Protocols

With Restasis in its crosshairs, Mylan adds a Botox biosim with Revance; Vertex starts second PhIII triple combo CF study

With Mylan $MYL already moving in for the kill with a generic version of Allergan’s Restasis, the big generics company has set up a new program that can also go after Allergan’s multibillion-dollar franchise for Botox. Mylan today announced a deal to partner with Revance Therapeutics $RVNC on a short-acting knockoff of Botox, which provided Allergan with chart-topping revenue of $3.4 billion last year. Revance is already angling to grab a share of the Botox market with a late-stage long-acting rival, along with competition from Evolus and Hugel. And there have been mixed reviews of just how successful that might be.

→ Vertex $VRTX is starting yet another Phase III study of VX-659 (a second-generation corrector candidate), along with tezacaftor and ivacaftor as an investigational triple combo regimen for people with cystic fibrosis. Specifically, the company is looking at CF patients with two copies of the F508del mutation, the most common form of the disease. The study will enroll 100 patients. This is the second triple combo study including these same therapies, with Vertex announcing the first in February. That trial was enrolling 360 patients. “The first Phase III study…is designed to support approval of the VX-659 triple combination in patients with one F508del mutation and one minimal function mutation who currently have no treatment that addresses the underlying cause of disease,” said Jeffrey Chodakewitz, Vertex’s executive vice president and CMO, in a statement. “This second study is designed to enable us to broaden the potential label for this regimen to include those with the most common genetic form of cystic fibrosis.”

Allergan’s $AGN has run into a speed bump along the regulatory road for a uterine fibroids drug. In a very brief note, the Dublin-based pharma acknowledged that the FDA has extended the review of its NDA for ulipristal acetate, setting a PDUFA target action date in August. The company is fairly optimistic about the drug — which is already available in Europe and Canada and aced both PhIII trials — forecasting $500 million to $1 billion in sales.

→ In the closing chapter to an embarrassing story about a failed government research subsidy program, Sanford Burnham Prebys Medical Discovery Institute has agreed to return $12.3 million to the state of Florida for failing to fulfill requirements made in an incentive agreement. The state first handed SBP $155 million in incentives in 2006 — under then-governor Jeb Bush — amounting to one of the largest incentive packages in the state’s recent history, according to the Orlando Sentinel. By 2016, however, the institute had decided to relocate to California for financial reasons, without reaching the goal of creating 303 jobs. SBP is still negotiating with local stakeholders regarding transition of its operations to another entity, but its officials insist that the institute had contributed significantly to Florida’s life sciences industry during its 10-year presence.

With contribution by John Carroll and Brittany Meiling.


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