Knobias Clip Report (10-4-2007)
Sumbmited From Knobias ClipReport
BJCT and TRMS Shares Decline After Trial of Fuzeon(R) w/B2000 Discontinued
Shares of Trimeris, Inc. (TRMS) fell 2.6% in late trading on Wednesday and declined in Thursday's session, after announcing with its partner, Roche, that they have withdrawn a supplemental FDA application for its HIV treatment Fuzeon(R) administered with Bioject Medical Technologies Inc.'s (BJCT) Biojector(R) 2000 ("B2000"), a convenient needle-free injection device with less side effects than traditional needle injections. Trimeris and Roche pulled the application because of the time required to generate additional data for the approval. This news fueled a 30% decline on heavy volume for BJCT in early trading.
Approved in the U.S., Canada and European Union, Fuzeon(R) (enfuvirtide) is the first in a class of anti-HIV drugs called fusion inhibitors. Its “mechanism of action” is completely different from existing anti-HIV drugs. Instead of working on the inside of T cells to stop virus replication, Fuzeon(R) works on the outside where it can block entry (“fusion”) to the cell. Fusion inhibitors are less likely to cause unwanted side effects. The latest HIV treatment guidelines currently support the use of Fuzeon(R) in combination with other anti-viral drugs to help treatment-experienced patients achieve undetectable viral loads.
Trimeris shares gross profits equally with Roche from the sale of Fuzeon(R) in the United States and Canada. Trimeris receives a royalty based on net sales of Fuzeon(R) outside the United States and Canada. This License Agreement with Roche accounted for 100% of the Company’s royalty revenue for the three and six months ended June 30, 2007. Total net sales of Fuzeon(R) in the United States and Canada were $62.2 million during the six months ended June 30, 2007.
Trimeris has completed Phase I/II trials for its second-generation fusion inhibitor for HIV, T-1249, that binds to a slightly different region of the HIV virus than FUZEON(R). Trimeris and Roche have selected TRI-1144 as a lead Next Generation Fusion Inhibitor ("NGFI") preclinical compound due to its favorable product profile, including potent antiviral activity against a broad range of HIV clinical isolates and its attractive pharmacokinetic properties in animals.
Bioject Medical is a developer and manufacturer of needle-free drug delivery systems. Needle-free injection works by forcing medication at high speed through a tiny orifice held against the skin. The B2000 was cleared by the FDA to deliver needle-free injections of liquid medicine under the skin and into muscle. National Institutes of Health have used the B2000 technology for HIV, Ebola and influenza vaccine research.
Recent research and development efforts have also focused on the Iject(R) single use disposable product and the next generation spring device with auto-disable syringe. The Company has also completed several projects with Merial with the launch of Merial’s Derma-Vac(TM) needle-free device for swine and the Vitajet(R) device for canine melanoma. An additional project is underway with an undisclosed European biotech partner. Other needle-free drug delivery technologies include Antares Pharma Inc.'s (AIS) Medi-Jector devices for insulin or human growth hormone; and Medical International Technology, Inc.'s (MDLH) needle free jet injectors for veterinary (AGRO-JET(R)) and human (MED-JET(R)) applications.
As of June 30, 2007, Bioject had an accumulated deficit of $116.7 million and cash/cash equivalent/short-term marketable securities of $2.8 million. The Company's revenues were $2.8 million for the quarter, and it reduced its loss per share to $0.07 from a loss of $0.21 in the same period of 2006.
Ralph Makar, who became Bioject's new President and CEO this week, commented on the Fuzeon(R)/B2000 application withdrawal, "We would have preferred to see the process completed and to have been able to provide the B2000 to all HIV patients. Our device offers benefits over the use of needle and syringe for the delivery of injectables, as millions of injections have been administered by the B2000 since its release by the FDA in 1993. We continue to pursue other opportunities with current and new partners for its use in benefiting patients. We are also pleased that patients who are currently delivering Fuzeon with the B2000 through existing programs and clinical trials may continue to do so."
Visit 1800blogger to see all of our industry leading blogs
Labels: BJCT, Knobias, small cap stocks, TRMS

0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home