Welcome to Editors' (re)View, a new feature where the Pharma Manufacturing editors handpick notable pharma world happenings that deserve some extra consideration. See what you may have missed this week in pharma.
Outlook stays positive
Earlier this week, Outlook Therapeutics shared disappointing news regarding the BLA for its investigational eye injection under development to treat wet AMD.
The treatment, ONS-5010, is an ophthalmic formulation of Roche's blockbuster cancer drug, Avastin. According to Outlook, the drug fills an important gap in the treatment of retinal diseases. Currently, clinicians who want to treat retinal patients with bevacizumab have to use unapproved repackaged IV bevacizumab provided by compounding pharmacies — which comes with higher risks of contamination and inconsistent potency.
While the CRL came as a surprise to onlookers, it was also a shock for Outlook. In a corporate update conference call, Outlook CEO Russell Trenary said the company was disappointed and was "certainly not expecting to receive CRL back from the FDA."
In the CRL, the FDA acknowledged that the company's pivotal trial met its safety and efficacy endpoints, but said it could not approve the BLA due to several CMC issues, open observations from pre-approval manufacturing inspections and a "lack of substantial evidence."
On the call, Trenary stressed that the endpoints met in the trial were "highly statistically significant" and that he believes the lack of substantial evidence was more a need for further additional evidence.
According to Trenary, all the CMC issues "appeared addressable" and the company didn’t “see any showstoppers there." "Our read as we went through the CMC section was ‘we can handle this,’" said Trenary.
Outlook was left with a lot of questions for the FDA and is hoping its upcoming Type A meeting will bring some answers. But it appears the company isn't giving up and do plan to resubmit its BLA.
"We collectively continue to believe in the public health NEED to provide the retina community with an FDA-approved bevacizumab treatment option," affirmed Trenary.
FTC clears Amgen-Horizon deal
In a surprising move, the FTC has shifted from opposing Amgen's $27.8 billion acquisition of Horizon Therapeutics to giving it the go-ahead.
When Amgen revealed its intentions to acquire Horizon, the FTC expressed concerns about industry consolidation driving up essential medication prices, highlighting the need to prevent pharmaceutical companies and pharmacy benefit managers from limiting affordable drug access.
Just a few days ago, the watchdog temporarily suspended its opposition to the acquisition, sparking questions about changing regulations. This suspension, disclosed in a court filing and effective until September 18, led to a 5.7% increase in Horizon's stock.
In a new announcement made today, the FTC revealed that it had reached an agreement with Amgen. Under the settlement, Amgen is barred from bundling its products with Horizon's Tepezza or Krystexxa and from using rebates or contracts to disadvantage competitors.
Additionally, the order stipulates that Amgen cannot make agreements to acquire products related to thyroid eye disease or chronic refractory gout without prior FTC approval, extending this requirement until 2032. Other aspects of the consent order, such as submitting annual compliance reports to the FTC and states and appointing a monitor to oversee Amgen's compliance, will remain effective for 15 years after finalization.
Following the deal's approval, Horizon's premarket shares rose by 2.8%.
— Andrea Corona