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Friday, 6 July 2007

Moody's Blues

Posted on 12:15 by Unknown
European pharmaceutical companies may soon find themselves in a bind at the bank.

The credit ratings company Moody's Investors Services said yesterday that high credit ratings for these companies could soon be a thing of the past, as companies like AstraZeneca and Shire use debt to finance their acquisitions of expensive biotech companies.

What's the catalyst for the Moody's report? Nothing specific as far as we can tell, aside from the acquisitions mentioned above and others, such as Merck KGAA's takeout of Serono last year. Moody's has simply woken up to the facts that a) pharmaceutical companies aren't very good at keeping their pipelines full all by themselves and b) those companies they turn to--the biotechs--have all the leverage in deal negotiations, resulting in top-dollar takeout and alliance prices. Many future deals could, like AZ's Medimmune buy, be financed with debt; that said debt will become more expensive is bad news.

For an industry with generally pristine credit ratings this "moderately negative" outlook isn't going to rock the boat too much. But at the same time as Big Pharma increasingly borrow to buy back their own shares and bulk up pipelines, it's another sign that things aren't what they used to be for several of the industry's blue chips. If borrowing becomes much more expensive and patent expirations tweak cash flow, the decline could accelerate.
Hat tip: Reuters, via Pharmagossip
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Posted in debt financing, financing, mergers and acquisitions | No comments

AZ, Silence team up in RNAi

Posted on 07:28 by Unknown

AstraZeneca is joining the RNA interference crowd via a deal announced earlier today with Silence Therapeutics (formerly SR Pharma/Atugen). AZ will pay the biotech an upfront fee of ₤7.5 million, two thirds of which is an equity investment in Silence at 146p/share, a 10% premium to the company's recent share price. The companies will focus on respiratory diseases, discovering and developing proprietary siRNA molecules against up to five targets over three years.

The alliance is certainly small potatoes in comparison with the Big Pharma's embrace of other large molecule technologies (see MedImmune etc.), but not wholly out of synch with the vast majority of deals in the RNAi space. Until the conspicuously high-value takeout of Sirna Therapeutics by Merck & Co. last year, just about every siRNA agreement was back-end loaded. With up to $400 million in fees and milestones this one is no different. A more apt comparison would be GSK's April 2006 deal with Sirna in the respiratory area, which netted the biotech only $12 million up-front (half in exchange for equity).

For Silence the AZ backing provides not a small degree of validation in a space that's quickly becoming crowded with variations on a technological theme and a multitude of IP skirmishes. Moreover respiratory disease is not Silence's singular focus--IN VIVO Blog is anticipating a bigger deal in the oncology area. Our most recent coverage of the RNA interference space is here.
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Posted in alliances, AstraZeneca, RNAi | No comments

Thursday, 5 July 2007

Phase II is the new Phase III

Posted on 10:40 by Unknown
It's what you might call a slow news day for us so we figured we would dip back into our colleague Roger Longman's presentation from our Euro-Biotech conference last week. Roger's on vacation, see, so he can't stop us from pilfering his slides.

One of the points he emphasized during his talk and illustrated with some data from our Strategic Transactions Database is the idea that products that have cleared clincal proof-of-concept, i.e. the Phase II hurdle, are attacting the kind of deal dollars only seen previously for Phase III-stage products. The value of relatively scarce Phase III products these days is another thing altogether.

Taking a look at this phenomenon using upfront payments as a proxy for deal value, above, and you can see what we mean. So while those biotechs that excel at drug discovery can in fact sustain themselves by selling IND-stage candidates, which we pointed out last week, others can play on the next valuation inflection point at proof-of-concept.

Are Phase II deals a remotely new feature of the biopharma dealmaking landscape? Of course not. But the volume of deals for Phase II products has shot up in the past few years, and upfront payments are simply booming. A few recent examples include Novartis and Antisoma's deal around the oncology product AS1404 ($75mm up front), Bayer and Regeneron's deal on ex-US rights to Regeneron's VEGF-trap product in ophthalmology ($75mm u/f), and going back to last summer, Johnson & Johnson's ex-North America, ex-Japan deal for Vertex's hepatitis C protease inhibitor ($165mm u/f). Follow the links to a more detailed analysis of each deal.

