Printer Friendly
The Free Library
5,677,878 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Warner-Lambert Reaffirms 30 Percent EPS Growth in 1999 and Expects to Achieve 20 Percent EPS Growth in 2000.


MORRIS PLAINS, NJ--(BUSINESS WIRE)--May 18, 1999--

Company Reveals New Co-Promotion Agreement with Sankyo

Warner-Lambert Company (NYSE NYSE

See: New York Stock Exchange
: WLA WLA Women's Land Army
WLA West Los Angeles (California, USA)
WLA Wisconsin Library Association (Madison, WI)
WLA World Lottery Association
WLA Western Lacrosse Association
WLA Wasteload Allocation
) Chairman, President and Chief Executive Officer, Lodewijk J. R. de Vink, today said that, based on current planning assumptions, the Company is on track to achieve 30 percent diluted earnings per share diluted earnings per share

An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of
 growth for 1999 and 20 percent diluted earnings per share growth in 2000.

The Company also announced a new agreement with Sankyo Co., Ltd. to co-develop and market a second generation compound from the thiazolidinedione, or "glitazone," class to treat type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
; and reviewed several product candidates in early and late-stage development.

Speaking to financial analysts as part of a half-day series of presentations on the Company's pharmaceutical pipeline, de Vink said, "Warner-Lambert has achieved seven straight quarters of 30 percent-or-better growth in earnings per share. We expect to achieve our goal of 30 percent earnings per share growth in 1999, to approximately $1.92 a share. Furthermore, we project earnings per share growth of 20 percent in the year 2000, a growth rate we expect to be in the top tier of the companies with whom we are logically compared."

de Vink noted that the Company's "organic-plus" strategy targets alliances as critical to Warner-Lambert's growth and ability to build shareholder value. He said, "today, more than 25 percent of the Company's discovery dollars are focused on alliances with biotech firms. Many offer intellectual property or research technologies, thus allowing Warner-Lambert to extend drug discovery beyond the Company's boundaries." Citing Warner-Lambert's strategy to meet its growth objectives, de Vink said the Company is "increasing the value of existing drugs through strategic life-cycle management and more aggressive market penetration. We are capitalizing on our strong financial position in order to fund acquisitions and alliances that improve our pipeline, expand our geographic reach, or reduce our costs." He added that while Warner-Lambert is no longer a company "built on three equal platforms," the consumer products businesses allow the Company to grow shareholder value on multiple fronts."

Sankyo Collaboration

Warner-Lambert also announced that it has entered into an agreement with Sankyo to co-develop and market R-119702, a novel anti-diabetic compound that is a second-generation glitazone for the treatment of type 2 diabetes. Based on its preclinical profile, R-119702 has the potential to provide greater efficacy than other glitazones, including effective treatment even in the most advanced stage of the disease when other agents are ineffective. The compound, significantly more potent than other known glitazones, will enter clinical trials later this year and both companies anticipate an accelerated development schedule.

Research and Development Productivity

Reviewing progress in pharmaceutical development, Peter B. Corr, Ph.D., president, pharmaceutical research and development, also cited the Company's "organic plus" strategy of internal growth complemented by acquisitions and alliances. Dr. Corr said, "Warner-Lambert is markedly accelerating its major initiatives to ensure our sustainable long-term growth." The Company has a total of 32 research and development alliances and numerous partnerships, each one linked to strengthening Warner-Lambert's pipeline. Dr. Corr said that the Company expects to spend nearly $1.2 billion in pharmaceutical research and development this year -- a 51 percent increase over 1998 and almost triple since 1995. In addition, he said that by the end of this year, the Company will have more than 4000 colleagues in research and development worldwide.

Highlighting Warner-Lambert's achievements during the past year, Dr. Corr said the Company moved nine compounds into preclinical development and submitted a record 10 investigational new drug applications (INDs). In addition, three projects moved into Phase I clinical trials, four advanced into Phase II and two moved into Phase III full scale development. In the U.S., two new drug applications (NDAs) were filed in addition to seven supplemental new drug applications (sNDAs). Outside the U.S., 13 submissions were made to regulatory authorities.

