ranbaxy labs mit neuem blockbuster! - 500 Beiträge pro Seite

[upstart]

Die indische Ranbaxy Laboratories hat ein neues Medikament auf den Markt gebracht, dass einer neuen Klasse von antibakteriellen Stoffen angehören soll. Das Medikament, Cilenum, soll die Marktposition von Ranbaxy im Bereich Infektionsbekämpfung weiter stärken.

© BörseGo

hier mehr dazu:

New Delhi- September 09, 2003

Ranbaxy Laboratories Limited (Ranbaxy), announced the launch of a high end anti-infective injectable under the brand name Cilanem. The product has been introduced for the first time in India, by Ranbaxy’s Pharma division. The anti-infective injectable having excellent gram positive, gram negative and anaerobic coverage, is used for nosocomial and life-threatening infections. The product is a combination of imipenem with cilastatin, and belongs to the new class of antibacterials - the carbapenems.

Cilanem would compete in the high-end injectable antibiotic segment. Presently molecules like pipericillin + tazobactam, meropenem, and 3rd & 4th generation premium cephalosporin injectables are being used in such indications. Potential market size in India for the product is expected to be around Rs. 150 cr (Source: ORG). Internationally, this molecule is a blockbuster with sales of around US$ 585 million.

Commenting on the product launch, Mr. Malvinder Mohan Singh, Regional Director, India, Ranbaxy, said, “The introduction of Cilanem will give the brand a first mover advantage in the highly progressive market and further strengthen the Company’s leadership position in the anti-infective segment”.

The product will be promoted by the Pharma division primarily through its dedicated field force of 30 Hospital Business Executives (HBEs) that cover about 80 corporate hospitals and teaching institutions. This would help quicker penetration of the product in the institutions. Intensivists, as well as Speciality Surgeons like Oncosurgeons & Plastic Surgeons will also be among the core prescribers of the product.

Ranbaxy Laboratories Limited, India`s largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy`s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy`s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 70 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in 7 countries.

For further information please contact:

Paresh Chaudhry
Director- Corporate Communications
Ranbaxy Laboratories Ltd.
No 19, Nehru Place,
New Delhi -110019
Tel (Direct) : 91-11-26002075
e-mail: [e-mail]

[upstart]

PRINCETON, N.J., Oct. 1 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the Office of Generic Drugs of the U.S. Food and Drug Administration to manufacture and market Pravastatin Sodium Tablets, 10 mg, 20 mg, 40 mg, and 80 mg. Annual sales for the Pravastatin Tablet market are $1.8 billion (IMS - MAT: June 2003).

Pravastatin Sodium Tablets (Pravachol(R))* are indicated in the treatment of primary prevention of coronary events such as in hypercholesterolemic patients without clinically evident coronary heart disease. Pravachol(R) is indicated to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures and reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes and is also indicated for treatment in the secondary prevention of cardiovascular events such as in patients with clinically evident coronary heart disease to reduce the risk of total mortality by reducing coronary death, reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures, reduce the risk of stroke and stroke/transient ischemic attack (TIA), and slow the progression of coronary atherosclerosis. Pravastatin Sodium is also used in treating hyperlipidemia as an adjunct to diet to reduce elevated Total-C, LDL-C, Apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). Pravachol(R) is also indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV) and for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

According to Jim Meehan, Vice President of Sales and Marketing for RPI, "This places RPI in a position to offer products to the U.S. healthcare system with a proven clinical record in the management of hyperlipidemia. Recently, we received tentative approval for Simvastatin, and now Pravastatin, which will be offered as an affordable generic alternative that will have a measurable effect on the economics of healthcare. The product will be made available under the Ranbaxy label through wholesalers, distributors and pharmacies on a nationwide basis upon final approval."

Dipak Chattaraj, President of RPI, stated, "The approval of Pravastatin again demonstrates the capabilities of the Ranbaxy global organization to develop products from Active Pharmaceutical Ingredients to manufacturing of the finished dosage form that will be sold under the RPI label and be available to all dispensing outlets across the nation." Mr. Chattaraj further remarked, "This too is another milestone since it represents the 20th ANDA approval granted to Ranbaxy thus far in 2003."

Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $296 Mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the U.S. generics market.

For more information, please contact: Charles M. Caprariello - [phone] Vice President, Business Development *Provachol(R) is a registered trademark of Bristol-Myers Squibb

Ranbaxy Pharmaceuticals Inc.

© PR Newswire

another one:

Press Release: Ranbaxy Laboratories Limited
29.09.03 (www.asia-economy.de)

RANBAXY GAINS TENTATIVE APPROVAL TO MANUFACTURE
AND MARKET SIMVASTATIN TABLETS USP

New Delhi - September 29, 2003

Ranbaxy Laboratories Limited (Ranbaxy), announced today that the Company has received tentative approval from the Office of Generic Drugs of the U.S. Food and Drug Administration to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg. Total sales for the Simvastatin Tablet market are $4.2 billion (IMS - MAT: June 2003).

