Cumberland Pharmaceuticals, Inc. (CPIX)

[pineyhill]

Nice upward move after the news.

[surf1944]

Cumberland Pharmaceuticals' CEO Discusses Q1 2013 Results - Earnings Call Transcript

http://seekingalpha.com/article/1402241-cumberland-pharmaceuticals-ceo-discusses-q1-2013-results-earnings-call-transcript?source=yahoo

[surf1944]

7:11AM Cumberland Pharma announces Caldolor reduces pain and fever in adult patients; Studies support shortened Caldolor infusion time (CPIX) 4.51 : Co announced top-line results from two registry studies evaluating the safety and efficacy of Caldolor Injection administered over a shortened infusion time in treating pain and fever in adult patients. The studies involved 450 patients receiving Caldolor at 35 leading medical centers throughout the United States. The first of two registry studies was a phase IV multi-center, open-label surveillance clinical study to assess the safety and efficacy of ibuprofen administered intravenously over five to ten minutes to adult patients in the hospital setting with temperature fever and/or pain of intravenous ibuprofen for up to a 24-hour dosing period. One hundred fifty patients from 13 clinical sites were enrolled in this study. Intravenous ibuprofen reduced fever and pain and the shortened infusion time was well tolerated.

[jas2mel]

Liking the chart here also.

[Wrinkles]

CPIX $4.11 double bottom, may be time for turn around? Grabbed a starter late Friday, we'll see what this week brings....

http://stockcharts.com/h-sc/ui?s=cpix

[surf1944]

CPIX on watch list...

[surf1944]

9:05AM Cumberland Pharma receives second acetadote patent notice of allowance (CPIX) 5.83 : Co announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for a second patent relating to its new formulation of Acetadote, which is used to treat acetaminophen overdose. The original composition of matter patent covered the Acetadote formulation and was issued in April 2012. The new patent includes claims regarding the use of the 200 mg/ml Acetadote formulation to treat patients with acetaminophen overdose.

[mlkrborn]

Redued doze: $6 ;Cumberland Pharma announces top-line results from a clinical pediatric pain study evaluating the safety and analgesic efficacy of Caldolor (ibuprofen) Injection; Caldolor significantly reduces the number of post-operative narcotic doses (CPIX) 6.02 : Co announced top-line results from a clinical pediatric pain study evaluating the safety and analgesic efficacy of Caldolor Injection in treating pain in tonsillectomy patients ranging from 6 to 16 years old. When administered prior to surgery, Caldolor use was associated with a statistically significant reduction in the number of post-operative narcotic doses required in patients in the efficacy evaluable population. There were also consistent trends toward reduction in pain scores and the incidence of nausea and vomiting in patients receiving Caldolor. Importantly, no safety concerns were observed during this study.

[surf1944]

Cumberland Pharmaceuticals, Inc. (CPIX)
Sector Healthcare
Industry Drug Manufacturers - Other
Market Cap $118.13M
Beta -

CPIX stock chart

Key Metrics
Current Ratio 12.09
Quick Ratio 11.07
5-Year Projected Earnings Per Share Growth Rate 30.00%
Short Interest 12.29%

Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company, engages in the acquisition, development, and commercialization of branded prescription products for the hospital acute care and gastroenterology markets primarily in the United States. The company's principal products include Acetadote, an intravenous formulation of N-acetylcysteine indicated for the treatment of acetaminophen poisoning; Caldolor, an intravenous formulation of ibuprofen for the treatment of pain and fever; and Kristalose, a prescription laxative administered orally for the treatment of constipation. The company markets and sells its products through sales representatives and managers. Cumberland Pharmaceuticals, Inc. was incorporated in 1999 and is headquartered in Nashville, Tennessee.

http://seekingalpha.com/article/862971-5-highly-liquid-healthcare-stocks-with-growth-on-the-horizon?source=yahoo

[surf1944]

5) Cumberland Pharmaceuticals, Inc. (CPIX)
Sector: Healthcare
Industry: Drug Manufacturers - Other
Market Cap: $127.71M
Beta: -

Cumberland Pharmaceuticals, Inc. has a Current Ratio of 14.01, a Quick Ratio of 13.03, and a 1-Year Projected Earnings Per Share Growth Rate of 38.24%. The short interest was 9.31% as of 07/01/2012. Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company, engages in the acquisition, development, and commercialization of branded prescription products for the hospital acute care and gastroenterology markets primarily in the United States. The company's principal products include Acetadote, an intravenous formulation of N-acetylcysteine indicated for the treatment of acetaminophen poisoning; Caldolor, an intravenous formulation of ibuprofen for the treatment of pain and fever; and Kristalose, a prescription laxative administered orally for the treatment of constipation. It is also developing Hepatoren injection, which is in Phase II clinical development for the treatment of hepatorenal syndrome.

