LONDON, Dec 6 (Reuters) – AstraZeneca’s new heart medicine Brilique — or Brilinta — won final clearance from EU regulators on Monday, putting it on track to compete with Plavix, the world’s second biggest-selling drug, next year.

AstraZeneca is relying on revenues from the new product to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.

The approval by the European Commission had been expected following a positive recommendation from experts at the European Medicines Agency in September.

AstraZeneca said that of the European markets that would start selling Brilique in 2011, the majority of launches would occur in the second half of the year due to pricing and reimbursement negotiations.

The drug is recommended for preventing dangerous blood clots in patients with serious chest pain or previous heart attacks.

It is a competitor for Sanofi-Aventis and Bristol-Myers Squibb’s top-seller Plavix, which had sales last year of more than $9.5 billion, and AstraZeneca will face a tough competitive marketplace, since Plavix is off patent in parts of Europe and loses U.S. patent protection in 2012.

In the United States, where the medicine will be sold as Brilinta, the Food and Drug Administration is due to decide on whether to approve it by Dec. 16. It was endorsed by a U.S. advisory panel in July, despite a perplexing lack of benefit seen among a North American sub-group of patients in a clinical trial that found it was superior to Plavix overall. (Reporting by Ben Hirschler, editing by Kate Kelland)

FDA Approves Eisai Inc. (ESALF.PK)’s Halaven For Late-Stage Breast Cancer
11/15/2010

SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient’s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Halaven shows a clear survival benefit and is an important new option for women.”

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late- stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

For more information:

FDA: Office of Oncology Drug Products
NCI: Breast Cancer

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

PRNewswire via COMTEX News Network/ — Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced last week that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV(TM) (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

“The approval of OFIRMEV is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children,” said Ted Schroeder, President and CEO of Cadence. “IV acetaminophen is the unit market share leader among all injectable pain medications in Europe. With our planned launch early in the first quarter of 2011, we believe that OFIRMEV will fill a significant gap in the United States for the treatment of pain and fever in the hospital setting.”

Acute pain, particularly postoperative pain, often requires a multi-modal approach in which two or more analgesics are used with the goal of providing better analgesic efficacy. U.S. physicians already prescribe acetaminophen frequently in combination with opioids for oral management of pain, where it is the most widely used non-opioid in fixed combination therapies. In clinical studies, OFIRMEV improved pain relief, reduced opioid consumption, and improved patient satisfaction when used as part of a multi-modal regimen.

“OFIRMEV is a long-awaited and much needed addition to postoperative pain management,” said Eugene R. Viscusi, M.D., Director of Acute Pain Management at Thomas Jefferson University in Philadelphia. “With the approval of OFIRMEV, clinicians will now be better able to use a multi-modal approach to pain management in the hospital setting, when oral medication can’t be used.”

FLORHAM PARK, N.J., Oct. 4 /PRNewswire/ — Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. Food and Drug Administration approval of the non-stimulant medication KAPVAY™ (clonidine hydrochloride) extended-release tablets, an extended-release oral formulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6-17 years. KAPVAY™ is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication. KAPVAY™ can also be used as monotherapy when treating ADHD.

An oral, non-stimulant, twice-daily therapy, KAPVAY™ is a centrally acting alpha2-adrenergic receptor agonist. While the mechanism of action of alpha2 agonists in ADHD is not known, it is believed to involve the pre-frontal cortex (PFC) of the brain. Studies suggest that the PFC regulates attention and plays a critical role in impulse control, working memory and executive function.

“The FDA approval of KAPVAY™ represents an exciting milestone in the field of ADHD,” said Donald C. Manning, MD, PhD, Chief Medical Officer of Shionogi Inc. “The extended-release formulation of KAPVAY™ minimizes the peaks and troughs in blood levels, thereby decreasing overactivation of the alpha receptors in the brain and periphery. We look forward to providing this important, beneficial treatment for ADHD to patients, both as monotherapy and add-on therapy to stimulants.”

“ADHD is a complex disorder that requires individualized treatment. While there are prescription treatment options available, many ADHD patients on stimulants do not achieve adequate control of symptoms,” explained Rakesh Jain, MD, MPH, Director of Psychiatric Drug Research for R/D Clinical Research at Lake Jackson, Texas, and an investigator in the clinical trials. “KAPVAY™, when added to a stimulant, addresses an unmet need, and improves ADHD symptoms beyond what is achieved by stimulants alone. This is a significant step forward for the treatment of ADHD to have an approved product for add-on therapy in our treatment armamentarium.”

ADHD is a neurobehavioral disorder that occurs in childhood and may continue into adolescence and adulthood, which affects more than 4.5 million children ages 3-17 in the U.S. alone. Approximately 3-7 percent of U.S. school-aged children are believed to suffer from this disorder. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity/over-activity.

For more information on Kapvay or Shionogi, please visit the corporate website or Kapvay product website.