The Festival of Lights officially began Wednesday night, and the halls of malls across the country have been swathed in equal parts blue and white and green and red for weeks in an effort to sway consumers to what used to be our national past time. But Adam Sandler aside, there's a pall in the air. The Senate's show down on tax reform. The bleak employment picture. The deepening conflict between North and South Korea. LeBron's return to Cleveland. No wonder President Obama made an unannounced visit to Afghanistan--at least there's some hope he can escape the relentless 24-hour news cycle.
To quote old Will "What freezings have I felt, what dark days seen. What old December's bareness everywhere."
In biopharma land, many are also channeling Richard III--or maybe Ethan Allan Hawley. It's hardly surprising. Words describing the IPO probably shouldn't be printed here (we are a family publication after all), and restructurings continue apace as firms accept it may be better to do less with less. The latest high flier to reach this conclusion: Exelixis, which used its annual R&D to announce a massive restructuring and a doubling down on its small molecule cancer med, XL-184.
If any company is eager to see the backside of 2010, it's got to be Exelixis. There's no denying it's been a turbulent year for the biotech, which saw the abrupt departure of long-time CEO George Scangos and the end to a key development agreement with long-time partner Bristol-Myers Squibb for XL184.
The good news: XL184, in Phase III trials after having reported "unprecedented results" at a recent cancer meeting, is now wholly owned by Exelixis. The bad news, of course, is that the drug is wholly owned by Exelixis, meaning it is picking up full development costs for the program.
Given the need to shoulder those expenses--especially in settings like prostate cancer, where the drug will go up against Amgen's newly approved Xgeva, Exelixis's decision to downsize and halt internal development of all non-partnered programs is imminently sensible. But that's likely cold comfort for the 40% of staff being laid off starting this month. Indeed, come some time in 2011, headcount at the firm will fall to around 240 from 670 the year before--and future cuts could trim employee numbers even further to just 140 personnel.
It's another reminder that as much as we like to talk about broad portfolios and multiple shots on goal, many biotechs--even very well capitalized ones like Exelixis (or Biogen for that matter)-- are ultimately forced to double-down on their best shot at commercial success. Yep, the more things change... (Kind of like the continuing Genzyme/Sanofi saga.)
In December's darkened days, are you tempted to snuggle into your pjs--and eat hot soup? Reading once, reading twice, reading
chicken soup with rice...
GE Healthcare/Janssen: GE and specialist drug developer Janssen are joining forces to develop a biomarker signature for detecting Alzheimer’s disease prior to the onset of clinical symptoms. The research collaboration will draw upon the resources of GE’s Medical Diagnostics division, which has an amyloid PET imaging agent, Flutemetamol, in Phase III, and Janssen’s neurology-related clinical, biomarker, and informatics expertise. At first blush, the arrangement may not seem remarkable for DOTW, but it is indicative of GE’s gravitation towards IVD businesses. (Remember, in early 2007, GE bid for Abbott’s immunoassay, clinical chemistry, hematology, and point-of-care businesses, but the deal fell apart.) For the most part, both before and after the Abbott near-miss, GE has focused on the development of new imaging agents, owing to its acquisition of Amersham--and that firm's contrast agent and medical isotopes business--in late 2003. While this isn't a division that historically has made acquisitions, recent signs suggest change could be afoot. In October 2010, GE paid just over a half-billion dollars for molecular oncology testing services provider Clarient (4), its first major external investment for molecular diagnostic content. “We are clearly seeing personalized medicine gaining in importance, and GE Healthcare is in a great position, with the diagnostics solutions we have in vivo,” says current president and CEO of Medical Diagnostics, Pascale Witz. Clarient “can be an engine to develop new tests that could come from a different horizon, from GE Healthcare, or other research institutions or companies,” she adds. The arrangement with Janssen aligns with that goal. – Mark Ratner
