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FDA extends NDA review of NVO’s degludec and degludecplus by three months:
#msg-6408031
The new PDUFA date for both products is 10/29/12.
These drugs are NVO's attempt to compete with SNY's blockbuster, Lantus.
Sanofi Cuts Jobs, Consolidates U.S. Facilities: #msg-68616715.
SNY and BIIY : anouncements same time? head to head competition for MS dollars..Why do they call them big pharma for?
Sanofi-Aventis reports Alemtuzumab significantly reduces relapses in multiple sclerosis vs interferon Beta-1a in a Phase III study (SNY) 35.63 : Co and its subsidiary Genzyme announce new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab to Rebif in patients with relapsing-remitting multiple sclerosis. New data show that 78% of patients treated with alemtuzumab remained relapse-free for two years, providing statistically significant improvement over interferon beta-1a (78% vs 59% at two years) and meeting this secondary endpoint. Additional findings from the CARE-MS I study presented today include other secondary endpoints that suggest positive outcomes with alemtuzumab. Improvement in Multiple Sclerosis Functional Composite scores was observed in alemtuzumab-treated patients, as compared to interferon beta-1a (0.12 vs 0.05 mean change from baseline at year two). MSFC is a composite measurement of physical and cognitive function.
1:21AM Biogen Idec and Abbott (ABT) present positive data for Daclizumab HYP from select Phase 2B trial (BIIB) 108.84 : Biogen (BIIB) and Abbott (ABT) announce additional results from the SELECT Phase 2b trial in people with relapsing-remitting multiple sclerosis. Results showed that DAC HYP, administered subcutaneously once every four weeks, met the trial's primary endpoint by significantly reducing the annualized relapse rate by 54% in the 150 mg dose group and 50% in the 300 mg dose group compared to the placebo group at one year. In addition to meeting the primary endpoint, both doses of DAC HYP met key secondary endpoints, including measures of magnetic resonance imaging. In a sub-study for a pre-specified subset of patients, both 150 mg and 300 mg of DAC HYP provided a significant reduction in the cumulative number of new gadolinium-enhancing lesions between weeks eight and 24 (69%; 78%). Both doses also provided a significant reduction in new or newly enlarging T2 hyperintense lesions (70%; 79%). In a tertiary endpoint, both 150 mg and 300 mg of DAC HYP also significantly reduced the number of new Gd+ lesions on the week 52 MRI (79%; 86%).
MS drug and tracking stox
Minyanville > Markets
Sanofi Tracking Stock Drops on Genzyme MS Drug
By Brett Chase Jul 11, 2011 1:10 pm
Study data doesn't support contention that Lemtrada will take market from other treatments.
At the heart of the standoff over Sanofi’s (SNY) $20 billion takeover of Genzyme was the value of a multiple sclerosis drug.
Genzyme argued that the drug Lemtrada’s market potential was not being recognized in Sanofi’s offering price. After months of back and forth, the two sides agreed on a compromise: a tracking stock that allowed investors to make an individual bet on the MS drug. If the drug met milestones, Sanofi would increase the value of the stock. (See Sanofi Nabs Genzyme.)
This morning, investors are dumping Sanofi’s tracking stock (also known as contingent value right or CVR) on study results of Lemtrada. While the drug appears to work better than an older treatment, Pfizer (PFE) and EMD Serono’s Rebif, the data doesn’t support the contention that Genzyme has a drug that can compete with more recently approved medicines made by Novartis (NVS) and Biogen Idec (BIIB).
RBC Capital Markets analyst Michael Yee predicts Lemtrada will be approved in the US but he considers it as “a last-line agent” to treat MS. In other words, other drugs will be used before doctors prescribe Lemtrada, which means sales will be limited. Novartis’ oral MS drug Gilenya and Biogen’s injectable Tysabri will be prescribed before Lemtrada, Yee says. Lemtrada is an injectable drug.
“Feedback from docs is that (Lemtrada) may be best for aggressive disease but long-term safety will be a concern,” Yee says.
The CVR stock, which trades on Nasdaq as GCVRZ, is down 10% to $2.28 in midday trading Monday. The stock is down almost 3% since it began trading in April.
