Sonus Pharmaceuticals Inc. (SNUS) - 500 Beiträge pro Seite

[benefactor [KommA]]

Sonus Pharmaceuticals, Inc. is a drug reformulation company focused on the optimization of therapeutic drugs to treat cancer and other serious diseases. The Company is developing a number of potential product candidates utilizing its TOCOSOL drug delivery technology. The TOCOSOL technology platform, designed to address the formulation challenges of therapeutic drugs, uses vitamin E oil (tocopherol) and tocopherol derivatives to solubilize and stabilize drugs for formulation enhancement, and is particularly suited to injectable drugs that are poorly soluble in water. The Company`s lead product, TOCOSOL Paclitaxel, is a formulation of paclitaxel, a prescribed anti-cancer drugs. TOCOSOL Paclitaxel is a ready-to-use injectable paclitaxel emulsion.
http://www.sonuspharma.com/




Sonus Pharmaceuticals Modifies Terms for Proposed Acquisition of Synt:em
Tuesday December 28, 8:30 am ET

BOTHELL, Wash.--(BUSINESS WIRE)--Dec. 28, 2004--Sonus Pharmaceuticals, Inc. (Nasdaq:SNUS - News) and Synt:em, S.A., a privately held biopharmaceutical company located in Nimes, France, today announced that they have revised the terms for Sonus` proposed acquisition of Synt:em, which had been announced on November 3, 2004.

Highlights of the new agreement include:

* Sonus will issue a maximum of 5.4 million shares to acquire 100% of the outstanding shares of Synt:em, compared to the issuance of between 7.6 million and 8.9 million of Sonus shares under the previous agreement.
* The new terms include the issuance of Sonus shares at closing having an approximate value of $12 million. The remaining Sonus shares will be issued upon achievement of contingent milestones based on Synt:em product candidates entering Phase 2 clinical trials, as compared to Phase 1 trials under the previous agreement.
* Under the new agreement, should the contingent milestone payments be earned, Synt:em shareholders would own 20% of the combined entity, based upon the number of shares of Sonus common stock outstanding today, which compares to ownership of 26% to 29% under the previous agreement should milestones have been met.
* The new agreement also includes a mechanism to reallocate a portion of the Sonus shares issued at transaction closing to the contingent milestone pool should Sonus reach agreement with the U. S. Food and Drug Administration (FDA) on Phase 3 testing or enter into a corporate partnership for TOCOSOL® Paclitaxel, the Company`s lead cancer product. The previous agreement had no such mechanism.

The Board of Directors of Sonus and Synt:em shareholders have unanimously approved the revised terms of the acquisition agreement. The transaction is targeted to close in the first quarter of 2005 and is subject to approval by the shareholders of Sonus and other customary closing conditions.

"The strategic rationale for combining Sonus and Synt:em remains compelling. This acquisition brings together two highly complementary companies and represents an outstanding opportunity to expand Sonus` potential product portfolio and technology capabilities, both of which will increase long-term shareholder value," said Michael A. Martino, President and Chief Executive Officer of Sonus Pharmaceuticals. "Since announcing the proposed Synt:em acquisition, we have gained further clarity on the regulatory strategy for TOCOSOL Paclitaxel following an end of Phase 2 meeting with the FDA in December. It therefore was appropriate to amend the original terms to more accurately reflect the increased value of Sonus` anticipated achievement of pending milestones for TOCOSOL Paclitaxel."

In September 2004, Sonus requested and was subsequently granted a meeting with the FDA to discuss its Phase 3 plans for TOCOSOL Paclitaxel. On December 21, the Company reported under Form 8-K that it had recently met with the Agency, and based on preclinical and clinical data generated to date, the FDA indicated that it is appropriate to pursue Phase 3 testing and submission of a TOCOSOL Paclitaxel New Drug Application (NDA) under a 505(b)(2) regulatory mechanism, as per Sonus` stated objective. The FDA`s use of 505(b)(2) is designed to streamline the NDA review process by not requiring duplicate work. The 505(b)(2) approval path will rely on the FDA`s previous findings of safety and efficacy for Taxol®, the reference paclitaxel product, supplemented by additional data supporting TOCOSOL Paclitaxel`s efficacy and safety.




