A Beverly Hills biotech company went public late last month in a reverse merger with a struggling Northern California drug developer, but it won’t tap the public markets anytime soon.
The bigger prize for Capricor Therapeutics Inc. is biotechnology that the company’s leadership believes is a perfect partner for its own stem cell-based drug candidate.
By acquiring technology developed by the formerly San Mateo-based Nile Therapeutics Inc., Capricor has a potential treatment for serious side effects that heart attack patients often develop.
“This was a pretty sweet deal for us as a heart failure biotechnology company,” said Chief Executive Linda Marbán, a cardiac physiologist and co-founder of Capricor. “Not only have we acquired some very compatible technology from Nile, but our own technology is mature enough to be able to take advantage of the public markets when the time is right.”
Since 2005, Capricor, a Cedars-Sinai Medical Center spin-off, has been developing a regenerative treatment for heart failure patients. The therapy uses adult stem cells to heal and grow damaged cells in the heart after a heart attack. A $19.6 million loan from the California Institute for Regen-erative Medicine is funding some midstage clinical trials that have just finished enrol-ling patients.
The Nile therapy, called Cenderitide, can be administered in an outpatient setting, making it less expensive and potentially more attractive to health insurers.
Capricor learned about Nile’s interest in seeking a partner or other strategic alternative last year from Capricor’s executive chairman, Dr. Frank Litvack, who once had served on Nile’s board. Litvack is an entrepreneur and former professor of medicine at UCLA who had co-directed the university’s Cardiovascular Intervention Center.
Nile had been in a cash crunch since the recession, Litvack said, and problems that Johnson & Johnson had with a therapy similar to Cenderitide had soured investors. But some recent studies have indicated that Cenderitide does have potential for reducing hospital readmissions, without potential kidney damage that caused concern for the J&J product.
“We now have a product portfolio that moves us toward our goal of building a sustainable biotech that can stay in Los Angeles,” said Litvack.
Both drugs are several years away from commercialization, however.
Afrezza Prep
While U.S. Food and Drug Administration scientists scrutinize 2,000 pages of new study data submitted last month for MannKind Inc.’s inhalable insulin device, the company is doing more than just waiting.
The Valencia biotech company, whose backers had hoped Afrezza would well be on its way to billion-dollar blockbuster status by now, was told by regulators to go back to the drawing board in early 2011 and prove that later upgrades to the inhaler unit hadn’t compromised patient safety.
The FDA has until mid-April to approve or reject MannKind’s revised application. In the meantime, much of the company’s preapproval checklist for launching the product has been taken out of mothballs.
The company had nearly $94 million in cash available at the end of the third quarter, and it has made arrangements to obtain millions more to fund operations past the FDA decision deadline. At its quarterly conference with analysts last month, founder and Chief Executive Al Mann and his team said the company was hiring and gearing up manufacturing facilities so that the plant would be running at least at 25 percent of its peak capacity by April 15.
MannKind scientists are planning additional clinical studies. The results will help market the drug should it be approved in April and hit the market in the fourth quarter of next year as planned.
Talks with potential drug company marketing partners also have become more serious. And Mann was clearly excited during a recent conference call when he described MannKind’s contributions to an ongoing UC Santa Barbara study that could add to Afrezza’s value.
In the study, Afrezza, a fast-acting insulin taken at meal time, has become a key com-
ponent in an experimental medical device system that would function as an artificial pancreas for juvenile diabetics and others with pancreas problems that lead to insulin deficiencies.
“This just has astounding potential because getting a so-called artificial pancreas that dispenses slow-acting insulin to handle the surge of glucose at meals was a hurdle that I always thought would be hard to overcome,” said Keith Markey, a biotech analyst for Griffin Securities in New York. “It’s a fascinating new use for Afrezza that should get the market excited once it’s approved.”
Staff reporter Deborah Crowe can be reached at [email protected] or (323) 549-5225, ext. 232.
