ddn Online

The Blog of Drug Discovery News

Theeey’re baaaaaaack

…well, to be honest, they never left.

They never left the news (they simply went into the background for a little while) and they never left the negotiating table (it just seemed like it).

I’m talking about Paris-based sanofi-aventis and Cambridge, Mass.-based Genzyme. The former has been trying to acquire the latter for months now. Genzyme says it’s worth too much to give in to a $69-per-share offer and sanofi points out that the biotech can’t hold out forever, particularly with no other suitors knocking at the door.

Truth is that they probably need each other. Genzyme probably needs to be part of something larger and sanofi-aventis certainly needs the pipeline and technology platforms that Genzyme can bring it in these challenging economic times.

So it’s probably with great relief to investors and to many market watchers that the companies announced at the beginning of this week that they are in negotiations about the acquisition. There is still a lot of ground to cover to get them on the same page…or in the same chapter, for that matter…but at least they’re talking.

Of course, they have been all the while. When the top execs haven’t been trading letters, the financial advisers for both companies have been talking. The difference now is that actual company representatives for both sides are now in on the talks.

More importantly, sanofi finally seems willing to budge on the price, and Genzyme seems willing to beat its chest a little less forcefully about how much it’s worth.

At least that’s how it looks…for now.

We’ll see how it all pans out, but like I said, a lot of people watching these companies are breathing easier as a possible deal seems to become more and more likely.

Frankly, I suspect the CEOs and boards of both companies are breathing easier too.

January 11, 2011 Posted by | Corporate, Dealmakers, M&A activity | 1 Comment

Who? What? How much?

So, as I was writing a news article (here) on the web site about Axcan Holdings getting prepped to buy out Eurand N.V., I was struck with an overwhelming question.

Who are these companies?

I don’t mean to be flip, mind you. They’re both legit pharma entities, with Axcan having a strong gastrointestinal focus and Eurand having six FDA-approved products under its belt. But I’ve never heard of either one of them.

This isn’t odd, of course. There are so many small and mid-size pharmas and biotechs that even the most hardened life sciences market analyst couldn’t know them all. No matter how much we are in the business or reporting about it, there will always be company names that make us say, “Never heard of ’em.”

But the reason this sticks out for me is that the buyout deal is for $583 million. That’s over a half-billion dollars.

Isn’t that a lot of money? Shouldn’t I have heard of these companies in passing before, with that kind of money about to change hands?

Or is it just that things have begun to move so quickly now, and so much money is being thrown around the world economy that a billion dollars is “the new black?” That is, being a millionaire now, even at the high ends, is perhaps passé, and now you don’t matter as a rich person unless you break the billion mark?

I realize that as I get older, I will look back at the “good old days” (or bad old ones, for that matter) and say, “What happened?” I already do, and I recognize it.

But still, half a billion dollars seems to me like the kind of money that gets thrown around by pharmas I’ve heard of before. It just doesn’t seem like in the mere five-and-a-half years that I’ve been on staff at ddn that we could have gone from half a billion being big news to simply being a blip on the radar.

So, I wonder: Is the fault in me that I’ve never heard of these companies before and should have? Or just that the world is moving so fast now that it’s hard to keep up with the dollars and the deals?

December 2, 2010 Posted by | Corporate, Dealmakers, M&A activity | , , , , , , | Leave a comment

Trying to make Alzheimer’s merely a bad memory

Our very own chief editor Amy Swinderman had a very nice editorial regarding Alzheimer’s disease for our October issue, which you can read by clicking here. Don’t worry, it’ll open up in a new tab or window, so I’ll be waiting for you when you’re done.

OK, you’re back? Great.

Alzheimer’s disease poses one of the biggest potential healthcare crises going, particularly in places like the United States, where a huge Baby Boom population is entering into the risk years for age-related dementias, of which Alzheimer’s may be the single most terrifying to them and their children (and grandchildren).

So, there is little doubt you’ll be seeing a lot about the disease in ddn magazine, as companies and other organizations delve into the research and commercialization of therapies and diagnostics; in our ddn Online e-newsletter, which will feature a “Bench Press” article on Oct. 27 on some Alzheimer’s research and will continue to highlight the disease frequently thereafter; and here at this blog, where we need stuff to talk about and oh, there is so much to talk about with diseases like this, both good and bad.

In the meantime, here are some of our October 2010 issue articles (in their online form) dealing with Alzheimer’s-related items:

New chapter for neurodegenerative diseases unfolds

An ounce of prevention

Anavex taps CROs for Alzheimer’s program

Plus, you can click here or a blog post from the recently launched Harvard Health Blog to give you some additional commentary, insights and leads regarding Alzheimer’s disease.

