Pharma News: Rutgers Scores Protein Study
After a series of news announcements regarding biotech companies moving into the area (including Pharmasset coming to College Road and Phyton Biotech moving 40 people to Princeton-Hightstown Road), good news has also surfaced on the academic front.
Rutgers University says that its scientists are in charge of a major national research project to learn how looking at the structure of protein molecules can lead to the developing new medicines. That’s because knowledge of the structure could unlock the secret to how proteins control cellular processes.
This National Institutes of Health project aims to build on information accumulated from the Human Genome Project and sequencing of other organisms’ genomes, such as mice, chickens, and bacteria.
"Most of those proteins, we don’t know what they do, we don’t know how they work, we don’t know how to prioritize studying them for human medicine," says Gaetano Montelione, professor of molecular biology and biochemistry at Rutgers’ New Brunswick campus and leader of the project team.
The Protein Structure Initiative is worth about $300 million over five years to four collaborating institutions. Rutgers’ part of this, the Northeast Structural Genomics Consortium (NESG), is nearly $53 million. Montelione’s 120-person team includes researchers from eight other institutions, including Columbia University and Robert Wood Johnson Medical School in New Brunswick. In a pilot program this team has already identified the structure of about 200 proteins, and the data is now stored in the national Protein Data Bank based at Rutgers.
"This grant, one of the largest in Rutgers’ history, will reinforce our dynamic position in the biomedical sciences, inspire our researchers toward new discoveries, and open new doors to longer and healthier lives," says Richard L. McCormick, president of Rutgers, in a prepared statement. "Federal funding of this magnitude recognizes the caliber of our faculty and the quality of their research, and positions us for broader collaborations with other institutions and industries in New Jersey and beyond."
The latest promising announcement: during the week of August 8 the New Jersey Commission on Science & Technology said it would make $5 million in grant money available to help companies conduct stem cell research. New Jersey’s offerings are pale in comparison to the $3 billion that California is setting aside for stem cell research, but this NJCST grant will help.
Each company could get up to $300,000 for a variety of projects, including clinical work, research using a variety of stem cells, and the development of training programs.
Independent panels will review applications based on their merit and ethical appropriateness. Former Princeton University president Harold Shapiro will head the ethics panel.
Other news from the publicly traded biotechs is upbeat, as noted below.
Kos Pharmaceuticals (KOSP), 1 Cedar Brook Drive, Cedar Brook Corporate Center, Cranbury 08512. Adrian Adams, president and CEO. 609-495-0500; fax, 609-495-0920. Home page: www.kospharm.com
Kos Pharmaceuticals and the National Institutes of Health are co-funding a study to evaluate whether Niaspan (made by Kos) and a statin drug will work better than the statin drug alone to prevent cardiovascular events such as heart attack, stroke, and acute coronary syndromes.
This is the first large-scale study using this combination of therapies to decide if it is beneficial to treat low HDL-C ("good" cholesterol) levels and high triglyceride levels in vascular disease patients who have managed to lower their LDL-C or "bad" cholesterol.
"Lowering LDL-C alone may be insufficient and could fail to prevent 60 to 70 percent of events related to coronary artery disease. While many clinical trials have supported the role of HDL-C in reducing risks associated with heart disease, to date, these trials have been limited in terms of patient numbers," says Mark McGovern, chief medical officer of Kos Pharmaceuticals.
Patients in this six-year study, called AIM-HIGH, will have both vascular disease and atherogenic dyslipidemia (low HDL-C and high triglyceride levels). Most of them will have metabolic syndrome as well. At least 30 percent of the participants will be women, in part because new American Heart Association guidelines have effectively tripled the number of women that need to raise their "good" cholesterol.
A previous study using a combination of niacin and simvastatin showed a 60 to 90 percent reduction in cardiac events – double what would be expected with a statin alone – and regression of coronary atherosclerosis.
"Kos Pharmaceuticals has pioneered the development of the HDL-C prescription market following the introduction of Niaspan in 1997. The combination of the most effective drug for raising HDL-C, Niaspan, and the world’s second most widely prescribed statin, simvastatin, will potentially provide multidimensional lipid intervention, thereby, reducing cardiac events further," said CEO Adrian Adams in a prepared statement. "This study is obviously of high interest to Kos as we are currently developing a Niaspan/simvastatin fixed-dose combination, with a potential launch date scheduled for 2007."
