Wasn't sure where to put this R&D update from Aventis, but since it mentions programs that are in collaboration or competition with some biotechs we follow, it seemed the thread with the most eyeballs would be appropriate . . .
>>STRASBOURG, France, June 18 /PRNewswire-FirstCall/ -- At its annual R&D Day, Aventis reaffirmed its intention to more than double the number of blockbusters in its portfolio by 2006 and expressed its confidence in achieving sustainable growth as a result of the progress being made on a series of compounds in clinical development.
"We have the ingredients to achieve our goal of sustainable growth in the coming years: the passion and expertise for creating innovation in our research, a strong pipeline, global marketing power and a commitment to deliver results. This should enable us to remain one of the fastest-growing pharmaceutical companies," said Igor Landau, Chairman of the Management Board of Aventis.
Potential for seven blockbusters will drive near-term growth
Significant growth potential remains for the three leading products of Aventis -- the allergy drug Allegra/Telfast, the antithrombotic Lovenox/Clexane and the chemotherapy agent Taxotere -- all of which have achieved blockbuster status.
Four additional products are anticipated to generate sales of more than euro 1 billion by 2006: the long-acting insulin Lantus, which has the potential to transform the treatment of diabetes; the antibiotic Ketek, which is expected to be launched in the United States in early 2003; and the cardiovascular drug Delix/Tritace, which is the only ACE inhibitor to offer cardiovascular risk prevention. The osteoporosis drug Actonel, which is being co-developed and co-marketed with Procter & Gamble, is also expected to achieve blockbuster status based on combined sales of both companies for this product. Actonel sales have been driven by its status as the only bisphosphonate to offer rapid and sustained reduction in vertebral fractures.
"Based on the continuing strong performance of our key products, the important new clinical data being generated on them and the overall strengthening of our pipeline portfolio, we feel more confident than ever before in our growth prospects," said Richard J. Markham, Vice Chairman and Chief Operating Officer of Aventis.
More than 40 compounds in clinical development
Aventis currently has more than 40 compounds in clinical development, including over 30 in early-stage clinical development and more than 10 in late-stage development and is building strong franchises in therapeutic areas such as oncology, diabetes, cardiovascular, respiratory/allergy and vaccines.
Late-stage projects will add to growth beyond 2005
Late-stage development projects progressed well during the last 12 months, and they are expected to fuel growth beyond 2005. These products include the chemotherapy agent flavopiridol (phase II), the asthma compound ciclesonide (phase III) in cooperation with Altana Pharma, the novel inhaled insulin Exubera® (phase III) in collaboration with Pfizer, the heart muscle protectant cariporide (phase III) and the fast-acting insulin 1964 (phase III) for type 1 and type 2 diabetes.
Early stage pipeline focused on truly innovative therapies
Aventis also provided updates on several compounds in the early-stage pipeline and highlighted the following projects: 1426, a new anti-obesity agent (phase IIa); NV1FGF, a plasmid-based gene therapy for inducing the formation of new blood vessels (phase II); 100,907, a selective serotonin antagonist for enhancing sleep quality (phase I); the asthma compounds 4011, an anti-inflammatory drug to orally treat asthma (phase II) in co-operation with Inflazyme, and AVE-0547 (phase I/IIa); and pralnacasan, a novel anti-inflammatory drug for rheumatoid arthritis (phase II) being developed in cooperation with Vertex.
The early-stage pipeline also includes two new-generation chemotherapy agents, Taxoids 109,881 and 106,258 (both in phase II), which have demonstrated a broad spectrum of anti-tumor activity in taxoid-resistant tumor cell lines and brain metastases. Another promising taxoid drug candidate is LIT-976, a new formulation of Taxotere currently in phase I/II that is designed to exhibit improved safety and tolerability.
In order to maximize the future success of its pipeline products in late-stage development, Aventis announced that it has discontinued KATP blocker 1098, an anti-arrhythmic compound in phase IIa, and the metabolism compound TGL-749.
New drug candidates added to early-stage pipeline
Among the more noteworthy compounds added to the early-stage pipeline are AVE-4579, a CRF1 antagonist for the treatment of depression and anxiety in collaboration with Neurogen Corp.; AVE-6971, a broad-spectrum antibiotic to target resistant pathogens; and AVE-8062, a novel compound in-licensed from Ajinomoto that demonstrated in recently completed studies its potential efficacy in attacking tumor cells by cutting off the tumor's vital supply of blood.
"We have a robust and productive pipeline to target major diseases. Our organization is uniquely structured to identify disease-relevant targets and to optimize our most promising leads, gain proof-of-concept early in development, and make disciplined decisions to move our most promising compounds forward as rapidly as possible," said Frank L. Douglas, member of the Management Board and Executive Vice President for Drug Innovation & Approval at Aventis.
In-licensing, partnerships and alliances to supplement internal development
With its enhanced financial flexibility and its status as an active partner in the industry, Aventis is pursuing a targeted in-licensing and business development strategy to supplement its vigorous in-house R&D efforts. Several promising projects have been added during the last two years to the portfolio in key therapeutic areas.
The latest example is Genasense(TM), an antisense drug candidate currently in multiple phase II and phase III clinical trials to test its ability to enhance the effectiveness of chemotherapy in patients with both hematologic cancers and solid tumors. This compound is being developed and commercialized jointly by Aventis and Genta Inc. Aventis is also an active partner for a number of companies including a series of inflammatory disease targets with Millennium Pharmaceuticals and CpG immuno modulators for asthma and allergies with Coley.
Aventis (NYSE: AVE - News) is dedicated to improving life by treating and preventing human diseases through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of euro 17.7 billion, invested approx. euro 3 billion in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: aventis.com
NOTE: A live Webcast and presentations of the R&D Day will be available on June 18, at 9:30 a.m. CET and on June 19 at 8:30 a.m. EDT (2:30 p.m. CET) at: aventis.com
Recorded versions of the events will be available later at this Web site.
- See appendix for additional information -
APPENDIX
Selected late-stage projects
* Flavopiridol -- This innovative chemotherapeutic agent inhibits
cyclin-dependent kinases through cell cycle arrest and cell death
and also inhibits tumor blood vessel formation. Flavo-piridol has
demonstrated synergistic effects in combination with other cytotoxic
agents and has also shown antitumor activity in early clinical
studies. Aventis is initiating phase III trials for flavopiridol in
combination with the chemotherapy agents Taxotere (targeting lung
cancer) and Campto (targeting colon cancer); regulatory submissions
are planned for 2005/2006.
* Ciclesonide -- An inhaled corticosteroid for the treatment of
asthma, which Aventis is co-developing and co-promoting in the
United States with Altana Pharma. Currently in Phase III trials,
ciclesonide is a potentially important advance in asthma therapy due
to its excellent efficacy, lower side effects and long duration of
action. Ciclesonide was submitted by Altana Pharma for approval in
the UK, Australia, Canada and Switzerland in early June. Regulatory
submission in the U.S. is planned for mid-2003.
* Exubera(R) -- A novel approach to delivering insulin in a dry powder
formulation by inhalation. Exubera(R) is being developed for
patients with type 1 and type 2 diabetes through a collaboration
with Pfizer. Phase III efficacy trials have been completed and
additional studies are underway to strengthen the long-term safety
data. Regulatory filings in the U.S. and in Europe are under review
pending more comprehensive data analysis.
* Cariporide -- A first-in-class heart muscle protectant targeted to
reduce the incidence of heart attack and death in patients
undergoing coronary artery bypass surgery. EXPEDITION, a phase III
trial to determine the ability of cariporide to reduce death and
myocardial infarction in patients undergoing coronary artery bypass
surgery, is currently underway and regulatory filings for cariporide
are planned for the second half of 2003.
* 1964 -- This fast-acting insulin analog for type 1and type 2
diabetes is an important compound intended to broaden the Aventis
diabetes portfolio. The international development program for 1964
is designed to achieve competitive labeling at launch, including
flexible mealtime dosing and a pump application for continuous
subcutaneous infusion. Phase III clinical trials began in summer
2001 and the product is on track for regulatory submissions in the
U.S. and EU in 2003.
Update on early-stage projects
* 1426 -- A new anti-obesity agent that offers a novel mechanism of
action by increasing the sensation of satiety. Results from a proof-
of-concept study demonstrated a significant reduction in body weight
and good tolerability. 1426 is currently in phase IIa. An additional
anti-obesity drug candidate, 1954, is currently in phase I trials.
This compound is in a different chemical class and appears in
preclinical studies to be more potent than 1426.
* NV1FGF is a proprietary plasmid-based gene therapy that offers an
innovative approach to induce the formation of new blood vessels.
This compound is designed to help people who might otherwise face
limb amputation due to lack of blood supply to the legs. Data from a
phase I study demonstrated significant improvement in blood flow,
healing of ulcerations, increasing skin oxygenation and pain
reduction as well as formation of new blood vessels in arteriograms.
Phase II proof-of-concept studies in peripheral arterial disease are
in progress.
* 100,907 is a novel therapy for enhancing sleep quality. As a
selective serotonin (5-HT2a) antagonist, 100,907 demonstrated a
marked benefit in a recently completed phase I study. While
sleep-inducing drugs often lead to tolerance and "rebound" effects
during the night, 100,907 could reduce the number of night-time
awakenings. An extensive phase II dose finding study is planned to
start in 2002.
* 4011 (IPL576,092), an anti-inflammatory drug to orally treat asthma,
a disease that affects more than 50 million patients worldwide. The
compound targets the need for a potent drug without the side effects
of steroids. In an allergen-challenge proof-of-mechanism phase II
study, 4011 showed positive results. This compound is being
developed in collaboration with Inflazyme. AVE-0547, another
compound for the same indication currently in phase I/IIa, has
demonstrated higher potency and an improved pharmacokinetic profile.
* The oncology pipeline of Aventis includes among others two
new-generation chemotherapy agents, Taxoids 109,881 and 106,258
(both in phase II), which have demonstrated a broader spectrum of
antitumor activity in both taxoid-resistant tumor cell lines and
brain metastases compared to other taxoids on the market. The safety
profile of these novel cytotoxics appears similar to that of
Taxotere. Another promising taxoid drug candidate is LIT-976, a new
formulation of Taxotere currently in phase I/II, which is designed
to exhibit improved safety and tolerability.
* Pralnacasan (3480), a novel anti-inflammatory drug candidate for the
treatment of rheumatoid arthritis and osteoarthritis, recently
completed a phase II proof-of-mechanism trial in rheumatoid
arthritis which demonstrated its ability to inhibit key mediators of
joint inflammation and destruction by a novel mechanism of action.
The data from this study indicated positive anti-inflammatory
effects and good tolerability, thereby supporting further clinical
development of this drug candidate. Pralnacasan is being developed
in cooperation with Vertex Pharmaceuticals Inc.
* Therapeutic cancer vaccines, which work by eliciting a
tumor-specific immune response without toxicity, are another
promising treatment approach in the early-stage pipeline of Aventis.
ALVAC-CEA, a therapeutic vaccine for colorectal cancer, is designed
to induce T-cell and antibody responses directed against specific
cancer cells bearing the tumor-associated antigen CEA. Phase I
studies in patients with advanced colorectal cancer have
demonstrated immune responses generated against CEA, and disease
stabilization was observed in one-third of the patients studied over
a two-year period. A second-generation vaccine is intended to target
multiple antigens.
* BARI 1453, a bile acid reabsorption inhibitor, is designed to lower
blood cholesterol by preventing the gastrointestinal re-absorption
of bile acids. A recently completed phase II study demonstrated a
reduction of LDL cholesterol by 10-12%. Aventis is now exploring the
potential of combining BARI 1453 with other cholesterol-lowering
therapies.
* HP-184 for improving function in chronic spinal cord injury. Data
from preclinical trials have indicated improved nerve conduction and
ambulation and Aventis expects that this compound, which is
currently in phase I, will reduce neuropathic pain in patients.
* 1726, an orally active immuno modulator for the treatment of
multiple sclerosis, for which phase II proof-of-concept enrollment
has been completed.
* 1766 and 1069 for the treatment of angina pectoris. Both guanylate
cyclase activators are currently in phase I to study their ability
to open up narrowed blood vessels.
* SERM 3471, a selective estrogen receptor modulator for the treatment
and prevention of post-menopausal osteoporosis, will be progressed
instead of SERM 3339 since it has demonstrated equal effectiveness
with an improved safety profile.
* AVE-7688, a new compound for the treatment of hypertension and
congestive heart failure is currently in a phase I study. This drug
candidate is potentially more effective in lowering blood pressure
than 100,240, another compound for the same indication in the
pipeline of Aventis. It is also under investigation to prevent
diabetes-induced renal damage. After studies on compounds comparable
to 100,240 demonstrated a higher incidence of angioedema than ACE
inhibitors, additional safety data from a larger phase II study on
100,240 are being awaited in 2002.
* The results of phase IIa proof-of-concept studies on two VLA-4
antagonists for the treatment of asthma are expected in 2002 to
evaluate further options.
* In order to maximize the future success of its most promising
pipeline products in late-stage development, Aventis has decided to
discontinue the KATP blocker 1098, an anti-arrhythmic compound in
phase IIa, and the metabolism compound TGL-749.
New drug candidates added to pipeline
Among the new compounds added to the early-stage pipeline are:
* AVE-4579, a CRF1 antagonist for the treatment of depression and
anxiety. Data from preclinical studies indicate AVE-4579 to be a
potent, selective blocker of CRF1 receptors in the brain that may
have fewer side effects than currently available anti-depressants.
Initial clinical trials are expected to start by the end of 2002.
AVE-4579 is being developed in collaboration with Neurogen Corp.
* AVE-6971 is a broad-spectrum antibiotic to target resistant
pathogens, which often cause severe and life-threatening diseases.
This novel bacterial antibiotic could offer a mechanism-of-action
that differs from fluoroquinolones and linezolid. Phase I trials are
planned to start in the fourth quarter of 2002.
* AVE-8062 is a novel compound for the treatment of cancer, which has
demonstrated in recently completed studies its potential efficacy in
attacking tumor cells by cutting off a tumor's vital supply of
blood. The worldwide rights to develop, manufacture and market
AVE-8062 have been licensed to Aventis by Ajinomoto Co., Inc. of
Japan.
Update on strategic products
* As the first and only insulin analog to provide 24-hour basal
glucose control following just one daily injection, Lantus has the
potential to fundamentally transform the treatment of diabetes and
improve the lives of patients through an aggressive treat-to-target
approach, convenient dosing and earlier insulinization. Lantus has
been growing strongly in the U.S. and Germany since its launch. New
facilities, which are expected to be fully operational in 2003, will
considerably expand production capacity to support additional
markets for Lantus. The UK launch of Lantus is currently planned
during the fourth quarter of 2002 and for most international markets
in 2003 and 2004. A new drug application for Lantus was filed in
Japan in April and regulatory submissions for flexible dosing of
Lantus (in the morning or evening) are imminent in the U.S. and
Europe. According to data presented at R&D Day, an important benefit
of Lantus is a lower risk of nocturnal hypoglycemia. This was
demonstrated in a recent 24-week study, during which patients
receiving Lantus achieved good metabolic control with less nocturnal
hypoglycemia compared to NPH insulin. A landmark trial with
approximately 10,000 patients is being prepared to demonstrate that
early treatment with Lantus could reduce life-threatening
cardiovascular events in diabetes patients. Aventis anticipates peak
annual sales of more than euro 1 billion for this unique, once-daily
insulin analog.
* The Aventis respiratory diseases portfolio includes Ketek, the
world's first ketolide antibiotic. Developed to overcome bacterial
resistance via a unique, dual-binding mechanism of action, Ketek is
a first-in-class, once-daily treatment option with significant
market potential. Several recent studies have confirmed the
excellent clinical efficacy and convenience of Ketek in treating
respiratory tract infections caused by common and atypical
respiratory pathogens, including penicillin and macrolide-resistant
strains of Streptococcus pneumoniae. Ketek had received an
approvable letter in 2001 for treatment of community-acquired
pneumonia, acute sinusitis and acute exacerbation of chronic
bronchitis (but a non-approvable letter for
tonsillitis/pharyngitis). Aventis announced that it plans to file
data in July from a 24,000 patient study for Ketek with the FDA.