Simvastatin Tablets (Zocor®)* are indicated for patients with coronary heart disease and hypercholesterolemia to reduce the risk of total mortality by reducing coronary death; reduce the risk of non-fatal myocardial infarction; reduce the risk for undergoing myocardial revascularization procedures; and reduce the risk of stroke or transient ischemic attack. Zocor® is indicated to reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb), for the treatment of patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia), for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia), and is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

According to Jim Meehan, Vice President, Sales and Marketing, Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy, “The opportunity to market Simvastatin clearly establishes RPI as one of the leading pharmaceutical companies to provide a generic alternative for a product that has had a dramatic impact in managing patients with hyperlipidemia and the associated effects of this condition. This product adds both recognition and credibility to the Ranbaxy organization as a leader in the generic pharmaceutical market place. The product will be made available by RPI under the Ranbaxy label through wholesalers, distributors and pharmacies on a nationwide basis upon final approval.”


Commenting on the development, Dipak Chattaraj, President, RPI, said ”The product illustrates Ranbaxy’s ability to develop products from API to formulation to manufacturing and finally commercialization, which truly fits the definition of a fully integrated pharmaceutical company,”.

Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $ 296 Mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the U.S. generics market.

29.09.03 (il)

Press Release: Ranbaxy Laboratories Limited
29.09.03 (www.asia-economy.de)

RANBAXY GAINS TENTATIVE APPROVAL TO MANUFACTURE
AND MARKET SIMVASTATIN TABLETS USP

New Delhi - September 29, 2003

Ranbaxy Laboratories Limited (Ranbaxy), announced today that the Company has received tentative approval from the Office of Generic Drugs of the U.S. Food and Drug Administration to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg. Total sales for the Simvastatin Tablet market are $4.2 billion (IMS - MAT: June 2003).

Simvastatin Tablets (Zocor®)* are indicated for patients with coronary heart disease and hypercholesterolemia to reduce the risk of total mortality by reducing coronary death; reduce the risk of non-fatal myocardial infarction; reduce the risk for undergoing myocardial revascularization procedures; and reduce the risk of stroke or transient ischemic attack. Zocor® is indicated to reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb), for the treatment of patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia), for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia), and is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

According to Jim Meehan, Vice President, Sales and Marketing, Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy, “The opportunity to market Simvastatin clearly establishes RPI as one of the leading pharmaceutical companies to provide a generic alternative for a product that has had a dramatic impact in managing patients with hyperlipidemia and the associated effects of this condition. This product adds both recognition and credibility to the Ranbaxy organization as a leader in the generic pharmaceutical market place. The product will be made available by RPI under the Ranbaxy label through wholesalers, distributors and pharmacies on a nationwide basis upon final approval.”


Commenting on the development, Dipak Chattaraj, President, RPI, said ”The product illustrates Ranbaxy’s ability to develop products from API to formulation to manufacturing and finally commercialization, which truly fits the definition of a fully integrated pharmaceutical company,”.

Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $ 296 Mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the U.S. generics market.

[upstart]

The board of directors of transnational pharma company, Ranbaxy Laboratories will convene on 22 October 2003 to consider the payment of interim dividend for the year ending 31 December 2003.

For the second quarter ending 30 June 2003, Ranbaxy Laboratories recorded a 20.7% rise in net profit to Rs 206.2 crore as compared to Rs 170.9 crore in Q2 –02. Net sales rose by 24% to Rs 1,134.9 crore from Rs 915.1 crore in Q2-02.

[werlet]

@ upstart,
bei den von Dir zitierten Medikamenten handelt es sich um alte - aus dem Patent gelaufene - Produkte.
Das "neue Antibiotikum" Cilenum bzw. Cilanem ist in Deutschland seit über 10 Jahren unter dem Namen "Zienam",
der Firma MSD (Merck, Sharp & Dohme) im Handel.
Offenbar handelt es sich bei Ranbaxy (WKN: 912364) um eine Generika-Firma, die hauptsächlich in Indien tätig ist.
Der Aktienkurs ist nach einem Zwischenhoch von 23,-Euro im September 20% gefallen und steht nun bei 18,50 Euro.
Der Kurs ist meiner Meinung überbewertet, zumal die Dividendenrendite bei 1,04% nicht zu Luftsprüngen verleitet...
Gruß
werlet

[Norbi2]

werlet,

schoen waers, aber Ranbaxi ist die zur Zeit aggressivste global auftretende Generikafirma. Natuerlich kann keine Firma ein Generikum vor dem Auslaufen des Patents zulassen, das ist ja eben die Definition eines Generikums.

Unternehmensstrategie eines Generikaherstellers ist in der Regel brutalstmoegliche Kostenfuehrerschaft (klassisch, nach Porter).

Wer die internationale Pharmaindustrie kennt weiss wer Ranbaxi ist. Du gehoerst scheibar nicht dazu.

Wer sich ueber Generikastrategien informieren will der sollte sich mal die Strategie von Novartis ansehen. Und die von Ranbaxi. Schwarz Pharma, Merck Deutschland, Gruenenthal, Boehringer Ingelheim etc.

Um bei diesem Thema mitreden zu koennen reichen Allgemeinplaetze nicht aus, das ist schon ein wenig komplexer.

Gruss,

Norbi

[werlet]

@ Norbi2,
Du als vermeintlicher Kenner der Szene solltest eigentlich wissen, dass Boehringer Ingelheim kein Generika-Hersteller ist.
Um brutalst mögliche Kostenführerschaft (Zitat) anzustreben, muss ein Unternehmen auch im Markt präsent sein, was man von Ranbaxy nicht behaupten kann. Die von Dir genannten Firmen (Ausnahme Orginalsparte von Novartis) spielen weltweit keine große Rolle, da die Marktführer - Gott sei Dank - immer noch die Orginalhersteller sind - ohne die es übrigens Generika-Trittbrettfahrer nicht gäbe.
Der Chart von Ranbaxy spricht für sich...
Meineserachtens ist Ranbaxy nur im eigenen Markt und den USA (teilweise) aktiv.
Also bevor Du hier den großen Fachmann mimst, solltest Du mal Deine Hausaufgaben machen und Dich einlesen...
Gruß
werlet

[Norbi2]

werlet,

Ranbaxy ist inzwischen selbst in Suedamerika aktiv. Allein die USA bedeuten ca. 42% des Weltpharmamarktes. 40% des US Marktes sind Generics. USA + Europa + Japan ca. 80%. Die am schnellsten wachsenden Exporteure kommen aus China und Indien. Der Markt der forschenden Unternehmen ist extrem fragmentiert, Pfizer+Pharmacia duerften gerade einmal 10% erreichen, die top 10 nicht mal 50%. Tendenz sinkend. Schau mal bei IMS rein.

Ich hatte beruflich mit (oder besser gegen) Ranbaxi zu tun.

Bin seit fast 20 Jahren international auf leitender Ebene in der Industrie taetig. Auf mittlerweile vier Kontinenten.

Wenn Du etwas gehaltvolles zum Thema hast koennen wir gerne weiterdiskutieren. Solltest Du am deutschen Markt orientiert sein lege ich dir die Lektuere verschiedener Gesetzesentwuerfe sowie die Untersuchung des Marktanteils von Generika in D und dessen Dynamik nahe.

Gruss,

Norbi

[werlet]

@ Norbi2,
duch die Generika-Brille gesehen möchte ich Dir ja nicht widersprechen...
Wenn Du Dir mal den Generika-Werdegang eines ehemaligen Blockbusters anschaust, so stürzen sich weltweit etwa 70 Firmen auf die
"Nachahmung". Entsprechend der Preisreduktion (bestes Beispiel ist die Preisspirale des damaligen Captopril-Generika-Wettbewerbs) bleiben für die einzelnen Generika-Firmen nur ein winziges Stück des ehemals riesigen Umsatzkuchens.
Weitere Probleme stellen Qualitätssicherung der Substanzen und Zulassungsprofil (Sichwort: Off-Label-Einsatz) dar.
Das heißt der Erfolg eines Generika-Unternehmens ist maßgeblich von seiner Diversifikation und globalen Marktpräsenz abhängig.
Bezogen auf Ranbaxy ist die Präsenz in Japan und Europa (den nach den USA wichtigsten Märkten) nicht gegeben.
Was mich wundert: nach jeder Anmeldung eines Medikaments bei der FDA, hat die Börse dies mit einem Kursrückgang quittiert
Für mich ist dieses Papier auf jeden Fall zur Zeit uninteressant (siehe Chart) - aber ich werde es auf jeden Fall weiterbeobachten.
Gruß
werlet

[Norbi2]

werlet,

ich werde bestimmt nicht in Ranbaxi investieren. Es gibt interessantere Papiere.

Aber schau Dir mal die realen Umsaetze von Generika in den USA an. Bei jedem Generikalaunch verliert das Originalpraeparat zwischen 70 und 80% des Umsatzes.

Und der Krieg der ACE Hemmer (Captopril vs. Enalapril vs. Lisinopril vs. Ramipril vs. Trandolapril vs. alle Generika) ist ein Extrembeispiel, da hier bereits die verschiedenen Originalpraeparate in einen Verdraengungswettbewerb traten und die generika den Verfall der NPVs der einzelnen Substanzen lediglich beschleunigten.

Die Praesenz in USA bedeutet Praesenz in 40+ % des Weltmarktes. Auf hohem Preisniveau.

Generikahersteller sind nicht an Niederigpreismaerkten interressiert da dort die Konkurrenz der Originalpraeparate relativ billig ist und die klassische Strategie der Unterbietung zu verringerten MArgen fuehrt.

Die Rolle und Preisfestlegung von Generika in Europa ist nicht homogen, die wichtigsten Maerkte sind Deutschland, Frankreich, Spanien und Italien. Der Rest ist static noise.