Various pharma execs have chalked the rise in Phase II prices up to their own companies' inability to reliably and predicably get products through proof-of-concept themselves. This is excellent news for clinical-stage biotechs. A few, like CNS-focused Synosia, have set themselves up as proof-of-concept specialists, in-licensing compounds in preclinical or IND or even Phase I, shepherding them through a human efficacy trial, and licensing them on for a significant profit.

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Posted in alliances, clinical development, Euro-Biotech Forum, Roger Longman | No comments

Tuesday, 3 July 2007

Dalton Joins Pfizer

Posted on 07:45 by Unknown
The make over of the corporate VC world continues.

IN VIVO Blog has recently learned that Pfizer Inc. brought aboard Barbara Dalton, formerly of SR One and EuclidSR, to lead its Pfizer Strategic Investment Group. In hiring Dalton, Pfizer is sticking with the decision to be represented by professionals with experience on the front lines of venture capital investing rather than shuffling people out from the corporate side of the business.

Dalton joins Debra Yu, formerly of Delphi Ventures and Bay City Capital, who helped start the group three years ago. She replaces Ilya Oshman. She’ll report directly to Ed Harrigan, senior vice president of worldwide licensing and business development. “We are certainly pleased to have Barbara join us – she brings a great deal of experience, is very well-respected in the field, and will surely put her stamp on Pfizer’s venture investment group,” Harrigan told IN VIVO Blog in an email.

Pfizer is taking a unique approach with this venture effort. First, as we stated earlier, it’s bringing in outside people with venture investing experience and, more important, connections. To be sure, any VC or chief executive will return a phone call from Pfizer. But the program clearly benefits from having familiar faces represent in the field at conferences and other venture gathering places.

Second, from the very first day the venture group steered clear of Pfizer’s internal research and development wheelhouse—pharmaceuticals—as well as some external efforts (remember the Pfincubator and our other posts?). Instead, the group sought to invest in companies that might influence how pharmaceuticals are used, marketed or paid for.

The group has built a significant portfolio in diagnostics and, no doubt as part of this effort, the corporate side of the house has stood up and taken notice, becoming an aggressive and progressive player in diagnostics. “She brings the needed talent and personality to the job that is important as our venture activity evolves to its new place in the organization," Yu told us in an email.

Prior to moving over to EuclidSR in 2003, Dalton had been president of SR One, one of the grand daddies of corporate venture programs in the pharmaceutical world, for two years. Founded by Peter Sears in 1985, SR One first invested on behalf of Smithkline Beckman. It has survived all these years as its corporate sponsor went through mergers.

Dalton became president in 2001 when Brenda Gavin, who took over for Sears in 1999, moved on to co-found Quaker BioVentures in 2001.

Dalton left SR One in 2003 with two other principals to become full-time investors at EuclidSR, a New York venture capital firm. This group grew out of a partnership between Euclid Partners, a venture capital firm, and SR One. The firm that sought to invest in companies that benefited from the “convergence” of health care and information technology.

EuclidSR raised at least one fund in 2000, the first year of the partnership. Dalton and other SR One principals invested on behalf of both GSK and EuclidSR until their departure in 2003. It’s unclear what Dalton’s departure means for EuclidSR. She couldn’t be reached for comment.
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Posted in corporate venture capital, Pfizer | No comments

Monday, 2 July 2007

Thank Goodness for Vaccines

Posted on 10:00 by Unknown
Novartis’ CEO and chairman Dan Vasella is probably feeling quite pleased that he bought his $5.1 billion ticket into the vaccines arena through acquiring Chiron in 2005.

It might not have been an easy, or cheap, buy (remember Novartis had to push up its bid and there were all sorts of problems with Chiron's Liverpool manufacturing plant), but it does give Novartis options beyond regular therapeutics, as we explained more fully here.
Options which it could do with, frankly. The Swiss group has seen Cox-2 inhibitor Prexige blocked out of the US so far, caught up in the Vioxx-wake (with prospects looking bleaker following the fall of Merck’s Arcoxia in April). It’s also having to watch Merck’s Januvia run away as the first DPP-IV inhibitor available to diabetes patients, since its own Galvus received only an approvable letter in February.

Enter vaccines. Although they have already, thanks to bioterrorism and pandemic preparedness, shed their image as fusty, low-margin cousins to therapeutics, vaccines have more recently achieved full stardom since the launch of Merck/Sanofi Pasteur MSD’s cervical cancer vaccine Gardasil. Vaccines are being investigated in a growing number of therapeutic areas, including cancer, and can now command premium pricing. (Their development, as we explained here, also provides some useful lessons for today’s pharma execs.)

That’s in part why the numbers in Novartis’ deal with Austria’s Intercell, announced this morning, look rather good. The Swiss group pays €120 million ($160 million) up front, plus a further €150 million in cash to buy equity in Intercell, in exchange for exclusive rights to Intercell’s adjuvant technology, IC31, for developing influenza vaccines, and non-exclusive rights in other areas. Novartis also gets opt-in rights to any of Intercell’s un-partnered vaccine targets after Phase II (or earlier), but must allow the biotech co-development or a licensing arrangement on any products that it opts in.

It’s Roche-Genentech all over again—or sort of. It would have been much cheaper for Novartis to buy Intercell outright (in addition to the total $360 million cash upfront, this deal could cost Novartis up to $134 million in development milestones for developing IC31 in influenza, $40-80 million in upfront and milestone payments on each other IC31 license, plus up to $150 million in development milestones post-Phase II…not to mention rich double-digit royalties on each product Novartis opts in on).

But these days, the arm’s length, leave-it-alone strategy of partnering with biotech is as fashionable as vaccines themselves (granted, of course, that the Big Pharma partner isn’t forced into buying outright, as many have been recently). Think of other portfolio-based, risk-sharing deals like Novartis’ own 2003 deal with Idenix, or GlaxoSmithKline’s respiratory tie-up with Theravance: the idea being to leave the biotech (largely) to its own devices.

This is the first such deal in vaccines, though, according to the partners. And although Novartis did take a majority stake in Idenix (which was private at the time), it’s sticking with a 16%, non-controlling stake in Intercell. “If they got to 25%, they’d have to make a mandatory bid,” explains Intercell’s CFO Werner Lanthaler. But, he says, “Novartis understand how important it is to leave us our independent spirit.”

Indeed, independent Intercell has done alright so far. Since listing in 2005, the company’s share price has climbed almost 300%, and the group has partnering deals with Merck, Sanofi Pasteur, Wyeth and Kirin, among others. It has submitted its first BLA, for a Japanese Encephalitis vaccine, and has a therapeutic vaccine for Hepatitis B and a prophylactic vaccine for pseudomonas both in Phase II trials.

Novartis may soon have two more Phase II candidates, plus a novel influenza platform to back up its own Optaflu cell-culture based vaccine, approved in the EU in June. And all thanks to vaccines.
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Posted in Novartis, vaccines | No comments

Which do you want first?

Posted on 07:45 by Unknown
Hologic Inc. management presented plenty of good news last week at the Jefferies Healthcare Conference in New York.

But there's a bit of bad as well.

First, the good. CFO Glenn Muir and Jack Cummings, Chairman/CEO, laid out a very promising picture for the future of Hologic as it acquires Cytyc Inc., maker of medical devices and diagnostics for women's health.

In their view, Hologic’s digital mammography business clearly will benefit from the channels that Cytyc’s sales force already built into OB/GYN offices. But don’t take our word for it. Listen to the web cast here. The good financial stuff comes up 19 minutes into it.

The $6.2 billion price tag obviously is a big undertaking for Hologic management. In a Q&A session, Cummings only half-joked that the biggest challenge facing Hologic management is to not mess up such a well-run company as Cytyc. But another challenge will be the $2.2 billion Hologic borrowed to make the deal.

The company is keeping its eyes on interest rates. At this point, the rising rates aren't impacting the accretive qualities of the deal. But Muir says management's goal will be to "rapidly pay down that debt."

