J. Adam Fenster/The Gazette Edward M. Rudnic, president and CEO of Advancis Pharmaceutical Corp. will speak at the upcoming biotechnology industry annual convention at the Washington Convention Center this weekend.

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A Gaithersburg biotech that's developing regenerative therapies for wound care has continued to broaden its scope by acquiring a North Carolina company focused on stem cell treatments for stroke and other conditions.

In an all-stock transaction, publicly traded Cytomedix agreed last week to pay $16 million — and up to $40 million, if certain milestones are achieved — for privately held Aldagen of Durham, N.C. As part of the deal, Aldagen investors bought $5 million of Cytomedix common stock in a private placement.

“We see this as a very attractive opportunity to expand our footprint and lead in the development and commercialization of autologous regenerative biotherapies,” Martin P. Rosendale, CEO of Cytomedix, said during a conference call with analysts last week. Compared with other companies in the stem cell field, the “discount is significant,” he said.

The acquisition is part of Cytomedix's longterm strategy since 2008, he said.

“Our vision has been to transform Cytomedix from a single-product, wound-care company into a leader in regenerative medicine,” Rosendale said. “To that end, we acquired Angel,” a blood separation technology that since 2010 has helped the company increase its sales every quarter. Annual sales are now in the neighborhood of $6 million, he said.

The company also expects a decision by May 9 from the Centers for Medicaid and Medicare Services on government reimbursement of its wound-healing product. A favorable decision could further boost revenues. “I really feel good about” the agency team with which Cytomedix is working, Rosendale said.

The company's wound treatment is making “excellent progress” in studies in Japan, in preparation for a regulatory filing there, he said.

“We're treating horrible wounds there,” in patients for whom standard of care is not effective and who face possible amputation, Rosendale said. There are “some very amazing data in 40 patients,” with results to be published in the next few months.

James Hinson, a physician and chief medical officer of Cytomedix, hailed the Aldagen acquisition.

“Regenerative medicine holds the most excitement and promise that I've seen in therapeutic medicine in my 36-year career,” Hinson said. He added that the acquisition of Aldagen will create a “synergy to treat complex diseases,” especially stroke.

Aldagen's technology — which it licensed from Duke and Johns Hopkins universities — is in a 100-patient, phase 2 clinical trial in stroke patients. Ten patients have been enrolled, with full enrollment expected within a year and top-line data available four months later, according to Cytomedix information.

The technology expands the window for effective treatment from hours after a stroke to 14 days, Hinson said.

If the treatment meets its phase 2 goals, Cytomedix probably would seek a partner to help finance phase 3 trials, Rosendale said.

“There's a lot of growing interest in this space from pharma,” he said. Annually, almost 800,000 Americans suffer a stroke, according to the American Stroke Association, causing 137,000 deaths.

The global market for acute ischemic stroke therapeutics was $303 million in 2009 and is expected to reach $544 million by 2017, according to research company GlobalData.

Aldagen also has completed a preliminary clinical trial, and has received federal approval to launch a phase 2 study, of its treatment for patients with critical limb ischemia — a severe obstruction of the arteries that cuts blood flow to hands, feet and legs. A phase 1 study in patients with heart failure also has been completed.

The deal also calls for three Aldagen directors joining the Cytomedix board, which has been expanded to nine seats. They are Richard Kent, chairman of Aldagen; Lyle Hohnke, Aldagen's former CEO; and Joseph Del Guercio, managing director of CNF Investments and a board observer for Aldagen. Also, Craig Mendelsohn has left from the Cytomedix board.

Edward L. Field, Aldagen's COO, was named COO of Cytomedix. Hinson becomes chief medical officer of Aldagen, now a wholly owned subsidiary of Cytomedix. It retains its manufacturing and product development facilities in Durham, where it has 14 employees.

In other Maryland bioscience industry news:

It's bad enough when your partner unexpectedly cuts off your relationship. It's even worse when you find out through a press release.

That was the scenario for Osiris Therapeutics, a Columbia stem cell company, which in 2008 had signed an agreement with Genzyme — now a wholly owned subsidiary of Sanofi — to help develop and commercialize its experimental treatment, Prochymal, for graft versus host disease.

Since then, Osiris has received $130 million in cash from its partner — and was potentially in line to receive milestone and royalty payments totaling an additional $1.25 billion.

But last week, Sanofi issued a news release, including a review of its research and development pipeline. In it, the company said it had “discontinued” its project with Osiris.

“The statement issued by Sanofi was made without consultation with or knowledge of Osiris,” Osiris said in a statement. “Osiris has not received any notification from Sanofi regarding the discontinuation of the agreement in place between the two companies.”

Osiris said it has advised Sanofi that it is treating the news release as Sanofi's election to end the agreement.

The 2008 agreement allows Sanofi to unilaterally end the partnership, Osiris said, in which case all rights to Prochymal revert to Osiris, which is free to enter into any other agreements for the treatment.

“Prochymal is used to treat a particularly lethal form of pediatric graft versus host disease, and to be perfectly clear, its development and commercialization efforts will continue,” said C. Randal Mills, president and CEO of Osiris, in the statement.

A familiar face in Maryland's bioscience industry is joining another.