Citing the Agouron acquisition as having complemented and enhanced the Company's research and development efforts, Dr. Corr said Agouron has provided Warner-Lambert with access to an additional library of more than 400,000 compounds, doubling the total number now available to the Company's global research teams. Agouron enhanced the Company's already strong drug discovery capabilities with access to state-of-the art technologies such as structure-based drug design that will enable and enhance Warner-Lambert's efforts to develop novel small-molecule drugs that play key roles in such serious diseases as cancer and AIDS. Another Agouron core competency is combinatorial chemistry - a technology that generates hundreds of thousands of compounds that can be analyzed by computerized high-speed robotics in screening assays against target molecules. With the inclusion of Agouron into the Company's portfolio, Warner-Lambert now has 46 new chemical compounds and 55 distinct clinical projects under active development. In 1999, Warner-Lambert's goals are to obtain marketing approvals or approvable letters on seven projects (NDAs/sNDAs) and to file regulatory submissions in the U.S. on another seven projects. Dr. Corr said the Company expects to file 11 INDs, and to select at least 10 high quality lead compounds and move them into active development. Through 2003, Warner-Lambert anticipates 37 NDAs and sNDAs to be submitted for regulatory approval in the U.S.

Life Cycle Management Program Overview

Robert Zerbe, M.D., senior vice president, worldwide clinical research and development, Parke-Davis Research and Anthony H. Wild, Ph.D., president, Warner-Lambert worldwide pharmaceutical sector presided over a discussion of the Company's plans to extend and expand the life-cycle of some of its most important marketed products. This includes plans to explore their full potential for therapeutic benefit and commercial success.

In 1998, Lipitor led Warner-Lambert's pharmaceutical sector growth with worldwide sales of $2.2 billion -- more than double the previous year. Lipitor, an HMG- CoA reductase reductase /re·duc·tase/ (-tas) a term used in the names of some of the oxidoreductases, usually specifically those catalyzing reactions important solely for reduction of a metabolite.  inhibitor, "or statin," continues to be the most prescribed cholesterol-lowering agent in the U.S., currently holding a 45 percent share of new prescriptions in the U.S. market for statins, by far the largest segment of the overall cholesterol-lowering market. Looking ahead, the Company envisions the global market for statins increasing to $10 billion, or more, and has set its sights on exceeding a 50 percent market share.

With Yamanouchi as its collaborator in Japan, the Company is preparing to launch Lipitor in the world's second biggest market for cholesterol lowering drugs, with worth an estimated $2.5 billion today. Hopeful of an introduction as early as the first quarter of next year, Warner-Lambert's ultimate sales goal in Japan is in excess of $1 billion per year.

The Company's life-cycle management plan for Lipitor is targeted at maximizing the compounds compelling clinical advantage -- better efficacy and lower doses than other available statins. In total, Warner-Lambert has nearly 200 clinical trials in over 100,000 patients underway to explore the full therapeutic range of Lipitor.

Randall Whitcomb, M.D., vice president, clinical research, Parke-Davis reviewed the outcome of a March 26th FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 Advisory Committee meeting to review Rezulin (troglitazone troglitazone

a thiazolidinedione compound that enhances peripheral insulin resistance in the management of diabetes mellitus.
) post-marketing safety and efficacy data and the Company's supplemental new drug application for combination therapy with sulfonylureas and metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus.

met·for·min
n.
. Rezulin is an oral agent for the treatment of type 2 diabetes. The Advisory Committee members reaffirmed that the benefits of Rezulin therapy outweigh the risks in combination therapy and commented favorably on the use of the drug in combination with metformin and sulfonylureas. Dr. Whitcomb said the Company is in the process of agreeing on labeling changes which should be finalized soon.

Dr. Zerbe also discussed the Company's epilepsy therapy, Neurontin (gabapentin), approved in 1993. He acknowledged that the product is facing the near-term loss of its epilepsy use patent but added that the Company has two additional patents extending into the next decade, which are currently in litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 with two potential generic competitors. However, the ultimate legacy of Neurontin will be the knowledge Warner-Lambert has gained about the entire class of compounds, the gabapentenoids. Citing the next generation compound, pregabalin, Dr. Zerbe said that the Company expects that it will be a superior product with greater potency, absorption and a longer duration of action.