*Company profiles were sourced from Finviz. Financial data was sourced from Google Finance and Yahoo Finance.

http://seekingalpha.com/article/695761-5-high-growth-healthcare-small-caps-armed-with-cash?source=yahoo

[investmn]

CPIX is looking nice. Just bought a Jan 13 strike 5 call option. Chart looks to be setting up nicely.

[surf1944]

Cumberland Pharmaceuticals to Present at Needham Life Sciences Conference in New York on April 3, 2012
PR NewswirePress Release: Cumberland Pharmaceuticals Inc. – Tue, Mar 27, 2012 4:31 PM EDT

NASHVILLE, Tenn., March 27, 2012 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX - News), a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, today announced that Chief Executive Officer A.J. Kazimi will present at the Needham Life Sciences Conference in New York at 2:00 p.m. Eastern Time on Tuesday, April 3, 2012. Mr. Kazimi will provide an update on the Company and its 2012 strategy.

[surf1944]

http://www.insidercow.com/history/company.jsp?company=cpix&B1=Search!

[surf1944]

Form 8-K for CUMBERLAND PHARMACEUTICALS INC

22-Nov-2011

Entry into a Material Definitive Agreement, Termination of a Mater


Item 1.01 Entry into a Material Definitive Agreement.

Effective November 15, 2011, we entered into an agreement with Mylan Inc., or Mylan, to acquire the worldwide rights to certain assets and the FDA registration related to the Kristalose? brand, collectively the Mylan Agreement. As consideration for the assets, we will pay to Mylan royalties based on future sales of Kristalose?.

As previously disclosed in certain our of prior SEC filings, prior to the acquisition of these assets, we had executed an agreement with Inalco S.p.A and Inalco Biochemicals, Inc., collectively Inalco, for exclusive distribution and marketing rights in addition to an exclusive license regarding the intellectual property for Kristalose? , or the Kristalose Agreement. As a condition precedent to the acquisition of the worldwide rights discussed above, Mylan acquired certain rights to Kristalose? from Inalco. Therefore, along with Inalco, we terminated the Kristalose Agreement on November 15, 2011 concurrently with the entry into the Mylan Agreement. We incurred no early termination penalties upon termination of the Kristalose Agreement. The foregoing description of the Kristalose Agreement is qualified in its entirety by Exhibits 10.9, 10.9.1, 10.9.2, 10.9.3, and 10.9.4 to the Company's Annual Report on Form 10-K filed on March 11, 2011.

The Mylan Agreement is attached hereto as Exhibit 10.28, and the foregoing summary is qualified in its entirety by such agreement.



Item 1.02 Termination of a Material Definitive Agreement.

The disclosures included in Item 1.01 of this Form 8-K are hereby incorporated by reference into this Item 1.02.



Item 9.01 Financial Statements and Exhibits.

d)

10.28? Asset Purchase and Royalty Agreement for Kristalose dated November 15, 2011 by and between Mylan Inc. and Cumberland Pharmaceuticals Inc.

? Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from Exhibit 10.28 and submitted separately to the Securities and Exchange Commission.

[surf1944]

http://www.insidercow.com/history/company.jsp?company=cpix&B1=Search!

[surf1944]

http://quotes.barrons.com/cpix/ownership

[surf1944]

Cumberland Pharmaceuticals Reports Second Quarter 2011 Financial Results
- Net revenue grows 34% over prior year period
- Phase II study for new pipeline candidate Hepatoren underway
- Caldolor® licensed for new Asian markets, application for approval submitted in Canada

Press Release Source: Cumberland Pharmaceuticals Inc. On Thursday August 4, 2011, 4:00 pm EDT

NASHVILLE, Tenn., Aug. 4, 2011 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX - News), a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, today announced second quarter 2011 financial results.