In Japan gelten generell ganz eigene Regeln zur Registrierung eines Medikamentes, aber der Generikaanteil steigt auch dort. Und das obwohl es in Japan selbst dispensierende Aerzte gibt.

Generell halte ich Generika fuer eine Zukunftsinvestition.

Happy trading,

Norbi

[Norbi2]

ach ja, sorry, off-label use ist eher ein accelerator, off label use bedeutet ueber die urspruengliche Indikation hinausgehenden Einsatz ohne Zulassung, per se ein Umsatzbooster.

Bestes Beispiel: Viagra

Norbi

[werlet]

@ Norbi2,
unter Off-Label-Einsatz bei Generics meinte ich die Verwendung bei Indikationen, bei denen das ursprüngliche Orginal zugelassen ist, das Generikum aber keine Zulassung hat.
Im Allgemeinen ist Off-Label-Use ein zweischneidiges Schwert und rechtlich bedenklich... Bei zunehmender Klagefreudigkeit von mündigen Patienten bleibt im Falle von Komplikationen der schwarze Peter meist beim Arzt hängen.
Viagra und Off-Label - mir fallen dazu etliche Witze ein - meinst Du etwa zur Behandlung pulmonaler Hypertonie ??
Soweit ich weiß, werden zur Zeit dazu erst Studien gemacht.

Gruß
werlet

[Norbi2]

@werlet,

das ist gar nicht so abwegig, Viagra wurde ja urspruenglich als Herz Kreislauf Mittel erforscht und entwickelt, die heutige Indikation ist die Konsequenz der Weiterentwicklung einer Nebenwirkung und nicht des Kardiovaskulaeren Effekts.

Aufgrund des Wirkmechanismus von sildenafil ist pulmonare Hypertonie sicherlich ein moegliches Einsatzgebiet.

Off-label use ist ein fest besetzter Begriff: Einsatz eines Pharmakona ausserhalb der registrierten Indikation.

Gruss,

Norbi

[upstart]

Thursday October 9, 3:23 PM

Ranbaxy may test higher level
By Tuhin Subhra Kar

Technical analyst Prakash Gaba is bullish on the Ranbaxy stock. He told CNBC-TV18 that if it stays above Rs 1,007 for a day or so, strongly, then it can test its earlier high of Rs 1,075 again.

He said it may see a resistance at around Rs 1,075-1,083. "If it is able to cross that, it might see a Rs 100-200 appreciation from those levels," he said. He suggested holding on to it with a stop-loss at Rs 970.

At 2.29 pm, Ranbaxy was at Rs 1,003, up 1.73%, with a volume of 207,572 shares traded. It saw an intra-day high of Rs 1,010.85 and a low of Rs 992. It touched a year-high of Rs 1,075 on September 9, and a low of Rs 485.05 on November 7, last year.

[upstart]

[upstart]

oben kurs in bombay (indischer rupie).
hier kurs in berlin.

[upstart]

Tuesday October 14, 12:06 PM

Lincoln Pharma hits a high on tieup with Ranbaxy
By reena prince

Lincoln Pharmaceuticals has touched a 52-week high of Rs 38.90 after the company announced that it has recently tied up with Ranbaxy Laboratories to manufacture their different human and veterinary products. Ranbaxy has inspected and approved the company’s plant and is satisfied with the manufacturing plant, process, and people.

At 11:17 am the share was quoting at Rs 36.90 up Rs 1.50, or 4.24%. Over 1 lakh shares have been traded so far, on the BSE.

Yesterday, the share closed up 5.83% or Rs 1.95 at Rs 35.40.

[Nix Wasa]

@ Norbi !!!

Du sagtest es gibt bessere Firmen wie Ranbaxy zum Investieren???


Was für Welche?


Nix Wasa

[upstart]

P R E S S R E L E A S E


GSK AND RANBAXY TO COLLABORATE ON DRUG DISCOVERY
AND DEVELOPMENT

London and New Delhi, October 22, 2003

Ranbaxy Laboratories Ltd. (Ranbaxy) and GlaxoSmithKline plc (GSK) today announced that they have entered into a drug discovery and clinical development collaboration covering a wide range of therapeutic areas.

Several collaborative scenarios are envisioned, with GSK and Ranbaxy leveraging their respective resources and expertise. Ranbaxy will be responsible for activities from optimization of a lead compound to generation of a development candidate. Leads may be provided by either GSK or Ranbaxy. For a proportion of the candidates selected within the collaboration, it is expected that Ranbaxy will conduct early clinical work. GSK and Ranbaxy will form an Executive Steering Committee to oversee the research. Once a compound has been selected as a development candidate, in most instances GSK will complete development. GSK will have the exclusive commercialization responsibilities worldwide, while Ranbaxy will take the lead in India. Ranbaxy, with the consent of GSK may co-promote in US and EU. The financial terms of the agreement were not disclosed.

“This collaboration provides an avenue to Ranbaxy to leverage its discovery and early product development strengths and gain access to cutting edge technologies,” said Dr. Rashmi Barbhaiya, President, Research & Development, Ranbaxy.

"This agreement furthers our strategy of building strong collaborations in drug discovery at the same time we accelerate our own internal drug discovery programmes," said Dr. Tadataka Yamada, Chairman, Research & Development, GlaxoSmithKline.

GlaxoSmithKline - one of the world`s leading research-based pharmaceutical and healthcare companies-is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

Ranbaxy Laboratories Limited - India`s largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy`s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy`s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 70 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in 7 countries.

For company information, visit Ranbaxy on the World Wide Web at www.ranbaxy.com

[upstart]

Wednesday October 22, 7:20 PM

Ranbaxy: Delivers a sweet pill
By Equitymaster.com

Ranbaxy has announced its 3QFY04 results. On a consolidated basis, the company has posted a topline growth of 14% and a bottomline growth of 25%. For 9mFY04, Ranbaxy has reported a 31% growth in net sales and a 35% rise in net profits. In this context let us make a detailed review of the company`s performance during the quarter.

Results at a glance
(Rs m) 3QFY03 3QFY04 Change 9mFY03 9mFY04 Change
Net Sales 10,658 12,113 13.7% 27,472 36,025 31.1%
Other Income 16 254 1487.5% 329 380 15.5%
Operating expenses 8,234 9,488 15.2% 21,625 27,576 27.5%
Operating Profit (EBDIT) 2,424 2,625 8.3% 5,847 8,449 44.5%
Operating Profit Margin (%) 22.7% 21.7% 21.3% 23.5%
Interest (net) 109 61 -44.0% 432 235 -45.6%
Depreciation 346 376 8.7% 946 1,122 18.6%
Profit before tax 1,985 2,442 23.0% 4,798 7,472 55.7%
Extra-ordinary Items 48 103 114.6% 915 252 -72.5%
Tax 544 674 23.9% 1,537 2,052 33.5%
Profit after Tax but before MI 1,489 1,871 25.7% 4,176 5,672 35.8%
Minority Interest (MI) 1 8 700.0% 3 27 800.0%
Profit after Tax and MI 1,488 1,863 25.2% 4,173 5,645 35.3%
Net profit margin (%) 14.0% 15.4% 15.2% 15.7%
No. of Shares (m) 116.0 185.0 116.0 185.0
Diluted earnings per share* 32.2 40.5 30.1 40.9
P/E ratio 24.5 24.2
(* annualised)

During 3QFY04, company`s dosage formulations sales grew by 12%. This growth was fuelled by revenues from Europe, CIS and Africa, which grew by 46% (as a group) as compared to 3QFY03. In Europe, UK (52% growth), Germany (37%), Poland (123%), Russia (103%) and Rest of Europe (98%) are the key markets in which the company operates. Dosage sales in the domestic and Middle East markets grew by 22%. In the domestic market, the company has managed to outperform the industry growth rates in every month of the quarter. The company now commands a leadership position in high growth statin segment.

In the US market, which at US$ 91 m contributes 37% of Ranbaxy`s global sales, growth rates were impacted due to the entry of generics competition for Cefuroxime Axetil, which was one of the key contributors of revenues in the previous quarters. During the quarter under review, Ranbaxy launched three generic products. Moreover, the company is expected to launch three more branded drugs in 4QFY04. However, the strong growth rates achieved by the company in the above markets was pared by a slump in the revenues from the Asia Pacific (ASPI.BO, news) and Latin American markets. While Ranbaxy`s bulk drug business also witnessed a respectable 11% growth, its allied businesses, which constitutes of animal healthcare, diagnostics and fine chemicals business, has recorded a 5% drop.


Revenue break-up
(Rs m) 3QFY03 3QFY04 Change
Dosage forms
India and Middle East 2,235 2,716 22%
Europe, CIS and Africa 1,361 1,980 46%
Asia Pacific and Latin America 1,118 829 -26%
USA 3,984 4,190 5%
Sub total 8,698 9,714 12%
API 1,118 1,243 11%
Allied Business 340 322 -5%
Other operating income 524 843 61%
Net Sales 10,679 12,123 14%

Although Ranbaxy`s operating margins saw a marginal decline, reduction in interest cost (in view of the debt restructuring exercise undertaken by the company) and a sharp rise in other income and extra-ordinary income has helped Ranbaxy improve its net margins by 140 basis points. While the rise in the other income was due to higher interest income, extra-ordinary income pertained to settlement compensation income received by the company in relation to a patent dispute.

On the R&D front, Ranbaxy`s BPH molecule, RBX-2258, which is out-licensed to Schwarz Pharma, has completed Phase I study. Meanwhile, the company has also received approval to initiate Phase II study in India on its respiratory compound, RBX-7796. Another key positive for the company is the fact that Bayer has received US-FDA approval to market 1 gm dosage form for Cipro in August `03. As Bayer is the licensing collaborator of Ranbaxy for Cipro, the approval is likely to trigger a milestone payment for the company. During 3QFY04, Ranbaxy received 7 ANDA approvals taking the total number of approvals in FY04 to 20. In all, the company has until now filed more than 100 ANDAs, with 25 awaiting approval.

Ranbaxy has also entered into a drug discovery and clinical development collaboration with GlaxoSmithKline plc (GSK), covering a wide range of therapeutic areas. As per the terms of the agreement, Ranbaxy will conduct early clinical trial on compounds selected by either Ranbaxy or GSK. Going forward, while GSK will have exclusive worldwide rights for the drug, Ranbaxy will have the right to sell the product in India. However, the detailed financial terms of the agreement have not been disclosed.

At Rs 990, Ranbaxy is trading at a P/E of 24x its annualised 9mFY04 earnings. The strong growth potential in the generics segment combined with its focus on developing a strong NCE and ANDA pipeline augur well for the company going forward. This coupled with the fact that Ranbaxy is likely to successfully meet its long-term target of achieving US$ 1 bn sales by 2005 in this year itself, we remain optimistic about the long-term prospects of the company.This coupled with the fact that Ranbaxy is likely to successfully meet its long-term target of achieving US$ 1 bn sales by 2005 in this year itself, we remain optimistic about the long-term prospects of the company.

[upstart]

RANBAXY GRANTED TENTATIVE APPROVAL
TO MARKET METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE 500 MG TABLETS

New Delhi - November 03, 2003

Ranbaxy Laboratories Limited (Ranbaxy), announced today that the Company has received tentative approval from the Office of Generic Drugs of the U.S. Food and Drug Administration to manufacture and market Metformin Hydrochloride Extended-release Tablets, 500 mg. Total market sales for all forms of Metformin were $1.6 billion with sales of $452.4 million for the Metformin Extended-release formulation (IMS - MAT: June 2003).

Metformin Hydrochloride Extended-release Tablets (Glucophage® XR*) as monotherapy is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Glucophage® is indicated in patients 10 years of age and older, and Glucophage® XR is indicated in patients 17 years of age and older.

"This adds yet another product offering to our ever-expanding product portfolio. Most importantly, this innovative formulation has proven to add value to patients, which is now available as an affordable generic alternative to the brand through Ranbaxy. Product will be made available by RPI at the time of final approval as granted by the U.S. FDA," according to Jim Meehan, Vice President of Sales and Marketing, Ranbaxy Pharmaceuticals Inc. (RPI).

Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of Ranbaxy, India, having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $296 Mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the U.S. generics market.

Ranbaxy Laboratories Limited, India`s largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy`s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy`s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 70 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in 7 countries


*Glucophage® XR Tablets is a registered trademark of Bristol Myers Squibb Company

[upstart]

RANBAXY JOINS HANDS WITH CLINTON FOUNDATION
ON DRUGS FOR HIV/AIDS

New Delhi-October 27, 2003

Ranbaxy Laboratories Limited (Ranbaxy), announced the signing of an agreement with The William Jefferson Clinton Foundation that will lead to a significant reduction in the price of HIV/AIDS drugs. This initiative will bring Anti Retroviral drugs (ARVs), now regarded as life-saving and essential drugs in many countries, within easy access to millions of people suffering from HIV and AIDS in developing countries.

The agreement covers countries in Africa and the Caribbean regions like, South Africa, Mozambique, Rwanda, Tanzania, Haiti, The Bahamas, Dominican Republic, and The Organization of Eastern Caribbean States. Around 1.5 to 2.0 million patients are estimated to benefit from this programme by 2008.

Presently, the agreement covers fixed dose combination of Triviro-LNS (Lamivudine+Stavudine+ Nevirapine), Aviro-LZN (Lamivudine+ Zidovudine+Nevirapine), Coviro (Lamivudine+ Stavudine), and Efavirenz. These drugs are already available in several countries.

Price reductions achieved through this landmark deal are due to consolidation and predictability of demand that has been facilitated by the Clinton Foundation. As a result, all those in the value chain were able to pass on benefits of economies of scale to the Clinton project. For instance, under the Clinton Foundation agreement, the price of one of the commonly used triple drug therapy combination will be substantially reduced, available for less than $140 per person per year. That translates into a cost of just 36-to-38 cents per person per day. This used to be around 80 cents per person per day earlier. Overall, the Clinton Foundation agreement will be reducing the cost of ARVs by one-third to one-half in the countries covered in the agreement.

The Clinton Foundation and Ranbaxy have been working towards this agreement for the past several months, focusing on ways to reduce costs and scale up production of the "triple drug cocktails," which can substantially extend the lives of people suffering from AIDS and also help prevent mother-to-child transmission of HIV.

Commenting on the development, Mr. D.S Brar, CEO & MD, Ranbaxy Laboratories Limited,said “ We are priveliged to join hands with the Clinton Foundation and glad to have been given the opportunity to serve this largely neglected segment. This is yet another step by Ranbaxy towards its social responsibilities”.

Ranbaxy entered the anti-HIV segment just over two years back. Ranbaxy today has one of the most extensive anti-HIV portfolio comprising, Anti Retroviral drugs with maximum number of WHO approved products for HIV/AIDS. The Company has over 150 registrations of ARVs already across 57 countries with over 100 in the pipeline.

Earlier this year Ranbaxy entered into an agreement with ‘Medicines for Malaria Venture’ (MMV), Geneva, for the development of Anti-Malarial Drug to provide better health care options in this vastly ignored segment.

Ranbaxy Laboratories Limited, India`s largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy`s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy`s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 70 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in 7 countries

[upstart]

WHO Pre-qualifies Ranbaxy`s Triple Drug Anti-AIDS Fixed Dose Combination

New Delhi, December 3, 2003

Ranbaxy Laboratories Limited (Ranbaxy) today announced that WHO, on the occasion of World AIDS Day, has declared pre-qualification of Ranbaxy`s three-drug fixed dose Anti-retroviral (ARV) combination products, Triviro - LNS 30 & 40mg tablets (sold in India as Virolans). The product, bio equivalent to the individual innovators` drugs has been available in several developing countries and in India for nearly two years.

Triviro- LNS is a combination of two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI). The product is a comprehensive first line Anti Retroviral treatment for HIV positive patients that have been prescribed the regimen.


Commenting on the launch, Mr. D.S. Brar, CEO & Managing Director, Ranbaxy Laboratories Limited, said "Approval of the triple combinations by WHO is a significant & welcome step. Several countries had been eagerly awaiting WHO`s certification of these products, which have already been used successfully in India and some other countries. More patients should now be able to use the convenient two-pill-a-day regimen from the current six-pill-a-day regimen".

Pill burden, which has been a bane of HIV treatment, prompted generic companies such as Ranbaxy to develop combination of ARVs in a single pill. Networks of HIV positive people and several NGOs have been urging WHO for the past several months to speed up approval of generic fixed dose combinations, which are seen as a major improvement in management of HIV. WHO`s pre-qualification of anti-HIV drugs has become a benchmark for quality since the first list was released in 2002.

Ranbaxy has always been at the fore-front in addressing the healthcare needs by providing cost-effective and quality medicines. The Company has been marketing a wide range of generic ARVs in several countries including India.

Presently, Ranbaxy markets 11 ARV products in India and its basket of bio-equivalent generic ARVs include Lamivudine, Lamivudine+Stavudine, Lamivudine+Zidovudine, Stavudine, Zidovudine and Didanosine, Efavirenz, Nevirapine, Lamivudine + Nevirapine + Stavudine, Indinavir, and Abacavir.

So far, Zidovudine 300 mg tablets, Nevirapine 200 mg tablets, Lamivudine 150 mg tablets, Lamivudine 150 + Zidovudine 300mg and Indinavir 400mg tablets were already on the WHO pre-qualifcation list. More drugs are under review with WHO. With the new additions, Ranbaxy has strengthened its position as the Company with maximum products on the WHO pre-qualification list.

04.12.03 (il)

[upstart]

Ranbaxy Labs erhält Genehmigung für Generika
Neu Delhi 09.12.03 (asia-economy.de) Der indiche Hersteller von Generika und pharmazeutischen Produkten, Ranbaxy Laboratories, hat am Montag die Zulassung zur Herstellung eines Nachahmerproduktes erhalten. Dabei handelt es sich um das Medikament der Glaxo Smithkline Namens Augmentin. Die Zustimmung erhielt Ranbaxy durch die US amerikanische Food and Drugs Administration.

Insgesamt schätzt man den Markt für Amoxicillin auf weltweit 31,4 Millionen US Dollar. 09.12.03 (rh)

[upstart]

Reuters
UPDATE - Glaxo, Boehringer allow more copying of AIDS drugs
Wednesday December 10, 10:42 am ET
By Jodie Ginsberg


(Adds Boehringer comments, paragraph 15-16)
PRETORIA, Dec 10 (Reuters) - South Africa moved a step closer to bringing desperately needed AIDS treatment to millions of its poor on Wednesday after two drug giants said they would allow more cheap generic versions of patented drugs to be made.

In an out-of-court settlement with AIDS activists, British-based GlaxoSmithKline Plc (London:GSK.L - News) and Germany`s Boehringer Ingelheim said they would grant more licences to generic firms to produce and import antiretroviral (ARV) drugs.

South Africa has more people living with HIV/AIDS than any other country -- an estimated 5.3 million, equal to 13 percent of the world`s infected. Despite steep price cuts in recent years, modern therapy to fight the HIV virus that causes AIDS remains out of reach for the vast majority of Africans.

The latest deal comes after South Africa`s Competition Commission found in October the two firms had a case to answer on anti-competitive behaviour over the sale of AIDS drugs and recommended to the Competition Tribunal, an enforcement body, they be fined and required to allow the manufacture of generics.

The Commission said on Wednesday that following the deal it would not ask for Glaxo to be fined, and was discussing a similar agreement with Boehringer.

COSTS SLASHED

"This is a big day for people living with HIV/AIDS," HIV sufferer Hazel Tau told a news briefing. "If it wasn`t for ARVs, I wouldn`t be living here today."

Tau said her ARV treatment cost around 1,200 rand ($187.5) a month -- twice the country`s average monthly income. Cheap generics could slash the cost to around 300 rand, or less if more firms are allowed to compete in the market.

In November, South Africa approved a national drug treatment programme to tackle the spread of AIDS, finally bowing to pressure to act against an epidemic killing an estimated 600 South Africans each day. This has yet to be implemented.

Activists said that cheaper drugs should help to speed up the process. The Treatment Action Campaign said that under the deal the two firms would charge no more than a five percent royalty fee on the sales of generic drugs in the country.

"We are pleased with the decision," Glaxo senior vice president Peter Bains said, adding that the firm had no estimate for the cost it would incur by limiting the royalty fee.

Nick Turner, industry analyst with Jefferies in London, said there would be little financial impact on Glaxo from the move.

A Glaxo spokesman in London said the company -- the world`s biggest maker of AIDS drugs -- would extend to other companies a voluntary licence it granted to local firm Aspen Pharmacare (APNJ.J) in October 2001 for the production of antiretrovirals.

It is in advanced talks with Thembalami Pharmaceuticals, a joint venture between Adcock Ingram (TBSJ.J) and India`s Ranbaxy Laboratories (Bombay:RANB.BO - News), and will consider issuing a further two possible licences for copies of its drugs AZT and lamivudine.

The British-based company said its preference would be to award licences to local producers but would consider imports into South Africa if this was not practicable.

BUSINESS IMPACT

Boehringer said it would grant three licences for the production and import of nevirapine, the drug used to prevent transmission of the HIV virus from mothers to children. The first of these has already gone to Aspen.

Spokesman Kevin McKenna said that if licensees manufactured the drugs in South Africa they would be able to export the drugs to the region but if they were imported, they would only be available in South Africa.

Drug industry figures show cut-price HIV/AIDS medicines from six companies were getting to only 76,000 Africans in June this year, a drop in the ocean when set against the need for treatment in sub-Saharan Africa, which is home to 30 million of the 42 million people infected with HIV worldwide.

The pandemic is starting to hurt South African firms, an independent survey on Wednesday showed.

The largest survey on the issue to date found that nine percent of companies reported a "significant" adverse impact on their business from the disease, while 43 percent envisaged this happening within five years.

(Additional reporting by Ben Hirschler in London and Sitaraman Shankar in Frankfurt)

[upstart]

Aventis to Sell French Generic Drug Unit to Ranbaxy (Update1)
Dec. 13 (Bloomberg) -- Aventis SA, France`s biggest drugmaker, said it will sell its generic drug business in France to Ranbaxy Laboratories Ltd. of India as part of a plan to focus on its main health care activities.

The transaction is expected to be completed in the first quarter of next year, Strasbourg, France-based Aventis said in a faxed statement. Financial details were not disclosed.

Aventis is selling assets to trim its 3.45 billion euros ($4.2 billion) in net debt and gain a higher credit rating. Aventis debt is rated A+ by Standard & Poor`s, lower than any of its larger competitors in the pharmaceutical industry.

The company, which plans to complete asset sales by the end of next year, earlier this week said it sold its blood products business to Australia`s CSL Ltd. for as much as $925 million. Aventis still plans to sell stakes in chemical makers Wacker- Chemie AG of Germany and Rhodia SA of France, spokesman Tony Roddam said.

Aventis has this year also sold a stake in Swiss specialty chemical maker Clariant AG for $257 million and cut its stake in Rhodia to 15.3 percent from more than 25 percent.

The French company is relying on revenue from blood thinner Lovenox and the allergy pill Allegra, which account for 20 percent of its sales, until they can be replaced by new drugs whose approval has been delayed. The company has said it would seek marketing approval for five new products by 2004.

The purchase of Aventis` generic drug business will help Ranbaxy, India`s biggest drugmaker, to boost sales. France has the fifth largest generic drugs market in the world after the U.S., Japan, Germany and the U.K.

Cheaper Drugs

Generic drugs are less expensive than brand-name medicines, while containing the same active ingredients. They can be sold once the brand-name version has lost its patent protection.

France is the world`s fourth biggest drug market with sales of $19.2 billion, Ranbaxy said.

``France is strategic to our European expansion plans,`` D. S. Brar, chief executive officer and managing director of Ranbaxy, said in a statement in New Delhi. ``The acquisition of Aventis will be a very important move as it would place us amongst the top generic companies in the French market.``

Indian drugmakers including Ranbaxy and Dr. Reddy`s Laboratories Ltd. are trying to expand in developed markets such as the U.S. and Europe where they can charge higher prices than in India.

Ranbaxy`s U.K. sales expanded 52 percent in the third quarter, German sales increased 37 percent, Russian sales doubled and Polish sales more than doubled. Sales in the rest of Europe climbed 98 percent. Indian sales rose 16 percent to 3.22 billion rupees ($71 million).

Last Updated: December 13, 2003 06:10 EST