Teva provides another lift to Rexahn

From By Robert Rand


Rexahn Pharmaceuticals, a Rockville biotech that develops treatments for cancer and central nervous system disorders, got another boost this week from the Israeli company that’s already a major investor and development partner.

Teva Pharmaceutical Industries of Petach Tikva agreed to buy $750,000 worth of Rexahn’s common stock next week, paying 120 percent of its previous day’s closing price. The deal is part of a 2009 purchase agreement between the companies.

Following this latest deal, Teva will have invested $7.5 million in Rexahn and will own a 5.7 percent equity stake in the company, according to Rexahn spokesman Constantine Theodoropulos.

Teva also agreed to provide $926,000 in research funding as Rexahn pursues trials of its RX-3117 treatment for pancreatic and other cancers. Preclinical studies show the compound can help overcome drug resistance in cancer cells.

The two companies finished a phase 1 trial of the treatment in August. That study, conducted in Europe, demonstrated that RX-3117 is bioavailable when administered orally to patients, according to Rexahn information.

In exchange for the research funding, Teva secured the right to file an investigational new drug application with the Food and Drug Administration for RX-3117.

“This new investment and research and development funding by our strategic partner Teva is important to the continued development for RX-3117,” Rexahn CEO Chang Ahn said in a statement. “Similar to other products we are developing, RX-3117 is a highly differentiated anti-cancer compound. As a potential future alternative to market leading antimetabolites, RX-3117 can be given by oral administration to potentially treat solid tumors. We look forward to working with Teva to take RX-3117 to its next stage of development.”

Teva, the world’s largest manufacturer of unbranded generic drugs, according to an industry trade group, has a U.S. subsidiary in Rockville.

Rexahn also announced Thursday that it plans to gross $6.3 million in an offering of 19.1 million shares of common stock and warrants for up to 10.5 million shares in an underwritten public offering.

In other Maryland bioscience industry news:

GeneDx, which provides genetic testing for rare hereditary disorders, is expanding its space and workforce in Gaithersburg.

The biotech plans to maintain its 45,000-square-foot headquarters in the Avenel Business Park on Perry Parkway and add 29,000 square feet nearby, according to a statement from city officials.

The company also expects to grow its workforce by 50, bringing it to 256 employees within two years.

GeneDx is receiving assistance from the Gaithersburg Economic Opportunities fund to help renovate both properties. On Nov. 19, the city council and mayor OK’d up to $3 per square foot for that purpose.

The city has used the $2 million fund to attract Novavax and Adventist HealthCare to Gaithersburg, and also is helping Cytomedix expand in Gaithersburg.

Supernus Pharmaceuticals reported that the Food and Drug Administration has granted its epilepsy treatment Oxtellar XR three years of market exclusivity.

The FDA approved the extended release drug last month as an adjunctive therapy of partial seizures in adults and in children 6 to 17 years old.

The Rockville biotech also reported that its experimental drug to treat impulsive aggression in attention deficity and hyperactivity disorder patients showed promising results in a phase 2b clinical trial.

The trial involved 121 patients, ages 6 to 12, who were given either a placebo or one of three doses of the treatment, SPN-810.

The study showed statistical significance among the groups taking low and medium doses in meeting the primary endpoints. However, the drug worked better in patients who weighed at least 66 pounds. Data from patients taking high doses did not meet these endpoints.

“Coupled with the fact that the high dose did not show efficacy with statistical significance, this unexpected result leads us to believe that the most effective doses are those that achieve certain plasma concentrations (related to body weight) that do not exceed a level beyond which some sort of saturation threshold is reached,” the company said in a statement.

“We are very excited about the positive results exhibited by SPN-810 at lower doses,” CEO Jack Khattar said in the statement. “The study accomplished its objectives of establishing a dose range at which the drug is effective and confirmed the efficacy of SPN-810 … in the treatment of impulsive aggression in ADHD patients. Because we have seen clear and consistent efficacy demonstrated by the low and medium doses in this study across several measures, we have decided to advance the program into later stage development. We will be analyzing the full dataset in depth, and subsequently planning on meeting with the FDA to discuss next steps in the development program and the design and protocol for phase 3 clinical trials.”

The SPN-810 molecule already has been approved by the FDA as a treatment for schizophrenia, marketed under the trade name Moban.

EntreMed’s experimental therapy for a type of breast cancer that’s especially hard to treat showed “robust anticancer activity” in a preclinical study, according to the Rockville biotech.

The oral treatment, called ENMD-2076, was effective against breast cancer cell lines lacking expression of the estrogen receptor and progesterone receptor, and without HER2-amplification: what’s known as “triple-negative” breast cancer, the company said in a statement.

“Triple-negative breast cancer is an aggressive breast cancer subtype which carries a high risk of developing metastasis,” Jennifer R. Diamond of the University of Colorado School of Medicine, who led the study, said in the statement. “A major barrier to the successful treatment of metastatic [triple-negative breast cancer] is the lack of effective targeted anti-cancer agents. Through this study, we show that ENMD-2076 has activity against preclinical models of breast cancer with more robust activity against [triple-negative breast cancer].”

The study data provide “strong support for the rational of our ongoing phase 2 … trial,” CEO Ken Ren said. “Upon further confirmation clinically, it may also provide guidance on future trials for patient selection, and may increase the probability of success. We are continuing to enroll patients in the ongoing Phase 2 trial and anticipate the initiation of a second site for this trial soon. We remain on track with our clinical development activities and expect our progress to accelerate in the coming months and year.”

Sucampo Pharmaceuticals and its partner, Abbott, have started selling Amitiza to treat chronic constipation not caused by organic diseases in Japan. Japanese regulators approved the drug in June.

“Millions of patients in Japan have been suffering from chronic constipation, without efficacious and well-tolerated, long-term treatment options, » Ryuji Ueno, Sucampo’s CEO, said in a statement from the Bethesda company. “We are pleased to bring Amitiza’s experience of six years and over 6 million prescriptions in the U.S. to the Japanese market, to benefit the health care providers and patients who need it.”

Chronic constipation affects several million people in Japan, according to the statement.

Abbott will promote and distribute Amitiza in Japan under its 2009 license, commercialization and supply agreement with Sucampo.

Cytomedix reported winning regulatory approval to sell its technology for processing blood and bone marrow aspirate for new uses in the European Union and other nations.

The Gaithersburg company received CE Mark approval for its Angel Concentrated Platelet Rich Plasma System for use in bone repair and regeneration procedures, including spinal, periodontal and joint revision surgery.

Global sales of the system have tripled during the past year and are expected to exceed $1 million this year, according to a company statement. Cytomedix expects to boost sales with entry into new Mideast nations such as Kuwait, Saudi Arabia and Bahrain with the expanded indications.

“We see this new indication having a noticeable impact on our promotional efforts and becoming a major driver of growth in various international markets,” CEO Martin Rosendale said in the statement. “On the strength of this approval, we believe that international Angel revenues have the potential to double in 2013.”


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