PHENTERMINE - Online Pharmacy

Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)

September 4, 2008Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals
[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses.  For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. 

[September 4, 2008 - Information for Healthcare Professionals - FDA]
[September 4, 2008 - Press Release - FDA]

Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch

Company to Discuss Phase 3 Plans with FDA

PRINCETON, N.J., September 3, 2008 /PRNewswire/ — Agile Therapeutics, Inc., announced today that it successfully completed two key clinical trials in the development of the company’s new, innovative low-dose, once-weekly, contraceptive patch, which the company refers to by its internal product code AG-200-15. The Phase 2b safety and efficacy study successfully met its primary endpoint of ovulation suppression, cycle control and safety. The pharmacokinetic (PK) study demonstrated estrogen levels comparable with the well-established, low-dose oral contraceptive, LEVLEN(R). There were no serious adverse events in either study. With the successful pharmacokinetic and Phase 2b safety and efficacy study results, the Company will discuss its Phase 3 plans for AG-200-15 with the Food and Drug Administration (FDA).

Daniel R. Mishell, M.D., Professor in the Department of Obstetrics and Gynecology at the , and a member of Agile’s Scientific Advisory Board, commented, “Successful completion of the Phase 2b safety and efficacy study is an important step forward in proving the safety and efficacy of Agile’s important, new low-dose contraceptive patch. For years, OB/GYN’s have been recommending low-dose oral contraceptives to their patients considering hormone-based contraceptives. If shown to be safe and effective, a low-dose, once-weekly contraceptive patch would be a natural and needed addition to the hormonal-based contraceptives and an alternative to once-daily oral contraceptives.”

Thomas Rossi, Ph.D., Agile’s President and Chief Executive Officer, commented on the top-line data, “The purpose of conducting these studies was to demonstrate that our product delivers an appropriate, low dose of estrogen, and an effective dose of the progestin, levonorgestrel. We are very pleased with the clinical outcomes, which, in addition to helping us select the optimal dose for our Phase 3 program, also demonstrate that our patch gives reliable adhesion and is well tolerated when worn for 7 days. Based upon these results, we have been able to select AG-200-15 as our candidate for Phase 3 development. We are looking forward to discussing our results with the FDA and solidifying our Phase 3 plan.”

Pharmacokinetic Study

The pharmacokinetic study was an open-label, randomized, comparative, single-center, two-period cross-over study with 39 patients that evaluated two contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral contraceptive, LEVLEN(R). As intended, both the EE and LNG exposure over time of both patches were less than LEVLEN(R) and consistent with the levels targeted by the company.

Phase 2b Study

In this multi-centered, multi-cycle Phase 2b safety and efficacy study of 123 women, the Company studied patches with different estrogen and progestin doses for three cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), cycle control and tolerability at the lowest hormonal dose. Top-line results from the trial showed there was a clear dose-response to ovulation suppression and cycle control. AG-200-15 provided the greatest ovulation suppression with the best cycle control of the three regimens studied.

About Agile’s Product

Agile’s low-dose contraceptive patch offers women a convenient, once- weekly form of birth control. Many women prefer a weekly patch over having to remember to take the pill daily. The Company’s low-dose, patented, round, soft, and flexible patch delivers 60 percent less estrogen than the only marketed patch available today, Ortho EVRA(R). New market research conducted by Agile in 2008 with approximately 1,000 women of reproductive age highlight that more than 30 percent of women are not satisfied with their current contraceptive methods. In addition, the vast majority of these women found Agile’s low-dose contraceptive patch appealing and over 50 percent would talk with their doctors about using it. Agile’s low-dose contraceptive patch is expected to fill a sizeable need in the $6 billion global ($2.5 billion U.S.) hormonal contraceptive market.

About Estrogen

Estrogen is associated with certain common side effects, such as breast tenderness, bloating/weight gain and nausea. These side effects are believed to be related to the level of hormones delivered into the blood stream, particularly with higher levels of estrogen. In some rare cases, high estrogen levels are thought to be linked with serious, cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are desired.

According to FDA labeling, women using Ortho EVRA(R) are exposed to about 60 percent more estrogen than if they were using typical birth control pills. Increased levels of estrogen may increase the risk of blood clots, which lead the FDA to add precautions to Ortho EVRA’s label.

About Agile Therapeutics, Inc.

Agile Therapeutics is a privately held, specialty pharmaceutical company focused on the development of innovative women’s healthcare products. Historically, the women’s healthcare market offers unique opportunities to a company with proven expertise in clinical development, regulatory affairs, transdermal drug delivery and commercialization experience.

Agile’s current venture investors include TL Ventures, Novitas Capital (formerly PA Early Stage Partners), ProQuest Investments, and The Hillman Company. The Company has raised a total of $35 million in venture funding to date. For more information, please visit http://www.agiletherapeutics.com.

LEVLEN(R) is a registered trademark of Berlex Laboratories

Ortho EVRA(R) is a registered trademark of OrthoMcNeil(TM)

CONTACT: Lisa Rivero, ext. 106, , or BenjaminNavon, ext. 104, , both of LaVoie Group for AgileTherapeutics, Inc., +1-978-745-4200 lrivero@lavoiegroup.com bnavon@lavoiegroup.com

Web site: http://www.agiletherapeutics.com/

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Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NEW YORK, September 03, 2008 /PRNewswire-FirstCall/ — Forest Laboratories, Inc. and Laboratorios Almirall, S.A. today announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD). In both the ACCLAIM/COPD I&II (AClidinium CLinical Trial Assessing Efficacy and Safety In Moderate to Severe COPD Patients) studies, once-daily aclidinium bromide showed a statistically significant difference vs. placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in moderate to severe COPD patients.