It would be a stretch to say that Sanofi is a clear winner here. After all, Lemtrada is the French drug maker’s product now. But it’s clear why company execs crafted a deal that reduced its risk on that particular product. Had Sanofi paid Genzyme’s original asking price, it would look foolish now. Instead, the company put some of the risk of the acquisition in the hands of shareholders who chose to hang on to the tracking stock.
Sanofi said it would add up to $14 a share in Lemtrada gets approved and becomes a blockbuster drug. But the drug needs to reach $2.8 billion in annual sales for Sanofi to pay out that full amount.
Celgene (CELG) created a similar CVR stock when it acquired Abraxis BioScience in October for $2.9 billion. That tracking stock (CELGZ) is down 69% since it starting trading and was $1.71 midday Monday.
Don’t be surprised if more big drug companies include -- or try to negotiate -- CVRs in their takeovers of smaller rivals.
sny made the list Top 10 Health Care Stories of 2010
http://www.itsfreeclassifieds.com/ads/community/fitness-dance-health/top-10-health-care-stories-of-2010-xoma-actc-abt-gsk-gern-agn-genz-acl-sny-pfe-mrk-rhhby-1737.html
SNY is creating diversions because its top-2 franchises—Plavix and Lovenox—are under assault. Lovenox has already gone generic in the US (#msg-56387532) and Plavix will go generic in 2012. Regards, Dew
How about SNY acquires GENZ.....read up on it here...
http://solutions.dowjones.com/tnt/assets/scottrade/tomorrowsnewstoday.html#hl7
I was a designer on this exhibit sponsored by Sanofi:
http://www.prnewswire.com/news-releases/interactive-traveling-diabetes-exhibit-to-be-unveiled-at-detroit-science-center-78413147.html
News
Sanofi-aventis to Acquire Merck's Interest in Merial
Future joint venture would be a global leader in animal health
Jul 30, 2009 1:01:00 AM
Copyright Business Wire 2009
View Additional ProfilesPARIS & WHITEHOUSE STATION, N.J. & KENILWORTH, N.J.--(BUSINESS WIRE)-- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Merck & Co., Inc. (NYSE: MRK) today announced that the companies have signed a definitive agreement under which Merck will sell its 50 percent interest in the companies' current animal health joint venture, Merial Limited (Merial), to sanofi-aventis for $4 billion (US) in cash. Formed in 1997, Merial is a leading animal health company that is a 50/50 joint venture between Merck and sanofi-aventis. Following the close of the transaction, sanofi-aventis will own 100 percent of Merial.
Sanofi-aventis said the acquisition price values Merial on the basis of 3.0 x 2008 sales and 10.2 x 2008 earnings before interest and taxes (EBIT). The acquisition is expected to be accretive to sanofi-aventis' adjusted net income from the first year.
In addition to the Merial agreement, Merck, sanofi-aventis and Schering-Plough announced the signing of a call option agreement. Under the terms of the call option agreement, following the closing of the Merck/Schering-Plough merger, sanofi-aventis would have an option to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be owned equally by the new Merck and sanofi-aventis.
"These agreements should enable us to proceed expeditiously with the closing of our merger with Schering-Plough in the fourth quarter as planned, and also gain an outstanding animal health business through Intervet/Schering-Plough Animal Health," said Richard T. Clark, Merck chairman, president and chief executive officer. "We are pleased that our long-time partner sanofi-aventis will purchase Merck's interest in Merial, the successful joint venture we built together," he added. "We look forward to the potential opportunity to bring together the strong animal health businesses of sanofi-aventis and the new Merck."
Commenting on these agreements, Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis said: "We are pleased with the acquisition of Merial, a major global player in animal heath, and the possibility of combining Merial and Intervet/Schering-Plough's complementary businesses. The combination would create a new leader in this USD 19 billion global animal health market, supporting our vision of a global diversified healthcare leader. In an environment of increasing complexity, I am convinced that alliances have an important place and I look forward to the prospect of further partnering with the new Merck in animal health to build on our longstanding relationship."
