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[grupo guitarlumber] 31/10/2007 08:44

Roche Ag Genentech to halt dose-packaged sales of cancer drug Avastin for ocular use




ZURICH (Thomson Financial) - Genentech Inc said it will stop sales of cancer
drug Avastin for the treatment of eye diseases to compounding pharmacies, which
repackage Avastin into doses for injection into the eyes, citing FDA concerns as
its main reason for the move.
In a letter posted on its website, the Roche subsidiary said it will stop
that category of sales as of Jan 1.
The company said the FDA raised concerns about the packaging of the drug for
ocular use in a warning letter to a compounding pharmacy.
Subsequently, in inspection of the company's South San Francisco
manufacturing facility, inspectors also raised concerns related to the ongoing
ocular use of Avastin, as it is not manufactured for that use.
Over 350,000 vials of Avastin with a market value of over 200 mln usd were
then destroyed, as they were deemed unsuitable.
"The implication of this event was that future supplies of Avastin would
likewise be at risk of having to be destroyed," said the company.
Genentech sought to counter claims that the decision to block Avastin usage
in the eye is motivated solely by profit, as it also makes a more expensive drug
- Lucentis - that is used to treat eye diseases.
"We did not and do not expect that this change in policy toward compounding
pharmacies will lead to any increase in Lucentis sales," it said in the letter.
It added that it will reinstate supply of Avastin to compounding pharmacies
if the FDA gave the go-ahead.

[e-mail]
hmn/jms

[waldron] 17/10/2007 06:06

Roche Ag Genentech's 1 bln usd 4(2) CP programme assigned 'A-1+' rating - S&P




MUMBAI (Thomson Financial) - Standard & Poor's Ratings Services said it has
assigned its 'A-1+' short-term corporate credit and commercial paper ratings to
biopharmaceutical company, Genentech Inc's new 1 bln usd 4(2) commercial paper
programme.
At the same time, S&P said it has affirmed all of its existing ratings on
Genentech.
The company will use the new programme for liquidity purposes and to help
fund the acquisition of Tanox Inc, the ratings agency said in a statement.
The investment-grade ratings reflect the company's success in developing and
commercialising monoclonal antibody-based and targeted therapeutics,
conservative financial policies and the positive influence of Switzerland-based
majority owner Roche Holding AG, S&P said.
The ratings agency has an 'AA+' and 'A-1+' rating on Roche with a stable
outlook.
[e-mail]
ndi/man

