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
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 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,
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
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
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 30, 2005.
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
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
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.
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
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
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
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.
Impax' generic verion of Ditropan XL got a tentative approval from FDA.
The Allure of Impax, Gen G. Marcial, Businessweek Online, March 14, 2005
US Pharmaceutical Product Digest
Issue: Q1 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. Zhion, April 2005