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									                                                                                                                                                                                                                                                                 ARAB TIMES, FRIDAY, MAY 14, 2010
HEALTH                                                                                                                                                                                                                                                                                                       31




                  Health


                           Drugs in trial stage

Biotech Regeneron on
verge of ‘big leagues’
NEW YORK, May 13, (RTRS):                       growth proteins that could cure some of
Regeneron Pharmaceuticals Inc, a rela-          the grimmest neurological scourges by
tively unknown biotechnology company            regenerating neurons, which are nerve
based in sleepy Tarrytown, New York, is         cells. Thus the name Regeneron.
not exactly a household name. But that is                        Original
likely to change fast.                             “The original idea, which you can find
   The company plans to steal the lime-         in the original business plan, was that we
light in the coming year with data from         would discover them and then spritz them
seven late-stage trials of its experimental     on people who needed them. We would
drugs for gout, colon cancer and a leading      cure a couple of diseases such as Lou
cause of blindness. It is rare for a biotech    Gehrig’s disease, maybe Parkinson’s dis-
of any size to have so much pivotal news        ease and Alzheimer’s disease, and sail off
coming out in such a short period of time.      into the sunset,” Schleifer said.
   “The cycle is getting to be in full             Schleifer nurtured those lofty ambi-
swing,” said Chief Executive Leonard            tions in a dilapidated studio apartment
Schleifer. “We need a big hit on one of         meant to house Cornell’s medical staff,
these drugs and then I think the world will     located on Manhattan’s Upper East Side.
start to pay a lot more attention to our           “The super was thrown out of the
pipeline” of new medicines.                     building because he was a drunk, so I
   In an exclusive interview with Reuters       convinced the hospital to let me sublet it
at company head-                                for awhile. The rent was about $500. That
quarters, Schleifer                             was Regeneron’s world headquarters. It
and his research                                was just me.”
chief         George                               Schleifer, a native of New York City’s
Yancopoulos out-                                borough of Queens with a gift of gab to
lined their plan for                            match his scientific enthusiasm, attracted
leaping from obscu-                             a scientific advisory board that included
rity to the big                                 several Nobel laureates and obtained a $1
leagues.                                        million grubstake from a venture capital
   They know from                               unit of Merrill Lynch.
experience, howev-            Schleifer            He set out to recruit a stable of scien-
er, that in biotech                             tists, most notably Yancopoulos, a 28-
there is no sure thing. In March 2003,          year-old molecular immunologist who
when the company’s Axokine obesity              had just won a kind of genius award for
treatment stumbled in clinical trials,          his research at Columbia Medical School
Regeneron shares lost more than half            and is now Regeneron’s head of research.
their value.                                       The company spread its wings in 1989
   But success in even one of its three         by renting 15,000 square feet of an empty      German Bertolt Meyer shows the handling of his finger prosthesis made by Scottish company Touch Bionics at the international trade show for orthopedics and rehabilitation tech
treatments now in late-stage studies could      Union Carbide factory in Tarrytown,                                                                          nology in Leipzig, eastern Germany, May 12. (AP)
propel Regeneron from a typical money-          where laboratories were built.
losing biotech into a profitable company
with a bright future. Its products could
                                                   Regeneron could afford the bigger digs
                                                because earlier that month it won $10
                                                                                                                                                                                                          Not proven effective: FDA
eventually take on Roche Holding AG’s           million in funding from Sumitomo
$6 billion cancer drug, Avastin, and $3
billion Lucentis eye-disease medicine.
The gout drug could attract annual sales
of $500 million or more, analysts esti-
                                                Chemical Co Ltd in exchange for giving
                                                the company rights to sell up to three of
                                                its future drugs in Japan.
                                                   At the time, only one protein involved
                                                                                                                                                     Walgreen backs off on genetic test kits
mate.                                           in the growth and survival of neurons —                                                              WASHINGTON, May 13, (AP): The largest
   Regeneron on Wednesday said two
other drugs in earlier-stage trials signifi-
                                                or neurotrophic factor — had been dis-                                                               U.S. drugstore chain, Walgreen Co., said
                                                                                                                                                     Wednesday it will hold off selling what was
                                                                                                                                                                                                                  Biomarkers don’t indicate better health: report
                                                covered: Nerve Growth Factor. But with-
cantly cut levels of “bad” LDL choles-          in weeks after Regeneron’s lab opened,                                                               poised to be the first over-the-counter genet-
terol and eased knee pain from
osteoarthritis.
