Antares Pharma Inc. , a specialty pharmaceutical company that develops and licenses drug delivery technology for next-generation lifestyle products, announced that it filed an Investigational New Drug (IND) application on Monday, March 14, 2005, for the Company's first proprietary pharmaceutical product (AP-1034), oxybutynin ATD(TM) gel for overactive bladder syndrome (OAB). Based on the evidence provided by the Company in its pre-IND meeting with the FDA, the Company was granted the right to proceed directly into a Phase II dose ranging study upon concurrence with the protocol submitted, as well as conduct only a single Phase III study.

Jack E. Stover, President and CEO of Antares Pharma, commented, "The submission of Antares Pharma's first proprietary pharmaceutical submission to the FDA is an important milestone in our specialty pharma strategy." Mr. Stover added, "It is especially rewarding to have been granted the right to proceed expeditiously with our clinical studies. We believe this accomplishment is indicative of our ability to execute on our commercial plans and bodes well for our future gel-based products."

Dr. Dario Carrara, Managing Director of Antares Pharma's Pharmaceutical and Formulation Division, stated, "Our development team has done an outstanding job in completing the filing within the projected timing. I am confident that they will continue to work with the Agency toward finalizing the Phase II protocol and then completing the studies with the same diligence exhibited to date."

OAB is characterized by involuntary muscle contractions leading to loss of urine, with symptoms including urinary frequency, urgency and urge incontinence. The syndrome affects an estimated 17 million people in the United States, with the highest incidence of occurrence in women of post- menopausal age. While it can affect a person at any age, it is most common among the elderly, with a prevalence of 33% to 61% in people over age 65. A SCRIPT report in 2004 highlighted that OAB is the fastest growing pharmaceutical sector, which will exceed $11 billion by the year 2008. Currently, the market for OAB is dominated by major pharmaceutical companies such as Pfizer and Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson.

AP-1034 utilizes Antares Pharma's proprietary Advanced Transdermal Delivery (ATD(TM)) gel technology designed to allow delivery of active substances across the skin. The Company's AP-1034 formulation is a cosmetic quality, clear and odorless gel designed to be rapidly absorbed through the skin following a once-a-day application on the abdomen, shoulders or thighs with reduced side effects.

Source: Antares Pharma

− Peptide slows Pancreatic Cancer Cell proliferation −

INNOVIVE Pharmaceuticals Inc., a biopharmaceutical company headquartered in Manhattan, announced it has licensed worldwide rights for the use of Opioid Growth Factor (OGF) in oncology from Penn State. OGF, also known as (Met5)-enkephalin, is a naturally occurring molecule found in the human body that has recently been shown to significantly reduce the proliferation of pancreatic cancer cells. OGF will be developed under the name INNO-105.
INNO-105 inhibits cell growth and division by interacting with OGFr, a unique receptor found on the nuclear membrane of a wide range of cells and tissues, including several malignant cells. OGFr has been found on pancreatic adenocarcinoma, head and neck squamous cell carcinoma, colon cancer, renal cell carcinoma, and neuroblastoma, among others.

The potential for INNO-105 as an anti-cancer compound was discovered by Ian S. Zagon, Ph.D., professor of neural and behavioral sciences, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center. Zagon and his research team, including Patricia J. McLaughlin, D.Ed., professor of neuroscience, Penn State College of Medicine, demonstrated that INNO-105 dramatically slows proliferation of brain, colon, head and neck, and pancreatic cancer cells in laboratory mice. The mice receiving INNO-105 in combination with a chemotherapy agent were overall healthier, maintained body weight and had a longer survival time compared to those receiving the chemotherapy agent alone. The studies were supported by grants from the National Institutes of Health and Pennsylvania Tobacco Settlement.

With these promising findings, Jill Smith, M.D., professor of medicine, Penn State College of Medicine, initiated a small, single agent Phase I clinical study in pancreatic cancer, sponsored by the National Institutes of Health. The maximum tolerated dose of INNO-105 was defined. Patients on the chronic dosing cohort of the study had a mean survival of nine months. The study findings were published in the March 2004 issue of the journal, "Anti-Cancer Drugs."

"INNO-105's unique mechanism of action, modest toxicity profile and early indication of efficacy, especially in untreatable cancers, places it in a class by itself and makes it an ideal development compound. We consider it an excellent candidate to combine with chemotherapy and/or biologics," said Steven Kelly, president and chief executive officer, INNOVIVE Pharmaceuticals Inc.

