Anda di halaman 1dari 25

Evaluate Pharma - Export Results Page 1 of 25

Full Report

All Financial Data in US $ (mln)


Ranked on: Annual Sales WW / 2012
Rank 1
Product Avonex
Company Biogen Idec
Strategy Organic
Product Status Active
Market Status (Current) Marketed
Phase (Current) Marketed
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Autoimmune, Inflammation & Other
Originator Biogen
Licensee Abbott Laboratories (Latin America - Argentina, Brazil, Chile, Columbia, Mexico), Genzyme (Japan), Dompe (Italy) & Gedeon
Richter (Hungary, Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia & Russia), Genesis Pharma (Greece), SGP
(Spain) & Nicholas Piramal (India & Nepal)
Markets WW ex. Japan, Latin America, India, Italy & Central & Eastern Europe
Routes of Admin. Injection
Dosing Once weekly
Prescription Single source
Product Comment NOV 2003 Acquired through Biogen. MAR'03 Out-licensed Central & E. Europe rights to Gedeon Richter. MAR'02 FDA approve
Rebif (Serono) for MS: overturns BGEN's ODE. FEB'99 NKTR deal re: inhaleable form: BGEN has WW rights. 3Q'98 GENZ given
Japan rights.
First Introduction 5/16/1996
WW Product Age (Yrs) 11.5
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - -1 1432 1,4173 1,5434 1,7075 1,845 1,914 1,978 2,024 2,062 2,099
Growth per Year (%) - - +894% +9% +11% +8% +4% +3% +2% +2% +2%
Change per Year (+/-) - +143 +1,275 +126 +164 +138 +69 +64 +46 +39 +37

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - 1 1 1 1 1 1 1 1 1 1

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - 83% 96% 96% 97% 92% 88% 83% 80% 77% 74%

2006 Status Actual


2005 Status Actual

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 2 of 25

WW Min 2012 1,681


WW Max 2012 2,520
Forecast Statistics 2.6% CAGR 2007-2012; #Forecasts: 6; Median Value (2012) 2049; Avg. Analyst Date: Oct 07
Forecasters Cowen to 2012 (23 Oct 07); JP Morgan to 2012 (15 Oct 07); Morgan Stanley to 2012 (15 Oct 07); UBS to 2010 (10 Oct 07); Credit
Suisse to 2011 (23 Oct 07); Merrill Lynch to 2010 (24 Jul 07)
WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - -6 937 9238 9399 1,02210 1,092 1,133 1,156 1,178 1,201 1,223
Growth per Year (%) - - +896% +2% +9% +7% +4% +2% +2% +2% +2%
Change per Year (+/-) - +93 +830 +16 +84 +70 +41 +24 +22 +23 +22

NDA Classification New molecular entity


NDA Received 5/22/1995
FDA Approval Date 5/16/1996
Approval Time (Mths) 11.8
US NME Age (Yrs) 11.5
Review Status Priority review
Patent Status Patented
Patent Expiry 12/31/2013
WW Patent Life Remaining 6.1
(Yrs)
WW Patent Life (Yrs) 17.6
Patent Comment Patent date refers to IFN beta1a patents expiring 2001 (US#5326859) & 2013 (US#5514567). 8 MAR 2002 FDA approve Rebif
(Serono): overturns BGEN's ODE which was due to expire 16 MAY 2003. 1996 FDA grant ODE for relapsing MS. EU patent
expires 2005. Source: FDA, Broker's Report & Press release.
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - 5011 40712 50013 -
Growth per Year (%) - - +714% +23% -
Change per Year (+/-) - +50 +357 +93 -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Marketed
Launch WW 5/16/1996
Launch US 5/16/1996
Launch Europe 3/1/1997
Launch Japan 9/15/2006
Source Interim report
Last Updated 11/9/2006
Indication Comment MAY'03 FDA approved prefilled syringe formula. FEB'03 FDA approve in secondary progressive MS. DEC'02 In PII combination
trials. MAY'02 EMEA approve in early stage MS. JAN'02 Inhaleable form abandoned in PI.
2
Indication Level 3 Peripheral neuropathy

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 3 of 25

Indication Status (Current) Abandoned in R&D


Source Annual report
Last Updated 3/3/2006
Indication Comment In development for Chronic Inflammatory Demyelinating Polyradioneuropathy. MAR 2005 In PIIb enrolment.
3
Indication Level 3 Glioma
Indication Status (Current) Abandoned in R&D
Source Annual report
Last Updated 12/31/2000
Indication Comment Not mentioned in 2002 annual report - assumed to be abandoned in PII development. 1998 Initiated PII trial in the treatment of
glioma. Source: 1998 10-K. Trial not mentioned in 1999 10-K.
4
Indication Level 3 Pulmonary fibrosis, idiopathic
Indication Status (Current) Abandoned in R&D
Source Press release
Last Updated 3/11/2002
Indication Comment MAR 2002 Disclosed as discontinued in PII development (source: MAR 2002 Broker's report). 1998 initiated PII trial in the
treatment of Idiopathic pulmonary fibrosis.

Notes
1 Evaluate Comment:

Prior to 2003, Avonex sales were booked by Biogen.

2
Evaluate Comment:

Represents Avonex sales for the period following the close of the merger between IDEC and Biogen on November 13, 2003 through December 31, 2003
only.

Company Comment:

Source: 2003 10-K, page 4:


We currently market and sell AVONEX worldwide for the treatment of relapsing MS. In 2003, sales of AVONEX generated worldwide revenues of $1.17
billion as compared to revenues of $1.03 billion in 2002. Prior to the merger, AVONEX was sold by Biogen, Inc. Our 2003 consolidated financial
statements include only those operations of Biogen, Inc. that occurred during the period between November 13, 2003, the day after the effective date of
the merger, and December 31, 2003. Our revenues from AVONEX during this post-merger period were $142.6 million.

MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control,
paralysis and, in some cases, death. Patients with active relapsing MS experience an uneven pattern of disease progression characterized by periods of
stability interrupted by flare-ups of the disease after which the patient returns to a new baseline of functioning. AVONEX is a recombinant form of a
protein produced in the body by fibroblast cells in response to viral infection. AVONEX has been shown in clinical trials in relapsing forms of the disease
both to slow the accumulation of disability and to reduce the frequency of flare-ups. Biogen, Inc. began selling AVONEX in the U.S. in 1996, and in the
EU in 1997. Currently AVONEX is on the market in more than 60 countries. Based on data from an independent third party research organization, our
distributors and internal analysis, we believe that AVONEX is the most prescribed therapeutic product for the treatment of MS worldwide. Globally, over
125,000 patients have selected AVONEX as their treatment of choice. AVONEX is also the only product in the MS market that is currently covered by
Medicare.

