UK biotech Antisoma can breathe a little easier following a deal that will fund operations for at least the next two years, taking the company through key Phase III data points for its two lead oncology compounds.
Antisoma sold rights to its oral version of the oncology drug fludarabine to Sanofi-Aventis in a deal worth up to $65 million. The drug was approved by FDA to treat chronic lymphocytic leukemia in December 2008.
"It was a competitive process, there were many interested parties," says Antisoma's general manager, autoimmune Mike Boss, PhD, who alongside VP business development Nick Adams ran the divestment process. As for the better-than-expected deal terms, Boss notes that there are few newly approved oncology assets up for sale. "Three new oncology drugs were approved by FDA last year, and this is the only asset that was available for purchase," he says.
The British firm acquired the drug when it bought Xanthus, a smaller, Cambridge-Mass.-based oncology outfit in an all-stock deal valued at $52.2 million in May 2008 (1"The Pink Sheet" DAILY, May 16, 2008). Xanthus had previously acquired rights to the drug in October 2006 from Schering AG, prior to that firm's acquisition by Bayer.
Antisoma had little interest in marketing the compound following its FDA approval. "At this point in Antisoma's development we don't have a commercial operation," explains Boss. "And in comparison to the two Phase III assets we are developing, ASA404 and AS1413, oral fludarabine is relatively small. It would have meant setting everything up from scratch and learning the ropes on this drug." It also would have been been expensive, at least at first. Instead Antisoma can now see 404 and 1413 through key data points, well into 2011. "In this economic environment we're in a very good position," says Boss.
Antisoma's '404, a first-in-class tumor-vascular disrupting agent in Phase III for non-small cell lung cancer, is partnered with Novartis and the Big Pharma picks up the development tab going forward; Antisoma has kept a co-promote option in the US. (2The IN VIVO Blog, April 2007). The biotech's '1413 (amonafide malate, formerly known as Xanafide and also acquired via the Xanthus deal alongside fludarabine) is a DNA intercalator in Phase III trials in secondary AML. Antisoma plans to retain US rights to that compound and partner in other territories.
Better than expected deal terms
Sanofi has paid $60 million to Antisoma, and the biotech will receive an additional $5 million should oral fludarabine remain free of generic competition for the next five years in the US, where it has orphan drug status (and therefore seven years of market exclusivity). Antisoma will receive no royalty--it was a straight divestiture geared toward maximizing the upfront payment to Antisoma, says Boss--but Sanofi will owe a royalty to Bayer.
Bayer's recent deal with Genzyme gave the latter company rights to three oncology assets, including the intravenous, already-generic, version of fludarabine, Fludara (3"The Pink Sheet" DAILY, April 3, 2009). That deal led some analysts to predict Genzyme was the front runner in the oral fludarabine sweepstakes. After all, the big biotech had demonstrated its willingness to spend on haematology assets with the Bayer deal and oral fludarabine would have fit nicely with those products: particularly in a market where IV-to-oral switching could occur.
Given the much-better-than-expected deal terms--analysts had been predicting a sale at roughly £20 million, about half the price tag--it isn't unreasonable to assume Genzyme and others had a hand in driving up the price, though Boss would not comment on other bidders for the drug.
Room to breathe
As a consequence of the deal Antisoma gains an increasingly rare commodity, particularly among European biotechs: time.
The Sanofi cash will allow Antisoma to see '404 and '1413 through to important Phase III data points and puts the biotech in a much stronger position for partnering '1413.
It cannot be said that Sanofi isn't doing its part to help Britain's struggling biotech sector. Only two weeks ago the French pharma was instrumental in extending the lifespan of another UK firm, Oxford Biomedica.
On April 29, Sanofi handed back rights to Oxford's TroVax cancer vaccine (along with an £11 million payment for incurred expenses) and struck an ophthalmology deal with the biotech that included a further £18 million up-front (4"The Pink Sheet" DAILY, April 29, 2009). Those payments give Oxford BioMedica enough cash to last until 2012, at its expected burn rate.
-Christopher Morrison (c.morrison@elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY –May 12, 2009
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