|FDA Approves First Generic To Treat Depression; Endocyte to Submit EU Conditional Marketing Authorization Applications|
|By Staff and Wire Reports|
|Wednesday, 14 March 2012 20:07|
Teva Pharmaceutical Industries (NASDAQ:TEVA) / IVAX Pharmaceuticals (NYSE:IVD) gained FDA approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults, to market generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths.
Depression is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime.
Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide.
People with generalized anxiety disorder (GAD) are filled with exaggerated worry and tension, even though there is little or nothing to provoke it. They anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work. GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least six months. People with GAD can’t relax, startle easily, and have difficulty concentrating.
“These psychiatric conditions can be disabling and prevent a person from doing every-day activities,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options.”
In the clinical trials for Lexapro, the most commonly observed adverse reactions were: sleeplessness (insomnia), ejaculation disorder, nausea, increase in sweating, fatigue and drowsiness, and low sex drive (decreased libido).
Escitalopram and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
The warning also says data did not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.
Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA cannot approve another generic version of escitalopram tablets before the end of that period. Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that, per discussions with EU health authorities, the Company will submit EU conditional marketing authorization applications (MAA) for EC145 and EC20 for treatment of patients with folate-receptor positive platinum resistant ovarian cancer. The therapeutic, EC145, and the diagnostic imaging agent, EC20, have also both been granted orphan drug status by the European Commission.
"After discussions with EU health authorities about Phase 3 trial plans and updated clinical data, including an updated overall survival analysis, we are pleased to move forward with these applications," said Ron Ellis, Endocyte's president and chief executive officer. "Targeting patients with a high unmet medical need is a prerequisite to pursuing this regulatory path and, by any measure, these patients fit that definition."
Endocyte plans to file two marketing authorization applications, one application for EC145 and another for EC20, in the third quarter of 2012. This will ensure that the Phase 3 PROCEED trial enrollment is well underway. Per agreement with the EU regulators, if conditional marketing authorization is granted, data from the PROCEED trial would be submitted following authorization and PROCEED would serve as the confirmatory trial to support conversion to regular marketing authorization for EC145 and EC20.
The marketing authorization applications will be supported by four clinical studies: a Phase 1 study in solid tumors, two single-agent, single-arm Phase 2 studies in ovarian cancer and non small cell lung cancer, and the PRECEDENT trial, a randomized study in platinum-resistant ovarian cancer. The results of the PRECEDENT trial demonstrated a statistically significant delay in disease progression or death in the overall population, with the largest improvement observed in the FR(++) patient population, those with all tumors positive for the folate receptor. Women with FR(++) platinum resistant ovarian cancer who received EC145-based therapy experienced a 62 percent decrease in their risk of progression [HR 0.381, p= 0.018] compared to women receiving chemotherapy alone. Median progression free survival (PFS; the time without disease progressing) in the EC145 based treatment arm was 5.5 months compared to 1.5 months of women who received chemotherapy alone. Tumor shrinkage (overall response rate) was observed in 17.3 percent of women receiving the EC145-based therapy compared to 6.7 percent in patients treated with chemotherapy alone.
In addition, Endocyte announced updated overall survival data from the PRECEDENT trial, which show improvement compared to the results announced in December 2011. Overall survival was a secondary endpoint in the PRECEDENT trial, but it was underpowered to demonstrate a definitive result in this endpoint. In particular, the overall survival hazard ratio for the FR(++) patient group was 1.097. Adjusting for prognostic imbalances between the study arms, the adjusted hazard ratio of 0.481 reflects a 52 percent reduction in the risk of death. Overall survival statistics in the intent-to-treat population were also slightly improved compared to those announced in December and those data will be presented at an upcoming medical conference.
"Patients with platinum-resistant ovarian cancer represent a high unmet medical need, and the presence of the folate receptor is associated with more rapid disease progression and shorter life expectancy," said Ignace B. Vergote, M.D., Ph.D., from University Hospital Leuven, in Belgium. "Because EC145 targets the folate receptor, these patients also have the potential to receive the greatest improvement over standard therapy. Being able to use EC20 to select patients who will most likely respond to the treatment will benefit both patients and doctors and is an important step towards implementing personalized medicine."
