FDA adds black box warning to Regranex
WASHINGTON The Food and Drug Administration has added a black-box warning to Johnson & Johnson’s foot ulcer medication Regranex, warning that when used in large amounts, it could heighten the risk of patients dying from cancer.
The new boxed warning states that patients who used three or more tubes of Regranex over a 20-month period were five times more likely to die of cancer. When patients used lower amounts of the cream, the FDA said their chances of developing cancer were no higher than patients who had never used the drug.
Regranex is a man-made version of a substance produced by the human body that helps heal ulcers. Because the drug causes cells to divide more rapidly, the FDA said Johnson & Johnson closely monitored patients for reports of cancer, which spreads through uncontrolled cell division.
Back in March, the FDA said it was reviewing the drug’s links to cancer.
Ipsen to acquire Tercica in $663 million deal
NEW YORK Paris-based pharmaceutical company Ipsen is buying Brisbane, Calif.-based biotechnology company Tercica for $663 million, or $9 a share.
Ipsen was already a major shareholder in Tercica, and the deal puts it in control of the remaining shares. It hopes to use the deal to expand operations in the U.S.
Ipsen will also buy British drugmaker Vernalis’ U.S. subsidiary and has acquired rights to Octagen’s experimental hemophilia drug OBI-1.
Taro tries to cancel deal with Sun
MUMBAI, India In response to Taro announcing that it was canceling a merger agreement with Sun Pharmaceuticals, Sun chairman Dilip Shanghvi fired off a letter telling the drugmaker it cannot exit the deal.
After a year in which Taro’s finances rebounded from red to black, the company said it wanted out of its deal with Sun because the deal did not reflect its improved performance. In response, Shanghvi expresses disappointment that Taro made its announcement without engaging in meaningful dialogue. He also points out that Taro had only $47 million in cash as of March 31 and, without Sun’s infusions of cash last year, “Taro would have virtually negative cash—hardly the ‘dramatic’ improvement of which Taro has boasted.”
Last May, Sun agreed to acquire Taro for $454 million. Some stockholders objected to the agreement’s $7.75 per share offer and petitioned the Tel Aviv District Court for a temporary injunction, which the court never issued, to prevent Taro from harming minority shareholders.
After Taro reported net sales of approximately $313 million and a gross profit of nearly $168 million for 2007, the company’s board of directors unanimously voted to cancel the merger agreement, saying the company’s improved financials made Sun’s offer inadequate. The move came even after Sun purportedly offered to raise the merger price to $10.25 per share, according to Taro.
In light of Taro’s actions, Sun is considering its options, including commencing legal proceedings, Shanghvi says, adding that he is available to discuss a negotiated transaction with Taro.