454 Life Sciences (Branford) and other Roche units have announced a collaboration with Eli Lilly and Company and SeqWright. The goal is to use genomic technologies to identify genetic variants possibly associated with various psychiatric diseases. SeqWright will utilize NimbleGen Sequence Capture technology to selectively enrich approximately 40 megabases of the human genome, which will then be comprehensively sequenced using 454 Life Sciences’ Genome Sequencer FLX System.

Commenting on 2Q results, Michael Kishbauch, President and CEO of Achillion Pharmaceuticals, Inc. (New Haven), said: "We strengthened our financial position with [a] recently announced standby equity distribution agreement that is expected to provide up to $15 million of capital ... . We are actively preparing for a pre-IND consultation with the FDA regarding ACH-1095, our NS4A antagonist for the treatment of hepatitis C virus ... . We initiated Phase 1 studies with our hepatitis C virus protease inhibitor, ACH-1625, and we continue to receive data regarding the drug's safety and tolerability profile, which we expect to announce late this summer."

Alexion Pharmaceuticals (Cheshire) announced that Soliris® (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS), an ultra-rare, inherited, and life-threatening complement-inhibitor deficiency disease that often progresses to end-stage kidney disease or failure. The U.S. FDA granted orphan drug designation to Soliris for the same indication in May 2009. (Soliris is not approved for the treatment of patients with aHUS.)

Amarin Corporation (Dublin/Mystic) announced it has executed an agreement for the private placement of convertible bridge loan notes in the amount of $3.0 million with select accredited and institutional investors. Amarin is a late-stage biopharmaceutical company with a focus on cardiovascular disease. The Company’s lead product candidate is AMR101, a prescription grade Omega-3 fatty acid. Amarin is NASDAQ listed and recently established its research and development headquarters in Mystic.

Applied Spine Technologies (New Haven) a medical device company focused on motion preservation of the lumbar spine, announced that their initial cohort of 15 Stabilimax System patients have reached the 24 month mark in the ongoing clinical trial. The Stabilimax System is a posterior dynamic stabilization device designed to support an injured or degenerative spine without eliminating motion. The company recently received permission from the FDA to resume a multi-center, randomized, controlled clinical trial to compare posterior dynamic stabilization using the Stabilimax®  Dynamic Spine Stabilization System to traditional spinal fusion stabilization to treat degenerative lumbar spinal stenosis. AST has enrolled more than 100 patients to date.

Bayer HealthCare (Leverkusen, Germany/West Haven) announced that the FDA has approved a 3000 IU (international unit) vial size of Kogenate® FS, antihemophilic factor (recombinant). The 3000 IU vial may eliminate the need for combining smaller vials and may allow some patients to achieve more precise dosing.

Boehringer Ingelheim (Ingelheim, Germany/Ridgefield) announced the initiation of a Phase 3 clinical study of BIBW 2992 as first-line treatment in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. BIBW 2992 is the first orally-administered irreversible dual inhibitor of EGFR to reach Phase III development in NSCLC.

Bristol-Myers Squibb Company (New York/Wallingford) and AstraZeneca announced that the FDA has approved ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor. ONGLYZA is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus.

Connecticut Innovations (Rocky Hill) announced it has made an investment of $750,000 in Soft Tissue Regeneration, Inc. (STR) through its Eli Whitney Fund. This investment is part of a $3.5 million Series A round also involving Philadelphia-based MentorTech Ventures II LP. STR is in the process of relocating its operations from Charlottesville, Virginia, to Connecticut.

Danbury Hospital (Danbury) said its Children’s Health and Wellness Center brings a variety of pediatric subspecialists together under one roof. Located at 79 Sand Pit Road in Danbury, the center has pediatric specialists in endocrinology (diabetes), pulmonology (asthma), psychiatry, cardiology, genetics, gastroenterology and physical medicine/rehabilitation. The 4,000-square-foot facility includes examination and consultation rooms, physician offices, and a conference center for community educational forums. Laboratory services are located on-site as well.

Genomas Inc. (Hartford) celebrated its fifth anniversary as the anchor of the Hartford Hospital Genetics Research Center with a ceremony and open house at the company’s laboratories in July.  Gualberto Ruaño, M.D., Ph.D., President of Genomas and Director of Genetics Research at Hartford Hospital, stated: "Personalized healthcare is often referred to as the 'future of medicine.' In 5 years, Hartford Hospital and Genomas together have advanced this field to the present for our patients, by being at the vanguard of the practice of DNA-Guided Medicine. Foremost in my mind is a deep appreciation to the patients we have served and to the physicians who referred them to us for improving the safety and efficacy of their drug treatments. At a personal level, I am very honored by the trust of our collaborators, advisers and investors on the formidable capabilities of the entire Genomas team and by their sharing our vision of personalized medicine in clinical practice."

GlaxoSmithKline plc (Research Triangle Park, NC) said August 14 that it is "making good progress" with the development of its vaccine against the Pandemic (H1N1) 2009 influenza virus. The first clinical trial, being conducted in Germany, will assess the use of the vaccine in healthy adults. Initial data is expected to be available for sharing with regulatory authorities in September.

Hartford Hospital (Hartford) announced plans to create a new business affiliation with The Hospital of Central Connecticut in New Britain. Further aligning the hospitals will strengthen their clinical programs, improve quality of care, and allow them to operate with greater financial efficiency and improved access to capital funding, the hospitals said.

The Ethicon unit of Johnson & Johnson (New Brunswick, NJ) announced that its BIOPATCH® Protective Disk with CHG (chlorhexidine gluconate) will include new design elements and updated packaging to make it easier for surgeons, nurses and other healthcare providers to apply the product correctly around catheters to reduce the risk of catheter-related bloodstream infections.

MannKind Corporation (Valencia, CA/Danbury) announced the completion of a public offering of 8,360,000 shares of its common stock, including 960,000 shares sold pursuant to the full exercise of an over-allotment option previously granted to the underwriters. MannKind’s chairman, chief executive officer and principal stockholder, Alfred E. Mann, purchased 1,000,000 of these shares from the underwriters. All of the shares were offered by MannKind. The net proceeds to MannKind from the sale of shares in this offering, after deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $59.7 million.

NanoViricides, Inc. (West Haven) reported comments by Konstantin G. Kousoulas, PhD, a professor at Louisiana State University, regarding the company's anti herpes drug candidates. "Over 90% of people are infected with herpes, whether they know it or not," Dr. Kousoulas said. "The duration of a cold sore could be reduced drastically, from a month to just a few days [by applying a nanoviricide skin cream]."

Neurogen Corporation (Branford) has agreed to be acquired by Ligand Pharmaceuticals Incorporated of San Diego. Neurogen stockholders will receive an estimated $11 million in Ligand common stock and will be granted Contingent Value Rights payable in cash as follows: net proceeds from any sale of Neurogen’s real estate within six months of closing; net proceeds from any sale of Neurogen’s Aplindore program within six months of closing; $3 million upon Merck initiating a Phase III clinical trial for Neurogen’s VR1 antagonist program or 50% of the net proceeds Ligand receives if it sells the program prior to the initiation of Phase III studies; $4 million if Ligand partners Neurogen’s H3 antagonist program or 50% of the net proceeds if it sells the IP related to this program. (Aplindore is a dopamine D2 partial agonist that Neurogen has developed for the treatment of Parkinson’s disease and Restless Legs Syndrome.)

CURE's president and CEO, Paul Pescatello, recently commented on the sale in the Hartford Courant and the New Haven Register.

Pfizer Inc. (New York, NY/Groton/New London) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease. The international safety and efficacy trial, known as HORIZON, is designed to evaluate the potential benefits of dimebon on cognition (thinking and memory) in patients with Huntington disease.

Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington, DC) issued a statement saying that "along with research universities, patients and healthcare providers, [we] support the development of a responsible, abbreviated approval pathway for biosimilars ... . Already, biologics have revolutionized health care with effective, targeted therapies that battle some of the most costly and complex diseases, such as cancer, and are looked to for future cures and treatments for Alzheimer’s and Parkinson’s. As of 2008, more than 300 biologics had been approved by the Food and Drug Administration and 633 biotechnology medicines were in development, including more than 250 for various cancers."

Protein Sciences Corporation (Meriden) was awarded a $35 million contract by the U.S. Department of Health and Human Services (HHS) "to pursue advanced development of a new way to make influenza vaccine," according to an HHS press release. The contract could be extended up to five years for a total value of $147 million. Under the Protein Sciences technology, a gene would be extracted from a flu virus and placed into an insect virus called baculovirus, which does not affect people and can multiply quickly to high levels in insect cells. The cells are purified to become a basic part of a human vaccine.

Purdue Pharma L.P. (Stamford)announced a collaboration with Transcept Pharmaceuticals to commercialize Intermezzo® (zolpidem tartrate sublingual tablet) in the United States. If approved by the U.S. Food and Drug Administration (FDA), Intermezzo® has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. The FDA has established October 30, 2009 as the Prescription Drug User Fee Act (PDUFA) action date for the Intermezzo® New Drug Application (NDA). 

Rib-X Pharmaceuticals, Inc. (New Haven) announced positive results from a Phase 2 clinical trial of radezolid in the treatment of community-acquired pneumoniae. "We are extremely encouraged by the positive results we've seen in this Phase 2 trial of radezolid in community-acquired pneumoniae," said Susan Froshauer, Ph.D., president and CEO of Rib-X Pharmaceuticals. "Together with previously reported positive results of the Phase 2 trial in uncomplicated skin infections, we are confident in the potential for radezolid to offer a safe therapeutic alternative for the treatment of methicillin-resistant Staphylococcus aureus and other bacterial infections. Radezolid has been shown to be efficacious and appears to have a favorable safety profile compared to other oxazolidinone compounds. We are looking forward to progressing the development of radezolid with the intravenous formulation in a more complicated disease setting."

Separately, the company announced that one of its discovery-stage programs has yielded several computationally designed series of chemically unique compounds demonstrating efficacy in the treatment of infection in animal models. The company has built five chemical scaffolds, some of which have demonstrated activity against both Gram-negative and Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. "In less than one year, our structure and computationally driven research engine has engineered a variety of new lead scaffolds that appear to exhibit promising activity in mice, good drug-like properties and good safety in early tests, in addition to varied profiles against MDR gram-negative pathogens in vitro," Froshauer said.

Following is recent news from The University of Connecticut (Storrs) and the University of Connecticut Health Center (Farmington).

The most recent issue of the UConn Office of Technology Commercialization newsletter reports faculty inventions were up in 2009. The newsletter also reports on LamdaVision, a company formed in July to pursue work on an artificial retina, Synaptic Dynamics, at work on Alzheimer's Disease, and TRH Therapeutics, focused on cancer-related fatigue. more

Linda Shapiro, a professor and stem cell researcher at the University of Connecticut Health Center, has spent years investigating the molecule CD13. Now, if her theories are correct, scientists could use what they know of CD13 to improve on the body’s own way of repairing itself after a heart attack, better guiding stem cells to the damaged heart — a process known as homing — and potentially improving a person’s chances for recovery. more

By adding fluorescent dyes to DNA and then spinning the DNA strands into nanofibers, researchers at the University of Connecticut have made a new material that emits bright white light. The material absorbs energy from ultraviolet light and gives off different colors of light--from blue to orange to white--depending on the proportions of dye it contains. more

Venomix, Inc. has changed its name to Vestaron Corporation. Vestaron is developing a new generation of insecticides using peptides from spiders. The company’s technology is based on ground-breaking research conducted at the University of Connecticut. more

Following is recent news from Yale University and the Yale School of Medicine (New Haven).

A team of Yale scientists led by Jesse Rinehart, associate research scientist in genetics and Richard Lifton, Sterling Professor of Genetics and Internal Medicine, report they used innovative new quantitative proteomics technologies to identify two key regulatory transporter sites that control the exit of potassium and chloride out of cells. "These transporters are overactive in sickle cell anemia and play a role in the dehydration of sickle cells," said Patrick Gallagher, professor of pediatrics at the Yale School of Medicine and a co-author of the study.

Yale University researchers led by Walther Mothes, associate professor of microbial pathogenesis at the Yale School of Medicine, and Jing Jin, a postdoctoral associate in Mothes’ lab, have made movies of viral activity within cells that help explain why cell-to-cell transmission is so efficient and provide potential targets for a new generation of AIDS drugs. The researchers also identified a possible weakness in the transmission chain. The team found that viruses express a sticky protein that docks with uninfected cells and then attracts viral assembly to these sites. If this adhesion molecule lacked a “cytoplasmic tail,” then the viral particles did not assemble at the jumping off point between cells.

A study in the journal Nature describes how two small molecules discovered by Cytokinetics Inc. block the action of a key complex that directs the assembly of actin filaments, which produce the force to help cells move. Thomas Pollard, senior author the study and Sterling Professor of Molecular, Cellular & Developmental Biology, said that the inhibitors will allow scientists to turn the complex off and on, helping shed light on the mechanism of cell movement. Pollard noted that cell biologists "desperately need these tools to switch Arp2/3 complex off reversibly without killing the cells." These inhibitors should help scientists determine how nerve cells grow processes to wire the nervous system, embryonic cells migrate to form organs and white blood cells find bacteria.

Yale School of Medicine scientists have found that reducing levels of a key enzyme in the brain decreased appetites and increased energy levels. "Our research provides the first evidence that breaking down molecules in the brain that regulate metabolism is an important component of weight control," said senior author Sabrina Diano, associate professor in the Departments of Obstetrics, Gynecology and Reproductive Sciences, and Neurobiology. "Our findings provide a possible new target for the development of drugs to control metabolic disorders such as obesity and type 2 diabetes."

To combat the many fetal deaths that occur annually because the placenta is too small, researchers at Yale School of Medicine have developed a method to measure the volume of the placenta, which provides nourishment to the fetus. Harvey J. Kliman, M.D., a research scientist in the Department of Obstetrics, Gynecology and Reproductive Sciences, is lead author of findings published in American Journal of Perinatology.

In post-colonial America, Lyme disease was isolated to a few islands along the Northeast coast and pockets of Wisconsin and Minnesota. But a new genetic analysis of the Lyme bacterium by Yale University researchers shows that the tick-borne disease roared back after the reforestation of this part of the country. "The current epidemic of Lyme disease is the result of infected ticks expanding their range independently from these isolated refuges," said Durland Fish, professor of epidemiology at the Yale School of Public Health and senior author of the analysis, reported in the Proceedings of the National Academy of Sciences. "This expansion is likely to continue until the ticks, and the diseases they carry, return to their former range."

Researchers at Yale University and the University of Calgary report that that predator-prey interactions are the "conductors" of synchronicity in living organisms. "Predators fundamentally change the way that their prey vary through time, creating a cyclic pattern that is quickly synchronized across many locations with only small amounts of dispersal," said David Vasseur, co-author of the paper and assistant professor of ecology and evolutionary biology at Yale. "The loss of these cycles, either through species extinctions or global change, may have drastic consequences for the stability of ecosystems and the persistence of species."

Five Yale School of Medicine investigators have received of new Pilot Project Program grants from Women’s Health Research at Yale. They are Hilary Blumberg, M.D., associate professor of psychiatry and director, Mood Disorders Research Program; Karl Insogna, M.D., professor of internal medicine (endocrinology); Joshua Johnson, assistant professor of obstetrics, gynecology and reproductive sciences; Joann Sweasy, professor of therapeutic radiology; Benjamin Toll, assistant professor of psychiatry.

Yale University’s Global Health Leadership Institute is partnering with Tsinghua University to launch a four-year leadership development program in healthcare management for women in China. The effort is part of the 10,000 Women initiative, a program launched by Goldman Sachs to provide business and management education to women around the world.

For more member news, see the Summer 2009 issue of CURE News