novartis’ latest iron chelation therapy
FLINT, Mich. — Diplomat Pharmacy on Monday announced it will distribute Jadenu, a drug recently approved by the Food and Drug Administration to treat patients with chronic iron overload.
Chronic iron overload is a life-threatening toxicity that results from blood transfusions required to treat sickle cell disease, myelodysplastic syndromes, thalassemia and other conditions. Chronic iron overload also can occur in patients with non-transfusion-dependent thalassemia syndromes, due to increased iron absorption in the stomach and intestines. If left untreated, chronic iron overload can damage the liver and heart.
Jadenu is a new oral formulation of Exjade (deferasirox) for the treatment of chronic iron overload due to blood transfusions in patients age 2 years and older, and chronic iron due to NTDT in patients age 10 years and older. The new drug is the only once-daily oral iron chelator that can be swallowed whole. It can be taken in a single step, with or without a light meal, simplifying daily treatment administration.
"Novartis has had a long-term commitment to improving the lives of patients with chronic iron overload," said Bruno Strigini, president, Novartis Oncology. "Exjade transformed iron chelation therapy. We responded to feedback from patients and their physicians, and now Jadenu, by simplifying treatment administration, offers an important new option to help meet these patients' needs."
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