nd01.jpg (5588 bytes)Abbott signs global agreement, announces co-promotions, defends against two lawsuits
Abbott Laboratories, Abbott Park, Ill., and Wakunaga Pharmaceutical Co, Ltd., Osaka, Japan, have signed a global licensing agreement for Abbott to develop and market two anti-infective compounds worldwide. The compounds are broad-spectrum quinolone antibiotics currently in pre-clinical stages for various respiratory and urinary tract infections.
     Abbott currently markets macrolide antibiotic Biaxin (clarithromycin), also known as Klacid and Klaricid, outside the United States. Abbott is also developing ABT-773, a ketolide in Phase II development. The agreement provides Abbott with two compounds in the quinolone class of antibiotics, a fast-growing segment of the worldwide anti-infective market.
     Under the terms of the agreement, Abbott will have exclusive rights to develop, manufacture and market the licensed compounds worldwide. Additional terms have not been disclosed.
     Abbott and specialty pharmaceutical company Sepracor Inc., Marlborough, Mass., announced a co-promotion agreement for Xopenex (levalbuterol HC1), a beta antagonist, for treatment of reversible bronchospasm. Under terms of this agreement, Abbott’s Ross Products Division will promote Xopenex to the pediatric market in the U.S. Sepracor’s sales force will market Xopenex to pulmonologists, allergists and primary care physicians in U.S. hospitals and clinics. Sepracor will be credited with all sales, and Abbott will receive a commission on pediatric sales. Each company is responsible for its own selling expenses. Terms of the deal were not disclosed.
     Sepracor received marketing clearance from the U.S. FDA for Xopenex inhalation solution in March 1999. Xopenex inhalation solution was cleared in two dosage strengths for use with a nebulizer. The drug is for the treatment or prevention of bronchospasm in adults and adolescents 12 years of age and older with reversible obstructive airway disease, such as asthma.
     In other Abbott news, the company has entered into an agreement with research-based pharmaceutical products company, ALZA Corp. of Mountain View, Calif., related to the approval by ALZA stockholders of the proposed Abbott-ALZA merger. The companies have agreed that the closing of the merger would not occur unless new proxy materials are issued and a new meeting is held at which, ALZA stockholders approve the merger. Closing of the merger would also remain subject to obtaining Federal Trade Commission clearance and other closing conditions. As disclosed in recent Securities and Exchange Commission filings, ALZA is also continuing to review previously reported information as part of its due diligence process.
     In the wake of the recent consent decree and settlement, Abbott is facing two new lawsuits. According to Bernstein Liebhard & Lifshitz, LLP, New York, N.Y., a securities class action lawsuit was commenced on behalf of purchasers of the common stock of Abbott, Inc., between March 17, 1999 and September 29, 1999, inclusive, (the "Class Period"), in the United States District Court for the Northern District of Illinois.
     The complaint charges Abbott and certain of its directors and executive officers with violations of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. It alleges that the defendants issued materially false and misleading statements about the company’s business, finances and prospects. Additionally, the firm’s release states that defendants failed to disclose that the FDA had warned the company that certain products manufactured at its Illinois Diagnostic Products Division were not manufactured in compliance with FDA quality assurance regulations and that Abbott had not taken any measures to bring its processes into compliance. According to the release, "As a result of these misrepresentations and omissions, the price of Abbott’s common stock was artificially inflated throughout the Class Period," and plaintiff seeks to recover damages on behalf of those who purchased or otherwise acquired Abbott common stock during the Class Period. Plaintiff has selected Bernstein Liebhard & Lifshitz, LLP to represent the class.
     In another lawsuit, two women contend that a test made by the company returned false positive results that caused them to have unnecessary chemotherapy and, in one case, a hysterectomy.
     This lawsuit was filed in federal court in Chicago on behalf of the women who allegedly received incorrect results from an Abbott B-hCG test . The assay, often used to test for pregnancy, detects the high levels of human chorionic gonadotropin (hCG) produced by pregnant women. The test determined the women were not pregnant but had elevated hCG levels, a sign of trophoblast disease, a form of cancer. Their doctors immediately put the women on chemotherapy. The doctors determined later that neither woman, one of whom had a hysterectomy, had cancer. The lawsuit seeks class action status and claims that other women mistakenly received serious medical treatment. Abbott denied the claims, and spokeswoman Rhonda Luniak said doctors are aware of the phantom hCG phenomenon, which can cause false positives and cause women to appear to have higher hCG levels. Luniak also said doctors would not treat a patient for cancer without performing a battery of other tests.