Net Revenue: For the three months ended June 30, 2011, net revenue was $14.4 million, up 34% from $10.7 million in the prior year period. The growth in revenue was due to an increase in sales volume for Acetadote following the Company's introduction of the new formulation for that product.

For the six months ended June 30, 2011, net revenue was $25.1 million, up 20% compared with $20.9 million for the six months ended June 30, 2010. This increase was largely attributable to the growth in net revenue during the second quarter of 2011.

Operating Expenses: Total operating expenses for the three months ended June 30, 2011, were $10.8 million compared with $9.7 million for the prior year period. The difference related primarily to increases in cost of products sold during the quarter as well as increases in general and administrative expenses. For the six months ended June 30, 2011, total operating expenses were $20.0 million compared with $19.1 million for the six months ended June 30, 2010.

EBITDA: Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) for the three months ended June 30, 2011, were $3.9 million, up from $1.2 million for the prior year period. EBITDA for the six months ended June 30, 2011, grew to $5.6 million, up from $2.3 million for the prior year period. The increase was primarily due to net revenue growth in the second quarter of 2011.

Net Income: Net income attributable to common shareholders for the three months ended June 30, 2011, was $2.2 million, or $0.11 per diluted share, up 658% from $0.3 million, or $0.01 per diluted share, for the prior year period.

For the six months ended June 30, 2011, net income attributable to common shareholders was $2.9 million, or $0.14 per diluted share, compared with $0.6 million, or $0.03 per diluted share, for the same period in 2010.

Balance Sheet: As of June 30, 2011, cash and cash equivalents grew to $69.8 million, compared to $66.0 million at March 31, 2011, due to strong operating cash flow during the quarter. Total assets at June 30, 2011, grew to $94.6 million. Cumberland's total debt as of June 30, 2011, was $5.8 million, including a current portion of $4.0 million, compared to $6.5 million in total debt at March 31, 2011. Following the end of the quarter, the Company repaid its term loan in full. Cumberland also increased its revolving line of credit to $10 million, which is expandable to $20 million and incorporated reduced pricing terms.

"We are very pleased with the Company's performance during the second quarter, having accomplished several key objectives for the year and delivering strong growth in revenue, income and cash flow," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Our team's execution of the launch of the new Acetadote formulation, the addition of a key pipeline candidate and growth in our network of international commercial partners are a few highlights from the quarter. From a historical performance perspective, this quarter also trends nicely with our consistent quarter-over-quarter growth in net revenue, EBITDA, operating income and net income."

Based on its second quarter performance, Cumberland is raising its full year 2011 revenue guidance to $51 - $55 million. This guidance represents the Company's best estimate of future results, which may be affected by factors described below in "Forward-Looking Statements."

Company Highlights

Acetadote®

New Formulation

In January 2011, the U.S. Food and Drug Administration (FDA) approved Cumberland's supplemental new drug application (sNDA) for a new formulation of Acetadote, which was the result of a phase IV commitment the Company made to the FDA upon receipt of initial marketing approval of the product. The new formulation does not contain Ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives. Cumberland launched the next generation product, which replaced the previously marketed formulation, in the first quarter of 2011 and during the second quarter worked to ensure widespread distribution and transition to the next generation product.

In July 2011, Cumberland filed a response with the U.S. Patent and Trademark Office for its patent application to protect proprietary discoveries related to the new Acetadote formulation. This formulation patent was allowed and issued in China in April 2011. The Company also recently filed a second U.S. patent application related to the safety profile of the new formulation.

sNDA for Non-Acetaminophen Induced Acute Liver Failure

In the first quarter of 2010, Cumberland submitted an application to the FDA for use of Acetadote in patients with non-acetaminophen acute liver failure. This sNDA included data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that early-stage acute liver failure patients treated with Acetadote have a significantly improved chance of survival without a transplant and that these patients can also survive a significant number of days longer without transplant. In December 2010, the FDA issued a Complete Response Letter indicating that it had identified additional items that must be addressed prior to any approval.

