05/04/2012 | 02:50am

Stallergenes S.a (Euronext Paris CAC small)(Paris:GENP) today announced results of a clinical study (VO67.10) of its house dust mites sublingual immunotherapy tablet, conducted in an Environmental Exposure Chamber (EEC).

Study VO67.10, a randomized, double-blind, placebo-controlled, dose ranging trial, evaluated the efficacy and safety of 6 months of treatment with 100 IR, 300 IR, 500 IR house dust mites sublingual immunotherapy tablets in 355 adults with house dust mites related allergic rhinitis.

the study met its primary objective. a clear dose effect was observed across the three active doses, with considerable reduction in allergic rhinitis symptoms observed for the 2 higher doses. the primary efficacy analysis demonstrated that, compared to placebo, treatment with the 500 IR dose resulted in a statistically significant reduction in allergic rhinitis symptoms. Secondary efficacy analyses are ongoing.

“We are pleased with the results of the VO67.10 study. They represent an important step forward for our future clinical development of our house dust mites sublingual immunotherapy tablet in Europe, Japan, and the United States”, indicated Roberto Gradnik, Chief Executive Officer of Stallergenes.

All three doses of house dust mites sublingual tablets were well tolerated confirming the favorable safety profile observed in previous studies.

ABOUT THE VO67.10 STUDY

this was a randomized, double-blind, placebo-controlled, dose ranging trial which assessed the efficacy and safety of three doses of house dust mites sublingual immunotherapy tablets for the treatment of allergic rhinitis in an environmental exposure chamber model. Adults aged 18 to 55 years with a history of house dust mites-associated allergic rhinitis, documented allergen-specific IgE antibodies, and symptoms during the baseline challenge to mites in the exposure unit were eligible for participation.

a total of 355 patients were randomized to receive 6 months of daily treatment with 500 IR, 300 IR or 100 IR house dust mites sublingual immunotherapy tablets or placebo. Efficacy was assessed via changes from baseline in rhinitis total symptom scores during environmental exposure chamber challenges to mites at Month 1, Month 2, Month 4 and Month 6 of the treatment period with the primary endpoint at Month 6.

ABOUT THE ALLERGEN CHALLENGE CHAMBER

the Environmental Exposure Chamber is a specially designed facility that enables study participants to be exposed to relevant allergens in a controlled, indoor setting. in this model, the variability in allergen exposure is reduced compared to that in natural field studies.

ABOUT STALLERGENES

Stallergenes is a European biopharmaceutical company dedicated to the treatment of allergy-related respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma, using allergen immunotherapy. the seventh largest pharmaceutical company in France and the leader in sublingual immunotherapy treatment, Stallergenes devotes almost 20% of its gross turnover to Research & Development and is actively involved in the development of a new therapeutic class, sublingual immunotherapy tablets.

in 2011, the company had a turnover of 235 million Euros, and more than 500,000 patients were treated with Stallergenes products.

Euronext Paris (Compartiment B)

Code ISIN : FR0000065674

Code Reuters : GEN.PA

Code Bloomberg : GEN.FP

Additional information is available at stallergenes.com

Forward-looking statements related to Stallergenes

This press release may contain forward-looking statements, including forecasts of future revenue and operating profit as well as expected business-related events. such statements are based upon the current beliefs and expectations of Stallergenes’ management and are subject to risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, changes in competitive factors and reliance on suppliers. the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law.

StallergenesRoberto Gradnik, CEOTel. +33 1 55 59 20 04orInvestor and Analyst RelationsChristian Thiry, Chief Financial OfficerTel. +33 1 55 59 20 95e-mail: Finance: Lucile de FraguierTel. +44 208 248 2793e-mail: Press RelationsLise Lemonnier, Senior Communication DirectorTel. + 33 1 55 59 20 96e-mail: Chicco Agency: Bahar TurkogluTel.: + 33 1 41 43 02 27e-mail: bturkoglu@ccapr.com

? Business Wire 2012

June 06, 2011 03:57 PM Eastern Daylight Time 

– Data show overall response rates of 55 percent; 37 percent in VELCADE refractory patients –

2011 ASCO Annual Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Millennium: the Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today reported results from two studies of VELCADE® (bortezomib) for Injection based combinations in patients with relapsed or refractory multiple myeloma (MM). the first study investigated the safety and efficacy of VELCADE in combination with LY2127399, a human monoclonal antibody. the second study assessed the safety and efficacy of VELCADE in combination with panobinostat. These data were presented at the annual meeting of the American Society of Clinical Oncology, held June 3 through 7 in Chicago, Illinois.

“These two studies provide encouraging evidence of VELCADE’s utility as a backbone for novel combinations”

“These two studies provide encouraging evidence of VELCADE’s utility as a backbone for novel combinations,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “We are especially pleased to see activity from VELCADE based combinations in these heavily pre-treated patient populations, including those who were refractory to VELCADE.”