October 14, 2010 Posted by | Academia & Non-Profit, Corporate, Dealmakers, Labwork & Science | , , , | Leave a comment

Becoming companions

In our October issue of ddn, on which we’re just putting the finishing touches before the printing plant takes up its work (hence the relative silence here at the blog the first half of this week), we have some notable coverage of companion diagnostics.

The most prominent story is the lead article in our latest Trends in Cancer Research feature (the third installment of a five-part series), which looks at the challenges and rewards of developing companion diagnostics for cancer therapies by focusing on Eli Lilly & Co.’s efforts to build a companion diagnostics capability, and Genentech Inc.’s continuing efforts in this arena. Along with that is a story on cancer diagnostic trends for the near future, with Kalorama Information noting, in part, that by 2025, one in five new drugs could be labeled with a companion test, many of which will be cancer drugs.

So, when I saw an e-mail in my inbox from the organizers of the upcoming World Companion Diagnostics Summit (Nov. 30 to Dec. 3 in Boston), it seemed an apt time to share with you something they shared with me: an excerpt from an interview with Cecilia Schott, business development director of personalized healthcare at AstraZeneca.

Q. What do you feel is the major difficulty with drug-diagnostic co-development?

A. Timing. The science is great, the technology is great. For all to be synchronized is a challenge. To make sure that everything is aligned is a challenge. The development of a diagnostic tool, using  a biomarker is complex but getting that into a stable diagnostic assay that is robust enough to be used on a selection of patients that respond to a therapy is the real difficulty. At the same time as developing a compound making sure that the two things are aligned developmentally is a great challenge.

On the business side, which is where I sit, I think it’s understanding each others business models that is often difficult and I think we are trying to understand how to be better partners and work together: pharma and diagnostic companies. You have a diagnostic industry and a pharma industry, and you become an integral part of each other’s businesses. So we need to learn more about our partners needs as we move forward.

Q. How do you see drug development changing over the next 5 years, specifically looking at personalized medicine?

A. I hope that I’m right in saying that it will become more and more efficient. If we can predict which patients will respond, this would make us more efficient at developing medications and the industry as a whole will become more cost-effective. We will be working with our diagnostics partners much earlier in the discovery and development stages. This will be a paradigm shift in the way that clinical trials and drug development is conducted. Trial designs will be more focused. We are used to conducting trials in thousands of patients and you cannot necessarily predict who will respond to your drug, but in the future you may require less patients. This will be a far more efficient drug development process and will undoubtedly lead to more drugs getting approval and better care for patients.

There’s more at the website for the event, but in this excerpt, I see what may be the key issue going forward.

There isn’t much question of the value of companion diagnostics. And no doubt the FDA will get better at figuring out how to approve them more efficiently in the future as they become ever more critical.

I don’t even see it as a matter of science. With increasing knowledge of biomarkers, for example, we will likely see a point in the foreseeable future at which companion diagnostic capabilities will explode, as with so many other transformative technologies and methodologies.

No, the problem, I think, will be (as Schott notes) getting pharma and diagnostics to fit together better. It will no doubt happen, but I suspect the biggest impediment to companion diagnostics will be these two very different (but intertwined) industry forces getting past the “getting to know you stage” in their courtship and becoming…well…very constant and devoted companions.

October 6, 2010 Posted by | Corporate, Dealmakers | Leave a comment

CROh-my-goodness!

Well, it looks like Christmas came early for Covance, landing a $2.2 billion deal with sanofi-aventis (more on that here). I don’t think I’m anywhere near alone when I say, “Didn’t see that one coming!”

Whether this is a sign of much larger things to come in terms of the contract research space and continued pharma and biotech outsourcing, only time will tell. But I’m guessing we’ll see more deals and even bigger dollar amounts before long.

By the way, maybe it’s me just showing my age (42, for the record), but I still have trouble wrapping my mind around multibillion-dollar collaborations. Buying a whole company for billions…well, I’ve gotten used to that, and understand it totally. But the world is moving fast, because I don’t recall too many deals (aside from acquisitions) going into the billions-and-billions of dollars territory until pretty recently.

Anyway, more details on, and insights into, the Covance/sanofi-aventis deal from us in the weeks to come.

September 30, 2010 Posted by | Corporate, Dealmakers | , , , , , | Leave a comment

Companion diagnostics ready to soar

As I’ve worked with companies putting together the next installment in our Trends in Cancer Research series, I’ve learned that pharma seems to be realizing that it needs to collaborate with diagnostic companies to stratify patients and to make safer, more effective drugs.

The development of companion drugs and diagnostics has the potential to improve treatment outcomes, enhance patient compliance with prescriptions and eliminate the need for insurers to pay for expensive therapies that often prove to be ineffective.