Cumberland has been in discussions with the FDA to determine a pathway forward for the potential new indication. The Company recently identified and is currently analyzing additional patient data to support the application, and plans to present the new information to the FDA.

Caldolor®

In June 2009, the FDA approved Caldolor, the Company's intravenous formulation of ibuprofen, for marketing in the United States through a priority review. In late 2009, Cumberland launched the product in the U.S. and Caldolor is stocked at wholesalers serving hospitals nationwide.

In 2010, the Company focused its sales and marketing efforts primarily on securing formulary approval nationally for Caldolor. Early in the second quarter of 2011, Cumberland implemented a strategic shift to begin focusing on pull-through activities necessary to build volume of use and bring Caldolor to a larger population of patients in facilities stocking the product.

During the second quarter of 2011, Cumberland also progressed four clinical studies to further evaluate Caldolor in patients. Two of these trials are designed to support pediatric use, including a pediatric fever study to evaluate safety, efficacy and pharmacokinetics of Caldolor in hospitalized children as well as a pediatric pain study. Two new registry studies will gather additional data in adults, including a study evaluating Caldolor in treating pain and fever in a wide range of hospitalized patients and another evaluating the product for management of pain in surgical patients.

Hepatoren™

In April 2011, Cumberland entered into an agreement to acquire the rights to ifetroban, a new Phase II product candidate. The Company has initiated clinical development under the brand name Hepatoren™ (ifetroban) Injection and is evaluating the product for treatment of critically ill hospitalized patients suffering from hepatorenal syndrome (HRS), a life-threatening condition involving progressive kidney failure for which there is no U.S. approved pharmaceutical treatment.

Ifetroban was initially developed extensively by a large pharmaceutical company for certain cardiovascular indications. The development program was eventually donated to Vanderbilt University, where researchers identified ifetroban as a potentially valuable compound in treating patients for several other niche indications. Cumberland acquired the rights to the ifetroban program from Vanderbilt through Cumberland Emerging Technologies and intends to develop it for several potential indications, including as an Orphan Drug for HRS for which it will pursue seven years of marketing exclusivity.

The FDA has cleared the Company's IND for this product candidate and Cumberland has initiated a Phase II dose escalation study to evaluate Hepatoren for the treatment of HRS. The Company has commenced manufacturing and filed patent applications to protect intellectual property related to the new indication. Cumberland believes Hepatoren is an excellent strategic fit given the Company's established presence in the hospital acute care market.

International Markets

During the second quarter, Cumberland executed agreements with partners for commercialization of Caldolor and Acetadote in Malaysia and Taiwan. In Malaysia, the Company is partnering with Insanbakti and in Taiwan with Harvest & Health Co., Ltd. These agreements are part of a larger initiative to secure distribution of Cumberland's products in Asian markets, and are in addition to a recent license agreement with DB Pharm Korea for Caldolor in South Korea.

The application for regulatory approval of Caldolor in Canada was recently submitted by Cumberland's Canadian partner, Alveda Pharma. Review of the application for regulatory approval of Caldolor in Australia is underway and Cumberland is working to identify additional arrangements for commercialization of its products in other markets as well.

http://finance.yahoo.com/news/Cumberland-Pharmaceuticals-prnews-1056534620.html?x=0&.v=1

[surf1944]

7. Cumberland Pharmaceuticals, Inc. (CPIX): Drug Manufacturers Industry. Market cap of $126.36M. PEG at 0.84. Correlation to the VIX index at 0.33. The stock is a short squeeze candidate, with a short float at 10.6% (equivalent to 15.85 days of average volume). The stock has lost 2.82% over the last year.

9 Undervalued Small Caps Correlated With Market Volatility

http://seekingalpha.com/article/287887-9-undervalued-small-caps-correlated-with-market-volatility?source=yahoo

[surf1944]

6:48AM Cumberland Pharma Caldolor study demonstrates significant reduction of fever in patients with severe thermal burns (CPIX) 4.95 : Co announces results from a clinical study evaluating the safety and efficacy of Caldolor Injection in treating fever and pain in hospitalized burn patients. The study demonstrated that Caldolor significantly reduces fever in these patients, including those with severe thermal burns. The newly published study also supports the safety of Caldolor as it involved the highest dose and duration of exposure to IV ibuprofen to date, demonstrating that the recommended maximum daily dose of 3200mg/day over five days of treatment was well tolerated.