[waldron] 16/10/2007 05:51

Genentech 3Q profit increases 21 percent




SAN FRANCISCO (AP) - Genentech Inc. barely beat Wall Street estimates
for the third quarter, and many analysts are skeptical that world's
second-largest biotech company can maintain its scorching momentum amid new
competition and a saturated market.
Genentech reported Monday that net profit in the three months ended Sept. 30
was $685 million, or 64 cents per share, up 21 percent from $568 million, or 53
cents per share, in the same period a year ago.
Revenue was $2.91 billion, up 22 percent from $2.38 billion in the third
quarter last year.
Not counting expenses, including those related to the $919 million buyout of
biotechnology company Tanox Inc. last quarter, the company earned $778 million,
or 73 cents per share, up 22 percent from a year ago.
On that basis, which does not comply with generally accepted accounting
principles, analysts expected Genentech to earn 72 cents per share on revenue of
$2.93 billion.
Executives at the South San Francisco-based company said in a conference
call Monday they were particularly happy about their $597 million in
third-quarter sales of Avastin, which treats lung, breast and colon cancer.
That's 37 percent more than in the year-ago quarter and several million dollars
more than analysts had expected.
Genentech's partner on Avastin, Swiss health care giant Roche, received
European approval for the drug as a treatment for certain forms of lung cancer.
Genentech is seeking approval from the Food and Drug Administration to use
Avastin as a treatment for metastatic breast cancer, or breast cancer that has
spread to other parts of the body.
Genentech is also running tests to determine whether Avastin, also known as
bevacizumab, is effective in "adjuvant therapy," the attempt to prevent the
recurrence of a cancer after a tumor is surgically removed.
But biotechnology analysts say such new uses are incremental and Avastin may
have already saturated its primary market.
"The double-edge sword of oncology is you get rapid adoption, but you tend
to reach full saturation quickly," said Lehman Brothers equity analyst Jim
Birchenough. He is forecasting net income growth of around 10 percent per year
for several years -- far lower than the 20 percent or more that many investors
are hoping for, based on the company's relatively lofty stock price-to-earnings
ratio.
Avastin -- which the FDA approved in February 2004 as the first drug to
thwart new blood vessels from developing and carrying nutrients to a tumor -- is
facing more competition.
Britain's GlaxoSmithKline PLC announced in March that its Tykerb was
approved for treatment of patients with advanced or metastatic breast cancer who
have received prior therapy. New York-based ImClone Systems Inc.'s Erbitux was
also approved in 2004 to treat advanced colorectal cancer that has spread to
other parts of the body.
Analyst Eric Schmidt said Genentech is relying too heavily on Avastin, the
company's only drug with a year-over-year growth rate of at least 30 percent.
Total U.S. product sales were $2.16 billion, up 18 percent from the third
quarter last year.
"Avastin had good growth, but the others have hit a wall," said Schmidt, who
works for equity research firm Cowen & Co. "The hope is that Avastin can lead
the charge, but that's dependent on whether Avastin works in adjuvant therapy."
Genentech's second biggest source of revenue, Rituxan, approved to treat
rheumatoid arthritis and non-Hodgkin's lymphoma, brought in $572 million last
quarter. That's up 12 percent from than a year ago.
Sales of its breast cancer drug Herceptin rose 6 percent to $320 million.
Genentech's macular degeneration drug Lucentis, approved in June 2006, had
sales of $198 million, a 29 percent jump. Lucentis is designed to inhibit the
formation and leakage of new blood vessels in the back of the eye, the primary
cause of central vision loss.
Sales of asthma drug Xolair increased 13 percent to $121 million. Xolair is
designed to control asthma triggered by year-round allergens, and executives are
bullish that the drug will soon be used to treat the growing incidence of
pediatric asthma.
Genentech spent $578 million on research and development, up 38 percent from
the third quarter of last year.
The company reaffirmed its outlook for full-year profit between $2.85 and
$2.95 per share, excluding charges. Wall Street analysts were predicting
earnings of $2.95 per share.
Shares of Genentech gained 25 cents to $77.50 before the results were
released at the end of regular trading. Genentech shares lost 70 cents
after-hours.
Sales leader Amgen Inc.'s shares fell 50 cents to $57.67 for a market
capitalization of $62.7 billion. In after-hours trading, Thousand Oaks-based
Amgen regained 50 cents.
Genentech is the biggest biotechnology company based on market
capitalization, valued at $81.6 billion. It has a price-to-earnings ratio -- a
common measure of Wall Street's bullishness for a stock -- of 31.8.
By contrast, Amgen's ratio is 16.6.

[grupo guitarlumber] 24/8/2007 10:00

Glaxo, Novartis May Have Bet Wrong in Flu-Shot Race (Update2)

By John Lauerman

Aug. 23 (Bloomberg) -- GlaxoSmithKline Plc and Novartis AG, two of the world's biggest vaccine makers, may have bet on the wrong technology in the race to develop a better flu shot.

The drugmakers are building U.S. factories to grow influenza virus in animal cells as an advance over the decades- old technique of making flu shots using chicken eggs. Now a small, privately held biotechnology company may leapfrog ahead of them with a more advanced method using DNA.

Losing the flu-shot race may be the latest in a series of setbacks to hurt the world's second- and fourth-biggest drugmakers. The Glaxo and Novartis plants are part of a $1 billion U.S. initiative to produce millions of inoculations within six months of an outbreak of a deadly flu. Closely held Protein Sciences Corp., with 40 employees, is close to winning approval for a method that would cut the time at least in half.

``The advantages of recombinant DNA are speed of production and volume of production,'' said David Fedson, a former director of medical affairs for Paris-based Sanofi-Aventis SA, the world's biggest vaccine producer.

Basel, Switzerland-based Novartis, which bought U.S. vaccine maker Chiron Corp. last year, has lost 9.5 percent of its market value over the past 12 months. The company's shares gained 35 centimes to 63.6 Swiss francs at today's close in Zurich. Its diabetes pill Galvus was delayed by U.S. regulators, and its painkiller Prexige was withdrawn from Australia on concern it may cause liver damage.