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that on Monday, March 12 it filed with the Securities and Exchange Commission a proxy statement containing a shareholder proposal for a reverse split of its common stock.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has maintained key claims in the company’s KSP RNAi patent (US Patent No. 7,718,629) in interference proceedings.
BioTime, Inc. (NYSE Amex: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today reported financial results for the fourth quarter and year ended December 31, 2011 and highlighted recent corporate accomplishments.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that the underwriters of its previously announced public offering of common stock have exercised in full their overallotment option to purchase an additional 1,575,000 shares of common stock at the public offering price of $3.85 per share, less underwriting discounts and commissions.
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it has made available via webcast a pre-recorded presentation delivered at an investor event held March 12, 2012, by Dr. Steven K. Libutti, Professor and Vice Chairman, Department of Surgery and Director of the Montefiore-Einstein Center for Cancer Care at the Montefiore Medical Center and the Albert Einstein College of Medicine.
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) announced today that Jack Talley, President and Chief Executive Officer, will be presenting at the BIO-Europe Spring 2012 event on Tuesday, March 20, 2012 at 10:15 AM local time at the Amsterdam RAI Convention Center in Amsterdam, the Netherlands.
Flamel Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarter and year ended December 31, 2011.
Forest Laboratories, Inc. (NYSE: FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced that Forest and Janssen Pharmaceutica NV have jointly filed a lawsuit in the U.S. District Court for the District of Delaware against several companies for infringement of U.S. Patent No. 6,545,040 (“the ‘040 patent”), relating to Forest’s BYSTOLIC® product. Forest licenses the ‘040 patent from Janssen.
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today reported financial and operational results for the fourth quarter and year ended December 31, 2011.
Marijuana, Inc. (PINKSHEETS: HEMP) released their Initial Company Information and Disclosure Statement concerning INITIAL COMPANY INFORMATION AND DISCLOSURE STATEMENT.
MedeFile International, Inc. (OTCQB: MDFI) (PINKSHEETS: MDFI), a leader in Internet-enabled Personal Health Record (iPHR) management solutions, and Promise Healthcare, Inc., a leading national long-term acute care (LTAC) hospital company, today jointly announced that the Companies have agreed to implement a 90-day pilot program to test and confirm the ease of use, functionality and cost benefits derived from adopting MedeFile's premium iPHR as an integral part of its employees' benefits package.
Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on bringing environmentally sustainable solutions to the plastics, chemicals and energy industries, today announced that it has granted a non-exclusive license to NatureWorks LLC for the U.S. patent No. 5,883,199, titled “Polylactic Acid-based Blends,” to make, use and sell blends of polylactic acid (PLA) with certain other polymers including polybutylene succinic polymers (PBS).
Plandaí Biotechnology, Inc. (OTCBB: PLPL) director, Dr. Ming Hu, recently addressed his published study on the bioavailability of flavonoids and polyphenols and its importance on human health and nutrition.
SANUWAVE Health, Inc. (OTCBB: SNWV) today reported financial results and accomplishments for the year ended December 31, 2011, and provided an update on the U.S. Food and Drug Administration (FDA) status of the Company’s dermaPACE® device.
SpectraScience, Inc. (OTCQB: SCIE) (PINKSHEETS: SCIE), a San Diego-based medical device company, today announced that it will hold a conference call on Tuesday, March 27, 2012 at Noon Eastern (9:00 a.m. Pacific) to provide an update on its business and conduct a question and answer session with investors.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that C. Martin Harris, MD, MBA, has been elected to its board of directors, effective March 30, bringing the company’s total number of directors to 13.
Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, today reported financial results for the year ended December 31, 2011 and also commented on certain corporate accomplishments and plans.
Viral Genetics (Pinksheets: VRAL) today published its March 2012 Letter to Shareholders.