news blog from Ewa

Oct 18 '11

CORRECTED - Halozyme: subcutaneous Herceptin trial met goals


* Halozyme patents valid through at least 2024By Deena BeasleyOct 18 (Reuters) - Halozyme Therapeutics , which specializes in reformulating drug products available only as infusions, said a pivotal trial of subcutaneous Herceptin, the cancer drug sold by Roche , met its goals.The under-the-skin injections offer a faster, more convenient way to administer the drug, according to Halozyme Chief Executive Officer Gregory Frost. Herceptin had 2010 global sales of $6.8 billion.In addition, Halozyme’s enzyme technology is patented globally until 2024, with formulation patents extending beyond that, he said.The Phase 3 Roche trial, involving patients with a specific type of breast cancer, showed that women receiving the subcutaneous injection responded to the drug as well as women treated with intravenous Herceptin, Halozyme said on Monday.No new safety signals were observed, with the most common side effects being infections and anemia, the company said.Frost said Roche plans to file next year for European regulatory approval of subcutaneous ready-to-use Herceptin, which takes about five minutes to administer, compared with at least 30 minutes for the intravenous infusion.Halozyme said the new formulation may also reduce pharmacy time since no preparation is needed.Roche is expected to present full details of the trial at an upcoming medical conference.Halozyme said it is “comfortable” with Wall Street estimates of a mid-single-digit royalty from Roche on sales of subcutaneous Herceptin. It also earns milestone payments from the development deal.Roche is also conducting pivotal trials of subcutaneous Halozyme-engineered Rituxan, also known as MabThera, in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.Both Herceptin and Rituxan are monoclonal antibodies that require such large-volume doses that they cannot currently be given subcutaneously.

17 notes Tags: CORRECTED Halozyme subcutaneous Herceptin trial met goals

Oct 12 '11

Lehman says JPMorgan botched securities sale


By Nick BrownOct 11 (Reuters) - Lehman Brothers Holdings Inc accused JPMorgan Chase , its former banker, of mishandling the sale of more than $27 billion worth of securities as Lehman was collapsing in 2008.Lehman, in court papers made public on Tuesday, lobbed myriad allegations at the bank as part of the companies’ ongoing dispute in Lehman’s bankruptcy proceeding.Lehman painted an unflattering picture of JPMorgan’s methods for selling certain securities held as collateral for facilitating repurchase deals for Lehman’s U.S. brokerage, Lehman Brothers Inc (LBI).A spokesman for JPMorgan declined to comment. A lawyer for the bank did not return a call seeking comment.In court documents filed in U.S. Bankruptcy Court in Manhattan, Lehman said JPMorgan traders made improper profits on the sales by “flipping” securities — selling them to themselves at low prices and reselling to third parties at higher prices, Lehman said.Lehman is hoping to avoid or reduce a $6.3 billion claim from JPMorgan related to the securities.JPMorgan demanded roughly that sum from Lehman to help cover $25 billion in losses it incurred through its role in the LBI repurchase deals, saying the securities alone did not generate enough cash to make it whole.But Lehman said the securities had a market value of more than $27 billion, and would have covered JPMorgan’s losses if not for JPMorgan’s improper sale process.”Perhaps because JPMorgan believed it could look to the extra LBHI collateral it held as a ‘cushion,’ JPMorgan rushed to liquidate the LBI collateral without any procedures to ensure it was sold at a fair market price,” Lehman said in the filing.Lehman, in the court papers, said JPMorgan dubbed the liquidation process “Project Tassimo” in honor of one JPMorgan employee’s coffee maker. The project was assigned to JPMorgan’s “Special Situations Group,” whose members had little to no actual experience liquidating collateral, Lehman said.The bank incentivized employees to make quick deals on the securities rather than good ones by refusing to compensate its traders, Lehman said. At the same time, it failed to effectively regulate traders who sought their own profits by flipping securities, Lehman said.JPMorgan also did not set a formal floor for prices, saying only that bidders who offered a “fraction of a cent” should not be considered, according to Lehman’s argument.Details of the filing had been redacted when it was first filed in August. The parties disagreed about whether the information should be made public, with Lehman filing a motion to unseal.JPMorgan never responded to the motion. Lehman filed its unredacted motion on Tuesday.The Lehman bankruptcy is In re Lehman Brothers Holdings Inc, in the same court, No. 08-13555.

85 notes Tags: Lehman says JPMorgan botched securities sale