This suggests—at least to us—that the new Hologic-Cytyc will be out of the company-buying business for a while, which would be too bad. Prior to the merger, venture capitalists and the blogs that cover them saw both Cytyc and Hologic as up-and-coming companies that could be steady acquirers of venture-backed businesses as they grew from their mid-tier status.

IN VIVO Blog suggested this to Cummings after the presentation, and he disagreed. Cummings said Hologic could be in the market for smaller companies with products that would plug easily into Hologic’s increasingly impressive sales and marketing machine.

As an example, he cited the company’s recent acquisition of BioLucent Inc. The privately held company makes and sells the MammoPad, "a radiolucent foam cushion that covers the cold, hard surfaces of all commercially available mammography equipment," according to the release. (Two side notes: Tom Fogarty had a role in starting the company. BioLucen's brachytherapy business, which you can read about here, will be spun out into a separate company.)

According to Muir, BioLucent had 10% penetration of its market with each pad costing $5 and carrying 64% gross margin. Hologic sees the company initially bringing in roughly $25 million in annual revenue. Hologic paid $70 million for the company with the potential for earn outs tied to revenue.

So Hologic appears to be on a solid path toward becoming a major mover in women’s health care. That’s the good news. The bad news is the company will need time to digest the recent merger. It may still make the occasional acquisition, but any such company will need to fit neatly into the company's current business.

p.s. Muir deserves extra credit for making a lucid presentation at 8:10 in the morning. In response to a poke from Cummings, he revealed his 2 p.m. Wed. shuttle out of Boston arrived at 1:30 a.m. "Not the flight to be on." IN VIVO Blog is glad we drove down to CT and grabbed a morning MetroNorth.
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Posted in medical devices, mergers and acquisitions | No comments

While You Were Kicking the Habit ...

Posted on 03:00 by Unknown
Not a big weekend for our particular brand of scuttlebutt, but here are a few tidbits of alliance- and health-care-oriented news that IN VIVO Blog picked up on over the weekend and in the wee hours of Monday morning ...
  • You may have heard that a small and little-discussed film called "SiCKO" was released in the US ... we haven't seen it yet but will likely comment once we have. We know of at least one big fan!

  • Late on Friday, Theravance said that GSK passed on its option to acquire 50% of the biotech's shares at $54.25. The option was a big part of the companies' 2004 deal that gave GSK the opportunity to cherry pick compounds from Theravance's pipeline (while simultaneously giving Theravance's shareholders a put option well north of the firm's IPO price). We wrote extensively about Theravance's strategy here.

  • Novartis wades further into vaccines this morning with a broad alliance with the Austrian biotech Intercell. For €270 million in upfront equity (€150mm) and cash/option payments Novartis is securing options to more than 10 Intercell programs, from preclinical through Phase II. Novartis now owns 16.1% of Intercell.

  • Finally, England's ban on smoking in public places took effect at 6am on Sunday, and we rejoiced. Now the UK-based members of our transatlantic blogging team can enjoy an ale at the pub without stinking like we've enjoyed an ale at the pub.
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Posted in cancer vaccines, GSK, mmm beer, Novartis, vaccines, While You Were ... | No comments
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Blog Archive

  • ▼  2008 (76)
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      • The Wacky World of Generics: Risperdal Edition
      • Botox, Friday Afternoon Press Calls and the Nissen...
      • AZ Makes Its Move in GI
      • Nektar Takes A Deep Breath
      • Sanofi Aventis: Sign of the Big Pharma Times?
      • The Blockbuster Model is Dead, Sort Of
      • Starring Role for Follow-On Biologics
      • While You Were Settling
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      • Friday Night Lowlights: Don't Leave Town Early
      • FDA-CMS Parallel Reviews: A Mixed Bag
      • Deals of the Week: Winter of Our Discontent
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      • Carl Icahn vs. Evil Corporate Governance
      • FDA’s Search for a Drug Chief Not Going Well: An I...
      • The Wacky World of Generics: Fosamax Edition
      • FDA’s Budget: “Maintain Momentum” or “Inadequate R...
      • White House Tries to Jump-Start Follow-On Biologics
      • Why Big Pharma Should Vote Democratic
      • The Wacky World of Generics: Protonix Edition
      • Perlmutter: We're Not Abandoning Japan
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