London-based GlaxoSmithKline, which began selling its shots in the U.S. during a vaccine shortage, has lost 12 percent of its value since May 18, when its top-selling diabetes drug Avandia was linked to elevated risks of heart attacks. The company's shares rose 3 pence to 1,290 pence in London.

Tough Investment

Investing in flu vaccine is a gamble for drugmakers as big as Glaxo and Novartis. The world market for seasonal influenza vaccines amounts to $2 billion a year, a third as much as the asthma drug Advair/Seretide generated last year for Glaxo and half as much as Novartis's sales of the blood-pressure medicine Diovan. The U.S. has stepped in with research grants, supply contracts and higher payments to encourage suppliers.

Governments are trying to reduce the threat to public health that may be posed by a global pandemic of a deadly virus such as the H5N1 strain that has spread across Asia to Africa, the Middle East and Europe since 2003. Health officials say a worldwide outbreak among humans is inevitable. Fifty million people died in a 1918 influenza pandemic.

Novartis's European Approval

Novartis is investing $600 million to build a cell-based flu-shot plant in Holly Springs, North Carolina. The company won a $221 million grant from the U.S. government for clinical trials of the vaccines. Glaxo is creating a similar factory in Marietta, Pennsylvania, in a facility acquired in 2005 from Wyeth for an undisclosed sum. Glaxo is getting $275 million in U.S. funding.

Cell culture probably ``won't be a factor'' if a pandemic occurs within the next three or four years because large-scale manufacturing isn't available, said Alice Hunt, a Glaxo spokeswoman.

Novartis and Brussels-based Solvay SA, which also received funding from the U.S., have won approval to sell animal cell- based shots in Europe. The process is safer, faster and more reliable than egg-based production, said Klaus Stoehr, head of Novartis's influenza division.

MedImmune, a unit of London-based AstraZeneca Plc, said today it licensed gene technology for making flu shots to Novartis. The technology, called reverse genetics, speeds development by allowing scientists to work with harmless segments of DNA from highly dangerous influenza viruses, such as H5N1.

Funding for DNA Shots

Even in an influenza pandemic, flu shots would probably contribute less than 1 percent to Glaxo's annual revenue, said Linda Bannister, an analyst at Edward Jones & Co. in Des Peres, Missouri.

Now the U.S. is preparing another round of funding for companies including Protein Sciences and publicly traded Novavax Inc. to develop flu shots using recombinant DNA.

``We were told they could produce a vaccine in less than 12 weeks after the start of a pandemic,'' Robin Robinson, director of pandemic influenza countermeasures for the Health and Human Services Department, said in a telephone interview.

Protein Sciences inserts flu genes into cells from a corn- eating caterpillar. The cells are then induced to make proteins that when injected into humans trigger a protective immune response. In the technique Glaxo and Novartis are developing, mammal cells are used to generate whole flu viruses, which are then modified to make influenza vaccine.

Biogen Co-Founder

Twenty-year-old Protein Sciences in Meriden, Connecticut, founded to produce pesticides, is owned by 450 shareholders, including the drugmakers Wyeth, based in Madison, New Jersey, and Diamyd Medical AB, based in Stockholm, according to Manon Cox, Protein Sciences' chief operating officer. The chief executive officer, Daniel D. Adams, 67, was a co-founder and the first CEO of Biogen Inc.

Protein Sciences may get U.S. market clearance for a seasonal vaccine next year. The Food and Drug Administration has offered the company an expedited, six-month review of its application, a process that usually takes a year.

The former Sanofi official Fedson estimated that factories around the world using Protein Sciences' recombinant DNA approach could make two doses of vaccine in three months for 3 billion people, almost half the world's population. That's 10 times as much as could be made in conventional egg-based flu- shot plants, he said.

Cell culture ``is an amazingly stupid investment to make for the future,'' said Protein Sciences' Cox. ``It's as if we're still living 100 years ago and recombinant DNA was never developed.''

