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GlaxoSmithKline (GSK) won FDA approval of Tykerb for advanced breast cancer. Because the indication is tightly limited, the effect on GSK will not be great until Tykerb becomes used for more types of cancer.

Initially, Tykerb, which will be administered along with Herceptin from Genentech (DNA), is to be given to patients with HER2 positive breast cancer as a second-line treatment. Tykerb inhibits both the HER2 and EGFR proteins. It is thought to be especially effective in preventing brain metastases. Tykerb remains in trials as a first-line breast cancer drug and for other types of cancer as well.

Adolor (ADLR) announced that GlaxoSmithKline, its partner on Entereg, is planning an additional Phase III trial of Entereg to prove safety. Entereg is a treatment for opiate-induced constipation. The FDA gave Entereg an approvable letter, but asked for more data about cardiovascular side-effects. Because GSK is willing to undertake the trial, analysts opined the company must surmise the drug is safe.

VentiRx, a privately held San Diego startup, licensed exclusive rights to the Toll-like receptor program from Array BioPharma (ARRY). The license includes rights to a number of development candidates that target TLRs to activate immunity, including one candidate each in oncology and allergy. Terms were not disclosed, but Array will receive equity in VentiRx in addition to an upfront payment, milestones and royalties. Array also has an opt-in right to buy 50% of the oncology program.

GTC Biotherapeutics
(GTCB) has granted expanded the rights to PharmAthene for Protexia. Protexia is a PharmAthene drug that uses GTC’s transgenic goats technology to make human butyrylcholinesterase [rBChE], a pre- and post-exposure therapy for chemical nerve agent attack. The drug, which is intended for civilians, will be manufactured by GTC. Terms were not disclosed. Recently, privately held PharmAthene announced it would be acquired by Healthcare Acquisition Corp. (HAQ), a special purpose acquisition company.

Enzo Therapeutics (ENZ) treated the first patient in a Phase I/II trial of its gene therapy for HIV. The compound is aimed at HIV-Type 1. The goal of the therapy is to create enough CD4+ cells to defer progression of the disease to AIDS.

Cell Therapeutics
(CTIC) has filed a Special Protocol Assessment request with the FDA for a Phase III trial of pixantrone for non-Hodgkin’s lymphoma. Endpoints of the trial will be complete remission rates and time to disease progression. Pixantrone will be administered as an adjunct to fludarabine and rituximab, and compared to results of a regimen using only the other two drugs.

Medtronic (MDT) received FDA approval for Infuse Bone Graft in specified oral maxillofacial and dental regenerative bone grafting procedures. Infuse, which has been on the market since 2002 for other indications, is a recombinant human bone morphogenetic protein-2 (rhBMP-2) to stimulate bone growth carried in an absorbable collagen sponge carrier.

Stocks moved broadly lower in Tuesday’s session. The Centient Biotech 200™ fell 34 points to 3806, a loss of .86%. That was, in relative terms better than the general market indexes, as the S&P 500 was down 2.04% and Nasdaq dropped 2.15%.

Disclosure: Centient management holds a position in Genentech shares and does consulting work for Genentech.

Source: Biotech Day in Review: Glaxo Gets Approval for Tykerb