Amgen Cashes out of Japan; Follows Bristol's Risk Sharing Example

It’s a sign of the times when Amgen starts licensing its drugs to mid-sized Japanese pharma.

Sure, we knew that troubled Amgen, hit by declining sales of EPO drugs and growing competition--including from forthcoming biogenerics--was looking for ways to cut costs. It had already last year declared workforce culls and its intention to partner certain R&D assets.

But this double-deal with Takeda, announced this morning, is still worth a second look. In Part I, Takeda gets Japanese rights to 12 of Amgen’s pipeline assets in exchange for $200 million up front, up to $340 million in development costs—not just for Japanese, but for worldwide development—plus up to $362 million in sales-linked milestones, and royalties. The Japanese firm will also buy Amgen’s Japanese subsidiary for an undisclosed sum.

That regional deal’s interesting enough: Amgen, while touting its wider international expansion outside of the US, is exiting Japan. It wouldn't be the first; other companies have acknowledged that this tough market is best tackled by locals, who’ll pay dearly for access to assets. Amgen's move is also about cutting infrastructure—a trend, and need, that we’ve talked about in the context of Big Pharma’s unwieldy bureaucratic machines (and Amgen, too, is increasingly compared to Big Pharma, as we noted in this IN VIVO feature.)

Part II is the most telling bit of this deal, though. For another $100 million upfront and $175 million in additional success-based milestones, Takeda takes on worldwide rights to Phase III motesanib, a small molecule angiogenesis inhibitor for cancer. It'll pay double-digit royalties on Japan sales, but will also cover 60% of ongoing development expenses outside of Japan, and share profits on a 50-50 basis.

This, in case you hadn't noticed, is Amgen doing risk- and cost-sharing, big time—like Bristol Myers Squibb did via monster deals in early 2007 with AstraZeneca and with Pfizer. Amgen's not only got itself a partner in a market that's now clearly non-core, but has also secured a good chunk of its ex-Japan costs, too, on all 13 molecules.

Amgen didn’t used to do out-licensing, at least, not until a lonely deal with InteKrin last January. Now it knows it has to: it needs the cash to help cushion some of the EPO blow (which may yet get worse following the next ODAC meeting in March) and, with commitments to cut 14% of staff, it doesn’t have the development muscle to deal with its entire pipeline in-house.

Not that motesanib is the crown jewel; far from it. It'll hardly be the first tyrosine kinase inhibitor to market, after all--hence Bear Stearns analyst Mark Schoenebaum's comment that the motesanib terms are particularly good for Amgen, since "we believe that the molecule's future is bleak."

Osteoporosis candidate denosumab is the company’s big hope—some say its only life-line—and Japanese rights to that went to Daiichi Sankyo last year, for what may now appear a rather paltry $20 million up front and $150 million contribution towards global development costs.

But Takeda’s nevertheless doing ok here. Twelve of the 13 Amgen assets are large molecules, granting the Japanese company its own foothold in biologics door, following similar moves by compatriots Astellas and Eisai Co. (along with most Western Big Pharma). Many of those were acquisition-driven, though (read more about the various strategies here).

By effectively signing a regional Japanese deal, Takeda gets to cut its teeth in biologics development alongside experts—albeit paying a price for that privilege—and will likely enjoy the comfort of ex-Japan approvals for some of the compounds before taking on the task itself at home.

And worldwide rights to motesanib—a small molecule—ticks another of the boxes on Takeda’s wish-list: international expansion. All Japanese firms (at least, all the larger ones) are desperate to expand outside their domestic market because of sluggish growth and harsh price cuts. That’s in large part what drove Eisai’s $3.3 billion cash acquisition of US spec pharma MGI Pharma in December 2007—a headline-grabbing transaction that Takeda will have badly wanted to answer to, if not, this time at least, out-do. (Read more about Eisai/MGI here.)

Photo "Pharma Spam Tower" by Flickr user shimown used under a Creative Commons license

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While You Were Snowed Under

Better to be snowed under by actual snow than pretty much anything else, we suppose. Here are a few other flakes that accumulated over the weekend ...

• Not everyone is happy with Shire's managment manouevrings. The Financial Times points out that the Association of British Insurers suggests its members, which the hold roughly one fifth of the equity, might press for a more detailed explanation of Matt Emmens' move from CEO to chairman.


