Credit: Shutterstock photoUpdates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval/label expansion status.
Late last week, Allergan plcAGN announced that the FDA has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adults to decrease the severity of increased muscle stiffness in ankle and toe muscles.
This makes Botox the first and only botulinum toxin product to be approved by the FDA for the treatment of multiple muscle groups of the upper (elbow, wrist, fingers, and thumb) and lower limbs that may be impacted by spasticity.
We are encouraged by the label expansion of Botox. According to the information provided by Allergan in its press release, spasticity affecting about 1 million people in the U.S. leads to an abnormal increase in muscle tone or stiffness of muscle interfering with movement.
We note that Acorda Therapeutics, Inc.'s ACOR Zanaflex, a short-acting drug, is also approved for the management of spasticity.
Apart from the treatment of spasticity, Botox is also approved for several other indications including overactive bladder, cervical dystonia, chronic migraine, and strabismus among others. The drug generated sales of $1.3 billion in the first nine months of 2015.
Currently, Allergan is evaluating Botox for cosmetic indications like the treatment of forehead lines, masseter hypertrophy and platysma bands and therapeutic indications like osteoarthritis and depression. We remind investors that Botox became a part of Allergan's portfolio following the Mar 2015 acquisition of Allergan Inc.
Meanwhile, Allergan is scheduled to divest its generics business to Teva Pharmaceutical Industries Limited TEVA in the first quarter of 2016. The company has also agreed to combine with Pfizer Inc. PFE in a deal representing a total enterprise value of approximately $160 billion. The deal is slated to close in the second half of 2016.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