To contact the reporter on this story: John Lauerman in Boston at [e-mail]

Last Updated: August 23, 2007 12:56 EDT

[grupo guitarlumber] 20/7/2007 06:13

Genentech Senate panel approves patent reform bill


WASHINGTON (AP) - The Senate Judiciary Committee approved a sweeping patent
reform bill Thursday that seeks to improve patent quality and reduce the number
of costly infringement lawsuits.
The committee's move comes after the House Judiciary panel cleared a similar
bill Wednesday. The bills will now need to be considered by the full House and
Senate.
Members of Congress and industry groups say the legislation makes the most
extensive changes to patent law in more than 50 years.
The Senate panel also approved several amendments to the bill, including one
sought by the financial services industry. That amendment would protect banks
from damage awards in patent infringement cases involving electronic
check-clearing technologies, such as check-imaging systems.
More than 60 banks have been hit with lawsuits alleging the infringement of
such technologies, the American Bankers Association said in a letter last week
to the House and Senate Judiciary Committees. Banks have paid millions of
dollars to settle the suits, the association said.
Both the House and Senate proposals would increase the information available
to patent examiners and set up a process to re-evaluate patents after they are
granted. Supporters argue such post-grant reviews would help weed out patents
for minor innovations and overly broad patents by allowing companies to
challenge them without having to go through lengthy litigation.
The bills also seek to reduce the incentives for litigation by making it
harder for a patent holder to show that another company has willfully infringed
its patents, which can entitle the patent holder to triple damages.
The bills are sponsored by Sens. Patrick Leahy, D-Vt., chairman of the
Senate Judiciary Committee, and Orrin Hatch, R-Utah, and Reps. Howard Berman,
D-Calif., and Lamar Smith, R-Texas.
The Senate committee began its consideration of the bill last week, when it
accepted an amendment offered by Sen. Arlen Specter, R-Pa., that would limit the
jurisdictions where patent holders can file lawsuits. The suits would have to be
filed where the plaintiffs or defendants are located, or where the alleged
infringement took place.
The House approved a similar measure Wednesday. The provisions are intended
to limit "forum shopping," where patent owners seek out fast-moving court
dockets and sympathetic juries.
The changes made by the two committees, so far, haven't satisfied many of
the bill's opponents, which include pharmaceutical, biotech and manufacturing
companies, as well as technology companies that rely on licensing patents, such
as Qualcomm Inc.
Those companies argue that the bill will weaken patent protection by
reducing the penalties for infringement and subjecting patents to additional
challenges under the post-grant review process.
The Biotech Industry Organization, whose members include Amgen Inc. and
Genentech Inc., said Thursday it opposed to the House bill, which "threatens
continued biotech innovation."
The legislation is strongly supported by software and technology companies,
such as Microsoft Corp. and Cisco Systems, which argue that their complex
products with hundreds of patents makes them easy targets for patent
infringement suits based on inadvertent or minor violations.
For instance, a $1.5 billion award was levied against Microsoft earlier this
year on a patent infringement suit brought by Alcatel-Lucent.

[waldron] 12/7/2007 07:59

Roche Ag Genentech Q2 earnings up 41 pct UPDATE


(Updating with further detail)
NEW YORK Thomson Financial - Genentech Inc., one of the world's largest
biotechnology companies, continued a positive earnings streak, posting a 41
percent boost in second-quarter profit Wednesday on sales of its blockbuster
cancer drugs.
The company earned $747 million, or 70 cents per share, compared with profit
of $531 million, or 49 cents per share, during the year-ago period.
Revenue rose to $3 billion from $2.2 billion.
The results topped Wall Street expectations. Excluding 6 cents per share for
stock-based compensation costs and 2 cents per share related to the redemption
of Genentech stock by Roche Holdings Inc. and litigation costs, Genentech earned
78 cents per share.
Analysts polled by Thomson Financial expected profit of 72 cents per share,
excluding stock-option costs and charges, on revenue of just under $2.86
billion.
The rheumatoid arthritis and non-Hodgkin's lymphoma drug Rituxan brought in
$582 million in sales during the quarter, an 11 percent increase.
Avastin, which treats lung, breast and colon cancer, had sales of $564
million, marking a 33 percent increase. Breast cancer drug Herceptin showed a 3
percent increase in sales to $329 million.
Sales of its Lucentis drug totaled $209 million. The drug, which treats
age-related macular degeneration, was approved last June.
Costs and expenses rose 30 percent to $1.88 billion from $1.44 billion.
During the quarter, the company began eight phase III clinical trials. Those
studies include Lucentis as a possible diabetic macular edema and retinal vein
collusion treatment and Avastin for a specific form of lung cancer and as a
second-line treatment for colon cancer.
For the full year, the company said it expects earnings per share, excluding
costs and charges, to range from $2.85 to $2.95. Analysts expect earnings of
$2.91 per share.
Shares of Genentech fell 11 cents to $75.82 in after-hours trading. They
rose $1.08 cents to close the regular session at $75.93.

