THP, which has a German subsidiary, will be integrated into the Roche Pharma Center of Excellence for Protein Research organization in Penzberg, Germany. THP was founded in 2002.
NeoPharm (NEOL) said its cancer drug failed a Phase II trial. LE-SN38, the active metabolite of irinotecan [Camptosar], was given as a second-line treatment to patients with metastatic colorectal cancer patients. After the first 21 patients, an interim analysis showed that the patients exhibited disease stabilization, but the regimen was not reducing the size of their tumors, the endpoint of the trial.
NeoPharm will stop enrolling patients into the trial, though it will continue to treat those who have begun treatment. NeoPharm has not decided whether it will continue development of the drug. NeoPharm slipped 6 cents lower to $1.64.
NovaVax (NVAX) published results from a pre-clinical test showing that its virus-like particle [VLP] vaccine produced a robust immune response against the H9N2 strain of avian flu. The report was published in the journal Vaccine. The tests were carried out in three animal models, including the ferret, which is highly predictive of flu activity in humans.
A virus-like particle copies the three-dimensional structure of a virus but does not contain genetic material, allowing it to cause an immune reaction without infecting the patient. NovaVax intends to commence human testing of the vaccine later this year. NovaVax climbed 46 cents to $3.05, a gain of 18%.
Cephalon (CEPH) was sent another approvable letter for Nuvigil, a treatment for daytime sleepiness in patients with narcolepsy, sleep apnea, and shift work sleep disorder. This letter contains a proposed warning label spelling out the potential side effects of skin rash and hypersensitivity. Still outstanding is an update of safety information from trials conducted since June 2006 and marketing materials. Cephalon expects to file a response in 30 days and the FDA to respond within 60 days from the filing. Nuvigil received its first approvable letter in April 2006. Cephalon gained $4.75, ending at $75.96, a jump of 7%.
Impax Labs (IPXL) settled a patent dispute over its generic version of Oxycontin with Purdue Pharma. The settlement allows Impax and its distributor Dava Pharma to continue selling the drug through June 14, 2007. It may also resume marketing of a limited amount of the product for a limited period of time. Impax was off 14 cents at $10.08.
Abbott (ABT) asked for U.S. and European approval of Humira as a treatment for severe chronic plaque psoriasis. This type of psoriasis is the fifth autoimmune indication for TNF-blocker Humira, which was originally approved for arthritis. Abbott edged up a penny to $55.81.
Alkermes (ALKS) asked for approval of Vivitrol, a one-month injectable drug for alcohol dependence, in the UK and Germany. It was approved in the U.S. in April 2006. Alkermes dropped 9 cents to $15.35.
Merck (MRK) received FDA approval of a new diabetes drug that combines Januvia, it DPP-4 inhibitor, with metformin. The combination, called Janumet, is aimed at type 2 diabetes patients. Merck moved 84 cents higher to $45.01.
In quiet trading, biotech ended the session with a gain. The Centient Biotech 200™ rose 8 points to 3887, an increase of .21%. The S&P 500 was .26% higher, and Nasdaq inched up .03%.