By Doug Macron
Tacere Therapeutics said this week that it has re-acquired the Asian rights to its preclinical expressed RNAi program in hepatitis C from Oncolys BioPharma, with a company official citing the slow pace of the lead drug candidate's development in that market as a key reason behind the move.
“Not a lot of development had been happening [with the drug, TT-034] in Asia, so we felt we'd be better suited to making something happen sooner rather than later,” Tacere Chairman, President, and CFO Mike Catelani told Gene Silencing News.“We reached an agreement [with Oncolys] that Tacere's re-acquisition of the rights is probably the best thing for both parties.”
Specific terms of the re-acquisition arrangement were not disclosed.
Meanwhile, there is some uncertainty about the HCV effort in the rest of the world after Pfizer, which holds the rights to the program in all markets outside of Asia, disclosed that it was shutting down its oligonucleotide therapeutics unit as part of a large-scale restructuring effort (GSN 2/3/2011).
Still, Catelani is optimistic, noting that Tacere's partnership with Pfizer was not overseen by a different group within the company and that the big pharma has not indicated that it plans to stop work on TT-034.
Tacere's HCV program was acquired from Benitec in late 2006. At the time, Benitec was slashing its workforce and research and development efforts under the financial strain of a protracted patent-infringement lawsuit (GSN 10/12/2006). The deal seemed to be a smart one given that Tacere's management includes a number of former Benitec officials who were familiar with the technology.
Less than a year later, Tacere found a partner for the program in Oncolys, which agreed to help develop an earlier version of TT-034 and had the option to handle the drug's Asian commercialization, which it exercised the next year (GSN 3/13/2008).
Meanwhile, Tacere scored an even bigger partnership for the HCV program when Pfizer licensed it in all markets outside of Asia in early 2008 (GSN 1/10/2008).
At the time, Tacere's CEO Sara Hall Renison told Gene Silencing News that the deal, which could be worth more than $145 million to the RNAi shop in upfront fees and milestones, was a validation of the potential of expressed RNAi.
However, it appears that the HCV program was less a priority for Oncolys than for Tacere and Pfizer.
“The program is going well with Pfizer … and the development [work] they've been running” has been positive, Catelani said. But Tacere's management felt that wanted “things moving more rapidly in Asia,” and made the move to end the partnership with Oncolys.
Currently, Tacere is evaluating how best to advance TT-034 in Asia, he said, noting that within that continent there are “a lot of different countries and regulatory jurisdictions that all have somewhat different rules. So we're determining where we ought to go first and what the regulatory pathways are.”
And while Tacere expects to be able to keep things going in Asia with the program for now, “the reality is that … hepatitis C is a big disease, and a small biotech couldn't possibly carry [a drug for the indication] all the way through to commercialization,” Catelani said. As such, “we are … very seriously looking at partnering opportunities.”
As far as the rest of the world is concerned, TT-034 is still being handled by Pfizer.
According to Catelani, the two companies had been working closely on the drug until the end of last year when “our heavy involvement … ended.
“The collaborative aspect is pretty much over,” he said. “We are no longer doing day-to-day work on the compound — it's Pfizer's drug at this point … [although] we provide support as needed.” And while that had always been the plan pursuant to the companies' licensing agreement, Pfizer's recent announcement that it was closing its in-house oligo drugs operations has raised questions about TT-034 future.
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Because the Pfizer news is so recent, Catelani said, it is unclear what the company plans to do with the drug.
Importantly, the HCV program was not a part of the soon-to-be closed oligo group, but rather overseen by Pfizer's anti-infectives group in Sandwich, UK, he said. However, as part of its restructuring, Pfizer said that it was shuttering its Sandwich site.
“The oligo group being shut down has, as far as we can tell, little to no effect on us whatsoever,” Catelani said. “However, Sandwich is being closed down and that does have an impact on us. … We've been communicating with the team members in Sandwich and we're all trying to figure out what happens with the program. At this point, nobody knows for sure.”
Should Pfizer ultimately decided there is no place for TT-034 in its restructured pipeline, Tacere fully intends to seek to regain the drug's rights, although it would rather not have to do so.
“We very much believe this is a valuable compound that we feel should work,” Catelani said. “We would absolutely take the program back if we had the opportunity. At the same time, we're a small biotech and resources are always somewhat limited. Obviously, we'd like to have somebody like a Pfizer who can put the resources necessary behind it to do all the clinical work in the future.”
Should the Pfizer arrangement remain in place, Tacere will be free to pursue a nascent ocular disease program that it has been considering since handing off TT-034 to Pfizer.
“We've been spending time trying to get our ducks in a row [and figure out] exactly how we'd like to design a drug for the ocular disease we're looking at,” Catelani said. “We haven't started any significant work at this point, but we have some pretty good ideas as to what we'd like to do.”
He declined to comment on the indication under review, but confirmed that Tacere will maintain its focus on its core expressed RNAi approach. The company also plans to stay independent for the time being after flirting with the idea of seeking an acquirer about a year ago (GSN 2/11/2010).
“We came to the conclusion that [although] we were in a pretty decent position, the market is not doing well,” Catelani said. “So we felt we weren't going to get the value that we ought to get, and decided … that we're not at a point right now where we're actively looking to do any kind of corporate transactions.”
Still, “if somebody comes knocking on our door, we'll listen to what they have to say,” he added. A deal is “not something we won't do, its just not something we're looking for at this point.”
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