Adeza Biomedical and Biotrin International sign agreement to distribute test for preterm labor
Ireland-based Biotrin International and Adeza Biomedical Corp. of Sunnyvale, Calif., have signed a marketing, sales and distribution agreement to market Adeza’s Fetal Fibronectin (fFN) test in France, Germany and Ireland. Adeza develops and manufactures diagnostic products for women’s reproductive healthcare.
     The fFN test, which is used to assess risk for preterm delivery in symptomatic and asymptomatic pregnant women, detects fetal fibronectin, which is a clinically proven, direct biochemical marker for assessing the risk of preterm delivery in pregnant women. The test has been the subject of several studies, with more than 120 peer-reviewed reports published to date, including studies showing cost benefit to the healthcare system.
     Gary Joffe, M.D., of Lovelace Medical Center, Albuquerque found that use of the fFN test resulted in a cost savings of $486,000 during a one-year clinical trial of 768 patients. There was a reduction of preterm labor admissions, hospital stays and prescriptions for tocolytic agents.

Quest Diagnostics reveals details of consolidation plans with Quest/SmithKline labs
Quest Diagnostics of Teterboro, N.J., a national provider of clinical testing, information and services, is offering further details on its integration plans for SmithKline Beecham Clinical Laboratories which it acquired August 16, 1999.
     Laboratory consolidations will occur in geographic markets currently served by more than one of the company’s laboratories. Labs will close or be substantially reduced in size in Deerfield Beach, Fla., Owings Mills, Md., Farmington Hills, Mich., Islip, N.Y., Valley View, Ohio, Norristown, Pa. and Dallas. In October, Quest announced plans to close its laboratory in Waltham, Mass.
     Tests currently sent to distant sites will be redirected to nearby labs to improve customer service. Specialized testing, now performed at the National Esoteric Testing Center in Van Nuys, Calif., will move to Quest’s Nichols Institute in San Juan Capistrano, Calif. All actions are due to take place during the next 18 months.
     These consolidations are expected to result in an employment cut of between 5 and 10 percent. Currently, the company employs more than 25,000 people. Integration-related expenses will result in a special charge in the fourth quarter, as previously disclosed.
     Clients are being given advance notice about how the changes will specifically affect them. The company will continue to maintain labs in or near Atlanta, Baltimore, Boston, Chicago, Cleveland, Dallas, Detroit, Houston, Los Angeles, Miami, Minneapolis, New Haven, Conn., New Orleans, New York, Philadelphia, Phoenix, Pittsburgh, Portland, Ore., San Diego, San Francisco, Seattle, and St. Louis. Quest, which operates labs in several other cities, maintains approximately 200 stat labs and more than 1,400 Patient Service Centers across the country. It also provides lab services in Mexico and London.

nd02.jpg (9392 bytes)Microplate innovators award for original research paper
TECAN AG is inviting members of academic institutions or companies engaged in clinical research that involves the innovative use of microplates to submit original research papers for the TECAN Award 2000. Entrants can be working in diagnostics, drug discovery or genomics, and be involved in a laboratory automation project or the development of a novel assay or procedure.
     The award will be given for the paper which describes the most outstanding and original research. An independent panel of judges has been nominated by the Mip Tec-ICAR 2000 program committee.
     This lab automation equipment company is offering a prize of $4000 Euro to the winner who also will receive free travel, registration and accommodations for the 3rd International Conference on Microplate Technology, Laboratory Automation and Robotics, Mip Tec-ICAR 2000 conference and exhibition. The conference will be held October 30 to November 2 in Basel, Switzerland. Application deadline is May 31, 2000.

nd03.jpg (11112 bytes)FDA clears Selfcare blood glucose monitoring test strip
Selfcare Inc., Waltham, Mass., has received notification of FDA clearance for an advanced electrochemical blood glucose monitoring strip for use with the FastTake Blood Glucose Monitoring System. Selfcare manufactures the system for Lifescan, a Johnson & Johnson company. Selfcare expects to begin shipments of the advanced strips in early 2000.

HSCA expands Mayo contract to improve outreach and costs
Health Services Corp. of America of Cape Girardeau, Mo., recently expanded its agreement with Mayo Medical Laboratories of Rochester, Minn., the reference lab for Mayo Clinic. Effective immediately, the national GPO’s 2,000 healthcare members and hospitals can use the resources and diagnostic expertise of Mayo Medical Laboratories to develop effective and profitable outreach programs for their lab business.
     The new focus of the four-year deal between HSCA and Mayo is outreach and hospital cost management. Mayo Medical Laboratories will provide esoteric testing and help HSCA hospitals regain volumes for standard testing in their region that may have been lost to national or regional reference laboratories.
     Another change to the original contract is access to electronic connectivity. Physicians can use a computerized test management system, Mayo Link, which functions 24-hours a day, seven days a week. Mayo Clinic specialists provide assistance with test selection and interpretation.

