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Amneal Gets Approval for Generic Version of Exelon Patch for Dementia

First transdermal product for this fast growing generic manufacturer (Image: Amneal Pharmaceuticals).

According to the World Health Organization (WHO), an estimated 50 million people are living with dementia globally. This number is projected to increase to 82 million by 2030 and over 150 million by 2050. Further, according to Alzheimer’s Disease International, these patients are mostly expected to come from low-income and middle-income countries. In the US, the Alzheimer’s Association estimates that about 5.7 million people are living with dementia, with Alzheimer’s accounting for 60% to 70% of these cases. As with the global trends, these numbers are expected to rise as life expectancy increases, hitting nearly 14 million US patients by 2050.

We’ve written previously in this space about the FDA’s concerted efforts in recent years toward increasing the public’s access to affordable generic and biosimilar medicines, and it’s clear that drug pricing will be a primary topic of discussion in 2019 and into next year’s nationwide elections. We’ve been following Bridgewater, New Jersey, based Amneal Pharmaceuticals AMRX, one of the largest and fastest growing generic pharmaceutical manufacturers in the US. While the company is obviously larger than most of the companies we follow, the stock is trading at nearly half of its levels from this past September and clearly in the realm of value territory to go along with its growth characteristics. The combination of the decline in valuation with its portfolio of 220 generic products makes Amneal a very interesting company to track.

Source: Amneal Pharmaceuticals

Amid an otherwise fairly quiet time at the FDA because of the federal government shutdown, Amneal announced this morning that it received FDA approval for a generic version of Exelon Patch (Rivastigmine Transdermal System) to improve cognition and function across all stages of Alzheimer’s disease. Exelon Patch, marketed by Novartis NVS, generated $444 million in 2016 and $381 million in 2017, as Novartis continues to feel pressure from generic manufacturers. Amneal will sell its patch in standard doses of 4.6 mg, 9.5 mg and 13.3 mg per 24 hours.

We are pleased to receive approval on the company’s first transdermal product, which demonstrates our commitment to develop and bring to market complex generic products. Our diverse pipeline of approximately 220 products is expected to deliver additional complex product approvals this year and help us achieve our goal of launching up to 50 generic products in 2019.

– Rob Stewart, President and CEO, Amneal.

Amneal’s portfolio includes 220 generic products, three biosimilar products and one specialty program in Phase 3 development for an extended-release capsule formulation of carbidopa-levodopa for Parkinson’s disease. The company led the US generics industry in 2018 with 62 ANDAs approved plus 10 tentative approvals. Amneal also led the industry with 42 product launches. The company said this week at the JP Morgan conference that it is on track to achieve more than $200 million in cost synergies earlier than planned as a result of the Impax merger that was completed in May 2018. The current valuation of just $3.9 billion puts the stock at an attractive position along the risk-reward spectrum given the company’s momentum and the FDA’s clear push for increased generic options.

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