INNOVIVE plans to initiate a Phase I trial this year to confirm INNO-105's maximum tolerated dose alone and in combination with chemotherapy as well as its anti-tumor activity in pancreatic cancer. The trial is expected to take six to nine months to complete. This study will be followed by a randomized trial comparing INNO-105 combined with gemcitabine to gemcitabine alone.
"We are pleased that INNOVIVE Pharmaceuticals has licensed INNO-105. Once commercialized, this compound has the potential to help the medical community extend the lives and to improve the quality of life for a broad range of cancer patients," said Zagon.

Source: INNOVIVE Pharmaceuticals

TheraQuest Biosciences, a development stage pain management company, unveiled new, positive Phase II clinical trial results for its intravenous ketoprofen (TQ-1011) product at the American Pain Society 24th Annual Scientific Meeting in Boston. TQ-1011 is a proprietary investigational injectable formulation of the non-steroidal anti-inflammatory drug (NSAID) ketoprofen. Injectable ketoprofen is being developed for the management of moderate to severe postsurgical pain. TheraQuest has held regulatory consultations with FDA, U.K. and Canadian authorities.

Najib Babul, PharmD, President and Chief Executive Officer of TheraQuest, stated, "TheraQuest is excited about the positive Phase II results from this large, double blind study in moderate to severe postsurgical pain. Intravenous ketoprofen was superior to placebo and IV morphine on all standard efficacy endpoints."

Paul Desjardins, DMD, PhD, Executive Vice President of SCIREX, a premier analgesic CRO that conducted this clinical trial, noted, "The results are striking because both doses of IV ketoprofen provided rapid onset of effect and robust, long lasting analgesia, superior to morphine and placebo. In particular, on the patient global assessment of therapy, approximately 90% of patients receiving IV ketoprofen reported 'Excellent,' 'Very Good' or 'Good' analgesia versus only 15% on morphine 4 mg IV and 3% on placebo."

Source: TheraQuest Biosciences

Demegen, Inc. (PRVG), a biotechnology company specializing in the development of peptides for the treatment of infectious diseases, announced it had granted a license to Pacgen Biopharmaceuticals Corporation (Pacgen) for certain Demegen peptides for prescription and over-the-counter pharmaceutical products to treat oral diseases.

Pacgen’s initial focus will be a treatment for oral candidiasis, for which Demegen already has an approved IND.  This condition is an AIDS-defining opportunistic illness that is highly prevalent in HIV-infected individuals.  Other immunocompromised individuals, including cancer patients receiving chemotherapy, are also susceptible to oral fungal infections. The disease causes pain, inability to eat, and increased risk of additional infection.  Oral candidiasis outbreaks often recur and maintenance therapy may be needed.

David Cheng, Ph.D., CEO of Pacgen said: “While Pacgen has a number of anti-microbial peptides in its pipeline, we are impressed with the clinical development achieved thus far by Demegen and believe we can get to market faster by working with Demegen.”

Pacgen Biopharmaceuticals Corp. is an international biotechnology company based in Vancouver, Canada with specialty in drug design and development in infectious diseases and immune system regulations.

Demegen develops novel and natural peptides for the treatment of bacterial and fungal infections.  Demegen operates primarily with strategic partners and development efforts are underway for a number of dermatological, ophthalmic, cosmetic and agricultural applications.  Other products to be developed include a treatment for cystic fibrosis infections.

Source: Demegen

The Global Alliance for TB Drug Development (TB Alliance) and GlaxoSmithKline (FTSE/NYSE: GSK) announced they will pursue a joint drug discovery program to improve the treatment of tuberculosis (TB). The program substantially enhances the worldwide TB drug pipeline by adding several novel classes of compounds that use new mechanisms of action.

The joint research program consists of a portfolio of four projects intended to yield new compounds that attack Mycobacterium tuberculosis (M. tb) on multiple levels. Drug candidates arising from these projects could shorten the treatment time for patients with TB and, because of their novel mechanisms of action, treat patients who are resistant to conventional therapies. These compounds will also be screened for their ability to be used simultaneously with HIV/AIDS treatments, known as antiretrovirals (ARVs). TB is a leading cause of death among people living with HIV/AIDS, but today simultaneous TB- HIV treatment is extremely difficult due to drug-drug interactions between some ARVs and current TB drugs.

"This partnership makes a significant contribution to the increasingly robust TB drug pipeline," said Dr. Maria C. Freire, President and CEO of the TB Alliance. "Ultimately, the revolution in TB treatment will be based on the best combinations of novel drugs. By joining both parties' expertise and committing to affordability, we are making a major step forward in solving a complex global health problem."

"We look forward to leveraging GSK's Diseases of the Developing World program by joining the TB Alliance's initiative to combat tuberculosis," said Dr. Tadataka Yamada, Chairman of Research and Development at GSK. "This joint research program exemplifies the type of partnership that is needed to speed the development of new therapies for the leading infectious diseases in developing nations."

The research program includes the pleuromutilins, a novel class of antibiotics, and two target-based projects, isocitrate lyase (Icl) and InhA. The fourth project will screen GSK's antimicrobial libraries for novel compounds that have the ability to kill M. tb. The program will be overseen by a Joint Steering Committee and is based at GSK's Tres Cantos, Spain facility, dedicated to the Diseases of the Developing World. The TB Alliance will help support 25 full-time scientists working exclusively on the TB drug program. GSK agrees to absorb all remaining overhead costs for the associated projects. GSK will also contribute a matching number of staff as well as its drug discovery expertise. The agreement stipulates that any resulting medicines will be affordable and accessible to those most in need.

"The TB Alliance's hard work in the past five years has paved the way for a set of major steps forward in TB treatment," said Mark Harrington, Executive Director of the Treatment Action Group. "The challenge ahead is to expedite the clinical trials of the most promising drugs in people with TB and with HIV/TB, so we can realize the promise of faster curative treatment that is safe and effective with anti-HIV drugs."

The TB Alliance's goal is to develop an entirely new therapeutic regimen that will shorten and simplify current TB treatment, which currently takes six to nine months to complete. There have been no new TB drugs introduced in over 40 years. In assembling the first global TB drug pipeline since the 1960s, the TB Alliance forges partnerships with industry, research institutes, and academia. In addition to supporting platform technologies, the TB Alliance is developing nitroimidazopyrans, quinolones, macrolides and other classes of antibiotics.

A shorter TB regimen is expected to improve patient compliance, increase cure rates and lower toxic side effects, thereby limiting the rise of new resistant strains. A novel TB regimen that is also compatible with HIV treatments would improve TB control and help in the fight on AIDS. The TB Alliance works to ensure that drugs are affordable, adopted by health practitioners and are accessible to patients who need them most.

Source: GlaxoSmithKline

ZLB Behring a CSL Limited Company, announced that it is working with the World Federation of Hemophilia and local governments to provide plasma therapeutic products to people in need in Asia struggling with a healthcare system severely challenged by the tsunami catastrophe. Efforts, which began earlier this year, were made to address both the immediate concerns following the tragedy as well as the ongoing special needs for chronic care populations that rely on life-saving plasma therapeutics.

To address needs soon after the tsunami, ZLB Behring donated supplies of human albumin, which is used to prevent and treat shock and trauma, to Sri Lanka through its Ministry of Health. This donation was the result of the company actively surveying affected countries and international aid organizations to determine their requirements, and Sri Lanka’s need surfaced.

“The primary aid focus after the tsunami were for basic supplies and emergency care to which ZLB Behring responded. As time progressed, however, we determined that there were other medical needs that demanded attention. People with hemophilia, for example, depend on specialized ongoing treatments to survive. These patients with chronic conditions were reported to be deprived of the therapies they needed in the extreme conditions following the tsunami,” said Alberto Martinez, MD, Head of Global Commercial Operations for ZLB Behring.

To help meet this need, ZLB Behring contributed to the World Federation of Hemophilia (WFH), approximately 5 million International Units (IU) of Helixate® FS Antihemophilic Factor (Recombinant) in addition to 1,756 vials of Stimate® (Desmopressin Acetate) Nasal Spray, both of which are used for bleeding disorders.

“With the focus on basic health needs in the aftermath of this disaster, our concern is that people with chronic conditions such as hemophilia, which requires a steady supply of blood clotting factor, will be adversely affected. The WFH is grateful that donations of blood clotting factor have been made available by ZLB Behring so that individuals with bleeding disorders will be able to treat their condition.” said Mark Skinner, President of the World Federation of Hemophilia. “These donations will be of great assistance to the national hemophilia programs in India, Indonesia and Thailand and other nations affected by the tsunami,” Skinner added.

Source: ZLB Behring