Abbott can market products until Jan. 10, not Dec. 6
The U.S. District Court, acting on behalf of the U.S. FDA, has amended its consent decree with Abbott Laboratories to allow the Abbott Park, Ill.-based diagnostics manufacturer to continue marketing 175 medically necessary products until January 10, 2000.
     Under a consent decree signed in November, 1999, Abbott agreed to pay a $100 million fine and discontinue manufacturing more than 100 of its products until it corrects repeated violations of federal quality rules in its North Chicago facility. The original discontinuation date was set for December 10, so buyers would have time to find alternative sources.
     The change allows Abbott to continue selling through January 10, only diagnostic tests or devices that the FDA deems medically necessary. Those approximately 175 products include tests that detect the AIDS virus and hepatitis in donated blood. The other elements of the consent decree remain unchanged.

Medi-Cal offers antidiabetes agent to type 2 diabetics
Medi-Cal of Glendale, Calif., a national Medicaid program, has added Avandia (rosiglitazone maleate) made by SmithKline Beecham of Philadelphia, to its formulary. Avandia is a new thiazolidinedione (TZD) that treats the symptoms of type 2 diabetes and directly targets insulin resistance. Launched in June 1999, Avandia is now available to Medicaid patients in 49 states.
     On May 25, 1999, Avandia received FDA clearance for the treatment of type 2 diabetes as both monotherapy and in combination with metformin as an adjunct to diet and exercise. The FDA clearance was based on a review of data from clinical studies involving more than 5,500 patients with type 2 diabetes. The FDA had placed the medication on a six-month priority review schedule. It was generally well tolerated in clinical trials. Reported adverse events were upper respiratory infections and headaches.

Bayer to acquire OSI Pharmaceuticals’ diagnostics business for $11 million
OSI Pharmaceuticals Inc., of Cambridge, Mass., has signed an agreement to sell all its assets including its wholly owned diagnostics subsidiary, Oncogene Science Diagnostics (OSDI), to Bayer Corp., Tarrytown, N.Y.
     OSI will receive $10 million up-front from Bayer for the acquisition of OSDI, with an additional payment of $1 million to be made to OSI by 2001. Bayer intends to retain all OSDI employees and its Cambridge, Mass. headquarters.
     OSDI is engaged in the development of a series of cancer diagnostic tests based on oncogenes, tumor suppressor genes and other gene targets whose proteins are directly involved in tumor growth or metastasis. These tests are designed to aid oncologists in the confirmation, monitoring, staging, screening or prognosis of human cancer.

nd04.jpg (7964 bytes)NIOSHA directs hospitals to implement improved controls against needlesticks
The Centers for Disease Control’s National Institute of Occupational Safety and Health has issued a Safety Alert instructing healthcare facilities to use safety needle devices. The Safety Alert directs hospitals and healthcare facilities to implement improved engineering controls to reduce needlestick injuries and to determine which controls are most effective.
     This alert comes after OSHA’s updated Compliance Directive mandating the use of safety needle devices and the need to assess which device will minimize or eliminate needlesticks.

Biomedical Disposal to produce safety syringe
Biomedical Disposal Inc. of Norcross, Ga., has entered the final stages of negotiations to unveil a new retractable safety syringe. On August 24, 1999, Biomedical, which provides safe needle products and services, acquired the patent rights to a solution that eliminates the need for a Sharpx needle destruction.
     Demand for the product and the federal OSHA directive mandating safe needle practices will force the company to enter immediate production ahead of its planned schedule. Initial indications are that the product will be on the market in early 2000, pending 510(k) submission and clearance.
     According to Michael Smith, Biomedical president, the syringe design provides for a mechanism that automatically retracts the needle into the plunger/barrel immediately upon completion of the injection. This product will extend the company’s existing product line, which includes the Sharpx needle destruction unit and NICSX behavior-based incident reporting system.

Safe needle campaign scores big with OSHA mandates for safer needlestick devices
The American Nurses Association’s Safe Needles Save Lives campaign made important progress for its constituents when the U.S. Occupational Safety and Health Administration published a November directive to mandate the immediate use of safer needlestick devices nationwide.
     The directive to the 1991 OSHA Bloodborne Pathogens Standard requires the evaluation and use of safer needlestick devices to prevent injuries and exposure to blood-borne pathogens. It will impact the lives of thousands of nurses and clinicians. The directive asks OSHA compliance officers to cite employers who fail to use safer needlestick devices and work practice controls, and whose work practice controls do not minimize exposure.
     The Washington, D.C.-based ANA will be involved in developing a tool that includes guidelines to help healthcare workers selection of healthcare devices.