• Highlights from the San Antonio Breast Cancer Symposium: GSK presented Phase II results suggesting Tykerb may be beneficial as part of combination therapy in breast cancer that has spread to the brain. Amgen's osteoporosis drug denosumab increases bone strength in patients receiving hormone therapy for breast cancer, the company reported. Genomic Health said it has confirmed the efficacy of its Oncotype Dx test in predicting breast cancer recurrence. Regenerative medicine company Cytori reported positive preclinical and clinical results from studies of its adipose-derived stem cell platform, in fat graft retention and breaset reconstruction, respectively.


• Intrigue at UCSF medical school. Bloomberg News is reporting that former FDA commish David Kessler says he was fired from the school's top post on Friday for pointing out financial irregularities. One hundred million dollar financial irregularities Hat Tip: Pharmalot.


• Hello, Santa!

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"FDA Doesn't Have to Follow the Panel's Recommendation, but It Usually Does"

How often have we seen that caveat in news reports about FDA advisory committee meetings? But seldom is it as close as it was yesterday, when Genentech/Roche's Avastin fell 5-4 before the agency's oncologic drugs advisory committee, which was considering the blockbuster cancer drug as a treatment for recurrent or metastatic breast cancer.

Reuters notes that so far Roche stock has fallen more than 4% on the news on Thursday morning in Europe, while Genentech took a whopping 9% hit on Wednesday.

The WSJ reminds us that docs in the US are already prescribing Avastin in these indications off label, but that the FDA's stamp would allow Genentech to promote in that indication and make it more likely insurers would pick up the tab.

What's more, Genentech based its application on a National Cancer Institute study that acutally shows a significant Avastin benefit in a measurement called "progression-free survival," which nearly doubled to 11.3 months for patients on the drug plus paclitaxel vs. 5.8 months on paclitaxel alone.

There was no meaningful difference in overall survival, however.

So, will FDA look at the panel's slim margin and go ahead and approve the drug on the progression-free survival data? If not, are other drugs out there in the clinic that show little in the way of survival benefit (yet solid surrogate-endpoint data) going to cause heartache for companies and their investors?

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While You Were at AHA

Well, the big prasugrel v clopidogrel showdown went down pretty much how observers expected it would: Lilly's prasugrel has the edge in efficacy--cutting heart attacks by 24% over Bristol/Sanofi's Plavix--but comes with an increased risk of bleeding. The press release is here. The WSJ covers the news here. We'll probably have more on this later.

• In other AHA news, Integrilin: a little jab'll do ya. Probably not great news for Schering-Plough, which, unsurprisingly, did not fund the study that suggested angioplasty patients do just as well with a significantly smaller dose of the drug.


• The New York Times chronicles Pfizer's fight to protect its Lipitor franchise from incursion by generic simvastatin. As the Financial Times pointed out last week, AstraZeneca has its own simvastatin-induced challenges with its blockbuster statin Crestor.


• GSK's gepirone antidepressant received a non-approvable letter from FDA. This is the third time FDA rejected gepirone, previously under development at Akzo Nobel (Organon), so not exactly a shocker.


• A study in Nature published on Sunday describes a new lung cancer target. Mutations in NKX2-1, which controls the activity of alveoli, may be responsible for up to 12% of lung cancers, according to researchers led by Matthew Meyerson of the Dana-Farber Cancer Institute and the Broad Institute. Reuters has the story.


• The Boston Globe looks at MIT professor Lenny Guarente's dormant relationship with Elixir Pharmaceuticals, the about-to-go-public company he founded in 1999, and his potential relationship with Elixir competitor Sirtris Pharmaceuticals.

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Nail in the Coffin for GPC?

Turns out FDA’s ODAC committee had a point when it announced, in July, that it would wait for overall survival (OS) data from GPC Biotech’s prostate cancer drug satraplatin (Orplatna) before considering review. Topline OS data—released today, sooner than expected—was negative. It wasn’t as if the p value just missed, either: it was 0.8. Median survival in the placebo arm was if anything a little longer than that in the treatment arm.

At the time, there were cries of despair: refusing to consider interim data around progression-free survival marked the FDA’s new ultra-conservative stance, noted some analysts, as we reported here. This was the end of accelerated approval.

Now the story looks rather different. This time it’s only about GPC—and whether it has a future. The overall survival data, one analyst predicted to IN VIVO Blog in July, “will decide the fate of the company, not just satraplatin.” Indeed, the ODAC decision to hang approval on a single end-point, rather than consider interim progression-free survival data as well, turned it into a make or break event for the company.