                 Focused
                                                Yancopoulos discovered a second one
                                                that became known as Brain-Derived
                                                                                                                                                     ic test, after the Food and Drug
                                                                                                                                                     Administration said the kit has not been
                                                                                                                                                     proven effective.
                                                                                                                                                                                                           ‘New tools need to check food, drugs’
                                                Neurotrophic Factor (BDNF).                                                                                                                                WASHINGTON, May 13, (RTRS): The US                  Harlan Krumholz, a cardiologist at Yale
   But Wall Street is more focused on its          “Literally within a week after that, we                                                              Pathway Genomics has announced that its
                                                                                                                                                     saliva swab would be on Walgreen’s shelves            Food and Drug Administration is stuck using         University who sat on the panel, said in a
drugs in late-stage trials.                     cloned another one called Neurotrophin 3                                                                                                                   crude tools to measure the benefits of food,        telephone interview.
   “We believe that Regeneron should            (NT3) and then a third one called Ciliary                                                            later this month, offering millions of
                                                                                                                                                                                                           drugs and supplements and needs a whole                One example: GlaxoSmithKline Plc’s dia-
represent a core holding in biotechnology       Neurotrophic         Factor       (CNTF),”                                                           Americans the chance peek into their genetic          new set of standards, a panel of experts said       betes drug Avandia lowers blood sugar well
portfolios, based on the depth of its           Yancopoulos said.                                                                                    code for signs of inheritable diseases like           on Wednesday.                                       but also raises the risk of heart failure and
pipeline and its partnerships,” Roth               Yancopoulos became one of the                                                                     Alzheimer’s.                                             Relying on so-called biomarkers is con-          heart attack.
Capital Partners analyst Joseph Pantginis       world’s most-cited neurologists due to his                                                              But within 24 hours the company’s plan             fusing the entire process of drug develop-             Krumholz said he was stunned to learn
said on Wednesday. He said he is encour-        rapid-fire discoveries. The attention led to                                                         was met with stiff response from FDA regu-            ment, the public and doctors alike, they said.      that tumor size is used as a surrogate to
                                                                                               Mitzi Perdue attends the Bal du                       lators who said the products may run afoul of            The FDA also needs to use the same strict        judge whether a cancer drug is working,
aged by new data from the early-stage tri-      a $100 million partnership in 1990 with                                                                                                                    standards for assessing health claims of            even though the shrinking of tumors does
als.                                            Amgen, an up-and-coming new biotech,           Printemps gala to benefit The Parkinson’s             federal laws governing medical tests. On
                                                                                               Disease Foundation at The Pierre Hotel                Wednesday, the FDA posted a letter to                 food and supplements as it does for drugs,          not necessarily help cancer patients live any
   Regeneron has some big backers and           that involved trials of BDNF against Lou                                                                                                                   said the panel appointed by the Institute of        longer.
one of the biggest research budgets of any      Gehrig’s disease and of NT3 for nerve             on May 12, in New York City. (AFP)                 Pathways online, indicating the San Diego-            Medicine, which advises the federal govern-            Another example would be breakfast
biotech, at more than $700 million this         pain in diabetics.                                                                                   based company never submitted its product             ment.                                               cereals that claim to provide immune-boost-
year. That includes spending by collabo-           Regeneron also began testing CNTF                                                                 for federal review, a requirement for medical            The committee recommended a new                  ing vitamins and minerals or to lower choles-
rators and $160 million of support from         against Lou Gehrig’s disease and signed a                                                            devices.                                              framework the FDA could use for judging             terol.
research partner Sanofi-Aventis SA.             $135 million deal in 1997 with Procter &                                                                “These kits have not been proven safe,             studies that companies provide to support              “A lot of people probably fed Cocoa
                                                                                                                                                     effective or accurate and patients could be           health and safety claims for their products.        Krispies to their kids this winter thinking it
   It currently sells only one product,         Gamble Co to develop a number of                                                                                                                              “Congress may need to strengthen FDA             would protect them from flu,” Krumholz said.
called Arcalyst, that brings in less than       Regeneron drugs, including using CNTF                                                                making medical decisions based on data
                                                                                                                                                     from a test that hasn’t been validated by the         authority to accomplish this goal,” the insti-      “What we say is there is a Wild West out
$20 million a year and treats a rare inher-     to treat obesity.                                                                                                                                          tute’s report reads.                                there with regard to food.”
ited inflammatory condition.                       But none of the drugs ultimately                                                                  FDA,” said agency spokeswoman Erica                      The Obama administration is tackling the            The Center for Science in the Public
   But the three drugs now wrapping up          panned out in clinical trials during a 10-                                                           Jefferson, in an earlier statement                    issue of food and health on several fronts.         Interest, a consumer group, welcomed the
late-stage studies, the final step before       year period.                                                                                         Wednesday.                                            On Tuesday, first lady Michelle Obama               report.
seeking regulatory approval, have far big-         “In many ways you could look at that                                                                 Walgreen said late Wednesday that the              released a 70-point plan for reducing child-           “Right now the supermarket is a jungle of
ger sales potential.                            as a lost decade because the ultimate prize                                                          Illinois company had decided not to stock the         hood obesity, including a call for marketing        unsupported health-related claims,” the
                                                                                                                                                     tests until it has “further clarity” on the issue.    healthier food.                                     group said in a statement.