Celexa (citalopram citalopram /ci·tal·o·pram/ (si-tal´o-pram)
1. an antidepressant compound used in the treatment of major depressive disorder, administered orally as the hydrobromide.

2.
), Forest Laboratories' selective seratonin reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance.

re·up·take
n.
 inhibitor for the treatment of depression, is co-promoted by Warner-Lambert and currently holds more than a 7 percent share of new prescriptions. Celexa, discovered by H. Lundbeck A/S, has quickly surpassed recent entrants into the category. Launched only 8 months ago, the Company expects Celexa to achieve 1999 sales of $300 million.

Accupril (quinapril), launched in 1991, has risen to the number three spot in the U.S. ACE inhibitor market, fueled by a continuing aggressive and creative clinical program focused on the drug's unique activity in tissue ACE - and translating that effect into real clinical advantages. For example, in the Company's "Quo Vadis" study, Accupril produced a 77 percent reduction in the occurrence of events in patients undergoing coronary by-pass surgery.

Omnicef (cefdinir), a third generation oral cephalosporin cephalosporin (sĕf'əlōspôr`ĭn), any of a group of more than 20 antibiotics derived from species of fungi of the genus Cephalosporium and closely related chemically to penicillin. Cephalosporins, e.g.  licensed from Fujisawa, holds the number one position in its category in Japan. Clinical studies demonstrated Omnicef's extended spectrum of activity, high potency, effectiveness once or twice daily and, in a 5-day regimen, superiority to penicillin in the treatment of pharyngitis pharyngitis

Inflammation and infection (usually bacterial or viral) of the pharynx. Symptoms include pain (sore throat, worse on swallowing), redness, swollen lymph nodes, and fever.
. Omnicef has also demonstrated efficacy in a wide spectrum of clinical infections including community acquired pneumonia, chronic bronchitis, sinusitis sinusitis

Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise.
 and skin infections.

Discovery and Exploratory Development

Wendell Wierenga, Ph.D., senior vice president, worldwide preclincal research, development and technologies, Parke-Davis Research, reviewed the Company's early drug discovery efforts and exploratory development programs. Dr. Wierenga also highlighted several of the Company's almost three dozen key research and development alliances and partnerships. Many of these partnerships are biotech alliances and they range from drug discovery and development to enabling technologies. He cited these alliances as contributing four new candidates for clinical development in 1999.

Dr. Wierenga discussed a new collaboration with Berlex/Schering AG in thrombosis research that was announced today. Specifically, the companies plan to co-develop inhibitors of factor Xa which are nearing clinical evaluation. Joining another Xa inhibitor in Warner-Lambert's pipeline, these compounds have the potential to prevent thrombus thrombus /throm·bus/ (throm´bus) pl. throm´bi   a stationary blood clot along the wall of a blood vessel, frequently causing vascular obstruction.  formation and are being targeted for indications that include acute coronary syndromes and the prevention of deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. , including primary and secondary prevention.

Agouron Acquisition

Peter Johnson, president, Agouron Pharmaceuticals, Inc., a wholly-owned subsidiary of Warner-Lambert provided analysts with an overview of their research and marketing efforts. Viracept, Agouron's first commercial product and the country's leading product for the treatment of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  infection and AIDS, continues to be the subject of a very aggressive Phase IV program of more than 125 studies. Johnson reviewed a portfolio of approximately 20 research and development initiatives spanning the areas of virology virology, study of viruses and their role in disease. Many viruses, such as animal RNA viruses and viruses that infect bacteria, or bacteriophages, have become useful laboratory tools in genetic studies and in work on the cellular metabolic control of gene expression , oncology and opthalmology. The most advanced compounds include:

-- Prinomastat (AG3340), an MMP MMP Matrix Metalloproteinase (enzymes related to tissue healing/remodeling and cancer cell metastasis)
MMP Mixed Member Proportional (New Zealand electoral system)
MMP Multi-man Publishing
 (matrix metalloprotease) inhibitor, the most advanced product in Agouron's oncology program, is currently in large-scale pivotal clinical trials and could move toward an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  submission by the end of next year. Prinomastat is also being studied for age-related macular degeneration Age-related macular degeneration (ARMD)
Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60.
, a progressive loss of central vision that is the leading cause of blindness in the elderly.