So is this the end of GPC? It’s not clear yet—we’ll find out more on the conference call scheduled today at 12.30 GMT. GPC’s shares lost over 60% first thing this morning, to add to the hammering they took in the summer. As your blogger blogs, analysts are downgrading the stock to sell on questions around long-term viability. Management's credibility, already shaken by the events in July, will probably be in tatters.

Indeed, given strong interim data, the accelerated approval granted by FDA in April 2007 (hah! what use now) and GPC officers’ general confidence, some analysts before today felt that the chances of good overall survival data were reasonable. For them it was a question of re-adjusting their time-lines for approval and questioning whether GPC could afford to maintain its full clinical program for satraplatin.

Today’s release looks more like a nail in the coffin for satraplatin. When GPC withdrew its NDA following the ODAC decision, it didn’t expect overall survival data to be available until 2008; a spokeswoman told us in July that top line data would take six months to collect. Yet sooner than that, GPC is announcing a “re-evaluation of the development plan”, the negative impact on satraplatin’s EU review led by partner Pharmion, and an almost valedictory 'thank you' to those taking part in the blighted trial.

Even if GPC could afford to continue developing the drug in other indications, would it (or a potential acquiror) want to? The drug's patent life is relatively short--to 2015 with extensions, according to one London-based analyst. As for potential acquisition, the shareholder suit filed against GPC in July--accusing the company of using "improper methods" to measure satraplatin's effectiveness--pretty much guards against that.

So to the lessons (yes, always a lesson or two): partner your drug before Phase III (look, after all, at the value of proof-of-concept stage deals!). Hedge your bets. Don’t get too excited about your wonder-drug’s approvability, even if the need is unmet. Diversify--not so much as to lose the plot, but enough to avoid this sort of thing. And, ok, this time FDA looks justified in having asked for overall survival data as proof that the drug does indeed have some beneficial effect. But that still doesn’t mean the agency’s any better disposed towards cancer drugs developed by small biotechs. In fact, the satraplatin saga is only likely to have made FDA warier still of early approval based on interim analyses.

UPDATE: There wasn't a lot of new information on the conference call. GPC CEO Bernd Seizinger, MD, PhD, noted that while there are upwards of 20 subgroups of patients still to be analyzed, he didn't want to raise anyone's hopes that a subgroup analysis could trump today's bad news in any way. He also flagged up GPC's November 8th third quarter results as a time when the company would be more prepared to discuss its strategies with regards to sataplatin as well as its corporate future.

GPC still considers satraplatin an asset of value--a "Phase II asset," Seizinger said. Finally, he noted, this is "certainly not the end of GPC biotech. We have a strong cash position and an excellent team , and we still have important assets in the company." The market may be disagreeing. The stock is down about 62%, valuing the company dangerously close to its cash position, which was €93.1 million ($134 million) as of the end of June 2007.

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Take the Money…or Let it Roll?

In his talk introducing the top-10 most licensable oncology drugs at the Therapeutic Alliances conference last Friday, Ben Bonifant of Campbell Alliance asked an intriguing question. If you’ve got an oncology product in Phase I, should you license it out – or spend the extra money to get phase II data?

Well, it depends (good consultant that he is, Bonifant qualifies all over the place). But basically the analysis, based on data Campbell consultants analyzed from Windhover’s Strategic Transactions Database, ain’t all that complicated. If you’re confident that you’ll get even reasonably good Phase II results, and can sign a middle-of-the road deal, wait to do the deal till you’ve got the data.

Here’s the argument. Take a multi-indication Phase I oncology product. You could sell rights to your candidate today, netting an NPV, Bonifant posits, of about $50 million. Or you could invest an additional $30 million or so in order to get Phase II data.

The decision depends on your answers to two additional questions. First, what’s the chance you’ll get positive Phase II data? Second, will that positive data generate a high-, medium-, or low-value deal?

If you believe your drug will only get low-value terms from a Phase II deal (even though “low” doesn’t look so bad--$50 million upfront and $130 million in milestones for two indications), you should take the money now. There’s almost no scenario in which you’ll get a better NPV from your deal than what Phase I data will bring.If, on the other hand, you think there’s an at least 50% chance your drug will generate positive Phase II data, and that data will net you an at least medium-case deal (say $65 million upfront and $175 million in milestones for two indications) – invest the money in a Phase II trial.