                 Testing                        eluded us in terms of applying our first
                                                                                                      Vilsack                    Paradis                Pathway’s test would have been the first              The committee’s report focuses on bio-              Committee chairman John Ball of the
   Most biotech companies are staking           discoveries,” Yancopoulos said. “These                                                                                                                     markers, which can include measures as              American Society for Clinical Pathology said
                                                neurological diseases were really chal-                                                              low-cost, mass-marketed version of kits that
their futures on only one or two drugs and                                                                                                                                                                 simple as temperature. Common biomarkers            consumers often assume the FDA regulates
                                                lenging and we recognized maybe we                                                                   screen for genes associated with diseases like        include levels of cholesterol and blood             food and supplements in the same way it
many have gone bankrupt trying.
Regeneron, which is now testing eight           weren’t as smart as we thought we were                    Health                                     prostate cancer, cystic fibrosis and diabetes.
                                                                                                                                                        A saliva collection kit plus full genetic
                                                                                                                                                                                                           sugar.                                              does drugs.
                                                and didn’t have the experience that                                                                                                                           Drugs to treat diabetes are often                   The FDA is also hobbled by the Dietary
drugs, plans to have as many as 40 more                                                                                                              analysis from Pathway was slated to cost              approved simply because they lower blood            Supplement and Health Education Act, or
in trials by 2017 under its lucrative deal      maybe we needed.”
                                                   Schleifer and Yancopoulos considered        Woman, Cargill settle E. coli case: A                 about $275.                                           sugar and heart drugs can win FDA approval          DSHEA, the report says.
with Sanofi to test Regeneron antibodies                                                                                                                Companies like 23andMe and Navigenics              because they lower cholesterol. But the                “Under DSHEA, dietary supplements are
                                                remodeling the company after Merck &           woman who became severely ill with an E. coli
against a wide range of diseases.                                                              infection from a tainted hamburger has reached a      have sold similar kits online for years, with         report said this does not mean they make            broadly presumed to be safe, and the FDA
   Regeneron claims to have perhaps the         Co, the US drugmaker nicknamed “the                                                                                                                        patients healthier.                                 does not have the authority to require dietary
                                                house that research built” under the lead-     settlement with the meatpacking arm of agribusi-      prices ranging between $400 and $1,000.
most effective drug-making technology                                                                                                                                                                         “This is a groundbreaking report that tells      supplements to be approved for safety and
                                                ership of Vagelos. Merck spread its bets       ness giant Cargill Inc, both sides announced             Those products have never been reviewed            us we should really think carefully about the       efficacy before they enter the market,” it
— mice with human immune-system                                                                Wednesday.                                            by the FDA, even though the agency has the
genes that produce better antibodies than       across many diseases and its many break-                                                                                                                   use of biomarkers and surrogates,” Dr               reads.
                                                                                                  Stephanie Smith, 23, and Cargill said the          power to regulate all such laboratory-devel-
rival companies.                                throughs included the first “statin” cho-      terms of the settlement were confidential, but that
                                                lesterol drug.                                                                                       oped medical tests.
   It cites another major weapon: the con-                                                     it will provide for Smith’s care throughout her          But agency officials said Wednesday that           Walgreen’s decision to hold off stocking the           The biology of how DNA variations actu-
tinual hands-on involvement of Merck &             “Vagelos had always been a hero of          life. The former children’s dance instructor was                                                            product.                                            ally lead to certain diseases is still poorly
                                                mine because I’m also the son of a Greek                                                             Pathway crossed “sanctioned boundaries”
Co Inc’s legendary former Chief                                                                left paralyzed, with cognitive problems and kid-      for such products by seeking to sell its prod-           The proliferation of consumer-marketed           understood, although a number of public and
Executive Roy Vagelos.                          immigrant,” Yancopoulos said. “My              ney damage.                                                                                                 genetic tests has troubled many public health       private institutions have been racing to find
                                                father cut out a Greek-language newspa-                                                              ucts in retail pharmacies.