Axcan/Eurand: The board of Belgium-based specialty pharma company Eurand and its majority shareholder have approved the sale of the company to Axcan Holdings for $583 million in cash, the companies announced on Dec. 1. At $12 a share, the offer is a 9% premium to Eurand's closing share price as of Nov. 30 and gives Eurand a market cap of roughly $574 million. That figure seems low compared to analysts' estimates of Eurand's value, but the deal appears likely to succeed since key shareholders Warburg Pincus, (which owns roughly 55% of the company's equity) and Eurand Chairman and CEO Gearoid Faherty (who owns another 3.7%) have already agreed to the terms. Eurand belongs to a cadre of small to mid-cap European specialty pharma companies that have struggled to transform their business models in the face of increased competition for assets and a difficult pricing environment. Eurand has adapted better than some of its peers, capitalizing on the success of its lead product, Zenpep (delayed release pancrelipase), which is an improved form of an enzyme replacement therapy for treatment of exocrine pancreatic insufficiency, or EPI. Axcan, a Canadian firm taken private by TPG Capital in 2007, competes in this so-called PEP market, but has been stymied by new regulatory requirements and two complete response letters for its version, called Ultrase (also known as Viokase). That's important because Axcan has become increasingly dependent on Ultrase/Viokase sales, with the drugs contributing 19% of Axcan's total revenues for the fiscal year ending September 2009.--Wendy Diller
GlaxoSmithKline/Theravance: GlaxoSmithKline hitched its wagon even tighter to long-time partner Theravance this week, increasing its stake in the company to 19% via a $129.4 million investment. The move isn't terribly surprising, coming after the companies announced positive Phase II data on their partnered asset Relovair in September. The once-daily, long-acting beta2 agonist/corticosteroid combination is in Phase III development to replace GSK's blockbuster Advair and the increased investment suggests GSK is confident in the companies' respiratory collaboration. GSK and Theravance have been allies in the respiratory space since 2002 thanks to an early-stage LABA deal. In 2004, that arrangement morphed into a broader strategic alliance in which GSK paid $129 million upfront and increased its stake in Theravance from 6% to 19% in exchange for an exclusive option to license new medicines from all of the company's development programs through 2007. Theravance took advantage of the IPO window that same year and over time, through public offerings, GSK's stake was reduced to around 12.8% of Theravance's capital stock. With the latest private placement, GSK will purchase 5.75 million shares of Theravance common stock at $22.50 per share. For Theravance, the deal extends the biopharma's cash runway and could see the company beyond the Phase III Relovair data release, expected in mid- to late-2011. CEO Rick Winningham told sister publication "The Pink Sheet" DAILY the investment should give Theravance enough cash to run the company out two years beyond the Phase III data release.--Jessica Merrill
Merck/SmartCells: In the wake of Phenomix's flame-out, VCs are understandably gun shy about investing in diabetes players. And yet this is clearly an area of interest to big pharma acquirers, who see the explosion in obesity and Type 2 diabetes as one way to fatten the bottom line. The latest proof that big pharma is on the prowl for diabetes assets? Merck's take-out Dec. 2 of privately-held SmartCells for an undisclosed upfront plus development and regulatory milestones that could drive the deal price above $500 million. (What? At this point in the year, an earn-out heavy deal can't still be surprising?) The acquisition gives Merck access to a preclinical insulin technology called SmartInsulin, a once-daily insulin injection for the treatment of type 1 and type 2 diabetes that is meant to automatically adjust to fluctuating levels of blood glucose. In doing so, the medicine presumably overcomes some of the stigmas associated with insulin therapy--the potential risks of either hyper- or hypoglycemia and the frequent daily monitoring required to maintain appropriate blood glucose levels. In its seven-year lifespan, SmartCells (read this Start-Up profile for more) has raised less than $20 million, relying heavily on grants from the Juvenile Diabetes Research Association, National Institutes of Health, and angels. (Hint: without traditional VCs in the picture, the company's founders seem likely to make a pretty penny even if the upfront is in the tens of millions.) The acquisition moves Merck into a new area of research since it doesn't currently offer insulin therapy. While some have speculated Merck is interested in building smart insulin for the Type 1 market, Merck's interest is likely in solidifying its stance in the all important (and much bigger) Type 2 population. This is an arena where Merck already has significant share of voice thanks to its juggernaut DPP IV inhibitor Januvia, and SmartCells' insulin seems uniquely positioned to take on long acting insulins like Sanofi's Lantus or Novo's late stage Degludec. Being preclinical, the company will have to show the compound has the commercial chops to survive the rise of long-acting GLP-1s, another reason an earn-out deal was a smart move on the part of the Merckies.--EL
Image courtesy of flickrer marcusjroberts via a creative commons license.