Form 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rules 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
Dated: January 6, 2004
ALTANA Aktiengesellschaft
(Translation of registrants name into English)
Am Pilgerrain 15
D-61352 Bad Homburg v. d. Höhe
Federal Republic of Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F þ Form 40-F o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes o No þ
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-
SIGNATURES | ||||||||
PRESS RELEASE ALTANA AG |
This Report on Form 6-K is hereby incorporated by reference into the Registrants Registration Statements on Form S-8, dated September 13, 2002 (File No. 333-99485) and dated September 24, 2003 (File No. 333-109074)
This Report on Form 6-K contains:
| Press Release of December 30, 2003, |
| Letter to the New York Stock Exchange, dated January 6, 2004 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ALTANA Aktiengesellschaft | ||||||
Dated: January 6, 2004 | By: | /s/ Hermann Küllmer | ||||
Name: | Dr. Hermann Küllmer | |||||
Title: | Chief Financial Officer and Member of the Management Board | |||||
/s/ Rudolf Pietzke | ||||||
Name: | Dr. Rudolf Pietzke | |||||
Title: | General Counsel |
Press release | ALTANA AG | |
Postfach 1244 | ||
61282 Bad Homburg v.d.H. | ||
Herbert-Quandt-Haus | ||
Corporate Communications | ||
Am Pilgerrain 15 | ||
61352 Bad Homburg v.d.H. | ||
Germany | ||
T +49 (0) 6172 1712-160 | ||
F +49 (0) 6172 1712-158 | ||
PR@altana.de | ||
www.altana.com |
Aventis Submits New Drug Application To FDA For Asthma Drug Alvesco®
(Ciclesonide)
Bad Homburg, Germany, Strasbourg, France, December 30, 2003 ALTANA (NYSE: AAA; FSE: ALT) and Aventis announced today that a new drug application (NDA) has been submitted to the US Food and Drug Administration (FDA) for Alvesco® (Ciclesonide). The companies are seeking marketing approval of Alvesco® for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children four years of age and older. ALTANA and Aventis signed an agreement in 2001 to jointly develop and market Alvesco® in the United States.
Alvesco is a new generation inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids are considered to be the foundation of asthma treatment, and they work by reducing inflammation the underlying disease process in the lungs and airways. The most frequently reported adverse events seen in Alvesco® US clinical trials were nasopharyngitis, headache and upper respiratory tract infection.
Alvesco is an innovative new asthma therapy that, if approved, we believe offers an important treatment for patients with asthma, said Hans-Joachim Lohrisch, Member of the Board of ALTANA AG and Chief Executive Officer of ALTANA Pharma. Alvesco is an important product in ALTANAs respiratory franchise, as it provides the company with a product with which to expand our presence in the US market and reinforce our commitment to providing innovative treatments for respiratory diseases.
Alvesco represents our continued commitment to providing patients with innovative new therapies for the treatment of respiratory disease, said Frank L. Douglas, Executive Vice President for Drug Innovation and Approval and a member of the Management Board of Aventis. Based on what we have seen in our clinical trials, we expect Alvesco to help fulfill an unmet medical need that still exists in the treatment of asthma.
Concurrent with the submission, Aventis has initiated a Phase IIIb, 12-month trial to further profile the safety and tolerability of high doses of Alvesco in adult patients with moderate to severe asthma. This trial will characterize the occurrence of lens opacity ocular events, as sometimes seen in patients who are treated with high doses of inhaled corticosteroids, including a small number of patients during one phase III Alvesco trial. The study was not a prerequisite for submission of the NDA to the US FDA.
About Asthma
Asthma is a chronic disease of the lungs and airways. It is characterized by
wheezing, coughing and a tightening of the airways, which causes shortness of
breath and can be life-threatening. According to the American Academy of
Allergy, Asthma and Immunology, more than 17 million Americans are currently
estimated to have asthma.
Page 2
For ALTANA
This press release contains forward-looking statements, i.e., current estimates
or expectations of future events or future results. The forward-looking
statements appearing in this press release include information on the expected
advantage in the treatment of asthma with ALTANAs pharmaceutical Alvesco®.
These statements are based on beliefs of ALTANAs management as well as
assumptions made by and information currently available to ALTANA. Many factors
that ALTANA is unable to predict with accuracy could cause ALTANAs actual
results, performance or achievements to be materially different from those that
may be expressed or implied by such forward-looking statements. These factors
include currently unknown and unforeseeable side effects of ALTANAs product.
Forward-looking statements speak only as of the date they are made. ALTANA does not intend, and does not assume any obligation, to update forward-looking statements to reflect facts, circumstances or events that have occurred or changed after such statements have been made.
For Aventis
Statements in this news release containing projections or estimates of
revenues, income, earnings per share, capital expenditures, capital structure,
or other financial items; plans and objectives relating to future operations,
products, or services; future economic performance; or assumptions underlying
or relating to any such statements, are forward-looking statements subject to
risks and uncertainties. Actual results could differ materially depending on
factors such as the timing and effects of regulatory actions, the results of
clinical trials, the companys relative success developing and gaining market
acceptance for new products, the outcome of significant litigation, and the
effectiveness of patent protection. Additional information regarding risks and
uncertainties is set forth in the current Annual Report on Form 20-F of Aventis
on file with the Securities and Exchange Commission and in the current Annual
Report -Document de Référence"- on file with the Commission des Opérations de
Bourse in France, recently renamed Autorité des marchés financiers.
This press release is also available on the Internet at www.altana.com or visit the Aventis Web site at www.aventis.com
For inquiries please contact:
ALTANA AG | Investor Relations: | |||
Dr. Thomas Gauly | Tel: + 49 (0) 6172 1712-163 | |||
Head of Corporate Communications & | Tel: + 49 (0) 6172 1712-165 | |||
Investor Relations | Fax: + 49 (0) 6172 1712-158 | |||
Media Relations: | Investor Relations USA: | |||
Tel: + 49 (0) 6172 1712-160 | Tel: +1 212 974 98 00 | |||
Tel: + 49 (0) 6172 1712-168 | Fax: +1 212 974 61 90 | |||
Fax: + 49 (0) 6172 1712-158 |
Aventis Contacts
Corinne Hoff | Lise Geduldig | |||
Aventis Global Media Relations | Aventis US Product Communications | |||
Tel: +33 (0) 3 88 99 19 16 | Tel: 908-243-6580 | |||
Corinne.Hoff@Aventis.com | Lise.Geduldig@Aventis.com | |||
Melissa Feltmann | ||||
Aventis US Product Communications | ||||
Tel: 908-243-7080 | ||||
Melissa.Feltmann@Aventis.com |
By Telefax-No. 001-212-656-5071 and by mail | ALTANA AG | |
Mr. Stefan Jekel Account Representative International Client Services New York Stock Exchange, Inc. 20 Broad Street New York, New York 10005 U.S.A. |
Postfach 1244 61282 Bad Homburg v.d.H. Herbert-Quandt-Haus Am Pilgerrain 15 61352 Bad Homburg v.d.H. Deutschland T +49 (0) 6172 1712-0 F +49 (0) 6172 1712-5 50 www.altana.de |
January 6th, 2004
ALTANA Aktiengesellschaft
Dear Mr. Jekel,
in accordance with Section 204.33 of the NYSE Listed Company Manual we hereby submit information about the re-purchase and re-sale of ALTANA shares by ALTANA AG during the fourth quarter of 2003.
Shares have been re-purchased and re-sold exclusively in transactions executed on the Frankfurt Stock Exchange.
| Number of treasury shares held by ALTANA AG as per October 1st, 2003: 4,481.849 |
| Number of shares re-purchased from October 1st to December 31st, 2003: 101.100 |
| Number of shares disposed of from October 1st to December 31st, 2003: 449.754 |
| Number of treasury shares held by ALTANA AG on December 31st, 2003: 4,133.195 |
With kind regards,
ALTANA AG
/s/ Paul Reuter | /s/ Rudolf Pietzke | |
|
||
Dr. Paul Reuter | Dr. Rudolf Pietzke |
Vorsitzender des Aufsichtsrats: Justus Mische Vorstand: Dr. h. c. Nikolaus Schweickart (Vorsitzender) Dr. Hermann Küllmer, Dr. Hans-Joachim Lohrisch, Dr. Matthias Wolfgruber |
Sitz und Registergericht: Bad Homburg v. d. Höhe, HRB-Nr. 1933 |