[e-mail]
jlw

[waldron] 26/6/2007 13:27

Abbott, Genentech to collaborate on development of cancer drugs


ABBOTT PARK, Illinois (Thomson Financial) - Abbott Laboratories and
Genentech Inc said they will collaborate on the development of two anticancer
compounds discovered by Abbott.
The companies said they will work together on development and
commercialisation of ABT-263 and ABT-869 and will jointly promote any resulting
products in the US. Abbott will promote any products outside the US.
No financial terms were disclosed.
The companies said both compounds are in phase I clinical trials, and phase
II trials for ABT-869 are scheduled for this year.
[e-mail]
wj

[maywillow] 23/6/2007 14:55

Lawmakers Offer U.S. Plan for Generic Biotech Drugs (Update3)

By Catherine Larkin

June 22 (Bloomberg) -- Makers of generic drugs would gain the right to sell copies of medicines developed by biotech companies such as Amgen Inc. and Genentech Inc. under legislation to be introduced in the U.S. Senate.

The measure would create a pathway for the Food and Drug Administration to approve copies of treatments made through biotechnology, the senators said today in an e-mailed statement. The sponsors are Democratic Senators Hillary Clinton and Edward Kennedy and Republican Senators Orrin Hatch and Michael Enzi.

Americans spent $40.3 billion on biotech drugs last year, and analysts say competition from lower-cost generics may cut prices by a third. Companies such as Barr Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd. have invested billions of dollars in acquisitions and facilities outside the U.S. for the technology to make generic versions of drugs whose patents have expired or been ruled invalid.

``Just as generic drugs have helped bring down the costs of medicines for millions of Americans, new `follow-on' versions of breakthrough biologics will make these innovative treatments more affordable for the patients who need them,'' said Kennedy of Massachusetts, chairman of the Senate health committee, in the statement.

The FDA approves copies of conventional drugs, made through chemical synthesis, under a 1984 law.

Biotech companies say their products, made from human proteins, can't be duplicated, and full-scale human trials would be needed to ensure that generic versions are safe and equally effective. Generic companies say the FDA should be allowed to decide on a case-by-case basis whether to waive the costly studies.

Leeway for the FDA

The senators' proposal would require generic companies to conduct animal studies and at least one clinical trial in humans unless the FDA determines that the steps aren't necessary. The FDA also would have leeway to decide if a generic product could be substituted by a pharmacist for a prescribed brand-name drug.

``If we thought that over a prolonged period of time and over a large number of cases that the FDA was making the wrong decision and being overly conservative, then we'd have to go back to Congress,'' said Bruce Downey, chief executive officer of Woodcliff Lake, New Jersey-based Barr, in an interview this month. ``The bigger risk now is not having a pathway.''

European regulators allow approval of generic versions they call ``biosimilars.'' The products aren't recognized as identical to the original drugs. Swiss drugmaker Novartis AG won backing from a European panel today to sell copies of Johnson & Johnson's Eprex, an anemia medicine sold in the U.S. as Procrit and as Amgen's Epogen.

`Future of Medicine'

``It's crucial that Congress get this right because biologics are the future of medicine,'' Hatch, of Utah, said in the senators' statement. ``It's taken a lot of effort, but we've achieved a good balance in this bill,'' Hatch said. Co-sponsor Clinton is from New York, and Enzi is from Wyoming.

The Senate health committee is expected to mark up the legislation June 27. Any bill would have to be passed by the full Senate and the House before being sent to President George W. Bush. Competing measures have been introduced in the House.

