Allergan (NYSE:AGN) and women’s health nonprofit pharma company Medicines360 touted 4-year data today from an ongoing pivotal trial for its Liletta intrauterine contraceptive. The system is approved for the prevention of pregnancy for up to 3 years.
More than 1,500 women ranging from 16 to 45 years old were enrolled and studied in the group’s clinical trial. The abstract, which was presented at the American College of Obstetricians and Gynecologists annual clinical and scientific meeting, includes safety outcomes and 4-year pregnancy rates from the ongoing trial.
The Pearl Index, which describes the number of unintended pregnancies per 100 women over 1 year of use, was 0.15 among women ages 16 to 35.
The team reported that perforation after device placement occurred in 2 women and that 63 participants experienced expulsion. Pelvic infection was found in 12 women and 38 participants stopped using the contraceptive due to bleeding complaints over 4 years.
“We are encouraged by this information presented today at ACOG, which represents the data from our ongoing clinical trial used in our recent submission to the FDA requesting approval of Liletta for up to 4 years of use,” Medicines360 CEO, Dr. Jessica Grossman, said in prepared remarks.
Also today, shares in Allergan rose after the company beat earnings and sales expectations on Wall Street with its 1st quarter results.
The Dublin-based company posted a net loss of -$2.63 billion, or -$7.86 per share, on sales of $3.57 billion for the 3 months ended March 31, for bottom-line loss of -93% on sales growth of 5% compared with the same period last year.
Allergan reportedly posted a 1st quarter loss due to amortization, R&D-related charges and in-process R&D impairments.
Adjusted to exclude 1-time items, earnings per share were $3.35, ahead of consensus on The Street, where analysts were looking for sales of $3.53 billion.
“2017 is a pivotal year for Allergan, and we started with a solid, well-executed 1st quarter. Many of our key brands continued to deliver significant year-over-year growth, led by Botox, our Juvederm Collection of fillers, our regenerative medicine business, Linzes and Lo Loestrin. We also saw strong performance from our newer launch products. We recently completed the acquisitions of LifeCell and Zeltiq, adding to our leading position in medical aesthetics. We are focused on executing successful integrations of those businesses. And our R&D team continued to advance many of our 6 ‘star’ R&D programs and deliver FDA approvals, including Vollure XC and TrueTear,” chairman & CEO Brent Saunders said. “These solid results and strong execution were delivered by our 18,000 global colleagues who continue to Be Bold. They are powering new ideas and building bridges with our customers to help them better care for their patients. They are acting fast and driving results that will continue to make a profound impact on global health and patient care. I thank them for their continued commitment as we focus on solid execution and delivering results for the remainder of 2017.”
Allergan raised its net revenue forecast to $15.8-$16 billion, up from $15.5-$15.8 billion, to reflect its $2.48 billion acquisition of Zeltiq Aesthetics.
AGN shares were trading at $242.07 apiece today in mid-morning activity, up 0.5%.
Material from Reuters was used in this report.