20-F l d20f.htIn ANNUAL REPORT ON FORM 20-F
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`Table of Contents
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`SECURITIES AND EXCHANGE COMMISSION
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`UNITED STATES
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`Washington, D.C. 20549
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`FORM 20-F
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`(Mark One)
`REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
`OR
`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2006
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`OR
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 1S(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`OR
`SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR l5(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`Date of event requiring this shell company report .
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`For the transition period from
`to
`Commission File Number: 001-31368
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`Sanofi-Aventis
`(Exact name of registrant as specified in its charter)
`N/A
`(Translation of registrant's name into English)
`France
`(Jurisdiction of incorporation or organization)
`174, avenue de France, 75013 Paris, France
`(Address of principal executive oflices)
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`Securities registered or to be registered pursuant to Section 12(b) of the Act:
`Name of each exchange
`on which registered:
`New York Stock Exchange
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`Tifle of each class:
`Ammican Depositary Shares, each
`represmting one half of one ordinary share, par
`value €2 per share
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`Ordinary sharia, par value €2 per share
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`New York Stock Exchange
`(for listing purposes only)
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`Securities registered pursuant to Section 12(g) of the Act:
`American Depositary Shares, each representing one quarter of a Participating Share Series A, par value €70.89 per share (removed from listing and registration on the
`New York Stock Exchange etfective July 31, 1995).
`The number of outstanding shares of each of the issuer’s classes of capital or
`common stock as of December 31, 2006 was:
`ordinary shares:
`1,359,434,683
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405
`of the Securities Act.
`YES E
`N0 El.
`If this report is an annual or transition report, indicate by check mark if the registrant is not
`required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
`YES El
`NO E.
`Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 fi'om their
`obligations under those Sections.
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
`during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
`requirements for the past 90 days.
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`No III
`Yes E
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer: See definition of “accelerated filer and
`large accelerated filer” in Rule 12h-2 of the Exchange Act. (Check one):
`Non-accelerated filer El
`Large accelerated filer E
`Accelerated filer El
`Indicate by check mark which financial statement item the registrant has elected to follow.
`Item 17 El
`Item 18 E
`If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
`YES El
`N0 E.
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`AVENTIS EXHIBIT 2102
`Mylan v. Aventis, IPR2016-00712
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`

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`Table of Contents
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`Apidra® (insulin glulisine, type 1 and type 2 diabetes mellitus; Japan and pediatrics developments). Apidra®, our
`rapid-acting insulin marketed in the United States and in Europe, completed Phase III trials in Japan, in line with
`the submission planned in 2007 in this country. Also, a Phase III pediatric program to support a planned 2007
`submission (US/EU) for the treatment of pediatric diabetic patients was completed.
`
`AVE5530 (Cholesterol absorption inhibitor, hypercholesterolemia; Phase Ilb). AVE55 30 was shown to inhibit
`cholesterol uptake and decrease LDL-C (Low Density Lipoproteins-Cholesterol) in relevant animal models.
`Clinically safe and well tolerated up to a dose of 100mg, it is currently in Phase IIb.
`
`Oncology
`
`The sanofi-aventis oncology portfolio represents a broad spectrum of novel agents with a variety of mechanisms of
`action for treating cancer and/or cancer side-eifects, including cytotoxic agents, anti-mitotic agents, anti-angiogenic agents,
`anti-vascular agents, monoclonal antibodies, and cancer vaccines as well as supportive care therapies. Our principal
`compounds in the field of oncology currently in clinical trials are described below.
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`S-1 (oral fluoropyrimidine, gastric and colorectal cancers; Phase III). S-1 is a novel oral fluoropyrimidine licensed
`from Taiho, Japan, in July 2006. S-1 is a combination product that contains Tegafu1® as an oral pro-drug of 5-FU,
`CDI-IP (5-chloro-2,4-dihydroxypyridine) as an oral dihydropyrimidine dehydrogenase (DPD) inhibitor to decrease
`5-FU metabolism, and potassium oxonate as an oral agent to reduce gastrointestinal toxicity of tegafiir. S-1 is
`approved in several indications in Japan. In collaboration with Taiho, sanofi-aventis is conducting a registration
`seeking Phase IH study, the FLAGS study, in first line advanced gastric cancer. Recruitment in this 1,05 0-patient
`study is expected to be completed in the second quarter of 2007. Sanofi-aventis is also evaluating further the
`therapeutic potential of S-1 in colorectal cancer and other 5-FU sensitive tumors. S-1 has the potential to become
`the reference oral fluoropyrimidine.
`
`Xaliproden (SR5 7746, neurotrophic, chemotherapy induced neuropathy; Phase III). Xaliproden is an orally active
`neurotrophic agent which is currently being studied in Phase IH trials for the treatment of chemotherapy-induced
`neuropathy.
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`Larotaxel (XRP988 1 , taxoid, breast cancer, pancreas cancer failing gemcitabine; Phase III). XRP988l is a taxane
`derivative that has been designed to overcome resistance to existing taxanes, docetaxel and paclitaxel. Larotaxel
`in monotherapy has proved to be active in metastatic breast cancer progressing after anthracycline/taxane therapy
`(Phase II study). In a subsequent Phase III study in the same population, activity and good tolerance of larotaxel
`was confirmed although it did not reach superiority versus capecitabine. A Phase III has been initiated in pancreas
`cancer patients failing gemcitabine therapy, and a program in combination with other anticancer agents in
`metastatic breast cancer is ongoing.
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`XRP6258 (taxoid, breast cancer, prostate cancer; Phase III). XRP6258 is a new taxane derivative that shares
`similarities with larotaxel. XRP6258 has demonstrated to be active on metastatic breast tumors progressing alter
`taxane therapy (Phase II). A Phase III study in hormone resistant prostate cancer alter failure of Taxotere® has been
`initiated.
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`Alvocidib (flavopiridol, I-llVIRl275, cyclin-dependent kinase inhibitor, chronic lymphocytic leukaemia (CLL);
`Phase III). Alvocidib is being developed in collaboration with Ohio State University and the U.S. National Cancer
`Institute. A pivotal clinical Phase II/III program to support accelerated/conditional approval in refractory CLL
`patients is under initiation in Europe and the United States. Additional studies will be exploring the potential
`benefit of alvocidib in various other hematological malignancies.
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`VEGF Trap (AVE005, anti-angiogenesis agent; solid tumors; Phase III). VEGF (vascular Endothelial Growth
`Factor) Trap is being developed under an alliance with Regeneron. VEGF Trap is a novel anti-angiogenesis agent
`that acts as a decoy receptor or “Trap” for circulating VEGF. Five Phase III studies in combination with
`chemotherapy in patients with several solid tumors are scheduled to start in 2007. The first potential regulatory
`submission is planned in 2008.
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`Table of Contents
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`Tirapazamine (SR25 9075, head and neck cancer; terminated). The development of tirapazamine as a hypoxic
`anti-cancer agent was terminated based on lack of efficacy.
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`CEP-7055 (anti-angiogenesis agent, with Cephalon: terminated). The development of CEP-7055 was jointly
`terminated with Cephalon due to lack of activity.
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`SR31747 (peripheral sigma ligand, prostate cancer; terminated). The development of SR3 1747 was terminated due
`to lack of efiicacy.
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`Central Nervous System
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`Certain of our principal compounds in the Central Nervous System field currently in Phase II or III clinical trials are
`described below.
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`Teriflunomide (HMR1726, immunomodulator, multiple sclerosis; Phase III). Teriflunomide is an orally active
`dihydroorotate dehydrogenase inhibitor. An international Phase I[[ development program is ongoing in multiple
`sclerosis.
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`Xaliproden (SR5 7746, neurotrophic, Alzheimer’s disease; Phase HI). Xaliproden is a non-peptide compound that
`activates the synthesis of endogenous neurotrophins. Xaliproden is also being developed for chemotherapy-
`induced neuropathy (see “— Oncology” below). Two Phase HI studies in Alzheimer’s disease are ongoing and will
`involve a total of 2,800 patients with Alzheimer’s disease. Very reassuring long-term safety and tolerability data
`have already been obtained fiom patients in several indications (amyotrophic lateral sclerosis, neuropathy,
`Alzheimer’s disease). A unique mechanism of action with a triple action on neurons (neuroprotection, repair,
`neurogenesis) gives this compound a potentially promising place in the treatment of dementias.
`
`Paliroden (SR5 7667, neurotrophic, Alzheimer’s disease, Parkinson’s disease; Phase IIb). SR57667, like
`xaliproden, is a non-peptide compound that activates the synthesis of endogenous neurotrophins. One Phase H
`study is ongoing in Alzheimer’s disease. Two Phase H studies are ongoing in Parkinson’s disease.
`
`Amibegron (SR58611, beta-3 agonist, depression, anxiety; Phase IH). Amibegron is the first selective beta-3
`adrenergic receptor agonist developed in Major Depressive Disorders (MDD). Amibegron stimulates neuronal
`activity in a specific region of the prefi'ontal cortex where an abnormally decreased activity has been observed in
`patients with depressive mood disorders. Amibegron has already shown clinical activity in Phase II and IH trials
`and has the potential to give rise to a new class of anti-depressants. The company is currently conducting six
`Phase HI trials in MDD as well as five trials in General Anxiety Disorders (GAD). The total number ofpatients
`enrolled exceeds 4,500. Initial results will become available in the second half of 2007.
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`Saredutant (SR48968, NK2 antagonist, depression, anxiety; Phase HI). Saredutant is a non-peptide selective
`antagonist of the human brain NK2 receptors developed for the treatment of MDD and GAD. Four Phase IH studies
`(two studies statistically significant, two studies not statistically significant versus placebo) evaluating saredudant
`in the treatment of MDD demonstrated a statistically significant overall efficacy versus placebo on depressive
`symptoms. Saredudant was very well tolerated in these studies. In addition, results of four other Phase HI studies
`are expected in 2007/2008.
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`SSR149415 (V1B antagonist, depression, anxiety; Phase Hb) SSR149415 is an antagonist of the vasopressin type
`lb (V lb) receptor which is being developed for depression and anxiety. A Phase II program in these two
`indications started in 2006.
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`Dianicline (SSR591813, nicotinic partial agonist, smoking cessation; Phase IH). Dianicline is being developed for
`smoking cessation. Following Phase Hb results obtained in 2005, a world-wide Phase HI program started mid 2006.
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`Surinabant (SR147778, CB-1 receptor antagonist, smoking cessation; Phase lIb). Surinabant has now entered
`Phase 11b for smoking cessation.
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