Transcript What is Nanocrystal Technology

Elan Corporation plc.
Advancing science, changing lives
1
Safe Harbor
This is an independent study performed by
students from the Faculté des Sciences
Pharmaceutiques of Lille.
The opinions expressed are our own and not
necessarily those of Elan Corporation plc.
2
Overview of the company
• Created on 18 December 1969 by Donald Panoz
• Became a public limited company in January 1984
• Stock Exchange Listings
– New York Stock Exchange (ELN)
– Irish Stock Exchange (ELN.I)
• Elan Corp = 2 business units:
Elan Drug Technology
Integrated technology
BioNeurology
BioPharmaceuticals
Science and clinical based
• Oral Controlled Release
• Parkinson’s disease
• NanoCrystal technology
• Alzheimer’s disease
• Multiple sclerosis
Elan website
28th Annual J.P. Morgan Healthcare Conference, on January 13, 2010
3
Locations and subsidiaries in 2009
OCR
NanoCrystal
Others
Dublin
King of Prussia
San Francisco, CA
• Leased
• R&D
• sales
• administration
• 334,000 sq. ft
Gainesville, GA
• Owned
• R&D
• manufacturing
• administration
• 89,000 sq. ft
http://www.elandrugtechnologies.com/locations
Annual Report 2009
• Leased
• R&D
• manufacturing, sales
• administration
• 113,000 sq. ft
• Leased
• Headquarters
• 41,000 sq. ft
Athlone
• Owned
• R&D
• manufacturing
• administration
• 463,000 sq. ft
Bermuda
Financial services
company
4
Elan Drug Technology’s pipeline
5
Elan website
Elan BioNeurology’s pipeline
Discovery
Pre-clinical
Phase I
Phase II
Phase III
Marketed
Parkinson’s
research
AAB-002
ELND006
Bapineuzumab
SC
Bapineuzumab
IV
Tysabri
(US/UE)
ELND007
Natalizumab
(Myelome
multiple)
ACC-001
LY450139
Tysabri US
Gamma
secretase
ELND004
ELND005
Prialt
ELND002
Natalizumab
SC
Azactam
Autoimmune
research
Alzheimer’s disease
Multiple sclerosis
Crohn’s disease
Chronic pain
Other
Maxepime
6
Elan website
Elan
Drug
Technology
 History with Donald Panoz
 NanoCrystal and Oral Controlled Release
 Yesterday : Tricor, Skelaxin, Ritalin, Verelan
 Today : Ampyra, Invega Sustenna, Zypadhera
 Tomorrow ?
1969
• Donald Panoz,, moves to Ireland and launches Elan Corporation.
1978
• Elan opens a research and development center in Athlone, Ireland
1984
• Elan floats its U.S. subsidiary on the NASDAQ
1990
• Elan absorbs its U.S. subsidiary and launches a full public offering on
the New York, London, and Irish Stock Exchanges.
1993
• The company acquires a manufacturing operation in Lugano,
Switzerland.
1995
• The company acquires a manufacturing facility in Israel.
1996
• New strategic direction as a full-scale pharmaceuticals company with
the acquisition of Athena Neuroscience in the United States
1998
• Elan acquires GWC Health and Neurex.
2002
• Elan's stock collapses after the Securities and Exchange Commission
launches an investigation into the company's accounting practices.8
• AN 1792: meningo-encephalitis
Business Overview
Expertise in drug formulation, development, scale-up & manufacture
• More than 30 products launched in 100+ countries
• 15 products in clinical development
• Extensive product development, scale-up and manufacturing capabilities in US and
EU
World’s leading drug delivery company
• 40 years of innovation and expertise in drug delivery
• Most successful drug delivery provider in US in recent times – 11 products launched
since 2001
Robust drug delivery portfolio in the industry
9
Elan collaborative model
10
Elan website
What is Nanocrystal Technology ?
