Genzyme

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Posted by r2d2 04/25/2009 @ 04:13

Tags : genzyme, biotechnologies, business

News headlines
Genzyme, Isis report positive drug study results - MarketWatch
The companies tested the drug on patients with an inherited condition that causes dangerously high LDL cholesterol levels. Mipomersen was tested in combination with other leading cholesterol-controlling therapies, such as statins. Genzyme hopes to file...
Genzyme spent $920K lobbying government in 1Q - Forbes
AP , 05.20.09, 10:59 AM EDT Biotech drugmaker Genzyme Corp. spent $920000 lobbying the federal government in the first quarter, according to a recent disclosure form. Cambridge, Mass.-based Genzyme ( GENZ - news - people ), which develops medicines to...
Genzyme and Isis Announce that Mipomersen Phase 3 Study in ... - WELT ONLINE
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25 percent reduction in LDL...
AnnTaylor, Palm Fall; Tween Brands Soars - Wall Street Journal
based Isis Pharmaceuticals and large-cap Genzyme said their mipomersen drug cut bad cholesterol levels by 25% in a late-stage study of patients who have a rare genetic disorder. But Isis shares fell 1.60, or 10%, to 13.88, as Genzyme said its initial...
Genzyme Sues Lupin Over Generic Renvela Plans - IP Law360 (subscription)
Law360, New York (May 18, 2009) -- Genzyme Corp. has sued India-based generics maker Lupin Ltd. over its efforts to make generic Renvela, more than two months after it sued Lupin over an earlier version of the same kidney treatment....
Genzyme, Isis cholesterol drug meets study goal - Reuters India
Genzyme shares rose. The drug, mipomersen, cut levels of "bad" LDL cholesterol by 25 percent after 26 weeks of treatment compared to 3 percent for those on placebo. The patients in the Phase 3 study had homozygous familial hypercholesterolemia,...
Genzyme plans new Lumizyme application in weeks - Forbes
AP , 05.06.09, 03:24 PM EDT Biotechnology company Genzyme Corp. said Wednesday that the Food and Drug Administration is ready to review an application for its drug candidate Lumizyme, and it expects to file the application by the middle of May....
The Motley Fool take - St. Augustine Record
Freeport-McMoRan Copper and Gold (NYSE: FCX), the world's largest publicly traded copper producer, took a 96 percent earnings hit in its March quarter over last year. Nevertheless, improving copper prices are leading to higher share values....
Four biotech CEOs offer their views on key trends - FierceBiotech
Genzyme's Henri Termeer: "Smaller biotechnology companies are having a hard time getting financed. What they are after is great. But in a moment like this--maybe for the next six months or so--they're stuck." Joshua Boger from Vertex: "There will be a...

Genzyme

Genzyme headquarters in Cambridge, MA

Genzyme Corporation (NASDAQ: GENZ) is a biotechnology company based in Cambridge, Massachusetts. Genzyme is the world’s third largest biotechnology company employing over 9,000 people around the world. At present, the company has approximately 80 locations in 40 countries. It includes 17 manufacturing facilities and 9 genetic testing laboratories. The company’s products are available in nearly 90 countries. In 2007, Genzyme generated $3.8 billion in revenues with more than 25 products in the world’s markets. The company is also involved in philanthropic acts, donating $83 million in global product donations and $11 million in cash contributions in 2006. In 2006 and 2007 Genzyme was named one of Fortune Magazine’s “100 Best Companies to Work for.” Additionally in 2005, Genzyme was awarded the National Medal of Technology, the highest level of honor awarded by the President of the United States to America’s leading innovators.

The company, started by Sheridan Snyder and scientist Henry Blair in 1981, was primarily devoted to finding drugs that would cure enzyme deficiency conditions that were essential to one’s survival and which usually afflict a very small percentage of the world’s population. Drugs used to treat such conditions are termed “orphan drugs.” In 1986, the company went public raising $27 million.

Genzyme focuses on six areas of medicine relating to lysosomal storage diseases, renal disease, orthopedics, transplant and immune diseases, oncology, genetics and diagnostics. The first orphan-drug for Genzyme that FDA approved was Ceredase, a drug for treating Gaucher disease. Ceredase was eventually replaced by Cerezyme, which currently accounts for approximately 30% of Genzyme's revenue. Other important drugs made by Genzyme are Renagel, used in treatment of dialysis patients, and Fabrazyme, used to treat patients with Fabry's disease. Other products in development are Tolevamer for Clostridium difficile colitis disease and Campath for chronic lymphocitic leukemia.

In 2007, CEO, President, and Board Chairman Henri Termeer, earned a salary of $2.5 million, and non-cash compensation worth $129 million.

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Erik Tambuyzer

Erik Tambuyzer

Dr. Erik Tambuyzer (born 1949) is a Belgian bio-engineer and businessman. He is Senior Vice President Corporate Affairs for Genzyme Europe and International, and a member of the European Management Committee of Genzyme Corporation.

Dr. Tambuyzer is a bio-engineer and holds a doctoral degree in bio-industrial sciences from the Katholieke Universiteit Leuven, (Leuven, Belgium).

He started his professional career at Baxter Healthcare (Baxter-Travenol in Europe) in 1977, he pursued his career six years later at Innovi NV (Brussels, Belgium), a technology management and consultancy company. He also worked as a consultant on biotechnology for minister-president Gaston Geens of the Flemish government. In 1985 he made the business plan and co-founded, together with Hugo Van Heuverswyn, the healthcare biotech company Innogenetics NV (Ghent, Belgium), of which he has been General Manager until 1992, at which time he joined Genzyme.

Dr. Tambuyzer is a founding Board member and past Chairman of EuropaBio, the European Association for Bioindustries, and founder of the Ethics Working Group of this Association, as well as the Chair of the joint EBE/EFPIA-EuropaBio Orphan medicines Task Force. He is also Vice-Chair of EPPOSI, the European Platform for Patients’ Organizations, Science & Industry. He published on policies regarding orphan medicines and advanced therapies in Europe and internationally, as well as about the European Clinical Trial Directive, and the impact of biotechnology on healthcare systems. From October 2000 until October 2002, Dr. Tambuyzer was Chairman of the Board of EuropaBio, the European Association for Bioindustries.

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Sheridan Snyder

Dr. Sheridan Gray "Sherry" Snyder OBE, LLB (born October 20th, 1936), often referred to as Sherry Snyder, is a legendary entrepreneurial figure in the biotechnology industry and a philanthropist, who has also made significant contributions to the development of the game of tennis.

Mr. Snyder graduated from The Lawrenceville School in New Jersey and is a 1958 graduate of The University of Virginia with a Bachelor of Arts in French & Romance Languages. Snyder received an Honorary Doctorate of Law degree from the University of Dundee in 2002..

Upon graduation from UVA, Snyder began his career as a Credit Analyst for New York Trust Corporation. In 1962, Snyder founded his first venture, Cambridge Machine Corporation, which initiated the development and invention of high-speed mailing/envelope inserting machines. In 1971, Snyder founded a packaging company, Instapak, which markets “foam-in-place packaging” (revolutionary for its time) that creates a protective barrier for heavy, fragile instrumentation and computer systems. Snyder sold Cambridge Machine Corporation to Pitney-Bowes and he became the National Sales Account manager at Pitney-Bowes. Instapak is now the largest division of Sealed Air Corporation (NYSE: SEE), with more than 5,500 employees and revenues of $1 billion..

In 1981, Mr. Snyder founded Genzyme and served as Chairman/President/CEO. Genzyme’s business focused on enzyme deficiency diseases. It first produced diagnostic enzymes for victims of Gaucher's disease, a rare chronic disorder causing enormous enlargement of the spleen, a change in skin pigmentation and bone lesions. It afflicts 10,000 young Hasidic Jews each year.. It currently employs 10,000 people worldwide, with approximately $3.6 billion in revenues, with a market valuation of $20 billion. Genzyme (NASDAQ:GENZ) is the largest private employer in Boston, Massachusetts. In 1986, Mr. Snyder initiated the first sale of Genzyme stock shares (Initial Public Offering).

Mr. Snyder founded Biotage in 1989 which focuses ono the development of novel drug development systmes. Biotage was acquired by the Swedish biotechnology company Pyrosequencing in 2004 which then took the name Biotage AB.

In 1994 Snyder founded Argonex a small biotech start-up in Charlottesville, VA. In 1996, Mr. Snyder founded and served as Chairman and Chief Executive Officer Upstate Biotechnology Incorporated merging it with Argonex. Upstate Inc. develops innovative cell signaling products, technology platforms and services to accelerate life science research and drug discovery efforts. Upstate was sold to Serologicals Corporation in 2004 for $205 Million..