Generic companies betting on the U.S. market are targeting drugs whose patents have already run out or are set to expire in coming years. Most development projects are kept secret, although analysts say Epogen and Genentech's breast cancer drug Herceptin are among the products that may be vulnerable to competition once they lose patent production.

Kelley Davenport, a spokeswoman for Amgen of Thousand Oaks, California, and Stephanie Fischer, a spokeswoman for the Washington-based Biotechnology Industry Organization trade group, declined to comment on the legislation until they had time to review it.

Patient Safety Cited

``Generally, we support a pathway for follow-on biologics,'' said Megan Pace, a spokeswoman for South San Francisco, California-based Genentech, in a phone interview. While she hadn't seen the proposal, she said the company urges ``that any legislation that is passed ensures patient safety and appropriate data protection for innovators.''

Andrea Hofelich, a spokeswoman for the Generic Pharmaceutical Association in Arlington, Virginia, said her group was also still reviewing the proposal.

To contact the reporter on this story: Catherine Larkin in Washington at [e-mail] .

Last Updated: June 22, 2007 19:41 EDT

[grupo] 19/6/2007 06:50

Roche Ag Roche buys US NimbleGen for 272.5 mln usd UPDATE


(Adds details on acquisition)
ZURICH (Thomson Financial) - Roche Holdings AG said it has agreed to acquire
NimbleGen Systems -- a US-based company active in high-density DNA microarrays
-- for 272.5 mln usd.
The deal is expected to close in the third quarter of 2007 and remains
subject to regulatory approval.
NimbleGen will become a fully integrated part of Roche Applied Science, part
of the group's diagnostic division, the Swiss pharma group said.
Roche said the deal allows it to enter the high-growth research microarrray
market, which is estimated to be worth 600 mln usd worldwide and growing by 10
pct annually.
The move will also strengthen its presence in the genomics research market,
Roche said.
DNA microarrays are a widely used discovery and research tool in pharma
research for the understanding of genetic causes of disease and predisposition
factors, comparative genomic analysis and identification of potential drug
targets.


[e-mail]
jmt/jfr/sf/bsd

[waldron] 25/4/2007 15:17

Novartis Ag QLT says CHMP to recommend deleting 'occult' indication of Visudyne drug in EU


ZURICH (Thomson Financial) - QLT INC, a Canadian biopharmaceutical group,
said the Committee for Medicinal Products for Human Use (CHMP) will recommend to
the EU Commission that the 'occult' indication for the age-related blindness
drug Visudyne be deleted.
The group said it is unclear what effect this decision will have on European
Visudyne sales, in which QLT and Novartis AG are partners.
The EU Commission is expected to endorse the CHMP's recommendation in a
final decision that should be issued within around two months, it said.
Age-related macular degeneration (AMD) appears in wet and dry forms. Dry AMD
is the more common one and may or may not develop into the wet form. Only about
10-20 pct of people with AMD have the wet type.
Wet AMD is characterised by abnormal, leaky blood vessels in the macula,
strikes quickly and can result in rapid vision loss.
The final decision is not expected to affect the approved use of Visudyne in
the predominantly 'classic' or pathologic myopia indications.
'Occult', meaning hidden, and 'classic' are terms used to describe different
patterns of CNV (choroidal neovascularisation) leakage.
Visudyne is currently approved for the treatment of patients with both
'classic' and 'occult' indications.
Full-year sales of Visudyne totalled 358.8 mln usd last year, down 27 pct
from a year earlier, due to stiff competition from Genentech Inc's rival drug
Lucentis and OSI Pharmaceuticals Inc's rival drug Macugen.


[e-mail]
ckj/cmr

[waldron] 27/3/2007 15:18

Genentech Seattle Genetics receives $4.5 million


BOTHELL, Wash. (AP) - Biotechnology company Seattle Genetics Inc. said
Tuesday it received a $4.5 million licensing payment from Genentech Inc.
The payment is for the exercise of exclusive licenses under the company's
collaboration for antibody-drug conjugate. Genentech has rights to use Seattle
Genetics' technology with antibodies against selected targets in drug
development. Seattle Genetics is entitled to fees, milestone and future royalty
payments.
Shares of Seattle Genetics rose 27 cents, or 3.4 percent, to $8.33 on the
Nasdaq Stock Market in morning trading. The stock has traded between $3.80 and
$9.52 over the last 52 weeks.
Shares of Genentech rose 22 cents to $83.29 on the New York Stock Exchange.