In both studies aclidinium therapy demonstrated a significant difference vs placebo in trough FEV1 at 12 weeks (p-value <0.001) and 28 weeks (p-value <0.001). The effect of aclidinium compared to placebo in trough FEV1 was maintained over one year (p-value <0.001). The improvement in the trough FEV1, at weeks 12 and 28, of aclidinium arms compared to placebo was in the range of 60 to 70 mL in both trials. The change from baseline in peak FEV1 observed after dosing aclidinium compared to placebo at 12 and 28 weeks was between 154 and 177 mL (p-value <0.0001), with a median time to peak of 2 hours.

“The studies confirm the bronchodilatory effect of aclidinium at the dose tested, although the magnitude was lower than seen in previous studies. We are working actively with Forest and members of the ACCLAIM/COPD Steering Committee to fully understand these findings to determine the best way forward including the extent of the benefit possible from dosing alternatives”, commented Per-Olof Andersson, Executive Director R&D of Almirall.

Aclidinium significantly improved the percentage of patients showing a clinically relevant improvement (greater than or equal to 4 points) in health-related quality of life compared with placebo in the ACCLAIM/COPD I study (week 52; p-value=0.025) as measured by the St. George’s Respiratory Questionnaire (SGRQ). ACCLAIM/COPD II did not reach statistical significance for SGRQ at week 52 (p-value=0.074), however the study showed statistical significance at all previous time-points (p-value<0.001). Pooled analysis of both studies showed a statistically significantly higher percentage of patients improving greater than or equal to 4 units in the SGRQ at week 52 (p- value=0.04).

Secondary endpoint results demonstrated that aclidinium significantly delayed the time to the first moderate to severe exacerbation in patients with COPD in ACCLAIM/COPD II (p-value=0.01), whereas results were not significant in ACCLAIM/COPD I. In the pooled analysis of both studies, there was a positive trend in delaying the time to first moderate or severe exacerbation (p-value=0.054).

“Forest is pleased with the results of these studies and remains committed with Almirall to the development of aclidinium bromide in COPD”, said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories.

ACCLAIM/COPD study design and results

Two double-blind, multicenter, parallel-group, placebo-controlled Phase III studies were conducted, one in Europe (ACCLAIM/COPD I) and the other primarily in North America (ACCLAIM/COPD II), to evaluate the efficacy and safety of inhaled aclidinium administered once daily. A total of 1,647 patients, across 23 countries participated in these trials. Patients had a diagnosis of moderate to severe COPD and were a minimum of 40 years of age with at least a 10 pack-year smoking history. The mean FEV1 values at baseline were 1.406 and 1.199L for ACCLAIM/COPD I and ACCLAIM/COPD II, respectively. Patients were randomized to receive aclidinium bromide (200 micrograms once daily) or placebo over a one-year treatment period.

The primary endpoints for ACCLAIM/COPD I and II were bronchodilation at the end of the dosing interval, assessed as trough FEV1 (measured at 23-24h post-dose). For both trials, the primary endpoint was measured at week 12 and week 28 to fulfill FDA and European requirements, respectively.

Aclidinium bromide and placebo were administered to patients using the Genuair(R)(1) device, a multi-dose dry powder inhaler which operates by a ‘one press and inhale’ technique.

Overall, safety and tolerability were comparable between aclidinium and placebo in terms of percentage of patients with Serious Adverse Events (aclidinium: 9.1%, placebo 10.7%), Fatal Adverse Events (aclidinium: 1.1%, placebo: 1.7%), or with Adverse Events leading to treatment discontinuation (aclidinium: 4.0%, placebo: 5.7%). The most frequently reported adverse events across both studies were nasopharyngitis (aclidinium: 14.5%, placebo: 12.9%) and headache (aclidinium: 12.7%, placebo: 12.6%). Potential anticholinergic adverse events were observed in a similarly low percentage of patients, (e.g. dry mouth - aclidinium: 0.7%, placebo: 1.2%).

“Almirall remains committed to continue the efforts to provide treatment options for COPD patients with aclidinium bromide”, commented Jorge Gallardo, Chairman and Chief Executive Officer of Almirall.

About COPD

The World Health Organisation (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and more than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke.

The most common symptoms of COPD are breathlessness (or a “need for air”), abnormal sputum (a mix of saliva and mucus in the airway), and a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens(2). There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function and control exacerbations.

About aclidinium bromide and Genuair(R)

Aclidinium bromide is a novel, long-acting inhaled anticholinergic bronchodilator which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors. Aclidinium is rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest Laboratories licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound.

Aclidinium bromide is administered to patients using a novel, state-of-the-art multidose dry powder inhaler (MDPI), Genuair(R). Genuair(R) was designed with an intuitive feedback system, which through a ‘coloured control window’, an audible click and a slightly sweet taste indicates that the patient has inhaled correctly. The Genuair(R) inhaler contains 30 doses with a visible dose level indicator and also incorporates significant safety features such as an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

About Forest Laboratories

Forest Laboratories is a US-based pharmaceutical company with a long track record of building partnerships and developing and delivering products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

About Almirall

Almirall, an international pharmaceutical company based on innovation and committed to health, headquartered in Barcelona, Spain, researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.

The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology in general.

Almirall is currently present in over 70 countries with direct presence in Europe and Latin America through 11 affiliates.

 For further information please visit the website at: www.almirall.com (1) Genuair is a registered trademark of Laboratorios Almirall, S.A. It is the proposed registered trademark for the Multiple-Dose Dry Powder Inhaler (MDPI) and is pending regulatory approval. (2) WHO fact sheet 315. May 2008. Chronic obstructive pulmonary disease (COPD). 