Biocatalyst International is the most recent of Mr. Snyder’s business enterprises, founded in 2005. Spearheaded by Sherry, with his expertise and insight of identifying technologies, Biocatalyst creates sustainable biotech companies in partnership with leading scientists.

Biocatalyst International to date incorporates three dynamic companies interfacing with diverse markets of the biotechnology world. These three prevailing and successful corporations were founded by Mr. Snyder, as he takes the biotechnology industry into the future. Biocatalyst International, Molecular MD and Xcovery are leading forces catapulting profitable biotech start-up ventures and expanding the boundaries of science today..

Mr. Snyder co-founded Xcovery with Dr. Chris Liang, Director of Medicinal Chemistry, Scripps Research Florida, and co-developer of Sutent, Pfizer’s first small molecule oncology drug. Xcovery has 5 lead compounds focused on cancer..

Molecular MD was co-founded with Dr. Brian Druker, inventor of Gleevec, Director of the Cancer Center at the Oregon Health Sciences University in Portland. Oregon. Gleevec is a revolutionary small molecule drug that prevents and stops the growth of cancer cells in chronic myeloid leukemia (CML). MMD is a molecular diagnostic company in the world of personalized medicine utilizing highly sensitive detection systems..

In 1999, the State of Virginia honored Snyder with its Biotechnology Lifetime Achievement Award..

In 2003, he was appointed to Scotland’s International Advisory Board and serves as an advisor to the Scottish government on the development of its biotech sector. In this capacity, Snyder played a major role with the development of an 800,000-square-foot (74,000 m2) bioscience translational center outside of Edinburgh..

Mr. Snyder was honored OBE (Officer of the Order of the British Empire)in 2005 by HM Queen Elizabeth II of the United Kingdom on the advice of the British government.

In 2008 Mr. Snyder was awarded the Intercollegiate Tennis Association Achievement Award for achievements outside the game of tennis..

He is a member of the Ivy Charitable Foundation..

Snyder funded and developed the National Junior Tennis League (NJTL), along with the encouragement and support of Arthur Ashe and Charles Pasarell. Snyder supported the NJTL for 15 years. This organization now operates, through the USTA, in 110 cities and reaches 250,000 inner-city youths..

In 1988, Snyder was the Founder, Chairman & CEO of Compuflo Inc., which developed a specialty high-end computer program used to analyze airflow to aid the design of aircraft and autos, a company donated to the University of Virginia to support its laboratories. Snyder also funded University Technology Corporation, where companies were formed with University of Virginia technology and the proceeds generated by these business ventures were donated back to the University..

In 1995 Snyder contributed to the construction of a new tennis center at the University of Virginia which was named the Sheridan Snyder Tennis Center. .

Snyder's sale of Upstate from in 2004 resulted in a gift of US45 million to the University of Virginia Health Center which has used this gift to construct a new Children's Hospital, the Emily Couric Cancer Center and the Sheridan G. Snyder Translational Research Center..

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Imiglucerase

Imiglucerase is a medication used in the treatment of Gaucher's disease.

It is a recombinant DNA-produced analogue of human β-glucocerebrosidase. Cerezyme is a freeze-dried medicine containing imiglucerase, manufactured by Genzyme Corporation. It is given intravenously after reconstitution as a treatment for Type 1 Gaucher's disease. It is available in formulations containing 200 mg per vial and 400 mg per vial.

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Alglucerase

Alglucerase is a modified form of human β-glucocerebrosidase where the non-reducing ends of the oligosaccharide chains have been terminated with mannose residues. Ceredase is a citrate buffered solution of Alglucerase manufactured by Genzyme Corporation from human placental tissue. It is given intravenously in the treatment of Type 1 Gaucher's disease although it has been largely replaced by Cerezyme which is produced by Recombinant DNA technology.

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Glycogen storage disease type II

Glycogen storage disease type II has an autosomal recessive pattern of inheritance.

Glycogen storage disease type II (also called Pompe disease or acid maltase deficiency) is a neuromuscular, autosomal recessive metabolic disorder in the family of lysosomal storage diseases caused by a deficiency in the enzyme Acid alpha-glucosidase (EC 3.2.1.20), which is needed to break down glycogen a long, branched glucose polymer and stored form of sugar used for energy. It is the only glycogen storage disease with a defect in lysosomal metabolism, and was the first glycogen storage disease to be identified, in 1932.

The build-up of glycogen causes progressive muscle weakness (myopathy) throughout the body and affects various body tissues, particularly in the heart, skeletal muscles, liver and nervous system.

