CV Therapeutics, Inc. (CVTX)
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CV Therapeutics is a biopharmaceutical company focused on discovery, development and commercialization of small-molecule class of drugs to treat cardiovascular diseases.
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Company Analysis
CV Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small-molecule drugs to treat various cardiovascular diseases. The company has 2 drugs in the market, ACEON and Ranexa. As of September 2006, the company has annual (ttm) revenue of $27.54 million and net loss of $280.3 million. [1]
Marketted Products
- Information about the company's product in the market from corporate website.
ACEON
- From August 2005 the company co-promoted ACEON with Solvay Pharmaceuticals to treat stable artery coronary disease and hypertension. However, CV Therapeutics ended the co-promotion agreement effective November 1, 2006 because the drug didn't meet the specified baseline minimum sales in the agreement. The drug only gave CV therapeutics $1.4 million in the first 2 quarters of 2006. [2]
Ranexa
Ranexa was approved by the FDA to be used in the United States for the treatment of chronic angina. However, the drug causes a side effect called QT interval prolongation, therefore it can only be used as second line treatment, which means it can only be prescribed for patients who has failed other treatment options.
The company is currently sponsoring a phase III clinical named MERLIN TIMI-36 research to prove that Ranexa is safe to be used long term as first line option for chronic angina sufferer. This clinical trial involves 5500 patients and is responsible for a large chunk of the company's R&D expense.
On March 6, 2007, the company announced topline result of the MERLIN TIMI-36 study. The study did not meet the primary efficacy endpoint for treatment of Non-ST Elevation Acute Coronary Syndromes. However The study showed there was no adverse trend in death or arrhythmias in patients on Ranolazine. In accordance with the company's special protocol assessment agreement with the U.S. Food and Drug Administration (FDA), the company believes that the data could support expansion of the existing Ranexa(R) (ranolazine extended-release tablets) indication to include first line angina. [3]
On March 27, 2007, the company presented full result of the MERLIN TIMI-36 study. The result was largely in line with the previously announced result. Ranexa did not stem overall incidence of heart attacks, death and recurrent ischemia, however it did show a statistically significant reduction in recurrent ischemia alone. Ischemia is a condition in which the heart doesn't get enough oxygen because of blocked blood flow. [4]
Analysts predict that FDA approval of Ranexa label expansion on successful MERLIN trial could make Ranexa a multibillion dollar drug. [5]
Even the QT prolongation issue has been attributed with some doctors' reluctance to prescribe Ranexa, and consequently the drugs' sales have been well below Wall Street's expectations. [6]
Product Pipeline
- List of the company's product in development from the company's website.
Regadenoson
On December 4, 2007, the company announced that phase 3 trial for the drug meets its primary endpoint and New Drug Application (NDA) is planned to be filed to the US food and drug Administration (FDA) in mid-2007. [7]
The drug is used to stimulate the heart for Myocardial Perfusion Imaging (MPI) studies for patient who are not healthy enough to use the treadmill. In this trial, the drug was compared to Astellas' Adenoscan that has about $300 million sales in North America.[1]
Regadenoson is developed under collaborative agreement with Astellas Pharma of japan. Under a collaboration agreement providing Astellas with exclusive North American rights to regadenoson, CV Therapeutics manages the clinical development program and Astellas is responsible for all commercial activities for regadenoson in North America, if the product is approved for marketing. Under the arrangement, Astellas reimburses CV Therapeutics for 75 percent of development costs and CV Therapeutics will receive a royalty on product sales of regadenoson, if approved, and may receive a royalty on another product. CV Therapeutics owns the rights for regadenoson outside of North America.[7]
News Feed
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| 11/19/08 1:11 pm | 9 Things You Should Do Instead of Buying Stocks (at Motley Fool) |
| 11/19/08 8:11 am | CV Therapeutics, Inc. Q3 2008 Earnings Call Transcript (at Seeking Alpha) |
| 11/13/08 9:11 am | CV THERAPEUTICS INC Financials (EDGAR Online Financials) |
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| 11/09/08 9:11 am | New Star Analyst Rankings for CV THERAPEUTICS I (StarMine) |
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| 11/07/08 2:11 pm | CV THERAPEUTICS INC Files SEC form 8-K, Other Events, Financial Statements and Exhibits (EDGAR Online) |
| 11/07/08 1:11 pm | CV THERAPEUTICS INC Files SEC form 10-Q, Quarterly Report (EDGAR Online) |
Risks
The company is still cash flow negative, and with current burn rate, the company has only about one year cash reserve (as of Sept. 2006). If FDA refuse to grant label expansion for Ranexa based on MERLIN trial results, and company's sales remain stagnant, the company may need to raise more funds.
Research Links
- CV Therapeutics, Inc. Snapshot
- Profile at Yahoo Finance
- Profile at MoneyCentral.com
- Company Events
- Earnings Estimates
- Competitors at Yahoo Finance
- CV Therapeutics, Inc. Leadership
- Officers and Directors at Reuters
- Salaries and Compensation at Reuters
- Insider Trades at Money Central
- Insider Trades at TheStreet.com
- Institutional Ownership at Money Central
- CV Therapeutics, Inc. Fundamentals
- Key Statistics Yahoo Finance
- Key Ratios at Reuters
- Dividends and Returns at Morningstar
- SEC Filings at Edgar Online
- Financial Statements Quickview at Morningstar
- Historical Prices at Yahoo Finance
- Analyst Estimates
- All Press Articles
- CV Therapeutics, Inc. Technical Analysis
- CV Therapeutics, Inc. Message Boards
Options
- Options Prices and Data at Yahoo Finance
- Options Prices and Data at IVolatility.com
- Call Options Data at OptionsBuddy.com
Notes
- ↑ CV Therapeutics quarterly income statement from corporate website, accessed on Feb 2, 2007
- ↑ [http://www.cvt.com/i_sec_text.aspx?secTextLink=4475024+%26+doc=+%26+attach=on CV Therapeutics 10Q for quarter ended September 30, 2006
- ↑ "CV Therapeutics Announces Topline MERLIN TIMI-36 Results," Company Press Release, March 6, 2007. Accessed March 7, 2007.
- ↑ "CV Therapeutics shares up on study data," Businessweek.com, March 27, 2007. Accessed on March 27, 2007
- ↑ Napodano, Jason. "GEN's Annual Wall Street Roundup", Genetic Engineering News, Feb 1 2007 (Vol. 27, No. 3). http://www.genengnews.com/ accessed on February 2, 2007
- ↑ Calls of Note Part 2 from http://notablecalls.blogspot.com, June 26, 2006. Accessed Feb 2, 2007.
- ↑ 7.0 7.1 Regadenoson Meets Primary Endpoint in Second Phase 3 Clinical Trial, Company Press Release, 12/4/2007, accessed 2/7/2007
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