Genzyme Transgenics (GTC; Framingham, Massachusetts), the company that has logged many firsts in transgenic compound production techniques, became the first to achieve successful results of Phase III trials of a transgenically produced product sufficient to support FDA filing. The news firmly positions the company to file a biologics license application early in 2001 for its recombinant human antithrombin III (rhATIII), which is produced in the milk of goats, the company said.
GTC said last month that it met the primary endpoints in a second Phase III trial evaluating the ability of rhATIII to restore heparin sensitivity and assist in managing coagulation during cardiopulmonary bypass surgery. The second Phase III trial endpoints were consistent with the results of an identically structured Phase III trial reported in January.
Company President and CEO Sandra Nusinoff Lehrman said the news opens avenues for manufacturing collaborations in the genomics market.
Cardima enters CHF market
Cardima (Fremont, California) in late August said it will enter the congestive heart failure (CHF) market with the development of a pacemaker lead placement system, known as the Pacefinder placement system. The system incorporates Cardima's deflectable Naviport hollow lumen guiding catheter and Vueport balloon technology in one catheter, designed to allow surgeons to place pacemaker leads in the coronary sinus. Gabriel Vegh, president and CEO of Cardima, said, "Our CHF lead placement system is designed to assist the surgeon in steeering the guide into the coronary sinus, inflate a balloon and inject dye, showing the venous architecture. Then the surgeon can place the lead with that 'map' of the patient's heart."
New financing news
Card-Guard Scientific Survival (Rehovot, Israel), which develops cardiovascular telemedical systems, said it intends to raise $200 million in its second public offering in Switzerland based on an issue of two million old shares and one million as a sale offer to interested parties.
Esperion Therapeutics (Ann Arbor, Michigan) sold 900,000 shares of common stock at $9 per plus an overallotment option in connection with Esperion's Aug. 9 IPO of 6 million shares of common stock, all sold by the company. With the exercise of the over-allotment option and after deducting underwriting discounts, proceeds were about $57.8 million. Esperion develops pharmaceuticals treating cardiovascular disease and intends to commercialize a class of drugs that focus on high density lipoprotein therapy.
Cambridge Heart (Bedford, Massachusetts) has raised $8.4 million through a private placement primarily with a group of institutional investors. The financing involves the sale of 2.4 million common shares at the effective price of $3.50 per share. The investors also will receive warrants to purchase 716,850 shares at an exercise price of $3.50. Cambridge Heart develops products for the noninvasive diagnosis of cardiac disesase.
CryoCor (San Diego, California), a company recently spun off from CryoGen, reported closing $7 million in financing from MPM Capital LLC. CryoCor will develop cardiac arrhythmia management systems based on cryogenic ablation technology licensed from CryoGen, a company that has developed a cryogenic system for uterine ablation. Funds from the financing will be used to complete development of CryoCor's Glacier Cardiac Ablation System, and for initiation of both U.S. and European clinical trials to evaluate the system for supraventricular tachyarrhythmias, including atrial fibrillation ablation. CryoCor's catheter-based products deliver cryogenic energy for creating cardiac lesions to interrupt arrhythmias.
Imetrx (Menlo Park, California), a developer of medical devices for detecting and treating atherosclerotic plaque, has raised its first round of venture financing, the amount undisclosed. Imetrx was founded last year as a joint venture of the Stanford University Medical Device Network and Nortech Ventures.
Companies .... in brief
Collateral Therapeutics (San Diego, California) will support the establishment of a research chair at the University of California San Diego Cardiovascular Center focused on discovery research in the field of non-surgical cardiovascular gene therapy. The associated discovery research support will be funded out of a contribution of up to 50,000 shares of Collaterial Therapeutics common stock to the UC San Diego Foundation
MedQuest Products (Salt Lake City, Utah) reported receiving ISO 9001 certification. The firm is completing development of its HeartQuest magnetically suspended implantable blood pump for heart failure patients
Synthetic Blood International (SYBD; Kettering, Ohio) has leased an additional 4,000 square feet of office and laboratory space in Costa Mesa, California, to house the company's executive offices and perfluorocarbon product research and development activities. SYBD's glucose biosensor laboratory and administrative office remain in Kettering.