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While You Were Coming Back

It would be wrong for us not to mention the Red Sox in this space, the Boston nine having completed their three-game comback victory over the Tribe last night (sorry, Steve). There are a few contributors to this page that despite seeming to be upstanding citizens in most other respects actually cheer for the Sox. Probably some of you dear readers too. So there you have it. Congratulations.

So what did you miss while your favorite baseball/football/rugby/formula one team was golfing/losing ugly/coming up short against South Africa/driving really slowly?

• Cancer rates may be declining in the US, says the American Cancer Society, but as the New York Times reports, rates of certain cancers are increasing. Why?


• The Times laments the loss of Cambridge Antibody Technology, the name anyway, in the wake of AstraZeneca's MedImmune integration.
  
• Kirin Brewery has settled on the terms of its offer for a stake in Japanese drug company Kyowa Hakko Kogyo. Kirin aims to take a nearly 28% stake in KHK in a deal valued at roughly $2.6 billion.
  
• Two days left to guess which big biotech will be the next pharma takeout target. Check out our poll in the upper-left hand corner of the blog.

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$80 million upfront? About Average

So Synta’s PR firm were pushing today’s deal with GlaxoSmithKline at us as “one of the biggest product deals this year” and indeed “among the largest in the industry”…and it’s true, the $80 million cash up front deal for an anti-cancer compound that’s entering Phase III isn’t at all bad.

But $80 million up front isn’t off the scale, either. In fact, it’s looking about average these days for an asset on the cusp of Phase III—Merck in July paid Ariad $75 million up front for its cancer compound, Novartis put the same on the table for Antisoma’s similar-stage oncology asset in April, and outside of cancer, GSK paid $75 million for XenoPort's Phase III RLS compound in February, Shire that same magic figure for Renovo’s late Phase II wound care treatment in June.

Indeed, $80 million even begins to look measly alongside the $102 million that GSK forked out for Genmab’s Phase III antibody, or the $165 million that Johnson & Johnson coughed up for ex-US rights only to Vertex’s then-Phase IIa Hepatitis C gem.

Ok, so these were outliers. Genmab’s contained the antibody premium; Vertex’s was special, too. But the point is, three-digit up front payments for late-stage assets will soon be common, so don’t waste the hyperbole.

And don’t forget to look behind the curtain, either. Milestones: “Up to $1.01 billion in potential payments," our PR friends say. We all know this trick, though. That’s the if-everything-goes-to-plan-across-all-indications-and-the-moon-goes-blue (or biodollar) figure. Think $135 million in pre-approval milestones.

This, according to Synta’s CEO Safi Bahcall, is more than enough to cover the costs of the compound’s Phase III trials and US submission, which Synta stays in charge of.

And that—control—is the bit that’s interesting in this deal; more interesting than the amount of cash that’s changing hands (most of which GSK can capitalize, incidentally--so it doesn't immediately hit the P&L and thus crimp any R&D budgets). Synta will pay for and finish Phase III, and take the compound past the US regulators for metastatic melanoma. That allows the biotech to boast about the “confidence GSK has in our ability to conduct a pivotal trial and register the drug,” as Bahcall explained. But it also allows GSK to hedge risk and be absolutely sure the compound gets past regulators in the first indication before committing any of the $300 million of potential commercial milestones, or much of the $450 million in potential development and regulatory milestones in other cancers.

Still, Bahcall’s right in saying that “it’s unusual, given GSK’s experience, that they allow us to take the lead” in development and regulatory. Typically Big Pharma would want to take the reins, re-do the Phase III trial design and start talking to regulators. (Especially, you might think, given recent biotech casualties at FDA like the one that hit GPC Biotech when it tried to get satraplatin past.) Not this time—no doubt the compound’s fairly straightforward clinical trial design, with an objective end-point of progression-free survival, helped.

And if Synta gets the drug past regulators, it gains credibility in the next stage of the relationship: co-commercialization. That feature’s about average, too, for deals these days—many biotechs want to have their own sales forces, despite all the future problems and complexities and costs those forces bring.

In reality, pharma-biotech co-promotes are usually a nightmare, as we discussed in this IN VIVO feature. But Bahcall’s confident that the partners have learnt from what’s gone before, with specific prescriptions and conditions for how the co-promote would work, plus measures to ensure that Synta doesn’t lose out on the tiered profit share, thought to start at 40% and rise to 50%, based on annual net sales. (Profit shares can bite small partners if pharma ramp up their cost of sales to reduce what’s left to distribute.)

