Friday, November 14, 2008

DotW: Change We Believe In

President-elect Barack Obama and his wife Michelle visited the White House this week: an event so closely tracked by the press that it was possible to immortalize the license plate numbers of the SUVs in the motorcade. (Could it be that even FOX news believes change is good?)

Meanwhile, the Dow Jones industrial average came roaring back yesterday, jumping 550 points after buyers swarmed back into the Standard & Poor's 500 index, the indicator most watched by traders. (Okay, we confess: descriptives such as "roaring" and "muscular" still seem a misnomer when the wide-scale sell-off earlier in the week wiped out roughly $1 trillion in shareholder value.) Still if Wall Street believes the market has finally priced in enough bad news, that's a change this blogger will accept--if not believe in.

Just don't ask Detroit. Or a number of biotechs, for that matter. Anecdotal evidence continues to amass illustrating just how tough it is for smaller companies in the biopharma industry. (See below.) Stem cell play MicroIslet joined AtheroGenics in filing for Chapter 11 this week (At least it wasn't Chapter 7.)

Pain play Anesiva announced its second, painful restructuring since September, reducing head-count and cutting the company burn-rate after its novel formulation of capsaicin, Adlea, narrowly missed a clinical endpoint. Other companies with restructuring news include Neurogen and Javelin Pharmaceuticals. Meanwhile, Pharmos revealed it's in non-compliance with NASDAQ listing requirements and Targeted Genetics has big changes at the top: after disclosing last week that the company is running out of cash, CEO H. Stewart Parker and CSO Barrie Carter announced their resignations.

Even larger biotechs are not immune. Concerned about the slower growth of its GLP-1 franchise Byetta, Amylin announced cost-cutting moves designed to reduce 2009 expenses, including the termination of 340 San Diego-based employees.

But before the whining commences, perhaps companies should adopt some of the changes put in place at BMS, which yesterday at the Credit Suisse Healthcare conference in Phoenix outlined steps to improve its cash flow by $750 million to $1 billion by 2011. And the measures are far from rocket science. Newly installed CFO Jean-Marc Huet is going back to basics, strengthening the company's cash position by better managing inventory, receivables, and payables.

AstraZeneca, meanwhile, is over the moon about the JUPITER trial results. Could this good news for AZ's Crestor spark the return of a bullish primary care market? That's change Big Pharma would like to believe in.

Here at IN VIVO Blog we know change can be hard. (Just look at the safe sartorial choices President-elect Obama has made in his transition from campaign mode to casual Friday.) And painful, as evidenced by the new look sported by Washington Wizard's point guard Gilbert Arenas.

That's why we're here for you week in and week out...

Affymetrix/Panomics: GeneChipper Affymetrix announced on Tuesday that it had acquired the private assay/consumables company Panomics (née Genospectra) for $73 million in cash. The deal brings Affymetrix a stronger position in “the high-growth validation and routine-testing market segments,” according to the Affy release. The deal unites two Alejandro Zaffaroni-related firms; the prolific investor and namer of biotechs was the founding investor of Genospectra, which acquired Panomics (and kept its name) in February 2006. The 8-year old Genospectra/Panomics has raised at least $56 million from VCs including Frazier Healthcare, Bay City Capital and Novartis BioVentures, among others, and as such this deal isn’t going to count among anyone’s top multiples--Chris Morrison.

Eisai/TorreyPines: Cash-hungry TorreyPines Therapeutics announced Monday that it had sold its Alzheimer’s disease research program to Eisai Co. for $1.5 million. The program—on which the two firms had collaborated since 2002—focuses on the discovery of targets using whole-genome family-based association screening. TorreyPines is sitting on less than a year’s worth of cash--approximately $14.3mm at the end of September compared with a burn rate of $5.4mm in the last quarter--with which to push forward its Phase II migraine project, tezampanel, and the rest of its development pipeline. The company also this week named a new chief executive, Evelyn Graham, the group’s former COO who became acting CEO in September when Neil Kurtz left the biotech to become CEO at the long-term care operator Golden Living. TorreyPines appears to be on its last legs: it has repositioned itself as a development-only firm but the market—which values the company at a mere $4.4 million—isn’t buying the turnaround. Earlier in October TorreyPines jettisoned some other research assets in a deal with Abraxis subsidiary Cenomed and we suspect further disposals can’t be far behind--Chris Morrison.

Daiichi/ArQule: Eisai wasn't the only Japanese pharma acting opportunistically this week. Daiichi-Sankyo signed a deal with ArQule Nov. 10 that gives the biotech important non-dilutive funding as well as validation for its kinase inhibitor discovery platform. In exchange for broad commercialization rights (worldwide excepting Japan, China, Taiwan and South Korea) to ArQule's lead compound, the Phase II oncologic ARQ 197, Daiichi will pay $75 million in up-front funding along with up to $560 million in potential milestones. In case you were wondering, ARQ 197 is a c-Met inhibitor currently in mid-stage clinical trials for the treatment of non-small cell lung cancer and microphthalmia transcription factor-associated tumors such as clear cell sarcoma. In addition, the two companies have established a broader research collaboration to identify novel kinase inhibitors using ArQule's proprietary AKIP platform. As "The Pink Sheet" DAILY reports, ArQule CEO Paulo Pucci called the deal "fundamentally transforming" and said it would make the biotech "a competitor in oncology." (Um, yeah.) There's no doubt, however, that the up-front adds to the biotech's $136.3 million cash cushion and helps off-load some expenses and developmental risk associated with ARQ 197. Some, but not all. Daiichi isn't willing to shoulder all of the clinical costs of the product--ArQule will share in Phase II and Phase III development costs, with ArQule's Phase III costs covered by milestone payments from Daiichi.

Novartis/Xoma: Joining the ranks of Torrey Pines, Targeted Genetics, and Amylin, Xoma also announced belt-tightening moves this weeks, including cashing in on programs partnered with Novartis and redoubling efforts to monetize its bacterial cell expression technology. “We are watching every dollar,” said Steve Engle, CEO of the Berkeley, Calif.-based antibody developer in an interview with "The Pink Sheet" DAILY. As Xoma refocuses its research dollars on XOMA-052, an interleukin-1b inhibitor for Type 2 diabetes, it's had to revise a research collaboration inked in 2004 with Chiron-- before that biotech’s acquisition by Novartis--around therapeutic antibodies for cancer. Initial terms of the deal required the two companies to share research and development costs 70-30, with Chiron (now Novartis) taking on the lion’s share of the expenses, especially related to HCD122, a fully human monoclonal that targets CD40 now in early clinical trials against lymphoma and multiple myeloma. But after a painful reality check, Xoma is relinquishing its 30 percent stake in the product to Novartis in exchange for a $7.5 million payment plus potential milestones of up to $14 million. Compared to other recent licensing agreements in the oncology space, that’s a paltry sum. But Xoma wasn’t in much of a position to bargain since Novartis already owned the majority of the product. To sweeten the deal, Novartis agreed to pay double-digit royalties for two ongoing programs, including HCD122. Also, it will provide Xoma with options to develop or receive royalties on four yet-to-be-selected additional programs.

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