Phase I study of LY2127399, a human anti-BAFF antibody, and bortezomib in patients with previously treated multiple myeloma

the primary objective of this Phase I study in 20 patients was to identify an efficacious dose of LY2127399 with VELCADE. Sixty-five percent of patients had received prior treatment with VELCADE. the results, which were presented by Noopur Raje, M.D., Massachusetts General Hospital, showed:

• the median number of cycles completed was 5, and no dose-limiting toxicities (DLTs) were observed
• the 100 mg dose of LY was selected for further study with VELCADE
• the most common grade 3/4 adverse events were thrombocytopenia (15 percent), neutropenia (10 percent), diarrhea (10 percent) and neuropathy (10 percent)
• Overall response rate (ORR) was 55 percent
• Ten percent of patients achieved a complete response (CR), 15 percent of patients achieved a very good partial response (VGPR) and 30 percent of patients achieved a partial response (PR)
• the median duration of response was 9.7 months

VELCADE was given at 1.3 mg/m2 IV on days 1, 4, 8, and 11 q21d and LY at 1, 10, 30, 100, or 300 mg IV (30 min) on day 1 in Cycles 1 – 3, and every other cycle thereafter. Corticosteroids were not allowed. Response was assessed per IMWG criteria and adverse events per CTCAE v3.0. Pharmacokinetics (PK) were assessed, and pharmacodynamic studies included B-cell immunophenotyping and serum markers of bone turnover. (Abstract #8012)

A phase Ib study of oral panobinostat and IV bortezomib in relapsed and refractory multiple myeloma

this Phase Ib study of 62 relapsed or relapsed and refractory multiple myeloma patients assessed the safety and efficacy of VELCADE in combination with panobinostat. Forty-five percent of patients had received prior treatment with VELCADE, and 31 percent were refractory to VELCADE. the results, which were presented by Jesus San Miguel, M.D., Ph.D., Hospital Universitario de Salamanca, showed:

• Maximum tolerated dose was established as 20 mg of panobinostat plus 1.3 mg/m2 of VELCADE
• the most common grade 3/4 adverse events were thrombocytopenia (79 percent), neutropenia (55 percent) and leukopenia (30 percent)
• across all dosing cohorts, ORR was 55 percent
• among VELCADE-refractory patients, ORR was 42 percent

this phase Ib study of relapsed or relapsed and refractory multiple myeloma completed enrollment (N=62) in Dec 2010 with 47 patients in the dose escalation phase and 15 patients in the dose expansion phase. in the dose escalation phase panobinostat was dosed orally 3 times/week (wk) in combination with VELCADE (IV Days 1, 4, 8, 11) in 21-day cycles (C). Dexamethasone was added for suboptimal response from C2 onwards. MTD was determined to be 20 mg panobinostat and 1.3 mg/m2 VELCADE. in the expansion phase, 15 patients received the MTD of panobinostat and VELCADE, with a modified panobinostat schedule (2 weeks on, 1 week off) and dexamethasone introduced for all patients at C2. this is identical to the dose and schedule in the ongoing phase II and III PANORAMA trials. (Abstract #8075)

About Millennium

Millennium: the Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, inc. was acquired by Takeda Pharmaceutical Company Ltd. in may, 2008. the Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, millennium.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. as the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, takeda.com.

About VELCADE

VELCADE is co-developed by Millennium and Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 230,000 patients worldwide.

Indications and important Safety Information (Patient)

What is VELCADE® (bortezomib) used for?

VELCADE is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of patients with mantle cell lymphoma (a cancer of lymph nodes) who have already received other treatments.

How is VELCADE administered?

VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. it is administered as an injection into your vein (IV) by a health care professional.

Who Should not Receive VELCADE?

Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. you should not receive VELCADE if you are:

• allergic to bortezomib, boron or mannitol
• pregnant or plan to become pregnant
• breastfeeding. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment.

the effects of VELCADE in children have not been evaluated.

What are the Possible Side Effects of VELCADE?

VELCADE can cause serious side effects including:

• Neutropenia (low levels of neutrophils, a type of white blood cell) and Thrombocytopenia (low levels of platelets). VELCADE can cause low levels of white blood cells (infection fighting cells) and/or platelets (clot-forming cells). you will have regular blood tests to check your cell counts during your treatment with VELCADE. if the number of these cells is very low, your doctor may change the dose and/or schedule of VELCADE. if your white blood cells become low, you can be at higher risk for infections. tell your doctor if you develop a fever or believe you have an infection. if platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion. There have been cases of bleeding in the stomach, bowels and brain during treatment with VELCADE.
• Gastrointestinal Problems. VELCADE treatment can cause nausea, vomiting, diarrhea, and constipation. if your symptoms are severe, your doctor may recommend IV fluids and/or medications.
• Peripheral neuropathy. VELCADE can cause damage to the nerves, a condition called peripheral neuropathy. you may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of VELCADE or stop it altogether.
• Low blood pressure. VELCADE can cause a drop in blood pressure. tell your doctor if you have low blood pressure, feel dizzy or feel as though you might faint. if you are taking drugs that lower blood pressure, your medications might need to be adjusted. if you are not drinking enough liquids, your doctor may need to administer IV fluids.

• Heart problems. VELCADE treatment can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.
• Lung Disorders. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. tell your doctor if you experience any cough, shortness of breath, wheezing or difficulty breathing.
• Liver disease. if you have liver problems, it can be harder for your body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease. in patients with moderate or severe liver disease, VELCADE should be started at a lower dose. Additional dose adjustments may be made based on your tolerance of the drug.
• Tumor Lysis Syndrome (TLS). TLS can occur with cancer treatments and your doctor will be monitoring blood and urine for any signs of this syndrome. if you develop TLS, your doctor will take appropriate steps to treat it.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS). There have been reports of a rare, reversible condition involving the brain called RPLS in patients treated with VELCADE. Patients with RPLS can have seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems. VELCADE treatment should be stopped in cases of RPLS.

the most common side effects seen in patients receiving VELCADE include: thrombocytopenia, neutropenia, nausea, peripheral neuropathy, neuralgia (nerve pain), pyrexia (high temperature), diarrhea, anemia, leukopenia (low levels of white blood cells), decreased appetite, fatigue, constipation, vomiting, dehydration, dyspnea (difficulty breathing), cough, asthenia (low energy), insomnia (trouble sleeping), peripheral edema (swelling of the limbs), and headache.

