March 21, 2006

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March 21, 2006

March 21 – March 27

March 22nd: BioLok International Receives FDA Clearance for Unique and Clinically Safe Time Release Bone Augmentation Product

BioLok International Inc. (OTC Bulletin Board: BLLI ), the manufacturer and worldwide distributor of leading-edge dental implant technology, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market BoneGen-TR. The FDA clearance, which could have taken up to 90 days or longer, was granted 5 weeks after BioLok made its submission.

BoneGen-TR from BioLok, a pioneer in merging technological innovation and cell biology, is a clinically safe, nano-composite, time release calcium sulfate product used for bone regeneration, augmentation, and as a soft tissue barrier in Implantology, Periodontology, Endodontics and Oral Surgery. The broad bone augmentation market is estimated at $1 billion annually.
BoneGen-TR is designed as a stand-alone product, having a substantially longer resorbtion rate, and costing significantly less than other materials in the market.
BioLok is ready for limited distribution of BoneGen-TR in the US for clinical evaluation and intends to have the product available for mass distribution in June/July 2006. A large multi-center, multi-national clinical study to enhance the product's marketability will be conducted in April in Argentina, Australia and Spain at multiple private practices and universities. Now that BioLok has FDA clearance for marketing BoneGen-TR, US clinical studies will be started at multiple private practices and Universities, all with a common protocol so that all the results can be used together.

BioLok International Inc. is merging cell biology and technology to develop and market products for the dental implant and tissue regeneration markets. The Company is the worldwide manufacturer and distributor of the BioLok Precision Dental Implant System

March 23rd: GlaxoSmithKline Begins Testing New Technology to Protect Patients against Counterfeit Medicine

GlaxoSmithKline has begun distributing a medicine tagged with radio frequency identification (RFID) technology as part of a pilot project to help protect patient safety.

The tags will be placed on all bottles of Trizivir® (an HIV medicine) distributed in the United States. When scanned at close range, the tags will help verify that the medicine bottle contains authentic Trizivir®. This specific medicine was selected for the project because it has been listed by the National Association of Boards of Pharmacy as one of 32 drugs most susceptible to counterfeiting and diversion.

The U.S. Food and Drug Administration (FDA) has asked the pharmaceutical industry to develop standards and pilot processes for RFID that may lead in the next few years to broad adoption and use of the technology.

RFID uses a tiny silicon chip and antenna about the size of a postage stamp that is attached to each bottle of medicine. The chip stores a unique product code that reflects information about the drug's manufacturing and shipping history. The product code can be read by pharmaceutical wholesalers and pharmacists using a hand-held or stationary electronic device that is placed within 2-18 inches of the tag. The tag can be read by wholesalers when it is received from the manufacturer and when it is shipped to pharmacies, who would then record when they have received the medicine. This allows manufacturers to more precisely account for medicine as it moves through the distribution chain and to authenticate medicine at the point of dispensing.

RFID-tagged bottles of Trizivir® will begin appearing on pharmacists' shelves in mid April. The testing of the RFID technology on additional products will be evaluated by GSK with guidance from the FDA as the Trizivir® pilot progresses.

GSK has worked with IBM to design and build the technology in the pilot program, which allows GSK to tag each bottle with a unique product code. The tags themselves are not easily copied.

Recently Counterfeit Viagra was found in the summer of 2004 in two retail pharmacies in California. Bottles were for 100mg, 30-counts. All Viagra bottles were coded by end of 2005 by Pfizer. Merck, Novartis, Barr lab, Johnson and Johnson, sanofi, Wyeth are planning to implement this system.

March 23rd: Medtronic Wins Stent Patent Arbitration

An independent arbitration panel has found in favor of Medtronic, Inc. (NYSE:MDT ) in a case in which Johnson & Johnson/Cordis alleged that the Medtronic Driver(TM) stent and several other Medtronic stents infringed certain Cordis patents. The arbitration panel issued its non-appeal able decision on February 20 and the award became final on March 22.Finding in favor of Medtronic on all issues before it, the arbitration panel ruled that the Medtronic stents in question were licensed under a 1997 Settlement and Cross License agreement between the companies, and that a 1998 Cordis "covenant not to sue" barred Cordis from filing a lawsuit that the Medtronic Vascular products infringed Cordis's patents.

As a result of this positive decision for Medtronic, the Driver stent and the other Medtronic stents in question have been found to be licensed to the Palmaz-Schatz patents owned by Johnson & Johnson/Cordis. Medtronic has moved to dismiss the related litigation involving the same subject matter that had been stayed in the U.S. District Court for the District of Delaware pending the outcome of the arbitration. In addition, future disputes between the two companies on these stents and patents are governed by the 1997 Settlement and Cross License Agreement.

Scott Ward, president of Medtronic Vascular, said: "This arbitration award gives Medtronic further confidence in the intellectual property strength of Driver and Endeavor, and reinforces our belief that the company is well positioned to defend against legal challenges and assert our own patent rights."

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