 Technology using tiny drug particles in the nanometre scale
 The drug size is reduced by a proprietary milling technique
 GRAS stabilisers are absorded on the nanoparticle to afford agglomeration
 GRAS stabilizers must be safe and are excipients commonly used in
marketed products ( fat acid, polymers)
Objective: obtain a
colloïdal dispersion
11
Elan website
Effects of NanoCrystal on bioavailability
• Nanocrystal technology is used:
 For poorly water soluble drugs: ↑ solubility ↑ bioavailability
 For moderately soluble drugs when high concentration is need in a low fluid volume
• Useful for all dosages forms both parenteral and solid ,liquid oral dosage forms
12
Point on Oral Controlled Release
Avinza, Cardizem,
Focalin, Ritalin,
Verelan, Luvox,
Zanaflex
Naprelan
Verelan
Afeditab
13
Yesterday…
Trade name
Generic name
Indication
Technology
Tricor® 145mg
fenofibrate
Dyslipidemia
NanoCrystal
Skelaxin®
metaxolone
Skeletal-muscular
pain
NanoCrystal
Ritalin®
/ Focalin®
Methylphenidrate/
Dexmethylphenidate
Hyperactivity
OCR
(SODAS)
Verelan®
verapamil
Cardiac disorders
OCR
(CODAS)
Parteners
14
Tricor® : what’s that?
• API: micronised fenofibrate (prodrug)
• Indications: Dyslipidemia type IIa, IIb, IV, III,V
• 2004: Tricor® 145 launched by Abbott and manufactured by Elan using
NanoCrystal technology
• Could market lower dosage strength with 9% improve in bioavailability
• Minimised food effect:
 Class formulation: 30-50% fasting Vs 60-90% while eating
 Micronized formulation: bioavailability 100% without conditions.
• Patented formulation expiry on 9-Jan-2018
15
Today…
Trade name
Generic name
Indication
Technology
Paliperidone
palmitate
Schizophrenia
NanoCrystal
Fosaprepitant
dimeglutine
Emetogenic
chemotherapy
NanoCrystal
Olanzapine
Schizophrenia
NanoCrystal
Fampridine
Cardiac disorders
OCR
(MXDAS)
Parteners
16
Ampyra® (Fampridine) : What is it ?
• FDA approval on 22 jan 2010
• Indication : improved walking in patients
with multiple Sclerosis
•
Extended released tablets using Oral release
technology MXDAS
• Mechanism = not fully elucidated =>
®
several hypotheses for Ampyra’s
mechanism:
 Fampridine is a broad spectrum potassium
channeblocker
 Fampridine increases conduction of action
potentials in demyelinated axons through
inhibition of potassium channels
 Increase acetylcholine release at the
neuromuscular junction
17
Ampyra®: the deal
Elan and Accorda, a joint venture since 1998 for MS
US$35.7millions
from Accorda for the
drug delivery
Biogen paid:
upfront: US$ 110 millions
milestones: US$400 millions
16% of royalties for elan
manufacture in Athlone’s facility
rest of the world marketing
http://seekingalpha.com/article/184252-acorda-after-fda-approval-what-s-next-for-ampyra
http://www.iguanabio.com/acorda-biogen-in-ex-us-deal-for-fampridine-sr-no-us/
18
Ampyra®’s forecast sales
•
•
Represents the sales in U.S
Ampyra will be launched in March 2010
19
… and tomorrow for Elan Drug Technology
20
Elan website
Elan BioNeurology
 Yesterday : Azactam®/Maxipime®, Prialt®
 Today : Tysabri ®
 Tomorrow :
• Alzheimer Immunotherapy Program
• Research in Parkinson’s disease
21
Timeline of Elan’s marketed products
• From 1969 to early 1990’s : Elan only worked in drug delivery domains
• Then, Elan’s activities widened with collaboration from research to market of drugs
1995
• Maxipime® (Cefepime)
• Azactam® (Aztreonam)
1996
•
Tysabri® (Natalizumab)
1998
•
Prialt® (Ziconotide)
2000
•
AIP Program
Beginning of a new business unit called Elan
Biopharmaceuticals, then Elan BioNeurology
22
Maxipime® (cefepime) : what’s that?
•
•
•
•
Semi-synthetic forth-generation cephalosporin
Mechanism of action :
– Inhibits final transpeptidation of peptidoglycan synthesis in bacterial cell walls
– inhibiting cell wall biosynthesis
Broad spectrum activity
Indications
– respiratory tract infection
– skin infections
– urinary tract infections
– febrile neutropenia
– Intra-abdominal infections
The product was
launched worldwide in
1995
Thomson
The basic U.S. patent
for Maxipime expired
in March 2007.
Elan acquired US
comarketing rights
from BMS in January
1999
Stop distributing
Maxipime as of
September 30, 2010.
23
Maxipime® (cefepime) revenues
150
120
90
60
- 78%
USD (Millions)
USD (Millons)
180
30
0
Annual report 2009
Thomson
Bristol-Myers Squibb Co
Elan Corp plc
24
Prialt® (ziconotide)
25
Prialt® (ziconotide) : what’s that?