[surf1944]

8:58AM Cumberland Pharma correction: David L. Lowranceas, co's CFO, will join Aucela Inc as Aucela's new CFO (CPIX) 5.12 : Acucela Inc announced that it has appointed David L. Lowrance as Chief Financial Officer. Lowrance is currently listed as Cumberland Pharma's VP and CFO. We previously noted Cumberland Pharma appointed David L. Lowranceas as CFO. Our 8:02 ET comment has been deleted.

[MONEYMADE]

,,,,,,,Huge news AH

[surf1944]

CPIX: Drug/indication:Acetadote for non-acetaminophen acute liver failure
Approval decision date: December 2010
Recent stock performance: At $4.92, stock is trading at its lows for the year.
The FDA review was extended three months beyond its original August approval date.

http://www.thestreet.com/story/10847027/6/21-drugs-facing-fda-approval-decisions.html

[surf1944]

Pre and Post-Operative Use of Caldolor® (Ibuprofen) Injection Significantly Reduces Pain and Opioid Use in Newly Published Study

http://finance.yahoo.com/news/Pre-and-PostOperative-Use-of-prnews-1727330074.html?x=0&.v=1

[surf1944]

Cumberland Pharma shares tumble after FDA delay
Cumberland Pharmaceutical shares fall after FDA extends review of Acetadote

http://finance.yahoo.com/news/Cumberland-Pharma-shares-apf-1909967917.html?x=0&.v=1

[mlkrborn]

CPIX declined from its initial pricing of $17 to $6.00! Is this a buy level?
tia
GL

[surf1944]

Cumberland Pharma CPIX Morgan Joseph Buy $15 » $10

[surf1944]

Cumberland Pharma CPIX Jefferies Buy » Hold $13 » $5.50

[BioRunUp]

Q2 results announced on 8/16

[surf1944]

Cumberland Pharmaceuticals to Announce Second Quarter 2010 Financial Results on August 16, 2010

http://finance.yahoo.com/news/Cumberland-Pharmaceuticals-to-prnews-3372843768.html?x=0&.v=1

[WI Biker]

Cumberland Pharmaceuticals to Present at the Bank of America Merrill Lynch Specialty Pharmaceuticals Conference in Southampton, New York on August 13, 2010

[BioRunUp]

CPIX- Priority Review PDUFA Date of 9/10/10 for Acetadote

The PDUFA date reported at BioRunUp on Tuesday has now been officially confirmed in Cumberlands latest 8-K filing with the SEC from 7/21/10

( See link )
http://investor.shareholder.com/cpix...299933-10-2760

CPIX- Priority Review PDUFA Date of 9/10/10 for Acetadote
http://www.biorunup.com/1102/cpix-pdufa-91010/

Highlights

In March 2010, we submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Acetadote in patients with non-acetaminophen acute liver failure. 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.

Acute liver failure is associated with a high mortality rate and frequent need for liver transplantation. Approximately half of acute liver failure cases are caused by acetaminophen poisoning while the other half result from a variety of causes including hepatitis and alcohol. Currently, transplantation of the liver is the only treatment for patients with liver failure not caused by acetaminophen overdose.

In May 2010, the FDA officially accepted the sNDA and granted a priority review, with a Prescription Drug User Fee Act date of September 10, 2010. In addition to expanded labeling for Acetadote, we have requested additional exclusivity for the product. If approved, we expect to begin marketing Acetadote with the new indication in 2011.

[surf1944]

10:30AM Cumberland Pharma injection shown to significantly reduce fever in Malaria patients in newly published clinical trial (CPIX) 5.90 -0.07 : Co announced that data supporting the efficacy of Caldolor in treating fever associated with falciparum malaria was published in the July edition of the peer-reviewed American Journal of Tropical Medicine and Hygiene. The study, which is the first to document an antipyretic effect of an injectable non-steroidal anti-inflammatory drug on fever caused by malaria, demonstrated that patients who received intravenous ibuprofen experienced a greater reduction in their temperatures than those who received placebo.

[surf1944]

Cumberland Pharma CPIX Morgan Joseph Buy $21 » $15

[surf1944]

10:30AM Cumberland Pharma partners in Canada with Alveda Pharmaceuticals to commercialize Caldolor (CPIX) 10.84 +0.19 : Co announced it has entered into an exclusive agreement with Alveda Pharmaceuticals Inc. (Alveda Pharma), a Toronto-based specialty pharmaceutical company, for the commercialization of Caldolor Injection in Canada. Designed to treat pain and fever in the hospital setting, Caldolor was approved by the FDA and launched by Cumberland in the United States in 2009. According to the terms of the agreement, Alveda Pharma will seek Canadian regulatory approval for Caldolor and, upon approval, handle ongoing regulatory requirements as well as product marketing, distribution and sales throughout Canada. Cumberland will maintain responsibility for product formulation, development and manufacturing. In exchange for the license to the product, Cumberland will receive royalties on future sales of Caldolor in addition to upfront and milestone payments as well as a transfer price.

[surf1944]

6:35AM Cumberland Pharma announces it has submitted a supplemental new drug application to the FDA for the use of Acetadote Injection (CPIX) 11.24 : Co announces it has submitted a supplemental new drug application to the FDA for the use of Acetadote 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.

[surf1944]

8:41AM Cumberland Pharma reports EPS in-line, misses on revs (CPIX) 12.00 : Reports Q4 (Dec) earnings of $0.01 per share, in-line with the First Call consensus of $0.01; revenues rose 9.2% year/year to $10.7 mln vs the $11.5 mln consensus. The decrease in net income is due primarily to a $0.9 million increase in net revenues offset by a $1.7 million increase in operating expenses and increased interest expense associated with the Company's new credit facility. This change in earnings per share was due to the decrease in net income and an increase in shares outstanding from Cumberland's initial public offering.

[surf1944]

Cumberland Pharmaceuticals Donates Caldolor(R) to Haitian Relief Effort
Drug to treat pain and reduce fever amid worsening health conditions

Press Release Source: Cumberland Pharmaceuticals Inc. On Wednesday January 20, 2010, 11:32 am EST
NASHVILLE, Tenn., Jan. 20 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) has donated 15,000 vials of Caldolor® (ibuprofen) Injection, an intravenous form of ibuprofen, to Haitian relief effort.

Caldolor is the first and only injectable product approved for the treatment of pain and reduction of fever in the United States. As health conditions in Haiti continue to deteriorate, Caldolor is expected to help those suffering from fever as a result of disease or infection as well as patients suffering with pain from traumatic injury or while recovering from surgery. Cumberland provided the drug through a U.S.-based medical unit that will support field medical personnel in Haiti, including the international aid group Doctors Without Borders.

"As we learn more about the devastation this quake has caused as well as the conditions aid workers are facing, it is incumbent upon us to do what we can to ease this suffering," said A.J. Kazimi, Cumberland's Chief Executive Officer. "We are hopeful the donation of Caldolor will be especially relevant in light of mounting public health concerns about the outbreak of disease and the lack of adequate medical facilities and supplies."

Survivors and aid workers are facing dire health conditions, including stifling heat and raw sewage as well as lack of access to food, water or medical treatment. Health experts have warned that thousands of people could die as a result of infectious disease or infection from improperly treated wounds.

Caldolor was approved by the FDA and introduced in the United States in 2009. Clinical trials have shown Caldolor to provide safe and effective relief from both pain and fever.

About Caldolor

Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor.

[surf1944]

Cumberland Pharmaceuticals Licenses Caldolor(R) (ibuprofen) Injection to DB Pharm Korea for Commercialization in South Korea
Press Release
Source: Cumberland Pharmaceuticals Inc.
On 9:00 am EST, Wednesday December 9, 2009

Nashville, Tenn., Dec. 9 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX - News) today announced that it has entered into an exclusive agreement with DB Pharm Korea Co. Ltd., a Korean-based pharmaceutical company, for the commercialization of Caldolor® (ibuprofen) Injection in South Korea. Designed to treat pain and fever in the hospital setting, Caldolor was approved by the U.S. Food and Drug Administration and launched by Cumberland in the United States earlier this year.