U.S. regulatory approval is expected by the end of 2002 or early
2003. Ketek has been approved in all major EU and Latin American
markets and has been successfully launched in several European
countries, Brazil and Mexico. Aventis anticipates peak annual sales
of more than euro 1 billion for Ketek.
* Aventis is investing to grow the Allegra/Telfast product line
globally and maximize the potential of this safe and effective
non-sedating antihistamine. A wide range of submissions is planned
for new indications, e.g. asthma, perennial allergic rhinitis and
once-daily Allegra-D, as well as new dosage forms, e.g. pediatric
tablets and fast-dissolving tablets. Aventis estimates the peak
sales potential of Allegra to be euro 3 billion.
* The foundation of the strong Aventis oncology franchise is Taxotere,
which generated sales of euro 1.003 billion in 2001. Taxotere is
currently approved for the treatment of locally advanced or
metastatic breast cancer and for locally advanced or metastatic
non-small cell lung cancer (NSCL). In February 2002, Aventis filed
for first-line treatment of NSCL in the U.S. and the EU. In Japan,
Taxotere is also approved for treatment of gastric, ovarian, and
head and neck cancer -- and Aventis is developing these indications
in Europe and the United States. A key differentiating feature of
Taxotere is its potential survival benefit in locally advanced or
metastatic breast cancer and non-small-cell lung cancer. Interim
results from a major international study presented at the American
Society of Clinical Oncology meeting in May suggested the use of
Taxotere in adjuvant treatment of early-stage breast cancer. In
addition, other development activities are underway in different
types of cancer, which are expected to extend the unique profile and
contribute to the future growth of Taxotere. Aventis is targeting
annual peak sales of euro 2 billion for Taxotere.
* The mainstay of the Aventis cardiovascular franchise is
Lovenox/Clexane, the world's leading low-molecular weight heparin
with the broadest range of approved indications. Due to its
demonstrated superiority over heparin in unstable angina and
non-Q-wave heart attack, Lovenox/Clexane has significant potential
for future growth. New indications are in development and launch in
Japan is planned for 2003-2004. Recent studies such as the ASSENT-3
trial have provided additional data on the efficacy and safety of
Lovenox/Clexane. A new trial with approximately 21,000 patients
worldwide, called ExTRACT, will specifically address the use of
Lovenox with thrombolytics in patients with ST-elevated heart
attack. The estimated peak annual sales potential of Lovenox/Clexane
is euro 2.5 billion.
* Delix/Tritace, the ACE inhibitor currently approved for
hypertension, heart failure and reduction in stroke, heart attack
and cardiovascular death in patients at risk for cardiovascular
events, is also showing excellent potential for further growth. The
results of the landmark HOPE trial will be leveraged in the DREAM
trial, which will investigate the ability of Delix/Tritace to
prevent the onset of diabetes in patients with impaired glucose
tolerance. Delix/Tritace has a peak sales potential of
euro 1 billion.
* In mid-May, the U.S. Food and Drug Administration approved a new
35-mg once-a-week dosage strength for Actonel for the prevention and
treatment of postmenopausal osteoporosis. The new dosage form, which
offers patients greater convenience and good gastrointestinal
tolerability, will be available in mid-June 2002 and is expected to
generate higher sales. Actonel is the only osteoporosis therapy that
has demonstrated its efficacy in reducing clinical vertebral
fracture at six months and is showing significant impact in
preserving bone architecture in as little as one year. Further
studies are planned to generate data to support new claims for
Actonel and expand the market for this drug: Potential peak sales
are expected to be euro 1 billion. Actonel is being co-developed and
co-marketed by Aventis and Procter & Gamble through the Alliance for
Better Bone Health.<<
snip
Cheers, Tuck |