There are also provisions in the deal, according to Bahcall, allowing for Synta to assume more responsibility for commercialization in the future—once the drug has been out there for a couple of years, for instance (IN VIVO Blog speculation, not his comment). In other indications, the partners will share development in and outside US, with Synta eligible for double-digit royalties on ex-US sales.

Don't get us wrong: for all our talk of 'average', Synta’s got a good deal, all the more so given it’s the company’s first. Shareholders started celebrating earlier this week on deal speculation. They needed a party; Synta’s shares have done very little since its February IPO.

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Even Cancer Ain't Exempt

No drug is exempt from FDA’s ultra-conservative stand, it seems, even those, like GPC Biotech’s satraplatin (Orplatna), that allegedly improve survival among cancer patients with few if any treatment alternatives.

An oncology advisory committee (ODAC) yesterday recommended that FDA delay considering prostate cancer candidate satraplatin for approval until overall survival data from the company’s 950-patient SPARC study is available. This recommendation came despite interim analysis strongly supporting the efficacy and safety of satraplatin, which was granted priority FDA review in April 2007.

Still, it wasn’t a complete surprise, at least since the rather negative FDA briefing documents released last week. These raised five “issues” including questions over the company’s assessment of pain progression, and, more importantly, over the definition and composition of one of GPC’s two key primary end-points used in the trial, progression free survival (PFS).

According to GPC’s “greatly disappointed” CEO Bernd Seizinger, GPC had communicated intensively with FDA throughout the application process and amended various aspects of the trials in accordance with FDA suggestions—including suggestions on what pain score to use. In sum, they’d done everything possible to make this work. (Listen for yourselves here.)

But FDA wasn’t having it. According to one analyst, “GPC walked into a complete stitch-up—FDA primed the advisory committee that they didn’t want this to happen.” Reading the briefing document, we’re inclined to agree.

Now, sources tell IN VIVO Blog that there’s no love lost between GPC and FDA—the ODAC meeting was “hostile and antagonistic,” according to one observer. Combine this with FDA’s overall caution (the last thing they want is to be hauled in front of the Senate for injudicious approvals) and you have a recipe for delay, if only temporary.

Still, GPC isn’t just an innocent victim here. Let’s go back to that issue of end-points. The briefing documents state that FDA had all along warned GPC that a PFS end-point may be problematic. Yet GPC failed to communicate this concern to the investment community.

That’s why analysts are so pissed—many had buy ratings on the stock, even after the review documents were released last Thursday. GPC shares fell 35% back then, and about the same again today. “Trust has been lost,” says one in London. “When it comes to the investment community, GPC are on their own.” (They can sulk in a corner beside Sanofi Aventis, which hasn't won any prizes for transparency among the investment community either, particularly with regard to Zimulti's rocky ride, on which we've reported extensively, including here.)

It’s a worrying time for the German biotech. All of a sudden, the overall survival data for satraplatin—which is the other primary end-point, alongside PFS--has become a make-or-break issue for the company. If it’s positive, the drug will probably still make it, although not in an accelerated fashion. If it’s not, the drug may not get onto the US market at all—which could prove fatal for GPC.

The rest of the sector has cause for concern, too, though (not to mention androgen-independent prostate cancer patients that have failed first-line therapy). This bleak little episode—besides showing up personal clashes between applicants and the agency, which, it seems, do matter—may mean that regulators’ caution is spreading beyond primary-care drugs like Avandia or the Cox-2s, where the main concern is safety.

Today, it seems, the tough hurdles can come from anywhere--including from non-safety-related issues like how pain is measured. Some might call this nit-picking.

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Genzyme Buys to Build in Oncology, Again

In a move reminiscent of its 2004 acquisitions of ImPath and Ilex Oncology, Genzyme is taking out Bioenvision, its biotech partner on the drug clofarabine, for $345 million in cash. The buyout is the Big Biotech's first move to create a global oncology business--Bioenvision launched the drug in Europe last year, where it is sold as Evoltra--and its first acquisition since its hostile takeover of Anormed last year for $580 million. Evoltra sales over the past nine months in Europe were just over $9 million.

The price represents a 50% premium over the 20-day average price of Bioenvision's shares, and is the latest in a long string of acquisitions of biotech development/marketing partners: see Genentech/Tanox, Lilly/Icos, Shire/New River, Amgen/Abgenix, etc. We expect more of these ally-to-buy scenarios: sometimes having a partner is just too expensive.