The sale of Merck's interest in the Merial joint venture is subject to clearance by the European antitrust authorities. Merck said it anticipates completing the transaction before its planned merger with Schering-Plough is finalized, which is expected to occur during the fourth quarter of 2009. Following the close of Merck's merger with Schering-Plough, sanofi-aventis would have an opportunity to conduct due diligence before any exercise of its call option to form the new joint venture.
As part of the call option agreement, the value of Merial has been fixed at $8 billion (US). The minimum total value received by the new Merck and its affiliates by contributing Intervet/Schering-Plough to the combined entity would be $9.25 billion (US), consisting of a floor valuation of Intervet/Schering-Plough of $8.5 billion (US) (subject to potential upward revision based on a valuation exercise by the two parties) and an additional payment of $750 million (US). Based on the valuation exercise of Intervet/Schering-Plough and customary transaction adjustments, if Merial and Intervet/Schering-Plough are combined, a true-up payment would be paid to establish a 50/50 joint venture with equal ownership between the new Merck and sanofi-aventis. Any formation of a new animal health joint venture with sanofi-aventis is subject to customary closing conditions including antitrust review in the United States and Europe.
Between September 30, 2009 and the closing of the merger between Merck and Schering-Plough, the agreements provide Merck with certain rights to terminate the option for a fee of $400 million or $600 million (US).
The companies said Merial and Intervet/Schering-Plough Animal Health will continue to operate independently until the closing of any potential combination of Merial and Intervet/Schering-Plough Animal Health.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
About Sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
About Merial
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,400 people and operates in more than 150 countries worldwide. Merial Limited is a joint venture between Merck & Co., Inc. and sanofi-aventis. For more information, please see www.merial.com.
Forward Looking Statements by Sanofi-aventis
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Forward Looking Statements by Schering-Plough
This communication also includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, the timing and completion of the sale of Merck's interest in Merial to sanofi-aventis, the exercise of sanofi-aventis's call option, and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's and Schering-Plough's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the ability to obtain governmental and self-regulatory organization approvals of the merger on the proposed terms and schedule; the failure of Schering-Plough or Merck stockholders to approve the merger; the possibility that the merger does not close, including, but not limited to, due to the failure to satisfy the closing conditions; the ability to obtain governmental approvals of the sale of Merck's interest in Merial to sanofi-aventis; and the failure of sanofi-aventis to exercise the call option. Schering-Plough undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Schering-Plough's Quarterly Report on Form 10-Q for the period ended June 30, 2009, the merger proxy statement/prospectus filed June 25, 2009, and Schering-Plough's other filings with the Securities and Exchange Commission (the "SEC") available at the SEC's Internet site (www.sec.gov).
Forward Looking Statements by Merck
This communication also includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's and Schering-Plough's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the proposed merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the ability to obtain governmental and self-regulatory organization approvals of the merger on the proposed terms and schedule; the actual terms of the financing required for the merger and/or the failure to obtain such financing; the failure of Schering-Plough or Merck stockholders to approve the merger; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; the possibility that the merger does not close, including, but not limited to, due to the failure to satisfy the closing conditions; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Current Report on Form 8-K filed on June 22, 2009, Merck's other filings with the Securities and Exchange Commission (the "SEC") available at the SEC's Internet site (www.sec.gov).
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6018735&lang=en
Source: Merck & Co., Inc.
----------------------------------------------
Media:
Merck
David Caouette
908-423-3461
or
sanofi-aventis
Jean-Marc Podvin
+33 1 53 77 44 50
or
Schering-Plough
Fred Malley
908-298-7428
or
Investors:
Merck
Eva Boratto
908-423-5185
or
sanofi-aventis
Sebastien Martel
+33 1 53 77 4545
or
Schering-Plough
Janet Barth
908-298-7436
Well I just bought ole girl, lets see if she has any spunk in her to pull herself back to HOD
WSJ(10/6) US Sees Need To Better Prepare Against Avian Flu
06 Oct 00:00
(From THE WALL STREET JOURNAL)
By Bernard Wysocki Jr.
WASHINGTON -- Amid growing concerns about bird flu spreading to humans, the
Bush administration says it plans to bolster vaccine production in the U.S.,
purchase huge quantities of antiviral drugs and lay out a detailed system to
coordinate federal, state and local response efforts to a pandemic.
