Friday, May 15, 2009

DotW: Meeting of the Minds

It was a slow week on the deal-making front, as industry watchers and biopharma types absorbed the Monday healthcare confab that included all the industry's players except BIO. As we wrote on Tuesday, the event, which was long on soft-focus pr shots and short on details was all about messaging. We remain impressed with Obama's Spock-like abilities to bring the various parties to the table (if, in fact, he actually did.), but admit that we try not to think too hard about the mind-meld with Merck's Dick Clark. (Some of us would rather focus on this.) As we prep for BIO, Amylin's shareholder meeting, ASCO and ADA, here's your weekly round-up of deal-making highlights.

Roche/Tekmira: On Monday Roche became the latest company to turn to Tekmira Pharma’s stable nucleic acid-lipid particle (SNALP, the best acronym we’ve heard in a while) technology for delivery of RNA interference candidates. Tekmira will get up to $18.4 million for pre-IND work and up to $32 million in clinical and commercial milestone payments and royalties spread over two undisclosed drug candidates—Roche’s first two siRNAs to approach human testing. Of all the RNAi delivery technologies out there (and there are a brazillion of them) Tekmira’s has to be counted among the few that the big players are taking quite seriously. Who else is working with the Canadian biotech? Alnylam is using SNALP for its first systemically delivered RNAi candidate, ALN-VSP for liver cancer, which entered Phase I only a few weeks back, and has a 3-year development and manufacturing deal with Tekmira. (Also Roche and Alnylam each hold a 4% stake in the delivery co, dating back to the merger of Tekmira and Protiva in March 2008 that created the company’s current incarnation.) Merck & Co. also has a license to SNALP, under a 2007 deal signed with Protiva. Takeda, BMS and Regulus (the Alnylam/Isis microRNA joint venture) each have access to Tekmira’s technology. All these R&D payments are helping Tekmira to advance its own set of drug candidates. The company says it will file an IND for its lead hypercholesterolemia candidate, ApoB SNALP, in the coming weeks.—Chris Morrison

Sanofi-Aventis/Antisoma: Antisoma sold US rights to its oral version of the oncology drug fludarabine to Sanofi-Aventis in a deal worth up to $65 million: $60 million up-front with another $5mm should the drug not face generic competition—unlikely considering its orphan status. The drug was approved by FDA to treat chronic lymphocytic leukemia in December 2008. The cash will give Antisoma a runway into 2011, and the breathing room necessary to take its two lead Phase III projects through key data-points, and in the case of one, partnership discussions. Antisoma's ASA404, a first-in-class tumor-vascular disrupting agent in Phase III for non-small cell lung cancer, is partnered with Novartis already, and the Big Pharma picks up the development tab going forward; Antisoma has kept a co-promote option in the US. The biotech's AS1413 (amonafide malate, formerly known as Xanafide) 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. Sanofi was not seen as a front-runner for oral fludarabine, which Antisoma has been promising to jettison since before its approval. After Genzyme’s recent oncology pact with Bayer that Big Biotech was largely seen as the perfect home for oral fludarabine. Genzyme gained rights to the now-generic IV version of the drug in the Bayer deal; its interest in hematology products confirmed and the prospect of IV-to-oral switching likely, Genzyme was the obvious destination for the product. "It was a competitive process, there were many interested parties," Antisoma's general manager, autoimmune Mike Boss, PhD, who alongside VP business development Nick Adams ran the divestment process, told us earlier this week. As for the better-than-expected deal terms, Boss points to undisclosed competitors for the deal and also 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. For Antisoma, beyond the cash the deal brings validation of its acquisition of Xanthus for $52 million in stock in May 2008. That deal brought both oral fludarabine and ‘1413 into the company. It has now paid for itself, and then some.—Chris Morrison

Sanofi-Aventis/Kyowa Hakko Kirin: It has been a sunny sort of week for Sanofi-Aventis. Thursday it bought worldwide rights from Kyowa Hakko Kirin to a pre-clinical monoclonal antibody that targets the LIGHT molecule, a novel member of the TNF superfamily thought to be a key mediator of inflammation. Sanofi hopes to create a first-in-class treatment for ulcerative colitis, Crohn’s disease and ultimately perhaps RA as well, providing an alternative to existing anti-TNFs such as Abbott’s Humira and more recent additions including J&J’s Simponi and UCB’s Cimzia. Unlike some of its Big Pharma peers, Sanofi-Aventis hasn’t relied on a single major biotech acquisition to jump-start its large molecule efforts; instead it has layered a series of licensing deals onto its existing insulin franchise and the vaccine capabilities of the Sanofi Pasteur division. Those deals include a long-standing collaboration with ImmunoGen granting Sanofi access to that company’s cancer-focused antibody platform, a $510 million agreement with Regeneron for a VEGF trap, and a cancer antibody alliance with Dyax from last February. It recently pulled out of a deal with Oxford BioMedica for cancer immunotherapy TroVax, paying $16.5 million for the privilege. The only number revealed in this latest deal is the next-to-meaningless $315 million biodollar figure—which includes the upfront (likely minimal) and milestone payments. But don’t despair, because in a release issued the following day, Sanofi announced the launch of sanofi-aventis tv, “a window on our company”. (Our question: will it become The Desperate Housewives of the pharma world?) We can look forward, then, to a new era of transparency at Sanofi-Aventis, which, to put it politely, wasn’t exactly renowned for its openness during the pre-Viehbacher era.--Melanie Senior

Celgene/GlobeImmune: When GlobeImmune Inc. was founded in the late 1990s, its premise certainly raised eyebrows: stemming from research coming from the University of Colorado, GlobeImmune has developed a genetically modified version of the yeast Sacchromyces cerevisiae (mmm, beer) designed to trigger an immune response specifically directed at a desired target, such as a virally infected cell or a cancer cell. So far the Colorado biotech has raised more than $90 million to advance its targeted molecular immunogen platform Tarmogens—for the treatment of cancer and infectious disease. But while the approach has garnered GlobeImmune investor attention, further enthusiasm—at least in terms of a validating partnership deal—was slow to materialize. "The response [was] 'Show me the data,'" GlobeImmune's President and CEO Timothy Rodell, told START-UP last fall. Validation--to the tune of $40 million up-front and potential biobiocks in the half billion range--came Friday when Celgene announced a world-wide strategic collaboration with the biotech in the cancer immunotherapy space. The deal calls for Celgene to make an equity investment in the biotech, but specific financial details of the ratio of cash to equity weren't broken out in the press release. For the money, Celgene is getting an exclusive option to all of GlobeImmune's oncology programs, including GI-4000, a Tarmogen in Phase II pancreatic cancer. GlobeImmune will continue early development work on GI-4000 and the other drugs, taking them to certain pre-defined endpoints, at which point Celgene can choose to exercise its option--or not. Immunotherapy treatments in oncology--as in the hepatitis C space--remain controversial, Dendreon's apparently stunning Provenge data not withstanding. The novelty of the science likely had an impact on the overall deal price. We could quibble about whether this deal is the knock your socks off kind of partnership that will bring other pharmas to the table to talk deals around GlobeImmune's unpartnered Hepatitis C program. As one of GlobeImmune's backers, Celgene has certainly been an early believer in the technology and is a logical partner--and now, potentially, the most likely acquirer. Still, $40 million in this economy is still $40 million, and we are sure that GlobeImmune's investors, which in addition to Celgene include Wexford Capital, Biogen Idec, and HealthCare Ventures, are glad they aren't being asked to put in additional money.--Ellen Licking

(Image courtesy of flickr user oceandesetoiles used with permission through a creative commons license.)

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