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United Therapeutics of Silver Spring, one of Maryland's more successful biotechs, has had mixed developments in its efforts to find new treatments for pulmonary arterial hypertension, which its flagship drug, Remodulin, already treats.

The company reported disappointing results from a 16-week trial of sustained-release oral treprostinil. Preliminary analysis showed that the trial, involving 354 patients, did not achieve statistical significance for the primary endpoint, a six-minute walk distance at week 16.

"While we are disappointed we did not achieve a statistically significant result for the primary endpoint, we believe the results fully support the continued development of oral treprostinil …," Roger Jeffs, company president and COO, said in a statement. The result "has not altered the fact that we believe that we have in place today all of the pieces that we need to continue growing our business."

Meanwhile, United Therapeutics will pay Eli Lilly and Co. $150 million upfront for exclusive rights to commercialize Lilly's tadalafil molecule for pulmonary arterial hypertension indications, now under regulatory review in the U.S. and other nations. Lilly also will purchase $150 million of common stock from United Therapeutics.

Lilly will manufacture and supply tadalafil to United Therapeutics and retain authority globally for all regulatory, development, intellectual property and manufacturing aspects of the tadalafil molecule for all potential indications.

In other Maryland bioscience news:

Psyadon Pharmaceuticals of Germantown — formerly Ruxton Pharmaceuticals — landed an $8 million financing round from venture capital firm New Enterprise Associates of Chevy Chase. Psyadon also will acquire worldwide rights to Schering Corp.'s selective dopamine D1 receptor antagonist, ecopipam; the new cash will help develop ecopipam to treat serious central nervous system disorders. James Barrett, general partner at New Enterprise Associates, will be chairman of Psyadon's new board.

Gaithersburg biotech GenVec has won Fast Track product designation by the U.S. Food and Drug Administration for its proposed use of TNFerade to treat locally advanced pancreatic cancer. The designation is based on GenVec having "provided evidence of the potential to improve survival in patients with pancreatic cancer," according to a company statement.

GenVec also reported encouraging preliminary results from an interim analysis of its ongoing phase 3 clinical trial with TNFerade in patients with locally advanced pancreatic cancer. The analysis, conducted after the 92nd death, one-third of the total expected, was designed to determine whether the study should continue.

"Successfully passing this milestone … represents an important step forward in the clinical development of TNFerade," Dr. Mark Thornton, senior vice president of product development, said in a statement. "We believe these data are encouraging and justify moving forward with the trial."

Another Montgomery County company working on pancreatic cancer treatments, Rexahn Pharmaceuticals of Rockville, has established an Oncology Scientific Advisory Board to help develop its lead cancer drug candidate, Archexin.

The board comprises Chairwoman Dr. Margaret Tempero, director of the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco; Dr. Barbara Burtness of the Fox Chase Cancer Center; Dr. David I. Quinn of the University of California's Kenneth J. Norris Comprehensive Cancer Center; Dr. Bruce G. Redman, clinical professor at the University of Michigan Health System; Dr. William Small Jr., professor at Northwestern University Feinberg School of Medicine; and Dr. Gauri Varadhachary of the M.D. Anderson Cancer Center in Houston.

Spherix of Bethesda has started recruiting more than 300 patients in India for a phase 3 trial of its type 2 diabetes drug candidate, Naturlose. Enrollment is scheduled for completion by March, with the trial expected to be finished in 2010. Spherix also hired Amarex, a contract research organization in Germantown, to oversee the work of two India organizations hired to execute the trial in India. Also, Spherix stockholders authorized the company to execute a reverse stock split any time in the next 12 months at a ratio ranging from 1-to-5 to 1-to-20.

Vanda Pharmaceuticals of Rockville, which was dealt a blow this summer when the Food and Drug Administration rejected its application for its lead drug candidate, iloperidone, to treat schizophrenia, said the FDA has accepted its resubmission of a new drug application. The agency set a new target action date of May 6, Vanda reported.

Privately held Alba Therapeutics of Baltimore has enrolled its first European patient with active celiac disease in an eight-week phase 2b clinical trial of larazotide acetate. "These are decisive times for our desire to one day be able to offer our celiac patients a treatment that allows them to live more normal lives," said Dr. Gemma Castillejo, the principal investigator in the study.

Celiac disease is an inherited autoimmune disorder in which gluten, an ingested protein in wheat, barley and rye, triggers intestinal inflammation. Symptoms include skin rash, anemia, fertility issues, joint pain, weight loss, tooth discoloration, depression, chronic diarrhea or constipation and abdominal pain; long-term complications include osteoporosis, intestinal cancer and lymphoma. The disease affects 3 million Americans and 6.5 million people worldwide.

Profectus BioSciences of Baltimore signed an assignment and license agreement with Wyeth Pharmaceuticals that provides Profectus with therapeutic and prophylactic vaccine programs for HIV, hepatitis C virus, human papilomavirus and herpes simplex virus.

"Bringing the Wyeth portfolio into Profectus boosts our ability to develop innovative ways to treat patients inflicted with some of the most destructive viral diseases of our day," Shawn O'Brien, Profectus president and CEO, said in a statement.

Struggling Bethesda biotech RegeneRx Pharmaceuticals has told federal regulators that it has enough cash and other resources to fund operations through December, or February, if it cuts certain expenses. "Accordingly, we have an immediate need for financing and are in the process of exploring various alternatives …," it said in a filing with the Securities and Exchange Commission.

Meanwhile, the company reported more positive news: Its ophthalmic drug candidate was used to treat four neurotrophic keratitis patients with non-healing eye ulcers caused primarily by the herpes zoster virus under a Compassionate Use Investigational New Drug application. The eye-drop formulation was "well-tolerated and there were no drug-related adverse events."

Xceleron of Germantown signed an agreement with Otsuka Pharmaceutical Development & Commercialization to provide clinical trial services. Xceleron will provide detailed absorption, distribution, metabolism and excretion data in phase 1, data not usually obtained until phase 2 or 3.

The Maryland Stem Cell Research Commission said it received 187 letters of intent — 60 more than last year — in response to its three official requests for applications for the third year of funding through the Maryland Stem Cell Research Fund, which has $18 million in fiscal 2009.

"This positive response is a testament to the growing interest in Maryland's stem cell research program, and our shared commitment to remaining a national leader in the life sciences industry," Gov. Martin O'Malley (D) said in a statement.

"The commission is extremely gratified and fulfilled by the impressive response to our request for letters of intent, as it serves as a vote of confidence from the stem cell research community," said chairwoman Karen Rothenberg.

PharmAthene of Annapolis has signed an exclusive, multiyear agreement with Medison Pharma of Israel to commercialize its biodefense products in Israel. Medison Pharma will be responsible for overseeing regulatory approval, marketing and distribution activities for those PharmaThene products in Israel.