The disease is named after Johann Pompe, who characterized it in 1932.

The disorder is estimated to occur in about 1 in 40,000-300,000 births.

It has an autosomal recessive inheritance pattern. This means the defective gene is located on an autosome, and two copies of the gene - one from each parent - are required to be born with the disorder. As with all cases of autosomal recessive inheritance, children have a 1 in 4 chance of inheriting the disorder when both parents carry the defective gene, and although both parents carry one copy of the defective gene, they are usually not affected by the disorder.

Infantile, or early onset, is noticed shortly after birth. Symptoms include severe lack of muscle tone, weakness, and enlarged liver (hepatomegaly) and heart. Mental function is not affected. Development appears normal for the first weeks or months but slowly declines as the disease progresses. Swallowing may become difficult and the tongue may protrude and become enlarged. Most children die from respiratory or cardiac complications before 2 years of age.

Juvenile onset symptoms appear in early to late childhood and include progressive weakness of respiratory muscles in the trunk, diaphragm and lower limbs, as well as exercise intolerance. Intelligence is normal.

Pompe's disease is one of the infiltrative causes of restrictive cardiomyopathy.

Cardiac and respiratory complications are treated symptomatically. Physical and occupational therapy may be beneficial for some patients. Alterations in diet may provide temporary improvement but will not alter the course of the disease. Genetic counseling can provide families with information regarding risk in future pregnancies.

The FDA approved Myozyme for administration by intravenous infusion of solution into a vein. The safety and efficacy of Myozyme were assessed in two separate clinical trials in 39 infantile-onset patients with Pompe disease ranging in age from 1 month to 3.5 years at the time of the first infusion.

Myozyme costs an average of $300,000 a year, and must be taken for the patients' entire life. Some insurers have refused to pay for it.

On August 14, 2006, Health Canada approved Myozyme for the treatment of Pompe disease. On June 14, 2007 the Canadian Common Drug Review issued their recommendations regarding public funding for Myozyme therapy. Their recommendation was to provide funding to treat a very small subset of Pompe patients (Infants less one year of age with Cardiomyopathy). The vast majority of developed countries are providing access to therapy for all diagnosed Pompe patients.

In June 2007 it was reported that ZyStor Therapeutics was in the process of developing an enzyme replacement therapy for Pompe disease by leveraging their glycosylation independent lysosomal targeting technology (GILT).

The prognosis for individuals with Pompe disease varies according to the onset and severity of symptoms. Without treatment the disease is particularly lethal in infants and young children.

Myozyme (alglucosidase alfa),which helps break down glucose, is a combined form of the human enzyme acid alpha-glucosidase, and is also currently being used to replace the missing enzyme. In a study which included the largest cohort of patients with Pompe disease treated with enzyme replacement therapy (ERT) to date findings showed that Myozyme treatment clearly prolongs ventilator-free survival and overall survival in patients with infantile-onset Pompe disease as compared to an untreated historical control population. Furthermore, the study demonstrated that initiation of ERT prior to 6 months of age, which could be facilitated by newborn screening, shows great promise to reduce the mortality and disability associated with this devastating disorder.

On December 13, 2007, Genzyme released the initial results of its Late Onset Treatment Study (LOTS). The study was undertaken to evaluate the safety and efficacy of Myozyme in juvenile and adult patients with Pompe disease. LOTS was a randomized, double-blind, placebo-controlled study that enrolled 90 patients at eight primary sites in the United States and Europe. Participants received either Myozyme or a placebo every other week for 18 months. The average age of study participants was 44 years. The primary efficacy endpoints of the study sought to determine the effect of Myozyme on functional endurance as measured by the six-minute walk test and to determine the effect of Myozyme on pulmonary function as measured by percent predicted forced vital capacity.

The results showed that, at 18 months, patients treated with Myozyme increased their distance walked in six minutes by an average of approximately 30 meters as compared with the placebo group (P=0.0283; Wilcoxon test). The placebo group did not show any improvement from baseline. The average baseline distance walked in six minutes in both groups was approximately 325 meters. Percent predicted forced vital capacity in the group of patients treated with Myozyme increased by 1 percent at 18 months. In contrast, it declined by approximately 3 percent in the placebo group (P=0.0026; Wilcoxon test). The average baseline percent predicted forced vital capacity in both groups was approximately 55 percent.

The results for both efficacy endpoints were consistent across various prospectively defined subgroups.

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Source : Wikipedia