The quarterly report for Kos Pharmaceutical shows revenue growth of 49 percent, with $51 million in cash generated from operations, and no debt on the balance sheet. The company’s remaining $19 million in debt has been converted to equity.
King and Palatin
King Pharmaceuticals (KG), 7 Roszel Road, Fifth Floor, Princeton 08540. 609-580-8000; fax, 423-274-2520. Www.kingpharm.com
Palatin Technologies Inc. (PTN), 4C Cedar Brook Drive, Cedar Brook Corporate Center, Cranbury 08512. Carl Spana PhD, CEO. 609-495-2200; fax, 609-495-2201. Www.palatin.com
Tennessee-based King Pharmaceuticals, which has an office on Roszel Road, and Palatin Technologies, based at Cedar Brook Corporate Center, have jointly started enrolling patients in a Phase II erectile dysfunction (ED) study to test PT-141. The two companies are developing PT-141 as a way of treating both male and female sexual dysfunction. The double-blind clinical trials, placebo controlled, will evaluate safety, treatment duration, patient populations, and range of doses.
Both diabetic and non-diabetic patients will participate in the trial, which consists of an "at home" three-month treatment period. About 35 clinical trial sites in the United States are supervising the trials, and they are expected to conclude next year.
"The initiation of these two double-blind, placebo-controlled Phase IIb clinical trials is a major milestone in the development of PT-141. We believe the data from this Phase IIb program will allow us to confidently select doses, end points and treatment periods for use in the design of the pivotal Phase III trials," says Carl Spana, CEO of Palatin Technologies.
PT-141, currently under development as nasal drops, is the first compound in a new drug class called melanocortin receptor agonists. Some degree of ED reportedly affects one half of all men over the age of 40.
Medarex (MEDX), 707 State Road, Princeton 08540. Donald L. Drakeman, president and CEO. 609-430-2880; fax, 609-430-2850. Home page: www.medarex.com
Medarex and PharmAthene are partnering on a Phase I clinical trial for Valortim (MDX-1303), a fully human monoclonal antibody that targets anthrax.
Valortim is designed to protect against inhalation anthrax, the most lethal form of illness in humans caused by the Bacillus anthracis bacterium. Valortim was developed using Medarex’s UltiMAb Human Antibody Development System and will be the 24th UltiMAb product candidate to enter clinical studies.
PharmAthene, a private firm, is located in Annapolis, Maryland, in the Chesapeake Innovation Center, the first technology incubator focused solely on Homeland Security (www.PharmAthene.com).
The two companies have filed an Investigational New Drug application with the U.S. Food and Drug Administration. The Phase I trial is supposed to collect safety data and could enroll up to 46 healthy volunteers. If the drug gets through Phase I, II, and III trials, it could be used to counter the bioterrorism threat of anthrax exposure.
"In preclinical animal studies Valortim has been shown to protect both rabbits and monkeys against the lethal effects of infection when administered at the time of exposure at doses as low as 1 mg/kg. When administered to rabbits after the development of symptoms, Valortim also improved survival as late as 48 hours post-exposure as compared to controls," said Israel Lowy, senior director of clinical science and infectious disease at Medarex, in a prepared statement.
Pharmacopeia Drug Discovery (PCOP), 3000 Eastpark Boulevard, CN 5350, Princeton 08543-5350. Leslie Browne, CEO. 609-452-3600; fax, 609-452-3672. Www.pcop.com
In July Pharmacopeia said it would partner with California-based Allergan to work on therapies for ocular disease – neovascularization, otherwise known as macular degeneration. Based at Exit 8A, Pharmacopeia offers patented chemical screening libraries for early drug testing and development.
Allergan paid cash to evaluate Pharmacopeia’s active lead compounds and could take one or more of those compounds through clinical trials. Pharmacopeia kept rights to other therapeutic areas.
"Pharmacopeia is advancing its internal, wholly-owned drug candidates focused on immunological diseases to clinical validation and beyond," says CEO Les Browne.
Early in August Michio Soga, the just-appointed CFO at Pharmacopeia, announced the firm had raised $8.47 million with a private placement financing to institutional investors. Soga is a graduate of Dartmouth and has a master’s degree from Yale.