-- AG7088, a compound designed to inhibit the rhinovirus rhinovirus

Any of a group of picornaviruses capable of causing common colds in humans. The virus is thought to be transmitted to the upper respiratory tract by airborne droplets.
 3C protease, the most frequent cause of the common cold, is potently active against all 48 strains of virus that have been tested. Currently in Phase II studies, AG7088 could enter large scale Phase III clinical studies later this year and possibly lead to an NDA by the end of 2001.

-- AG1549, a non-nucleoside reverse transcriptase inhibitor Noun 1. non-nucleoside reverse transcriptase inhibitor - an antiviral drug used against HIV; binds directly to reverse transcriptase and prevents RNA conversion to DNA; often used in combination with other drugs
NNRTI
, is currently completing Phase II dose-ranging studies in preparation for larger pivotal trials that, if successful, could lead to an NDA submission toward the end of next year.

-- Remune, an immune-based therapeutic agent for the treatment of HIV infection and AIDS, was discovered by The Immune Response Corporation and is currently being co-developed by Agouron. Remune, a first in class therapy, represents a novel approach to treating HIV infection and is intended to supplement current anti-HIV drugs. Phase III surrogate marker trials involving Remune are scheduled to begin this year.

Advanced Development Overview

Dr. Zerbe also reviewed progress in pharmaceutical development and highlighted compounds either awaiting marketing clearance or in advanced clinical development. Dr. Wild addressed the commercial potential of these and other selected compounds. The products include:

-- FemHRT (norethindrone norethindrone /nor·eth·in·drone/ (nor-eth´in-dron) a progestational agent having some anabolic, estrogenic, and androgenic properties; used as the base or the acetate ester in the treatment of amenorrhea, dysfunctional uterine bleeding,  acetate/ethinyl estradiol), a continuous combined estrogen replacement product, is highly effective in the prevention of bone loss in postmenopausal post·men·o·paus·al
adj.
Of or occurring in the time following menopause.


postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr
 patients. A head-to-head study comparing FemHRT to Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) is well underway and an additional study comparing FemHRT to both Prempro and Evista (raloxifene hydrochloride) will begin soon.

-- Clinafloxacin, a quinolone antimicrobial, currently awaiting FDA approval. When approved, clinafloxacin will be the most potent antibiotic available in the U.S. and other major markets. The product's use will be limited to parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc.

par·en·ter·al
adj.
1.
, in-hospital use due to photosensitivity Photosensitivity Definition

Photosensitivity refers to any increase in the reactivity of the skin to sunlight.
Description

The skin is a carefully designed interface between our bodies and the outside world.
 and glucose lowering, both potentially serious side effects.

-- Darbufelone, a dual inhibitor for the treatment of rheumatic rheu·mat·ic
adj.
Relating to or characterized by rheumatism.

n.
One who is affected by rheumatism.



rheumatic

pertaining to or affected with rheumatism.
 disorders including arthritis and inflammation. While clinical trials confirmed the excellent gastrointestinal safety profile of the drug, the efficacy in osteoarthritis and rheumatoid arthritis was no better than NSAIDs. Preclincial data indicates that higher doses may be more efficacious and the Company has reinitiated efficacy studies at higher doses.

-- Igmesine, a unique antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy.  that was shown to be superior to placebo in a Phase II study of outpatients in Europe. Three additional Phase II placebo and positive controlled studies began last year which should provide results by early summer.

-- Avasimibe, an ACAT ACAT

See: Automated Customer Account Transfer
 inhibitor, for the reversal or prevention of atherosclerosis represents a new frontier in vascular disease. The Company has initiated eight clinical studies evaluating various functional and anatomical markers which should begin reporting next year. Warner-Lambert envisions avasimibe being used broadly and along with lipid lowering medications to reverse atherosclerotic plaque.