   The stock, with big current stakes held                                                        Smith became ill in 2007 after eating a patty         The agency’s letter to Pathways, dated             officials and doctors who worry that the            answers.
by Sanofi, T. Rowe Price Group affiliates       per article for me in the 1970s when Roy       produced by Cargill Meat Solutions Corp, a                                                                  products are built on flimsy data.                     Khoury said that knowing a patient’s med-
                                                became head of research at Merck and           Wichita, Kansas-based unit of Minnetonka-based        May 10, requests a response within 15 days.
and Carl Icahn, has risen 57 percent over                                                                                                               “We give them a chance to respond and                 “The problem with all of these products is       ical history — including whether diabetes or
the past year, compared with a 70 percent       said: ‘If you’re going to become a scien-      Cargill Inc. Her E. coli infection led to kidney
                                                                                                                                                                                                           they’re based on incomplete, invalidated data       heart disease run in their family — is actual-
                                                tist instead of a doctor,’ which was always    failure. She went into seizures and was kept in a     tell us why do you think that this is, in fact,
gain for the NYSARC Biotech Index and                                                                                                                actually a legal product,” said Dr Alberto            and we don’t know what the impact on con-           ly more useful than current genetic testing.
a 27 percent advance for the Standard &         his dream for me, ‘at least become like        medically induced coma for three months.
                                                                                                  Smith’s battle to recover was the centerpiece      Gutierrez, the FDA’s director of diagnostic           sumers will be,” said Dr Muin Khoury, direc-        He and other experts worry that increasing
Poor’s 500. In morning trade, it rose a         this scientist.’”                                                                                                                                          tor of the National Office of Public Health         prevalence of genomic tests could pressure
                                                   Yancopoulos said he and Schleifer           story last year in a New York Times series that       testing.
further $1.09 or 4.3 percent to $26.61 on                                                      won a Pulitzer Prize. The story spurred several          Pathways said in a statement it is commu-          Genomics at the Centers for Disease Control         doctors to order unnecessary tests and treat-
Nasdaq.                                         “always talked about Roy. And we                                                                                                                           and Prevention.                                     ment.
                                                thought just like he and Merck followed        members of Congress to demand better enforce-         nicating with the FDA and respects
   Regeneron’s market capitalization is                                                        ment of food safety laws and a pledge from
about $2 billion, far below industry lead-      the science as a foundation, we could do
                                                                                               Agriculture Secretary Tom Vilsack for stepped
ers such as Amgen Inc at $53 billion and        that as well.”                                 up efforts to fight E. coli contamination. The           “Implementing a ban would not protect work-        prohibited for many years.”                         minerals found in natural rock formations.
$129 billion for Roche, owner of                   Schleifer startled Yancopoulos one day      story traced how the beef trimmings that went         ers or the public against past uses that have been       Asbestos is a generic term for various fibrous   Because the fibres are strong, durable and non-
Genentech, a biotech Regeneron emu-             with a suggestion that they hire Vagelos       into her hamburger came from four plants in the                                                                                                                 flammable, they were widely used in industrial
lates.                                          instead of just emulating him.                 US and Uruguay, and that while such scraps are                                                                                                                  furnaces and to insulate buildings until the 1970s
   The company is based in the home-               “At that time, Roy had been a top CEO       particularly vulnerable to contamination, many                                                                                                                  in Canada.
town of author Washington Irving, whose         in America for a half dozen years in a         companies including Cargill did not normally test                                                                                                                   Now local production is largely exported to
famous tale “Rip Van Winkle” concerns a         row, so I told Len: ‘Roy is not even going     them prior to grinding.                                                                                                                                         developing nations where activists fear checks on
man who falls asleep for 20 years and           to answer your phone calls!’”                     Her Seattle-based attorney, Bill Marler, said                                                                                                                its safe use are lacking. When inhaled the fibres
awakens to find everything changed. But         Yancopoulos said.                              Smith’s case continues to generate public and                                                                                                                   can scar lungs and cause disease, including can-
unlike Rip, who was habitually idle,                           Convinced                       industry discussion about the importance of bet-                                                                                                                cer.
Regeneron has worked at a feverish pace            “But Len called up Roy, and Roy             ter food safety.                                                                                                                                                    “I’m asking (the government) to stop mining
since 1988 to change everything about                                                             “Stephanie’s tragedy has taken on a life of it’s                                                                                                             and stop selling this product,” said Sandra
                                                answered. And he was planning to step          own, and hopefully it will continue to focus peo-
drug development.                               down at Merck and wanted to do some-                                                                                                                                                                           Kinart, a community activist whose husband died
                                                                                               ple on why food safety is so important,” Marler                                                                                                                 of lung disease linked to asbestos mining.