What other information should you discuss with your doctor?

you should also tell your doctor if you:

• have kidney disease. if you are on dialysis, your doctor will administer VELCADE after the dialysis procedure.
• are taking medication for diabetes. VELCADE can affect your blood glucose levels. Your doctor may require close monitoring of your blood glucose levels and change the dose of your diabetes medicine while you are being treated with VELCADE.
• have liver disease.
• are using medicines like ketoconazole (an anti-fungal) and ritonavir (an anti-viral), which will require close monitoring during treatment with VELCADE.
• are using any other medications (including over the counter drugs), herbal or dietary supplements, or holistic treatments.
• develop a rash of any type while receiving VELCADE.

the side effects of VELCADE may impair your ability to drive or operate machinery.

These are not all of the possible side effects with VELCADE. it is important to always contact your doctor if you experience any side effects while on VELCADE. if you have any questions about VELCADE, contact your doctor. Additional information and full prescribing information is available at VELCADE.com.

Please see the full prescribing information for VELCADE including warnings and precautions.

for more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

Editors’ Note: this press release is also available under the Media section of the Company’s website at: millennium.com/InTheNews.aspx.

PharmaGap inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) (“PharmaGap” or “the Company”) today announced initial results from preclinical testing at the Ottawa Hospital Research Institute (“OHRI”). Initial results from this study are positive and provide evidence that a peptide formulation of PharmaGap’s lead cancer drug GAP-107B8 administered via the intraperitoneal route can reduce tumour burden (19%) and significantly suppress ascites formation (73%) relative to controls. the test was undertaken at OHRI in collaboration with Dr. Barbara Vanderhyden.

Dr. Vanderhyden, upon initial review of the data commented “The reduction in ascites volume is very interesting in its own right, because this is a notable cause of morbidity in women with ovarian cancer. There is currently no drug therapy that is effective against ovarian cancer-associated ascites accumulation. Paracentesis, the removal of abdominal ascites, is commonly used to alleviate symptoms and prolong survival of women with ovarian cancer. the presence of ascites in ovarian cancer has been reported to be an indicator of poor prognosis for survival and correlates with a significantly decreased 5-year survival rate (5% with ascites vs. 45% without ascites) among women with stage III or IV epithelial ovarian carcinoma.”

The efficacy screening study was conducted over 2 weeks with twice daily dosing. with respect to this schedule the maximum tolerated dose as predetermined from a preliminary in-vivo study for each formulation (20 and 40 mg/Kg respectively) was administered.

In this study two formulations of GAP-107B8 peptides were tested in an established intraperitoneal xenograft model in immune-deficient mice and evaluated for tumour burden and accumulation of malignant ascites (excess fluid containing cancer cells in the abdominal cavity). the cell line selected for testing (OCC-1 human ovarian cancer) is of a phenotype characterized by the production of peritoneal ascites with growth of multiple small solid tumours.

Dr. Ken Sokoll, PharmaGap’s Vice President of Clinical Development and Chief Operating officer stated “We are continuing the analysis of this data along with Dr. Vanderhyden’s group and will provide additional details as they become apparent. This work has provided key information on preferred GAP-107B8 peptide formulations, relevant to our ongoing clinical development and peptide-based formulation program. Future efficacy studies to be conducted in the ovarian cancer model will include more broad-based screenings with liposomal formulations in order to determine if these initial positive findings can be improved further and reproduced in other ascites-producing cell lines. it is noteworthy that ascites formation is not unique to ovarian cancer, and a high incidence has been reported in other cancer types, including endometrial, breast, colon, stomach and pancreatic cancers.”

About OHRI and Dr. Barbara Vanderhyden

The Ottawa Hospital Research Institute (OHRI) is the research arm of the Ottawa Hospital and is an affiliated institute of the University of Ottawa, closely associated with the University’s Faculties of Medicine and Health Sciences. the OHRI includes more than 1,500 scientists, clinical investigators, graduate students, postdoctoral fellows and staff conducting research to improve the understanding, prevention, diagnosis and treatment of human disease. ohri.ca

Dr. Vanderhyden is a Senior Scientist, Cancer Therapeutics at the Ottawa Hospital Research Institute and a Professor in the Departments of Cellular & Molecular Medicine and Obstetrics & Gynecology at the University of Ottawa. She holds the Corinne Boyer Chair in Ovarian Cancer Research. She has published over 60 peer-reviewed journal papers primarily in the area of ovarian cancer and collaborates extensively with many pharmaceutical and biotechnology companies focused on the development of therapies for ovarian cancer.

About PharmaGap inc.

PharmaGap inc. (TSX VENTURE:GAP), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap’s GAP-107B8 is a novel peptide drug that has been shown to be highly cytotoxic to numerous cancer types, including chemo-resistant cancers, in vitro. For more information on PharmaGap please visit the Company’s website at pharmagap.com.

Forward Looking Statements

This news release contains certain statements that constitute forward-looking statements as they relate to the Company and its management. Forward-looking statements are not historical facts but represent management’s current expectations of future events, and can be identified by words such as “believe”, “expects”, “will”, “intends”, “plans”, “projects”, “anticipates”, “estimates”, “continues”, and similar expressions. although management believes that expectations represented in such forward-looking statements are reasonable, there can be no assurance that they will prove to be correct.

