People and Places in the News – October 2010

FDA Approvals

Talecris has been granted orphan drug designation by the Food and Drug Administration for the development of an aerosol formulation of Alpha1- Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency.

CSL Behring has received FDA approval to extend the shelf life for Privigen, immune globulin intravenous (human), 10% Liquid from 24 months to 36 months. The approval makes Privigen the first liquid IVIG in the U.S. that can be stored at room temperature throughout its entire 36-month shelf life.

Phadia has received FDA 510 (K) clearance for four new EliA autoimmune antibody assays—anti-cardiolipin (aCL) IgG/IgM and anti-B2-glycoprotein 1 (anti-B2-GP1) IgG/IgM — that will provide physicians with additional tools needed to aid in the diagnosis of antiphospholipid syndrome (APS).

The FDA approved marketing authorization for Sanofi-aventis’ Jevtana Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

Appointments

Theresa Wrangham, immediate past president of SafeMinds, has been appointed executive director of the National Vaccine Information Center.

CEO and Co-Founder of Lifetree Clinical Research and Lifetree Center for Neuroscience Research Alice Jackson has been named to the board of directors for the Alzheimer’s Association, Utah Chapter.

John Maraganore, PhD, CEO, of Alnylan Pharmaceuticals, has been appointed to Taligen Therapeutics’ board of directors. Taligen is a biotechnology company developing therapies that regulate the complement system to treat inflammatory and immune diseases.

Idera Pharmaceuticals has appointed three new executives to the staff of the Cambridge-based autoimmune disease drug developer. Rober Arbeit is vice president of clinical development, Nicola La Monica is vice president of biology, and Timothy Sullivan is vice president of development programs and alliance management.

Nutra Pharma Corp., a biotechnology company that is developing treatments for adrenomyeloneuropathy (AMN), HIV and multiple sclerosis, has hired David Isserman to serve as its chief marketing officer.

Richard Hockins has been appointed vice president of sales and marketing at Hycor Biomedical, a manufacturer of in vitro diagnostic products for allergy, autoimmune and urinalysis markets.

Biologics Consulting Group, a regulatory affairs consulting firm, has appointed Craig A. Halverson, MS, as a senior consultant. Halverson was previously vice president of regulatory affairs at Zymogenetics, which supported multiple investigational new drugs in hemostasis, oncology, immunology and infectious disease.

Tanabe Research Labs USA Inc. (TRL) has opened a facility in San Diego to develop biological drugs for the treatment of autoimmune diseases. TRL commenced operations in May with the appointment of three new senior executives, Masaki Yamada, PhD, chief executive officer; Toshihiro Hosaka, PhD, senior vice president; and Roland Newman, PhD, vice president and chief scientific officer.

Acquisitions/Alliances

Sanofi-aventis has completed its acquisition of Chattem Inc., making it a wholly owned subsidiary of the Sanofi-aventis group. The move is intended to strengthen the company’s presence in the U.S. consumer market and provide new channels for maximizing the potential of converting Sanofi-aventis’ prescription medicines to over-thecounter products, beginning with Allegra.

Talecris Biotherapeutics has signed a co-promotion agreement with Novartis Vaccines to jointly market and sell their respective post-exposure rabies products. Talecris provides HyeperRAB(R) S/D (rabies immune globulin [human]), which is administered in combination with rabies vaccines. Novartis provides RabAvert(R) rabies vaccine for both preexposure and post-exposure prophylaxis.

Grifols SA has acquired various forms of intellectual property associated with the treatment of post-polio syndrome (PPS) from Swedish company Pharmalink AB. In addition, Grifols has acquired U.S., European and Japanese patents for a specific PPS treatment method utilizing human immunoglobulin and unrestricted use of existing Pharmalink clinical trial data supporting the treatment method.

Laboratory instruments and solutions provider Tecan Group AG has signed a global OEM agreement with the diagnostics business of Novartis to provide instruments that will be used to meet the needs of blood banks testing individual or pooled donations.

ZymoGenetics Inc. has signed a licensing agreement with Danish drug maker Novo Nordisk A/S for ZymoGenetics’ autoimmune and inflammatory drug IL-21mAb.

Viral Genetics Inc. has signed licensing agreements for medical technology developed by Karen Newell, a University of Colorado at Colorado Springs associate biology professor. The company plans to seek FDA approval to begin testing a new type of drug that targets the response of an individual’s immune system to fight off HIV, cancer, lupus, diabetes, rheumatoid arthritis and other autoimmune diseases.

Cornerstone Pharmaceuticals Inc. has entered into a collaboration agreement with the U.S. National Cancer Institute (NCI) to evaluate the potential of combining Cornerstone’s proprietary Emulsiphan cancer selective delivery nanotechnology platform with NCI’s class of agents that can be turned into toxic compounds by targeted radiation and ultrasound to reduce tumors.

Inspiration Pharmaceuticals Inc. and Ipsen SA are merging their hemophilia portfolios. Ipsen will fund clinical development of its two lead products, and Inspiration will handle the work.

MediConnect Global, a player in the electronic medical records industry, has acquired the personal health record Internet portal PassportMD, and has changed the program’s name to myMediConnect.

Calgene Corp. has acquired Abraxis BioScience, adding Abraxane forInjectable Suspension to Calgene’s existing portfolio of leading cancer products. Abraxanewas approved by the FDA in January 2005 for the treatment of breast cancer after failure of combination chemotherapy.

Award

Taligen Therapeutics has been selected as the Bioscience Company of the Year by the University of Colorado with its 7th Annual Technology Transfer Awards in recognition of its leadership position in developing a pipeline of novel protein therapeutics that modulate the complement system to treat a wide range of inflammatory diseases.

Grants/Donations

Privately owned Immune Targeting Systems has secured an additional $13.6 million of funding from a group of investors that includes the venture capital arm of Novartis to develop its universal flu vaccine to protect people against all flu strains by targeting elements of the virus that do not change from season to season. The funding will allow the company to progress its lead candidate FP-01 through to completion of Phase II proof of concept studies. Initial Phase I clinical trials started in early 2010.

Inovio and collaborators from Drexel University, Cheyney University and the University of Pennsylvania received a $2.8 million grant to develop a DNA vaccine to treat the hepatitis C virus.

The National Institutes of Health has awarded a $600,000 grant to Corgenix for a two-year study to develop novel, recombinant-based diagnostic tests for the Ebola and Marburg viruses.

Dr. Jean Pfau, an assistant professor of biological sciences atIdaho StateUniversity, has received a $192,000 grant from the National Institutes of Health to research the effects of asbestos on healthy cells.

Vical Inc. is collaborating with leading pediatric infectious disease researchers Stuart P. Adler, MD, and Michael A. McVoy, PhD, of the Virginia Commonwealth University under a five-year, $4 million grant from the National Institute of Allergy and Infectious Diseases to support development and animal testing of novel vaccine approaches designed to protect women of child-bearing age from infection with cytomegalovirus (CMV).

Researchers at the University of Cincinnati Interstitial Lung Disease Center have received a $715,000 K23 clinical research grant from the National Heart, Lung and Blood Institute to study ways ILD first appears in certain patient groups with autoimmune diseases and how to more efficiently diagnose and treat it.

Kineta Inc. has received a $600,000, twoyear Phase I Small Business Innovation Research grant to finance its IND-enabling studies of ShK-186, the first-in-class therapeutic for type 1 diabetes mellitus, multiple sclerosis and other autoimmune diseases.

The California Institute for Regenerative Medicine, the state’s stem cell research funding agency, has awarded $25 million to 19 projects, including nearly $13.9 million for 11 San Francisco Bayarea projects dealing with immune rejection of transplanted stem cells. Among those 11 projects are $1.4 million to Escape Therapeutics Inc., more than $2 million to University of California, Berkeley, researchers, and $3.8 million to University of California, San Francisco, researchers.

Clinical Trials

Grifols, SA, will initiate a new clinical investigation of Alzheimer’s disease in January 2011 that will involve a combined treatment of therapeutic plasmapheresis and the administration of human albumin and intravenous immune globulin at different doses and frequencies.

Medicago Inc., a small Canadian biotechnology company, began midstage trials of its H5N1 avian flu vaccine in mid-2010, following positive results of its Phase I clinical trial.

Upsher-Smith Laboratories has initiated a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults.