) -- The U.S. Food and Drug Administration is reconvening an advisory panel of cancer experts on March 22 to review
lymphoma drug pixantrone, following the postponement of the previously scheduled meeting in February due to severe winter weather.
In advance of the postponed advisory panel meeting, the FDA issued a
, highlighting numerous concerns about
Shares of Cell Therapeutics were down 12% to 59 cents Monday after auditors attached a "going concern" letter to the company's 10-K annual report filed with the Securities and Exchange Commission Friday.
is really nothing new. The company had $58.7 million in its coffers at the end of January, but is facing debt payments totaling $40 million in July. At its current burn rate, Cell Therapeutics will run out of cash before the end of the year, according to its annual report.
Cell Therapeutics' total share count ballooned to more than 615 million at the end of January, compared to 296 million shares at the end of January 2009, according to SEC filings.
That share count may go even higher if Cell Therapeutics is successful in getting shareholder approval to boost the company's stock treasury to as much as 1.2 billion shares. The company holds its annual shareholder meeting in April.
Cell Therapeutics has racked up an accumulated deficit of $1.4 billion since the company was founded in 1991. The company's shares have lost 99% of their value since early 2005, according to its annual report.
In 2009, the top five Cell Therapeutics executives earned $32 million in total compensation, most of which came in the form of company stock awards.
Chief Executive Officer Jim Bianco made over $12 million in total compensation in 2009, including $650,000 in salary and $11.3 million in stock awards. By comparison, Bianco earned just $1.5 million in total compensation in 2008 and $2.2 million in 2007, according to the company's annual report.
Meantime, Cell Therapeutics also disclosed another setback for its experimental cancer drug Opaxio. The Gynecologic Oncology Group (GOG) turned down Cell Therapeutics' request to conduct an interim analysis of the phase III study of Opaxio in patients with advanced ovarian cancer, according to Cell Therapeutics annual report.
Late last year, European regulators rejected Cell Therapeutics' application to approve Opaxio as a treatment for lung cancer.
Cell Therapeutics had been telling investors as late as the company's Feb. 11 conference call to expect the results from this interim analysis from the Opaxio study later this year. GOG did not provide a reason for why the interim analysis request was denied, said a spokesman for Cell Therapeutics.
GOG now plans to conduct an interim analysis of overall survival from the study in 2011, according to Cell Therapeutics. Started five years ago, the phase III study of Opaxio in ovarian cancer has enrolled only 600 out of a planned 1,100 patients.
A Cell Therapeutics' spokesman would not say if the company plans to halt enrollment in the Opaxio ovarian cancer study now that the early interim analysis off the table.
By the way, last September, Cell Therapeutics trumpeted in a press release the news of the
reaching the 600-patient enrollment milestone and plans for the interim analysis with GOG.
Yet Cell Therapeutics chose not to issue another press release disclosing GOG's vote to deny the company's request for an early interim analysis. Instead, Cell Therapeutics only disclosed the bad news in its annual report filed with the SEC.
Astellas Launches Hostile Bid for OSI Pharma
(At 6:38 AM EST)
Japanese drug maker
has launched a $3.5 billion hostile tender offer for U.S. biotech firm
( OSIP), maker of the lung cancer drug Tarceva.
Astellas is seeking to acquire all outstanding shares of OSI Pharma for $52 a share, representing a 40% premium over OSI Pharma's Friday closing price of $37.02, Astellas announced Monday.
The hostile tender offer for OSI Pharma comes after numerous previous entreaties by Astellas to buy the U.S. drugmaker were spurned, Astellas said in a statement.
"This offer follows our attempts over the past 13 months to engage OSI in meaningful discussions. We firmly believe in the compelling strategic rationale behind the combination and the opportunity it provides to the OSI stockholders to realize full and fair value, in cash, immediately," said Masafumi Nogimori, president and CEO of Astellas, in a statement.
Sales of OSI Pharma's lung cancer drug Tarceva rose 17% to $1.2 billion in 2009. Tarceva is co-marketed by the Swiss drug giant
Last year, Astellas launched an unsuccessful and hostile tender offer for U.S. drugmaker
, which was ultimately acquired by
-- Reported by Adam Feuerstein in Boston.
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