AIDS GlaxoSmithKline Plc. started phase III clinical trials of a drug
called ONO-4128/873140. This treatment for AIDS is made by
Osaka-based Ono Pharmaceutical Co. Glaxo starts phase III trials
of AIDS drugs,
The Financial Express, July 26, 2005

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
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.

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.

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.

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

INSOMINIA Takeda Pharmaceuticals' Rozerem was approved for
insomnia by FDA. This is the first prescription sleep aid not
designated as a controlled substance. Rozerem is chemically
related to melatonin, which helps regulate the body's sleep-wake
cycle. Rozerem may work by stimulating melatonin receptors in the
brain.
FDA Approves New Treatment for Insomnia Associated Press July 22,
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.

MULTIPLE MYELOMA 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

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.

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.

SKIN INFECTION Bayer's anti-biotic Avelox has been approved for
use in the treatment of skin infections in Europe. The other two
indications are asthma and bronchitis.
Bayer shares up on new approval
for antibiotic Avelox. AFP, July 18, 2005.

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

OTHER
Teva may buy rival Ivax Corp. for $7.4 billion in a deal that vaults the
Israeli firm back to the position as world's biggest maker of generic
drugs. Teva buys Ivax for $7.4 bln. Reuters. July 25, 2005.

OLDER ISSUE
US Pharmaceutical Product
Digest
                    Issue: summer
2005
The U.S. Food and Drug Administration (FDA) approved 27 new drugs last year, up from 21 in 2003. And, there
are 10,800 brand and generic drugs are sold in the States. American are living and staying on prescriptions
longer with a life expectancy reaching a record high in 2003 of 77.6 years. The demand for medications
increases, accordingly.    This web-page highlights the new drug development, and generic competition in the
US pharmaceutical industry in different therapeutic
areas.                                                                                                                                                                 
PHARMCEUTICAL
INDUSTRY

Foundamental
Science
Colloidal
Stabilization

Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat

Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-lowering
Drug-Terminologies
Packaging
Materials

Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market

Novo Norkdisk
R&D

Equipment
Blenders

CONTRACT
MANUFACT.
Nutrition
Supplements

NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2

Double-blind
Study