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Genzyme General Expresses Confidence in Fabrazyme Data
CAMBRIDGE, Mass., Sep 6, 2000 /PRNewswire via COMTEX/ -- Genzyme General (Nasdaq: GENZ chart, msgs) today said it was extremely pleased with the results of its pivotal clinical trial of Fabrazyme(TM) (agalsidase beta) and confident that the trial data provide a very strong foundation for marketing approval. An abstract for the trial was recently published on the Web site of the American Society of Human Genetics. Fabrazyme is Genzyme`s investigational enzyme replacement therapy for patients with Fabry disease.

Genzyme submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) in June, and filed a European Marketing Authorization Application in July. The regulatory submissions include data from a Phase 3 double-blinded, randomized, and placebo-controlled clinical trial, which enrolled 58 patients at eight medical centers in the United States and Europe.

The trial results were highly statistically significant (p<0.0001) in meeting the primary endpoint, which was clearance of GL-3 in the blood vessels of the kidney. The accumulation of the lipid GL-3 in the cells of Fabry patients causes devastating symptoms such as severe pain, numbness, kidney failure, and cardiac disease, leading to early death. This endpoint was developed in collaboration with the FDA as a likely predictor of clinical response because clearance of GL-3 addresses the underlying pathology of the disease.

Fabrazyme also had a significant effect in clearing GL-3 from the heart and skin of treated patients, and the safety record in the trial was very good. All patients completed the trial. Some patients had mild infusion reactions, which were easy to manage and do not constitute a significant safety concern for continued therapy.

As expected, antibody formation to Fabrazyme was observed, given that approximately 80 percent of patients with Fabry disease are completely missing the alpha-galactosidase enzyme that was administered. Antibody formation did not effect the efficacy of Fabrazyme. Antibody formation commonly occurs with the therapeutic use of many other human proteins and has not diminished the safety or efficacy of many of these products.

Highlights from Genzyme`s Phase 3 clinical trial of Fabrazyme will be presented on September 17 by Dr. Robert Desnick, chairman of the Department of Human Genetics at Mount Sinai School of Medicine, during the plenary session of the Society for Inborn Errors of Metabolism conference in Cambridge, U.K. In addition, Dr. Christine Eng, the trial`s principal investigator, will provide a full presentation of the trial results on October 5 at the American Society of Human Genetics Meeting in Philadelphia.

Fabry disease is an inherited metabolic disorder caused by a deficiency of the enzyme alpha-galactosidase. This deficiency results in the body`s inability to break down certain naturally occurring glycolipids, primarily GL- 3, which then accumulate predominantly in the lining of blood vessels within the kidney, heart and other organs. Due to severe organ complications, death typically occurs around age 40 for those afflicted with the disorder. Fabry disease is estimated to affect 1 in 40,000 males, or approximately 2,000-4,000 people worldwide.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of therapeutic products in development focused primarily on the treatment of genetic diseases. A division of the biotechnology company Genzyme Corporation, Genzyme General has its own common stock intended to reflect its value and track its economic performance.

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Genzyme Transgenics and Genzyme General Announce rhATIII Phase III Study Results
FRAMINGHAM, Mass., Sep 7, 2000 /PRNewswire via COMTEX/ -- Genzyme Transgenics Corporation ("GTC") (Nasdaq: GZTC chart, msgs) and Genzyme General (Nasdaq: GENZ chart, msgs) announced today the primary endpoint results of a second phase III trial evaluating the ability of their recombinant human antithrombin III (rhATIII) to restore heparin sensitivity and assist in managing coagulation during cardiopulmonary bypass surgery. The primary endpoint of reduction in the use of fresh frozen plasma was met and was statistically significant (p=<0.001). The primary endpoint results of the second phase III trial were also consistent with the results of the identically designed first phase III trial announced in January.

"This second set of phase III data confirms that rhATIII has the potential to reliably support the management of anticoagulation in cardiopulmonary bypass patients who are resistant to heparin," said Jerrold Levy, M.D., director of cardiothoracic anesthesiology, Emory University School of Medicine. "The prospect of using this reliable source of antithrombin III may enable physicians to reduce use of donor blood products."

Patients undergoing cardiopulmonary bypass typically receive heparin to prevent clotting when their blood comes into contact with the surfaces of the heart-lung machine during surgery. Treatment of heparin-resistant patients with fresh frozen plasma is one option available to attempt to address heparin sensitivity and achieve adequate anticoagulation to permit initiation of cardiopulmonary bypass.

"Our rhATIII is the first transgenically produced medicine to successfully complete phase III studies," stated Sandra Nusinoff Lehrman, M.D., President and Chief Executive Officer of GTC. "We anticipate discussions with the U.S. Food and Drug Administration to determine what information may be necessary in addition to the results of these clinical studies to ensure the strongest possible filing for approval."

The primary endpoint results of the second phase III study demonstrated that of the patients not initially demonstrating adequate heparin response, only 19%, or 5 out of 26 of the patients in the rhATIII treated group, required fresh frozen plasma to extend coagulation times. In the placebo group 81%, or 22 out of 27 patients, required fresh frozen plasma. This double-blinded, randomized, placebo-controlled study evaluated 53 patients in medical centers in the U.S. and Europe.

The degree of anticoagulation activity found during the study was measured by the activated clotting time (ACT), a point of care standard monitor used to assess coagulation status during cardiac surgery. In this study, an ACT of 480 seconds or greater reflects adequate anticoagulation for initiation and maintenance of CPB. Patients whose ACT was still less than 480 seconds after receiving a total of 400 U/kg of heparin were randomized into either a placebo or rhATIII group. Fresh frozen plasma was given to those patients whose ACT remained below 480 seconds after receiving either a placebo or rhATIII.

The trial`s secondary endpoints included maintenance of antithrombin levels in the patient`s blood and examined changes in two biochemical markers of coagulation: D-dimer and fibrin monomer. Antithrombin III blood levels in patients provided rhATIII increased to an average of 123% of normal 30 minutes after the start of cardiopulmonary bypass, and were 114% of normal at the end of surgery. Antithrombin III blood levels in placebo patients that received fresh frozen plasma were 51% of normal 30 minutes after the start of bypass, and were 52% of normal at the end of surgery. There were no significant differences in D-dimer or fibrin monomer between groups.

GTC and Genzyme General have established a joint venture, ATIII LLC, for the development, marketing, and distribution of rhATIII in the US and Europe. The companies believe that rhATIII may have significant advantages over plasma ATIII, including a consistent and reliable supply, and the ability to economically increase production, as additional patient needs are identified. The joint venture expects to file for FDA approval of rhATIII early in 2001.

Genzyme Transgenics Corporation is a leader in developing medicines from the milk of specially bred animals, primarily goats. Many of the medicines under development are monoclonal antibodies and immunoglobulin fusion proteins or other therapeutic proteins. To date, GTC has formed more than a dozen collaboration agreements which provide for production of specific proteins. Additional information is available on the GTC web site, http://www.trangenics.com.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of therapeutic products in development focused primarily on the treatment of rare genetic diseases. A division of the biotechnology company Genzyme Corporation, Genzyme General has its own common stock intended to reflect its value and track its economic performance.

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Genzyme General to buy GelTex in nearly $1 billion deal
CAMBRIDGE, Mass., Sept 11 (Reuters) - Biotechnology company Genzyme General Corp. (NASDAQ: GENZ) on Monday said it has agreed to buy drug maker GelTex Pharmaceuticals Inc. (NASDAQ: GELX) in a cash-and-stock deal worth nearly $1 billion.

Under the deal, Cambridge-based Genzyme General obtains two GelTex drugs and a pipeline of "promising" potential products, it said. GelTex has two approved products -- Welchol, a newly approved cholesterol fighter, and Renagel, a dialysis medicine expected to earn as much as $43 million this year.

Genzyme already jointly markets Renagel with GelTex and said in the deal announcement that it now expects the product to drive its future growth and become a blockbuster within 10 years.

The deal, expected to close in the fourth quarter, calls for GelTex shareholders to receive 0.7272 of a share of Genzyme General common stock or $47.50 in cash for each GelTex share owned. That price reflects a 27 percent premium over GelTex`s closing share price of $37-3/8 on Friday. The total deal value will be roughly $1 billion, based on GelTex`s 21.4 million shares outstanding currently and Genzyme General`s closing share price of $65.3125 on Sept. 8.

Genzyme said that the GelTex purchase may result in a one-time charge in the fourth quarter of 2000, related to the write-off of in-process research and development. The combination, to be accounted for as a purchase, is expected to hurt Genzyme General`s near-term earnings but it predicted to boost them in 2002, before depreciation and amortization of good will.

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Genzyme General to Acquire GelTex Pharmaceuticals Sees Renagel(R) as Potential Blockbuster and Important Driver of Growth
CAMBRIDGE and WALTHAM, Mass., Sep 11, 2000 /PRNewswire via COMTEX/ -- Genzyme General (Nasdaq: GENZ chart, msgs) and GelTex Pharmaceuticals Inc. (Nasdaq: GELX chart, msgs) today announced that they have entered into a definitive merger agreement under which Genzyme will acquire GelTex. The transaction is expected to close in the fourth quarter, pending regulatory and GelTex shareholder approval.

With the acquisition, Genzyme General will obtain two patent-protected, marketed products-Renagel(R) (sevelamer hydrochloride) and WelChol(TM) (colesevelam hydrochloride) -- along with a significant pipeline of promising products and a proven and productive polymer technology platform. Renagel is a rapidly growing product used in the treatment of patients with end-stage renal disease undergoing dialysis. WelChol is a new cholesterol-lowering agent, which will be launched this month by Sankyo-Parke Davis.

Genzyme believes that the worldwide market opportunity for Renagel is far greater than originally anticipated, and believes that Renagel will transform clinical practice and outcomes. Genzyme expects that at least four fundamental factors will propel the product`s exponential growth: rapidly increasing market share driven by mounting evidence about the role of calcium in cardiovascular disease among dialysis patients; appropriate adjustment of daily doses of Renagel by physicians to lower patient phosphorus levels into the normal range; substantial growth in the dialysis patient population; and the potential for Renagel to lower the overall cost of caring for dialysis patients.

"We have concluded that Renagel has the potential to become a blockbuster product and that it will serve as an important driver of our future growth," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "We believe that Renagel represents the most important advance in the treatment of dialysis patients since the introduction of Epogen(R). We expect to soon begin a large clinical trial to study the product`s ability to improve morbidity and mortality. Genzyme expects that the market potential for Renagel will surpass $500 million within five years and that it will reach $1 billion within the decade. We have developed a very close relationship with the GelTex team through our successful partnership to bring Renagel to the market. We value them highly and look forward to a promising future together."

Mark Skaletsky, president and chief executive officer of GelTex, said: "Our merger with Genzyme will provide tremendous value to GelTex shareholders and employees. The combination of Genzyme`s resources and global commercial infrastructure with GelTex`s demonstrated ability to develop products, creates a very powerful company with an outstanding product pipeline. We are very proud of all that we have accomplished over the last eight years and look forward to joining with Genzyme to build a significant company that provides therapeutic products that improve human health."

