- Allergan has pulled back from its planned $200 million plant expansion in Waco, Texas, a company spokesperson confirmed to BioPharma Dive.
- The spokesperson explained its change of heart as a result of the loss of exclusivity for Restasis and a drive to improve manufacturing efficiency. The news was first reported in the Waco Tribune Herald on Oct. 26.
- The company first broke ground on the site in April 2016, in a plan that was to add as many as 250 jobs and 322,000 square feet of manufacturing space. Instead, Allergan stated it has 45 open positions across manufacturing, packaging, engineering and quality.
The anticipated loss of exclusivity on Restasis (cyclosporine ophthalmic emulsion) in 2018 "has shifted our priority from expanding the Waco site to investing significantly in our existing operations," said Lisa Brown, Allergan's associate director of media relations.
Brown added the company has invested more than $180 million in the past four years on Allergan's development and production facilities.
"[Allergan] continues to depend on [Waco] for both our currently commercialized eyecare products and those that result from Allergan's pipeline of future eyecare treatments," she said.
Allergan's Waco plant manufactures its dry eye treatment, Restasis.
The company has been fighting a patent battle against generic competition using some rather unusual means — in September 2017, it did a deal with the St. Regis Mohawk Tribe, transferring ownership of the patents to the Native American tribe, while simultaneously licensing back exclusive use for all indications.
Despite its creative effort, a federal district court judge invalidated a number of patents covered by the deal in October 2017. In February 2018, a U.S. patent board ruled the tribe could not use its immunity to defeat an inter partes review (IPR).
The Food and Drug Administration also rejected Allergan's third citizen petition, designed to block Restasis copycat drugs.
The market is now open to generic drugmakers as earlier as this year potentially. Restasis sales fell about 19% in the third quarter of 2018 compared to the same period in 2017.
Other recent and forthcoming losses of exclusivity troubling Allergan include Estrace (estradiol vaginal cream), Namenda XR (extended release memantine), Delzicol (mesalamine) and Aczone (dapsone).
Allergan announced in May that it plans to sell of its women's health and anti-infective business units, a decision it reached after initiating a strategic review aimed at reversing two year's of slippage in its stock value.
On a recent earnings call, however, company CEO Brent Saunders indicated that offers it's received have been below Allergan's valuation of those units.