Allergan has struck a deal to acquire the floundering Repros Therapeutics. The bargain-basement takeout gives Allergan the rights to a uterine fibroid drug that is on the cusp of phase 3, but also responsibility for compiling the large safety database the FDA wants to see before signing off on further development.
Repros began the year looking to build on phase 2 data showing progesterone receptor blocker Proellex stops menstruation and reduces fibroid size. But the wheels quickly came off after the company failed to alleviate the FDA’s concerns about the drug’s effect on the liver, resulting in the partial clinical hold dragging on for longer than hoped.
The situation went from bad to worse in July when the FDA said only a large safety database will persuade it to clear Proellex for further development. With Repros deep in penny-stock territory after years of struggles and its cash reserves down to $1.8 million, that looked beyond the biotech.
Now though, Allergan has dug out some loose change to rescue the program. Repros had a market cap of less than $19 million before news of the takeover broke. Allergan sealed the deal with a $0.67-a-share bid, a 43% premium over Repros’ closing price yesterday.
For that relatively small sum and the cost of the safety study, Allergan could gain a phase 3-ready uterine fibroid drug to sit alongside its existing approved product in the indication, Esmya. Or the company may simply prove that Proellex is beyond saving.
Allergan is taking on the challenge of answering that question at the same time as regulators in Europe are pressuring it to show Esmya has a favorable risk-benefit profile. Liver effects are behind Esmya’s problems, too.
Repros is also developing Proellex for use in endometriosis and has a treatment for hypogonadotropic hypogonadism, estrogen receptor antagonist enclomiphene, in the clinic.
By Nick Paul Taylor
Source: Fierce Biotech
Politico’s Agency IQ reported earlier this month that, due to the Trump administration’s laying off of thousands of staffers, the FDA risked hitting a “trigger,” whereby the FDA could be required to refund industry fees if spending by the agency falls below a certain level.
Pharmaceutical companies are demanding changes in European regulation as looming tariffs implemented by US President Donald Trump “threaten” billions of planned pharma investments on the continent. A group of 32 pharma companies sent a letter to European Commission (EC) President Ursula von der Leyen listing requests to avoid an exodus of operations.
Christian Boehringer, Chairman of the Shareholders’ Committee since 2007, has decided to step down from his position as of June 30, 2025. The Shareholders’ Committee has appointed Hubertus von Baumbach, currently Chairman of the Board of Directors, as his successor from July 1, 2025.
