United Therapeutics suffered a setback this week, as preliminary results from a phase 3 clinical of its oral treatment for pulmonary arterial hypertension failed to show a statistically significant improvement.

Patients who received oral treprostinil in conjunction with other available treatments did walk farther in six minutes than patients in the control group, who received only the other treatments. But by the end of the study both groups in the 310-patient study could walk farther than they did at the beginning, and those receiving oral treprostinil didn’t walk a significantly farther distance than the others.

The Silver Spring company has been testing oral treprostinil as both a standalone therapy and in conjunction with other available treatments. Based on stronger results from an earlier study of the drug as a standalone treatment, the company plans to apply to the U.S. Food and Drug Administration and European regulators for marketing approval in the first quarter of next year, executives said in a conference call Wednesday morning.

The drug should be made available for first-line use as the “gold standard of therapy,” President and COO Roger Jeffs said.

Company officials are “confident” that the results from the previous study of the drug as a standalone therapy will support its marketing application, said CEO Martine Rothblatt.

Still, Rothblatt acknowledged her “disappointment” with the results from the latest study.

Investors shared the sentiment, sending United Therapeutics stock plunging almost 19 percent on the news Wednesday, with no recovery on Thursday.

The company already markets intravenous, subcutaneous and inhaled treatments for pulmonary arterial hypertension, and anticipates sales of $1 billion in 2013, Rothblatt said, calling its drug portfolio a “fantastic franchise.”

The company has about $900 million in cash and equivalents, she said, and its reserves continue to grow as sales increase and margins improve. But the company is due to redeem $250 million in convertible notes in a few months.

Rothblatt said she and other officials “constantly review the market” to determine the timing for any stock buybacks, and they “will look at it more now than had the [trial] results gone the other way.”

In other Maryland bioscience industry news:

Nabi Biopharmaceuticals reported receiving a $5 million milestone payment from the U.S. manufacturing subsidiary of Fresenius of Bad Homburg, Germany.

The payment was related to the first commercial sale of Phoslyra under the Rockville biotech’s 2006 sale of PhosLo and related assets to Fresenius. That deal included the rights to a new liquid formulation of PhosLo that Fresenius has commercialized as Phoslyra.

The product is used to reduce serum phosphorus in patients with end-stage kidney disease.

Nabi received $65 million when the deal closed in November 2006 and has since collected an additional $18 million in milestone payments. It also may receive a $2.5 million milestone payment tied to approval of a new indication for PhosLo, plus about $65 million in potential royalty payments based on annual sales of Phoslyra until November 2016.

"We are pleased that this milestone has been achieved and hope that it will unlock the significant remaining value of our potential PhosLo revenue stream," said Raafat Fahim, Nabi’s president and CEO, said in a statement. "Since closing the sale in 2006, we have successfully achieved five of the six milestones under the sale agreement. We look forward to receiving additional potential PhosLo revenues."

A Rockville biotech’s patent infringement dogfight has been settled.

Mars Veterinary, a subsidiary of candy giant Mars, along with the Fred Hutchinson Cancer Research Center and Argus Genetics, both of Seattle, in December sued BioPet Vet Lab and PetSafe in U.S. District Court, claiming the defendants infringed on their patent for dog DNA identification kits.

Last week, Mars reported that the parties had reached a confidential settlement.

Under the agreement’s terms, BioPet may process dog DNA samples for a limited period for people who purchased its kit on or before June 15. Mars will process dog DNA samples through Dec. 15 for people who bought a PetSafe-branded DNA Breed Identification kit on or before June 15.

Otherwise, both BioPet and PetSafe have exited the canine DNA breed identification market, according to Mars.

The Mars kits come in two versions: one that uses a mouth swab and one used by veterinarians that uses a blood test. The test, which can detail the breed composition of mutts, was developed by using analyses of more than 19 million DNA markers from more than 13,000 dogs, according to a Mars statement.

The Hutchinson center owns the patent; Mars has a sublicense to it through Argus, which licensed it from Hutchinson.

RegeneRx Biopharmaceuticals reported enrolling all 72 patients in its phase 2 trial of its RGN-259 treatment for dry-eye syndrome.

Patients will receive RGN-259 or a placebo twice daily until Sept. 23. The Rockville biotech expects preliminary data available in October.

In animal models, RGN-259 worked better than Restasis — the only FDA-approved drug for dry-eye syndrome — for certain conditions, according to a RegeneRx statement.

From 25 million to 30 million Americans have dry-eye syndrome, according to RegeneRx. The annual global market for dry-eye disorders totaled $1.9 billion in 2010, and is expected to reach $2.8 billion by 2017, according to industry research cited by the company.

Annapolis biodefense company PharmAthene has landed a $5.7 million contract from the Pentagon to help develop bioproduction of its nerve agent medical countermeasure program.

