* Rimsa plant the focus of high-stakes lawsuit
* Teva shares trading at decade low
* Mexican regulator says medicines are safe
By Tova Cohen and Ari Rabinovitch
TEL AVIV, April 25 (Reuters) - Teva Pharmaceutical Industries hopes to resume some production at its newly purchased Mexican plant in the coming months, but an overhaul needed to bring the factory up to speed will take a few years, the company said on Tuesday.
Teva, the world’s largest generic drugmaker, bought the Rimsa plant in 2016 in a $2.3 billion deal, only to shut it down immediately, saying the operation was overrun by improprieties. Rimsa’s previous owners, the Espinosa family, deny this, and the two sides are locked in a legal battle.
The prospect of starting production, albeit limited, is welcome news for Teva after a string of costly acquisitions, and delayed drug launches. These have sent Teva shares plummeting and led to calls for management and structural changes. CEO Erez Vigodman stepped down in February.
The company’s shares hit a decade low last week even though Teva exceeded earnings expectations in the last quarter of 2016. The shares closed at $31.6 on Monday.
“We expect to begin the first phase of resuming operations, starting with the oral solid dose manufacturing, in the coming months,” Teva told Reuters in an emailed statement.
Teva said it was working with the Mexican pharmaceutical regulator Cofepris at restarting manufacturing lines on an “individual product basis”, but the “comprehensive remediation process” would be completed at the end of 2019 or early 2020.
Cofepris is carrying out its own investigation into Rimsa and 147 medicines in question.
The Mexican regulator, in an internal document from March that was recently made public, said it found that “said medicines are safe, since their risks are considered acceptable in relation to the preventative and therapeutic benefit that they provide”.
It said Rimsa still needed to provide analytic results for every batch of the medicines according to existing regulations before it could sell the products.
The Espinosa family’s lawyer Juan Morillo welcomed the regulator’s findings as going “to the very heart of Teva’s allegations, which the family has always maintained are baseless.”
Teva said the regulator’s memorandum did not touch on the main problems it found in Rimsa’s drug registration and testing and that its findings “are not inconsistent with the company’s claims”. (Additional reporting by Michael O‘Boyle in Mexico. Editing by Jane Merriman)