Endo International PLC is a Dublin, Ireland based company with US headquarters in Malvern, Pennsylvania. Endo International is pharmaceutical and medical device holding company with four operating subsidiaries:
- AMS / American Medical Systems – Gynecological, Urologic and incontinence medical devices development, manufacturing, and marketing
- Endo Pharmaceuticals – Brand name pharmaceutical development, manufacturing, and marketing in endocrinology, pain management, and oncology
- Paladin Labs – Specialty pharmaceutical development and licensing for Canada
- Qualitest – Generic pharmaceutical development, manufacturing, and marketing
- SOMAR – Generic and OTC pharmaceutical development, manufacturing, and marketing for Mexico
Endo recently acquired DAVA Pharmaceuticals and Boca Pharmacal, both of which were incorporated into the Qualitest division and has made a public announcement about intentions to acquire Auxilium Pharmaceuticals at an estimated $2.2 billion. The Auxilium portfolio will be added to the Endo Pharmaceuticals operating line.
Endo Pharmaceuticals manufactures a number of popular pain-killers such as Opana and Percocet, along with Lidoderm and Voltaren topical pain relievers. The company also manufactures three testosterone products including Fortesta – a topical gel for the treatment of low testosterone levels in men. Several testosterone gel manufacturers, including Endo, are facing hundreds of lawsuits regarding the medication.
AMS, the medical device company of Endo, manufacturers medical devices for prostate and erectile dysfunction, incontinence in both men and women, female pelvic disorders and a number of urologic devices. Transvaginal mesh products manufactured by AMS including those for pelvic organ prolapse and those for stress urinary incontinence may have caused injury to thousands of women and the company still faces many lawsuits.
History of Endo International
Endo International was established in 1920 as Intravenous Products of America. The company changed its name to Endo Products in 1935 and was acquired by DuPont (E.I. du Pont de Nemours and Company) in 1970.
In 1994, DuPont Merck established Endo Laboratories LLC as a separate generic division of the pharmaceutical and chemical company and in 1997, three DuPont Merck executives purchased all of the Endo Laboratories generic products along with 12 brand name medications including Percocet and Percodan, Endo’s original and premier products, establishing Endo Pharmaceuticals.
In 2000, Endo acquired Algos Pharmaceutical Corporation through merger to become publicly traded, listed on the NASDAQ as ENDP. Between 2001 and 2007, Endo continued development and licensing of pain medication products including multiple Percocet strengths, Lidoderm patch, Voltaren topical gel and Opana.
Endo has made a number of acquisitions since its establishment including:
- 2006 – RxKinetix Inc.
- 2009 – Indevus pharmaceuticals
- 2010 – Penwest Pharmaceuticals
- 2010 – Qualitest Pharmaceuticals
- 2010 – HealthTronics
- 2011 – American Medical Systems (AMS)
- 2014 – Paladin Labs
- 2014 – Boca Pharmacal
- 2014 – Grupo Farmaceutico Somar (SOMAR)
- 2014 – DAVA Pharmaceuticals
The company is now a global aggregation of companies operating under the Endo International, PLC umbrella with estimated 2013 revenue of $2.6 billion.
Endo International, AMS, and Transvaginal Mesh
Transvaginal mesh was first introduced in 1996 for the treatment of stress urinary incontinence (SUI) in women. It was modeled after surgical mesh that was in use to repair other tissue damage such as hernia and was designed to be safer than traditional surgical repair methods as the mesh was implanted through the vagina or “transvaginally”. The product was later approved to treat pelvic organ prolapse (POP) but the first product was recalled after only three years due to safety concerns.
Since the first products were introduced, hundreds more have come on the market and have been shown to cause serious side effects that are permanently damaging and may become life-threatening such as:
- Vaginal erosion – the mesh erodes the vaginal wall and may become implanted
- Organ perforation – mesh erosion may persist all the way through the vaginal wall or may perforate other organs
- Revision surgery – corrective surgery may be required to address injury caused by the mesh or to correct new or untreated SUI or POP
American Medical Systems produced a number of transvaginal mesh products before acquisition by Endo International. AMS continues to produce transvaginal mesh and some of these may have caused significant injury including:
- BioArc products
- In-Fast Ultra
- IntePro Y-graft
- MiniArc products
- Monarc Subfascial Hammock
- RetroArc Retropubic Sling
- SPARC Sling
Thousands of patients have been injured by transvaginal mesh, including several deaths. The FDA stated in a safety release that transvaginal mesh does not appear to be safer than traditional surgery and may pose a significant risk to patients who receive the devices.
American Medical Systems and the parent company have paid nearly $900 million so far to settle over 20 thousand lawsuits regarding transvaginal mesh products, though the company did not admit fault. At least 5,000 cases have yet to be settled and more may be expected.
Endo Pharmaceuticals and Testosterone Replacement
Testosterone replacement therapy is approved to treat low testosterone levels in men with hypogonadism. Multiple pharmaceutical manufacturers have aggressively promoted their topical testosterone replacement products for “Low-T” and are used by as many as 3 percent of men over the age of 40, though many of those men have never been tested for low testosterone levels.
Testosterone replacement therapy such as Endo’s Fortesta Gel, have been shown to contribute to a number of serious medical conditions such as:
Hundreds of lawsuits have been filed against testosterone replacement manufacturers including at least one filed in Pennsylvania in May of 2014. Many of the lawsuits have been consolidated into multidistrict litigation in US District Court for the Northern District of Illinois but many more lawsuits remain at the state and local levels. No lawsuit settlements have yet been reached but hundreds more may be expected.
In September of 2014, Endo also released an “authorized” generic form of Fortesta Gel, produced by the subsidiary Qualitest.
Endo International in the Future
Recent acquisitions including Paladin Labs at $1.6 billion, Boca Pharmacal at $225 million, Somar for an undisclosed amount and DAVA from $575 million have expanded Endo’s pharmaceutical portfolio and global pharmaceutical business. Despite legal concerns and massive payouts, the company’s stock has more than doubled since 2012. Endo has also announced plans to buy Auxilium Pharmaceuticals for an estimated $2.2 billion.