[waldron] 26/3/2007 05:56

Roche Says EU Panel Recommends Herceptin With Hormone Therapy

By Marthe Fourcade

March 26 (Bloomberg) -- Roche Holding AG, the world's biggest maker of cancer medicines, said a European Union advisory panel recommended approval of its Herceptin drug in combination with hormone therapy for breast cancer sufferers.

The panel, whose advice is generally adopted by European regulators, said post-menopausal women with a type of breast cancer that is receptive to hormones as well as Herceptin can use the drug in combination with a treatment known as aromatase inhibitor, Basel, Switzerland-based company said in an e-mailed statement. Genentech Inc. developed Herceptin.

To contact the reporters on this story: Marthe Fourcade in Paris at [e-mail]

Last Updated: March 26, 2007 01:44 EDT

[ariane] 23/3/2007 13:28

Genentech still sees 25-30 pct non-GAAP FY EPS, sees 'flat' Q1 sales


LONDON (AFX) - Biotechnology company Genentech Inc reiterated it expects
25-30 pct growth in non-GAAP full-year earnings per share, but warned it sees
first-quarter US product sales "essentially flat" compared with the final
quarter of last year.
The company said in a statement after hosting its annual analysts meeting it
is still aiming to meet its Horizon 2010 financial goals, to achieve a compound
annual non-GAAP EPS growth rate of 25 pct and to achieve cumulative free cash
flow of 12 bln usd by 2010.
Gentech said it also believes overall product demand trends remain strong,
particularly related to recent product launches.
The company said it now aims to bring at least 20 new molecular entities
into clinical development between 2006 and 2008 and more than 30 new molecular
entities between 2006 and 2010.
This compares with a previous goal of 20 new molecular entities between 2006
and 2010.
The company added it will proceed with a phase III study of Omnitarg,
Herceptin and Taxotere versus Herceptin and Taxotere for patients with
HER2-positive first-line metastatic breast cancer.
[e-mail]
wj

[ariane] 07/3/2007 07:39

Roche Ag Genentech, Tercica reach settlement with Insmed in Iplex court case


ZURICH (AFX) - Genentech Inc and joint-venture partner Tercica Inc have
resolved their outstanding litigation against Insmed Inc in the US and the UK
over growth-failure drug Iplex, Tercia and Insmed announced.
They said the settlement includes a patent infringement suit and unfair
business practices suit brought against Insmed by Tercia and Genentech, in which
Roche Holding AG holds a majority stake.
In parallel, the companies announced that they have entered a license and
development agreement in order to end the dispute, while Tercica and Genenentech
have waived the damages awarded by the jury in the US patent infringement
litigation.
Under the terms of the settlement, Insmed will no longer provide Iplex to
patients with severe Primary IGF-1 deficiency and other short stature
indications and will withdraw its Iplex marketing application in the EU, Tercica
and Insmed said.
In turn, Insmed will have freedom regarding manufacture, development and
commercialisation of the drug for certain non-short stature indications, subject
to opt-in righs and royalty provisions for Tercica and Genentech, the companies
said.
Furthermore, the parties will form a joint-development committee to guide
the development and commercialisation of Iplex in non-Tercica/Genentech
indications, they said.
[e-mail]
at/hjp

[waldron] 21/2/2007 18:17

Genentech Stronger label ordered for asthma drug


WASHINGTON (AP) - The government ordered stronger label warnings for an
injected asthma medication Wednesday because of reports some patients taking the
drug, marketed as Xolair, had suffered a delayed and potentially
life-threatening reaction known as anaphylaxis.
A patient experiencing anaphylaxis might have trouble breathing, feel tight
in the chest, have swelling in the mouth and throat, suffer dizziness or feel
faint, or have itching and hives.
The risk of anaphylaxis was known when Xolair, also called omalizumab, was
approved as an asthma treatment in 2003. But the Food and Drug Administration
ordered the drug manufacturer, Genentech, Inc., to strengthen the label warnings
because of reports of patients having a delayed reaction of anaphylaxis or
reacting to a subsequent dose even when they had no problems after a first dose.
The new warning says:
-- Doctors should observe patients for at least two hours after the drug is
injected and be ready to manage a potentially life-threatening reaction.
-- Anaphylaxis can occur even if a patient did not react to a previous
Xolair injection.
-- Anaphylaxis can occur up to 24 hours after the injection is given.
-- Patients using Xolair should be prepared for to treat themselves for
anaphylaxis in emergency situations.