Genzyme's share of clofarabine comes via Ilex, which it bought for $1 billion in stock in February 2004 as an early step in building its oncology presence. The drug is marketed as Clolar for pediatric acute lympoblastic leukemia (ALL) since its FDA approval in December that year. The companies are aiming to expand the drug's remit into adult indications such as acute myeloid leukemia (AML).

Genzyme chairman and CEO Henri Termeer noted on a call a few moments ago to discuss the deal with analysts that the companies expect roughly $600 million in peak sales from clofarabine, and stressed the efficiencies of combining Genzyme's and Bioenvision's efforts under one global clofarabine program.

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Antisoma Licenses AS1404: The Sequel

Only occasionally are sequels better than the original. The Godfather Part II. The Empire Strikes Back, of course. Add to those classics UK biotech Antisoma's second go-around with its vascular disrupting agent AS1404, which today it partnered with Novartis in a world-wide deal worth up to $890 million (including $100 million in near-term payments) plus royalties. Novartis will conduct and fund all development in all indications going forward.


Only ten months ago Roche returned rights to 1404 to Antisoma, on the same day Antisoma reported positive Phase II proof of concept results in lung cancer. Since then the biotech has issued a steady stream of positive news surrounding the product and hinted at serious interest from would-be pharmaceutical partners.

The original Roche deal was broad, encompassing Antisoma's entire clinical pipeline, including the Phase III ovarian cancer candidate pemtumomab, and a raft of Phase I compounds including 1404 (then known as DMXAA, and recently acquired by Antisoma from the non-profit Cancer Research Campaign for about $1 million). That deal included cost-sharing provisions for clinical trials of 1404 and other compounds but where Antisoma stood to gain the most was when drugs entered Phase III. Roche, citing commercial considerations, pulled the plug and returned all rights to Antisoma in June 2006.

At the time, noted Antisoma CEO Glyn Edwards today on a call to announce the Novartis deal, there was little clinical data available on 1404. "We were just starting to see survival data in the lung at that time," he says. There is a lot more clinical data available now, and Roche's decision was only partly related to 14o4 itself, says Edwards. The pharma's own portfolio was taken into consideration, and "Roche made the right decision for Roche just as Novartis has made the right decision for Novartis."

Roche it turns out also made the right decision for Antisoma. The Novartis deal is much more lucrative than anything Antisoma would have received from Roche, reflecting both the drug's clinical success to-date and the realities of biotech-pharma partnering today. Novartis will pay $75 million up front and $380 million in developmental milestones spread over four oncology indications and one non-oncology indication; future sales milestones could reach $325 million. Not least Antisoma has retained the right to co-promote the product in the US, a privilege Novartis will partially fund.

"Any Antisoma reps will have the ability to co-detail other Antisoma products" in the future, says Edwards, which "gives us a lower-cost, lower-risk entry into the US oncology market." It also means that in addition to adding early-stage assets via the biotech's business development efforts, Antisoma can also look to bring in mid-stage oncology candidates with an eye toward marketing niche products in the US, he says.

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Move Over Erbitux

Genmab's fully human antibody HuMax-CD20 just took the title for the biggest single-product biopharma collaboration: up to $2.1 billion in biobucks with an impressive $1o2 million in cash and $357 million in equity (at a 50% premium to Genmab's previous 20-day average) up-front. The price tag underscores the rabid demand among pharma companies for new projects and the relative lack of available late-stage compounds.

While new partner GSK suddenly finds itself out a few hundred million bucks, it has landed global rights to one of--if not the--most promising unlicensed projects available. If Genmab had a list of conditions for a potential deal, it's fair to say they probably ticked all the boxes on that list. You can check out the details here.

HuMax-CD20 is being developed in chronic lymphocytic leukemia (B-CLL), follicular non-Hodgkin's lymphoma (NHL), and rheumatoid arthritis (RA). Expect expanded development--Genentech and Biogen Idec's anti-CD20 mab Rituxan, which boasted nearly $2 billion in US sales last year--is thought to be effective in a variety of oncology and autoimmune indications.

In October Genmab CEO Lisa Drakeman, PhD, told analysts that a deal was imminent. "I don't want to overpromise [on the timing]," she said at the company's R&D day in London. "We don't need more data, it's about finding the best possible fit." That same day she also noted that since Genmab had so far invested approximately $100 million in HuMax-CD20, any potential deal's upfront payment should reflect that expense. Job done.

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