Symphogen $25M Funding

Denmark ’s Symphogen raised $25 million in a Series D funding that attracted one new investor. The company has now raised $60 million since it was formed in 2000 and plans to move its first project into the clinic, Sym001. This is a recombinant polyclonal antibody treatment for alleviating idiopathic thrombocytic purpura and preventing hemolytic disease in newborns. The therapy may be a replacement for existing anti-D immunoglobulin products derived from human blood.

Symphogen will file an investigational new drug application in late spring, and by the summer, aims to administer the first human dose in healthy volunteers, with efficacy data available by late 2006 or early 2007, after which the company would move to pivotal trials.

The company has three other projects at earlier stages of preclinical development: Sym002, a recombinant polyclonal antibody for post-exposure prophylaxis against vaccinia virus and for adverse events associated with smallpox vaccination; Sym003, an anti-respiratory syncytial virus (RSV) antibody preparation for prevention of RSV infection in children; and Sym004, for developing a polyclonal antibody panel against cancers associated with complex antigens.

Symphogen also is close to entering its first out-licensing agreements for its proprietary polyclonal antibody technology platforms.

Successful GMP production of recombinant polyclonal antibodies in quantities sufficient for undertaking clinical trials has been a major milestone for the company.

The new funding will support the company's current programs to late 2008 or early 2009. By that time, pipeline should be developed sufficiently to warrant an initial public offering.

Published January 11, 2006.

Potential New Flu Vaccine Supplier for US Market

Australia ’s CSL Ltd., plans to deliver 20 million flu vaccine doses to the US for the 2007-08 season upon US FDA approval. The company maintains US operations in King of Prussia, Pennsylvania through its US subsidiary ZLB Behring. ZLB is a blood products firm.

The US Centers for Disease Control and Prevention has set a goal to have 185 million Americans vaccinated for the flu annually.

CSL is a global biopharmaceutical company that has manufactured flu vaccine outside the US since 1968. CSL sells 15 million to 20 million flu-vaccine doses in 16 countries, mostly in the Southern Hemisphere and Europe and bulk influenza vaccine in 24 countries.

ZLB will sell and distribute the product to US hospitals, doctors, clinics and retail pharmacies and will

hire 15 to 20 employees for its new vaccine group, but will use existing large distributors to get the vaccine to health-care providers and pharmacies.

As part of the FDA approval process, CSL will test its vaccine in a human clinical trial this year and present the data within 12 months when it files for a biologics license with the FDA. CSL plans to manufacture two versions containing inactivated influenza virus: a formulation for adults and a preservative-free version for children.

For the 2005-2006 US flu season, about 87 million flu-vaccine doses were produced for the US market, - with more than 80 million distributed, by Sanofi Pasteur, Chiron, GSK, and MedImmune Vaccines Inc. Sanofi produced 63 million doses, Chiron produced 14.6 million doses, GSK produced 7.5 million doses, and MedImmune (nasal-spray vaccine) produced 2 million doses.

Source: The Philadelphia Inquirer, February 7, 2006.

Dr. Angela Wong , appointed vice president of service biology at WuXi PharmaTech

Amal Naj , appointed vice president, investor development and strategy at Pfizer

Nicholas Allen , associate director, business development, PharmaNet, joins

Advantage Software board of advisors

Philip S. Schein , MD, FRCP , elected to OncoMethylone Sciences board of directors

William W. Crouse elected to Targanta Therapeutics board of directors

AHI & Gleneagles Venture

The 140-bed Asian Heart Institute (AHI) has new business development plans. It has made a deal with Singapore-based Gleneagles Management Service of Parkway Group Healthcare PTE Ltd for Gleneagles to manage the facility’s day-to-day administration, leaving AHI’s CEO, Dr. Ramakant Panda, with more time for surgery and patient care.

The new management feels that the administrative move will increase profit margin as the number of angioplasties and surgeries should increase. The hospital has a weekly turnover of nearly Rs two crore. Dr. Panda states: “our target is to do 2000 surgeries and scale up angioplasties by 30 to 40%.”

The hospital is currently doing around 1500 surgeries per year. AHI does the highest cardiology work in Mumbai (one third of the city’s procedures). The hospital has three surgeons, 17 interventional cardiologists and preventive cardiologists.

Gleneagles has strengthened guidelines for “Clinical Governance Structure” for physicians, which outline patient care, quality assurance and infection control, and CMEs. The management agreement is on a fee-for-service basis.

The Parkway Group Healthcare PTE Ltd holds 70% of Singapore’s private healthcare market, including Mt Elizabeth Hospital, East Shore Hospital and Gleneagles Hospital, which are prime ‘medical tourist’ destinations in the Far East. It has a joint venture with Apollo Group to run the 325-bed Apollo Gleneagles Hospital in Kolkata.

AHI and Gleneagles also formed a joint venture to build an over 200-bed hospital at Bandra Kurla Complex on equity-sharing basis.

The new hospital will start operations from AHI within this year; 100 beds have been allocated for the project in the AHI building. The new hospital will center on “super-specialties” such as orthopedics and oncology. Gleneagles may bring its successful liver transplant program to AHI.

Source: Express Healthcare Management, January 2006.