Cephalon has presented promising data of a late-stage study of Treanda, its new compound for the treatment of indolent non-Hodgkin's lymphoma.

Specifically, the 100-patient Phase III trial of Treanda (bendamustine) looked at patients with indolent NHL whose cancer is no longer responsive to treatment with Genentech/Biogen Idec’s Rituxan (rituximab). The overall response rate was 75% and the median duration of response was 40 weeks and the most common side effects included nausea, fatigue, neutropenia, diarrhoea and vomiting.

Based on these data, which replicate those seen in a Phase II study, “confirming the substantial efficacy in this difficult-to-treat population," said Lesley Russell, the firm’s executive vice president for worldwide medical and regulatory operations, “we are on track to file a New Drug Application in the fourth quarter” for the aforementioned indication. That will follow on the heels of an NDA submitted to the US Food and Drug Administration last month requesting approval of Treanda for the treatment of patients with chronic lymphocytic leukaemia, for which the agency has granted orphan drug status.

According to the National Cancer Institute, 30,000 people in the USA will be diagnosed in 2007 with indolent NHL, which Cephalon says is difficult to treat because patients are prone to relapse after treatment. The firm licensed the rights to Treanda from Astellas Deutschland and bendamustine is marketed in Germany by the latter's licensee, Mundipharma under the tradename Ribomustin, where it is approved for multiple myeloma, as well as indolent NHL and CLL. SymBio Pharmaceuticals holds exclusive rights to sell the drug in Japan and selected Asian countries.

FDA adds warning to Provigil label

The news sent Cephalon shares up 3.8% to $73.79 but the company received some bad news after the markets closed when the FDA added a warning to the label on the firm’s sleep drug Provigil (modafinil).

The agency and Cephalon issued a statement revising prescribing information on the medicine to include warnings regarding serious rash, including Stevens-Johnson Syndrome, hypersensitivity reactions and psychiatric symptoms. They noted that “rare cases of serious or life-threatening rash”, including toxic epidermal necrolysis, have been noted in adults and children in postmarketing reports, as have angioedema and multi-organ hypersensitivity reactions.

The FDA added that psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil and “caution should be exercised when Provigil is given to patients with a history of psychosis, depression or mania”. The new label is similar to that on recently-approved Nuvigil (armodafinil) a longer-acting version of Provigil.

Provigil, which is indicated to treat narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder, is a big earner for Cephalon and second-quarter sales of the drug reached $214.2 million.