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.
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
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
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,
Currently, Genentech is marketing Herceptin in the United
States, Chugai in Japan and Roche internationally.  U.S.
sales of Herceptin (Trastuzumab) increased 19 percent to
$129.6 million from $108.7 million in the first quarter of 2004.
 Genentech Announces First Quarter 2005 Results, Press Release,
April 11, 2005.
FDA recently approved an effective medicine - Avastin - for
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
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
NSAID drug protects against intestinal tumors in mice, despite poor
diet and gene losses, innovations report, April 19, 2005.
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
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.
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
Researchers have found that oldermen who are taking Viagra
can develop an eye problem that may lead to permanent
Viagra may cause vision loss, Anthony J. Brown, Reuters, March 30,
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
Sanofi-Aventis gets flu vaccine contract, The Associated Press, April 1,
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,
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.
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
Millennium to discuss full approval of VELCADE (bortezomib) for
injection in second-line multiple myeloma, Press Release, March 28,
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
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
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
Abbott shares rise on new Biaxin patent, BusinessWeek online, March
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,
Impax' generic verion of Ditropan XL got a tentative approval
The Allure of Impax, Gen G. Marcial, Businessweek Online, March 14,
US Pharmaceutical Product
Digest Issue: Q2 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. Zhion, April