In an interview, Health and Human Services Secretary Michael Leavitt said an
administration plan to be put forth in coming weeks is designed to ensure a far
more robust domestic vaccine industry, with expanded U.S. manufacturing
capacity. White House and congressional officials have said the request to
Congress will be in the range of $6 billion to $10 billion.
The U.S. once boasted a large vaccine industry. But in recent decades drug
makers have exited the business, for reasons including low profit margins,
exposure to lawsuits and manufacturing difficulties. As a result, the U.S. has
lost much of its capacity to produce vaccines for seasonal flu, leaving it
largely dependent on a plant in Pennsylvania, which is owned by Paris-based
Sanofi-Aventis Group.
Increasingly, bird flu, or avian influenza, has stoked worries among world
health officials of a global pandemic as it has devastated poultry flocks and
Asia and begun spreading to migratory birds and humans. Since late 2003, more
than 60 human deaths in Asia have been blamed on the current strain of the flu,
known as H5N1.
Adding to the concerns, a group of scientists yesterday said they had shown
that the 1918 Spanish flu epidemic blamed for 50 million deaths had started
among birds and then mutated and spread to humans.
Researchers said the discovery, while frightening in its implications, also
could help researchers track and perhaps contain a major outbreak. "We have
been able to unmask the 1918 virus, and it's revealing to us some of the
secrets that will help us prepare for a pandemic," said Julie Gerberding,
director of the Centers for Disease Control and Prevention.
That process is very much a work in progress, officials admit. "We are not
prepared for a pandemic, and it is important that we become prepared," said Mr.
Leavitt, who has become the administration's point person on the subject,
immersing himself in the issue and in the history of pandemics. "Pandemics
require the full measure of our attention. We have to improve our readiness."
There remains considerable uncertainty about a possible pandemic. It's
unclear whether human-to-human contact of the virus ever will be widespread.
Even if that happens, advance preparations could be effective or futile
depending on how the virus mutates. Mr. Leavitt noted that he had studied
carefully the swine-flu episode of 1976, which despite widespread fear, didn't
turn into a devastating killer.
Efforts to develop a vaccine for the H5N1 strain are continuing. In August,
the National Institutes of Health reported that the first human trials of an
avian-flu vaccine made by Sanofi-Aventis were effective.
But at the time, Dr. Anthony Fauci, director of the National Institute of
Allergy and Infectious Diseases, cautioned that many hurdles remain before a
vaccine will be available for widespread use, including producing enough to
meet potential demand.
The administration already has received much attention for its effort to have
20 million treatments of an avian-flu vaccine stockpiled and on hand to
inoculate U.S. citizens. Sanofi-Aventis has received six contracts to develop
and manufacture some quantity of its vaccine, including a $100 million award in
September to bolster the manufacturing capacity for avian-flu vaccine in the
U.S.
Mr. Leavitt didn't discuss many other details of his plan, but said he plans
to put in place a comprehensive surveillance system to track the pandemic. He
is traveling to Southeast Asia next week to countries grappling with the flu.
In the wake of criticism over its response to Hurricane Katrina, the
administration is taking pains to highlight its efforts to prepare for a
possible pandemic. In recent days, several prominent Democrats have accused the
White House of failing to prepare for a pandemic. President Bush spoke at
length on pandemic flu plans during a news conference Tuesday, discussing a
possible quarantine of citizens -- perhaps even using the military -- and
saying he is in touch with NIH.
Besides Sanofi-Aventis, a number of big drug companies could benefit from the
expanded effort being pushed by the administration and Congress. Switzerland's
Roche Holding AG, for instance, has received orders from more than 30 countries
for treatments of Tamiflu, an antiviral medicine that is in high demand but
short supply. Most of the big orders would be staggered over two to three
years, analysts say.
The administration also plans to buy 20 million doses of Tamiflu for the
U.S., though Mr. Leavitt wouldn't specify how or when they would be available.
Today, the U.S. has enough Tamiflu on hand to treat 4.3 million people. (The
department also recently agreed to spend $2.8 million for quantities of another
antiviral made by GlaxoSmithKline.)