Member of the ω conotoxin family
o 25 aminoacids and 3 disulfide bonds
o prepared by chemical synthesis
Pain
Transmitting
nerves
Pain signal
Targets N-Type voltage sensitive calcium
channels = > diminished neurotransmitter
release
Ziconotide
Intrathecal formulation
N-type
calcium
channel
Calcium
26
History of Prialt® (ziconotide)
May 1993
Neurex (now Elan) joined Warner-Lambert (now Pfizer) in a collaboration to cooperate in the
development and commercialization of ziconotide for the treatment of brain ischemia
early 1995
phase II trials for the prevention of brain damage halted due to some patients experiencing hypotension.
Neurex received permission from the FDA in May 1995 to resume these trials
Aug. 1999
9th World Congress on Pain meeting in Vienna, Austria : results of a placebo controlled study into the
use of intrathecal ziconotide in the treatment of chronic pain in opioid-resistant non-cancer patients
May 2001
37th ASCO meeting in San Francisco : clinical data for chronic pain in cancer and AIDS patients
9 Jul. 2001
Orphan designation granted by the European Commission
Feb. 2002
Elan had reached an agreement with the FDA and had agreed to conduct one additional phase III
2004
Pain Management 2004 meeting in London, UK
4th annual conference on Ion Channels in Drug Discovery Development in Philadelphia, PA.
Apr. 2005
Lauch market in the USA
Mar. 2006
Eisai acquired the European rights to ziconotide from Elan
Elan received ~ $60 million for the launch in key European markets +$40 million contingent on Prialt
achieving revenue related milestones in Europe.
2016
Expiration of fundamental U.S. patent covering the use of ziconotide
27
Thomson
Tysabri® (natalizumab)
28
Tysabri® (natalizumab) : what is it ?
•
•
•
Humanized Monoclonal Antibody (recombinant IgG4)
Targets selectively human α4-integrine
Trade names : Tysabri®, Antegren®
Integrines α-4
• Expressed on cell membrane
• In association with β1 or β7 integrines
• Adherence molecules on activated T-cells, B-cells,
monocytes, eosinophils, basophils, leukocytes, NK
cells, dendritic cells, and vascular endothelium of
some organs.
• Implicated in leukocytes homing to CNS and GIT
GASTROENTEROLOGY, 2009, Vol. 136, Issue 4, 1182-1197
M/S : medecine sciences, vol. 21, n° 10, 2005, p. 797-798.
Drug Discovery Today Volume 12, Numbers 13/14 July 2007
29
Tysabri® dealings
1996
Elan was collaborating with
Axogen on the development of
natalizumab
1999
Elan acquired Axogen
August 2000
Elan entered into a worldwide exclusive
collaboration with Biogen for the joint
development, manufacture and
commercialization of natalizumab.
23-Nov-2004
Initially approved by FDA
for treatment of RRMS.
30
Thomson
Tysabri®’s timeline
23-Nov-2004
25-Feb-2005
05-Jun-2006
FDA approval for
treatment of relapsing
forms of MS
Voluntary
suspension of
Tysabri market
FDA approved a special
restricted distribution
program for Tysabri
(TOUCH®)
18 MONTHS
18-Feb-2005
Mar- 2006
Jul-2006
Biogen learnt about 1
case of death to PML
and 2 suspected cases
of PML
REMS presented to
FDA : advisory panel
voted to support the
drug’s return
Tysabri’s reintroduction
to the market
Drug Discovery Today Volume 12, Numbers 13/14 July 2007
Nature Biotechnology, Nov 2009,vol 27, Numero 11
31
Tysabri® and PML
•
25-Feb-2006: Confirmation of 3 cases of PML (initial trials: 3,417 patients)
 2 patients during MS trial (SENTINEL) + 1 patient in trial for Crohn’s disease
 All 3 were on combination therapy with another immunosuppressive drug
 No patients on Tysabri alone developed PML
•
Progressive Multifocal Leucoencephalitis = opportunistic disease
 Agent = JC virus (Polyomavirus family)
 infects oligodendrocyts => local demyelinisation => neurologic dysfunction
 ~ 80% of population already met JCV before adult age => latent form (bone
marrow and kidneys)
•
Natalizumab + another immune drug
 fixation of natalizumab on VCAM-1 and MAdCAM-1 of endothelial cells
 inhibition of T-cells homing
 uncontrolled replication of JCV in CNS
32
N Engl J Med 2006;354:924-33.
33
Consequences on the stock
25-Mar-2005
26,90 $
28-Mar-2005
8,00 $
-67%
ELAN
25-Mar-2005
67,28 $
BIOGEN
28-Mar-2005
38,65 $
-50%
34
Yahoo finance
Tysabri®’s REMS: TOUCH® program
•
7-8 March 2006 : Risk Minimalisation Action Plan exposed to Peripheral and
Central Nervous System Drugs Advisory Committee Meeting => Goals :
o Warn patients about risk-benefit balance forTysabri use in treatment of MS patients.
o Contraindicated in immunocompromised patients
o Minimize health consequences of PML (death/disability) through early diagnosis
• Key elements of Tysabri Outreach: Unified Commitment to Health program
o
o
o
o
o
Mandatory enrollment of prescribers, infusion sites, and afflilated central pharmacies
Controlled distribution to authorized infusion sites and pharmacies
Education program for health care providers and patients
Safety surveillance of PML, serious opportunistic infections, and deaths
Program evaluation of health outcomes, process compliance, and assessment of
knowledge
Business Insights, 2009 « THE AUTOIMMUNE OUTLOOK TO 2013, Competitive landscape, pipeline analysis and growth opportunities »
Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, 31-Jul-2007
35
The benefit
• Natalizumab versus β-IFN is:
-
Sligthly more effective (MRI data)
Twice as effective (relapse-rate data)
More effective (EDSS data)
• Many people strongly believe
that Natalizumab is the most
effective drug we currently have.
• Patients asked the right to choose
and accept the risk
Tysabri returned to the US market in July 2006
36
Top 5 Multiple Sclerosis Drugs in 2007 (m$)
N°5 !
 Will Tysabri marketing setback affecting its own sales and
Elan’s business ?
37
Tysabri® sales rose, fell… then rise again!
Total Tysabri revenues
Elan corp revenues
350.0
300.0
250.0
200.0
150.0
100.0
50.0
0.0
Forecast Tysabri in-market net sales in 2013 : 1,3 b$
NB: Expected patent expiry by 2015
Life cycle management:
natalizumab SC
extension of indication to multiple myeloma
Nature Biotechnology, novembre 2009, vol 27, numero 11
Natalizumab, Thomson 2009
Business Insights, 2009
28th Annual J.P. Morgan Healthcare Conference, on January 13, 2010
38
Existing and Emerging Therapies for MS
2005
2006
2007
2010
2011
2012
2013
Orals
Injectables
BG 12 Oral
Fumarate
Oral
Cladribine
Rebif
Teriflunomide
Betaseron
FTY 720
Laquinimod
Copaxone
Fampridine
SB683699
ambulation indication?
Avonex
IV
IV Novantrone
Tysabri
Campath
Rituximab
II - RRMS; III - PPMS
Generic
Mitoxantrone
(oncology)
Daclizumab
(MS)
MBP 8298
approved
In phase II
In phase III
Filed
MLN1202
39
Alzheimer’s disease
40
The Alzheimer Immunotherapy Program
Alzheimer
Immunotherapy
Program
Research, develop
and commercialize
selective products
Main product:
Bapineuzumab
Includes multiple
compounds being
evaluated for slowing
the progression of
Alzheimer's disease.
41
http://www.ihsglobalinsight.com/SDA/SDADetail17223.htm
Two approaches for Alzheimer’s disease
Mécanismes Moléculaires dans les Démences Neurodégénératives Inserm-UM2-EPHE U710
La maladie d’Alzheimer : aspects moléculaires, diagnostiques et thérapeutiques
Octobre 2009
42
Figure 6
Neuropsychopharmacology (2009) 34, 142–158;
doi:10.1038/npp.2008.115
3 approaches in the Beta amyloid cascade
Three Approaches to
Disrupting the Beta
Amyloid Cascade
Preventing production
of beta amyloid in the
brain with secretase
inhibitors
Clearing existing beta
amyloid from the
brain
Preventing
aggregation of beta
amyloid in the brain
(ELND005)
44
Tomorrow : AIP
Gamma
secretase
ELND006
ELND007
Followson
Beta
amyloid anti
aggregation
ELND005
AIP
P75
modulator
Bapineuzumab
ACC-001
Follows-on
Beta
secretase
Janssen Alzheimer
Immunotherapy
Bapineuzumab
ACC-001
Follows-on
45
28th Annual J.P. Morgan Healthcare Conference, on January 13, 2010
The Deal
$885 M
18,4% Elan's capital
$ 500 M
IP Elan (AIP)
49,9% Janssen AI's capital
Estimated at $500 M
Royalties
Under conditions
BioCentury, the Berstein report on biobusiness
July 6, 2009
http://www.ihsglobalinsight.com/SDA/SDADetail17223.htm
Page A22 of 37
46
The Deal
Transaction
J&J purchased 107.3 million Elan's shares at $8,241/share
J&J also agreed not to acquire any more shares for the next five years
Royalties : ONLY after J&J has earned profits from the AIP equal to its $500 M
Janssen AI: all annual in-market sales
Royalties for Elan
$2 billion - $4 billion
5%
$4 billion - $ 10 billion
7%
> 10 billion
9%
The program will remain partnered with Wyeth, which was acquired by Pfizer Inc
(01/2009, $68 billion)
47
BioCentury, the Berstein report on biobusiness
July 6, 2009
Page A22 of 37
Bapineuzumab (AAB-001)
•
•
•
•
•
•
•
•
•
Name: AAB-001
Other Name: Bapineuzumab
Class: Humanized monoclonal antibody
Therapeutic Applications: Mild to moderate AD
Therapy Types: Protein : humanized monoclonal antibody against Aβ
Mechanisms: Designed to bind and remove the Aβ peptide that accumulates in
the brain
Development Status: Fast Track status from FDA in U.S
FDA Phase: Phase III
Side Effects:
– Passive immunotherapy will induce similar side effects is largely unknown.
One report has shown that frequency and severity of cerebral
microhemorrhage
– Vasogenic edema
48
Thomson
Bapineuzumab (AAB-001) : Phase III
Design
Multicentrique, randomized, double-blind, placebocontrolled, parallel-assigned trial, studies
4 studies : 2 with ApoE4 (+) & 2 withApo E4 (-)
2 US trials and 2 European phase III trial
Safety Objective
The safety and tolerability
Estimated study
Duration
18 Months
Dosing
0.5 mg/kg
1 mg/kg
Development
Fast Track designation from the FDA
Source : http://www.elan.com/Images/Bapineuzumab%20_AAB-001_%20Backgrounder%20Final_tcm3-20147.pdf
http://clinicaltrials.gov/ct2/show/NCT00574132?term=bapineuzumab&rank=1
http://clinicaltrials.gov/ct2/show?term=bapineuzumab&rank=4
49
Forecast sales and market share for bapineuzumab
50
2010 THOMSON REUTERS
Research on Parkinson’s disease
•
Several active early discovery efforts in Parkinson’s disease
•
The Michael J. Fox Foundation for Parkinson’s Research Program « Novel
Approaches to Drug Discovery »
•
In 2009, the program funded six research projects.
•
2006 : Michael J. Fox Foundation and Elan Commit up to $2 Million to Drive Novel
Therapies for Parkinson's
Annual report 2009
MJFF website
51
Our opinion about Elan Corporation plc.
• Financial Analysis
• SWOT
• Would we join Elan?
52
Major owners of Elan Corp. at 22-Feb-10
Janssen
Pharmaceuticals
18.4%
Shareholders
50.3%
Fidelity Management
and Research
Company
13.0%
Wellington
Management
5.9%
T. Rowe Price
4.0%
All directors and
officers as a group
(18 persons)
2.0%
Annual Report 2009
Norges Bank (The
Central
Bank of Norway)
3.1%
Westfield Capital
Management
3.2%
53
Total product revenue for 2009
106 m$
38.4%
61,6 m$
22.3%
34,9 m$
12.6%
32,6 m$
11.8%
22,1 m$
18,7 m$
6.8%
8.0%
0 m$
0.0%
EDT business
24,8%
BioNeurology
business
75,2%
724,3m$
86.5%
81,4m$
9.7%
16,5 m$
2.0%
13,2m$
1.6%
1,7m$
0.2%
54
Annual Report 2009
Revenues from marketed products of BioNeurology
900
800
700
600
Maxipime
500
Prialt
400
Azactam
Tysabri
300
200
100
0
2004
2005
2006
2007
2008
2009
55
Annual Reports
Elan Drug Technology: total revenue
350
300
250
Focalin XR / Ritalin LA
200
Skelaxin
Verelan
150
Tricor
Other
100
50
0
2004
2005
2006
2007
2008
2009
56
Annual Reports
Five years performance : EBITDA improvement
Adjusted EBITDA
150
100
USD (millions)
50
0
-50
-100
-150
-200
-250
2005
2006
2007
2008
2009
57
Annual Reports
Operating margin
50
31.9
0
2005
2006
2007
2008
2009
USD (millions)
-50
-100
-150
-200
-143.5
-164.4
-198.5
-250
-300
-265.3
58
Annual Reports
The consolidated Balance Sheet
Annual Report 2009
Assets
Current Assets
Cash and cash equivalents
Restricted cash and cash equivalents -- current
Investment securities -- current
Deferred tax assets -- current
Other current assets
Total current assets
Non-Current Assets
Intangible assets, net
Property, plant and equipment, net
Equity method investment
Investment securities -- non-current
Deferred tax assets -- non-current
Restricted cash and cash equivalents -- noncurrent
Other assets
Total Assets
Liabilities and Shareholders' Equity/(Deficit)
Accounts payable, accrued and other liabilities
Long-term debt
Shareholders' equity/(deficit)
Total Liabilities and Shareholders'
Equity/(Deficit)
2008
US$m
2009
US$m
375.3
20.2
30.5
95.9
240.1
762.0
836.5
16.8
7.1
23.9
274.9
1,159.2
553.9
351.8
-8.1
145.3
15.0
417.4
292.8
235.0
8.7
174.8
14.9
31.5
1,867.6
42.9
2,345.7
334.8
1,765.0
(232.2)
1,867.6
311.5
1,540.0
494.2
2,345.7
59
Elan’s debt 2005-2009
Elan's long term debt
2500
Due dates :
millions USD
2000
•
•
•
1500
1000
November 2011:300 m USD
December 2013: 615 m USD
October 2016: 625 m USD
500
0
2005
2006
2007
2008
2009
Strong indebtedness => the success of AIP is essential
Elan plc is restricted among various other things :
• Incur additional debt
• Enter into transactions with related parties
• Enter into some types of investment transactions;
• Engage in some asset sales or sale and leaseback transactions
• Pay dividends or buy back our ordinary shares
• Consolidate, merge with, or sell substantially all our assets to another entity
Widen
their capital
60
Annual Report 2009
61
Annual Report 2009
Five years performance : cost management
Operating expenses (m$)
Approximate 5
years change
700.0
600.0
500.0
232.0
220.0
262.9
323.4
400.0
293.6
↑ > 30%
300.0
200.0
359.0
360.0
339.3
292.7
268.2
2,005
2,006
2,007
2,008
2,009
100.0
↓ > 20%
0.0
SG&A expenses
R&D expenses
 Reduced SG&A and reinvest savings in R&D
62
28th Annual J.P. Morgan Healthcare Conference, on January 13, 2010
Number of employees in Elan corp.
700
600
500
R&D activities
Manufacturing and supply activities
Sales and marketing activities
400
300
General and administrative area
200
100
0
2005
2006
2007
2008
2009
Year
R&D
activities
Manufacturing and
supply activities
Sales and
marketing activities
General and
administrative area
Total
2005
471
583
310
365
1729
2006
494
543
328
369
1734
2007
553
547
211
299
1610
2008
656
601
123
307
1687
63
Annual Reports
Elan’s lawsuits
2002
2009
Elan vs Wolf
Popper LLP
Elan/J&J vs
Biogen
2008
Elan vs
Shareholders
64
Evolution of the stocks
AN1792 +
Wolf popper LLP
Yahoo finance
Launch
of Tysabri
Results of
Bapineuzumab
Clinical Trial
Tysabri withdrawal
65
Strengths
Weaknesses
•Leadership position in drug delivery
Important endebtedness
•Tysabri, its key product, sustaining the revenue growth
•patent expiry and risk of generic competition
•Strategic alliances bolstering the company’s business
•Geographic concentration enhancing business risk
•Tysabri marketing restricted indications affecting
Elan’s business
Elan Corp.
Opportunities
Threats
• Focus on Alzheimer’s market, could be a source of
revenues
• Intense competition from Avonex, Rebif against
•Benefits to accrue from growing incidences of
neurological disorders
•Patent expiries could affect company’s Revenues
•Favorable demographic shift increasing Alzheimer drug
market
Tysabri in the MS drug market.
•Legal proceedings could affect company’s
Reputation
•Reimbursement policies could affect company’s
product sale
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Conclusion
•
•
•
•
An important debt and short due dates.
Cash flow left only for 12 months!…
Tysabri revenues will not be enough.
No more constant revenues from BioNeurology
business unit.
• Elan depends on the success of the AIP, especially
on bapineuzumab success.
• So ?…
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Thanks for your attention!
Any question?
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