MDRNA Gets Tentative OK for Generic Non-RNAi Osteoporosis Drug
MDRNA said this week that the US Food and Drug Administration has tentatively approved the company’s abbreviated new drug application for generic calcitonin-salmon nasal spray for the treatment of osteoporosis.
The drug is a legacy product from Nastech Pharmaceutical, which transformed into MDRNA, a pure-play RNAi drug developer, earlier this year (see RNAi News, 6/12/2008).
The company said that full FDA approval of the ANDA is expected in June.
"Although we are now a company solely focused in the research and development of RNAi-based therapeutics, we are pleased to see the successful culmination of years of hard work on the part of many current and former members of the MDRNA/Nastech team,” MDRNA President and CEO Michael French said in a statement. “We are assessing our short- and long-term options to understand how this tentative approval can be leveraged toward the continued advancement of our RNAi drug-discovery engine."
Senetek Acquires Rights to Second RNAi Drug Candidate
Senetek said this week that it has acquired the exclusive rights to a second RNAi-based cancer drug candidate from the Polish Academy of Sciences.
The company acquired the drug rights in exchange for undisclosed royalties. Additional terms were not disclosed.
The deal comes about two years after Senetek acquired an RNAi-based brain cancer drug from the Polish Academy of Sciences (see RNAi News, 11/20/2006). And while that agent has already been tested in humans, at least one RNAi expert has expressed doubts over the viability of the therapy (see RNAi News, 10/9/2008).
A Senetek official did not return a request for additional comment on the newly licensed drug.
Exiqon Says First miRNA Dx to Launch in January
Exiqon this week announced that it would launch its first microRNA-based diagnostic, a test designed to predict colon cancer recurrence in stage II patients, in January.
The news comes less than one week after RNAi News reported that the company had pushed back the launch date for the diagnostic from late 2008 to early 2009 (see RNAi News, 12/11/2008).
As expected, the test will be commercialized through Exiqon Diagnostics, formerly Oncotech, which Exiqon acquired in the spring (see RNAi News, 4/10/2008).
Abbott Exercises Option to Buy Isis Dx Unit for $215M
Abbott has exercised an option to acquire the remaining 81.4 percent stake of Ibis Biosciences, the molecular diagnostics subsidiary of Isis Pharmaceuticals, that it didn’t already own for $175 million, the companies said this week.
Earlier this year, Abbott acquired an 18.6 percent stake in Ibis in two tranches for $40 million. At that time, it took an exclusive option to acquire the remaining interest in Ibis by June 30, 2009, for $175 million to $195 million, plus an earn-out tied to sales of instruments and assay kits.
Ibis sells the Ibis T5000 Biosensor System, which is used for rapid identification and characterization of infectious agents. According to Ibis, the system interrogates common sequences among common classes or organisms and can identify “virtually all bacteria, viruses and fungi, and can provide information about drug resistance, virulence, and strain type of these pathogens within a few hours.”
Closing of the acquisition is subject to the terms and conditions of a stock purchase agreement signed by the parties and clearance from US antitrust authorities.