More coverage. Another Round up story
CONSUMER HEALTH: Regenetive Medicine Becoming More Mainstream
9:02a ET March 10, 2011 (Dow Jones)
CONSUMER HEALTH: Regenetive Medicine Becoming More Mainstream
By Kristen Gerencher
A DOW JONES COLUMN
Investors Take Note
The market capitalization of 22 publicly traded companies in the cellular therapy business hit $2.5 billion this year, up 40% from last year, said Robin Young, chief executive of data firm Pearl Diver and organizer of the annual New York Stem Cell Summit. He projects U.S. sales will grow to about $1 billion by 2015.
Cell-based approaches involve changing the course of diseases, said Morrie Ruffin, managing director of the Alliance for Regenerative Medicine, a trade group of 80 companies based in Bethesda, Md., that launched in 2009.
"One of the ways we're going to have to address the long-term cost increase we face in health care is by focusing on innovation and getting out of this cycle of looking at very small incremental gains in treating diseases to finding transformative solutions," Ruffin said. "That's why regenerative medicine is so exciting. It takes us in that direction."
The industry wants Congress to reintroduce the Regenerative Medicine Promotion Act of 2010, which would provide federal funds for research and development and streamline the approval process for products deemed safe and effective.
Meanwhile, Wall Street wants to see signs of clinical viability, said Mark Monane, managing director of equity research at Needham & Co. in New York.
"Investors are not giving these companies the benefit of the doubt," he said. "They trade at a discount relative to other like-stage companies. For the most part, the jury is still out on whether this can be a product in the real world or if they are doing a science experiment."
Even so, investors appear increasingly interested. In January, the Alliance for Regenerative Medicine held its first annual "state of the industry" briefing during the Biotech Showcase and the J.P. Morgan Healthcare Conference in San Francisco. The turnout of attendees forced administrators to shift the event to a bigger room as executives gave company overviews and took questions.
Tapping Embryonic Stem Cells
Earlier this year, the U.S. Food and Drug Administration cleared Advanced Cell Technology Inc. (ACTC) of Marlborough Mass., to pursue a multicenter clinical trial to treat dry age-related macular degeneration, which affects 10 million to 15 million Americans. The treatment involves inducing a cell line grown from human embryonic stem cells to become retinal pigment epithelial cells, which sit at the base of the retina on top of what's called the Bruch's membrane.
"It's the death of these RPE cells that leads to a variety of retinal disease, the biggest of which is dry age-related macular degeneration," ACT Chief Executive Gary Rabin said.
In the upcoming trials, eye surgeons will inject the new cells into patients' diseased eyes with the aim of having the cells graft and reverse the damage in an area of the body known for being insulated from typical immune responses that would reject the new cells, he said.
Embryonic stem cells are much more malleable than adult stem cells, Rabin said, and he expects ACT's method to gain acceptance no matter how the politics of embryonic stem cells evolves.
In February, the company received a patent on an extraction technique called "single blastomere" that doesn't harm the two-day-old embryos. Advanced Cell Technology acquires them from vitro fertilization clinics with patients' consent, uses the embryos to start cell lines and then returns them to the clinic for their original purpose--for making babies or storing for the future.
"The extraction method we use is used in the birth of thousands of babies each year using PGD [pre-implantation genetic diagnosis]," Rabin said. "We're not changing the fate of the embryo we borrowed."
Another company, Kinetic Concepts Inc. (KCI), acquired a regenerative-medicine outfit called LifeCell in 2008. One of its flagship products, Strattice Reconstructive Tissue Matrix, used mostly for breast and abdominal wall reconstruction, is changing how surgeons practice, said Dr. Ron Silverman, a plastic surgeon and chief medical offer for Kinetic Concepts in San Antonio.
"LifeCell's approach has been to provide a natural matrix, like scaffold, and allow your own cells go into the scaffold," he said. "Within a day there are already cells within the product. When you have your own cells, there's no rejection."
Strattice provides an alternative to the synthetic mesh often used in hernia surgery, which can cause suffering and complications if infection develops, he said. With plastic, a second surgery would be required to remove the mesh whereas regenerative tissue doesn't require invasive correction, Silverman said. "We see this as tremendously economically advantageous," he added.
It's an example of how regenerative medicine facilitates the body's ability to grow new cells, Silverman said. "If you don't have regeneration, then the only thing the body knows how to do is heal things by scarring. Regeneration allows not just scarring but replacement of natural tissue."
For companies struggling to bring products to market, collaboration will be key, said Monane of Needham & Co.
"There's so much opportunity to win," he said. "They're all at a stage where they're learning from each other."