CONTACT: Frank Perier, Jr. Senior Vice President - Finance and ChiefFinancial Officer of Forest Laboratories, Inc., +1-212-224-6611,; or Helen Swift, Senior Account Manager, direct+44-(0)- 207798-9924, mobile +44-(0)-77-7966-0939, or Scott A. Clark, ChiefExecutive Officer, direct +44-(0)-20-7798-9901, fax +44-(0)-20-7233-8780,both of Tonic Life Communications Ltd., +44-(0)-20-7798-9900, for Almirall Frank.Perier@frx.com

Web site: http://www.frx.com/http://www.almirall.com/

Ticker Symbol: (NYSE:FRX)

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A United Business Media Company

Prasugrel Significantly Reduced New or Recurrent Heart Attacks in Both Acute and Longer-Term Settings Following PCI, Compared with Clopidogrel

MUNICH, Germany, September 3, 2008 /PRNewswire-FirstCall/ — A sub-analysis of the TRITON-TIMI 38 clinical trial showed that treatment with prasugrel compared with clopidogrel significantly reduced the risk of new or recurrent heart attacks (7.4 percent vs. 9.7 percent, p<0.0001), regardless of whether the events occurred around the time of an artery-opening procedure known as percutaneous coronary intervention (PCI), or if they occurred spontaneously during the longer-term maintenance phase. The analysis was presented today at the European Society of Cardiology (ESC) in Munich, Germany.

The sub-analysis assessed the effect of prasugrel on new or recurrent heart attacks, occurring in the acute setting and during long-term medical treatment (up to 15 months) in 13,608 acute coronary syndromes (ACS) patients who were managed with PCI. New or recurrent heart attacks were classified according to the ESC Universal Definition of Myocardial Infarction as spontaneous (Type 1) or procedure-related (Type 4 or 5).(1) The analysis showed that prasugrel consistently and significantly reduced spontaneous (Type 1) heart attacks by 29 percent compared with clopidogrel (2.5 percent vs. 3.4 percent, p=0.0015) and procedure-related recurrent heart attacks (Type 4 or 5) 24 percent in prasugrel-treated patients compared with those taking clopidogrel (4.9 percent vs. 6.4 percent, p=0.0002).

Long-term treatment with prasugrel, continuing after 30 days for up to 15 months, significantly reduced the risk for patients who suffer any form of heart attack by 23 percent compared with clopidogrel (2.9 percent vs. 3.7 percent, p=0.01). In the sub-analysis, prasugrel was also shown to reduce the risk of a future severe heart attack (ST elevation myocardial infarction (STEMI), a more severe form of ACS with a higher risk of death) by more than 50 percent compared with clopidogrel (p=0.0001).

The main TRITON-TIMI 38 clinical trial, for which overall results were previously published in the New England Journal of Medicine in November 2007 (Vol. 357 No.20), compared prasugrel with clopidogrel (Plavix(R)/Iscover(R)) in patients with ACS undergoing PCI. In the primary analysis of the trial, prasugrel reduced the risk of the composite of cardiovascular death, heart attack or stroke by 19 percent, with an increased risk of major bleeding compared with clopidogrel (2.4 percent vs. 1.8 percent).(2)

Heart attacks are a major manifestation of coronary heart disease, a global health problem. About 7.2 million people die each year from coronary heart disease worldwide.(3) In the United States, the annual rate of heart attack is 920,000, with 600,000 being first-time attacks and 320,000 repeat attacks.(4)

“In this new sub-analysis of TRITON-TIMI 38, we found that the reduction of heart attacks seen with prasugrel compared with clopidogrel was consistent across the spectrum of heart attacks based on type, timing and magnitude,” said David Morrow, M.D., M.P.H., associate professor of medicine at and the Brigham and Women’s Hospital, Boston, USA, and investigator with the Thrombolysis in Myocardial Infarction (TIMI) Study Group.

About TRITON-TIMI 38

TRITON-TIMI 38 was a Phase III, randomized, double-blind, head-to-head clinical trial comparing the effects of prasugrel versus clopidogrel in patients with ACS who were managed with PCI, a procedure to open blockages in heart arteries including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was to compare the effects of prasugrel to clopidogrel on the combined incidence of cardiovascular death, non-fatal heart attack and non-fatal stroke during a median period of at least 12 months following PCI. Patients were randomly assigned to one of two treatment groups and given a loading dose of either prasugrel 60 mg or the approved loading dose of clopidogrel 300 mg anytime between randomization and one hour after the completion of the PCI procedure, followed by a daily maintenance dose of either prasugrel 10 mg or clopidogrel 75 mg. All patients also received a daily low dose of aspirin.

About Acute Coronary Syndromes

Acute coronary syndromes, which is comprised of heart attacks and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.(5) ACS, a fatal consequence of coronary heart disease, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(6) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.(7) Many ACS patients are managed with PCI, which usually includes a stent placement.

About prasugrel

Daiichi Sankyo Company, Limited , and Eli Lilly and Company are co-developing prasugrel, an investigational oral antiplatelet agent invented by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndromes undergoing PCI. Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke.

About Daiichi Sankyo Company, Limited

Daiichi Sankyo Company, Limited, established in 2005 after the merger of two leading century-old Japanese pharmaceutical companies, is a global pharmaceutical innovator, continuously generating innovative drugs that enrich the quality of life for patients around the world. The company uses its cumulative knowledge and expertise in the fields of cardiovascular disease, cancer, metabolic disorders, and infection as a foundation for developing an abundant product lineup and R&D pipeline.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world’s most urgent medical needs.