   By next month, Regeneron plans to            thing different, to get into this biotech-     said. (AP)
release data from Phase III trials of its                                                                                                                                                                                                                          “This just shouldn’t be happening,” she said.
                                                type stuff. And Len convinced him to                              ❑      ❑     ❑                                                                                                                               “Employers have a responsibility to their work-
drug to prevent and treat pain from gout,       come visit Regeneron for a couple of                                                                                                                                                                           ers to keep them safe. No man gets dressed to go
a form of arthritis that often hits the big     days, for me to give him a total overview      ‘Ban asbestos exports’: Activists and law-                                                                                                                      to work in the morning to die.”
toe. It uses the same active ingredient as      of the company.”                               makers urged Ottawa Wednesday to ban asbestos
                                                                                                                                                                                                                                                                   Tushar Kant Joshi, India’s leading anti-
Arcalyst, rilonacept, and works by block-          Vagelos became chairman of                  mining, saying it was “exporting human misery
                                                                                               on a monumental scale” by allowing sales of the                                                                                                                 asbestos advocate and occupational health expert,
ing an inflammation-causing protein             Regeneron’s board in 1995 and made a                                                                                                                                                                           was also on hand. He commented that asbestos
called Interleukin-1.                           deep impression. He urged the company          fibrous mineral to developing nations.
                                                                                                  Asbestos is the “greatest industrial killer that                                                                                                             exports “have done little to improve Canada’s
   In the second half of the year it plans to   to study other diseases and to exploit its                                                                                                                                                                     economic health,” but have seriously damaged
provide data from late-stage trials of its      understanding of cell receptors — pro-         the world has ever known,” opposition member
                                                                                               of parliament and former asbestos miner Pat                                                                                                                     public health abroad.
macular degeneration product, called            teins on the surface of cells that set into                                                                                                                                                                        If Canada bans exports, other major exporting
VEGF Trap, and its aflibercept drug for                                                        Martin told a press conference.
                                                motion biological reactions within the            And it is “Canada’s greatest shame that we                                                                                                                   countries like Zimbabwe or Russia or Brazil will
colon cancer. Both drugs, like Avastin,         cell.                                          continue to be one of the largest producers and                                                                                                                 take note, he earlier told the daily Globe and
block the VEGF protein which is                    Likewise, Vagelos stressed the compa-       exporters of asbestos in the world,” he said. “We                                                                                                               Mail.
involved in growth of blood vessels.            ny’s other strong suit developed during its    are exporting human misery on a monumental                                                                                                                          Canadian asbestos exports have steadily
   Schleifer said the company’s top com-        years of neuroscience research — its           scale.”                                                                                                                                                         declined from a peak in 1979 valued at $652 mil-
mercial opportunity is probably VEGF-           expertise in cell signaling, communica-           Natural Resources Minister Christian               Parents pick up their children at the end of the school day from an elementary school                     lion to less than $100 million annually in recent
Trap, being developed with Bayer AG.            tion among cells and how errors in that        Paradis rejected a ban, saying Canada has “pro-       in Beijing on May 12, as security guards stand at the entrance. The latest deadly school                  years, according to Statistics Canada.
   The company was started in 1988 by           process can lead to disease.                   moted the safe and controlled use of chrysotile”      attack shows China is paying the price for focusing on economic growth for decades                            “People in third world countries will curse the
Schleifer, an assistant professor of neurol-       Fifteen years later, Vagelos remains a      both at home and abroad.                              while ignoring the mental health problems linked to the nation’s rapid change, experts                    name of Canada if this (mining) continues,”
ogy at Cornell University Medical               totally involved company chairman and             “All recent scientific studies show that           say. Despite rising living standards and greater freedoms, Chinese today face new                         commented Mike Bradley, mayor of Sarnia,
College. He planned to discover nerve-                                                         chrysotile fibres, the only asbestos fibre that is    pressures unknown 30 years ago, when China began opening again to the world —                             Ontario, an industrial town at the southern tip of
                                                owns 1.8 percent of Regeneron’s shares.                                                              particularly the struggle to keep up in a dog-eat-dog capitalist landscape. (AFP)
                                                                                               produced and exported from Canada, can be used                                                                                                                  Lake Huron that suffered an epidemic of
                                                                                               safely under controlled conditions,” he told AFP.                                                  See Page 32                                                  asbestos-related cancers and deaths. (AFP)

								
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