By Debbie Strickland
CV Therapeutics has aligned itself with the market leader for development and marketing of a fast-acting drug for people unable to exercise sufficiently to take a cardiac stress test.
Fujisawa Healthcare Inc., of Deerfield, Ill., has agreed to pay $34 million up front and in milestones for rights to CVT-3146, plus fund 75 percent of development costs, as well as "a very high double-digit royalty," according to Louis Lange, chairman and CEO of CV.
"They created the market, and they understand it," Lange said.
Fujisawa markets Adenoscan, a $100 million-a-year product whose active ingredient, adenosine, interacts with a variety of adenosine receptors, including one called A2A that stimulates vasodilation and stimulates coronary blood flow so that cardiac perfusion imaging studies can be done without exercise. But because adenosine acts on all of its receptors, not just A2A, it also can cause side effects. When it reacts with the adenosine receptor A2B, for example, adenosine can cause lung complications in some patients; an A1 reaction can cause excessively slow heart rate.
CVT-3146 targets A2A - the vasodilating receptor - specifically, thereby potentially avoiding those side effects. The temporary nature of its effects also offers an advantage to another competitor, dipyridamole, whose effects can take hours to wear off. CVT-3146 has undergone preclinical testing and is slated to enter Phase I clinical trials late this year or in early 2001.
CV will handle development of CVT-3146, with three-fourths of the expense reimbursed from Fujisawa, which will market the product in North America. Fujisawa also has rights to a backup compound. The payments to CV consist of $10 million in cash and an equity purchase (at a premium), plus $24 million in cash milestone payments. In addition to royalties on CVT-3146, CV will receive royalties on another, undisclosed Fujisawa product (Lange could not confirm that Adenoscan is the product in question).
In 1997, 5.2 million cardiac perfusion imaging studies were performed in the U.S., of which 1.8 million were conducted using a pharmacologic agent such as Adenoscan.
The CV-Fujisawa alliance grew out of the longstanding relationship of Luiz Belardinelli, CV's executive director of pharmacological sciences, with Fujisawa. Belardinelli discovered the role of adenosine in the heart while at the University of Virginia and receives royalties from Fujisawa for Adenoscan sales.
"He joined us full-time two years ago and has worked with us to make the second-generation product, which is markedly improved," Lange said.
The deal frees up CV to concentrate its considerable financial resources on late-stage therapeutic programs. The company's ranolazine is in a Phase III stable angina trial expected to complete enrollment by the end of the year. In May, the company announced plans to move CVT-510 into Phase III clinical trials for atrial arrhythmia. Trial data from both products will be released at the American Heart Association meeting this fall.
To fund these programs, as well as development of a promising preclinical slate of products, CV earlier this year raised $196 million in an offering of convertible notes. As of March 31, the company had $273 million in cash.
CV's partnering finesse was honored in May when the company received the Breakthrough Alliance of the Year Award at the Allicense 2000 conference in Basel, Switzerland. The award recognized an innovative deal CV struck with Innovex, a business unit of Quintiles Transnational Corp., of Research Triangle Park, N.C. Under the May 1999 agreement, Innovex will promote ranolazine for at least three years after launch, and CV will receive 25 percent to 33 percent of revenues.
Investors have given a thumbs-up to CV's pipeline and partnering skills over the past year. This time last year, shares in the Palo Alto, Calif., company were trading between $5 and $6. Wednesday CV shares (NASDAQ:CVTX) closed at $81.75. The Fujisawa deal, disclosed Tuesday, lifted the stock 5.6 percent.