Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Allergan Gains Another Approval for Botox Amid Patent Controversy Over Restasis

XTALKS VITALS NEWS

Botox

The neurotoxin-based drug has now been approved for the temporary improvement of forehead lines, in addition to its two other indications for crow’s feet and glabellar lines. Image credit: Oceanview Medical Weight Loss Spa of Frisco, TX.

Share this!

October 5, 2017 | by Sarah Hand, M.Sc.

Pharmaceutical company Allergan has just received another FDA approval for its blockbuster cosmetic product Botox. The neurotoxin-based drug has now been approved for the temporary improvement of forehead lines, in addition to its two other indications for crow’s feet and glabellar lines.

“Allergan recognizes that forehead lines are a top area of concern for patients,” said David Nicholson, Chief Research and Development Officer at Allergan, in a statement about the approval. “Our goal in pursuing a third indication for Botox Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes.”

In clinical trials, up to 61 percent of participants showed significant improvements in the severity of forehead lines, compared to the placebo. The approval makes Botox the only neurotoxin product to include indications for three facial treatment areas.

“Few products have the level of impact that Botox Cosmetic has had on the medical facial aesthetics industry,” said David Moatazedi, Senior Vice President US Medical Aesthetics at Allergan. “Botox Cosmetic is the brand that created a new category in facial aesthetics with its first FDA approval 15 years ago. Since then, it has continued to be the leading neurotoxin treatment and the world's number one selling product of its kind.”

But the new approval comes as Allergan is facing government criticism regarding its unconventional patent transfer for Restasis, its valuable dry eye drug. In an effort to avoid patent challenges from generic drugmakers, the Ireland-based pharmaceutical company has transferred the patent rights to Restasis to the Saint Regis Mohawk Tribe.

Allergan is paying $13.75 million to the tribe – recognized as a sovereign nation – with plans to send up to $15 million each year in order to license the rights to Restasis back. In response to the deal, four senators – reps. Trey Gowdy, Elijah Cummings, Dennis Ross, and Peter Welch – contacted Allergan CEO Brent Saunders to express their concern regarding the dangerous precedent set by the arrangement.

Saunders responded by challenging the inter partes review (IPR) patent challenge system as a whole, saying that Congress should make changes to the process. He also stressed the importance of the $1.5 billion in annual revenue from Restasis to Allergan’s ability to conduct R&D.


Keywords: Allergan, Patent, FDA


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Janssen’s iSTEP Mobile Clinical Trials Program Aims to Improve Medication Adherence

October 17, 2017 - Johnson & Johnson’s pharmaceutical division Janssen has developed a new mobile clinical trials platform to streamline clinical supply management and potentially improve patient reporting and medication adherence in these studies.

Featured In: Clinical Trials News


Antihypertensive Drugs Don’t Fully Restore Microvascular Function

October 17, 2017 - According to Researchers at Lancaster University, standard treatments for high blood pressure may not be addressing damaging circulation issues in small blood vessels.

Featured In: Pharmaceutical News


Fluorescent Dye Helps Surgeons See Cancerous Lymph Nodes

October 16, 2017 - To help identify cancerous lymph nodes, surgeons at Penn Medicine are leading a trial to see whether a fluorescent dye can be a better way to identify diseased tissue during surgery.

Featured In: Life Science News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub

REGISTER FOR THESE WEBINARS

Vendor Oversight: Five Best Practices in Optimizing Limited Resources


Treatment Allocation in Randomized Trials: Challenges and Best Practices


Daily Diabetes Management in the Virtual World


Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes


Copyright © 2016-2017 Honeycomb Worldwide Inc.