Under the terms of the agreement, DB Pharm Korea is responsible for seeking regulatory approval for Caldolor in South Korea, and following approval would handle ongoing regulatory reporting, product marketing, distribution and sales in the territory. Cumberland maintains responsibility for product formulation, development and manufacturing, and will provide finished product for sale. In exchange for the license to the product, Cumberland will receive upfront and milestone payments, a transfer price and royalties on future sales of Caldolor.

"We are very pleased to expand our network of international partners for Caldolor with this new agreement," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "DB Pharm Korea has a strong infrastructure to handle commercialization of hospital pharmaceutical products, and we look forward to working with them toward making Caldolor available to a larger population of patients."

Following regulatory approval for Caldolor in South Korea, DB Pharm Korea would promote the product to key South Korean hospitals through its existing sales force. Used primarily in hospitalized patients who are unable to receive oral therapies, Caldolor is expected to be the first and only injectable ibuprofen product available in South Korea for the treatment of pain and fever, featuring analgesic, antipyretic and anti-inflammatory properties.

"We believe Caldolor can fill an unmet need in the hospital market in South Korea, and look forward to communicating its benefits to the medical community here," said Hong Kee Lee, Representative Director for DB Pharm Korea. "Cumberland's strong clinical data and profile for use of the product should help facilitate regulatory approval and encourage widespread hospital use in our country."

A recently published study in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, entitled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen for the Management of Postoperative Pain in Adults," concluded that postoperative patients receiving Caldolor required less narcotic and experienced less pain compared to patients receiving morphine alone. The World Health Organization has recommended a multi-modal approach to pain management, with non-opioid analgesics such as ibuprofen recommended as first-line treatment.(1)

In October 2009, Cumberland Pharmaceuticals entered into an agreement with Phebra Pty Ltd. for commercialization of Caldolor in Australia and New Zealand. The Company also has an agreement with Alveda Pharmaceuticals Inc. to make the product available in Canada. Cumberland handles commercialization of Caldolor in the United States.

SOURCE: Cumberland Pharmaceuticals Inc.

[surf1944]

Cumberland Pharmaceuticals to Announce Third Quarter 2009 Financial Results on November 10, 2009
Press Release
Source: Cumberland Pharmaceuticals Inc.
On 10:00 am EDT, Tuesday October 27, 2009

Companies:Cumberland Pharmaceuticals, Inc.
NASHVILLE, Tenn., Oct. 27 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX - News) announced today that it will report third quarter 2009 financial results before the market opens on Tuesday, November 10, 2009. A conference call and live Internet webcast will be held on Tuesday, November 10, 2009 at 10:00 a.m. Eastern Time to discuss the results.

To participate on the call, please dial 888-417-8462 (for U.S. callers) or 719-457-2552 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 888-203-1112 (for U.S. callers) or 719-457-0820 (for international callers). The passcode for the rebroadcast is 9695498. The live webcast and rebroadcast can be accessed via Cumberland Pharmaceuticals' website at http://investor.shareholder.com/cpix/events.cfm.

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland markets Acetadote® for the treatment of acetaminophen poisoning and Kristalose®, a prescription laxative. The Company also recently launched Caldolor®, the first injectable treatment for pain and fever available in the United States. Cumberland is dedicated to providing innovative products which improve quality of care for patients. The Company completed its initial public offering of common stock in August 2009.

For more information on Cumberland Pharmaceuticals, please visit www.cumberlandpharma.com

[surf1944]

Newly Published Clinical Data Shows Caldolor(R) (Ibuprofen) Injection Reduces Opioid Use While Improving Pain Relief in Post-Operative Patients
-- Data demonstrates that IV ibuprofen is associated with significant reduction in morphine use in managing pain over immediate 24 hours following surgery
-- Intravenous ibuprofen also significantly reduces post-operative pain compared to patients with open access to morphine

Press Release
Source: Cumberland Pharmaceuticals Inc.
On 11:43 am EDT, Monday October 19, 2009

Companies:Cumberland Pharmaceuticals, Inc.
NASHVILLE, Tenn., Oct. 19 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX - News) announced today that its Phase III study on intravenous ibuprofen as a post-operative analgesic was published in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, distributed in October. The study concludes that patients emerging from orthopedic and abdominal surgeries required less narcotic and experienced less pain with 800 mg of intravenous ibuprofen every six hours compared to morphine alone.