And the available information on biomarkers that indicate whether a therapy could work on a particular individual continues to grow rapidly.

Still, it can be a daunting task to develop drugs and companion diagnostics.

One company—Eli Lilly & Co.—has announced plans to build a diagnostics capability. A big part of the company’s innovation strategy is providing improved outcomes for individual patients—which it says can be achieved through tailored therapies.

Several technologies exist that enable the development of biomarkers into companion diagnostics. PCR, microarrays and expression profiling are being used to improve the sensitivity and selectivity of companion diagnostics. Next-generation sequencing and proteomics are two other growing areas of interest.

Biomarkers that are validated have the ability to lead to safer and more effective products, especially when developed into a companion diagnostic.

There certainly are challenges, such as identifying the right biomarker early in the discovery process; developing a robust biomarker assay in advance in the clinic; developing companion diagnostics well before reaching Phase III trials; and gaining approval of a drug and diagnostic at the same time.

An example of just how far this area has come is the World Companion Diagnostics Summit—to be held Dec. 1-2 in Boston. The summit will be addressing exactly these most crucial challenges, and has been developed in collaboration with the companion diagnostic pioneers from Roche, Genentech, Johnson & Johnson, AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer, Amgen, Abbott, Qiagen and Dako.

According to the website, the meeting has “evolved from the urgent need for those committed to personalized medicine to come together and share expertise that will underpin the path for making companion diagnostics a reality.”

Workshops will be held Nov. 30 and Dec. 3.

The summit will provide the scientific community an opportunity to have an open discussion of strategies for developing companion diagnostics and making strides in the quality and efficacy of research results. In the end, hopefully, we will all be winners.

(Note: If your company or institution is doing pharma or biotech research and development the oncology arena and would like to serve as a source for the last installment in ddn’s Trend in Cancer Research series, contact David Hutton at hutton@drugdiscoverynews.com.)

September 27, 2010 Posted by | Corporate, Dealmakers | , , | Leave a comment

Collaboration in the Cleve

Just weeks after German pharma Merck KGaA closed on its $7 million acquisition of Millipore Corp., the bioscience research and biopharma manufacturing technology, tool and service provider—now operating under the name EMD Millipore—entered into a licensing agreement with the Cleveland Clinic for a method to rapidly assess tissue.

The method co-developed by EMD Millipore and the world-renowned hospital research center uses the immunohistochemistry (IHC) application of EMD Millipore’s SNAP i.d. Protein Detection System to stain and study patient tissue, and reduces the time it takes to do so from hours to minutes.

Launched in April 2008, the SNAP i.d. system uses a vacuum to actively drive reagents through membrane-fixed tissue sections, dramatically increasing exposure of tissue antigens to blocking reagents, antibodies and wash buffers. Traditional tissue staining involves mounting sections on glass slides and relies on diffusion for reagent permeation through the sections, which can take as long as 12 hours. But the SNAP i.d. system reduces this time to about 22 minutes, says Don O’Neil, director of product management at EMD Millipore.

“SNAP i.d. is a simple and elegant system that leverages our core competency in membrane technology development with some really cool ideas that came out of our engineering group,” he says. “It’s an injection-modeled system about half the size of a shoebox. You run your Western blots, pull the vacuum and within 22 minutes, you are getting results.”

According to O’Neil, the initial application of the method will focus on melanoma research, and will be a game-changer in terms of easing many of the time burdens of a typical Mohs procedure, a pathology sectioning method that allows for the complete examination of the surgical margin. The procedure—which involves the surgical removal of tissue; mapping, freezing, cutting and staining the piece of tissue; interpreting microscope slides; and reconstructive surgery—is both time-consuming and has a high incidence of false negatives.

O’Neil says ultimately, scientists at EMD Millipore will collaborate with doctors at the Cleveland Clinic to validate the use of SNAP i.d. for diverse tissue types and fixation protocols to accelerate translational research and drug discovery.

“This system enables the pathologist and surgeon to work together, hand-in-hand,” O’Neil says. “They can use the SNAP i.d. system for IHC during the surgical procedure, and make a decision on what to do next right there and then.”

In the current research environment, there is a critical need to be able to evaluate test results in a timely and effective way, says Chris Coburn, executive director of Cleveland Clinic Innovations, the technology commercialization arm of the clinic. Ranked among the top corporate venturing arms in the world, Cleveland Clinic Innovations works on more than 200 new technologies per year and engages in dozes of similar transactions.

“SNAP i.d. is widely in use already as a means of conducting Western Blots,” Coburn notes. “The Cleveland Clinic technology expands the applications of SNAP i.d. to not only Western Blots, but also immunohistochemistry, which currently is a eight-hour procedure. But by using the SNAP i.d. application developed at the Cleveland Clinic, that immunohistochemistry time is reduced to around 30 to 45 minutes. This system will allow all researchers to increase their immunohistochemistry volume by reducing the time it takes for each procedure, which will help make lab work more efficient.”

Coburn says the first use of SNAP i.d.’s immunohistochemistry application will be for basic science research in the lab. Clinical applications, such as in the pathology lab, will follow in the future.

The Cleveland Clinic, he notes, has had a long relationship with Millipore in terms of licensing and product usage.

“The SNAP i.d. application was a good fit for the Cleveland Clinic to work with Millipore since Millipore sells the device,” Coburn says. “In addition, the Cleveland Clinic’s unique blend of clinical expertise and research prowess make us a good partner for a company like Millipore.”

O’Neil says Millipore is “excited to partner with such a world-class organization.”

“It’s a huge honor for us to have this opportunity,” he says. “I know they are an exceptional organization and a tremendous group of people who are very dedicated and collaborative. They are one of the highest volume centers for Mohs surgery in the world. While this initial application is very specific to that procedure, there are certainly other opportunities within IHC that we want to leverage—potentially in higher-volume workflows where time is of the essence.”

September 10, 2010 Posted by | Academia & Non-Profit, Corporate, Dealmakers | , , | 1 Comment

One less suitor for Genzyme?

Well, it looks like GlaxoSmithKline may be removing itself from any potential bidding war over Genzyme Corp. based on Moncef Slaoui, the British pharma’s head of research and development, telling French newspaper Les Echos recently, “An offer by GlaxoSmithKline for Genzyme does not make sense. It is too expensive.”

The reason analysts have even been predicting a bidding war was because sanofi-aventis made public a non-binding offer Aug. 30 to buy Genzyme Corp. for about $18.5 billion in cash, with Genzyme refusing the offer less than a day later and sanofi-aventis hinting at possible hostile takeover action.

“If the best idea is to be found outside the company, it is better to conclude a partnership agreement.” Slaoui added in the interview with Les Echos. His statement is in line with GSK’s stated goal of looking to balance its R&D portfolio more or less evenly with drugs developed through in-house research along with outside partnerships. Also, while Genzyme has a foothold in niche disease areas, GSK, already has a presence in rare diseases through its partnership with JCR Pharmaceuticals.

According to coverage by Reuters, analysts are now saying it looks far less likely that any “white knight” would emerge to trigger a bidding war to either force sanofi to significantly its offer or give Genzyme a more desirable suitor.

Genzyme is considered attractive to sanofi partly because its pipeline includes promising drugs for treating high cholesterol but also because of treatments for other disorders that are in late development. Also, Genzyme already sells some lucrative drugs for rare genetic disorders, and sanofi, like so many pharmas, has been buying smaller companies or paying for rights to experimental drugs as generic competition to blockbuster drugs continues to heat up.

Dr. Brian Abrahams, an analyst with Oppenheimer Funds, has said that he thinks a better deal than the $18.5 billion one will be negotiated between sanofi and Genzyme, despite the former implying it is considering a hostile bid. Abrahams says the price could range between $72 and $74 per share, given historical biotech acquisition premiums and Genzyme’s products. At the moment, sanofi’s offer stands at $69 per share.

Genzyme has said that in unanimously rejecting the sanofi offer, its board of directors felt that they were “not prepared to engage in merger negotiations with [sanofi-aventis] based upon an opportunistic proposal with an unrealistic starting price that dramatically undervalues our company.”

For its part, sanofi has publicly expressed doubts over Genzyme’s performance under its chief executive, Henri Termeer, noting in particular manufacturing problems that have created challenges for the company bringing products to market.

As MarketWatch noted Sept. 5, “Genzyme’s stock plunged in early 2009 after the U.S. Food and Drug Administration found problems relating to microbiological monitoring at a manufacturing facility. The FDA’s scrutiny led to the company effectively losing control over one of its largest production facilities, in Allston, Mass., and contributed to the company cutting 2009 earnings expectations. The unwanted regulatory scrutiny has prompted the attention of some key shareholder activists who will be watching Sanofi’s moves carefully. Earlier this year billionaire activist investor Carl Icahn said he planned to nominate four directors to the Genzyme board, including himself. Genzyme also agreed to name Ralph Whitworth, head of Relational Investors to the board.”

The notion that GSK might have been interested in entering a bidding tug-of-war with sanofi-aventis wasn’t at all far-fetched, though—even if it does seem unlikely now. After all, as the Wall Street Journal reported in July, GSK made a “very casual approach” to Genzyme asking to be notified by the company’s officials if they considered selling to anyone.

September 7, 2010 Posted by | Corporate, Dealmakers, M&A activity | , , | Leave a comment