(Reuters)
- Gilead Sciences Inc said 48-week data from a mid-stage trial of its closely
watched four-medicine HIV pill known as the "Quad" show the drug works
as well as the company's widely used Atripla three-drug tablet.News (Updated
September 19, 2010)
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Sep 13, 2010
(Reuters)
- Gilead Sciences Inc said 48-week data from a mid-stage trial of its closely
watched four-medicine HIV pill known as the "Quad" show the drug works
as well as the company's widely used Atripla three-drug tablet.
Analysts said the
findings met expectations and the company's shares inched up by just a fraction.
Most of the company's
current HIV drug sales come from Atripla -- which is composed of Emtriva, known
generically as emtricitabine, Viread, or tenofovir, and Bristol-Myers Squibb
Co's Sustiva, also known as efavirenz.
After 48 weeks of
treatment in the Quad-Atripla study, 90 percent of patients taking the Quad
achieved target reductions in levels of HIV in the blood, known as viral load,
compared with 83 percent of those who received Atripla -- matching earlier
24-week results from the trial.
Three patients
discontinued treatment in each arm of the study, but only one, an Atripla
patient, dropped out due to an adverse side effect, which was thoughts of
suicide.
Two cases of serious side
effects were reported among Quad patients -- pneumonia and anogenital warts, and
two among Atripla patients -- B-cell lymphoma and low levels of white blood
cells.
In a separate trial, the
booster, used in combination with Bristol-Myers' Reyataz and Gilead's Truvada
reduced the virus to undetectable levels in 82 percent of patients, compared
with 86 percent of patients treated with a booster called Norvir, which is made
by Abbott Laboratories.
Results from the trials
were presented on Monday at the Interscience Conference on Antimicrobial Agents
and Chemotherapy in
BMO Capital Markets
analyst Jason Zhang said
Shares of
(Reporting by Deena
Beasley; editing by Andre Grenon)
Dr. Albert Liu, director
of HIV Prevention Intervention Studies at
Credit: Reuters/Kimberly
White
By TOBY
In a joint statement, the
companies said Johnson & Johnson, which already owns a 17.9 percent stake in
Crucell, intends to offer euro24.75 per share in cash for the remainder — a 58
percent premium to Crucell's closing price Thursday of euro15.70.
Shares in Crucell, whose
board will recommend the offer to stockholders, jumped 56 percent to euro24.41
in
"The companies
expect that Crucell's strength in the manufacture, discovery and
commercialization of vaccines would create a strong platform for Johnson &
Johnson in the vaccine market," the companies said.
Johnson & Johnson,
headquartered in
While it has a strong
biotech business with its Centocor division, it's new to the vaccine market and
has been looking to grow its business.
Last year it bought both
its Crucell stake and an 18 percent stake in Irish biotech company Elan Corp.,
which is developing an Alzheimer vaccine and treatment.
Crucell's biggest-selling
vaccine is Quinvaxem, which protects against five childhood diseases. But it has
a number of interesting vaccines and treatments under development.
Last year it was awarded
a $69 million
Crucell, based in
"It's a fair price,
but not a top price," said Rabobank Securities analyst Fabian Smeets. He
said that J&J's stake had given it the inside track in negotiating a deal
with Crucell, and other big pharmaceuticals firms were not likely to launch a
rival bid.
"There's always a
chance, but I consider it pretty small," he said, citing change-of-control
clauses that J&J has already signed with Crucell.
In addition to its
vaccine business, Crucell sells a line of human cells widely used by big
pharmaceutical firms as a platform for developing vaccines.
J&J bought its stake
in Crucell last year shortly after Wyeth had dropped a bid for Crucell when it
was itself acquired by Pfizer Inc.
Crucell Chief Executive
Ronald Brus said that at the time J&J took a stake, his company hadn't
wanted to form partnerships with the existing vaccine giants.
"You want to partner
with the one that wants to enter the market, not the ones that want to defend
their market," he said.
Giles Somers, an analyst
at Datamonitor, said the buyout of Crucell is a good fit for J&J, citing
other moves the company has made into expanding its role in infectious diseases.
He noted "vaccines are increasingly regarded as a key revenue generator for
Big Pharma, as they are generics-proof."
"Furthermore, backed
by J&J's global sales and marketing capabilities, Crucell could compete more
effectively with the Big Pharma players already in the vaccines space," he
said.
Shares of J&J rose 28
cents, or 0.5 percent, to close Friday at $61.57.
EPALINGES, SWITZERLAND,
Sep 13, 2010 (MARKETWIRE via COMTEX) -- Mymetics Corporation /quotes/comstock/11k!mymx,
a pioneer in the development of vaccines preventing mucosal transmission of
human infectious diseases, announced today that its innovative HIV vaccine will
enter a new preclinical trial at the University of California, Davis. The study
will be led by Professor Christopher J. Miller of the
Professor Christopher J.
Miller said, "Mymetics' HIV vaccine is the first with a demonstrated
ability to prevent viral transmission in primates. We are happy that the NIH has
decided to partially fund this study and we hope to confirm the previous
findings and learn more about this vaccine's mechanism of action in providing
mucosal protection."
Jacques-Francois Martin,
CEO of Mymetics, commented, "Almost all other HIV vaccines under
investigation target late infection events, once the virus has already invaded
the body. Our recent results, showing that protection by mucosal antibodies
might play a key role, have elicited strong interest among key opinion leaders,
challenging the current dogma that blood antibodies will provide the main
protection against mucosally transmitted pathogens like HIV."