The program involves rBChE, a recombinant form of a naturally occurring protein, human butyrylcholinesterase, which is found in minute quantities in blood, according to a PharmAthene statement. It works as a natural bioscavenger, like a sponge, to absorb toxins such as organophosphorous poisons such as nerve agents and certain pesticides, before they cause irreversible neurological damage.

Preclinical studies in animals indicate rBChE could protect against chemical nerve agent poisoning when administered prophylactically and also may increase survival when administered therapeutically.

Funding under the contract, which has a base period of 18 months, will be used to evaluate a novel mammalian cell-based manufacturing system for rBChE. That system could increase yield, manufacturing flexibility and cost-effectiveness of the program, the company said.

"This contract builds upon the body of knowledge we have established over the years with a specific focus on the expression of rBChE using a novel mammalian cell line that has been used for the advanced-stage bioproduction of other recombinant proteins with considerable FDA oversight and review," said Thomas Fuerst, executive vice president and chief scientific officer with PharmAthene.

SG Austria of Singapore, an affiliate of Nuvilex of Silver Spring, received a milestone payment from that nation’s Economic Development Board.

The payment was related to achieving scientific milestones following independent scientific review of the cell encapsulation company's ongoing research and development projects. The payment is part of the board’s 2008 five-year, $1.5 million grant to the company.

“We are also pleased to note that other, separate grant and milestone payments are on track over the next 12 months, increasing the value of our energies in Nuvilex, and in particular our affiliate SG Austria, the live-cell encapsulation platform, and the promises it holds for the scientific and medical fields,” Robert Ryan, president and CEO of Nuvilex, said in a statement.

Qiagen of the Netherlands, whose North American headquarters are in Germantown, is partnering with Pfizer to develop a companion molecular diagnostic test for use with an investigational Pfizer compound now in global clinical development for treating non-small cell lung cancer. Terms were not disclosed.

Qiagen’s proposed companion diagnostic will be based on its proprietary assay technology that detects mutations of the KRAS gene that are frequently found in human cancers, according to Qiagen information.

Emergent BioSolutions has launched a phase 1b/2 study of its treatment for relapsed indolent non-Hodgkin’s B-cell lymphomas.

The Rockville biotech is developing TRU-016 in collaboration with Abbott.

“Although patients show a high rate of clinical response to first line therapies they often relapse and in many cases, develop a resistance to treatment,” Scott Stromatt, vice president of clinical research and chief medical officer at Emergent, said in a statement. “Our preclinical studies show that when used together, TRU-016 and bendamustine resulted in increased anti-tumor activity beyond results achieved when either drug was administered alone. TRU-016 is also synergistic with rituximab in preclinical models.”

The company expects to enroll 88 patients with the cancer for both phases of the study.

BioElectronics of Frederick has enrolled about 40 of the 200 patients it plans to include in a clinical study of its electronic healing patch following caesarean sections.

"C-section surgeries involve relatively complex incisions penetrating the abdomen and uterus, usually requiring significant levels of narcotic pain medications to control pain during post-operative recovery,” CEO Andrew Whelan said in a statement. “Clinical research demonstrating the reduction of pain, accelerated postoperative recovery along with decreased narcotic pain medication use during C-section recovery will help significantly in the broader acceptance of our RecoveryRx product line."

Pending the study’s results, BioElectronics plans to apply to FDA for authorization to market the patch for this purpose.

“There are approximately 1.4 million cesarean deliveries each year in the United States, making this a substantial market opportunity for BioElectronics," Whelan said.

The company also announced that it has introduced a new shoe insole that contains the technology.

"We believe this product holds the promise to radically change the market dynamics within the billion dollar-plus foot care market," said Hudson Levy, ActiPatch brand manager, in a statement.

Pharmaceutics International reported passing a joint inspection of its manufacturing facility by the Food and Drug Administration and the European Medicines Agency.

The four-day inspection was part of the agencies’ joint initiative that focuses on increasing international regulatory collaboration among the agencies to enhance global drug quality and safety, according to a statement from the Hunt Valley company, which provides contract formulation and pharmaceutical development, clinical trial materials and commercial manufacturing services.

"We are extremely pleased to have achieved this major regulatory milestone," said Steve King, senior vice president, in the statement. "This approval allows Pii to continue providing commercial manufacturing services to the global pharmaceutical industry.”

BioMarker Strategies raised $1.1 million of a $4.0 million equity offering from 12 investors, according to a regulatory filing.

The Baltimore company develops cancer diagnostics.

Innovative Therapies of Gaithersburg was selected by the University of Tennessee Medical Center to provide its negative pressure wound therapy.

“This is a big win” for the company, CEO Richard Vogel said in a statement.

“This negative pressure device allows us to treat patients with complex wounds that we previously had not been able to treat,” said Ron Collins, the medical center’s executive director-supply chain. “Also, from an efficiency perspective, we are able to effectively treat and reach the desired outcomes for more patients in a quicker time frame.”

The therapy uses foam dressings and a proprietary simultaneous irrigation technology.