FDA Panel Recommends Against Genasense Approval in CLL
Antisense drug developer Genta said this week that the US Food and Drug Administration’s Oncologic Drugs Advisory Committee has recommended against the agency’s approval of Genasense for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia.
Although the FDA is not obligated to follow the recommendation of its advisory panels, it usually does.
On the news, shares of Genta tumbled more than 40 percent, falling to a 52-week low of $0.5097.
Through initially promising, Genasense, Genta’s lead product candidate, has had a troubled history.
In 2002, Genta and Aventis (which later merged with Sanofi-Synthelabo) agreed to jointly develop and market the drug as part of a deal potentially worth up to $480 million to Genta. However, that deal ran aground after Genasense failed to hit its mark in phase III testing and an FDA advisory panel recommended against approving the drug in its key indication, melanoma.
Genta has continued to move forward on Genasense, filing the drug with the European Medicines Agency for advanced melanoma about a year ago and advancing clinical studies of the drug in other cancers, including CLL.
Despite this week’s setback, Genta said it remains committed to the drug.
"While we are disappointed with today's outcome, we strongly believe in the potential of Genasense and what it may offer patients with advanced cancer,” Raymond Warrell, Genta's CEO, said in a statement. "We remain committed to the development of this agent and will continue working with FDA regarding their review of this application."
Alnylam, Nastech Secure NIAID Grants for RNAi-Based Flu Drugs
Alnylam Pharmaceuticals this week announced that it has received a Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases to support its work in developing an RNAi-based therapy for pandemic flu.
The grant will provide Alnylam with roughly $590,000 over a one-year period, the company said.
"This grant … represents a continuation of our ongoing public sector-private sector partnership to advance RNAi therapeutics for pandemic flu,” John Maraganore, president and CEO of Alnylam, said in a statement. “In addition to this grant from the NIAID, we have submitted a response to the Request for Proposal from the Department of Health and Human Services for advanced development of new anti-viral agents for influenza."
Meanwhile, Nastech Pharmaceuticals last week said that it has also received an SBIR grant from the NIAID to develop its own siRNA-based flu therapy, which was acquired through the purchase of the RNAi assets of Galenea earlier this year (see RNAi News, 2/23/2006).
Nastech did not disclose the size of its grant.
Inex Moves Forward to Spin out Assets into New Firm;
Protiva Files Motion to Block the Move
Inex Pharmaceuticals said last month that it has filed with Canadian regulators and mailed to shareholders materials regarding its upcoming stockholder’s meeting on Sept. 20, at which the company will seek approval to spin out its technology, products, cash, and partnerships into Tekmira Pharmaceuticals.
Included in the spinout is Inex’s partnership with Alnylam Pharmaceuticals for an oligo delivery technology that is at the heart of an ownership dispute with Inex’s one-time subsidiary Protiva Biotherapeutics (see RNAi News¸6/22/2006).
In response to Inex’s efforts to transfer its assets into Tekmira, Protiva last week said it has filed a motion in the Supreme Court of British Columbia seeking, among other things, an order preventing the spinout.
Protiva said it is requesting a hearing on the matter before Inex’s shareholder meeting later this month.
ABI Settles Disputes with Promega
Applied Biosystems said this week that it has settled outstanding legal disputes with Promega.
A company spokeswoman said that the dispute was related to the sale of forensic identification and paternity testing kits.
Exact terms of the settlement were not disclosed.
Thermo, Fisher Shareholders Approve Merger; Regulatory OK Still Sought
Thermo Electron and Fisher Scientific International said last week that their shareholders have approved their merger.
The companies said that the deal remains subject to regulatory approval. Fisher has previously said it would divest an undisclosed product line to satisfy the requirements of the US Federal Trade Commission. The line is worth $17 million, Fisher said.
As originally expected, the $10.6 billion deal is scheduled to close by the end of the fourth quarter. The firms announced the deal in May.