He added: "We are
very pleased about our collaboration with Chris Miller, a leading expert in this
field and are grateful to the NIH for supporting this new study. This funding
represents a milestone and an important recognition of the work performed by
Mymetics over the last years, and in particular by Sylvain Fleury, our Chief
Scientific Officer, and his team."
With its HIV-1 (Human
Immunodeficiency Virus type 1) vaccine, produced through its proprietary
virosome technology and judicious antigen design, Mymetics aims to provide both
a first line of defense through mucosal protection as well as a second line of
defense against infection through the generation of blood antibodies. By
minimizing homology between the vaccine and native human proteins, Mymetics
further aims to avoid potential auto-immune complications resulting from
cross-reactivity. The new trial, to begin in October 2010, will involve 48
macaque monkeys of a commonly used strain (n=12 per group) and compare three
antigen vaccination regimens with placebo, followed by heterologous
intra-vaginal challenges with live virus. Results, which will include several
new immunological parameters, are expected at the end of Q4 2011.
Recent results obtained
from a smaller scale macaque trial in
About HIV and the
Mymetics vaccine approach 2.7 million new people were infected by HIV in 2008
while an estimated 2 million people died of AIDS in that year. HIV-related
illness remains one of the leading global causes of death and is projected to
remain so in the coming decades. There is as yet no vaccine available against
HIV. However, results of a large Phase III clinical study on an HIV vaccine in
Traditional approaches to
creating a vaccine against HIV have aimed to elicit specific blood antibodies or
CTLs (cytotoxic T cells). Both approaches have been largely unsuccessful to
date, and importantly, no protection has been seen with heterologous challenges,
in which the virus strain differs from the original vaccine. Some of the reasons
for the lack of success in the past include the selection of antigens that
poorly mimic native viral proteins and folding, as well as the ability of HIV to
escape the CTL response through mutations. A CTL response has the further
drawback of requiring infection to have already occurred. Despite their
importance as protection mechanisms, neither approach is suitable for protecting
against initial mucosal transmission of HIV.
A vaccine that blocks HIV
transmission across mucosal membranes represents a highly promising but, until
now, poorly investigated approach to preventing HIV infection. Obstacles have
included a lag in knowledge about the mucosal immune system and its antibody
response, as well as the invasiveness of the methods required and the
sensitivity of the tests needed to detect mucosal antibodies, compared with
blood. However, mucosal antibodies, mostly of the functionally distinct IgA type
as opposed to the IgG type found in the blood, are produced in high quantities
and may prevent HIV from reaching the bloodstream. Women and men who produce IgA
antibodies against the HIV gp41 protein in their mucosal secretions have been
found to display resistance to HIV transmission and infection. Mymetics has used
its technology and expertise to design a vaccine specifically intended to induce
a mucosal antibody response against HIV while also inducing blood antibodies.
About the NIH grant to
Professor Christopher J. Miller A supplement to the Base Grant Operating Grant
of the
The National Institutes
of Health (NIH) -- The United States' Medical Research Agency -- includes 27
Institutes and Centers and is a component of the U. S. Department of Health and
Human Services. It is the primary federal agency for conducting and supporting
basic, clinical and translational medical research, and it investigates the
causes, treatments and cures for both common and rare diseases. For more
information about NIH and its programs, visit http://www.nih.gov.
About Mymetics Mymetics
Corporation is a Swiss-based biotechnology company registered in the US /quotes/comstock/11k!mymx
developing next-generation preventative vaccines for infectious diseases.
Mymetics' core technology and expertise are based on the use of virosomes,
lipid-based carriers containing functional fusion viral proteins, in combination
with rationally designed antigens. The company's vaccines are designed to induce
protection against early transmission and infection, focusing on the mucosal
immune response as a first-line defense, which for some pathogens may be
essential for the development of an effective vaccine. Mymetics is led by an
international and experienced management team and is supported by a strong
Scientific Advisory Board composed of renowned experts. The company has
established contacts with world leaders in vaccine development.
Mymetics currently has 5
vaccines in its pipeline: HIV-1/AIDS, Influenza, Respiratory Syncytial Virus,
Malaria and Herpes Simplex Virus. The company's HIV vaccine is entering a new
proof-of-concept preclinical trial following unprecedented results in a first
study, and is also currently in a Phase I clinical trial in human volunteers. A
Phase 1b clinical trial for its Malaria vaccine on children in Tanzania has been
completed, while RSV and HSV vaccine candidates are in the preclinical phase.
The Influenza vaccine has been out-licensed to Solvay Pharmaceuticals (now
Abbott). For further information, please visit www.mymetics.com.
Forward looking
statements The Private Securities Litigation Reform Act of 1995 provides a
"safe harbor" for forward-looking statements, which are identified by
the words "believe," "expect," "anticipate,"
"intend," "plan" and similar expressions. The statements
contained herein which are not based on historical facts are forward-looking
statements that involve known and unknown risks and uncertainties that could
significantly affect our actual results, performance or achievements in the
future and, accordingly, such actual results, performance or achievements may
materially differ from those expressed or implied in any forward-looking
statements made by or on our behalf. These risks and uncertainties include, but
are not limited to, risks associated with our ability to successfully develop
and protect our intellectual property, our ability to raise additional capital
to fund future operations and compliance with applicable laws and changes in
such laws and the administration of such laws. See Mymetics' most recent Form
10-K for a discussion of such risks, uncertainties and other factors. Readers
are cautioned not to place undue reliance on these forward- looking statements
which speak only as of the date the statements were made.