VIVUS (VVUS) Stock Climbs On FDA Approval


VIVUS, Inc. (NASDAQ: VVUS) is headed for the top in the market this morning after the company announced the United States Food and Drug Administration approval of a new formulation of PANCREAZE. Of course, the approval is leading to excitement. As a result, the stock is up around 30% early on. Here’s what’s happening:

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VVUS Stock Pops On FDA Approval

In a press release, VIVUS said that the FDA has approved its supplemental New Drug Application for an improved formulation of PANCREAZE Delayed Release Capsules. Importantly, the newly-approved formulation has an improved shelf life, with all doses now having a shelf life of 36 months.

VVUS reminded investors that PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency, also known as EPI, that is the result of cystic fibrosis or other conditions.

The drug was originally approved in 2010. It is essentially a pancreatic enzyme preparation that consists of pancrelipase. Extracted from porcine pancreatic glands, pancrelipase, in combination with other enzyme classes, is known to be effective in treating EPI.

In a statement, John Amos, CEO at VVUS, had the following to offer:

The approval of this sNDA is an important milestone for VIVUS and for the patients with EPI we seek to treat. It highlights our ability to derive additional value from our marketed products and allows patients to store PANCREAZE for longer periods of time, which may help to reduce their out-of-pocket expenses. We also expect that the 36-month shelf life will limit the amount of returned product and, over time, will lower our overall supply chain costs. We look forward to working with Nordmark and our supply chain and commercial partners on the transition to the improved formulation.

A Longer Shelf Life Leads To A Stronger Opportunity

At the end of the day, the shelf life of any product, especially a medical product, plays a role in the success, or lack thereof, of the product. This is key from a patient perspective. Due to the longer shelf-life, patients are able to store the treatment for longer periods of time, adding a level of convenience. Moreover, this may allow patients to order larger quantities, ultimately reducing overall healthcare costs.

From a company perspective, VIVUS will not have to deal with as many returns as less medication is likely to become expired before use. Over time, the company also believes that the sNDA approval will reduce supply chain costs.

All in all, this is a win for VVUS and the patients that they serve, making it a win for investors.

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