Terms of the Agreement

Under the terms of the agreement, GelTex shareholders will receive 0.7272 of a share of Genzyme General common stock or $47.50 in cash for each GelTex share owned, subject to proration to maintain the cash portion of the consideration at 50 percent, approximately $500 million. The merger consideration represents a 27 percent premium over GelTex`s closing share price on September 8, 2000.

The tax-free transaction has a total value of approximately $1 billion, based on GelTex`s 21.4 million shares outstanding today and Genzyme General`s closing share price of $65.3125 on September 8.

The boards of directors of Genzyme Corp. and GelTex have approved the transaction, which is subject to clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act. The transaction will require the approval of GelTex shareholders, and is subject to customary closing conditions.

Genzyme General expects that the acquisition of GelTex may result in a one-time charge in the fourth quarter of 2000, related to the write-off of in-process research and development. The acquisition, which will be accounted for as a purchase transaction, is expected to be dilutive to Genzyme General`s near-term earnings but is expected to become accretive to earnings in 2002 prior to depreciation and amortization of good will.

GelTex employs approximately 110 people. Genzyme plans to retain GelTex`s administrative offices and laboratories in Waltham, Massachusetts. In addition to its marketed products, its pipeline, and unique polymer technology, GelTex has assets that include approximately $119 million in cash, usable net operating loss tax carry forwards, important intellectual property protecting Renagel and their other products, and research facilities.

Renagel`s Potential Far Greater Than Initially Anticipated

Renagel`s growth will be driven by four key factors: rapidly increasing market share from its establishment as a preferred first-line treatment, dose adjustment by nephrologists to lower phosphorus levels into the normal range, substantial growth in the number of dialysis patients worldwide, and Renagel`s potential to lower the total cost of treating these patients.

Specifically, Genzyme expects that the fundamental change in clinician perspectives toward calcium-based binders will rapidly drive the growth of new prescriptions for Renagel, which is the only calcium-free, aluminum-free phosphate binder on the market. Currently, the majority of all dialysis patients are still on a calcium-based phosphate binder.

Within the last year, independent clinical evidence showing the relationship between elevated calcium intake and cardiovascular disease among dialysis patients has led to questions about the safety of calcium-based binders. Cardiovascular disease occurs at a markedly higher rate-and is the leading cause of death-in the dialysis population.

In response to this new clinical evidence, thought leaders within the nephrology community have begun to change the way dialysis patients are managed. According to Dr. Geoffrey A. Block, lead author of the landmark 1998 study correlating poor phosphorus management with mortality in dialysis patients: "The changing mindset of nephrologists across this country is based on both research and personal clinical experience. Too many of our patients die from heart disease, and now we recognize that our treatment of patients is inadvertently contributing to the problem. Leading experts on dialysis are recommending much lower levels of calcium intake. Renagel is the only FDA approved product on the market that lowers phosphorus without adding calcium. Renagel is therefore becoming the standard of care and first-line therapy for every single patient on dialysis."

To demonstrate Renagel`s ability to slow cardiac calcification, Genzyme is currently conducting a three-year study comparing the product with standard calcium binders. One-year results will be available during the first half of 2001.

This study is also designed to further study Renagel`s ability to lower phosphorous into the normal range. Renagel has shown that it can safely lower serum phosphorous levels into the normal range-a historically difficult challenge for nephrologists. Many physicians have begun to increase the dosage level of Renagel in their patients in order to achieve that goal. The launch of a new tablet formulation of Renagel this month will help nephrologists manage patients into the normal serum phosphorus range.

Renagel`s growth will also be driven by a substantial increase in the number of patients undergoing dialysis. Worldwide, approximately 1 million people are now on dialysis and the number is expected to reach 1.7 million by 2009, led by the increased incidence of diabetes, hypertension, and a growing elderly population. The current annual cost of Renagel therapy is approximately $1,000 per patient and is expected to double within the decade from a combination of prescription-driven dosage increases and compliance improvements. Based on market penetration estimates and the availability of reimbursement, Genzyme expects Renagel revenues to reach $500 million within five years and $1 billion in ten years.

Another major driver of Renagel`s growth will be its potential to improve patient morbidity and mortality. In a study to be published next month, Dr. Allan Collins of the University of Minnesota showed a significant improvement in morbidity and observed improved trends in mortality among Medicare patients treated with Renagel compared with patients treated with calcium binders. In this retrospective analysis of data from the U.S. Renal Data System, Collins found a statistically significant 50 percent reduction in hospitalization among Renagel patients compared to the calcium-treated patients. He also observed a 35 percent reduction in deaths among Renagel patients, although the small sample size studied did not allow Collins to confirm its statistical significance. Collins` data has been presented at the 1999 American Society for Nephrology meeting and the 2000 National Kidney Foundation meeting.

Genzyme is currently designing-and plans to begin early next year-a large, prospective, randomized, clinical trial designed to confirm the impact of Renagel on patient morbidity and mortality.

One of the more intriguing aspects of the Collins study was its analysis of patient Medicare payment histories. In this analysis, Collins found dramatic annual costs savings for patients treated with Renagel. These savings averaged more than $17,000 per patient annually based on decreased hospitalizations alone. Genzyme believes Renagel`s ability to lower the overall cost of care for dialysis patients will play a critical role in the product`s long-term growth.

Finally, an additional and significant attribute of Renagel is that it has been shown in clinical studies to dramatically lower LDL cholesterol while increasing HDL cholesterol.

Renagel Revenue Growth

Renagel has generated average quarter-to-quarter revenue growth of 25 percent since its introduction. Renagel sales in 1999-the product`s first full year on the market-were $19.5 million. For 2000, Renagel sales are expected to more than double, and Genzyme is now revising its revenue guidance upward, for the second time this year, to around $45 million. Renagel revenues are expected to double again in 2001 and-within five years-to exceed $500 million.

Renagel is currently marketed in the United States, Europe, Canada, and Israel under a 50/50 joint venture between Genzyme and GelTex. The product is being developed and will be commercialized in Japan and other Pacific Rim countries by Chugai Pharmaceuticals and Kirin Pharmaceuticals under agreements with GelTex.

Other Benefits of the Transaction

In addition to Renagel, Genzyme`s acquisition of GelTex will also give it access to WelChol, three products in clinical trials and three more product candidates potentially entering clinical trials next year.

Genzyme will receive royalties from sales of WelChol, which is being launched by Sankyo-Parke Davis this month. A Phase 2 clinical trial of a second-generation version of WelChol will be completed this quarter and additional clinical trials are planned.

GelTex also has a number of exciting products in its pipeline. Its leading product in development is a toxin binder known as GT160-246 for Clostridium difficile (C. difficile), which is a major cause of antibiotic associated colitis, a condition common in hospitals and nursing homes. C. difficile affects over 500,000 patients per year, resulting in prolonged hospital stays and increased costs, and is the cause of an estimated 5,000 deaths annually. A Phase 1 trial of GT160-246 in normal volunteers was completed in August, and a Phase 2 clinical trial of the product is expected to begin later this year.

In addition, GelTex has made significant progress in its research efforts toward discovery of a new class of fat-absorption inhibitors. GelTex has identified a family of polymers that inhibit pancreatic lipase, the key enzyme involved in fat digestion in the intestine. In pre-clinical studies, these compounds have shown they can inhibit lipase with a potency in the range of that of known inhibitors. They have also show that they can significantly inhibit fat absorption. GelTex has also identified polymers that bind fat and prevent the oily stool associated with lipase inhibition. Since these compounds are high-molecular-weight polymers, they are unlikely to be absorbed into the blood stream. Such compounds could potentially inhibit fat absorption without causing oily stool side effects associated with current therapy.

GelTex`s robust polymer technology platform has produced two approved products and several promising product candidates within a short six-year timespan. Genzyme expects that this technology will be a consistent and productive source of product candidates to feed its therapeutics pipeline. Polymer technology has wide ranging applications, and polymer-based products enjoy a relatively quick development pathway and have proven to be very safe. GelTex`s scientists are widely respected in the industry, and the company`s two most senior scientists recently received an award from the American Chemical Society for their innovative application of polymer technology to the development of therapeutic agents.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of products in development focused on the treatment of genetic disorders. Genzyme General is a division of the biotechnology company Genzyme Corporation.

GelTex develops and markets non-absorbed polymer drugs that bind and eliminate targeted substances within the gastrointestinal tract. In addition, GelTex is developing small-molecule pharmaceuticals consisting of novel polyamine analogues and metal chelators.

This press release contains forward-looking statements, including statements about the consummation and anticipated timing of the merger, the potential market opportunity for Renagel, the expected drivers of growth for the market opportunity, the anticipated impact of Renagel on Genzyme`s future growth, the potential short and long-term revenues from Renagel, the expected benefits of the merger, the value of the merger consideration, the tax-free nature of the transaction, the anticipated impact of the acquisition on Genzyme`s earnings, cash-earnings-per-share, and development programs, Genzyme`s plans concerning the operation of GelTex`s business after the merger, estimates concerning the current and future dialysis patient population, the anticipated impact of Renagel on patient morbidity and mortality, the cost of care for patients, plans to launch a new tablet formulation of Renagel, the anticipated benefits of the tablet formulation, plans to announce trial data, plans to initiate clinical trials of Renagel, GT 160-246, and other product candidates, estimates concerning the C. Difficile Colitis patient population, expectations concerning GelTex`s product candidates and polymer technology platform. Actual results may materially differ due to numerous factors, including without limitation conditions in the financial markets relevant to the proposed merger, the receipt of regulatory and other approvals of the transaction, the operational integration associated with the transaction and other risks generally associated with such transactions, increasing market acceptance of Renagel, increasing doses of Renagel, market acceptance of Renagel tablets, the competitive environment for the dialysis market, the results of clinical trials, the efficacy and safety of products, enrollment rates for clinical trials, the content and timing of submissions to and decisions by regulatory authorities, the availability of reimbursement from third-party payers, the ability to manufacture sufficient quantities of product for development and commercialization activities, the accuracy of the companies` information about the dialysis and the C. Difficile Colitis patient populations and the market for Renagel, the accuracy of the companies` expectations about growth in the dialysis patient population, the ability of Genzyme to successfully commercialize products and the risks and uncertainties described in Genzyme and GelTex`s reports filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation Exhibit 99.2 to Genzyme`s Annual Report on Form 10-K for the year ended December 31, 1999, as amended. GENZ stock is a series of common stock of Genzyme Corporation. Therefore, holders of GENZ stock are subject to the risks and uncertainties described in the aforementioned reports.

This material is not a substitute for the prospectus/proxy statement Genzyme and GelTex will file with the Securities and Exchange Commission. Investors are urged to read that document because it will contain important information, including detailed risk factors. The proxy statement/prospectus and other documents filed by Genzyme and GelTex with the SEC will be available free of charge at the SEC`s website ( www.sec.gov ) and from Genzyme or GelTex.

GelTex, its directors, and certain of its executive officers may be considered participants in the solicitation of proxies in connection with the merger. Information concerning GelTex`s directors and executive officers can be found in the documents filed by GelTex with the SEC. Certain directors and executive officers of GelTex may have direct or indirect interests in the merger due to securities holdings, vesting of options, and rights to severance payments if their employment is terminated following the merger. In addition, directors and officers, after the merger, will be indemnified by Genzyme, and benefit from insurance coverage, for liabilities that may arise from their service as directors and officers of GelTex prior to the merger. Additional information regarding the participants in the solicitation will be contained in the proxy statement/prospectus.

There will be a conference call beginning at 9:00 a.m. EDT today to discuss this morning`s news announcement regarding Genzyme General`s proposed acquisition of GelTex Pharmaceuticals, Inc.

If you would like to participate in this call, please dial 212-346-0257 beginning at 8:45 a.m. EDT. A replay of this call will be available from 12:30 p.m. EDT on September 11 through 12:00 p.m. midnight on September 18 by calling 800-633-8284 in the U.S., or 619-812-6440 outside the U.S., reference confirmation #16318162.

A replay of this call will also be broadcast over the internet at 1:00 p.m. EDT today on Genzyme`s Web site: www.genzyme.com . The replay of the call will be available through midnight EDT September 25.

Genzyme`s releases are available on the World Wide Web at http://www.genzyme.com . They are also available from Genzyme`s fax-on-demand service at 1-800-436-1443 within the United States or 1-201-521-1080 outside the United States.

GelTex`s press releases are available at http://www.geltex.com .



Source: Genzyme General

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Important US Patent Secures Pharming`s Position on human alpha-Glucosidase
LEIDEN, Netherlands, Sep 13, 2000 /PRNewswire via COMTEX/ -- Pharming Group N.V. (AEX:PHAR; EASDAQ:PHAR) announced the issuance of US patent No. 6,118,045, with claims covering both pharmaceutical compositions containing human alpha-Glucosidase and the production thereof. Through this patent, a viable production method for human alpha-Glucosidase to treat Pompe`s disease was disclosed for the first time ever.

The patent covers two types of claims, the first protects all transgenic animals capable of producing human alpha-Glucosidase (hAG) in their milk and the use of these animals to produce hAG, the second protects pharmaceutical compositions containing hAG for parenteral use, independent of the production method used for hAG. The second set of claims is of particular interest to Pharming in light of the earlier decision to move to CHO cell culture for the production of hAG. This patent applies to all production methods for hAG, not just the transgenic platform. The inventions claimed in this patent have resulted from a fruitful collaboration between scientists from Pharming, the Erasmus University Rotterdam and the University Hospital Rotterdam at the University of Leiden.

"This is a clear demonstration of Pharming`s strategy to obtain protection throughout the development track, from technology to product," according to George J.M. Hersbach, Pharming`s president and Chief Executive Officer. He continues: "With already 32 patents issued to Pharming worldwide on different aspects of transgenic technology, products and applications, we have ensured a strong and broad protection of both our technologies and products. The strength of our portfolio is increasingly recognized by others, just recently we closed an agreement with Genencor International Inc., on the out-licensing of our large transgenes patent."

Jan van Heek, Executive Vice-President of Genzyme Corp., adds: "This patent will be extremely important in ensuring the successful development and commercialization of human alpha-Glucosidase. It is also testament to the substantial expertise that Pharming brings to our collaboration to develop a therapy for Pompe`s disease. Genzyme and Pharming share a common commitment to helping patients who are suffering from this terrible disorder, and we are working as quickly as possible to make a treatment available."

Human alpha-Glucosidase is under development as an enzyme replacement therapy for Pompe`s disease, a hereditary, lethal muscle disorder that affects 5,000-10,000 people in the Western World. In 1998, Pharming formed a joint venture with Genzyme (Nasdaq: GENZ chart, msgs) for the development and commercialization of transgenic human alpha-Glucosidase for Pompe`s disease. Earlier this year, Genzyme acquired the exclusive rights to Pompase(TM) from Synpac, Inc. This enzyme replacement therapy for Pompe`s disease is based on human alpha-Glucosidase produced in CHO-cells. The newly formed Genzyme-Pharming Alliance LLC, will further develop and commercialize Pompase on a 50/50 basis.

Pharming focuses on the development, production and commercialization of human therapeutic proteins to be used in highly innovative therapies. Pharming has developed a proprietary production platform of transgenic animals, capable of producing human therapeutic proteins at high levels in their milk. The company`s product portfolio is aimed at treatments for genetic disorders, surgery and trauma, infectious and inflammatory diseases, tissue and bone repair and blood-related disorders. Pharming has operations in Belgium, Finland, the Netherlands and the USA and currently employs more than 200 people.

Source: Pharming Group N.V.

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Diacrin/Genzyme Joint Venture and FDA Agree to Maximize Product Efficacy Data In Ongoing NeuroCell(TM)-PD Blinded Phase 2 Clinical Trial
CAMBRIDGE, Mass., and CHARLESTOWN, Mass., Sep 14, 2000 /PRNewswire via COMTEX/ -- Genzyme General (Nasdaq: GENZ chart, msgs) and Diacrin Inc. (Nasdaq: DCRN chart, msgs) today announced that based on discussions with the U.S. Food and Drug Administration (FDA) and clinical investigators, they have collectively agreed to extend the blinded NeuroCell-PD phase 2 clinical trial for Parkinson`s disease to 18 months from 12 months. The extension is intended to enable investigators to maximize the amount of long-term durability data for NeuroCell-PD, and to provide the best efficacy data for potential product approval. The unblinding of this pivotal trial data is expected to take place in March 2001.

"We are committed to the NeuroCell program and are very excited about the potential of NeuroCell to benefit patients who suffer from the devastating symptoms of Parkinson`s disease," said Henri Termeer, president and chief executive officer, Genzyme Corporation. "The decision by the joint venture, the FDA, and our clinical investigators to extend the trial illustrates a collective dedication to ensure the best data possible from the blinded phase 2 study. The joint venture is near completion in preparing for the confirmatory phase 3 study and will be ready to begin treating patients once the data is unblinded and a decision to move forward is made."

Genzyme transferred its interest in the NeuroCell joint venture from Genzyme Tissue Repair (Nasdaq: GZTR chart, msgs) to Genzyme General in April 1999. A milestone payment, based on the initiation of a phase 3 clinical trial for NeuroCell, is part of the terms of the transfer agreement.

To accommodate the extension of the pivotal phase 2 trial, Genzyme Corporation will propose to its Board of Directors an extension of the first milestone date for the NeuroCell program to June 30, 2001 from December 31, 2000. This will allow investigators time to complete and review the results of the phase 2 clinical trial. Genzyme expects that its Board of Directors will approve the milestone extension at its next regularly scheduled board meeting.

NeuroCell Clinical Trial Background

Preparations for the phase 3 confirmatory trial are moving ahead. The FDA has reviewed the trial protocol and trial sites and investigators have been selected. To date, the joint venture has received five Institutional Review Board (IRB) approvals for the phase 3 trial protocol.

In May 2000, final study results from a phase 1 clinical trial for NeuroCell-PD were presented and showed that all patients tolerated the treatment well and a group of patients continued to show improvement 36 months after surgery. No safety concerns related to treatment have been identified. Safety and efficacy data will continue to be collected on these patients for up to five years. Additionally, all patients enrolled in the study will be followed for safety in a life-long registry.

In October 1999, the FDA granted NeuroCell-PD Fast Track designation, making the joint venture eligible to receive expedited review of an application for NeuroCell-PD product approval.

Background on NeuroCell Transfer

In 1996, Genzyme and Diacrin, Inc. established Diacrin/Genzyme LLC, a joint venture to develop cell therapies for the treatment of Parkinson`s and Huntington`s diseases.

In April 1999, Genzyme Tissue Repair transferred the 50 percent interest in the joint venture to Genzyme General based on a strategic decision to focus on products and devices in orthopedics and burn care. Genzyme General believes that NeuroCell-PD has shown early promise and is an excellent fit with its specialty therapeutics product pipeline.

Under the terms of the transfer, Genzyme Tissue Repair received $25 million from Genzyme General in 1999, of which $5 million is non-refundable and $20 million is a pre-payment related to the achievement of two milestones.

The two milestones are now: repayment of $20 million to Genzyme General if Diacrin/Genzyme LLC does not initiate a phase 3 clinical trial of NeuroCell-PD by December 31, 2000; repayment of $15 million to Genzyme General if the phase 3 clinical trial is initiated by December 31, 2000 but Diacrin/Genzyme LLC does not obtain FDA product approval of NeuroCell-PD prior to June 30, 2004. Genzyme expects its Board of Directors to extend the December 31, 2000 milestone to June 30, 2001 to accommodate the extension of the phase 2 trial.

In addition to the advance cash payment already received, Genzyme Tissue Repair will receive royalties of three percent on sales of any products successfully developed and marketed by the joint venture.

Diacrin is developing cell transplantation technology for treating human diseases that are characterized by cell dysfunction or cell death and for which current therapies are either inadequate or nonexistent. Products under development include: NeuroCell-PD for Parkinson`s disease; porcine neural cells for stroke, focal epilepsy and intractable pain; porcine spinal cord cells for spinal cord injury; NeuroCell-HD(TM) for Huntington`s disease; porcine liver cells for acute liver failure; human liver cells for cirrhosis; human muscle cells for cardiac disease; and porcine retinal pigment epithelial cells for macular degeneration. Diacrin is developing NeuroCell-PD and NeuroCell-HD in a joint venture with Genzyme Corporation.

Genzyme Tissue Repair is a leading developer of biological products and devices for the treatment of orthopedic injuries such as cartilage damage, and severe burns.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of products in development focused on the treatment of rare genetic disorders.

Both Genzyme General and Genzyme Tissue Repair are divisions of the biotechnology company Genzyme Corporation and have their own common stocks intended to reflect their value and track their performance.

This press release contains forward-looking statements, including statements about the expected timing of unblinding of trial data, plans to propose a milestone deadline extension to the Genzyme Board of Directors, the expected receipt and timing of approval of the milestone deadline extension by Genzyme`s Board of Directors, the potential benefits and promise of NeuroCell-PD, the anticipated initiation of a phase 3 clinical trial, and potential royalties. Actual results may differ materially depending on many factors, including whether the joint venture decides to initiate a phase 3 clinical trial of NeuroCell-PD, the actual timing and content of a decision by Genzyme`s Board of Directors concerning the milestone deadline, the enrollment rate for clinical trials, the actual timing and results of clinical trials, the ability to demonstrate long-term safety and efficacy of the NeuroCell(TM) products, the timing and content of submissions to and decisions by the FDA and other regulatory authorities, the ability of Diacrin/Genzyme LLC to manufacture sufficient quantities of product for clinical trials, the availability of reimbursement for products, the competitive environment for any products developed by Diacrin/Genzyme LLC, the continued funding of the joint venture by Genzyme and Diacrin, and the risks and uncertainties described in Exhibit 99.2 to Genzyme Corporation`s Annual Report on Form 10-K for the year ended December 31, 1999, as amended and Diacrin`s Annual Report on Form 10-K for the year ended December 31, 1999.

Genzyme`s releases are on the World Wide Web at http://www.genzyme.com. They are also available from Genzyme`s fax-on-demand service at 1-800-436-1443 in the United States and 1-201-521-1080 elsewhere.

Source: Genzyme General

[Hemden]

...

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TKT Files Complaint Seeking Declaratory Judgment Against Genzyme
CAMBRIDGE, Mass., Sep 19, 2000 /PRNewswire via COMTEX/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX chart, msgs) today announced the Company has filed a complaint against Genzyme Corporation seeking declaratory judgments of patent non-infringement and invalidity in the U.S. District Court of Massachusetts in Boston. In the complaint, TKT asserted that the Company`s activities relating to Replagal(TM) (agalsidase alfa), an investigational enzyme replacement therapy for the treatment of Fabry disease, do not infringe U.S. Patent No. 5,356,804 and that the patent is invalid.

"Genzyme filed a groundless lawsuit in Delaware two months ago amid much publicity, but has not commenced the suit by serving process on TKT," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "We believe Genzyme resorted to this tactic in order to persuade opinion leaders, patients, and potential partners not to work with TKT. These actions are improper and unacceptable, and we intend to put an end to Genzyme`s pre- approval marketing campaign as soon as possible." Dr. Selden added, "It is a shame that Genzyme has chosen to compete based on a frivolous lawsuit rather than on the merits of their product."

On July 25, 2000, Genzyme brought suit against TKT in the United States District Court of Delaware in Wilmington claiming that TKT`s activities relating to Replagal(TM) infringe one or more claims of U.S. Patent No. 5,356,804. The suit has not commenced because Genzyme has refused to serve process on TKT. Serving process is the notice provided to a party that allows a lawsuit to proceed.

[gholzbauer]

Genzyme General`s Fabrazyme(TM) BLA Accepted for Review by FDA Fabrazyme Data Presented For First Time at Medical Conference
CAMBRIDGE, Mass., Sep 19, 2000 /PRNewswire via COMTEX/ -- Genzyme General (Nasdaq: GENZ chart, msgs) announced today that its Biologics License Application (BLA) for Fabrazyme(TM) (agalsidase beta) has been accepted for review by the U.S. Food and Drug Administration (FDA). The action means that the FDA has determined that the submission contains sufficient information for the agency to perform a meaningful review for marketing authorization.

The FDA has also approved Genzyme`s request for priority review of the Fabrazyme BLA, meaning that the agency`s review of the filing should be completed within six months of submission. Genzyme submitted the BLA for Fabrazyme at the end of June. Fabrazyme is Genzyme`s investigational enzyme replacement therapy for patients with Fabry disease.

Results from Genzyme`s two clinical trials of Fabrazyme were presented for the first time this past weekend at a meeting of the International Congress of Inborn Errors of Metabolism held in Cambridge, U.K.

During a plenary session talk Sunday, Dr. Robert Desnick, chairman of the Department of Human Genetics at Mount Sinai School of Medicine, presented brief highlights from Genzyme`s Phase 3 clinical trial of Fabrazyme.

The double-blinded, randomized, and placebo-controlled clinical trial enrolled 58 patients at eight medical centers in the United States and Europe. The trial results were highly statistically significant (p<0.0001) in meeting the primary endpoint, which was clearance of GL-3 in the blood vessels of the kidney. The accumulation of the lipid GL-3 in the cells that line the blood vessels of Fabry patients results in devastating symptoms such as severe pain, numbness, kidney failure, and cardiac disease, leading to early death. This endpoint was developed in collaboration with the FDA as a predictor of clinical response because clearance of GL-3 addresses the primary pathology of the disease.

Dr. Desnick explained that "the demonstration of Fabrazyme`s ability to return severely affected capillary vessels of the kidney and other organs studied to an essentially normal appearance provides strong evidence that these vessels should function normally as a result of treatment."

A full presentation of the Phase 3 results, including secondary and tertiary endpoints, will be provided by the trial`s principal investigator, Dr. Christine Eng of the Mount Sinai School of Medicine, on October 5 at the American Society of Human Genetics Meeting in Philadelphia.

Phase 1-2 Trial Results

During an earlier session of the Inborn Errors of Metabolism conference, Dr. Eng reviewed results from Genzyme`s Phase 1-2 clinical trial of Fabrazyme. The trial was an open-label, single-center, dose-finding study, which enrolled 15 patients with Fabry disease. The trial results showed that Fabrazyme was safe and well-tolerated.

Three doses (0.3 mg/kg; 1.0 mg/kg; 3.0 mg/kg) and two dosing frequencies were evaluated over a three-month period. Each patient received a total of five doses of Fabrazyme, which was shown to be effective in clearing GL-3 from the liver and from the small blood vessels of the skin, heart, and kidney, as well as from the plasma and urine. GL-3 clearance was observed at all doses, but a dose effect was observed-with higher doses producing better, more complete, and consistent results in the plasma and liver.

Measurements of pain also appeared to improve, with treated patients showing a statistical reduction in scores of the McGill Pain Questionnaire compared to baseline. Present pain intensity also improved in treated patients (p<0.004) when compared to baseline. Several parameters of quality of life as measured by SF-36 also improved. No control groups were available for comparison in the Phase 1-2 trial.

Fabry disease is an inherited metabolic disorder caused by a deficiency of the enzyme alpha-galactosidase. This deficiency results in the body`s inability to break down certain naturally occurring glycolipids, primarily GL- 3, which then accumulate predominantly in the lining of blood vessels within the kidney, heart and other organs. Due to severe organ complications, death typically occurs around age 40 for those afflicted with the disorder. Fabry disease is estimated to affect approximately 2,000-4,000 people worldwide.

Additional Genetic Disease Presentations

The Inborn Errors of Metabolism conference also featured several additional presentations related to Genzyme`s genetic disease development programs.

Seng Cheng, Ph.D., a Genzyme scientist, reviewed pre-clinical studies demonstrating the feasibility of gene therapy for Fabry disease. Genzyme researchers have been able to demonstrate clearance of GL-3 lipid storage from affected tissues following gene transfer in a mouse model of Fabry disease.

This result was achieved with both a standard adenovirus and adeno- associated virus (AAV) vector, and the effect persisted for six months. AAV vectors are particularly promising for treatment of lysosomal storage disorders such as Fabry disease, as they yield long term expression and appear safer than current-generation adenovirus vectors. These results are likely to be applicable to other storage disorders and will form the basis for a common approach to treating these devastating diseases. Genzyme is collaborating with Genovo Inc. in the development of AAV vectors for the treatment of lysosomal storage disorders.

Dr. Cheng`s Genzyme colleague John Marshall, Ph.D., presented an assessment of in vivo gene therapy approaches to Gaucher disease. Genzyme is exploring gene therapy approaches to treating patients with Gaucher disease, consistent with its commitment to developing next-generation treatments for these patients. It is sponsoring a Phase 1 gene therapy clinical trial for patients with Gaucher disease at the University of Pittsburgh. Genzyme currently markets Cerezyme(R) (imiglucerase for injection), an enzyme replacement therapy for Gaucher disease.

The conference also featured a talk by Dr. Edward Schuchman of the Mount Sinai School of Medicine, who presented results from pre-clinical studies of enzyme replacement therapy for type B Niemann-Pick disease. Genzyme is collaborating with Dr. Shuchman and Dr. Desnick to develop a treatment for patients with this disease, which is a lysosomal storage disorder similar to Gaucher disease. Genzyme plans to begin a Phase 1 clinical trial for Niemann- Pick disease during the second half of next year.

The conference included several other clinical presentations related to Genzyme-sponsored development programs, including a discussion by Dr. J.E. Wraith of Royal Manchester Children`s Hospital of data from the initial clinical trial of Aldurazyme for MPS I. Dr. Ans van der Ploeg of Sophia Children`s Hospital in Rotterdam presented data from the initial clinical trial of transgenic human alpha-Glucosidase for Pompe disease.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of therapeutic products in development focused primarily on the treatment of genetic diseases. A division of the biotechnology company Genzyme Corporation, Genzyme General has its own common stock intended to reflect its value and track its economic performance.

[gholzbauer]

Quelle: www.america-invest.com Rubrik: "Biotech Tuesday" vom 17.10.2000, Autor: Paul Schneider



Genzyme General, on the other hand, seems to be making all the right moves while selling at reasonable valuations, by biotech standards anyway.
One of the reasons to favor Genzyme is its announcement last month that it will pay
$1 billion in cash and stock to acquire Waltham, Mass.-based GelTex Pharmaceuticals (GELX).

With GelTex, Genzyme General gets two products already on the market -- Renagel, used to treat patients with end-stage renal disease undergoing dialysis, and the cholesterol-lowering drug WelChol -- as well as GelTex`s pipeline and polymer technology platform. Genzyme said that it sees sales of Renagel exceeding $500 within five years, and that it expects the market for the drug will reach $1 billion within a decade.

At nearly $6 billion in market capitalization, Genzyme General offers the safety of size. Also, priced at five times book, 29 times earnings and nine times sales, Genzyme General`s valuations look pretty reasonable compared to its big-cap biotech peers.

Genzyme General is expected to report third-quarter earnings before market open on Thursday, Oct. 19.

[AbneyPark]

Genzyme restates tracking stock earnings
CAMBRIDGE, Mass., Oct 18 (Reuters) - Biotechnology holding company Genzyme Corp. said on Wednesday it would restate the earnings of several of its tracking stocks in accordence with guidence from the U.S. Securities & Exchange Commission.

Genzyme established a tracking stock in June 1999 for its surgical products unit called Genzyme Surgical Products (NASDAQ: GZSP). Prior to the creation of the tracking stock, however, the company had excluded the losses and earnings from that unit from its Genzyme General Corp. (NASDAQ: GENZ) business.

"When we created Genzyme Surgical Products, we retroactively adjusted historical earnings-per share information to provide investors with an `apples-to-apples` comparison," said Michael Wyzga`s chief financial officer in a statement.

The SEC ruled that such exclusions could only be made after the trading stock is issued. Consequently, Genzyme has restated earnings of its Genzyme General to include such losses prior to the issuing of Genzyme Surgical Products stock.

"We have modified our financial statement presentation to reflect SEC`s guidance in this area," Wyzga said. "The overall operating results for Genzyme Corp. will not change as a result of these revisions."

Genzyme General`s 1999 net income was revised downward to $146.4 million, or $1.71 a share, from $176.9 million, or $2.00 a share. Its 1998 net income was cut to $121.1 million, or $1.48 a share, from $170.9 million, or $2.06 a share, and its 1997 net income was trimmed to $77.4 million, or 98 cents a share, from $107.2 million, or $1.36 a share.

Genzyme Surgical Products 1999 net loss was narrowed to $20.5 million, or $1.38 a share, from its pro forma net loss of$48 million, or $3.25 a share. No earnings are being reported in 1998 and 1997, because the tracking stock had not yet been issued.

[gholzbauer]

Genzyme Molecular Oncology and Purdue Pharma L.P. Announce Tumor Antigen Discovery and Licensing Agreement
FRAMINGHAM, Mass. and Stamford, Conn., Oct 18, 2000 /PRNewswire via COMTEX/ -- Genzyme Molecular Oncology (Nasdaq: GZMO chart, msgs) and Purdue Pharma L.P., a privately held pharmaceutical company, today announced their entry into a discovery and licensing agreement related to the discovery and product development of up to 20 cancer antigens. This agreement has the potential to provide Genzyme Molecular Oncology with more than $330 million in up front and milestone payments from Purdue Pharma if all 20 selected antigens are ultimately developed and approved for sale.

Antigens are important markers that alert the immune system to a foreign invader, such as cancer cells, and prompt T cells to attack and destroy the invader. Antigens are an essential element in the development of powerful, targeted cancer vaccines.

Genzyme Molecular Oncology expects to identify dozens of antigens during the research term. The agreement allows for Purdue Pharma to select a specified number of cancer antigens identified by Genzyme Molecular Oncology under the research program. Genzyme Molecular Oncology and Purdue Pharma may each commercialize products using those selected antigens based on delivery technology. Genzyme Molecular Oncology estimates that the selected antigens will be less than half of the total number of antigens it expects to discover during the research term. Genzyme Molecular Oncology will retain rights to those antigens not selected by Purdue Pharma.

Purdue BioPharma L.P., a biopharmaceutical subsidiary of Purdue Pharma, will use its proprietary technologies, including its SYNTHEBODY(TM) antibody engineering platforms, epitope strings, and anti-idiotype inducers against these antigen targets to develop cancer agents and vaccines. Genzyme Molecular Oncology will use its own proprietary technologies, including gene therapy, cell therapy, peptide, and protein-based technologies, against these antigen targets for its cancer product development.

Under the agreement, Genzyme Molecular Oncology will receive over $21 million in committed funding from Purdue Pharma, which includes technology access fees, research funding over a three-year period, and an equity investment in Genzyme Molecular Oncology at a premium to market. Of this, approximately $12 million was received upon execution of the agreement. If Purdue Pharma selects antigens under the research program, Genzyme Molecular Oncology also may receive in excess of $310 million in milestone payments from Purdue Pharma related to research and development progress. In addition, Genzyme Molecular Oncology is entitled to receive royalties on sales of any Purdue Pharma therapeutic product containing antigens discovered under this agreement.

"The magnitude of our agreement with Purdue Pharma illustrates the power and value of our antigen discovery platform technologies and defines us as a formidable leader in the field of antigen discovery," said Gail Maderis, president, Genzyme Molecular Oncology. "Not only will we receive significant research funding for our program, but we may use the antigens discovered under the agreement in our own approaches for developing cancer vaccines. Additionally, we can leverage our antigen discovery platform with other partners interested in infectious disease and autoimmune disorders."

"With this agreement, we plan to enhance the depth and breadth of our cancer immunotherapy development program," said Dr. Paul Goldenheim, Executive Vice President for Worldwide Research and Development of Purdue Pharma L.P. "We anticipate that this collaboration with Genzyme Molecular Oncology will yield novel antigen targets against which we can apply our proprietary technologies to develop new anticancer drugs and vaccines."

The significant strength and speed of its antigen discovery program distinguishes Genzyme Molecular Oncology as a leader in the antigen discovery field. Using its powerful, high-speed platform, Genzyme Molecular Oncology can identify potent antigens and antigen fragments (epitopes) for cancer drug development in as little as three months, and move an antigen into the clinic within 12 to 18 months.

Background on Antigen Discovery Program

Genzyme Molecular Oncology established its antigen discovery program to overcome long-standing limitations in the development of cancer vaccines caused by the lack of known antigens in cancer indications other than melanoma. Genzyme Molecular Oncology believes providing physicians with an arsenal of off-the-shelf cancer vaccines based on an abundance of known antigens is the future of immunotherapy.

To reach this goal, Genzyme Molecular Oncology`s antigen discovery platform was created by integrating four proprietary technologies-SELEC-T, SCAN, SAGE(TM), and SPHERE.

SELECT-T and SCAN are functional approaches that utilize immune cells derived from patient tumor samples to analyze the antigen profiles of various tumor cell lines. Genzyme Molecular Oncology has generated over 2000 immune cell profiles to date. These functional profiles are combined with SAGE genomics data to determine the identity of the antigen genes. Genzyme Molecular Oncology`s proprietary SAGE gene expression database currently contains over three million datapoints on a wide variety of tumor types.

In addition to identifying the native antigen, Genzyme Molecular Oncology uses SPHERE, a high throughput screening methodology employing a combinatorial library of over 47 million peptides, to identify potent, modified antigen fragments.

Four fundamental principals distinguish Genzyme Molecular Oncology`s antigen discovery program from competing programs:


-- Genzyme Molecular Oncology utilizes functional approaches at the start
of the discovery process to rapidly focus the search on clinically
relevant targets.
-- The power of gene expression analysis is significantly enhanced by
combining it with functional approaches.
-- Modified antigen fragments have superior potency to naturally occurring
antigens.
-- All parts of Genzyme Molecular Oncology`s discovery program have been
designed for high throughput analysis and the data generated is
accumulated in an "evergreen" database.

Genzyme Molecular Oncology is using its antigen discovery platform to identify new antigens for development in its internal antigen-specific peptide and gene cancer vaccine programs. Genzyme Molecular Oncology plans to file an Investigational New Drug Application (IND) for its first proprietary antigen in 2001.

Its antigen discovery platform can also be used to identify antigens and epitopes for development in vaccines and antibody therapeutics for infectious disease and autoimmune disorders. Genzyme Molecular Oncology plans to seek additional collaborative partners to use its integrated platform in these areas.

About Purdue Pharma L.P.

Purdue Pharma L.P., headquartered in Stamford, CT, is a privately-held pharmaceutical company engaged in the research, development, production, and sale of both prescription and over-the-counter medicines and hospital products. Purdue Pharma`s sales grew 50% in 1999 to a record $901 million. The company is a leading provider of patented prescription controlled-release medications for chronic pain such as OxyContin(R) (oxycodone hydrochloride controlled-release) tablets and fast-acting formulations to manage acute pain. With the acquisition of CoCensys Inc. in 1999, Purdue Pharma expanded its scope into CNS discovery and development.

Purdue BioPharma in Princeton, New Jersey, is a biopharmaceutical company focused on the discovery and development of antibody-based therapeutics and vaccines. Purdue Pharma is part of a privately-held international group of associated companies with operations in 18 countries, including the Mundipharma companies which operate throughout Europe, Asia, Australia, and South America; Napp Pharmaceutical Group in the U.K; and Purdue Pharma of Canada. The group had worldwide sales of $1.2 billion in 1999 and employs more than 4,000 people in research, development, manufacturing, and marketing worldwide. Visit the Purdue Pharma web site at http://www.purduepharma.com.

Genzyme Molecular Oncology is developing a new generation of cancer products focusing on cancer vaccines and angiogenesis inhibitors. It is shaping these new therapies through the integration of its genomics, gene and cell therapy, small-molecule drug discovery, and protein therapeutic capabilities.

A division of Genzyme Corporation, Genzyme Molecular Oncology has its own common stock intended to reflect its economic value and track its performance

[gholzbauer]

Genzyme Corp. Announces Third-Quarter Financial Results for Genzyme General
Strong Earnings and Revenue Growth Reported
CAMBRIDGE, Mass., Oct 19, 2000 /PRNewswire via COMTEX/ -- Genzyme Corp. today announced third-quarter financial results for Genzyme General (Nasdaq: GENZ chart, msgs). Net income allocated to Genzyme General for the quarter increased 55 percent to $59.4 million, or $.64 per diluted share, compared with net income of $38.2 million, or $.43 per diluted share, for the same quarter of 1999.

Reported net income for the third quarter of 2000 includes a pre-tax gain of $10.9 million from the sale of Genzyme Transgenics Corp. stock and a pre- tax charge to research and development of $2.0 million associated with a collaboration agreement with Cambridge Antibody Technology.

Excluding these items, Genzyme General`s earnings were $.58 per diluted share, up 23 percent from $.49 per diluted share before special items in the third quarter of last year.

Revenues for the third quarter grew 22 percent to $192.2 million, compared with revenues of $157.7 million for the same quarter of 1999.

"This was another excellent quarter for Genzyme General, marked by a solid financial performance and several defining events significant to our future growth," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "Revenues increased across all of our businesses, led by sales of Renagel that once again surpassed our expectations. We also announced in September that we will acquire GelTex Pharmaceuticals, which will expand our portfolio of marketed products, our development pipeline, and our technology base. We look forward to closing this transaction in December or January."

The effective net tax rate allocated to Genzyme General in the third quarter, including allocated tax benefits, was 21 percent. Genzyme expects the effective tax rate allocated to Genzyme General to be in the mid-twenty- percent range for 2000, increasing to the high-twenty-percent range in 2001.

Earnings per share of Genzyme General stock were calculated this quarter using approximately 97 million shares. This calculation reflects the net impact of anticipated dilution, offset by the reduced interest expense, that would be caused by the conversion of outstanding notes and debentures allocated to Genzyme General.

Consistent with the recently announced modifications to the format for its financial statements, Genzyme Corp. is now presenting earnings-per-share, earnings-allocation, and tax-allocation information for each tracking stock within Genzyme Corp.`s consolidated financial statements rather than in the financial statements of each division. The new format is designed to provide greater clarity for investors.

[gholzbauer]

Genzyme says FDA to bypass advisory panel review of Fabrazyme
CAMBRIDGE, Mass., Nov. 1 (Reuters) - Genzyme General (NASDAQ: GENZ) on Wednesday said U.S. regulators have told the biotechnology company they will bypass an advisory committee review of the firm`s marketing request for Fabrazyme.

Fabrazyme is Genzyme`s experimental enzyme replacement therapy for patients with Fabry disease. The company`s marketing request had earlier been accepted for priority review by the U.S. Food and Drug Administration (FDA), which speeds up the review process to about 6 months from the usual 12.

Fabray disease is a rare genetic disorder caused by insufficient amounts of the enzyme alpha-galactosidase, without which patients are unable to break down blood fats. That causes blood fats to collect in blood vessels of the kidney and other organs and typically results in death by age 40.

Regulatory clearance for Fabrazyme is expected by mid- January.

The FDA often uses advisory committees to provide guidance for clinical issues related to marketing applications.

Genzyme General is a division of Genzyme Corp. and develops and markets therapeutic products and diagnostic products and services.

[gholzbauer]

Genzyme General Says Fabrazyme(TM) BLA Will Not Need December Advisory Committee Review
CAMBRIDGE, Mass., Nov 1, 2000 /PRNewswire via COMTEX/ -- Genzyme General (Nasdaq: GENZ chart, msgs) announced today that the U.S. Food and Drug Administration (FDA) has said that there is no need for a December advisory committee review of Genzyme`s Biologics License Application (BLA) for Fabrazyme(TM) (agalsidase beta).

The FDA frequently uses advisory committees to provide guidance regarding clinical issues related to marketing applications.

Fabrazyme is Genzyme`s investigational enzyme replacement therapy for patients with Fabry disease. The Fabrazyme BLA has been accepted for priority review by the FDA. ction on U.S. marketing authorization is expected by mid- January.

[gholzbauer]

Transkaryotic leads as biotechs slip

By Ted Griffith, CBS.MarketWatch.com
Last Update: 1:51 PM ET Nov 3, 2000 NewsWatch
Latest headlines

NEW YORK (CBS.MW) -- Biotechnology shares slipped in afternoon action, with shares of Transkaryotic Therapies among the decliners after some analysts made favorable comments about rival Genzyme Corp.

The Amex Biotechnology Index ($BTK: news, msgs) slipped 1.4 percent and the Nasdaq Biotechnology Index ($IXBT: news, msgs) lost 0.2 percent.

Transkaryotic (TKTX: news, msgs) declined 6.5 percent, or $2.81, to trade at $40.56 in recent action. Shares of Genzyme`s primary division, Genzyme General (GENZ: news, msgs), gained $6.06, or 7.6 percent, to $86.06. Earlier, Genzyme General shares touched a 52-week high of $86.75.

In June, both Transkaryotic and Genzyme applied to the Food and Drug Administration seeking marketing clearance for a treatment for a rare genetic condition called Fabry disease. Analysts expect that ultimately, only one of the companies, both of which are based in Cambridge, Mass., will be granted permission to sell the Fabry disease treatment.

Genzyme said late Wednesday the FDA has indicated there is no need for a December advisory committee review of the company`s application for clearance to sell the treatment, Fabrazyme. Genzyme said it expects the agency to make its decision on the marketing clearance application by mid-January.

Edge to Genzyme or Transkaryotic?

At least one analyst interpreted Wednesday`s announcement as favorable to Genzyme and issued positive comments about the company.

In a note to clients, PaineWebber analyst Elise Wang said that Genzyme "may have an advantage" over Transkaryotic in the effort to gain FDA approval. Among other things, Wang said, Genzyme`s studies have included more patients than Transkaryotic`s.

Another analyst, though, gave the edge to Transkaryotic. Pacific Growth Equities analyst Thomas Dietz said in a note to clients that Transkaryotic`s drug has "a distinct advantage," reflecting what he said has been its effectiveness in patient testing.

Elsewhere, shares of Affymetrix (AFFX: news, msgs), which had opened lower, recovered and resumed their ascent Friday, gaining $6.19 to $85.63 in recent action.

Shares of Affymetrix gained 32 percent Thursday following news that the company scored a legal victory in a patent dispute with Oxford Gene Technology, an English biotech.

Shares of Human Genome Sciences (HGSI: news, msgs), which also gained significant ground this week, rose 63 cents to $99.06. Human Genome Sciences announced this week two separate collaborations with other companies aimed at developing new treatments for cancer and autoimmune diseases.

[gholzbauer]

BIOMATRIX INC - Genzyme and Biomatrix Announce Registration Statement for Genzyme - Biosurgery Declared Effective by SEC
New York, New York, Nov. 06, 2000 (Market News Publishing via COMTEX) -- Genzyme Corp. and Biomatrix, Inc. announced that the Securities and Exchange Commission (SEC) has declared effective the registration statement for the merger of Genzyme and Biomatrix and for the planned formation of Genzyme Biosurgery, a new Genzyme division.

A joint proxy statement/prospectus will be mailed on November 9 to holders of Biomatrix stock and to holders of each of Genzyme Corp.`s four tracking stocks. The record date for Biomatrix shareholders is November 2 and for Genzyme shareholders the record date is October 25.

Biomatrix will hold a special meeting of its shareholders on December 7, 2000 at the Marriott-Glenpointe, 1000 Frank W. Burr Boulevard, Teaneck, New Jersey, to obtain the required approvals for Biomatrix`s merger with Genzyme. Upon completion of the merger, the business of Biomatrix will be combined with the businesses of Genzyme Tissue Repair and Genzyme Surgical Products to form Genzyme Biosurgery, a new division of Genzyme Corp.

Genzyme will hold a special meeting of its shareholders on December 15, 2000 at The Residence Inn, 6 Cambridge Center, Cambridge, Massachusetts. Holders of each of Genzyme Corp.`s four tracking stocks will be asked to vote to approve a charter amendment creating Genzyme Biosurgery stock, a new Genzyme Corp. tracking stock, and eliminating Genzyme Tissue Repair stock (Nasdaq: GZTR chart, msgs) and Genzyme Surgical Products stock (Nasdaq: GZSP chart, msgs).

The boards of directors of both Genzyme Corp. and Biomatrix have unanimously approved the merger. Dr. Endre Balazs and three other executive officers of Biomatrix have agreed to vote their Biomatrix shares, totaling approximately 36 percent of the outstanding shares, in favor of the transaction.

Genzyme intends to list Genzyme Biosurgery stock for trading on the Nasdaq National Market under the symbol GZBX following completion of the merger and recapitalization, which is expected to be completed this year. Upon formation, Genzyme Biosurgery will have approximately 35 million shares outstanding.

"When formed, Genzyme Biosurgery will represent a powerful business in the growing biosurgical marketplace," stated Duke Collier, president of Genzyme Surgical Products, who will become president of Genzyme Biosurgery. "We believe that the combination of Biomatrix`s product development expertise and Genzyme`s commercialization infrastructure will build significant value more rapidly than each enterprise could achieve on its own."

What Shareholders Will Receive Under the terms of a definitive merger agreement, Genzyme Biosurgery will be formed by combining Genzyme Tissue Repair, Genzyme Surgical Products and Biomatrix. Holders of Genzyme Tissue Repair stock will receive 0.3352 of a share and holders of Genzyme Surgical Products stock will receive 0.6060 of a share of Genzyme Biosurgery stock for each share of their stock.

Under the merger agreement, Genzyme has agreed to pay cash at $37 per share for up to 28.38 percent of the outstanding shares of Biomatrix common stock and to exchange Genzyme Biosurgery stock on a one-for-one basis for 71.62 percent of the outstanding shares of Biomatrix common stock. The cash portion of the merger consideration is limited to approximately $245 million, but may be reduced to accommodate the exercise of appraisal rights, and for tax purposes to assure that at least 45 percent of the total consideration is Genzyme Biosurgery stock. Biomatrix will send its shareholders an election form on which they will be able to indicate their preference for the standard consideration -- a fixed combination of cash and stock; a cash consideration; and/or a stock consideration. Assuming no adjustment to the aggregate cash consideration occurs, Biomatrix shareholders who select the standard consideration will receive $37 in cash for 28.38 percent of their Biomatrix shares and will receive one share of Genzyme Biosurgery stock for one share of Biomatrix stock for 71.62 percent of their Biomatrix shares.

If Biomatrix shareholders elect in the aggregate to receive cash for more than the available cash consideration, the amount of cash distributed to shareholders who make cash elections will be reduced on a prorated basis and offset with shares of Genzyme Biosurgery. Conversely, if Biomatrix shareholders elect in the aggregate to receive more shares of Genzyme Biosurgery stock than are available, the number of shares of Genzyme Biosurgery stock distributed to shareholders who make stock elections will be reduced on a prorated basis and offset with cash. Therefore, the consideration received by a Biomatrix shareholder may differ from the shareholder`s expressed preference, except in the case of those shareholders who elect the standard consideration -- assuming no adjustment
to the aggregate cash consideration is necessary. Upon completion
of the merger, Biomatrix shareholders will own approximately 47 percent of the outstanding Genzyme Biosurgery shares, holders of Genzyme Tissue Repair stock will own approximately 27 percent, and holders of Genzyme Surgical Products stock will own approximately 26 percent.

About Genzyme Biosurgery Genzyme Biosurgery will represent a powerful new enterprise in the biosurgery field with a portfolio of 24 marketed products, a pipeline of innovative products, leading technology platforms and scientific team to drive its R&D programs, and sufficient financial resources to expand its presence in an exciting and rapidly growing global business.

Once established, the new division will have approximately 1,300 employees; six dedicated manufacturing facilities; global clinical and regulatory capabilities; an extensive intellectual property portfolio; several established sales organizations in focused surgical markets in both the United States and Europe; and marketing and distribution agreements with a number of large, multinational healthcare companies.

Genzyme Corporation is a biotechnology company that develops and markets innovative products and services designed to address significant unmet medical needs. Genzyme Surgical Products, a division of Genzyme Corp., develops and markets a portfolio of devices, biomaterials, and biotherapeutics primarily for the cardiovascular and general surgery markets. Genzyme Tissue Repair, a division of Genzyme Corp., is a leading developer of biological products for the treatment of orthopedic injuries such as cartilage damage and severe burns.

Biomatrix, Inc., headquartered in Ridgefield, New Jersey is an international biomedical company that develops, manufactures and commercializes elastoviscous products made from proprietary polymers called hylans, which are derivatives of the naturally occurring substance, hyaluronan, and are used in a variety of therapeutic medical applications and in skin care products.

This press release contains forward-looking statements, including statements concerning the mailing of a joint proxy statement/prospectus, the holding of Biomatrix and Genzyme shareholder meetings to vote on the formation of Genzyme and Biosurgery and the Biomatrix merger, the formation of Genzyme Biosurgery and the consummation of the merger with Biomatrix, the creation of a new publicly traded stock for Genzyme Biosurgery, the future growth and success of Genzyme Biosurgery and Genzyme Biosurgery`s products, the growth of the biosurgery market and Genzyme Biosurgery`s penetration of that market, the sufficiency of the cash and other resources of Genzyme Biosurgery, and the ability of Genzyme Biosurgery to expand its business. Actual results may differ materially depending on many factors including the accuracy of information about the biosurgery market, the competitive environment for the biosurgery market, market acceptance of Genzyme Biosurgery`s products and services, the enrollment rate for clinical trials, the ability to successfully complete preclinical and clinical development of products, the actual safety and efficacy of products, the timing and content of submissions to and decisions by the FDA and other regulatory authorities, conditions in the financial markets relevant to the proposed creation of Genzyme Biosurgery, the receipt of all approvals necessary to complete the creation of Genzyme Biosurgery and the merger with Biomatrix, the operational integration associated with the transactions and other risks generally associated with transactions of this type.

This press release is not a substitute for the joint proxy statement/prospectus. We urge investors to read that document because it contains important information. The joint proxy statement/prospectus and the documents incorporated by reference may be obtained free of charge at the SEC`s website (http://www.sec.gov) or by contacting Genzyme or Biomatrix.

Genzyme`s releases are on the World Wide Web at http://www.genzyme.com. They are also available from Genzyme`s fax-on-demand service at 1-800-436-1443 within the United States or 1-201-521-1080 outside the United States.

[gholzbauer]

Genzyme looks for growth


By Ted Griffith, CBS.MarketWatch.com
Last Update: 6:27 AM ET Dec 8, 2000

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CAMBRIDGE, Mass. (CBS.MW) - By biotechnology standards, Genzyme Corp. is an old-timer.
Genzyme opened for business in Boston`s Chinatown section nearly 20 years ago, not many years after the biotech industry itself got its start.

But just because it has been around since 1981, doesn`t mean Genzyme has grown reluctant to push into new territory, said CEO Henri Termeer.

Termeer said Genzyme, which today has its headquarters in Cambridge, Mass., moved into an entirely new phase earlier this year when it agreed to buy another Massachusetts biotech, GelTex Pharmaceuticals (GELX: news, msgs) , in a $1 billion stock swap.

The acquisition helped broaden Genzyme`s product portfolio by adding GelTex`s Renagel, which is used in the treatment of patients with severe kidney disease, Termeer said. Genzyme for several years has relied heavily on sales of Cerezyme, a treatment for a rare genetic disorder called Gaucher disease. With an annual, average per patient cost of $168,000, Cerezyme has been highly lucrative for Genzyme and helped make the company one of the relatively few biotechs that regularly posts profits. But even Termeer acknowledges investors and analysts were growing impatient waiting for Genzyme to deliver an encore to Cerezyme.



The CEO said Renagel is that encore and he predicts sales of the drug could eventually reach $1 billion, an ambitious, long-term goal given that the company expects about $48 million in Renagel revenue this year. Genzyme hopes sales of Renagel will be boosted by recent studies that have indicated it is better for patients than alternative calcium-based treatments. Renagel is used to lower high blood phosphate levels in patients receiving kidney dialysis.

"The short-term driver for the company clearly relates to Renagel, we expect it to be a blockbuster," the Dutch-born Termeer said in an interview with CBS MarketWatch.

The stock market has reacted positively to the GelTex acquisition and other developments at Genzyme this year. Shares of Genzyme`s primary division, Genzyme General (GENZ: news, msgs) , are up more than 100 percent since the beginning of the year and recently touched an all-time high of $94.31

And investors may not have to wait long for Genzyme to deliver product encores to Renagel, Termeer said. Genzyme is racing against Transkaryotic Therapies (TKTX: news, msgs) , also based in Cambridge, Mass., to win approval to sell a treatment for a rare genetic illness, Fabry disease. Genzyme could win U.S. Food and Drug Administration clearance to sell Fabrazyme in January, according to analysts.

Building on its expertise in fighting rare genetic illnesses, Genzyme said recently it began the third phase of patient testing for a drug to treat a disease known as MPS-1. Typically, biotechnology companies must successfully complete three phases of patient testing before they can pick up FDA marketing clearance.

"We have never had a time where we had a combination of a product in the early part of a sales growth cycle while at the same time such a broad research pipeline," said the 54-year-old Termeer, who has served as Genzyme`s CEO since 1985. "We can drive the top line and that allows us to spend on R&D and grow earnings."

In October, Genzyme General reported a 55-percent increase in third quarter net income to $59.4 million, or 64 cents per share, from $38.2 million, or 43 cents per share, in the year-ago quarter. Revenue rose 22 percent to $192.2 million.

Risk remains

As with any biotech, however, Genzyme faces a considerable amount of risk. Most immediately, there is the chance that the FDA might not approve the company`s Fabry disease treatment and instead give clearance to rival Transkaryotic`s product.

"The biggest risk currently is that Genzyme gets closed out of the U.S. Fabry disease market," said Caroline Copithorne, a Morgan Stanley Dean Witter analyst, who is positive about Genzyme despite the risks.

Another potential pitfall is on the governmental front. Given the high cost of Cerezyme, Genzyme would appear to be a target if the U.S. government ever imposes drug price caps. But analysts say Genzyme is not as vulnerable as it might seem. For one thing, price caps, if they are ever adopted, would be connected to the Medicare program. Medicare primarily pays for the health care of the elderly while Cerezyme fights a genetic illness that is present at birth.

In any event, analysts say, the narrowly divided Congress makes it unlikely that something as controversial as drug price controls could win quick passage.

For investors, there is also the question of valuation: Can a stock near its all-time peak go much higher?

"I don`t know that I would be backing up the truck and loading it up with Genzyme stock at these levels, but I also wouldn`t be selling at these levels either," said John Borzilleri, who manages the State Street Research Health Sciences Fund.

Borzilleri said even at its current levels Genzyme stock is reasonably priced when compared to some of its highflying peers, which trade at lofty price-to-earnings or price-to-revenue ratios

"The reality is that, even though it`s up a lot this year, Genzyme stock still trades at a discount to other biotechs," said Borzilleri, who said Genzyme stock is one of his fund`s top holdings. "It`s all relative."

Separate divisions

Another issue Genzyme investors have to contend with is complexity. Biotechnology, in general, is not easy to understand and Genzyme`s diverse business only makes it more of a challenge.

In addition to its primary division, Genzyme has three other divisions with their own tracking stocks: Genzyme Molecular Oncology (GZMO: news, msgs) , Genzyme Surgical Products (GZSP: news, msgs) and Genzyme Tissue Repair (GZTR: news, msgs) .The company also owns a 30-percent stake in Genzyme Transgenics Corp. (GZTC: news, msgs) , which specializes in producing therapeutics in the milk of genetically modified goats.

Genzyme executives said the structure gives the separate divisions independence to focus on their business segments while still being able to call on the resources of a big parent corporation.

But Genzyme will soon reduce its number of separate divisions, which could simplify matters for investors. Genzyme expects to win shareholder approvals in December for a plan to combine an acquired company, Biomatrix (BXM: news, msgs) , with its surgical products and tissue repair divisions. The end result will be that Genzyme will reduce its divisions from four to three. The newly created division will be called Genzyme Biosurgery and trade under the symbol GZBX

Among other things, Genzyme Biosurgery is working to develop a gene therapy that could help regrow damaged blood vessels, said Duke Collier, who will be president of the new division. If successful, the technique could significantly enhance the benefits of conventional heart surgery, Collier said.

The other division, Genzyme Molecular Oncology, is in the early stages of developing potential cancer treatments. Gail Maderis, president of the division, said she is hopeful that recent advances in genomics, or genetic research, will lead to cancer treatment breakthroughs

"Genomics data can allow us to attack cancer on a more specific and selective basis," Maderis said. "There is cautious optimism we really can make a difference."

As for the primary division, Genzyme General, analysts say next year could be a good one if Genzyme succeeds in meetings its goals, including increasing Renagel sales and winning approval for the Fabry disease treatment.

"It certainly looks like 2001 could be a big year for Genzyme," said William Tanner, an analyst with SG Cowen. "A lot of things seem to be going in the right direction."

[gholzbauer]

Der Kurssprung am Freitag ist wohl auf die optimistischen Prognosen des CEO zurückzuführen. Das KGV von GENZ beträgt bei einem Kurs von 103$ um die 35, allerdings rechne ich damit, daß die Gewinnprognosen in nächster Zeit weiter angehoben werden. Damit ist wohl noch Luft nach oben.
Falls und Nasdaq und/oder Biotechsektor allgemein mitspielen.
Einen größeren Rüchschlag kann es geben, falls TKTX die Fabry-Angelegenheit für sich entscheidet. Dann kann ich mir ein Minus von 20$ für GENZ durchaus vorstellen. Also nicht überoptimistisch werden!

[gholzbauer]

Thursday December 14, 4:21 pm Eastern Time
Press Release
SOURCE: Genzyme Corp.
Genzyme Completes Merger with GelTex
CAMBRIDGE, Mass., Dec. 14 /PRNewswire/ -- Genzyme Corp. announced that it has completed its acquisition of GelTex Pharmaceuticals, Inc., a biotechnology company and leader in developing therapeutic products based on polymer technology. The transaction became effective this morning. GelTex shares (Nasdaq: GELX - news) ceased trading at the close of market on December 13, 2000. GelTex`s assets, liabilities and operations have been allocated to Genzyme General (Nasdaq: GENZ - news), a division of Genzyme Corp.

GelTex shareholders had the opportunity to elect to receive stock or cash payment for each share of GelTex they held by the election deadline of Friday, December 8, 2000. Because most shareholders elected to receive stock, and because no more than 50 percent of the GelTex shares will be exchanged for shares of Genzyme General stock, the actual consideration those stockholders receive will be prorated under the terms of the merger agreement. Therefore, GelTex shareholders who made a valid election to receive stock will receive $22.59 in cash and .3813 of a share of Genzyme General stock for each share of GelTex exchanged. This transaction will thereby increase the amount of Genzyme General stock outstanding by approximately eight million shares.
GelTex shareholders who made valid elections to receive all cash, as well as
GelTex shareholders who did not make valid elections, will receive $47.50 in
cash for each share of GelTex common stock owned.

At a special meeting of stockholders held yesterday at GelTex`s headquarters in Waltham, MA, GelTex stockholders voted in support of the merger with more than 97 percent of the shares represented at the meeting voting in favor of the merger.

``The completion of this merger is an important event for Genzyme. The addition of Renagel and WelChol to our product portfolio is in line with our strategy to continue to increase our revenue growth momentum,`` said Henry A. Termeer, chairman, president and chief executive officer, Genzyme Corp. ``We are also pleased to add their excellent team of people, wealth of intellectual property and significant pipeline of therapeutics in development. We have a long-standing and close relationship with GelTex, and we are excited to have them now become part of Genzyme.``

Under the terms of the merger agreement, announced on September 11, 2000, the stock-and-cash transaction will be accounted for under the purchase method of accounting. In line with its previous guidance, Genzyme anticipates the in-process research and development write-off for the transaction will be between 6 and 12 percent of the total consideration. Tangible assets and the usable net operating losses are expected to be approximately 20 to 25 percent of the total consideration on a pretax basis. The remaining portion of the consideration would fall to the intangibles and goodwill, amortized over approximately 15 years.

Based on these assumptions, the anticipated dilution to Genzyme`s 2001 earnings would be in the range of 12 to 15 percent prior to depreciation, amortization of goodwill and any other deal-related compensation. It is expected to become accretive to earnings in 2002 prior to these three factors and accretive to earnings in 2003, inclusive of these factors.

In conjunction with the closing of the transaction, Genzyme also announced the appointment of Timothy Noyes to the position of senior vice president and general manager of GelTex, which will become a business unit of Genzyme General. The GelTex business unit will be responsible for the discovery and development of products based on three technology platforms: polymer pharmaceuticals, metal chelators and small molecule polyamine analogs. GelTex will remain at its current location in Waltham, MA.

With the merger, Genzyme General has gained access to two patent- protected, marketed products-Renagel® brand sevelamer hydrochloride and WelChol(TM) brand colesevelam hydrochloride-along with a significant pipeline of promising products, a solid patent portfolio, and a proven and productive polymer technology development team.

Renagel is a rapidly growing product used in the treatment of patients with end-stage renal disease undergoing hemodialysis. Based on an increasing body of evidence, Genzyme expects the market potential for Renagel will surpass $500 million within five years and could reach $1 billion in revenue. Renagel sales in 1999-the product`s first full year on the market-were $19.5 million. For 2000, sales of the product are expected to more than double to approximately $48 million.

WelChol is a new cholesterol-lowering agent that was launched in the United States in September 2000 by Sankyo Pharma Inc. Genzyme will receive a royalty on sales of WelChol.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of products in development focused on the treatment of genetic disorders and other chronic and debilitating diseases. Genzyme General is a division of the biotechnology company, Genzyme Corporation.

This press release contains forward-looking statements, including statements about: Genzyme`s plans to increase its revenue growth momentum; the anticipated impact of the merger on Genzyme`s earnings through 2003; the expected benefits of the merger; Genzyme`s plans concerning the operation of GelTex`s business; expectations concerning GelTex`s product candidates and polymer technology platform; the potential market opportunity for Renagel; and potential revenues from Renagel and royalties on sales of WelChol. Actual results may materially differ due to numerous factors, including without limitation: Genzyme`s ability to increase market acceptance of Renagel; optimizing patient compliance and dosing of Renagel; the competitive environment for the dialysis market; the results of clinical trials; the efficacy and safety of products; enrollment rates for clinical trials; the content and timing of submissions to and decisions by regulatory authorities; the availability of reimbursement from third-party payers; the ability to manufacture sufficient quantities of product for development and commercialization activities; the accuracy of Genzyme`s information about the dialysis patient population and the market for Renagel; the accuracy of Genzyme`s expectations about growth in the dialysis patient population; the ability of Genzyme to successfully commercialize its products; the ability of Sankyo Pharma Inc. to successfully commercialize WelChol; and the risks and uncertainties described in the information included under the caption ``Risk Factors`` in the proxy statement/prospectus Genzyme filed with the Securities and Exchange Commission on November 1, 2000, as amended, and in Genzyme and GelTex`s reports filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation Exhibit 99.2 to Genzyme`s Annual Report on Form 10-K for the year ended December 31, 1999, as amended. Genzyme General Division Common Stock is a series of common stock of Genzyme Corporation. Therefore, holders of Genzyme General Division Common Stock are subject to all of the risks and uncertainties described in the aforementioned reports.

Genzyme`s releases are available on the World Wide Web at http://www.genzyme.com. They are also available from Genzyme`s fax-on-demand service at 1-800-436-1443 within the United States or 1-201-521-1080 outside the United States.

SOURCE: Genzyme Corp.

[gholzbauer]

Goldman Sachs initiates coverage on GENZ - "Market Perform"

[Audianer]

Genzyme General Announces CPMP Positive Opinion for Fabrazyme
WEDNESDAY, MARCH 28, 2001 11:40 AM
- PRNewswire

CAMBRIDGE, Mass., Mar 28, 2001 /PRNewswire via COMTEX/ -- Genzyme General (Nasdaq: GENZ), a division of Genzyme Corp., announced today that the Committee for Proprietary Medicinal Products (CPMP) has issued a positive opinion of the marketing authorization application for Fabrazyme(TM) (agalsidase beta), an enzyme replacement therapy for Fabry disease. The proposed labeling recommended by the CPMP includes the following indication: "Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (galactosidase A deficiency)."

The CPMP is the scientific body composed of representatives from the 15 member states of the European Union that provides advice to the European Commission on the approval of medicinal products. The CPMP decision has been forwarded to the European Commission, which is expected to make a final decision on marketing authorization within 3-4 months. The European Commission generally follows the advice of the CPMP.

Assuming marketing authorization is granted, Genzyme General plans to launch Fabrazyme in Europe immediately on a country-by-country basis, pending pricing and reimbursement approvals. Genzyme began selling Fabrazyme in France late last year under an Authorisation Temporaire d`Utilisation, which allows patients with Fabry disease in France to receive treatment with Fabrazyme before marketing authorization for the product is granted in the European Union.

When it launches Fabrazyme in Europe, Genzyme will draw on a decade of experience in marketing an enzyme replacement therapy for Type 1 Gaucher disease on the continent. Fabrazyme will be sold by Genzyme`s existing European Cerezyme(R) (imiglucerase for injection) sales force, which maintains close relationships with physicians who specialize in the treatment of genetic disorders. Genzyme has a substantial and long-standing commercial infrastructure in Europe that includes more than 600 employees in 15 countries.

"This is an important step forward toward the introduction of a breakthrough treatment for patients with Fabry disease, who previously have had few medical options," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "In anticipation of marketing approval, we have made good progress in preparing to launch Fabrazyme this summer in Europe. We expect that our highly respected sales and marketing organization will enable us to effectively deliver this product to patients and physicians throughout Europe."

About Fabrazyme and Fabry disease

Fabry disease is caused by a deficiency of the enzyme alpha-galactosidase. This deficiency results in the body`s inability to break down certain glycolipids, primarily globotriaosylceramide (GL-3), which then accumulate in the lining of the blood vessels within the kidney, heart, skin and other organs. The progressive accumulation of these lipids in the blood vessels results in symptoms such as kidney failure, stroke, cardiovascular disease, severe pain and numbness. Due to organ complications, death typically occurs around age 40 for the estimated 2,000-4,000 people worldwide afflicted with the disorder.

Fabrazyme is a recombinant form of alpha-galactosidase designed to replace the deficient enzyme and prevent the lipid accumulation that leads to the devastating symptoms of Fabry disease.

Results from Genzyme General`s Phase 3 clinical trial of Fabrazyme showed that the product has a robust effect in clearing GL-3 from the blood vessels of the major organs affected in Fabry disease. The trial`s primary endpoint-the nearly complete clearance of GL-3 from the blood vessels of the kidney-was met with high statistical significance (p<0.0001). The trial also met two of its three secondary efficacy endpoints: composite scores indicating clearance of GL-3 from the capillaries of the heart, kidney, and skin were statistically significant (p<0.001), as were scores showing a reduction of GL-3 in each of these organs individually. The double-blinded, placebo-controlled, multicenter study enrolled 58 patients.

Results from the ongoing open-label extension study of Fabrazyme confirm the findings of the Phase 3 study. In the extension study, the vast majority of patients who were treated with Fabrazyme in the pivotal study maintained or continued the GL-3 clearance that had been achieved in the kidney, heart, and skin. In addition, patients who switched from placebo to Fabrazyme experienced a significant reduction in GL-3 accumulation to negligible levels in the blood vessels of the kidney within six months of beginning treatment.

Adverse event profiles of placebo and treated patients were comparable with the exception of transient infusion reactions in a portion of the treated patients.

Genzyme General has four therapeutic products on the market and a strong pipeline of therapeutic products in development focused on the treatment of genetic disorders and other chronic debilitating diseases with well-defined patient populations. Genzyme General is a division of the biotechnology company Genzyme Corporation.

This press release contains forward-looking statements based on management`s current expectations, including statements about: the potential approval by the European Commission of the marketing authorization application for Fabrazyme and the expected timing of a final decision; the anticipated significance and impact of the CPMP decision on the decision to be made by the European Commission; the potential receipt of pricing and reimbursement approvals for Fabrazyme in Europe; the potential commercialization of Fabrazyme in Europe and related plans; the anticipated ability to make Fabrazyme available in Europe expeditiously; estimates concerning the Fabry disease patient population; and the results observed to date from the on-going extension trial of Fabrazyme. Actual results may materially differ due to numerous factors, including: the actual timing and content of decisions made by the European Commission with respect to submissions made by Genzyme and its competitors with respect to therapies for Fabry disease; the final results of a Phase 4 trial and the extended trial protocol of Fabrazyme; the actual safety and efficacy of products; the accuracy of Genzyme`s information about the Fabry disease patient population; the competitive environment in the Fabry disease market; and the risks and uncertainties described in reports filed by Genzyme Corporation with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation Exhibit 99.2 to Genzyme`s 1999 Annual Report on Form 10-K, as amended. Genzyme General Division common stock is a series of common stock of Genzyme Corporation. Therefore, holders of Genzyme General Division common stock are subject to all of the risks and uncertainties described in the aforementioned reports.

Fabrazyme(TM) is a trademark of Genzyme Corporation. Genzyme(R) and Cerezyme(R) are registered trademarks of Genzyme Corporation. All rights reserved.

Genzyme`s releases are available on the World Wide Web at http://www.genzyme.com . They are also available from Genzyme`s fax-on-demand service at 1-800-436-1443 within the United States or 1-201-521-1080 outside the United States.

Note: Genzyme Corporation will report first-quarter earnings results on April 19 for Genzyme General (Nasdaq: GENZ), Genzyme Molecular Oncology (Nasdaq: GZMO) and Genzyme Biosurgery (Nasdaq: GZBX). Conference calls to discuss these results will follow. If you wish to participate in the calls, please dial the following numbers:

For Genzyme General, dial 212-346-0294 at 11:00 a.m. EST; for Genzyme Molecular Oncology, dial 212-346-0281 at 1:00 p.m. EST; and for Genzyme Biosurgery, dial 212-346-7440 at 3:00 p.m. EST.

Conference call and Webcast information will available on www.genzyme.com.
SOURCE Genzyme General

[gholzbauer]

TKTX hat für deren Fabry-Medikament "Replagal" in Europa eine positive Empfehlung bekommen. Wir dürfen gespannt sein, wer v.a. in den USA das Rennen macht, vielleicht werden auch beide zugelassen.

Ich habe übrigens im Dezember meine GENZ verkauft (hätte besser ein paar andere Bios rausschmeißen sollen), weil ich dachte, ich könnte sie billiger zurückkaufen. War bisher falsch gedacht.

[gholzbauer]

Thursday March 22, 12:01 pm Eastern Time
RESEARCH ALERT-Goldman ups Genzyme stock rating
NEW YORK, March 22 (Reuters) - Goldman Sachs raised its rating on biotechnology firm Genzyme General Corp. (NasdaqNM:GENZ - news) on Thursday to market outperformer from market performer based on price.

``While we are not calling a bottom to the biotech sector, we believe that when the tide turns, investors will first adopt a flight to quality approach to healthcare allocations, favoring top-tier companies with solid operating earnings and a strong pipeline,`` Goldman analyst Meg Malloy said in a research report. ``We believe that Genzyme fits this profile and that it is attractive on a relative price to growth basis.``

[gholzbauer]

Prudential Securities Morning Summary Covering HD, GENZ, ATYT, HPOL and NVDA
03/29/01 06:28 AM
Source: Prudential Securities

....




Genzyme General (GENZ-$89.51)
GENZ: FABRAZYME AND REPLAGAL PROGRESS IN LOCK-STEP AS BOTH DRUGS GAIN CPMP CLEARANCE IN EUROPE


GENZ and TKT (TKTX--17 3/8;Not Rated) simultaneously announced yesterday that Europe`s CPMP (Committee for Proprietary Medicinal Products) has recommended both Fabrazyme and Replagal for marketing to the EC.


We estimate that the EC may take up to 3 months to formally clear both products for sale as treatments of Fabry disease. As such, we anticipate measurable Fabrazyme revenue beginning in Q3, 2001.

...