In the United States, approximately 80 percent of patients experience pain following surgery, with 86 percent of these patients reporting moderate to severe pain(1,2). Both the World Health Organization and the American Society of Anesthesiologists Task Force recommend a multi-modal approach to pain management, with non-opioid analgesics such as ibuprofen recommended as first-line treatment(3,4).

"These clinical findings support the use of intravenous ibuprofen in achieving improved post-operative pain control," said Stephen Southworth, M.D., orthopaedic surgeon at the North Mississippi Sports Medicine & Orthopaedic Clinic, PLLC and lead author of the study. "IV ibuprofen is a valuable pain management option for physicians seeking a multi-modal approach to post-operative pain management for their orthopaedic and abdominal patients."

The goal of this study was to evaluate the safety and efficacy of two different doses of intravenous ibuprofen as an effective post-operative analgesic medication. It focused on the results of hospitalized patients undergoing orthopedic or abdominal surgery who were randomized to receive either a placebo or 400 or 800 mg of intravenous ibuprofen every six hours. All patients had access to morphine by patient controlled analgesia (PCA). The first dose of ibuprofen was administered intra-operatively at the initiation of surgical closure. The double-blind, placebo-controlled trial was conducted at 17 different sites in three countries on 406 patients who were scheduled to undergo elective, single-site orthopedic or abdominal surgery between February 2005 and September 2006.

Median morphine use and pain assessed at rest and with movement were significantly reduced during the first 24 hours after administration in patients who received the 800-mg dose of ibuprofen. Pain reduction with Caldolor was also significantly greater versus patients with open access to morphine.

According to the study, "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain," intravenous ibuprofen is safe and well-tolerated when administered intra- and post-operatively. There was no significant difference between placebo and IV ibuprofen in the number of patients with renal function abnormalities, bleeding adverse events or in the incidence of blood transfusions. The publication can be found online at www.clinicaltherapeutics.com.

SOURCE: Cumberland Pharmaceuticals Inc.

About Caldolor

Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, including boxed warning, visit www.caldolor.com.

[stock_observer_77]

Just found out about this company through a friend.

Very interesting.

[surf1944]

Cumberland Pharmaceuticals Announces Pricing of Its Initial Public Offering of Common Stock
Press Release
Source: Cumberland Pharmaceuticals Inc.
On Monday August 10, 2009, 10:20 pm EDT

Companies:Cumberland Pharmaceuticals, Inc.
NASHVILLE, Tenn., Aug. 10 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. announced today the pricing of its initial public offering of 5,000,000 shares of the Company's common stock at a price to the public of $17.00 per share, raising $85.0 million in gross proceeds. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares at the initial public offering price to cover any over-allotments. The common stock is expected to begin trading on the NASDAQ Global Select Market on August 11, 2009 under the trading symbol "CPIX".

Net proceeds to the Company are expected to be approximately $75.2 million after deducting underwriting discounts and commissions as well as offering expenses, and before exercise of any over-allotment option. Cumberland expects to use these proceeds primarily for potential acquisitions, the pending launch of the Company's Caldolor(®) product, expansion of the Company's hospital sales force, product development, debt repayment and general corporate purposes.

UBS Investment Bank, Jefferies & Company, Inc. and Wells Fargo Securities are acting as book-running managers for the offering, and Morgan Joseph is acting as co-manager.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on August 10, 2009. This offering is being made only by means of a written prospectus. A copy of the final prospectus relating to the offering may be obtained from the prospectus department of UBS Investment Bank, Attn: Prospectus Department, 299 Park Avenue, New York, New York 10171.

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland markets Acetadote(®) for the treatment of acetaminophen poisoning and Kristalose(®), a prescription strength laxative. The Company also recently received FDA approval for Caldolor(®), the first injectable treatment for pain and fever available in the United States, and is preparing for the commercial launch of that product. Cumberland is dedicated to providing innovative products which improve quality of care for patients.

[surf1944]

Cumberland Pharma CPIX Morgan Joseph Buy $21
Cumberland Pharma CPIX Jefferies & Co Buy $21
Cumberland Pharma CPIX UBS Buy