PHARMACY

FDA approves new indication for Genentech’s Lucentis

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Genentech’s Lucentis (ranibizumab injection). The drug has been approved to treat patients with myopic choroidal neovascularization, which is a complication of severe near-sightedness that can lead to blindness. 
 
“Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness,” Genentech chief medical officer and head of global product development Dr. Sandra Horning said. “With Lucentis, people with this condition now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study.”
 
Myopic CNV is estimated to affect some 41,000 people in the United States. This is the fifth approved indication for Lucentis. 
 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

Judge blocks sale of Sanofi’s, Regeneron’s Praluent; companies plan appeal

BY David Salazar
WILMINGTON, Del. — U.S. District Court Judge Sue Robinson on Thursday issued an injunction on the sale of Praluent, a PCSK9 inhibitor from Sanofi and Regeneron. Amgen, maker of another PCSK9 inhibitor Repatha, filed the request for the injunction in 2016 after a jury found its patent infringement claims against Sanofi and Regeneron valid. 
 
The injunction’s imposition has been delayed for 30 days to allow for a business resolution or appeal and request for expedited review from the Federal Circuit. Sanofi and Regeneron say they plan to appeal the decision. 
 
“We will immediately appeal today's ruling, along with the jury's earlier finding upholding the validity of Amgen's patents,” Sanofi EVP and general counsel Karen Linehan said. “It is our longstanding position that Amgen's patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.”
 
Amgen chairman and CEO Robert Bradway said the company was pleased with the decision, noting, “Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases.”
 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

OncoGenex to acquire Achieve Life Science

BY Brian Berk

BOTHEL, Wash., and VANCOUVER, British Columbia — OncoGenex Pharmaceuticals will acquire Achieve Life Science in all-stock transaction. OncoGenex is a publicly traded oncology biopharmaceutical company, while Achieve is a privately held specialty pharmaceutical provider.

Under terms of the agreement, expected to close in mid-2017, Achieve’s shareholders will own 75 percent of the combined company, while OncoGenex shareholders will own the remaining 25 percent.

According to the companies, the proposed merger will create a clinical-stage company focused on clinical and commercial development of cytisine, a selective nicotine receptor partial agonist currently in late-stage development for smoking cessation. In addition to cytisine, the combined company's pipeline will also include apatorsen (OGX-427), a once-weekly intravenous drug designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells' defenses and overcome treatment resistance.

"After extensive and thorough review of strategic alternatives, we are very pleased to announce this proposed merger with Achieve as it adds both immediate and long-term product opportunities in indications with significant patient need and commercial opportunity," said Scott Cormack, President and CEO of OncoGenex. "With cytisine in late-stage development for smoking cessation and having a defined regulatory path with [the U.S. Food and Drug Administration] we believe the proposed merger provides our stockholders with an opportunity to realize value from their investment in OncoGenex."

The combined company's executive management team will be led by Rick Stewart, chairman of Achieve; Anthony Clarke, chief scientific officer of Achieve; John Bencich, CFO of OncoGenex; and Cindy Jacobs, chief medical officer of OncoGenex.

"Achieve is expecting to meet a number of significant clinical and regulatory milestones within the next 12 to 18 months culminating in a final, large-scale Phase 3 clinical trial,” said Stewart. “The merger of OncoGenex and Achieve provides additional clinical and corporate resources to meet those milestones."

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES