Looking for similars parity

So, I’m seeing talk of biosimilars showing up a bit more on the news feeds and in my e-mail inbox. Hard to say yet whether it’s a sign of a rising trend in pharma and biotech or whether it’s just a little jump in the frequency.

But I will say that in our January issue (heading out in the mail and also available online – key stories here and full issue in PDF form here), we had a sizable commentary about biosimilars. Given that the FDA is supposedly going to finally catch the U.S. up somewhat with its European peers in terms of an approval pathway and regulatory guidelines, I won’t be at all surprised to see a lot more stories on biosimilars like the one below that hit the newswires yesterday:

Merck & Co. and PAREXEL form strategic alliance focused on clinical development of biosimilar candidates

WHITEHOUSE STATION, N.J. & BOSTON—Merck & Co. Inc. and PAREXEL International Corp., a leading global biopharmaceutical services provider, today announced that they have entered into an alliance by which PAREXEL will provide strategic access to global clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures, a division of Merck, is focused on the delivery of high quality biosimilars to the patients that need them.

“PAREXEL has extensive, industry-leading experience with biosimilar development, and we truly understand the scientific complexities, and regulatory pathways involved,” said Josef von Rickenbach, chairman and chief executive officer of PAREXEL. “We are committed to working with Merck BioVentures to assist in advancing its biosimilar portfolio in this rapidly developing market segment for the benefit of patients worldwide.”

Under the terms of the agreement, PAREXEL will provide Merck BioVentures with strategic access to a broad range of regulatory strategy and clinical development planning capabilities for the development of certain broad classes of biosimilars across various therapeutic areas, including exclusivity for certain candidates. The agreement also provides for the establishment of a dedicated Merck BioVentures unit within the PAREXEL organization. Further details of the agreement were not disclosed.

“Through this agreement, Merck BioVentures has secured broad strategic access to PAREXEL’s proven biosimilar clinical development experience,” said Michael Kamarck, president of Merck BioVentures. “This agreement positions Merck BioVentures for success with an industry leading partner that has the expertise and resources to conduct clinical development of our diverse portfolio of candidates to allow timely delivery of products to the marketplace.”

I think probably the biggest hangup for biosimilars (and thus news about any work on them) really has been the sluggish pace at which FDA seems to have been addressing this topic. I know that biosimilars pose many more challenges than do generic versions of some small-molecule drug or the like, but I can’t help but think that with European regulators already having trod this ground that the FDA has really been dropping the ball (as opposed to simply being wisely cautious).

Of course, that assumes that they agency even makes good on getting workable guidelines out this year. Lot of people and organizations fail at New Year’s resolutions.

Leaders, layoffs and losses

It’s been an interesting month in the pharmaceutical industry, with a few of the top pharma’s leaders leaving, more pink slips piling up and stocks morphing in the face of all of the change.

On Nov. 30, Merck & Co. Inc. announced its appointment of President Kenneth Frazier, who as Merck’s former chief counsel was instrumental in helping the pharma overcome its Vioxx litigation, as its new CEO. Frazier will succeed current CEO Richard Clark, who will reach Merck’s mandatory retirement age next year. Clark will continue as chairman of the board. Although analysts are optimistic that Frazier will see Merck through its next big challenge—the expiration of the Singulair patent, which accounts for 11 percent of the company’s sales—and continue Clark’s work on investing in the next generation of blockbusters, the announcement prompted a 4 percent drop in Merck’s shares to $34.64.

Recently retired Pfizer CEO Jeffrey Kindler speaks at the Reuters Health Summit in New York

Days later came the news that Pfizer Inc. Chairman and CEO Jeffrey Kindler abruptly announced his resignation after four years of leadership at the company. Although Kindler said he needed to “recharge my batteries,” analysts have speculated that he was forced out by a board and investors who are unhappy with Pfizer’s languishing stock price, late-stage clinical failures and a strategy emphasizing repeated acquisitions to boost revenue and cut costs as a way to improve the bottom line. The appointment of Ian Reid, Pfizer’s head of global pharmaceuticals, as Kindler’s replacement has also raised analyst concerns about Pfizer’s long-term performance and leadership. With Pfizer’s shares down 9.6 percent over the last year of Kindler’s tenure, shares rebounded on the resignation news, gaining 20 cents to $16.92.

With the holidays upon us, and many analysts taking a look at the highlights of 2010, layoffs are also making headlines. Fierce Pharma recently unveiled its annual top 10 layoffs list, highlighting the 10 largest job cut announcements by company. Counting the year’s total pink slips at more than 50,000 jobs, the list begins with AstraZeneca, which let 8,550 employees go this year, and counts job losses in the thousands at Pfizer, GlaxoSmithKline, Roche, Bayer, Abbott Labs, sanofi-aventis, Takeda, Novartis and Bristol Myers-Squibb. Given how often these companies made the front page of ddn this year with their merger and acquisition activity, these cuts are no surprise, as all of these transactions inevitably mean consolidation of resources.

With new leadership, more modest operations and the pressure of patent expirations, all of this should make for a very interesting 2011 in Big Pharma. As the Yieldpig blog notes, “with the dicey situation in Europe, stubborn domestic unemployment, a housing market that’s bottoming at best, and the great unknown of interest rates, equity portfolios should probably continue to play defense. Big, cheap, pharmas with sick dividend yields should help.”

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.”