FDA Grants Orphan Drug Designation to Sonus Pharmaceuticals` TOCOSOL Paclitaxel in Bladder Cancer Indication
Thursday January 27, 7:30 am ET
Company conducting Phase 2b bladder cancer clinical trials in U.S. and Europe

BOTHELL, Wash.--(BUSINESS WIRE)--Jan. 27, 2005-- Sonus Pharmaceuticals, Inc. (Nasdaq:SNUS - News) today announced that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug designation to its lead oncology candidate, TOCOSOL® Paclitaxel, for the treatment of non-superficial urothelial cancer. The most common form of urothelial cancer is bladder cancer. The Orphan Drug designation adds to the Fast Track designation awarded in 2003 by the FDA Division of Oncology Drug Products for the development of TOCOSOL Paclitaxel for the treatment of metastatic or locally advanced, inoperable transitional cell carcinoma (TCC) of the urothelium. TOCOSOL Paclitaxel is a novel formulation of paclitaxel, a widely prescribed anti-cancer drug for the treatment of solid tumors.

In parallel with developing TOCOSOL Paclitaxel for the treatment of bladder cancer, Sonus is pursuing initial market entry through a 505(b)(2) New Drug Application in an indication for which paclitaxel-based products have already been approved, e.g. breast, ovarian or lung cancers. The Company is currently in discussions with the FDA to finalize the pivotal Phase 3 protocol for TOCOSOL Paclitaxel, which Sonus believes will be initiated in 2005.

"We have been pursuing the Phase 2b program since the end of 2003 to demonstrate the value of TOCOSOL Paclitaxel for treating bladder cancer," said Michael B. Stewart, M.D., Chief Medical Officer of Sonus Pharmaceuticals. "By granting both Orphan Drug and Fast Track status to TOCOSOL Paclitaxel, the FDA recognizes the potential of our drug to treat advanced cancers of the bladder and urinary system -- an uncommon, but important medical need. Currently available treatments are not particularly effective and/or have serious side effects. Despite the challenge of performing rigorously controlled clinical trials in a disease with a small patient population, we believe that addressing this need is an important component of the overall development objective for TOCOSOL Paclitaxel, and we are pleased that the FDA has agreed with us."

The Company is conducting Phase 2b bladder cancer studies in Cleveland, Philadelphia, Baltimore and Seattle, and will soon be opening sites in Spain and the U.K. In addition to the bladder cancer program, Sonus is also conducting a Phase 2b study of TOCOSOL Paclitaxel in patients with metastatic breast cancer.

Sonus has completed patient enrollment in Phase 2a studies of TOCOSOL Paclitaxel in bladder, ovarian and lung cancer patients, and these trials have generated encouraging data on safety and anti-tumor activity. The Company reported results of the Phase 2a studies in three presentations at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2004. TOCOSOL Paclitaxel offers the convenience of a ready-to-use formulation, which does not require reconstitution, dilution or pharmacy preparation as is required with the marketed paclitaxel products. Additionally, TOCOSOL Paclitaxel is administered to patients in a short 15-minute infusion, compared to the three-hour infusion required with Taxol®, the innovator paclitaxel product.

[xanda1]

der fast track status bedeutet, dass
SNUS jeweils vorliegende forschungs-teil-ergebnisse
sofort an die FDA weiterleiten darf und nicht
wie sonst die gesammelten ergebnisse übermitteln
muß.
langsam könnte sich wieder etwas tun bei SNUS.

[xanda1]

SNUS wurde gestern in einem US TV sender
positiv erwähnt worauf der kurs vorbörslich
um 11% anzog.

mit dem schwachen gesamtmarkt hat sich
dieser gewinn im tagesverlauf auf 3% reduziert.

trotzdem weist SNUS in den vergangenen wochen
eine ausgezeichnete entwicklung auf.