Allergan Frown Lines Study Passes Test on Higher Botox Dose

Allergan Plc AGN announced that a study evaluating higher doses of its facial aesthetics drug Botox for the treatment of moderate-to-severe glabellar lines, met the primary endpoint.

The study was conducted to evaluate the safety and efficacy of Botox’ higher doses (40, 60, and 80-unit doses) against the current marketed 20 mg dose. Data from the study showed that patients receiving Botox (cosmetic) in 40, 60 or 80 units achieved a greater duration of treatment effect than those injected with the current dosage of 20 units.

Glabellar lines are the frown lines found between the eyebrows and the central forehead.

In the study, response rates for the 40, 60 and 80-unit groups were 32%, 30.6% and 38.5%, respectively, compared with 16% in the 20-unit group at week 24. The study clearly demonstrated that higher doses of Botox extend the treatment effect duration for glabellar lines in approximately one of three patients. Overall, higher doses of the drug were safe and well tolerated with serious adverse event (SAE) unrelated to the line of treatment.

Shares of Allergan have rallied 15.1% so far this year, comparing favorably with the industry’s increase of 4.1%.

Approved for therapeutic and aesthetic use, Botox is a key top-line driver for Allergan. Its cosmetic indication includes three facial aesthetic treatments — forehead lines, crow’s feet wrinkles at the outer corner of eyes and glabellar lines.

Botox’s therapeutic diseases include overactive bladder, cervical dystonia and strabismus among others.

Notably, Botox is one of the key revenue catalysts for Allergan. The drug generated sales of $1.75 billion in the second half of 2018. In the chronic migraine indication, there have been concerns regarding possible new competitors to Botox with the entry of calcitonin gene-related peptide (CGRP) antibodies.

Amgen AMGN/Novartis’ CGRP antibody Aimovig was launched in May while Teva’s TEVA Ajovy (fremanezumab) was approved this month. Moreover, a decision on Lilly’s LLY CGRP antibody Emgality (galcanezumab) is also due by September-end.

In a separate press release, the company announced that it has agreed to acquire the privately held biotech Bonti, Inc., a developer of fast-acting neurotoxin treatments for aesthetic and therapeutic applications.

Per agreement, Allergan will make an upfront payment of $195 million plus potential milestone payments, subject to certain adjustments and customary closing conditions.

The acquisition will add two phase II stage candidates, namely EB-001A (aesthetic) and EB-001T (therapeutic) to Allergan’s portfolio. The main component in both programs, a botulinum neurotoxin serotype E has a two-to-four-week duration of effect, which should be an attractive offer for consumers, especially for those seeking an aesthetic treatment for the first time.

Allergan plc Price and Consensus

Allergan plc Price and Consensus | Allergan plc Quote

Zacks Rank

Allergan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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