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Success, Better Technology Drive Pharma's Antibody Lust
By Jennifer Boggs
Assistant Managing Editor
ATLANTA - There's no question that "antibodies have come a long way in the last 20 to 25 years," said Fritz Rudert, general manager of German consulting firm FHR Consult and moderator of a panel on antibodies at the first annual BioPharm America conference.
Most of the success has followed the 1998 approval of Genentech Inc.'s Herceptin (trastuzumab), the first commercially successful antibody. Now, antibodies have become the go-to drugs for big pharma looking to fill emptying pipelines and aiming for a competitive position in the biologics market.
Over the past several years, antibody drugs and antibody technologies have been at the center pharma's craze for biologics. On the acquisition front, deals have included London-based AstraZeneca plc's 2006 purchase of Cambridge Antibody Technology, which it later merged with more recent acquisition MedImmune Inc., and London-based GlaxoSmithKline plc's buyout of privately held Domantis Ltd., of Cambridge, UK, in early 2007.
Meanwhile, other antibody firms have formed lucrative partnerships, such as Tarrytown, N.Y.-based Regeneron Inc., which signed a potential $1 billion discovery and development deal with Sanofi-Aventis Group, of Paris, and Rockville, Md.-based MacroGenics Inc., which secured a deal, also potentially worth $1 billion, with Indianapolis-based Eli Lilly & Co. to develop anti-CD3 antibody teplizumab in Type I diabetes.
Deal-making in the antibody field "has really taken off in the last few years," Rudert said, adding that both mean up-front payments and overall deal volumes are on the rise for antibodies and varying antibody technologies. M&A also is up, "sort of culminating" with Roche Holdings AG's $44 billion offer for Genentech Inc., which has two of the biggest antibody products on the market, Herceptin and blockbuster Avastin (bevacizumab).
Genentech has rejected Roche's offer, though the general consensus is that the deal ultimately will go through, but at a higher price.
And panelists said the hunger for antibodies is not likely to abate any time soon, especially as antibody development and manufacturing capabilities continue to improve.
"It's such a good class of drugs," said Simon Moroney, CEO of MorphoSys AG. "It took so long to iron out all the bugs, but [antibodies] will probably stay popular for at least two to three more decades."
An Inauspicious Beginning
While Herceptin is credited with kicking off the antibody space's success story, it was not the first antibody to gain FDA approval. That distinction goes to Johnson & Johnson's Orthoclone (muromonab), an anti-CD3 antibody developed using a murine antibody technology, which was approved in 1986 for treating organ rejection but failed to make a big splash in the market due in part to its association with serious side effects such as anaphylactic shock, cardiovascular problems and life-threatening episodes of cytokine release syndrome.
The problem, it turned out, was that murine antibody technology had only limited success because there's just too much dissimilarity between mouse and human antibodies, Rudert said.
Chimeric antibody technologies (a combination of mouse and human antibodies) were better, but it wasn't until the development of human antibody technologies that the space began to heat up. And coming down pipelines now are drugs created using antibody-drug conjugate (ADC) technologies, which might prove even more effective.
Beyond that, there are the antibody-drug conjugate technologies - the attachment of a drug to an antibody - which might prove even more effective. Among the most advanced ADC drugs in development is Branford, Conn.-based CuraGen Corp., which last week completed enrollment in a Phase II study of CR011-vcMMAE, a product that comprises a fully human monoclonal antibody against GPNMB that is linked to monomethyl auristatin, a tubulin destabilizing agent, in patients with advanced melanoma.
But, even with the advancements, antibodies still carry a certain amount of development risk.
"A lot of people think antibodies are a slam dunk," said panelist Margaret Karow, executive director of research at Thousand Oaks, Calif.-based Amgen Inc., which markets Vectibix (panitumumab), an anti-EGFR antibody approved in colorectal cancer. "But they are proteins," meaning they come with the same challenges as other protein drugs in development.
They've had their share of safety issues, for one. Cambridge, Mass.-based Biogen Idec Inc.'s multiple sclerosis drug Tysabri (natalizumab, partnered with Dublin, Ireland-based Elan Corp. plc) has been linked to potentially fatal brain disease progressive multifocal leukoencephalopathy, and the FDA recently issued an alert on the increase in serious fungal infections associated with anti-tumor necrosis factor-alpha inhibitor antibodies such as Centocor's Remicade (infliximab). Even worse was the shocking Phase I trial of now-defunct Tegenero AG's TGN1412 antibody that sent six healthy volunteers to intensive care.
Despite those bumps, antibodies have become the fastest-growing drug class, with nearly 1,000 compounds in research and development, many of those in partnership with big pharma.
Pharma "Scrambling" for Antibodies
In one of the largest antibody partnerships to date, German biotech MorphoSys AG signed a massive 10-year discovery and development alliance with Novartis AG that could be worth more than $1 billion, including $600 million that Novartis has committed to pay over the course of the agreement.