There has been some controversy around Tamiflu, and Mr. Leavitt, a former
three-term governor of Utah and ex-head of the Environmental Protection Agency,
said he considered purchasing the drug to be akin to an automobile seat belt.
"It doesn't eliminate wrecks but it helps you survive when they occur," Mr.
Leavitt said. He said he was aware about recent scientific reports suggesting
that Tamiflu might be only modestly effective against the H5N1 virus.
Roche doubled manufacturing capacity of Tamiflu in 2004 and again in 2005 and
said it will further increase manufacturing capacity in 2006. "We're bringing
manufacturing capacity to the U.S. for the first time at a number of
facilities," said spokesman Terence Hurley. "We'll now have the capability to
produce Tamiflu from start to finish for the first time on U.S. soil this
quarter. That's important if borders are closed; HHS asked us to do this."
Indeed, Mr. Leavitt said there needs to be a focus on producing vaccines in
the U.S. so as to potentially prevent the infection instead of treating those
already infected. Today, the only major flu-vaccine manufacturing facility in
the U.S. is the Swiftwater, Pa., plant owned by Sanofi-Aventis, which produces
seasonal flu vaccines.
One U.S. company, Emoryville, Calif.-based Chiron Corp. produces flu vaccine
for the U.S. at a United Kingdom plant, although that supply was curtailed last
year after contamination problems surfaced at the plant. In addition, MedImmune
Inc., of Gaithersburg, Md., produces an inhaled flu vaccine, for healthy people
ages 5 to 49. Last week, MedImmune said it will work with NIH to develop a
vaccine to be used against strains of influenza that could cause widespread
outbreaks, including avian flu that has appeared in Southeast Asia.
Though infectious diseases are huge killers, with about 35,000 to 40,000
Americans dying each year from seasonal flu, big drug companies are largely
ignoring investing in vaccines. Instead, they are placing their bets on chronic
diseases or on lifestyle drugs with big profit potential, resulting in a
growing public-health problem.
HHS officials warn that tight vaccine supply could be further strained if
needs for seasonal flu occur at the same time a pandemic requires huge extra
production to meet a crisis. Experts also say a beggar-thy-neighbor policy
could occur in a crisis, in which governments "nationalize" their supplies, so
that non-U.S. production would quickly be grabbed by those countries and
unavailable outside their borders.
Congress already has been taking up the U.S.'s lost vaccine production
capacity. A bill introduced this summer by Sen. Judd Gregg, a New Hampshire
Republican, would give liability protection to drug companies that produce
either biodefense drugs or countermeasures to combat pandemic flu. Other plans
would give tax breaks to companies that make vaccines. Some members of Congress
are proposing laws that would offer the same incentives for companies to
develop countermeasures against either man-made or naturally occurring
pathogens such as flu.
An important part of the government's plan, Mr. Leavitt said yesterday, is to
clearly delineate the roles of federal, state and local officials in the event
of a pandemic crisis -- a source of much contention in the response to
Hurricane Katrina.
"What if this were happening in Seattle and Portland, Maine, and Chicago and
Omaha and Santa Fe and Miami and Austin and Salt Lake City and 500 other places
-- all at the same time?" Mr. Leavitt said. He said that response would have to
be managed by local public-health authorities, not by the CDC, which is based
in Atlanta.
He also said, though, that state and local preparations need bolstering,
quickly. Last December, Trust for America's Health, a nonprofit advocacy group
based in Washington, concluded that only six states had achieved "green" status
for the Strategic National Stockpile, meaning they were adequately prepared to
distribute vaccines and antidotes in an emergency. It found that two-thirds of
the states can't track diseases electronically and 60% of states don't have the
scientists needed to test for anthrax or plague.
---
Marilyn Chase contributed to this article.
(END) Dow Jones Newswires
10-06-05 0000ET
Copyright (c) 2005 Dow Jones & Company, Inc.
DJ Ypsomed: OptiClik Pen Doesn't Infringe Patents >YPSN.Eb -2
07 Oct 03:17
Ypsomed launched its investigation after Novo Nordisk started a lawsuit in
the U.S. against Sanofi-Aventis earlier this year, blaming the company to have
infringed a patent for the Danish company's insulin pen Flexpen.