Note: neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. no Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.

SAN FRANCISCO — Hereditary angioedema attacks resolve faster with the novel agent icatibant (Firazyr), according to a clinical trial designed to answer FDA doubts over its efficacy in the wake of conflicting results from two pivotal studies. In the multinational trial, icatibant cut median time to clinically significant relief from acute swelling and pain to 2.0 hours compared with 19.8 hours on placebo (P<0.001), William R. Lumry, MD, of the University of Texas Southwestern Medical Center in Dallas, and colleagues found. Composite visual analog symptom scores continued to drop over the first four hours and remained significantly lower compared with placebo at every point through 12 hours, Lumry’s group reported here at the American Academy of Allergy, Asthma & Immunology meeting. the FDA rejected the drug in 2008 over disappointing results from the two key phase III trials of icatibant.Action Points  

• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
• Note that in this study icatibant, a selective bradykinin beta-2 receptor antagonist, relieved symptoms in attacks of acute hereditary angioedema significantly faster than placebo.
• Point out that the drug is investigational and has not been approved by the FDA, in part due to less than significant results in prior studies.

The first trial, FAST-1, showed no advantage over placebo in the same endpoint of time to relief of acute angioedema attacks.

FAST-2 did show an advantage over the active comparator tranexamic acid, but this was likely due to the low use of rescue medications that made the comparator look worse than placebo in FAST-1.

The third trial in the series, sponsored by German drugmaker Jerini in response to the FDA’s concerns, was seen as good news by Lumry, who played up the drug as “much more effective” than placebo.

Until recently, the only treatment option for the rare genetic disorder that causes frequent attacks of painful swelling in various parts of the body were straight replacements for the defective protein derived from human plasma.

Within the past two years, a synthetic option became available to treat acute attacks, the drug ecallantide (Kalbitor) that targets the main chemical that causes the swelling, bradykinin.

Icatibant, which blocks the same bradykinin pathway in a different way, could be useful as another synthetic option, Lumry suggested.

“This is a unique action type of a product and hopefully it will add to the things we can do to treat this population,” he told MedPage Today.

The FAST-3 trial randomized 98 adult patients in 11 countries to double-blind treatment with a single subcutaneous injection of icatibant (3 ml) or saline placebo within 12 hours of the onset of a moderate to very severe swelling attack of Type I or II hereditary angioedema.

The trial included cutaneous, abdominal, and laryngeal sites of swelling, so severe laryngeal cases were given open-label icatibant immediately to protect their airway.

Among the secondary endpoints for the nonlaryngeal intent-to-treat population, the researchers showed that icatibant was faster than placebo for the following:

• Time to initial symptom relief (0.8 versus 3.5 hours, P<0.001)
• Time to onset of primary symptom relief (1.5 versus 18.5 hours, P<0.001)
• Time to “almost complete” symptom relief (8.0 to 36.0 hours, P=0.012)

The 10 laryngeal cases treated in the study tended to show faster relief with icatibant as well.

Rescue therapy, a concern in the prior trials, was allowed but withheld, if possible, until eight or nine hours after study drug injection.

In the nonlaryngeal population, 35.6% of placebo-group patients got rescue medications prior to onset of symptom relief — and a total of 40.0% got them at any point during the attack through the five days after treatment compared with 7.0% in the icatibant group (P<0.001).

In the laryngeal population, half of the patients who got placebo needed rescue medications and one of the double-blind icatibant group patients (33.3%) did as well through five days post-treatment.

These rates were much higher than the criticized 20% rate of rescue therapy use in the active comparator group of FAST-2 and more on par with the 45% who got it within the first 12 hours in the placebo group of FAST-1.

Adverse events overall occurred less often with icatibant in FAST-3 (41% versus 52% placebo), although all icatibant-treated patients experienced some type of transient injection site reaction.

The drug was not associated with any serious adverse events, but drug-related adverse events were one case each of diarrhea, nausea, dyspepsia, headache, and injection site erythema. Laboratory and vital signs remained unaffected by icatibant.

No cases of the hypersensitivity or anaphylactic reactions seen in some cases with ecallantide were mentioned in the FAST-3 presentation, and Lumry noted that none of the patients tested positive for antibodies to icatibant.

Head-to-head comparisons with other acute treatments for hereditary angioedema attacks have yet to be done, and comparison is difficult due to the different endpoints used to assess symptom relief, he noted.

In the FAST trials, this primary endpoint was time to a clinically significant 50% reduction in visual analog symptom score from baseline whereas others used measures such at improvement at four hours.

But, “we’ve looked at this data and the on-demand therapies all seem to work in the same time frame, in about one to two hours,” he told attendees at the session.

The study was sponsored by Jerini in collaboration with Shire Human Genetic Therapies.

Lumry reported conflicts of interest with Alcon Laboratories, AstraZeneca, Boehringer Ingelheim, CSL Behring, Dyax, Genentech, GlaxoSmithKline, Meda, Merck, Novartis, sanofi-aventis, Shire, Viropharma, Teva, Pfizer, Sepracor, Biotest, and UCB Pharmaceuticals.

Two co-authors reported employment with Shire Human Genetic Therapies.

Data suggest the drug could address the most important unmet medical need in schizophrenia

PRINCETON, N.J.–(BUSINESS WIRE)–Nov 30, 2010 – Cyrenaic Pharmaceuticals inc. (“Cyrenaic”), a private drug development company focused on the treatment of CNS disorders, today announced Phase IIa clinical results for CYR-101, its novel investigational drug for the treatment of schizophrenia. the results from the study showed that the drug alleviated the symptoms of the disease, including the negative and cognitive symptoms.