Edward M. Rudnic, founder and former CEO of Advancis Pharmaceuticals — renamed MiddleBrook Pharmaceuticals — in Germantown, is joining QRxPharma, led by CEO John W. Holaday. Holaday also founded Rockville biotech EntreMed in the '90s.

Rudnic, who left MiddleBrook in 2008 after a Chicago investment firm pumped $100 million into it and it moved to Texas, also is former chairman of the Tech Council of Maryland.

Rudnic was named COO of QRxPharma of North Sydney, Australia, which has a U.S. office in Bedminster, N.J.

“For over three decades, Dr. Rudnic has established an impressive track record of successfully growing companies and launching innovative products in the global therapeutics marketplace,” Holaday said in a statement. “The addition of Dr. Rudnic to our senior management team is exciting, especially as we progress towards commercialising our first Dual Opioid product later this year. His knowledge and expertise will prove invaluable during this process.”

Rudnic is to help coordinate those commercialization plans with the company's strategic partner, Actavis, with the goal of launching the product in the $2.5 billion U.S. acute pain market in the third quarter. The product, called MoxDuo is a patented 3-to-2 fixed dose combination of morphine and oxycodone.

Actavis, of Morristown, N.J., has a research and development facility in Owings Mills.

Before founding Advancis, Rudnic worked for Shire Pharmaceuticals, Pharmavene, Schering Plough and E.R. Squibb.

Micromet, which last month agreed to be sold to Amgen for $1.16 billion, has a court date on Feb. 27 in Delaware with investors who claim the deal shortchanges them.

The Rockville biotech develops treatments for cancer, including leukemia. It faces suits from 11 investors, according to a recent regulatory filing. They allege, among other complaints, that Micromet should have sold to the California biotech giant for at least $12 per share. The agreed price was $11 per share; the closing price the day before the deal was announced was $8.28.

Seven of the suits were filed in the Delaware Court of Chancery, with three filed in Montgomery County Circuit Court and one in U.S. District Court in Maryland. Among the plaintiffs suing in Delaware is the Louisiana Municipal Police Employees' Retirement System.

The Delaware court has scheduled a hearing for Feb. 27 on the request by the plaintiffs in those cases for the court to grant preliminary injunctive relief, according to the Micromet filing.

Micromet and Amgen also announced this week that the Federal Trade Commission ended the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976 for the acquisition early. The agency ended the period, initially scheduled to expire Friday, on Tuesday.

RegeneRx Biopharmaceuticals reported that its thymosin beta 4 peptide, which it is developing to treat a variety of conditions, also might help patients with traumatic brain injury.

In a new study conducted by the neurosurgery department at the Henry Ford Hospital System in Detroit, rats that had traumatic brain injury had improved brain function after being treated with the product, according to a company statement. Rats receiving a higher dose fared better than those receiving a lower dose; both groups recovered better than the placebo group.

The results were published in the Journal of Neurosurgery.

"This preclinical study on the use of Thymosin beta 4 for the treatment of traumatic brain injury adds to the growing body of literature demonstrating the use of Tß4 in neurological injury,” Dan Morris, a senior staff physician with the hospital and an investigator, said in the statement. “The collective evidence of the neurorestorative properties of [thymosin beta 4] in animal models of multiple sclerosis, stroke and traumatic brain injury are compelling and we look forward to evaluating this drug in clinical trials."

RegeneRx is developing products based on thymosin beta 4 to treat dry eye syndrome, cardiovascular and central nervous system diseases, and the skin disease epidermolysis bullosa.

Advanced BioScience Laboratories and a Michigan company, AlphaCore Pharma of Ann Arbor, have received funding from a National Heart, Lung and Blood Institute program under which the Rockville company will manufacture an enzyme that could be used to treat atherosclerotic cardiovascular disease by helping the body remove cholesterol.

Under the program, “Science Moving towards Research Translation and Therapy,” Advanced BioScience will manufacture recombinant human lecithin-cholesterol acyltransferase, which is in a phase 1 clinical trial. The longterm goal is to reduce the risk of cardiovascular events in patients with acute coronary syndrome, according to a joint statement.

“Research in rare genetic diseases can encounter funding hurdles, yet through this NHLBI-sponsored manufacturing project we have the potential to advance an urgently needed enzyme replacement therapy,” Thomas VanCott, CEO of Advanced BioScience, said in the statement.

CosmosID of College Park is partnering with an Indian biotech to develop diagnostic kits for tuberculosis that identify particular strains of the disease — with the goal of treating it with the most appropriate antibiotic.

“Our collaboration will provide significant benefits for TB patients worldwide and demonstrates a new paradigm for medical diagnostic screening of infectious disease,” Rita Colwell, founder and chairwoman of CosmosID, said in a joint statement.

Typically, tuberculosis patients are treated with antibiotics without regard to the particular strain and whether it is resistant to that treatment, according to the statement from CosmosID and Avesthagen of Bangalore.

“Avesthagen has been working on TB for some time and has developed a genomic data pool,” Villoo Morawala-Patell, founder of Avesthagen, said in the statement. “In CosmosID we have found a leader and strong partner, developing rapid pathogen identification methods, MetaSeq Genomics, to facilitate more precise diagnostic screening of infectious disease in a single, rapid, and accurate test.”

rrand@gazette.net