VioQuest Pharmaceuticals (also Chiral Quest) (VQPH), 7 Deer Park Drive, Princeton Corporate Plaza, Suite E-2, Monmouth Junction 08852. Daniel Greenleaf, president and CEO. 732-274-0399; fax, 732-274-0402. Home page: www.vioquestpharm.com
Quarterly news for VioQuest Pharmaceuticals showed a dramatic revenue increase of 320 percent. Revenue in the second quarter was $1.5 million compared $357,000 in the second quarter of last year. That is partly because ChiralQuest, a subsidiary on Deer Park Drive, is shipping more of its proprietary ligands and catalysts. It provides chiral catalysts and contract process research synthesis expertise to 12 of the top 18 pharmaceutical companies worldwide.
Instead of 50 customers in the second quarter last year, VioQuest had 60 this year, and more than 80 percent of them were repeat sales.
Fighting Bone Infections
John F. Hartmann may be retired, but from his home office in Princeton Junction he is going full speed ahead with a research-based 10-year-old biopharmaceutical company and a biopolymer company.
The former Merck scientist has ElizaNor Biopharmaceuticals Inc. to develop a therapy for hard-to-cure osteomyelitis, a bone infection.
He also has ElizaNor Polymer LLC, to work on new biomolecular delivery nano-devices for targeting drugs to malignant tumors.
The biopharmaceutical company just renewed a defense department grant to continue working with scientists in Hungary, and a Canadian biotech may license the antibiotic technology.
The son of a Hungarian-born cabinet maker in North Philadelphia, Hartmann graduated in 1958 from the Philadelphia College of Pharmacy, spent seven years in the Army Reserve medical corps, earned a PhD at the University of Toronto in cell biology, and did postdoctoral work at Harvard and Penn. He spent most of his career at Merck, working in the asthma and diabetes areas and developing systems for testing drugs.
His inspiration for ElizaNor was a bone infection, osteomyelitis, that he had as a teenager. "I was hospitalized for two weeks," he says, "and antibiotics don’t really work for osteomyelitis, which can turn into a chronic condition. Many GIs who have had compound fractures (where the bone is visible) never quite get rid of the infection and must return to the VA hospital on a regular basis."
"Our antibiotic, designed to prevent osteomyelitis, would be used as an emergency treatment under battlefield conditions. The first 12 to 24 hours are very critical."
The drug works by focusing into areas rich in calcium. "We have taken antibiotics on the market but off patent and we change them in such a way that they still kill bacteria but they also bind to calcium rich areas," he says. Additional applications could be for other bone conditions and teeth.
The pharmaceutical company has received $150,000 from a more than $1 million biomedical grant from the Department of Defense. U.S. Army investigators at the Eisenhower Army Medical Center at Fort Gordon, Georgia, received $876,000 to continue to develop ElizaNor’s antibiotics for emergency treatment of severe bone injuries suffered in combat. "We ran out of money, and so did the army. This grant will allow us to resume work," Hartmann says.
The research was done in Hungary because it was cheaper there. "When I decided to form a company, in the middle 1990s, I asked a chemist friend of mine to look up some labs in Eastern Europe, where the lab work could be done inexpensively," he says. Now F. Sztaricskai and P. Herczegh have done the chemistry at the University of Debrecin, and the biological testing is being done by the army at Fort Gordon.
For the polymer company, he licensed all the technology created by a Hungarian polymer chemist Janos Borbely since 2000. This technology might be able to deliver any chemotherapy drug in a safer, more effective way. "By encapsulating the drug in nano particles, covered by a shell with targeting molecules, we can focus the drug into tumors," he says. This gives it delivery flexibilities "which are virtually unprecedented."
"Nano particles carry the payload of the old-fashioned chemo therapeutics that made people very sick. Stronger doses can focus more directly into tumors thereby reducing side effects," he says.
The polymer company, nevertheless, needs investment to continue. It was one seven finalists for the NJTC venture fund investment, but it did not win. John Butler of Gallagher, Briody, Butler is the corporate attorney, and the patent attorney’s office is on Long Island.
Hartmann’s wife, Betsy, is the bookkeeper for the two firms. Their son, John William Hartmann, an attorney in Princeton Junction and a former Republican Assemblyman for the state, has a toddler child. Their late daughter, Elizabeth, had been pregnant with Nora in 1989. Due to a blood clot, she died in the fifth month of her pregnancy. The companies are named after Elizabeth and Nora.
ElizaNor Biopharmaceuticals, 1 Woodmeadow Lane, Princeton Junction 08550-1323. John F. Hartmann, president. 609-799-2812; fax, 609-897-9660. E-mail: firstname.lastname@example.org