Ypsomed produces a competitor insulin product, OptiClik, which is distributed
by Sanofi-Aventis. Sanofi-Aventis earlier said Novo Nordisk's charges were
without foundation.
"The expert opinion received from patent specialists reflects the internal
investigation by Ypsomed and the statement of Sanofi-Aventis that the
accusations are unjustified", Ypsomed Chief Executive Matthew Robin said.
The result of the investigation is likely to help Ypsomed shares.
Ypsomed, one of Switzerland's stock market darlings, fell almost 10% on the
lawsuit news in September, because OptiClik was perceived as the Swiss
company's best chance to penetrate the $2-billion U.S. insulin market.
The stock came further under pressure when speculation rose that majority
owner Will Michel and BV Holding, another large shareholder, were selling
Ypsomed stock.
Despite the recent sharp share price decline, Ypsomed shares have advanced
around 42% since the start of the year.
Company Web Site:http:/www.ypsomed.com
-By Goran Mijuk and Anita Greil, Dow Jones Neswires; +41 43 443 80 44,
anita.greil@dowjones.com
(END) Dow Jones Newswires
10-07-05 0317ET
Copyright (c) 2005 Dow Jones & Company, Inc.
Sanofi-Aventis: Ambien CR Available In US Drugstores
07 Oct 02:38
PARIS -(Dow Jones)- Sanofi-Aventis SA (SNY) Friday said Ambien CR, a new
version of its Ambien sleeping pill, is now available by prescription at
drugstores in the U.S.
(MORE TO FOLLOW) Dow Jones Newswires
10-07-05 0238ET
Copyright (c) 2005 Dow Jones & Company, Inc.
------------------------------------------------------------------------
Sanofi-Aventis: Ambien CR Available In US Drugstores -2-
07 Oct 03:17
Sanofi-Aventis had secured approval from the U.S. Food and Drug
Administration to sell Ambien CR in September.
The previous version of the drug - Ambien, also sold under the Stilnox brand
in some countries - generated sales of EUR1.42 billion in 2004.
-By David Gauthier-Villars, Dow Jones Newswires; +33 1 40 17 17 40;
david.gauthier-villars@dowjones.com
(END) Dow Jones Newswires
10-07-05 0317ET
Copyright (c) 2005 Dow Jones & Company, Inc.
Bush To Meet With Vaccine Manufacturers Friday
06 Oct 18:27
(Updates the names of the companies Bush will meet with.)
WASHINGTON -(Dow Jones)- Amid increasing concern over avian flu, U.S.
President George W. Bush will meet with the heads of vaccine-manufacturing
companies Friday to discuss ways to expand the mass production of a flu
vaccine, the White House said Thursday.
The chief executive officers of Chiron Corp. (CHIR), Sanofi-Aventis (SNY),
Wyeth (WYE), GlaxoSmithKline (SKBEECHAM.LA) Merck & Co. Inc. (MRK) and
MedImmune Inc. (MEDI) will meet with Bush at 2:00 p.m. Friday, the White House
said.
A number of manufacturers have stopped producing vaccines because of their
exposure to lawsuits. Bush spokesman Scott McClellan said the issue will be
discussed in the meeting.
"One of the concerns that manufacturers have had is certainly the issue of
liability and lawsuits," McClellan said.
The president also met with his top advisers Thursday in the White House to
discuss avian flu, and how the government can prepare for a potential outbreak.
Health and Human Services Secretary Michael Leavitt told the Wall Street
Journal in an interview Thursday that the administration will put forth a plan
to ensure a more robust domestic vaccine industry. The newspaper said a $6
billion to $10 billion request will be sent to Congress.
"The good news is, we do have a vaccine," Leavitt said on CBS's The Early
Show. "The bad news is we don't have the capacity ... to manufacture it fast
enough or in large-enough quantities. And that's a big gap in our preparation,
and we need to solve it."
Paris-based Sanofi-Aventis runs the largest vaccine-production facility in
the U.S.
-By Henry J. Pulizzi, Dow Jones Newswires; 202-862-9256;
henry.pulizzi@dowjones.com
(END) Dow Jones Newswires
10-06-05 1827ET
Copyright (c) 2005 Dow Jones & Company, Inc.
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