This press release contains certain forward-looking statements about the potential of the investigational compound prasugrel (CS-747, LY640315) and reflects Daiichi Sankyo’s and Lilly’s current beliefs. However, as with any pharmaceutical compound under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the compound will receive regulatory approval, that the regulatory approval will be for the indication(s) anticipated by the companies, or that later studies and patient experience will be consistent with study findings to date. There is also no guarantee that the compound will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s filing with the United States Securities and Exchange Commission and Daiichi Sankyo’s filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward-looking statements.

Plavix(R)/Iscover(R) are registered trademarks of sanofi-aventis.

P-LLY

1. Type 1: Spontaneous myocardial infarction related to ischemia due to a primary coronary event

Type 2: Myocardial infarction secondary to ischemia due to either increased oxygen demand of the heart or decreased blood supply

Type 4/Type 5: Myocardial infarction associated with PCI/CABG

Thygesen K et al. Universal Definition of Myocardial Infarction. EHJ(2007);28:2525-2538 http://www.escardio.org/guidelines-surveys/esc- guidelines/GuidelinesDocuments/guidelines-universal-MI-FT.pdf. Accessed August 13, 2008.

2. Wiviott, S, Braunwald, E, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. New England Journal of Medicine. November 2007;357:2001-15.

3. World Health Organization. The Atlas of Heart Disease and Stroke - Deaths from Coronary Heart Disease. http://www.who.int/cardiovascular_diseases/en/cvd_atlas_14_deathHD.pdf. Accessed August 13, 2008.

4 .American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.f inal.pdf. Accessed August 13, 2008.

5 .American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.f inal.pdf. Accessed August 13, 2008.

6. British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf, Accessed August 13, 2008.

7. WebMD Medical Reference in Collaboration with the Cleveland Clinic. Heart Disease: Coronary Artery Disease. http://www.webmd.com/heart- disease/guide/heart-disease-coronary-artery-disease. Accessed August 13, 2008.

CONTACT: Carole Copeland (OUS), +1-317-277-3661, Cell: +1-317-610-6196, orTammy Hull (U.S.A.), +1-317-651-9116, Cell: +1-317-614-5132, both of EliLilly and Company; Kim Wix, Daiichi Sankyo (U.S.A.), +1-973-695-8338, Cell:+1-908-656-5447, or Shigemichi Kondo, Daiichi Sankyo (Tokyo),81-3-6225-1126

Ticker Symbol: (NYSE:LLY)

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LUNESTA Next-Day Function and Discontinuation Data from a Long-Term 12-Week Study in Elderly Patients Presented at ECNP

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sept. 3, 2008 - Sepracor Inc. (Nasdaq: SEPR) today announced the presentation of LUNESTA(R) brand eszopiclone Phase IV study data at the 21st European College of Neuropsychopharmacology (ECNP) Congress in Barcelona. The poster presentations reflected results from a 12-week, double-blind, randomized safety and efficacy study of 388 elderly patients (65-85 years of age) who were administered either LUNESTA 2 mg or placebo nightly. Upon conclusion of the 12-week, double-blind treatment period, all patients received single-blind placebo for two weeks to assess rebound and withdrawal effects. This two-week, single-blind period was then followed by an additional two-week evaluation period in which patients received neither LUNESTA nor placebo in order to assess the durability of the response.

A 12-Week Study of Eszopiclone in Elderly Out-patients With Primary Insomnia: Effects of Treatment Discontinuation

In this study, sleep latency, wake time after sleep onset and total sleep time were all statistically significantly (p < or = 0.01) improved compared to baseline measures following discontinuation of LUNESTA treatment, indicating absence of rebound insomnia (defined as a worsening of sleep relative to pretreatment levels). Twelve weeks of nightly LUNESTA administration were not followed by withdrawal symptoms after discontinuation. Key findings from the study included:

– No statistically significant difference in Benzodiazepine Withdrawal Symptoms Questionnaire (BWSQ; an assessment of symptoms associated with benzodiazepine discontinuation) scores for LUNESTA-treated patients at the end of the double-blind treatment period (Week 12) relative to the end of the single-blind placebo administration period (Week 14). At Week 14, the BWSQ scores for patients treated with LUNESTA during the initial 12-week period were comparable to those who received placebo throughout the study duration; and

– The percentages of patients taking LUNESTA with “no insomnia” and “sub-threshold insomnia”, as measured by the Insomnia Severity Index (ISI; a measure of patients’ perception of insomnia), declined from the end of the double-blind period to the end of the 4-week follow-up period. However, despite this decline, the percentages of patients in these categories were still higher at the end of the 4-week follow-up period than they were at baseline, prior to the start of LUNESTA therapy.

The Efficacy of 12 Weeks of Eszopiclone Treatment in Elderly Patients With Primary Insomnia: Effect on Daytime Function

Electronic diaries, which were completed at the end of each day, captured patient-reported measures of daytime ability to function and duration and number of naps. Daytime function was assessed using an 11-point Likert-type scale, as well as by Insomnia Severity Index (ISI) questionnaires administered at three-week intervals. Quality of life and level of disability were also assessed using the 36-Item Short-Form Health Survey (SF-36) and Sheehan Disability Scale (SDS), respectively.

Patients administered LUNESTA reported significant improvements from baseline in key measures of daytime function versus the placebo group when averaged over the 12-week, double-blind treatment period. These measures included improvements in:

– Daytime alertness (p less than 0.001) scores

– Ability to function (p less than 0.001) scores

– Ability to concentrate (p less than 0.001) scores; and

– Sense of physical well-being (p less than 0.001) scores.

The abovementioned parameters were also statistically significantly improved versus placebo during the first three weeks of treatment, and these improvements were sustained through the last three weeks of the double-blind period.

Both number of naps and total daily nap time decreased from baseline for subjects who napped for both the LUNESTA and placebo treatment groups, and these decreases were statistically significantly different between the two treatment groups (p=0.0064 for number of naps and p=0.0138 for daily nap time) during the first three weeks of the study but not for the remainder of the study period.

Using the ISI, patients administered LUNESTA reported significant improvements versus the placebo treatment group on several of the extended items that measured next-day function. At Week 12, these statistically significant differences were seen in measures of:

– Improved sleep quality (p less than 0.0001) scores;

– Improvement in feeling refreshed/rested (p=0.0001) scores;

– Reduced daytime fatigue (p=0.0104) scores; and

– Reduced number of nights per week with sleep difficulties (p=0.0023) scores.

These abovementioned ISI measures, as well as attention/concentration, were also statistically significantly improved for patients taking LUNESTA versus patients administered placebo when averaged over the double-blind treatment period. There were no significant differences from placebo in ISI scores measuring attention, concentration, relationship enjoyment or mood disturbance.

Results of the SF-36 showed that patients administered LUNESTA reported statistically significantly improved general health (p=0.0088) and vitality (p=0.0084) at Week 12 versus patients administered placebo. Patients administered LUNESTA showed general improvements from baseline in the social life and family life/home responsibilities items of the SDS versus patients administered placebo, which were statistically significant when measured at Week 6 (p=0.0154 for social life and p=0.0279 for family life/home responsibilities), but not at Week 12. A numerical difference in scores was seen in the work/school item of the SDS, but this difference was not statistically significant.

Important Information About LUNESTA

LUNESTA is indicated for the treatment of insomnia in patients 18 years of age and older who are experiencing difficulty falling asleep and/or maintaining sleep through the night. LUNESTA is available in 1 mg, 2 mg and 3 mg tablets, and treatment should be individualized based on a patient’s age, medical history and insomnia symptoms. Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of the elderly and/or debilitated patients. The recommended starting dose of LUNESTA for these patients is 1 mg. LUNESTA is a Schedule IV controlled substance.

LUNESTA works quickly and should only be taken immediately before bedtime. Patients should have at least eight hours to devote to sleep before becoming active. Patients should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. Patients should use extreme care when engaging in these activities the morning after taking LUNESTA. Patients should not use alcohol while taking any sleep medicine. Most sleep medicines carry some risk of dependency. As with all sleep medicines, somnambulism (sleepwalking), including eating or driving while not fully awake, with amnesia for the event, has been reported. Additionally, rare cases of severe allergic reactions have been reported. Patients who report these events should discontinue treatment and should not be rechallenged with LUNESTA. Patients should not use sleep medicines for extended periods without first talking to their doctor. Patients should see their doctor if they experience unusual changes in thinking or behavior, or if sleep problems do not improve in 7 to 10 days as this may be due to another medical condition. Side effects may include unpleasant taste, headache, drowsiness and dizziness. For complete prescribing information, please visit the LUNESTA web site at www.lunesta.com, or click here.

About Sepracor

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving large and growing markets and unmet medical needs. Sepracor’s drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA(R) brand eszopiclone, XOPENEX(R) brand levalbuterol HCl Inhalation Solution, XOPENEX HFA(R) brand levalbuterol tartrate Inhalation Aerosol, BROVANA(R) brand arformoterol tartrate Inhalation Solution and OMNARIS(TM) brand ciclesonide Nasal Spray. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.

LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. OMNARIS is a trademark of Nycomed GmbH. For a copy of this release or any recent release, visit Sepracor’s web site at www.sepracor.com.

Contact

Sepracor Inc.
Jonaé R. Barnes, 508-481-6700
Sr. Vice President, Investor Relations &
Corporate Communications

Phase III U.S. Pivotal Study Results on CSL Biotherapies’ Afluria Published in Vaccine

KING OF PRUSSIA, Pa.–(BUSINESS WIRE)–Sept. 3, 2008 - Phase III pivotal study findings in the journal Vaccine showed that two formulations of CSL Biotherapies’ influenza virus vaccine Afluria(R) elicited an immune response (also known as immunogenicity) in healthy adults aged 18 - less than 65 years. The results, from a study performed at nine centers affiliated with the National Institutes of Health (NIH), met the U.S. Food and Drug Administration’s (FDA) requirements for influenza vaccine immunogenicity. These data formed the basis of CSL Biotherapies’ US biologics licensing application for Afluria that was approved through priority review by the FDA in September 2007.

Afluria is indicated for the active immunization of persons age 18 years and older against influenza disease (commonly referred to as the “flu”) caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria. Afluria is available in both single-dose, thimerosal-free, pre-filled syringes and in multi-dose vials.

“The flu remains a serious health threat that impacts thousands of Americans every year,” said Kathryn M. Edwards, MD, of Vanderbilt University School of Medicine and Pediatrics and principal study investigator. “An ample supply of flu vaccine is critical, particularly as the Centers for Disease Control’s Advisory Committee on Immunization Practices has expanded its recommendations for influenza vaccination in the U.S. population. Having on hand additional safe and effective doses of influenza vaccines, such as Afluria, offers healthcare providers a greater ability to protect more Americans from this preventable disease.”

“CSL Biotherapies has a long heritage in influenza vaccines and a track record of producing vaccines for Europe and the Southern Hemisphere,” said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations. “The published study results on Afluria reinforce CSL’s commitment to addressing unmet needs, enlarging the supply of influenza vaccine in the United States and to providing consumers and doctors with diverse options, including thimerosal-free Afluria.”

CSL recently announced completion of a $75 million (U.S.D.) investment in plant and equipment to double the manufacturing capacity of the company’s Melbourne facility to 40 million doses a year, making it one of the largest vaccine manufacturing plants in the world. CSL has also commenced construction of additional flu vaccine fill and finish capabilities in the United States.

About the Phase III Study

The pivotal study was a National Institutes of Health (NIH)-supported clinical study that enrolled 1,359 volunteers at nine clinical sites in the U.S. A randomized, double-blind, placebo-controlled study, its primary objective was to evaluate the immunogenicity of the thimerosal-free and thimerosal-containing formulations of Afluria influenza vaccine in healthy adults aged 18 to less than 65 years. Secondary objectives included the clinical consistency of the vaccine across formulations and age groups, as well as the safety and tolerability of Afluria.

Administration of Afluria resulted in seroprotection (the presence of a significant level of antibodies) for the three antigens included in the vaccine in over 90% of those studied - a result that exceeded the FDA’s benchmarks for the approval of an influenza vaccine. Study investigators also noted in the publication that this immunogenic response was consistent between the formulations and age groups studied. Afluria was well-tolerated, with few local or systemic adverse events.

About Afluria

Afluria is a purified, inactivated, trivalent influenza vaccine propagated in embryonated chicken eggs. Each dose contains the required dose of influenza virus hemagglutinin antigens from the influenza strains recommended and prioritized by FDA’s Vaccine and Related Biological Products Advisory Committee. Previous international flu vaccine studies sponsored by CSL Ltd., and a clinical trial conducted by the NIH, formed the basis for CSL Biotherapies’ biologics licensing application submission.

Important Safety Information

Afluria should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria, and to anyone who has had a life-threatening reaction to previous influenza vaccination. The most common injection-site adverse reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches. Vaccination with Afluria may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barre - syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give Afluria should be based on careful consideration of the potential benefits and risks. Full prescribing information on Afluria can be found at http://www.Afluria.com.

About CSL Biotherapies

The U.S. headquarters of CSL Biotherapies are located in King of Prussia, Pa. Its parent company, CSL Limited, in Melbourne, Australia, operates one of the world’s largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its U.S. headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally. At CSL Biotherapies, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 8,500 employees and operates in 21 countries worldwide. For more information, visit us at http://www.cslbiotherapies-us.com, or call 1-888-435-8633.

Contact

Media:
CSL Biotherapies
Sheila A. Burke, 610-290-7403
Director, Public Relations & Communications
Worldwide Commercial Operations
Sheila.Burke@cslbiotherapies.com
or
Weber Shandwick
Abenaa (Abby) Hayes, 212-445-8337
ahayes@webershandwick.com

MorphoSys Announces Publication of First MOR103 Data

MOR103 anti-GM-CSF Antibody Shows Subpicomolar Affinity for its Target Molecule
 
MUNICH, Germany, Sept. 2, 2008–MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today the publication of a first data package for its most advanced proprietary drug development program MOR103, a fully human HuCAL antibody directed against GM-CSF, in the journal “Molecular Immunology”.
 
The data presented show that MOR103 is able to block disease-relevant processes such as GM-CSF dependent proliferation and signal transduction in vitro.  Additionally, the publication describes that MorphoSys was able to achieve a 5,000-fold increase in affinity and a 2,000-fold increase in potency compared to the parental antibody using its established optimization technology.  With a resulting affinity - or binding strength - of 400 femtomolar, MOR103 represents the first known anti-GM-CSF agent with a subpicomolar affinity for its target.  Targeting of antigens, which are present only at low concentrations in patients such as GM-CSF, will require antibodies with low picomolar to subpicomolar affinities in order to reach efficacy in vivo at low dose levels.  The high affinity is also expected to lead to a beneficial dosing regimen and cost of goods advantage.
 
MOR103 is currently tested in a Phase 1 clinical trial to assess safety, tolerability and the pharmacokinetics of this fully human high affinity anti-GM-CSF HuCAL antibody.  MorphoSys intends to present pre-clinical data for MOR103 at the HAH - Human Antibodies and Hybridomas Conference on November 12, 2008 in New York, USA, as well as at the IBC’s 19th Annual International Antibody Engineering Conference on December 9, 2008 in San Diego, USA.
 
“We are very pleased with the results we have seen so far with MOR103 and the generation process stands out as a showcase for MorphoSys’s antibody generation capabilities using our HuCAL technology,” commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys.  “While the antibody’s affinity is merely one feature which influences its capability as a drug we believe based on the overall data we have generated so far that MOR103 represents a very promising therapeutic candidate in our pipeline.”
 
 
For further information please contact: Dr. Claudia Gutjahr-Löser, Head of Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Manager Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com
 
 
About MOR103 to treat RA:
Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints and affects in particular a membrane, called synovium, which lines each movable joint. It is a disabling and painful inflammatory condition, which can lead to substantial loss of mobility due to pain and joint destruction. As a systemic disease, RA often affects extra-articular tissues throughout the body including the skin, blood vessels, heart, lungs, and muscles. The disease affects approximately 4-6 million people worldwide. In patients suffering from RA, white blood cells move from the bloodstream into the synovium. Here, these blood cells appear to play an important role in causing the synovial membrane to become inflamed. The HuCAL-based antibody MOR103 targets GM-CSF as a means to treat inflammatory diseases such as psoriasis, multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), asthma, and especially RA. The granulocyte macrophage colony-stimulating factor (GM-CSF) stimulates stem cells to produce granulocytes and other macrophages and subsequently activates these differentiated immune cells. GM-CSF is part of the natural immune and inflammatory cascade but has also been identified as an inflammatory mediator in autoimmune disorders like RA leading to an increased production of pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction. By neutralizing GM-CSF the HuCAL-based antibody MOR103 reduces undesired proliferation and activation of inflammatory granulocytes and macrophages and intervenes in several pathophysiological pathways. More information and picture material is available at: http://www.morphosys.com/en/mor103
 
 
About MorphoSys:
MorphoSys is a publicly traded biotechnology company focused on the generation of fully human antibodies as a means to discover and develop innovative antibody-based drugs against life-threatening diseases. MorphoSys’s goal is to establish HuCAL as the technology of choice for antibody generation in research, diagnostics and therapeutic applications. The Company currently has therapeutic and research alliances with the majority of the world’s largest pharmaceutical companies including Boehringer Ingelheim, Centocor/Johnson & Johnson, Novartis, Pfizer and Roche. Within these partnerships, more than 50 therapeutic antibody programs are ongoing in which MorphoSys participates through exclusive license and milestones payments as well as royalties on any end products. Additionally, MorphoSys is active in the antibody research market through its AbD Serotec business unit. The business unit has operations in Germany (Munich), the U.S. (Raleigh, NC) and U.K. (Oxford). For further information please visit http://www.morphosys.com/
 
 
HuCAL(R) and HuCAL GOLD(R) are registered trademarks of MorphoSys AG
 
 
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company’s assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
 

Theratechnologies Announces Publication in AIDS

MONTREAL, Sept. 2, 2008 – Theratechnologies (TSX: TH) today announced that the 52-week results from its first Phase 3 clinical trial, using tesamorelin, are published in the September 2, 2008 Journal of the International AIDS Society (www.aidsonline.com). The study entitled, “Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation” outlines, in detail, the 52-week data of the first Phase 3 trial. Top-line results were initially disclosed in October 2007.
 
“The long-term data discussed in this publication are congruent with previous efficacy and safety data and highlight the ability of tesamorelin to be used in the long-term. Moreover, no new or unexpected side effects occurred with the long-term exposure which is building an attractive product profile for tesamorelin,” commented Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies. “I would like to take this opportunity to thank all the people involved in the study,” added Mr. Rosconi.
 
“Excess visceral fat is associated with insulin resistance, altered lipid levels, and contributes to increased cardiovascular risk. The ability of tesamorelin to specifically reduce excess visceral adipose tissue (VAT) without impacting insulin resistance, long term, is an important clinical attribute for tesamorelin,” commented Dr. Steven Grinspoon, Professor of Medicine, Harvard Medical School, Director of the Massachusetts General Hospital Program in Nutritional Metabolism, Lead Investigator for the tesamorelin trial in the United States and corresponding author for the AIDS publication. “The maintenance of VAT reduction over 52 weeks compared to baseline is clinically significant, though this effect is lost once treatment with tesamorelin is stopped,” noted Dr. Grinspoon.
 
“The publication of our long-term data in AIDS demonstrates the impact that excess visceral fat can have on HIV-infected patients with lipodystrophy and the data discussed therein shows that tesamorelin can safely be used over the long term,” commented Dr. Julian Falutz, Director, HIV Metabolic Clinic, McGill University Health Centre, Assistant Professor, McGill University Medical School, and Lead Investigator for Canada. “These positive results bring hope to those patients who have a reduced quality of life that is brought about by having excess abdominal fat in the setting of HIV/HAART associated lipodystrophy,” said Dr. Falutz.
 
HIV-Associated Lipodystrophy
Caused by several factors including the antiviral drug regimen and the virus itself, HIV-associated lipodystrophy is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess visceral fat accumulation and loss of subcutaneous fat in the limbs and in the face. Excess VAT and its concomitant metabolic profile have recently been shown to be a risk factor for cardiovascular diseases in HIV patients. There is currently no approved treatment available for HIV-associated lipodystrophy, a serious condition that can stigmatize patients and discourage HIV treatment adherence.
 
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers innovative drug candidates in order to develop them and bring them to market. The Company targets unmet medical needs in financially attractive specialty markets. Its most advanced program is tesamorelin, now in a confirmatory Phase 3 clinical trial for a serious metabolic disorder known as HIV-associated lipodystrophy. The Company also has other projects at earlier stages of development.
 
Forward-looking statements
This press release contains certain statements that are considered “forward-looking information” within the meaning of applicable securities legislation. This forward-looking information includes, but is not limited to information regarding the efficacy of tesamorelin on the health of patients with HIV-associated lipodystrophy. Words such as “will”, “may”, “could”, “should”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms or variations of them and the use of the conditional tense as well as similar expressions denote forward-looking information.

Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Company’s control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include, but are not limited to, the risk that patients with HIV-associated lipodystrophy using tesamorelin experience results that may differ from those indicated herein. The Company refers potential investors to the “Risks and Uncertainties” section of its annual information form (the “AIF”) dated January 29, 2008. The AIF is available at www.sedar.com under the Company’s public filings.

Although the forward-looking information contained in this press release is based upon what the Company believes are reasonable assumptions, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information. Certain assumptions made in preparing the forward-looking information include the assumption that patients with HIV-associated lipodystrophy will react positively to the administration of tesamorelin in the long term.

Consequently, all of the forward-looking information contained in this press release is qualified by the foregoing cautionary statements, and there can be no guarantee that the results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences or effects on the Company, its business, financial condition or results of operation. The Company does not undertake to update or amend such forward-looking information whether as a result of new information, future events or otherwise, except as may be required by applicable law.

Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
 

Anavex Completes Successful Preclinical Studies on Lead Alzheimer’s Drug Candidate

“The completion of preclinical studies is a key milestone for our company, and means that we are now ready to prepare our first IND for Alzheimer’s disease and move towards human trials,” said Harvey Lalach, President of ANAVEX. “Our novel approach is based on ANAVEX’s expertise and leadership in the field of sigma receptors and our highly productive drug discovery platform. This approach has made it possible for us to develop the first in a series of novel, new-generation drugs using sigma ligands to treat a range of CNS and oncological conditions. We are excited to be advancing this first novel compound for Alzheimer’s disease toward clinical trials.”

In preparation for an IND/IMPD filing, ANAVEX is engaging an expert Contract Research Organization (CRO) to perform final toxicity, pharmacokinetic, pharmacodynamic and metabolism studies in various animal species. Thereafter the IND (or IMPD) file will be submitted to the FDA (or the EMEA respectively) for approval in order to start Phase 1 clinical trials targeted for the first half of 2009.

ANAVEX 2-73 is a novel tetrahydrofuran that exhibits high affinity and selectivity to sigma-1 receptors and synergistic action with muscarinic receptors. Additional beneficial effects have been demonstrated on NMDA receptors. During preclinical studies (in-vitro and in-vivo in mice), ANAVEX 2-73 demonstrated significant neuroprotective, anti-amnesic and anti-convulsive properties. It also exhibited an excellent safety profile and therapeutic activity at very low doses.

ANAVEX 2-73 has been shown to provide protection from oxidative stress, which damages and destroys neurons and is believed to be a primary cause of Alzheimer’s disease. Research in recent years indicates that oxidative stress is a precursor to amyloid-beta plaques and tau (Neuro-Fibrillary Tangles or NFT) and, as such, is the appropriate therapeutic target. ANAVEX 2-73 is not focused on reducing or dissolving amyloid-beta protein, unlike drug candidates from other biopharmaceutical companies that have recently produced disappointing clinical results.

Preclinical studies on ANAVEX 1-41, another lead compound targeting Alzheimer’s disease and depression, are scheduled for completion in Q4 2008.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (www.anavex.com<http://www.anavex.com/>) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer’s, epilepsy and depression. The company’s proprietary SIGMACEPTOR(tm) Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.

ANAVEX’s SIGMACEPTOR(tm)-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s. ANAVEX 1-41, uses sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compound has performed extremely well in well-recognized animal models of Alzheimer’s disease, underscoring the promise of this alternative approach to the disease.

ANAVEX SIGMACEPTOR(tm)-C program involves the development of novel and original drug candidates targeting cancer. The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information

Anavex Life Sciences Corp.

Research & Business Development

Email: info@anavex.cominfo@anavex.com>

Shareholder & Media Relations

Toll-free: 1-866-505-2895

Outside North America: +1 (416) 489-0092

Email: ir@anavex.comir@anavex.com>

www.anavex.com<http://www.anavex.com/>

ApoA-I Data Presented at European Society of Cardiology Congress

Multiple presentations included Resverlogix data

TSX Exchange Symbol: RVX

CALGARY, September 02, 2008 /PRNewswire-FirstCall/ - Resverlogix Corp. (”Resverlogix” or the “Company”) is pleased to announce that Dr. Norman Wong presented key clinical data pertaining to its lead compound, RVX-208, at the European Society Cardiology (ESC) 2008 Congress in Munich. The presentation titled “RVX-208 a novel small molecule that increases apolipoprotein A-I enters into human clinical trials” was delivered on August 31, 2008. In addition to this presentation, other important data relating to RVX-208 from Resverlogix’s extensive data portfolio was presented by Dr. Jacques Genest of and Dr. Stephen Nicholls of the Cleveland Clinic, at the same conference.

“Over the past year, the scientific community has pushed to the forefront the importance of a small molecule in the form of an oral tablet that significantly increases ApoA-I production, HDL functionality and thereby treats atherosclerosis cardiovascular disease,” stated Dr. Jan Johansson, Senior Vice President Medical Affairs Resverlogix. Johansson further added, “The ESC is a well regarded scientific meeting as well as one of the largest with an estimated 25,000 participants. We are pleased to have presented our data to this esteemed audience.”

Apolipoprotein A-I (ApoA-I), the main component of high-density lipoprotein (HDL) represent the body’s natural defense system against atherosclerosis by mediating reverse cholesterol transport, i.e. transport of peripheral cholesterol including that of the vessel wall to the liver for elimination from the body. In multiple human and animal studies over-expression or repeated infusion of ApoA-I inhibit progression and induce regression of atherosclerosis in animals and humans.

RVX-208, a novel small molecule drug that facilitates endogenous ApoA-I production, is positioned as an emerging drug that holds the most promise for the treatment of atherosclerosis. RVX-208 is designed to increase ApoA-I production and thereby raise HDL levels thus enhancing HDL functionality to augment reverse cholesterol transport.

About Resverlogix Corp.

Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet needs. The NexVas(TM) program is the Company’s primary focus which is to develop novel small molecules that enhance ApoA-I. These vital therapies address the grievous burden of atherosclerosis and other important diseases such as acute coronary syndrome, diabetes, Alzheimer’s disease and other vascular disorders. The Company’s secondary focus is TGF-Beta Shield(TM), a program that aims to address burgeoning grievous diseases, such as cancer and fibrosis. Resverlogix Corp. trades on the Toronto Stock Exchange . For further information please visit www.resverlogix.com.

This news release may contain certain forward-looking statements that reflect the current views and/or expectations of Resverlogix Corp. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly. The TSX Exchange does not accept responsibility for the adequacy or accuracy of this news release.

CONTACT: Theresa Kennedy, VP, Corporate Communications, Resverlogix Corp.,Phone: (604) 538-7072, Email: ; Sarah Zapotichny,Manager, Investor Relations, Resverlogix Corp., Phone: (403) 254-9252,Email: , Website: www.resverlogix.com Theresa@resverlogix.com Sarah@resverlogix.com

Ticker Symbol: (Toronto:RVX)

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