[ariane] 21/2/2007 17:26

U.K. DNA Analysis Failures Lead to Review of Criminal Cases

By Nick Allen and Kitty Donaldson

Feb. 21 (Bloomberg) -- A series of U.K. criminal cases may have to be reviewed after forensic scientists failed to use the latest techniques properly when analyzing DNA evidence.

The Government asked the Association of Chief Police Officers to establish how many investigations were affected by the blunders which happened between 2000 and 2005. ACPO has written to all 43 police forces in England and Wales to establish the extent of the problem. DNA samples are sent by police for analysis by the Forensic Science Service.

``Towards the end of 2006 we became aware that a small percentage of DNA samples may need to be re-examined as a result of differences in the way forensic suppliers were using new techniques to analyze forensic material,'' Home Office spokeswoman Zoe Paxton said by telephone today.

If the most up-to-date techniques weren't used properly then DNA matches may have been missed and guilty people may have escaped conviction. DNA is often central to serious cases, including murders and rapes. Hundreds of cases may have to be reviewed, Sky News said, citing unidentified people. The Home Office said it won't know how many cases are involved until ACPO reports back.

``It is another flaw in our criminal justice system that will leave dangerous people at large and put a lot of people at risk,'' David Davis, who speaks for the main opposition Conservative Party, told Sky News. Davis said the Home Office knew about the problem last year and it now appeared as though it had tried to mount a ``cover-up.''

The situation was not announced publicly last year because police wanted it kept secret for ``operational reasons,'' Paxton said.

Home Secretary John Reid is under growing pressure after a series of failings at his department, including prison overcrowding and a failure to keep track of criminals who committed offenses abroad.

The cases requiring review were ones involving Low Copy Number DNA samples, which have tiny traces of DNA and only detectable since 2001, the British Broadcasting Corp. reported.

To contact the reporter on this story: Nick Allen in London at [e-mail] . Kitty Donaldson in London at [e-mail]

Last Updated: February 21, 2007 09:47 EST

[ariane] 21/2/2007 15:48

Genentech 'Cabilly' patent rejected


SOUTH SAN FRANCISCO, Calif. (AP) - Genentech Inc. said Wednesday the U.S.
Patent Office rejected its claims to a lucrative antibody patent that was the
focus of a January U.S. Supreme Court decision.
The "415," or Cabilly patent, covers methods of making certain antibodies.
It was issued to Genentech in 2001.
Medimmune Inc., one of the companies with a license to the patent, had sued
Genentech in order to declare it invalid. Medimmune uses the patent for its
blockbuster children's respiratory drug Synagis, which has more than $1 billion
in annual sales. Medimmune claimed the patent was invalid because it was based
on methods already covered in another patent with an earlier expiration date.
The loss of rights to the Cabilly patent could cost Genentech a large
portion of royalty revenue, analysts have said.
Genentech said despite the ruling, the patent remains "valid and
enforceable" through the appeals process and it estimates that process could
take up to two years or longer.
"Genentech plans to respond to the final Office action within the next
several months and, if necessary, appeal the decision through all appropriate
means of review within the Patent Office and the courts," the company said in a
statement.
In January, the Supreme Court ruled that Medimmune could pursue in the lower
courts its claim that it owes no royalties to Genentech for the patent.
Genentech had argued that the company could not pursue a lawsuit as it was
paying royalties for the patent.
The case pitted government against corporations, with many corporations
supporting Genentech over fears that the decision could open the floodgates for
other licensees to challenge existing patents.
The Bush administration supported Medimmune in the case, arguing that
invalid patents can hurt licensing and hinder competition.
Shares of Genentech rose 8 cents to $87.02 on the New York Stock Exchange in
morning trading. Shares of Medimmune fell 43 cents to $32.57 on the Nasdaq Stock
Market.