Actavis plc (NYSE: ACT), during its Investor Meeting in New York, today provided a detailed look into its standalone global pharmaceutical development pipeline that supports the Company's long-term organic growth. The Company provided details regarding key development programs, including clinical data, development milestones and an overview of potential market opportunities, as well as an updated look at Actavis' world-class generics pipeline, which continues to hold an industry-leading position in First-to-File opportunities in the U.S.
"Today, we provided an overview of the rationalized, standalone pharmaceutical development pipeline that will power Actavis' ascent into the fastest growing and most dynamic growth pharmaceutical company in global healthcare," said Brent Saunders, CEO and President of Actavis. "Our pipeline is strategically focused within our core therapeutic areas - with key opportunities in GI, CNS, Women's Health and Anti-infectives - and anchored by nine compounds currently in mid or late-stage development that have the potential to generate more than $6 billion in peak sales following launch. It is built on novel compounds in specialty and primary care markets where there is significant unmet medical need, and supported by a strong intellectual property portfolio providing an average of more than 10 years of patent protection.
"Our productivity in brand product development is complemented by our best-in-class generics pharmaceutical development engine. We have approximately 230 Abbreviated New Drug Applications (ANDAs) pending at the Food and Drug Administration (FDA), more than 40 of which were filed in 2014. We are a leader in generic First-to-File (FTF) opportunities, with 25 new FTF applications confirmed last year. While supporting our industry-leading U.S. generic development efforts, we also are expanding our product portfolios around the world, with nearly 1,000 filings in 2014. Importantly, we remain focused on the development of complex generic products with barriers to entry that support longer-term value in this competitive pharmaceutical segment.
"As we move into the next stage of our Company's evolution with the acquisition of Allergan, our portfolio and pipeline will gain further strength in Ophthalmology, Neurology, Urology and Dermatology/Aesthetics. We have committed to investing $1.7 billion in R&D in 2015 to support our continued brand and generic development initiatives. With impressive pipelines across both global businesses, we are uniquely positioned within our industry to ensure our development activities support sustainable long term organic growth."
Actavis Pipeline Highlights
Gastroenterology: Potential to Reach $3 Billion in Sales
Eluxadoline - IBS-D
Actavis' GI pipeline includes eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D).
Relamorelin - diabetic gastroparesis
Actavis has an exclusive option to acquire relamorelin, a novel peptide ghrelin agonist (prokinetic) investigational drug for the treatment of diabetic gastroparesis and other GI functional disorders.
CNS: Building on Blockbuster Success
Namzaric - moderate to severe Alzheimer's disease (approved Dec. 2014)
NAMZARIC (memantine hydrochloride extended-release and donepezil hydrochloride) was approved by the FDA in December 2014 for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Actavis expects to launch NAMZARIC in the U.S. in the second quarter of 2015.
Cariprazine -schizophrenia; bipolar disorder; bipolar depression; Adjunctive MDD
Cariprazine, an investigational drug, is a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic with preferential binding to D3 receptors for the treatment of patients with schizophrenia and for adult patients with manic or mixed episodes associated with bipolar I disorder. Cariprazine has the potential to provide patients suffering with schizophrenia a treatment that can reduce the risk of relapse associated with this serious illness. In addition, cariprazine is being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder (MDD) in adults.
Anti-infectives: Emerging and Fast Growing
AVYCAZ - complicated intra-abdominal infections; complicated urinary tract infections
AVYCAZ (ceftazidime-avibactam) combines ceftazidime, a cephalosporin with in vitro activity against certain Gram-negative and Gram positive bacteria, and avibactam, a non-beta-lactam beta-lactamase inhibitor that inactivates certain key beta-lactamases and protects ceftazidime from degradation by these beta-lactamases. AVYCAZ should be reserved for use in patients who have limited or no alternative treatment options.
DALVANCE™ (dalbavancin) for injection, approved by the FDA in May 2014, is the first and only IV antibiotic for acute bacterial skin and skin structure infections (ABSSSI) with once-a-week dosing for two weeks. A single-dose regimen of DALVANCE is in late-stage development for ABSSSI, with a supplemental New Drug Application (sNDA) filing expected by mid-2015. The Company is also studying DALVANCE in pediatric and adult osteomyelitis and endocarditis.
Women's Health: Industry-Leading Product Line
Liletta - contraception
LILETTA is an Intrauterine Device (IUD), designed to initially deliver 20 mcg of levonorgestrel per day for the indications of long term contraception. In June 2013,the NDA for LILETTA was accepted for filing by the FDA, with an approval decision expected on February 28, 2015. A patent portfolio covers this product until 2031.
Esmya - uterine fibroids
ESMYA (ulipristal acetate) is a first-in-class, orally active selective progesterone receptor modulator for the treatment of abnormal uterine bleeding in women with uterine fibroids. Approved in Canada in 2013, where it is marketed as FIBRISTAL, it is the first approved medication to reduce fibroid size as well as control symptoms. ESMYA is currently in Phase [III] clinical trials, with results expected in 2016.
Dermatology: An Emerging Leader
Sarecycline - acne vulgaris
Actavis is developing Sarecycline, a novel once-daily oral formulation tetracycline derived antibiotic being developed for treatment of acne vulgaris as a once daily administration. In In vitro studies, Sarecycline demonstrated potent activity against P. acnes and showed anti-inflammatory activity. Sarecylcine is currently in Phase 3 studies and results are expected in the 2016.
Global Generics: Best-in-class R&D Organization
Actavis' Global Generics R&D operations continued to lead the industry in 2014, with 42 ANDAs filed in the United States, 25 of which were confirmed as new first-to-file applications. The Company continues to focus on the development of complex modified-release and other dosage forms that enhance its ability to offer distinctive products to customers around the world, and create sustainable long-term value. In January 2015, Actavis announced the launch of a leading portfolio of generic specialty injectable medications to be marketed to hospitals across the United States.
Biosimilars: Building for the Future
Actavis is positioned to be a leader in the burgeoning biosimilars market. Through its collaboration with Amgen, the companies will capitalize on their combined best-in-class capabilities in originator biologics, specialty pharmaceuticals and generics, with Actavis' speed, agility, technologies and world class supply chain complementing Amgen's deep expertise in biologics development and strong Oncology sales teams. The companies currently have four Oncology products in development, with biosimilar versions of HERCEPTIN®, AVASTIN®, RITUXAN® and ERBITUX®. Actavis continues to explore additional biosimilar opportunities internally and via partnerships