Using the subscribers calendar from MikeHavRx.com I recently ‘discovered’ CPIX.  The company has a sNDA (Supplemental New Drug Application) with priority 6 month review and a PDUFA date of 9/10/10 for its drug, Acetadote. This medication is already the first FDA -approved injectable drug to treat acetaminophen overdose. This sNDA would allow for treatment in patients with non-acetaminophen acute liver failure.

The sNDA includes data from a clinical trial indicating that acute liver failure patients treated with Acetadote have a significantly improved chance of survival without a transplant. These patients can also survive a significant number of days longer without transplant, providing patients requiring transplant increased time for a donor organ to become available.

Currently CPIX has NOT issued a press release regarding their 9/10/10 Priority sNDA PDUFA Date.  The only information regarding this is from their most recent 10Q statement and an email I received from their corporate relations (see below).  I am assuming that once news of this Priority sNDA hits the wires CPIX share prices will begin to rebound from their current lows.

Recent Market Action

In August of 2009 CPIX had its IPO (Initial Public Offering) at over $17 a share, and since then has drifted down to its current lows in the $5 range.  CPIX has not done a very good job keeping investors informed of its products in relation to the FDA.  I had to contact the Corporate Relations Director directly to get the official PDUFA date, which has not been published.  I sent an email to the board of directors asking why we have seen no press release regarding the 9/10/10 Priority PDUFA Date, and I am awaiting a response.  Take a look at the chart for CPIX, from Aug 09 to current…

Chart

About CPIX

From their Google Finance Summary:

“Cumberland Pharmaceuticals Inc. (Cumberland) is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company’s primary target markets are hospital acute care and gastroenterology. The Company’s product portfolio include Acetadote (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor (ibuprofen) Injection, the injectable treatment for pain and fever available in the United States, and Kristalose (lactulose) for Oral Solution, a prescription laxative.”

From Barron’s Article “Five Quality Biotechs” Regarding CPIX ( LINK ):

“Cumberland: Because Cumberland’s story could be considered to have been driven primarily by Caldolor since its initial public offering, we believe the stock has underperformed due to disappointing Caldolor sales. However, what we think has escaped investors’ attention is the good news about its largest-selling drug, Acetadote: It could potentially be approved for an important indication label expansion (acute liver failure) for which the Food and Drug Administration has given the company a priority review.”

Take a look at the large percentage of institutional investors (from Yahoo Finance):

Who are these institutional investors?  Their largest is JP Morgan, holding almost 9% of the shares. See the chart below:

Do those who run the company have confidence in their product?  Apparently so, look at the insider holdings total nearly 25% of the shares. With this low of a float on the open market, this stock can really move quickly.  (See the article “Low Float Stocks- What Does that Mean?” ):

Regarding the sNDA, CPIX Announced the following on March 30, 2010 ( link ):

“NASHVILLE, Tenn., March 30, 2010 /PRNewswire via COMTEX News Network/ – Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Acetadote(R) (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

The sNDA includes data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have a significantly improved chance of survival without a transplant. These patients can also survive a significant number of days longer without transplant, providing patients requiring transplant increased time for a donor organ to become available.”

According to their recent 10Q statement ( link ):

“FDA Accepts Acetadote sNDA for Review

In May 2010, the FDA officially accepted the Company’s aforementioned sNDA for Acetadote and granted a priority review. In addition to expanded labeling for Acetadote, the Company has requested additional exclusivity for the product. If approved, Cumberland expects to begin marketing Acetadote for the new indication in 2011.”

Nowhere on Cumberland’s website is an official listing of the PDUFA date, which was assumed to be 9/30/10 (March 30th submission plus 6 months for Priority Review = September 30th). Over the weekend I sent an email to CPIX’s Corporate Relations Department asking when the official PDUFA date was.  I was surprised by their response: The PDUFA date is 9/10/10

From MikeHavRx.com Regarding CPIX:

“Shares of Cumberland Pharma (NASDAQ:CPIX) have shed approximately 65% of market value since its initial public offering (IPO) last August at $17 per share.

With shares of this specialty pharmaceutical company focused on the hospital market niche now trading around 6 bucks, a market cap of about $122 million, and an enterprise value of about $63 million ahead of an expected FDA decision later this quarter; investors may want to take a second look at the stock.

Summary of 1Q10 Results and Financials for CPIX…

- $10.1 million (M) (+7% from year-ago period): $7.7M ACETADOTE, $2.3M KRISTALOSE

- Total operating expenses of $9.3M vs. $7.3M in year-ago period, increase due to hiring expenses to expand hospital sales force associated with market launch of CALDOLOR (intravenous or IV formulation of the widely used NSAID ibuprofen for treatment of pain and reduction of fever)

- Net income of $0.3M vs. $1.2M in the year-ago period, lower due to increased sales/marketing expenses and increased number of common stock shares outstanding associated with IPO

- Weighted average diluted shares outstanding of 21.4M vs. 16.1M in the year-ago period

- Ended 1Q10 with $73.8M in cash/equivalents and $98.7M in total assets vs. $78.7M and $103.7M, respectively, at year-end 2009

- Total debt of $15.3M at end of 1Q10 vs. $6.8M of total debt in the year-ago period

Pending FDA decision under priority review…

In May 2010, the FDA officially accepted the Company’s supplemental New Drug Application (sNDA) for ACETADOTE (acetylcysteine for injection) and granted a six-month priority review. In addition to potential expanded product labeling, CPIX has requested additional exclusivity for the product. If approved, CPIX expects to begin marketing ACETADOTE for the new indication in 2011.

On 3/30/10, CPIX announced its sNDA filing to expand the FDA-approved product use in patients with non-acetaminophen acute liver failure, and the Agency subsequently accepted the sNDA with a priority (six-month) review designation in May 2010. ACETADOTE is currently used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter (OTC) pain drugs such as TYLENOL. ACETADOTE is the only approved injectable product in the US for the treatment of acetaminophen overdose.”

Article provided by Biorunup.com

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