Schizophrenia affects approximately 1% of the general population and is characterized by three major symptom classes: positive symptoms, such as hallucinations and delusions; negative symptoms, such as apathy and emotional flattening; and cognitive symptoms, including impaired memory and attention deficit. Most patients experience some degree of cognitive symptoms during the course of their disease, even during the prodromal phase. furthermore, if left untreated negative symptoms often lead to poor patient compliance with existing medications and poor control of disease burden.

Whilst existing medications primarily target positive symptoms but have no direct efficacy on other symptoms of this disease, there are currently no approved treatments for the specific treatment of negative or cognitive symptoms. a treatment for these symptoms therefore remains a major unmet medical need in schizophrenia. Despite these shortcomings, the global market for existing antipsychotics was estimated at $16 billion in 2008.

Commenting on the Phase IIa study results, Geoff race, Strategic Advisor to Cyrenaic, said: “We are very encouraged by the results of this study. We believe CYR-101 has the potential to deal with the important aspects of schizophrenia, including those symptoms currently not managed by existing therapies.

“These results confirm the promising efficacy signal that was observed in relevant animal models and open the door to treatment alternatives not only in schizophrenia but also in a number of other debilitating neurological and psychiatric diseases, suggesting a large spectrum of additional potential indications for CYR-101”.

The double-blind, randomized, placebo-controlled, multicentre study was conducted in Europe in 100 patients diagnosed with schizophrenia or schizoaffective disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders (Edition IV-TR). the most salient result observed after treatment with CYR-101 was a reduction of negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) compared to placebo. CYR-101 also improved cognition as measured by the Brief Assessment of Cognition in Schizophrenia instrument (BACS). Confirming the benign safety profile observed in four previously completed Phase I clinical studies, CYR-101 was well tolerated with no evidence of the side-effects associated with typical and atypical antipsychotics, including weight gain, prolactin increase and extrapyramidal symptoms.

Cyrenaic’s CYR-101 studies have been conducted by Forenap Pharma, an international leader in the field of neuroscience and psychiatric clinical trials.

-ends-

About Cyrenaic Pharmaceuticals Cyrenaic is focused on the development of CYR-101, an innovative antipsychotic in development for the treatment of schizophrenia that has the potential to treat all symptoms of the disease. the Company was established through a joint investment by Care Capital and Index Ventures in 2007. Cyrenaic is headquartered in Princeton, new Jersey, USA. Cyrenaic’s clinical studies are being conducted by French neuroscience CRO Forenap Pharma based in Rouffach, France.

For more information, please visit cyrenaicpharma.com

About CYR-101 CYR-101 is a small molecule new Molecular Entity with a novel mechanism of action that was in-licensed from a leading Japanese pharmaceutical firm. it shows potent antagonistic effects at 5-HT2A and sigma-2 receptors in vivo and in vitro and is devoid of direct modulatory activity on dopamine transmission.

About schizophrenia Schizophrenia is a chronic, severe and disabling mental disorder affecting 2.4 million Americans (approx. 1.1% of the U.S adult population) and approximately 5 million people globally. While there is no cure for the disease, correct medication and treatment is able to keep the disorder in check. According to Datamonitor, the global schizophrenia market was valued at US$16 billion in 2008. the symptoms of schizophrenia are broadly categorized as positive, negative, and cognitive symptoms. Positive symptoms are psychotic behaviors not seen in healthy people, such as hallucinations and delusions. Negative symptoms are associated with disruption to normal behavior and emotion, such as a lack of ability to sustain planned activity or a lack of pleasure in everyday life. Cognitive symptoms include problems with working memory and trouble focusing or paying attention.

Contact: Media enquiries College Hill Life Sciences Nicole Yost and Jayne Crook Email: cyrenaic@collegehill.com Ph: +44 (0)20 7866 7855 or Corporate enquiries Geoff race Email: geoff@cyrenaicpharma.com Ph: (+44) 7968 961 275 or US: Care Capital – Dr. Lorenzo Pellegrini Email: lorenzopellegrini@carecapital.com Ph: (+1) 609-683-8300 or Europe: Index Ventures – Dr. Michele Ollier Email: michele@indexventures.com Ph: +41 (0)22 737 00 00

Posted: November 2010

Sentara Cardiovascular Research Institute announced it is one of 35 heart centers in the U.S. involved in clinical trials studying the safety and efficacy of a heart monitor designed to warn patients of an impending heart attack. Riverside Regional Medical Center has been a part of the trial since 2009.

The trial involves implanting a device, called the AngelMed Guardian, just under the skin in a patient’s chest with wires connected to the heart. Smaller than a flip phone, the device is designed to monitor the heart for changes indicating it’s not getting enough oxygen. If something’s wrong, it will alert the patient by sending a wireless message to a pager-like device carried by the patient. that way, the patient can get to the hospital faster.

“The first few minutes of a heart attack are most dangerous, and every minute lost means more damage to the heart muscle. This study is designed to help our cardiac patients who are at high risk of having another heart attack improve their chances of survival. The hope is for them to get a warning even before symptoms occur,” says cardiologist Allen Ciuffo, M.D., principal investigator at Sentara Cardiovascular Research Institute.

One of every six deaths in the U.S. is due to heart disease, and 50 percent of heart attack deaths occur within one hour of symptoms or before the patient reaches the hospital, according to the American Heart Association. Other studies have shown that most damage to the heart occurs within two hours of blood flow being blocked from the heart muscle.

Find more health news at dailypress.com/health.

A Riverside patient holds an AngelMed device.

Image of the AngelMed device implanted in a Riverside patient’s chest.

CSL Behring announced today it has been granted national marketing authorization in Israel to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. with this most recent approval, Berinert is now licensed in 30 countries, including Europe, Japan, North America, South America and Australia.

CSL Behring completed a European Mutual Recognition Procedure (MRP) for Berinert for the treatment of acute attacks of HAE, a rare and serious genetic disorder, in 23 European countries in December 2008. It was subsequently granted all respective national licenses. in October 2009, the United States Food and Drug Administration approved Berinert for the treatment of acute abdominal or facial attacks of HAE in adolescent and adult patients in the United States. National marketing authorizations were also granted for Berinert in Australia in January 2010 and Canada in June 2010. CSL Behring has marketed its C1-esterase inhibitor concentrate in Germany for more than 30 years. CSL Behring also markets it in Argentina, Japan and Switzerland.

The approvals for Berinert are mainly based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.1), the largest single placebo-controlled HAE trial ever, that studied the efficacy of a C1-esterase inhibitor (C1-INH) concentrate.

“The approval of Berinert in Israel is a very important step toward optimal treatment of patients with HAE, many of whom have suffered with the symptoms of this debilitating disease for years,” said Dr. Avner Reshef, Head of the Allergy & Immunology Unit of Sheba Medical Center, Israel. “Because it is rare, and symptoms can appear similar to other medical conditions, HAE is often misdiagnosed. Swellings are wrongly treated as allergic reactions and abdominal pain can often lead to unnecessary surgery.”

“For years, most HAE patients in Israel had to rely on therapy with drugs that are associated with severe side-effects or which were not effective enough in treating symptoms. other patients had no therapy at all and were forced to endure often very painful or disfiguring attacks,” explained Tali Levy, head of the national patient association EDEMA. “However, a patient’s biggest fear is usually the prospect of having an attack of the larynx or throat, which can be life-threatening. Only the assurance that an effective treatment such as Berinert is immediately available can remove this fear and allow such people to live a normal life.”

About Hereditary Angioedema

HAE is a rare genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in the hands, feet, the face, the abdomen, and/or the larynx. Patients who have abdominal attacks of HAE can experience episodes of extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation, and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH. For further information about HAE, please visit the website of the International HAE Patient Organization: HAEI.org, the website of the national patient organization in Israel: edema.co.il and the disease information website allabouthae.com.

About I.M.P.A.C.T.

I.M.P.A.C.T. 1 was a randomized controlled trial of 124 HAE patients with acute, moderate, or severe abdominal or facial attacks. C1-INH concentrate was administered at two different dose levels and compared to placebo. The main study endpoints were: time to onset of symptom relief from HAE attacks, proportion of subjects with worsening clinical HAE symptoms, and safety.  

The I.M.P.A.C.T. 1 study found that C1-esterase inhibitor concentrate (C1-INH) is effective and safe in rapidly treating acute abdominal and facial skin swellings in patients with HAE.  The study found that the median time to symptom relief was 30 minutes after receiving C1-INH compared to 1.5 hours with a placebo.

I.M.P.A.C.T. 2 was an open-label extension study conducted in North-America. The results showed the efficacy and safety of multiple open-label treatments with C1-INH concentrate for HAE attacks at any body location. A total of 1,085 attacks in 57 patients were successfully treated with C1-INH, including 48 laryngeal attacks in 16 patients. The median time to onset of symptom relief was 22 minutes and the median time to complete resolution of all HAE symptoms was 14.3 hours (per-attack analysis). Across all types of attack, median times to onset of relief ranged from 15 minutes (laryngeal attacks) to 30 minutes (peripheral attacks) and median times to complete resolution ranged from 8.4 hours (laryngeal attacks) to 28.3 hours (facial attacks).  A single dose of 20 U/kg plasma-derived C1-INH was sufficient to effectively treat 99 percent of all HAE attacks in this study.

About Berinert ®

Berinert® is a highly purified, human, plasma-derived C1-esterase inhibitor concentrate. As intravenous therapy, it rapidly treats the fundamental cause of hereditary angioedema (HAE) symptoms by providing C1-INH deficient patients with the missing human protein. Berinert is a unique HAE therapy because of its reliable record of proven efficacy and safety in over 30 years of international clinical use in more than 500,000 treatments. in Israel, Berinert is distributed exclusively by Mediline ltd. (mediline.co.il).

About CSL Behring

CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients’ lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company’s therapies are used in the treatment of immune deficiency disorders, hereditary angioedema, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit cslbehring.com.

Findings Demonstrate LATUDA 80 and 160 mg/day Significantly more Effective than Placebo

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) today announced the results of the PEARL 3 study, the third phase 3 worldwide clinical trial of Latuda® (lurasidone HCl) tablets, a once-daily atypical antipsychotic agent recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with schizophrenia. In this six-week, placebo-controlled trial, both fixed doses of LATUDA 80 and 160 mg once-daily, demonstrated statistically significant improvement in symptoms of schizophrenia versus placebo across both primary and secondary efficacy measures. LATUDA was also well tolerated with a relatively low discontinuation rate. the LATUDA 160 mg/day dose has not been reviewed or approved by FDA. the study was presented today at the American College of Neuropsychopharmacology (ACNP) 49th Annual Meeting in Miami, Florida.

“the PEARL 3 results are an important addition to the LATUDA clinical database, and our fifth placebo-controlled trial demonstrating efficacy in schizophrenia”

“The recent FDA approval of LATUDA provides an additional treatment option for patients with schizophrenia. the PEARL 3 study data demonstrating clear efficacy coupled with weight and metabolic properties similar to placebo add to our understanding of the future role of LATUDA in managing the debilitating symptoms that can be challenging to treat,” said Steven G. Potkin, M.D., professor, department of psychiatry and human behavior, University of California, Irvine and presenting author of the study.

the PEARL 3 study (Program to Evaluate the Antipsychotic Response to Lurasidone) was part of an extensive worldwide clinical development program involving more than 2,900 subjects, which evaluated the safety and efficacy of LATUDA for the treatment of adult patients with schizophrenia.

Schizophrenia is a chronic, disabling and serious brain disorder that affects approximately 2.4 million American adults or 1 in 100 people. Schizophrenia is characterized by symptoms such as hallucinations, delusions, disorganized thinking, lack of emotion, lack of energy, as well as problems with memory, attention and the ability to plan, organize and make decisions.

PEARL 3 Key Study Findings

the PEARL 3 study was a double-blind, fixed-dose, placebo-controlled, six-week clinical trial involving 488 patients with schizophrenia and was conducted at 64 sites worldwide. the study had three active treatment arms: LATUDA 80 mg/day and 160 mg/day, and quetiapine extended-release (XR)* 600 mg/day. the use of quetiapine XR was intended to establish assay sensitivity; the study was not designed to directly compare the efficacy of quetiapine and LATUDA. Patients were diagnosed with schizophrenia (using DSM-IV criteria) and were required to have an acute exacerbation of psychotic symptoms with a PANSS [the Positive and Negative Syndrome Scale] total score of 80 or higher at study baseline.

LATUDA 80 and 160 mg once daily were significantly more effective than placebo (-22.2 and -26.5 vs. -10.3 placebo) at Week 6 in the treatment of patients with schizophrenia, with improvements seen as early as day four on the PANSS, the primary efficacy measure. a total of 65% of patients on LATUDA 80 mg/day and 79% of patients on LATUDA 160 mg/day demonstrated a 20% or more improvement on the PANSS total score from baseline versus 41% on placebo at Week 6/Last Observation Carried forward (LOCF) endpoint.

In addition, both LATUDA dose groups were significantly more effective than placebo on the Clinical Global Impressions Severity scale (CGI-S), the key secondary efficacy endpoint, as early as week one. CGI-S score changes from baseline for LATUDA 80 and 160 mg/day versus placebo were -1.5 and -1.7 vs. -0.9, respectively, at Week 6.

Based on the results of this study, the overall safety profile of the drug is not changed. LATUDA 80 and 160 mg/day treatment was well tolerated with a lower overall discontinuation rate than placebo (29% and 23%, respectively vs. 39% placebo), while adverse event-related discontinuations were comparable to placebo (4% and 3%, respectively vs. 4% placebo). the most commonly reported adverse events for LATUDA 80 and 160 mg/day (greater than 5% and at least twice the rate of placebo) were akathisia (8.0% and 7.4% vs. 0.8% placebo); nausea (8.0% and 6.6% vs. 3.3% placebo); parkinsonism (5.6% and 6.6% vs. 0% placebo); dizziness (4.8% and 5.8% vs. 1.7% placebo); and somnolence (4.0% and 6.6% vs. 0.8% placebo).

the effect of both LATUDA doses (80 and 160 mg/day) on weight was similar to placebo: mean weight change was 0.6 kg (1.3 lbs) for both doses compared to 0.1 kg (0.2 lbs) for placebo, at Week 6/LOCF endpoint. Median changes in total cholesterol and other lipid measurements for both LATUDA doses (80 and 160 mg/day) were also similar to placebo: total cholesterol -4.0 mg/dL and -7.5 mg/dL as compared to -7.0 mg/dL placebo; and triglycerides -2.0 mg/dL and -9.0 mg/dL as compared to -9.0 mg/dL placebo, respectively, at Week 6/LOCF endpoint.

“The PEARL 3 results are an important addition to the LATUDA clinical database, and our fifth placebo-controlled trial demonstrating efficacy in schizophrenia,” said Antony Loebel, M.D., executive vice president, Clinical Research and Medical Affairs at Sunovion Pharmaceuticals Inc. “In this study once-daily LATUDA was given in the evening with food. This regimen was well-tolerated at the doses studied.”

Quetiapine XR Key Study Findings

Quetiapine XR 600 mg/day produced significantly greater improvements than placebo at Week 6 on both the PANSS total score (-27.8 vs. -10.3 placebo) and CGI-S (-1.7 vs. -0.9 placebo). a total of 79% of patients on quetiapine XR demonstrated a 20% or more improvement on the PANSS total score from baseline versus 41% on placebo at Week 6/LOCF endpoint. Quetiapine XR was associated with an overall discontinuation rate of 19% vs. 39% placebo. the most commonly reported adverse events for quetiapine XR (greater than 5% and at least twice the rate of placebo) were dizziness (13.4% vs. 1.7% placebo), somnolence (13.4% vs. 0.8% placebo), increased weight (6.7% vs. 0.8% placebo), constipation (6.7% vs 2.5% placebo); dry mouth (7.6% vs. 0.8% placebo); arthralgia (5.9% vs. 0.8% placebo) and, ?upper respiratory tract infection (5.0% vs. 0.8% placebo).

Patients given quetiapine XR reported a 2.1 kg (4.6 lbs) increase in mean weight gain vs. 0.1 kg (0.2 lbs) placebo, at Week 6/LOCF endpoint. Patients treated with quetiapine XR had a greater increase in lipid parameters versus placebo (median change: cholesterol 6.0 mg/dL vs. -7.0 mg/dL placebo; and triglycerides 8.0 mg/dL vs. -9.0 mg/dL placebo at Week 6/LOCF endpoint).

About Latuda® (lurasidone HCl) tablets

LATUDA is an atypical antipsychotic indicated for the treatment of patients with schizophrenia. the efficacy of LATUDA in schizophrenia was established in four 6-week controlled studies of adult patients with schizophrenia. the effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Dosage and Administration

the recommended starting dose of LATUDA is 40 mg once daily. LATUDA should be taken with food. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg/day to 120 mg/day. In the 6-week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose, but there was a dose-related increase in certain adverse reactions. therefore, the maximum recommended dose is 80 mg/day.

the LATUDA 160 mg/day dose has not been reviewed or approved by FDA.

IMPORTANT SAFETY INFORMATION FOR LATUDA

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5% compared to a rate of 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Contraindications: LATUDA is contraindicated in any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation. LATUDA should not be used in combination with a strong CYP3A4 inhibitor or inducer.

Cerebrovascular Adverse Events: In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with administration of antipsychotic drugs, including LATUDA. NMS can cause hyperpyrexia, muscle rigidity, altered mental status, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

Tardive Dyskinesia (TD): the risk of developing TD and the potential for it to become irreversible may increase as the duration of treatment and the total cumulative dose increase. however, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with the need to minimize TD. If signs and symptoms appear, discontinuation should be considered.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of and during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the antipsychotic drug.

Weight Gain: In short-term schizophrenia studies, there were differences in mean weight gain between LATUDA-treated and placebo-treated patients. the mean weight gain was 0.75 kg for LATUDA-treated patients compared to 0.26 kg for placebo-treated patients. the proportion of patients with a ?7% increase in body weight was 5.6% versus 4.0% for placebo-treated patients. In longer-term studies (primarily open-label extension studies), LATUDA was associated with a mean change in weight of -0.38 kg at week 24 (n = 531), -0.47 kg at week 36 (n = 303) and -0.71 kg at week 52 (n = 244).

Orthostatic Hypotension, Syncope, and other Hemodynamic Effects: LATUDA may induce orthostatic hypotension and syncope. LATUDA should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that predispose them to hypotension and in the elderly. LATUDA should be used cautiously when treating patients who receive treatment with other drugs that can induce hypotension, bradycardia, respiratory or central nervous system depression. Monitoring of orthostatic vital signs should be considered in all such patients, and a dose reduction should be considered if hypotension occurs.

Leukopenia, Neutropenia, and Agranulocytosis: In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Patients with a preexisting low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy, and LATUDA should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.

Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, LATUDA can elevate prolactin levels, and the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

In short-term placebo-controlled studies, the median change from baseline to endpoint in prolactin levels for LATUDA-treated patients was 1.1 ng/mL and was -0.6 ng/mL in the placebo-treated patients. the increase in prolactin was greater in female patients. In the longer-term studies (primarily open-label extension studies), LATUDA was associated with a median change in prolactin of -1.9 ng/mL at week 24 (n = 188), -5.4 ng/mL at week 36 (n=189) and -3.3 ng/mL at week 52 (n = 243).

Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold (eg, Alzheimer’s dementia).

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer’s dementia. LATUDA is not indicated for the treatment of dementia-related psychosis, and should not be used in patients at risk for aspiration pneumonia.

Potential for Cognitive and Motor Impairment: Somnolence and sedation were reported in patients treated with LATUDA. Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that LATUDA therapy does not affect them adversely.

Body Temperature Regulation: appropriate care is advised when prescribing LATUDA for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.

Suicide: the possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy. Prescriptions for LATUDA should be written for the smallest quantity of tablets in order to reduce the risk of overdose.

Alcohol: Patients should be advised to avoid alcohol while taking LATUDA.

Commonly Observed Adverse Reactions (?5% and at least twice that for placebo): the most commonly observed adverse reactions associated with the use of LATUDA versus placebo in short-term clinical studies were somnolence, akathisia, nausea, parkinsonism, and agitation.

before prescribing LATUDA, please read the full Prescribing Information, including Boxed Warning.

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the central nervous system (CNS) and respiratory disease areas and improve the lives of patients and their families. Sunovion’s drug development program, together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical products including LATUDA® brand lurasidone HCl, LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate inhalation aerosol, BROVANA® brand aformoterol tartrate inhalation solution, OMNARIS® brand ciclesonide nasal spray and ALVESCO® brand ciclesonide HFA inhalation aerosol.

Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma Co., ltd., is headquartered in Marlborough, Mass. more information about Sunovion Pharmaceuticals Inc. is available at sunovion.com.

About Dainippon Sumitomo Pharma Co., ltd. (DSP)

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. DSP aims to produce innovative pharmaceutical products in the CNS field, which has been designated as the key therapeutic area and will also focus in on other specialty disease categories with significant unmet medical needs, which are designated as frontier therapeutic areas. DSP is based on the merger in 2005 between Dainippon Pharmaceutical Co., ltd., and Sumitomo Pharmaceuticals Co., ltd. Today, DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at ds-pharma.com.

LATUDA® is a registered trademark of Dainippon Sumitomo Pharma Co., ltd. LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH.

* Manufactured by AstraZeneca.

for a copy of this release or any recent release,

visit Sunovion’s web site at sunovion.com.