As part of our commitment to AVONEX, we work to make treatment more convenient. In May 2003, the FDA approved a new pre-filled syringe
formulation which became available in the U.S. in August 2003 and replaced the dry powder form. We plan to reintroduce the dry powder form as an
additional alternative in the U.S. in 2004. The new formulation was approved by the EMEA in July 2003 and is being made available in the EU on a

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 4 of 25

country-by-country basis. We continue to explore other ways to improve the delivery and convenience of AVONEX.

We also continue to work to expand the quantity and quality of data available about AVONEX. The AVONEX label was amended in January 2003 to
include in the indication section MS patients with a first clinical episode and MRI features consistent with MS. This label change is based on the data
from our Controlled High Risk AVONEX Multiple Sclerosis Prevention Study, or CHAMPS. In CHAMPS, AVONEX was shown to have a highly
statistically significant beneficial effect on delaying the onset of a second exacerbation in patients who had experienced a single neurological event
consistent with MS. Based on the CHAMPS data, the regulatory authorities in the EU made a similar change to the AVONEX label in 2002. Given the
chronic nature of MS, we continue to study the long-term use of AVONEX. In May 2003, we announced that data presented at the Consortium of Multiple
Sclerosis Centers’ annual meeting demonstrated that AVONEX was generally well tolerated and produced low levels of neutralizing antibodies in
patients treated for up to eight years

An important component of our activities related to AVONEX is our ongoing clinical trial work. In September 2003, we announced the results of our
Controlled High Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance, or CHAMPIONS, an extension of CHAMPS,
which was designed to determine whether the effect of early treatment with AVONEX in delaying relapses and reducing the accumulation of MS brain
lesions could be sustained for up to five years. The study results showed that AVONEX altered the long-term course of MS in patients who began
treatment immediately after their initial MS attack compared to initiation of treatment more than two years after onset of symptoms. We decided to extend
CHAMPIONS for an additional five years in order to determine if the effects of early treatment can be sustained for up to 10 years. We also recently
completed a long-term, safety extension study of AVONEX in patients with relapsing MS and continue to support Phase 4 investigator-run studies
evaluating AVONEX in combination with other therapies.

Source: 2003 Preliminary Results (2 MAR 2004):


Revenues from AVONEX® (Interferon beta-1a), Biogen Idec's therapy for patients with relapsing forms of multiple sclerosis (MS), for the fourth quarter
increased 21 percent to $310 million (pro forma combined) from the fourth quarter of 2002. Full year AVONEX sales were $1.168 billion (pro forma
combined), an increase of 13 percent over the prior year sales. In 2003, U.S. sales of AVONEX were $800 million and international sales for AVONEX
were $368 million (pro forma combined).

Source: 2003 10-K, page 41:


AVONEX is the most prescribed therapeutic product in MS worldwide. Globally over 125,000 patients have chosen AVONEX as their treatment of
choice. Our results of operations for 2003 include sales of AVONEX for the period from November 13, 2003 through December 31, 2003. During that
period, sales of AVONEX generated worldwide revenues of $142.6 million, of which $92.6 million was generated in the United States and $50 million in
the rest of the world, primarily the European Union, or EU. Product sales from AVONEX represent approximately 21% of our total revenues in 2003.

Source: Q1 2003 Results (17 APR 2003):


In January, the U.S. Food and Drug Administration (FDA) approved the use of AVONEX to treat patients who have experienced their first Multiple
Sclerosis (MS) attack if brain scans show abnormalities characteristic of MS.

3
Company Comment:

Source: 2004 10-K, page 46:


AVONEX is the most prescribed therapeutic product in MS worldwide. Globally over 130,000 patients have chosen AVONEX as their treatment of
choice. During 2004, sales of AVONEX generated worldwide revenues of $1.4 billion, of which $922.6 million was generated in the U.S. and $494.6
million was generated outside the U.S., primarily in the EU. Product sales from AVONEX represent approximately 64% of our total revenues in 2004. Our
results of operations for 2003 include sales of AVONEX for the period from November 13, 2003 through December 31, 2003. During that period, sales of
AVONEX generated worldwide revenues of $142.6 million, of which $92.6 million was generated in the U.S. and $50.0 million in the rest of the world,
primarily the EU. Product sales from AVONEX represented approximately 21% of our total revenues in 2003. We expect to face increasing competition
in the MS marketplace in and outside the U.S. from existing and new MS treatments, including TYSABRI if it is reintroduced to the market, that may
impact sales of AVONEX. We expect future growth in AVONEX revenues to be dependent to a large extent on our ability to compete successfully.

Source: 2004 10-K, page 4:


We currently market and sell AVONEX worldwide for the treatment of relapsing MS. In 2004, sales of AVONEX generated worldwide revenues of $1.42
billion as compared to worldwide sales of $1.17 billion in 2003. AVONEX was sold by Biogen, Inc. until November 12, 2003. Our consolidated financial
statements include only the results of operations of Biogen, Inc. since November 13, 2003. Our revenues from AVONEX during the period from
November 13, 2003 to December 31, 2003 were $142.6 million.

MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control,

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 5 of 25

paralysis and, in some cases, death. Patients with active relapsing MS experience an uneven pattern of disease progression characterized by periods of
stability interrupted by flare-ups of the disease after which the patient returns to a new baseline of functioning. AVONEX is a recombinant form of a
protein produced in the body by fibroblast cells in response to viral infection. AVONEX has been shown in clinical trials in relapsing forms of MS both to
slow the accumulation of disability and to reduce the frequency of flare-ups. AVONEX is approved to treat relapsing forms of MS, including MS patients
with a first clinical episode and MRI features consistent with MS. Biogen, Inc. began selling AVONEX in the U.S. in 1996, and in the EU in 1997.
AVONEX is on the market in more than 60 countries. Based on data from an independent third party research organization, information for our
distributors and internal analysis, we believe that AVONEX is the most prescribed therapeutic product for the treatment of MS worldwide. Globally, over
130,000 patients have selected AVONEX as their treatment of choice.

As part of our commitment to AVONEX, we work to make treatment and delivery more convenient. For example, AVONEX is now available in a pre-filled
syringe formulation as well as a dry powder form. A syringe grip device to aid patients with compromised manual dexterity in injecting AVONEX was
approved by the FDA in 2004.

We also continue to work to expand the data available about AVONEX. We have extended the Controlled High Risk AVONEX Multiple Sclerosis
Prevention Study In Ongoing Neurological Surveillance, or CHAMPIONS. CHAMPIONS was originally designed to determine whether the effect of early
treatment with AVONEX in delaying relapses and reducing the accumulation of MS brain lesions could be sustained for up to five years. The study
results showed that AVONEX altered the long-term course of MS in patients who began treatment immediately after their initial MS attack compared to
initiation of treatment more than two years after onset of symptoms. The five-year study extension is intended to determine if the effects of early
treatment with AVONEX can be sustained for up to 10 years. We are conducting a study with Surromed, Inc. to investigate the biologic markers and
phenotype of MS patients with and without AVONEX treatment. We also continue to support Phase 4 investigator-run studies evaluating AVONEX in
combination with other therapies. In addition, we recently initiated enrollment into a Phase 2b study of AVONEX as a treatment for Chronic Inflammatory
Demyelinating Polyradioneuropathy.

In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of our other MS drug
TYSABRI and suspended dosing in all clinical studies of TYSABRI, including clinical studies of TYSABRI in combination with AVONEX. These decisions
were based on reports of two serious adverse events that have occurred in patients treated with TYSABRI in combination with AVONEX. These events
involved two cases of PML, a rare and frequently fatal, demyelinating disease of the central nervous system. Both patients received more than two years
of TYSABRI in combination with AVONEX.

Source: 2004 Preliminary Results (7 FEB 2005):


Full year AVONEX sales increased 21% to $1.42 billion (2003 adjusted pro forma non-GAAP: $1.17 billion). In 2004, U.S. sales were $922 million and
international sales were $495 million.

4
Company Comment:

Source: 2005 10-K, page 5:


We currently market and sell AVONEX worldwide for the treatment of relapsing forms of MS. In 2005, sales of AVONEX generated worldwide revenues
of $1.5 billion as compared to worldwide revenues of $1.4 billion in 2004. AVONEX was sold by Biogen, Inc. until November 12, 2003. Our consolidated
financial statements include only the results of operations of Biogen, Inc. since November 13, 2003. Our revenues from AVONEX during the period from
November 13, 2003 to December 31, 2003 were $142.6 million.

MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control,
paralysis and, in some cases, death. Patients with active relapsing MS experience an uneven pattern of disease progression characterized by periods of
stability that are interrupted by flare-ups of the disease after which the patient returns to a new baseline of functioning. AVONEX is a recombinant form of
a protein produced in the body by fibroblast cells in response to viral infection. AVONEX has been shown in clinical trials in relapsing forms of MS both to
slow the accumulation of disability and to reduce the frequency of flare-ups. AVONEX is approved to treat relapsing forms of MS, including patients with
a first clinical episode and MRI features consistent with MS. Biogen, Inc. began selling AVONEX in the U.S. in 1996, and in the EU in 1997. AVONEX is
on the market in more than 60 countries. Based on data from an independent third party research organization, information from our distributors and
internal analysis, we believe that AVONEX is the most prescribed therapeutic product for the treatment of MS worldwide. Globally, over 130,000 patients
have selected AVONEX as their treatment of choice.

We continue to work to expand the data available about AVONEX and MS treatments. In September 2005, we announced the initiation of the Global
Adherence Project, or GAP, the largest multi-national study of its kind to date to evaluate patient adherence to long-term treatments for MS in a real-
world setting. GAP is a global multi-center, cross-sectional observational study that will investigate factors that influence non-adherence to MS therapies.
The study aims to enroll over 1,800 patients with relapsing remitting MS in 24 countries who are currently taking one of the following therapies:

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 6 of 25

AVONEX, Betaseron® (Interferon beta-1b), Copaxone® (glatiramer acetate), or Rebif® (Interferon beta-1a). Patients will be evaluated through a
validated MS quality of life scale, as well as a self-reported questionnaire that collects data on disease status, treatment, and factors that may have
affected adherence to treatment during the course of their therapy.

We have also extended the Controlled High Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance, or CHAMPIONS.
CHAMPIONS was originally designed to determine whether the effect of early treatment with AVONEX in delaying relapses and reducing the
accumulation of MS brain lesions could be sustained for up to five years. The study results showed that AVONEX altered the long-term course of MS in
patients who began treatment immediately after their initial MS attack compared to initiation of treatment more than two years after onset of symptoms.
The five-year study extension is intended to determine if the effects of early treatment with AVONEX can be sustained for up to ten years. We also
continue to support Phase 4 investigator-run studies evaluating AVONEX in combination with other therapies. In addition, we are conducting a Phase 2
study of AVONEX as a treatment for Chronic Inflammatory Demyelinating Polyradioneuropathy.

In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of our other MS drug,
TYSABRI, and suspended dosing in all clinical studies of TYSABRI, including clinical studies of TYSABRI in combination with AVONEX. These decisions
were based on reports of two cases of PML, a rare and frequently fatal, demyelinating disease of the central nervous system, that have occurred in
patients treated with TYSABRI in combination with AVONEX.

Source: 2005 Results (15 FEB 2006):


Full year AVONEX sales increased 9% to $1.54 billion. In 2005, U.S. sales were $939 million and international sales increased 22% to $604 million.

5 Company Comment:

Source: 2006 10-K, Page 3:


We currently market and sell AVONEX worldwide for the treatment of relapsing forms of MS. In 2006, sales of AVONEX generated worldwide revenues
of $1.7 billion as compared to worldwide revenues of $1.5 billion in 2005.

Page 47:
For 2006 compared to 2005, U.S. sales of AVONEX increased $83.5 million, or 8.9%, due principally to the impact of price increases and a reduction in
discounts associated with the introduction of the Medicare Part D prescription drug benefit. These increases were offset by lower volume. For 2006
compared to 2005, international sales of AVONEX increased $80.1 million, or 13.3%, primarily due to increases in volume and price, including the impact
of patient mix. Foreign exchange accounted for a 0.6% increase in reported revenues; on a local currency basis, international sales increased 12.7%.

For 2005 compared to 2004, U.S. sales of AVONEX increased $16.1 million, or 1.7%, due to price increases, offset by lower volume. For 2005
compared to 2004, international sales of AVONEX increased $109.8 million, or 22.2%, primarily due to increases in volume and price, including the
impact of patient mix. Foreign exchange accounted for a 2.1% increase in reported revenues; on a local currency basis, international sales increased
20.1%.

Source: FY 2006 Results (15 FEB 2007):


Full year AVONEX sales increased 11% to $1.71 billion. In 2006, U.S. sales increased 9% to $1.02 billion and international sales increased 13% to $685
million.

Source: Q3 2006 10-Q, page 35:


AVONEX® (interferon beta-1a). AVONEX is approved for the treatment of relapsing forms of multiple sclerosis, or MS.

6 Evaluate Comment:

Prior to 2003, Avonex sales were booked by Biogen.

7
Evaluate Comment:

Represents Avonex sales for the period following the close of the merger between IDEC and Biogen on November 13, 2003 through December 31, 2003
only.

Company Comment:

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 7 of 25

Source: 2003 10-K, page 41:


AVONEX is the most prescribed therapeutic product in MS worldwide. Globally over 125,000 patients have chosen AVONEX as their treatment of
choice. Our results of operations for 2003 include sales of AVONEX for the period from November 13, 2003 through December 31, 2003. During that
period, sales of AVONEX generated worldwide revenues of $142.6 million, of which $92.6 million was generated in the United States and $50 million in
the rest of the world, primarily the European Union, or EU.

Source: 2003 Preliminary Results (2 MAR 2004):


In 2003, U.S. sales of AVONEX were $800 million and international sales for AVONEX were $368 million (pro forma combined).

8 Company Comment:

Source: 2004 Preliminary Results (7 FEB 2005):


AVONEX: In 2004, U.S. sales were $922 million and international sales were $495 million.

9 Company Comment:

Source: 2005 Results (15 FEB 2006);


Full year AVONEX sales increased 9% to $1.54 billion. In 2005, U.S. sales were $939 million and international sales increased 22% to $604 million.

10 Company Comment:

Source: 2006 10-K, Page 47:


For 2005 compared to 2004, U.S. sales of AVONEX increased $16.1 million, or 1.7%, due to price increases, offset by lower volume. For 2005
compared to 2004, international sales of AVONEX increased $109.8 million, or 22.2%, primarily due to increases in volume and price, including the
impact of patient mix. Foreign exchange accounted for a 2.1% increase in reported revenues; on a local currency basis, international sales increased
20.1%.

Source: FY 2006 Results (15 FEB 2007):


Full year AVONEX sales increased 11% to $1.71 billion. In 2006, U.S. sales increased 9% to $1.02 billion and international sales increased 13% to $685
million.

11 Company Comment:

Source: 2004 10-K, page 46:


AVONEX is the most prescribed therapeutic product in MS worldwide. Globally over 130,000 patients have chosen AVONEX as their treatment of
choice. During 2004, sales of AVONEX generated worldwide revenues of $1.4 billion, of which $922.6 million was generated in the U.S. and $494.6
million was generated outside the U.S., primarily in the EU. Product sales from AVONEX represent approximately 64% of our total revenues in 2004. Our
results of operations for 2003 include sales of AVONEX for the period from November 13, 2003 through December 31, 2003. During that period, sales of
AVONEX generated worldwide revenues of $142.6 million, of which $92.6 million was generated in the U.S. and $50.0 million in the rest of the world,
primarily the EU. Product sales from AVONEX represented approximately 21% of our total revenues in 2003. We expect to face increasing competition
in the MS marketplace in and outside the U.S. from existing and new MS treatments, including TYSABRI if it is reintroduced to the market, that may
impact sales of AVONEX. We expect future growth in AVONEX revenues to be dependent to a large extent on our ability to compete successfully.

12 Company Comment:

Source: 2004 10-K, page 46:


AVONEX is the most prescribed therapeutic product in MS worldwide. Globally over 130,000 patients have chosen AVONEX as their treatment of
choice. During 2004, sales of AVONEX generated worldwide revenues of $1.4 billion, of which $922.6 million was generated in the U.S. and $494.6
million was generated outside the U.S., primarily in the EU. Product sales from AVONEX represent approximately 64% of our total revenues in 2004. Our
results of operations for 2003 include sales of AVONEX for the period from November 13, 2003 through December 31, 2003. During that period, sales of
AVONEX generated worldwide revenues of $142.6 million, of which $92.6 million was generated in the U.S. and $50.0 million in the rest of the world,
primarily the EU. Product sales from AVONEX represented approximately 21% of our total revenues in 2003. We expect to face increasing competition
in the MS marketplace in and outside the U.S. from existing and new MS treatments, including TYSABRI if it is reintroduced to the market, that may

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 8 of 25

impact sales of AVONEX. We expect future growth in AVONEX revenues to be dependent to a large extent on our ability to compete successfully.

13 Company Comment:

Source: 2005 Results (15 FEB 2006):


Full year AVONEX sales increased 9% to $1.54 billion. In 2005, U.S. sales were $939 million and international sales increased 22% to $604 million.

Rank 2
Product Avonex
Company Gedeon Richter
Strategy In-licensed
Product Status Active
Market Status (Current) Marketed
Phase (Current) Marketed
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Anti-inflammatory
Originator Biogen
Licensee -
Markets Hungary, Estonia, Latvia, Lithuania, Poland, the Czech Republic, Slovakia & Russia
Routes of Admin. Injection
Dosing Weekly
Prescription Single source
Product Comment Q2 2004 Launched in Czech Republic. Q1 2004 Launched in Hungary. Q2 2003 Launched in Russia. MAR 2003 In-licensed
exclusive marketing rights from Biogen for 5 yrs to Central & Eastern Europe.
First Introduction 3/1/1997
WW Product Age (Yrs) 10.7
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - 3 1014 1115 11 13 14 15 15 16 16
Growth per Year (%) - - +281% +8% -1% +19% +9% +4% +4% +4% +4%
Change per Year (+/-) - +3 +8 +1 0 +2 +1 +1 +1 +1 +1

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - 20 10 11 11 11 10 10 10 10 10

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - 1% 2% 2% 1% 1% 1% 1% 1% 1% 1%

2006 Status Estimate


2005 Status Estimate

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 9 of 25

Forecast Statistics 3.9% CAGR 2007-2012; #Forecasts: 1; Median Value (2012) 2900; Avg. Analyst Date: Jun 07
Forecasters Single estimate based on Evaluate to 2012 (25 Jun 07) forecast
WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

NDA Classification New molecular entity


Review Status -
Patent Status Patented
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - 3 10 11 11
Growth per Year (%) - - +281% +8% -1%
Change per Year (+/-) - +3 +8 +1 0

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Marketed
Launch WW 3/1/1997
Launch Europe 3/1/1997
Source Press release
Last Updated 3/26/2003

Notes
14 Company Comment:

Source: 2004 Annual Report (page 49):


Regarding those products which were launched in the last couple of years on the Company’s markets, the multiple sclerosis drug AVONEX (interferon
beta-1a) licenced-in from the US-based Biogen.

15 Company Comment:

Source: 2005 Annual Report (page 46):


Regarding those products which were launched in recent years on the Company’s markets, the multiple sclerosis drug AVONEX (interferon beta-1a)
licenced-in from the US-based Biogen showed substantial growth during the year.

Rank -
Product Avonex
Company Abbott Laboratories
Strategy In-licensed
Product Status Active
Market Status (Current) Marketed

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 10 of 25

Phase (Current) Marketed


Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Neuroscience & Pain
Originator Biogen
Licensee -
Markets Latin America
Routes of Admin. Injection
Dosing Weekly
Prescription Single source
Product Comment FEB 1998 Latin America rights in-licensed from Biogen.
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - - - - - - - - - - -

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - - - - - - - - - - -

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

NDA Classification New molecular entity


Review Status -
Patent Status Patented
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 11 of 25

Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Marketed
Source Annual report
Last Updated 12/31/1998
Indication Comment Indicated for the treatment of relapsing multiple sclerosis.

Rank -
Product Avonex
Company Serono
Strategy Out-licensed technology
Product Status Inactive
Market Status (Current) Marketed
Phase (Current) Dead company
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Autoimmune & Inflammatory Diseases
Originator Biogen
Licensee -
Markets WW (~5% royalties)
Routes of Admin. Injection
Dosing Once weekly
Prescription Single source
Product Comment 1993 Serono signs deal with Biogen to receive royalties (estimated at 5%) on WW sales of Avonex. Deal relates to a license for
Serono's patents & technologies.
First Introduction 5/16/1996
WW Product Age (Yrs) 11.5
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales -16 -17 -18 -19 -20 -21 - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking 15 15 15 17 17 16 - - - - - -

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - - - - - - - - - - -

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 12 of 25

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - 58 71 85 95 - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

NDA Classification -
Review Status -
Patent Status Patented
Patent Expiry 12/31/2013
WW Patent Life Remaining 6.1
(Yrs)
WW Patent Life (Yrs) 17.6
Patent Comment Patent date refers to IFN beta1a patents expiring 2001 (US#5326859) & 2013 (US#5514567). 8 MAR 2002 FDA approve Rebif
(Serono): overturns BGEN's ODE which was due to expire 16 MAY 2003. 1996 FDA grant ODE for relapsing MS. EU patent
expires 2005. Source: FDA, Broker's Report & Press release.
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Dead company
Launch WW 5/16/1996
Launch US 5/16/1996
Launch Europe 3/1/1997
Source Annual report
Last Updated 3/1/2005

Notes
16 Evaluate Comment:
Serono receives royalty payments from Biogen on its worldwide sales of Avonex under an agreement entered into in 1993. Royalties are estimated at
5% and relate to a license for Serono's patents & technologies.

17 Evaluate Comment:
Serono receives royalty payments from Biogen on its worldwide sales of Avonex under an agreement entered into in 1993. Royalties are estimated at
5% and relate to a license for Serono's patents & technologies.

18 Evaluate Comment:
Serono receives royalty payments from Biogen Idec on its worldwide sales of Avonex under an agreement entered into in 1993. Royalties are estimated
at 5% and relate to a license for Serono's patents & technologies.

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 13 of 25

19 Evaluate Comment:
Serono receives royalty payments from Biogen Idec on its worldwide sales of Avonex under an agreement entered into in 1993. Royalties are estimated
at 5% and relate to a license for Serono's patents & technologies.

20 Evaluate Comment:
Serono receives royalty payments from Biogen Idec on its worldwide sales of Avonex under an agreement entered into in 1993. Royalties are estimated
at 5% and relate to a license for Serono's patents & technologies.

21 Evaluate Comment:
Serono receives royalty payments from Biogen Idec on its worldwide sales of Avonex under an agreement entered into in 1993. Royalties are estimated
at 5% and relate to a license for Serono's patents & technologies.

Rank -
Product Avonex
Company Merck KGaA
Strategy Company acquisition
Product Status Active
Market Status (Current) Marketed
Phase (Current) Marketed
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Neurology
Originator Biogen
Licensee -
Markets WW (~5% royalties)
Routes of Admin. Injection
Dosing Once weekly
Prescription Single source
Product Comment JAN 2007 Acquired Serono. 1993 Serono signs deal with Biogen to receive royalties (estimated at 5%) on WW sales of Avonex.
Deal relates to a license for Serono's patents & technologies.
First Introduction 5/16/1996
WW Product Age (Yrs) 11.5
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - - - - - - - - - - -

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 14 of 25

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - - - - - - - - - - -

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - 123 135 144 154 160 166

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

NDA Classification -
Review Status -
Patent Status Patented
Patent Expiry 12/31/2013
WW Patent Life Remaining 6.1
(Yrs)
WW Patent Life (Yrs) 17.6
Patent Comment Patent date refers to IFN beta1a patents expiring 2001 (US#5326859) & 2013 (US#5514567). 8 MAR 2002 FDA approve Rebif
(Serono): overturns BGEN's ODE which was due to expire 16 MAY 2003. 1996 FDA grant ODE for relapsing MS. EU patent
expires 2005. Source: FDA, Broker's Report & Press release.
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Marketed
Launch WW 5/16/1996
Launch US 5/16/1996
Launch Europe 3/1/1997
Source Annual report
Last Updated 3/1/2005

Rank -
Product Avonex
Company Schering-Plough
Strategy In-licensed
Product Status Active
Market Status (Current) Marketed
Phase (Current) Marketed
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 15 of 25

Technology Recombinant product


Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Unclassified
Originator Biogen
Licensee -
Markets Spain
Routes of Admin. Injection
Dosing Weekly
Prescription Single source
Product Comment MAR 1997 EU approval. AUG 1996 SGP to distribute in Spain for Biogen.
First Introduction 3/1/1997
WW Product Age (Yrs) 10.7
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - - - - - - - - - - -

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - - - - - - - - - - -

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

NDA Classification -
Review Status -
Patent Status Patented
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 16 of 25

Indication Level 3 Multiple sclerosis (MS)


Indication Status (Current) Marketed
Launch WW 3/1/1997
Launch Europe 3/1/1997
Source Company Information
Last Updated 9/1/2003

Rank -
Product Avonex
Company Biogen
Strategy Organic
Product Status Inactive
Market Status (Current) Marketed
Phase (Current) Dead company
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Unclassified
Originator Biogen
Licensee Abbott Laboratories (Latin America - Argentina, Brazil, Chile, Columbia, Mexico), Genzyme (Japan), Dompe (Italy) & Gedeon
Richter (Hungary, Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia & Russia), Genesis Pharma (Greece) & SGP
(Spain)
Markets WW ex. Japan, Latin America, Italy & Central & Eastern Europe
Routes of Admin. Injection
Dosing Weekly
Prescription Single source
Product Comment MAR'03 Out-licensed Central & E. Europe rights to Gedeon Richter. MAR'02 FDA approve Rebif (Serono) for MS: overturns
BGEN's ODE. FEB'99 NKTR deal re: inhaleable form: BGEN has WW rights. 3Q'98 GENZ given Japan rights.
First Introduction 5/16/1996
WW Product Age (Yrs) 11.5
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales 97122 1,03423 1,02624 - - - - - - - - -
Growth per Year (%) +7% -1% - - - - - - - - -
Change per Year (+/-) +64 -8 - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking 1 1 1 - - - - - - - - -

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 17 of 25

% Share 100% 100% 97% - - - - - - - - -

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales 710 74325 70726 - - - - - - - - -
Growth per Year (%) +5% -5% - - - - - - - - -
Change per Year (+/-) +33 -36 - - - - - - - - -

NDA Classification New molecular entity


NDA Received 5/22/1995
FDA Approval Date 5/16/1996
Approval Time (Mths) 11.8
US NME Age (Yrs) 11.5
Review Status Priority review
Patent Status Patented
Patent Expiry 12/31/2011
WW Patent Life Remaining 4.1
(Yrs)
WW Patent Life (Yrs) 15.6
Patent Comment Patent date refers to IFN beta1a patents expiring 2001 (US#5326859) & 2013 (US#5514567). 08 MAR 2002 FDA approve Rebif
(Serono): overturns BGEN's ODE which was due to expire 16 MAY 2003. 1996 FDA grant ODE for relapsing MS. Source: FDA &
Press release.
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales 247 276 27327 - - -
Growth per Year (%) +12% -1% - - -
Change per Year (+/-) +29 -2 - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Dead company
Launch WW 5/16/1996
Launch US 5/16/1996
Launch Europe 3/1/1997
Source Press release
Last Updated 10/28/2003
Indication Comment MAY'03 FDA approved prefilled syringe formula. FEB'03 FDA approve in secondary progressive MS. DEC'02 In PII combination
trials. MAY'02 EMEA approve in early stage MS. JAN'02 Inhaleable form abandoned in PI.
2
Indication Level 3 Glioma
Indication Status (Current) Abandoned in R&D
Source Annual report
Last Updated 12/31/2000
Indication Comment Not mentioned in 2002 annual report - assumed to be abandoned in PII development. 1998 Initiated PII trial in the treatment of
glioma. Source: 1998 10-K. Trial not mentioned in 1999 10-K.

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 18 of 25

3
Indication Level 3 Pulmonary fibrosis, idiopathic
Indication Status (Current) Abandoned in R&D
Source Press release
Last Updated 3/11/2002
Indication Comment MAR 2002 Disclosed as discontinued in PII development (source: MAR 2002 Broker's report). 1998 initiated PII trial in the
treatment of Idiopathic pulmonary fibrosis.

Notes
22 Company Comment:

Source: 2001 10K:


Over 118,000 patients worldwide have chosen AVONEX as the treatment of choice for relapsing MS. In 2001, Biogen focused its efforts on continuing to
drive AVONEX growth in the United States and Europe. As a result of these efforts, the Company achieved revenues from sales of AVONEX of
approximately $971.6 million in 2001, as compared to $761.1 million in AVONEX revenues in 2000 and $620.6 million in 1999. Of these AVONEX
revenues, approximately 73% in 2001, 73% in 2000 and 71% in 1999 were generated in the United States.

Preliminary Results (24 JAN 2002):


For the fourth quarter and full year 2001, AVONEX growth accelerated to 28 percent year-over-year. For the quarter ended December 31, 2001, sales
reached a record $259 million. AVONEX sales in 2001 were $972 million versus $761 million in 2000. At the end of 2001, more than 118,000 patients
were on AVONEX, which remains the number one therapy worldwide for patients with multiple sclerosis (MS).

23
Company Comment:

Source: 2002 10-K, page 3:


Product revenues from AVONEX represented approximately 90% of the Company’s total revenues in 2002 as compared to 93% in 2001. Product
revenue growth in 2002 was attributable to an increase in the sales price in the United States (“U.S.”) and an increase in sales volume of AVONEX
worldwide. U.S. product revenue growth was affected by increased competition and a softening of the MS marketplace growth rate in the U.S. Product
revenues outside of the U.S. increased 12% compared to 2001, consisting of a 13% increase based on higher sales volume in 2002, offset by a 1%
decrease from the impact of foreign exchange rate changes. The Company expects sales from AVONEX outside the U.S. to continue to increase as a
percentage of total product sales. The Company, however, expects to face increasing competition in the MS marketplace in and outside the U.S. from
existing and new MS treatments that may impact sales of AVONEX. The Company expects future growth in AVONEX revenues to be dependent to a
large extent on the Company’s ability to compete successfully. Biogen also expects that future AVONEX sales may be affected by slower growth in the
MS market.

In 2002, we focused our marketing and sales activities on continuing to drive AVONEX growth in the U.S. and the EU in the face of increased
competition. The result was revenues from sales of AVONEX in 2002 of $1,034.4 million, compared to revenues from sales of AVONEX of $970.5 million
in 2001 and $760.3 million in 2000. Of these revenues, approximately 72% in 2002, 73% in 2001 and 73% in 2000 were generated in the U.S.

Our efforts have also included work on the legislative front. In May 2002, the Center for Medicare and Medicaid Services restored Medicare coverage for
certain injectable medicines, including AVONEX. Medicare now provides coverage for MS patients treated with AVONEX as part of physician services,
making AVONEX the only product in the MS market that is covered by Medicare.

We also continue to work to expand the quantity and quality of data available about AVONEX. In 2002 the results of our efforts in this area included the
FDA’s approval of a change to the AVONEX label to lower the specified rate of occurrence of neutralizing antibodies associated with AVONEX from 24%
to 5%. The AVONEX label was amended again in January 2003 to include in the indication section MS patients with a first clinical episode and MRI
features consistent with MS. This label change is based on the data from our Controlled High Risk AVONEX Multiple Sclerosis Prevention Study
(“CHAMPS”) study. In the CHAMPS study, AVONEX was shown to have a highly statistically significant beneficial effect on delaying the development of
clinically definite MS in patients who had experienced a single neurological event consistent with MS. Based on the CHAMPS data, the regulatory
authorities in the EU made a similar change to the AVONEX label earlier in 2002.

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 19 of 25

An important component of our activities related to AVONEX is our ongoing clinical trial work. In 2002, we completed an open-label, follow-up study of
AVONEX initiated in 1995 to obtain long-term safety and antigenicity data. The data from this study will be submitted to the FDA and the regulatory
authorities in the EU as part of our post-marketing commitment. Ongoing studies of AVONEX also include an open label follow-up study initiated in 2000
to study the long-term effect of AVONEX on patients who participated in the CHAMPS study.

As part of our commitment to AVONEX, we also work to improve the product. In the first half of 2002, we filed with the FDA and regulatory authorities of
the EU for approval to market a pre-filled syringe formulation of AVONEX. In February 2003, the CPMP issued a positive opinion for the pre-filled syringe
formulation. We expect to receive approval in the U.S. and the EU in the second or third quarter of 2003. We continue to explore other ways to improve
delivery of AVONEX.

In the past year, we have also been working to enhance the services associated with AVONEX. In July 2002, we launched a newly enhanced version of
MSActiveSource.com, a comprehensive Internet site for people living with MS, their caregivers and healthcare professionals. Registrants on the site are
provided with a broad selection of customizable content and resources, including disease information, current news and the latest research studies about
MS. We also maintain AVONEX.com, an Internet site designed for people taking AVONEX. AVONEX.com incorporates the personalized information and
customizable features of MSActiveSource.com to facilitate the management of therapy programs.

In the U.S., Canada, Australia and most of the major countries of the EU, we use our own sales force to market and sell AVONEX. In those countries, we
distribute AVONEX principally through wholesale distributors of pharmaceutical products, mail order, specialty distributors or shipping service providers.
Sales to a specialty distributor and three major wholesale distributors in the U.S. accounted for approximately 20%, 19%, 17% and 16%, respectively, of
total revenues in 2002. In countries outside the U.S., Canada, Australia and the major countries of the EU, we sell AVONEX to distribution partners who
are then responsible for most marketing and distribution activities.

Q3 2002 Results Conference Call (18 OCT 2002):


On track to deliver 6-10% WW growth vs. 2001, ie. >$1bn.

10-Q (Q1 2002):


The Company expects to face increasing competition in the MS marketplace in and outside the United States from existing and new MS treatments that
may impact sales of AVONEX. In the United States, Biogen expects future growth in AVONEX revenues to be dependent to a large extent on the
Company's ability to compete successfully with Serono and its REBIF(R) interferon beta 1a product which was launched in the United States in March
2002 as a treatment for relapsing/remitting MS. The FDA approved REBIF for sale in the United States over a year before the expected expiration of
AVONEX's orphan drug marketing exclusivity. Biogen expects Serono to compete aggressively in the United States market. REBIF is already on the
market in the EU.

Company Disclosed Competitive Profile:

Source: 2002 10K, page 9:


In 2002, AVONEX competed in the U.S. and EU markets primarily with four products: COPAXONE® glatiramer acetate, sold by Teva in the U.S. and co-
promoted by Teva and Aventis Pharma in the EU; BETASERON®, sold by Berlex in the U.S. and sold under the name BETAFERON® by Schering A.G.
in the EU; NOVANTRONE® (mitoxantrone for injection) sold by Amgen and Serono S.A. in the U.S. and sold by Amgen in the EU; and REBIF®, which
was launched in the U.S. by Serono in March 2002. Serono announced in July 2002 that it reached an agreement to co-promote REBIF in the U.S. with
Pfizer Inc. In 2002, AVONEX had worldwide revenues of approximately $1,034.4 million, BETASERON and BETAFERON had combined worldwide
revenues of approximately $747.7 million, REBIF had worldwide revenues of approximately $548.8 million, COPAXONE had worldwide revenues of
approximately $538.8 million, and NOVANTRONE had worldwide revenues of approximately $76.3 million.

A number of companies, including us, are working to develop products to treat MS which may in the future compete with AVONEX. AVONEX also faces
competition from off-label uses of drugs approved for other indications. Some of our current competitors are also working to develop alternative
formulations for delivery of their products which may in the future compete with AVONEX.

2002 Preliminary Results (28 JAN 2003):


The U.S. Food and Drug Administration (FDA) approved a label change for AVONEX, lowering the rate of occurrence of neutralizing antibodies to five
percent from the original label rate of 24 percent. (November 2002)

24
Evaluate Comment:

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 20 of 25

Sales figure represent sales booked by Biogen before being acquired by IDEC Pharmaceuticals to form Biogen Idec on 12 November 2003. Sales for the
remainder of 2003 can be found in Biogen Idec.

Company Comment:

Source: 2003 Preliminary Results (2 MAR 2004):


Revenues from AVONEX® (Interferon beta-1a), Biogen Idec's therapy for patients with relapsing forms of multiple sclerosis (MS), for the fourth quarter
increased 21 percent to $310 million (pro forma combined) from the fourth quarter of 2002. Full year AVONEX sales were $1.168 billion (pro forma
combined), an increase of 13 percent over the prior year sales. In 2003, U.S. sales of AVONEX were $800 million and international sales for AVONEX
were $368 million (pro forma combined).

Source: Q1 2003 Results (17 APR 2003):


In January, the U.S. Food and Drug Administration (FDA) approved the use of AVONEX to treat patients who have experienced their first Multiple
Sclerosis (MS) attack if brain scans show abnormalities characteristic of MS.

25 Company Comment:

Source: 2002 10-K, page 3:


In 2002, we focused our marketing and sales activities on continuing to drive AVONEX growth in the U.S. and the EU in the face of increased
competition. The result was revenues from sales of AVONEX in 2002 of $1,034.4 million, compared to revenues from sales of AVONEX of $970.5 million
in 2001 and $760.3 million in 2000. Of these revenues, approximately 72% in 2002, 73% in 2001 and 73% in 2000 were generated in the U.S.

Our efforts have also included work on the legislative front. In May 2002, the Center for Medicare and Medicaid Services restored Medicare coverage for
certain injectable medicines, including AVONEX. Medicare now provides coverage for MS patients treated with AVONEX as part of physician services,
making AVONEX the only product in the MS market that is covered by Medicare.

We also continue to work to expand the quantity and quality of data available about AVONEX. In 2002 the results of our efforts in this area included the
FDA’s approval of a change to the AVONEX label to lower the specified rate of occurrence of neutralizing antibodies associated with AVONEX from 24%
to 5%. The AVONEX label was amended again in January 2003 to include in the indication section MS patients with a first clinical episode and MRI
features consistent with MS. This label change is based on the data from our Controlled High Risk AVONEX Multiple Sclerosis Prevention Study
(“CHAMPS”) study. In the CHAMPS study, AVONEX was shown to have a highly statistically significant beneficial effect on delaying the development of
clinically definite MS in patients who had experienced a single neurological event consistent with MS. Based on the CHAMPS data, the regulatory
authorities in the EU made a similar change to the AVONEX label earlier in 2002.

ctivities related to AVONEX is our ongoing clinical trial work. In 2002, we completed an open-label, follow-up study of AVONEX initiated in 1995 to obtain
long-term safety and antigenicity data. The data from this study will be submitted to the FDA and the regulatory authorities in the EU as part of our post-
marketing commitment. In 2001, we completed a randomized, double-blind, placebo controlled study initiated in 1998 to evaluate the efficacy of a higher
dose of AVONEX IM formulation delivered once a week in the treatment of secondary progressive MS. We are currently discussing the outcome and
endpoints of the study with the FDA and regulatory authorities in the EU. Ongoing studies of AVONEX also include an open label follow-up study initiated
in 2000 to study the long-term effect of AVONEX on patients who participated in the CHAMPS study.

26 Evaluate Comment:

Sales figure represent sales booked by Biogen before being acquired by IDEC Pharmaceuticals to form Biogen Idec on 12 November 2003. Sales for the
remainder of 2003 can be found in Biogen Idec.

Company Comment:

Source: Q1 2003 Results (17 APR 2003):


In January, the U.S. Food and Drug Administration (FDA) approved the use of AVONEX to treat patients who have experienced their first Multiple
Sclerosis (MS) attack if brain scans show abnormalities characteristic of MS.

27
Company Comment:

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 21 of 25

Estimate based on previous year Europe/ worldwide sales split.

Rank -
Product Avonex
Company Nektar Therapeutics
Strategy Out-licensed technology
Product Status Inactive
Market Status (Current) Abandoned in R&D
Phase (Current) Abandoned - Phase I
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Partner Products
Originator Biogen
Licensee -
Markets N/A
Routes of Admin. Inhalation
Prescription Single source
Product Comment JAN 2002 BGEN stops development for MS - evaluating other potential indications. FEB 1999 BGEN agreement re: dry powder
form for inhalation. BGEN to fund R&D, pay fee, milestones & royalties. NKTR to manuf., package dry powder & supply inhalation
devices.
Termination Date 1/31/2002
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - - - - - - - - - - -

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - - - - - - - - - - -

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues -28 - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 22 of 25

NDA Classification -
Review Status -
Patent Status Orphan drug
Patent Comment Patent protection refers Orphan Drug Exclusivity - specifically to Nektar's novel delivery systems.
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Abandoned in R&D
Source Annual report
Last Updated 3/28/2003
Indication Comment JAN 2002 Biogen does not plan to further develop product for MS at this time. Was in PI development as an inhaleable treatment
for relapsing MS.

Notes
28 Includes in $m:
1) +3.5 Revenue related to R&D collaboration.

Rank -
Product Avonex
Company AstraZeneca
Strategy In-licensed
Product Status Inactive
Market Status (Current) Marketed
Phase (Current) Disposed
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Neuroscience
Originator Biogen
Licensee -

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 23 of 25

Markets N/A
Routes of Admin. Injection
Dosing Weekly
Prescription Single source
Product Comment 1999 Distribution agreement with BGEN dissolved following merger of Astra & Zeneca. MAR 1997 Approved in Europe. AUG
1996 BGEN granted Astra rights to market in Nordic countries (Denmark, Iceland, Finland, Norway & Sweden).
First Introduction 3/1/1997
Termination Date 12/31/1999
WW Product Age (Yrs) 10.7
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - - - - - - - - - - -

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - - - - - - - - - - -

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

NDA Classification -
Review Status -
Patent Status Patented
Annual Sales Europe 2001 2002 2003 2004 2005 2006
Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Disposed
Launch WW 3/1/1997
Launch Europe 3/1/1997
Source Analyst report
Last Updated 7/31/2000
Indication Comment 1999 Withdrawn following merger of Astra & Zeneca.

Rank -
Product Avonex

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 24 of 25

Company Genzyme
Strategy In-licensed
Product Status Active
Market Status (Current) Marketed
Phase (Current) Marketed
Generic Name interferon beta-1a
Other Brand Names -
Research Codes -
Technology Recombinant product
Pharmacological Class Interferon beta
Therapeutic Category Central Nervous System
Therapeutic Subcategory MS Therapies
EphMRA ATC Code Level 1 L (Antineoplastic & Immunomodulating Agents)
EphMRA ATC Code Level 2 L3 (Immunostimulating Agents)
EphMRA ATC Code Level 3 L3B (Interferons)
EphMRA ATC Code Level 4 L3B2 (Interferons, Beta)
Company's Classification Transplant & Immune Disease
Originator Biogen
Licensee -
Markets Japan
Routes of Admin. Injection
Dosing Weekly
Prescription Single source
Product Comment SEP06 Received reimbursement price in Japan clearing way for launch. JUN06 Approved in Japan. Q1'03 Filed in Japan. SEP98
BGEN commercialisation & distribution agreement in Japan. GENZ responsible for clinical development. Established in USA &
Europe.
First Introduction 9/15/2006
WW Product Age (Yrs) 1.2
Annual Sales WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - -29 - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

Ranking in WW Company 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Portfolio Ranking - - - - - - - - - - - -

% Share of Company's WW 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Rx & OTC Sales % Share - - - - - - - - - - - -

WW Revenues (Royalty, 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Alliance & JV) Revenues - - - - - - - - - - - -

Annual Sales USA 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Sales - - - - - - - - - - - -
Growth per Year (%) - - - - - - - - - - -
Change per Year (+/-) - - - - - - - - - - -

NDA Classification -
Review Status -
Patent Status Orphan drug

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007
Evaluate Pharma - Export Results Page 25 of 25

Annual Sales Europe 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

Annual Sales Japan 2001 2002 2003 2004 2005 2006


Sales - - - - - -
Growth per Year (%) - - - - -
Change per Year (+/-) - - - - -

1
Indication Level 3 Multiple sclerosis (MS)
Indication Status (Current) Marketed
Launch WW 9/15/2006
Launch Japan 9/15/2006
Source Press release
Last Updated 11/8/2006
Indication Comment PIII data indicates delayed development of MS in individuals at high risk for the disease.

Notes
29 Company Disclosed Competitive Profile:

Source: 2002 10-K, Page 9:


AVONEX® (Interferon-beta 1a).
In September 1998, we entered into an agreement with Biogen, Inc. under which Genzyme General will, following regulatory approval, exclusively
distribute AVONEX in Japan. AVONEX is Biogen's treatment for relapsing forms of multiple sclerosis. Genzyme General is managing the clinical
development program for AVONEX in Japan and is working to obtain registration and reimbursement approvals for the product. Genzyme General
completed a bridging study of the product during 2002 and submitted a regulatory dossier to the Japanese Ministry of Health, Labor and Welfare seeking
approval of the product in Japan in the first quarter of 2003. Review of the regulatory filing is expected to last approximately one year. Genzyme General
estimates that there are 5,000 multiple sclerosis patients in Japan.

Source: Q3 2002 Results (16 OCT 2002):


In Japan, Genzyme is assembling its regulatory submission for Biogen Inc.'s AVONEX® (Interferon beta-1a), after completing the bridging study of the
product in August. The study definitively met its primary endpoint and met secondary endpoints, as well. Genzyme expects to file for approval to market
AVONEX in Japan in the first quarter of next year. The review of the filing by the Ministry of Health, Labor and Welfare is expected to last approximately
one year. Genzyme is collaborating with Biogen to commercialize AVONEX in Japan, and will act as the product's exclusive distributor there following
regulatory approval. AVONEX is Biogen's treatment for relapsing forms of multiple sclerosis.

http://www.evaluatepharma.com/webreport/exportreport.aspx?linkId=&printOption=all&withComments... 12/11/2007

Anda mungkin juga menyukai