-- Zenarestat is an aldose reductase inhibitor aldose reductase inhibitor Clinical therapeutics Any of a family of compounds–eg, epalrestat, ponalrestat, sorbinil, tolrestat, which block aldose reductase; ↑ intracellular glucose leads to ↑ sorbitol, which competitively inhibits glomerular and  licensed from Fujisawa for the prevention of diabetic neuropathy. Following encouraging Phase II studies, large-scale prevention trials are currently underway. One trial is using nerve conduction velocity and quantitative sensory function to determine benefit. The other trial is an endpoint study looking at ulcer and amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly . The results of the two prevention trials will not be known for approximately two years after enrollment is complete.

-- Pregabalin, an anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this.

an·ti·con·vul·sant
n.
A drug that prevents or relieves convulsions.
 in the gabapentonoid class, is under development for epilepsy, neuropathic pain and other CNS See Continuous net settlement.

CNS

See continuous net settlement (CNS).
 disorders such as panic, generalized anxiety, social phobia and bipolar disease. The compound is minimally metabolized, making drug interactions unlikely. 26 studies are already underway or completed and an additional 50 are planned and scheduled to start within the next year. The Company said that of all the compounds in its pipeline, pregabalin is the most commercially promising.

-- A new Neurontin/NSAID (non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. ) combination product with striking synergies has shown promise in preclinical models. The Company has preclinical evidence that when Neurontin is co-administered with ulcerogenic ulcerogenic /ul·cer·o·gen·ic/ (ul?ser-o-jen´ik) causing ulceration; leading to the production of ulcers.

ul·cer·o·gen·ic
adj.
Tending to cause an ulcer.
 doses of NSAIDs such as indomethacin indomethacin /in·do·meth·a·cin/ (in?do-meth´ah-sin) a nonsteroidal antiinflammatory drug; used in the treatment of various rheumatic and nonrheumatic inflammatory conditions, dysmenorrhea, and vascular headache. , there is clear reduction of gastrointestinal ulcers. Phase II studies in dental pain and osteoarthritis flare with gabapentin and naproxen naproxen and naproxen sodium, potent nonsteroidal anti-inflammatory drugs (NSAID) used to alleviate the minor pain of arthritis, menstruation, headaches, and the like, and to reduce fever.  have been initiated.

Warner-Lambert is a global company devoted to discovering, developing, manufacturing, and manufacturing quality pharmaceutical, consumer health care, and confectionery products. It employs more than 43,000 people worldwide.

Statements made in this press release that state "we believe," "we expect" or otherwise state the Company's predictions for the future are forward-looking statements. Actual results might differ materially from those projected in the forward-looking statements. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in the Company's annual report on Form 10K-A K-A Kids to Adults (former ESRB game rating, 6 yrs. and up)  for the year ended December 31, 1998 filed with the U.S. Securities and Exchange Commission. For a copy of this filing, call the media contacts listed on the press release.

Note to Editors: Warner-Lambert's press releases can be found on our Website at www.warner-lambert.com or through Business Wire at www.businesswire.com
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:May 18, 1999
Words:2622
Previous Article:Carreker-Antinori Reports Record First Quarter Fiscal 1999 Financial Results.
Next Article:Petal Gas Storage Company Announces Contract With Southern Company Services, Inc. for Natural Gas Storage.
Topics:



Related Articles
Warner-Lambert Reports Record Sales and Earnings for Fourth Quarter and Year.
Warner-Lambert Announces Goodes to Retire; de Vink Named Successor.
Warner-Lambert Reports First Quarter EPS Gain of 36% On Sales Increase of 29%.
Warner-Lambert Reports Third Quarter EPS Gain of 38% On Sales Increase of 20%.
Warner-Lambert and American Home Products to Merge, Creating World's No. 1 Pharmaceutical and Consumer Health Products Company.
Warner-Lambert Reports Record Sales and Earnings for Fourth Quarter and Year.
Warner-Lambert Reports First Quarter Sales and Earnings Results.
Rezulin: fast track to failure.
First Horizon Pharmaceutical Corporation Reports Second Quarter Earnings.
The perils of playing to quarterly expectations: focusing on the short term in order to please investors can be a destructive trap. Two consultants...

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles