US Pharmaceutical
Product Digest
Product Development / Market / Strategy / Generic Competition 7/7/2004
GENERIC COMPETITION
THE INDIAN GROUP
The leaders of this group are Ranbaxy Laboratories Ltd,
Reddy's Laboratories and Wockhardt. They are ready to
make inroad in the US.

Dr. Reddy's Laboratories Ltd
(1)
Dr. Reddy's (RDY) had filed an ANDA with FDA for
Moxifloxacin tablets 400 mg, with a Paragraph IV
certification. Moxifloxacin is the generic version of Bayer's
Avelox with market of 207 million in the US.
(2)They also have the first-to file status along with one
other filer for
Levetiracetam Tablets, on all dosage
strengths and if successful in its litigation, would enjoy a
180-day marketing co-exclusivity. Levetiracetam is the
generic version of UCB's Keppra(TM) and its market are
appr. $234 million in the US.
(3) It gave notice it is looking to produce cheap generic
version of Seroquel.  AstraZeneca Plc said it
had "every confidence" in the patent
protecting its Seroquel, despite moves by Dr Reddy's that
could presage a generic challenge in the US.
(4) Dr Reddy's launched Redotil for management of acute
diarrhoea in April, 2004.

Related News:(1)Dr. Reddy's Announccs ANDA Filing for
Moxifloxacin Tablet; March 29, 2004
(2)Dr. Reddy's
Announces ANDA Filing for Levetiracetem Tablet, March
22,2004
(3) AstraZeneca faces generic threat, by Tudor et
al, Reuters UK, April 16, 2004
(4) Drug Reddy's launches
drug for diarrhoea, Business Line, April 3, 2004.

Ranbaxy' ambition April 1, 2004
Ranbaxy has products in 100 countries, its total sales of
pharmaceuticals in India was $5 billion last year. It has
81 generic products approved by the US FDA and 40
pending approvals. Last year, Ranbaxy spent $60 million
(6% of its revenues) on R&D;And, it plans to expand
its R&D to 10%. It also have NDA programs. Its
experimental molecule, SPM969 for treating prostate
enlargement, was licensed to Schwarz Pharma and now
this experimental drug is in phase one trial. Ranbaxy is
also working with Glaxo to commercialize a few
promising compounds. In addition to the new
compounds, Ranbaxy is  also active to
develop novel drug delivery systems, such as once-a-day
version for ciprofloxacin. It has 15 or more of improved
generics in the pipeline.

Ranbaxy gets tentative U.S. nod for generic Accupril  
March 15, 2004
Ranbaxy's drug was a generic form of Pfizer Inc's
antihypertension drug Accupril which had sales worth
$589 million in 2003 in the US.


Indian pharma giants make
inroads in the US...March 14, 2004
India's pharmaceuticals giants like Ranbaxy Laboratories
Ltd, Reddy's Laboratories, Wockhardt among others are
making sure-footed moves to secure a bigger global
presence.

THE US COMPANIES'Teva Pharmaceuticals.

Forest Laboratories
Forest Lab. receives notification of ANDA filing for a
generic equivalent with a Paragraph IV Certification of
Lexapro(R).  However, Alphapharm Pty. Ltd.
an Australian unit of Merck KGaA has filed with the US
FDA seeking a generic version too.

Related News: Forest Labs says competitor seeking
Lexapro copy, Reuters, April 16, 2004.

MYLAN's NEW MOVES
Levothyroxine
FDA granted Mylan to market generic versions of the
popular thyroid drug levothyroxine sodium. Sales of
Levoxyl in 2003 were $134 million.
Source Levoxyl rivals' approval undercuts King, by Val
Brickates Kennedy, CBS MarketWatch.com, June 24,
2004.

Aprokyn FDA approved Apokyn, an injectable drug to treat
periods of immobility in patients with Parkinson's
disease. About 1.5 million Americans have Parkinson's.
Related News: US FDA OKs Bertek drug for Parkinson's
immobility, Reuters, April 21, 2004.
Nitrofurantoin Mylan Receives FDA Approval and 180 Day
Exclusivity for Nitrofurantoin (copycat for PG's Macrobid).
Related News: Mylan Receives FDA Approval and 180
Day Exclusivity for Nitrofurantoin March 24,
2004.RisperidoneRisperidone is the copycat of Janssen
Pharmaceutical's Risperdal Tablet. Mylan may have one
of ten potential first-to-file opportunities. Related News:
Mylan Announces Tentative Approval for Risperidone
Tablets.Fentanyl A federal court in Vermont ruled Mylan's
copycat version of a pain patch violated J&J
patent.The US sales for that product (fentanyl) were $1.27
billion in 2003. And, the FDA approved Mylan's generic
version of the patch last year. Related News:A federal
court in Vermont ruled Mylan's copycat version of a pain
patch violated J&J patent. March 26, 2004

ENDO
There are more than 10 million Americans suffering from
chronic pain with a minized ptential for abuse. These are
the first generic versions of the potent painkiller Oxycontin
approved for market.
Related News: FDA cleared Endo and Teva
Pharmaceuticals to sell copycat version of
extended-release oxycodone (Oxycontin) March 24, 2004

King Pharmaceuticals Responds to Letter to ANDA
Applicants for Skelaxin (R). March 12, 2004
The letter stated that ANDA applicants may delete the use
listed in the Orange Book for U.S. Patent No. 6,407,128
from their product labeling.

IVAX
(1) Ivax launches glyburide/metformin HCl Tablets and
Triggers 180 day marketing exclusivity. The market for the
branded-product, Glucovance, was about $500 million in
2003.
Extracted from:Ivax' news release on May 4, 2004.
(2) IVAX recieves tentative approval for fluconazole
Tablets. The US sales for this medicine were $475 mllion
druing 2003. Related News: IVAX recieves tentative
approval for fluconazole
Tablets    March 18,
2004
(3) European Commission has approved IVX to market
its injectable paclitaxel drug as a treatment for metastatic
breast cancer and metastatic ovarian cancer. Related
News: Ivax: EU OKs copycat cancer drug, March 11, 2004
(4) Ivax is the first company to challenge the Zyprexa
patent, Ivax would gain 180 days of market exclusivity for
generics at most doses. Both expect a ruling sometime
this summer. Related News: Eli Lilly's Zyprexa fortunes
rest with courts by Bill Berkrot, Reuters, April 19, 2004.

IMPAX
Update-Metformin HCl ER Tablet
FDA has granted IMPAX a second tier 180 day exclusivity
related to its pending ANDA for Glucophage XL
(Metformin HCl ER Tablets, 500 mg). BUT, Impax has
seletively waived its rights to this exclusivity to Teva and
will be sharing in the profits of Teva's Metformin HCl ER
Tablets under an agreement signed in June of 2001.
Sales for this product are $430 million in 12 months
ended March 31, 2004.
Source Press Release June 18, 2004.

Lawsuit drops Impax shares March 11, 2004
Aventis, along with partner AMR Technology Inc., filed
patent infringement lawsuits in U.S. District Court against
five companies, including Impax, that are currently
seeking approval to produce and market generic versions
of Allegra.

FDA OKs Impax' high-dosage form of
Wellbutrin  March 22, 3004
The US market in 2003 for Glaxo's 150 mg Wellbutrin
were about $1.3 billion. To "extend"
the profit in Wellbutrin-market, Glaxo has launched a
controlled-release dosage form of Wellbutrin-Wellbutrin
XL. This product is rapidly becoming popular, because it
only needs to be taken once-a-day.

Barr (BRL)
Barr Lab. has received tentative approval for its generic
version of Aventis' Allegra-D extended-release tablets.  
The company will launch the product following the
resolution of the patent challenge litigation surrounding
this product. Barr believes it was the first applicant to file
an ANDA with Paragraph IV patent challenge on some of
the patents relating to the Allegra-D product.
SOURCE Barr gets tentative approval for Allegra-D
extended release tab., Woodcliff Lake, Pharmabiz.com,
July 6, 2004.
Barr Lab. has received approval from FDA for its
application to manufacture and market a copycat of
Galen's Ovcon-35 21-day and 28-day Tablets oral
contraceptive. The annual sales for Ovcon-35 was $63.1
million. Extracted fromBarr's Press Release on April 23,
2004.

ANDRX
Clarithromycin ER Tablets
FDA has approved its generic version of Biaxin XL (Sales
in 2003 were $280 million). Co does not plan to launch
the generic version prior to the patent expiration of May
2005. Source Press Release, June 25, 2004.

THE CANADIAN GROUP

Federal Court Rules Copycat Infringes on Abbott Lab.
Patent March 18, 2004
The US District Court in Chicago found that a product
manufactured by Apotex Inc.'s TorPharm unit infringes on
Abbott's patents for Depakote ($1 billion in sales).
NEW PRODUCT DEVELOPMENT
ALLERGIC RHINITIS
Impax was granted tentative approval of Allegra-D
from FDA in February 2004. However, Bar
Laboratories brought suit against FDA in an
attempt to prevent the agency from granting the
final approval to IMPAX for the generic version.
Now, Impax has filed a motion in the US District
Court for the District of Columbia to intervene as a
defendant.
Impax files motion to intervene as defendant in litigation
related to generic Allegra-D, Press Release, Business Wire,
Feb 28, 3005.

ASTHMA
FDA approved the use of schering-Plough's
Asmanex(R) Twisthaler(R) 220mcg (mometasone
furoate inhalation powder) for the first-line
maintenance treatment of asthma as preventive
therapy in patients 12 years of age and older.
Currently, about 20 million people suffer from
asthma.
FDA approves Asmanex(R) (mometasone furoate) for once
daily management of asthma. PR Newswire, March 31,
2005.


AVIAN FLU VACCINE
Sanofi pasteur, Swiftwater, PA manufactured an
inactivated vaccine for  clinicial trials of total 450
healthy adults for H5N1 avian influenza infection
study.
NIDAID Initiates Trial of Experimental Avian Flu
Vaccinei-Newswire.com, March 25, 2005

CANCER

HEAD AND NECK CANCER
About 40,000 Americans are diagnosed each year
with oral, head and neck cancers. Radiation is a
standard treatment. Tumors were less likely to
spread in patients who took ImClone Systems'
Erbitux in combination with radiation. Erbitux works
by blocking a protein called epidermal growth
factor which helps tumor cells reproduce.
Extracted fromErbitux Prolongs Survival in Head
and Neck Cancer, Ransdell Pierson, Reuters,
June 5, 2004.

Viventia initates a second Phase I clinical trial for
treatment of head and neck cancer with Proxinium.
Source: Press Release, June 7, 2004


COLORECTAL CANCER
ADVENTRX (ANX) iniiated patient recruitment in
Europe as an extension of its CoFactor first line
Phase II clinical trial in metastatic colorectal
cancer. CoFactor (5,10-methylenetetrahydrofolate),
a form of folic acid, enhances the anti-tumor
effects of 5-fluorouracil (5-FU) while reduces its
side effects.
SOURCE Press Release July 7 2004.

HIV
AnorMED announces new HIV entry inhibitor drug
candidate (AMD070) to advance to Phase II clinical
program. AMD070 targets the CXCR4 chemokine
receptor and prevents HIV from entering and
infecting healthy cells.
SOURCE Press Release July 9, 2004.

PROSTATE CANCER
230,900 new cases of prostate cancer may occur
this year in the United States. It was found that
men with aggressive prostate cancer treated with
Aventis' Taxotere lived longer than patients treated
with other standard chemotherapy drugs in Phase
III trials.  Related NewsAventis Drug Prevails in
Prostate Cancer Trials, by Pierson et al, Reuters,
Jun 7, 2004.

Merck & Co is developing a vaccine called
Gardasil which can protect women against four
strains of the human papillomavirus (HPV). The
papillomavirus are prime cause of cervical cancer
and genital warts. The new vaccine may reach the
market in 2006 to compete with GlaxoSmithKline's
Cervarix. Merk is partnering with Sanofi-Aventis to
seek first regulatory approvals for its vaccine in
Europe. Currently, the cervical cancer victimizes
about 470,000 women a year.
A vaccine for cervical cancer found, Earthtimes.org, April
5, 2006

Pfizer and Coley Pharmaceuticals have entered
into an exclusive global license agreement to
develop, manufacture and commercialize Coley's
ProMune TM (CPG 8909), a toll-like receptor
receptor 9 (TR9) agoinst delivered by
subcutaneous injection for treatment and
prevention of cancers.
Coley may earn up to $455 million plus royalties
from Pfizer based on the successful development
and commercialization of the product.
Reference Pfizer in cancer drug pact with Coley, The
Associated Press, New York, March 24, 2005

Insmed Inc. entered an exclusive option
agreement with University of California, San
Francisco for the patented use of IGF-receptor
antagonists to treat prostate cancer. In 2004,
about 30,000 people died as a result of prostate
cancer.
Insmed Announces exclusive option agreement with UCSF
for Series..Press Release, March 17, 2005.

HERCEPTIN A recent study showed that
Herceptin, an antibody-based drug, helps women
fight an aggressive form of early-stage breast
cancer after surgery. The estimated sales for
Herceptin in 2009 is about 4.2 billion francs.
Roche's Breast Cancer Drug Gets More Positive Data,
Reuters, April 28, 2005.

Currently, Genentech is marketing Herceptin in the
United States, Chugai in Japan and Roche
internationally. [5] U.S. sales of Herceptin
(Trastuzumab) increased 19 percent to $129.6
million from $108.7 million in the first quarter of
2004. [6]
Genentech Announces First Quarter 2005
Results, Press Release, April 11, 2005.

FDA recently approved an effective medicine -
Avastin - for colorectal cancers.
The interim results of a late-stage trial showed
that Avastin was successful when used with
chemotherapy in untreated breast cancer which
has spread to other parts of the body. About 8-9%
of women will develop breast cancer during their
lifetime.
Roche's Avastin Works in Third Type of Cancer, Reuters,
April 15, 2005

Sulindac was found to be a highly effective
chemoprevention agent because it worked to
induce expression of the p21 gene in a study of
mouse. Sulindac is a NSAID and a COX-2 inhibitor.
NSAID drug protects against intestinal tumors in mice,
despite poor diet and gene losses, innovations report, April
19, 2005.

CHOLESTEROL REDUCTION
Phosphagenics Limted's Phospha E(vitamin E
product) reduced LDL-C (bad cholesterol)
concentrations up to 40%.
Phosphagenics Ltd: Successful cholesterol reduction
trials, Press Release, March 31, 2005.
Pfizer's Torcetrapib
This experimental medicine is amazing.
Torcetrapib can double the level of good
cholesterol and may herald a new way of fighting
heart disease. Its effect on increasing HDL can be
intensified in the presence of Lipitor. On the other
hand, Torcetrapib can enhance Lipitor's effect on
LDL-lowering abilities. Pfizer has a plan to market
torcetrapib in combination with Lipitor.

In addition, Pfizer is developing a
controlled-release dosage form for Torcetrapib. It
could be a osmotic tablet, matrix tablet, coated
swellable form or multiparticulate form. And, in
these dosage forms, they used various methods
to improve the dissolution rate (i.e. absorption),
including amorphourous solid dispersion and
nano-particle approaches.

Sources: (1) Update-Pfizer drug boosts 'good"
cholesterol-study by Gene Emery, Reuters, April 7, 2004.
(2) US Patent Application No. 20030198674, Curatolo et
al.

Chronic Sleeplessness
Some 40 million Americans are suffered from
chronic sleeplessness.

Drugs in development (or new) to treat chronic
sleeplessness: Estorra (Sepracor),
Gaboxadol (Merck), Indiplon (Neurocrine
Biosciences/Pfizer),.

CONGESTIVE HEART FAILURE
Johnson & Johnson's Natrecor caused a 40-50%
greater risk of reduced kidney function when
compared with more conventional therapies for
heart paients.
Popular heart drug tied to kidney ills, report says,
Stephanie Saul, New York Times, March 22, 2005

DEPRESSION
GlaxoSmithKline's Wellbutrin XL is used to treat
depression. US sales of Wellbutrin XL tablets
were about $1 billion in 2004. Impax, Abriaka and
Anchen have filed ANDAs for generic versions of
Wellbutrin XL to FDA under Paragraph IV of the
Hatch-Waxman Amendments.
IMPAX announces Biovail's lawsuit related to generic
versions of Wellbutrin XL, Press Release, business Wire,
March 09, 2005 Biovail suing U.S. drug company over
generic Wellbutrin XL, CBS News, March 09, 2005.

GLUMETZA
FDA accepted Biovail (BVF) and Depomod
(DEPO)' NDA for 500 mg and 1000 mg tablets of
Glumetza(TM), once-a-day, extended release
formulations of metformin. The 500 mg dosage
strength was developed using Depomed's Gastric
Retention (GR(TM)) drug delivery technology and
the 1000 mg dosage strength was developed by
Biovail's Smartcoat delivery technolgy.
According to the news release, diabetes affects 17
million Americans and 90% of diabetics suffer
from type II diabetes.
Source Press Release, June 24, 2004.

ENDOMETRIOSIS
Pfizer gets FDA Approval for depo-subQ-provera
104, which is the first new treatment option for the
gynecological condition.
New Medication helps Women's Pain Problem,
Clickondetroit, March 30, 2005
.

ERECTILE DYSFUNCTION
Researchers have found that oldermen who are
taking Viagra can develop an eye problem that
may lead to permanent vision loss.
Viagra may cause vision loss, Anthony J. Brown, Reuters,
March 30, 2005

FLU VACCINE
The US Department of Health and Human
Services gave a five-year contract ($97 million) to
Sanofi Pasteur (a subsidiary Sanofi-Aventis)  to
speed up production of new influenza vaccines.
Sanofi-Aventis gets flu vaccine contract, The Associated
Press, April 1, 2005.

GROWTH HORMONE INSENSITIVITY SYNDROME
FDA accepted for review Insmed's NDA for
SomatoKine (mecasemin rinfabate) for the
treatment of growth hormone insensitivity
syndrome.SomatoKine is an insulin-like growth
factor I (IGF-I) therapy, orphan drug designation
(less than 200,000 patients in the United States).
FDA accepts for review Insmed's NDA for SomatoKine for
the treatment of growth hormone insensitivity syndrome,
Press Release, March 10, 2005.

Heart Attacks and Strokes
Heart attacks and strokes killed bout 1 million
American.

Drugs in development (or new) for related
diseases: 480848 (prevention of heart attack,
GlaxoSmithKline), Acomplia (combat obesity,
Sanofi-Synthelabo), AGI-1067 (combat artery
inflammation, AtheroGenics), DG031 (combat
artery inflammation, DeCode Genetics), ETC-216
(remove chloesterol from arteries, Pfizer), Exanta
(blood thinning, AstraZeneca), Lipitor-torcetrapib
(raise good cholesterol, Pfizer), Pactimibe (keep
cholesterol not to stick to arteries, Sankyo Pharm.),
PPAR alpha agonist (raise good cholesterol, lower
triglycerides, Eli Lilly), Sitaxsentan (treat pulmonary
hypertension, Encysive Pharm.) and SPP100
(reduce high blood pressure, Novartis).

HEPATITIS B
The FDA has approved Bristol-Myers Squibb's
Baraclude (entecavir) to treat chronic hepatitis B in
adults. About 1.25 million Amercians are infected
with the hepatitis B virus.
FDA Approves New Hepatitis B Treatment, Miranda Hitti,
WebMDHealth, March 30, 2005

HIGH BLOOD PRESSURE (HYPERTENSION)
CVRx' Rheos System device (at experimental
stage) has been implanted in a 36-year-old
woman in controlling wayward blood pressure
through electronic stimulation of neck-artery
nerves. Currently, about 65 million American
adults have high blood pressure.
Patient receives blood pressure implant, Ben Dobbin,
Associated Press, April 1, 2005.

HYPERACTIVITY DISORDER ( ATTENTION DEFICIT)
According to Public Cilzen, Abbott's Cylert
(Pemoline) has caused more than 21 cases of
liver failure.
ADHD drug Cylert discontinued, Miranda Hitti, WebMD
Medical News, March 25, 2005

Adderall XR is the lead product in Shire's protfolio.,
Its patents will expire in 2018. Currently, Barr
Laboratories, Impax, Colony and Teva
Pharmaceuticals filed abbreviated new drug
application (ANDA) generic versions of this
product.
Teve files ANDA for generic ADHD drug Adderall, Globes
correspondent, Feb 05, 2005

LIPODYSTROPHY Insmed Inc. initiated a Phase II
clinical trial examining the therapeutic benefit of
treating HIV-associated lipodystrophy with
SomatoKine-once daily IGF-I therapy.
Insmed Initiates Phase II HIV-Associated Lipodystrophy
Trial With Somatokine(R) Insmed Inc. Press Release, April
21, 2005.


MYASTHENIA GRAVIS
Mygasthenia gravis is a debilitating neurological
autoimmune disease, in which, autoantibodies
are produce to prevent the nerves from sending
messages to the muscles. Difficulties in
performing simple every-day tasks,  breathing and
swallowing may occur. The overall prevalence is
14 per 100,000. Recently, Aspreva's CellCept
enters phase III trial.
Source: Company Press, June 7,
2004
.

MULTIPLE MYELOMA (BLOOD CANCER)
Multiple myeloma affects about 50,000 American.
About 14,600 new cases occur annually.
Celgene's thalidomide was found to be effective
for treating patients with multiple myeloma, a form
of blood cancer in a phase III trial.  
Related News:
Celgene Says Blood Cancer Patients Respond to Drug,
Reuters, June 7, 2004.

The U.S. FDA approved Millennium Pharmauticals,
Inc.'s supplemental New Drug Applications
(sNDA) for VELCADE on March 25, 2005. The
number of U.S. patients who potentially benefit
from VELCADE is about 22,000.
Millennium to discuss full approval of VELCADE
(bortezomib) for injection in second-line multiple
myeloma, Press Release, March 28, 2005.

Osteoporosis medication - Boniva Boniva for
treating and preventing postmenopausal
osteoporosis  was approved by FDA in March
2005. It is being co-promoted by GlaxoSmithKline
and Roche. It is about 44 million Americans older
than 50 suffered from the disease.
Reference FDA OKs Monthly Drug for Osteoporosis,
Associated Press, March 25, 2005
i. Osteoporosis Medicine
NPS Pharmaceuticals Inc. said its experimental
osteoporosis medicine significantly reduced
spinal fractures in a late-stage trial. Preos and
Forteo are similar types of drugs, both are
bioengineered versions of human parathyroid
hormone to keep a constant level of calcium in
body-tissues.Forteo is a hormone fragment while
Preos is the full-length hormone. The projected
annual sales for both Forteo and Preos are about
$400 million. Forteo was launched in November of
2002 and its sales in 2003 were $65 million.
On April 21, 2004, NPS announced that they have
signed a distribution and license agreement with
Nycomed, which granted Nycomed rights to
develop and market PREOS(R) in Europe. In this
deal, Nycomed has agreed to make an equity
investment of $40 million, pay NPS up to $25
million in milestones upon regulatory approvals
and achievement of certain sales targets and pay
NPS royalties.(3)
NPS Pharmaceuticals and Nycomed
Announce US$90+Million PROS(R) Marketing Agreement
for Europe, Press Release, April 21, 2004.

Its experimental medicine for osteoporosis, AMG
`162, would likely enter Phase III trials. This
product would be taken only
once-every-six-months, compared to daily or
weekly pills available on the market, such as
Merck's Fosamax and
Procter&Gramble/Aventis' Actonel.
Update-Amgen unveils drug pipeline; stock drops by Jed
Seltzer and Ransdell Pierson, Reuters, March 23, 2004

PNEUMONIA VACCINE
An experimental pneumonia vaccine developed by
Wyeth Pharmaceuticals has been confirmed by
studies that it could save the lives of children in
Africa. The study tested the vaccine on more than
17,000 children in Gambia and found that it could
reduced the chances of getting pheumonia by
37%.
Study confirms pneumonia vaccine could save children's
lives in Africa, Emma Ross, Canadian Press, March l25,
005.

Prostate Drug Combo

FDA has approved use of Merck's Proscar with
Pfizer's Cardura for enlarged prostates. Cardura
has first quarter sales of $148 million while
Proscar had Q4 sales of $168 million. Our View:
The sales for both are huge. It is worthwise to
develop a combo tablet containing both drugs.
Related News: Upate 1-Merck says FDA approves prostate
drug combo, Reuters, April 20, 2004

REPIRATORY TRACT INFECTIONS
Abbott Laboratories Inc. received a new patent for
Biaxin XL, the extended-release form of
clarithromycin. They think, this can block a handful
rivals from launching generic versions of the drug.
Abbott shares rise on new Biaxin patent, BusinessWeek
online,  March 29, 2005.

RHEUMATOID ARTHRITIS
Rituxan improved symptoms in patients with
moderate to severe rheumatoid arthritis when
taken with methrotrexate, another arthritis drug.
Genentech (majority owned by Roche Group) said
Rituxan is a therapeutic antibody that selectively
depletes B-lymphocytes which play a central role
in rheumatoid arthiritis..
Extracted fromDrug Companies
Say Rituxan is Promising, Associated Press, June 16, 2004.

Another experimental medicine for rheumatoid
arthritis, AMG 714, showed an ;extremely good
safety profile" and it should complete
Phase II trials this year. While, Panitumumab is in
good progress.

Source: Update-Amgen unveils drug pipeline; stock drops
by Jed Seltzer and Ransdell Pierson, Reuters, March 23,
2004

Short Bowel Syndrome
This is a pivotal Phase III study (80 patients, six
months) for this investigational drug-teduglutide.
Teduglutide is an analog of glucagon like peptide
2 (GLP-2), a naturally occurring hormone that
regulates the growth, proliferation and
maintenance of cells lining the gastrointestinal
tract. Teduglutide was able to increase the size
and number of these cells in previous animal and
human clinical trials. There are about
16,000-20,000 adult SBS patients in the US. On
the other hand, teduglutide is being tested in a
Phase II study in patients with Crohn's disease (2).

Related News:(1) NPS Begins Pivotal Study With
Teduglutide in Patients With Short Bowel Syndrome (SBS)
April 6, 2004 (2) NPS Osteoporosis Drug Proves Effective
in Trial; March 30, 2004

THROMBOCYTHEMIA Thrombocythemia is a
condition where the concentration of platelets in
the blood rises above normal levels and can result
in blood clots. Ivax Corp., Barr Pharmaceuticals,
Inc. and Mylan Laboratories Inc. received approval
from FDA to market generic versions of Shire
Pharmaceuticals Group's Agrylin. Currently, the
annual sales of Agrylin are about $106 million.
Three Drug Makers Get Generic Agrylin OK, Associated
Press, April 18, 2005.

URINARY INCONTINENCE
Impax' generic verion of Ditropan XL got a tentative
approval from FDA.
The Allure of Impax, Gen G. Marcial, Businessweek
Online, March 14, 2005
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levothyroxine
Protein Drug 1
Protein Drug2

Double-blind
Study