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Conatus Pharmaceuticals Inc. To Present At Two December Investor Conferences

November 23, 2014 – 5:00 pm | Edit Post

SAN DIEGO, Nov. 24, 2014 (GLOBE NEWSWIRE) — Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced its scheduled participation in two upcoming investor conferences. The company…

Sevion Therapeutics Announces Chimerasome Research Agreement

November 23, 2014 – 5:00 pm | Edit Post

LA JOLLA, Calif.–(BUSINESS WIRE)–Sevion Therapeutics (OTCQB:SVON), a biopharmaceutical company which discovers, develops and acquires next-generation biologics for the treatment of cancer and immunological diseases, today announced that it has entered into a research agreement with Avidity NanoMedicines LLC related to the use of Sevions chimerasome technology for delivery of nucleic acids. Terms…

GlySens Incorporated Awarded $2 Million Grant From The NIH

November 23, 2014 – 5:00 pm | Edit Post

SAN DIEGO, Nov. 24, 2014 /PRNewswire/ –GlySens Incorporated announced today that it has been awarded a two-year, two million dollar grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the National Institutes of Health (NIH). The…

Nicotine addiction linked to neuron

November 22, 2014 – 2:25 pm | Edit Post

A newly discovered kind of neuron unites the buzz of nicotine and withdrawal pangs.

Aurora Spine to Present at Brean Capital Life Sciences Summit Conference

November 22, 2014 – 7:01 am | Edit Post

CARLSBAD, CALIFORNIA–(Marketwired – Nov. 22, 2014) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it will be presenting at the Brean Capital Life Sciences Summit Conference in New York, NY on November 24, 2014. Brean Capital’s Corporate Access product offering includes a number of industry-specific and regional “best idea” investment conferences to facilitate the interaction of company management and institutional investors throughout the year.

Ichor Wields Weapon in Biological Threat Fight

November 21, 2014 – 11:33 am | Edit Post

Ichor Medical Systems Inc., a San Diego-based biotech, recently was awarded funding potentially worth $20.2 million over five years from a national defense organization to develop a special kind of immunization to protect U.S. military members and the general population against biological threats.

Rock Creek Pharmaceuticals to Present at the Biotech Showcase 2015

November 21, 2014 – 6:30 am | Edit Post

SARASOTA, Fla., Nov. 21, 2014 /PRNewswire/ – Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI) announced that the Company is scheduled to present at the Biotech Showcase™ 2015 taking place in San Francisco, CA on January 12-14, 2015.

Michael Mullan, MBBS, PhD, Chairman and CEO of Rock Creek Pharmaceuticals, will present preclinical and clinical data for anatabine citrate, a small molecule cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics. Dr. Mullan will outline the Company’s regulatory strategy and ongoing drug development initiatives designed to advance its the lead molecule into phase I and phase II trials.

About Biotech Showcase 2015:

Biotech Showcase is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week, which is widely viewed as setting the tone for the coming year.

About Anatabine Citrate:

Rock Creek Pharmaceuticals’ anatabine citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics. The Company has sponsored extensive pre-clinical (in vitro and in vivo) studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer’s Disease, and Auto-Immune Thyroiditis. All these studies demonstrated the anti-inflammatory effects of anatabine. In addition, the Company’s compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies and post-marketing data collection of the previously marketed nutraceutical product, has provided important insights for clinical development.

About Rock Creek Pharmaceuticals, Inc.:                 Rock Creek Pharmaceuticals, Inc. is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic inflammatory disease, neurologic disorders and behavioral health.

For more information, visit: http://www.rockcreekpharmaceuticals.com

Forward Looking Statements:

Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “targets,” “projects” and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices and the outcome of the ongoing investigations as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2013 filed on March 17, 2014 and our latest 10-Q Report filed on August 11, 2014. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

CONTACT:

Ted JenkinsVice President, Corporate Strategy, Development, Investor RelationsRock Creek Pharmaceuticals            2040 Whitfield Avenue, Suite 300           Sarasota, FL  34243              Direct: 941-251-0488tjenkins@rockcreekpharmaceuticals.com

Stephanie Carrington             Investors                Integrated Corporate Relations, Inc. (ICR): Redefining Strategic Communications            685 Third Avenue, 2nd Floor,          New York, NY 10017              (646) 277-1282               stephanie.carrington@icrinc.com

Logo – http://photos.prnewswire.com/prnh/20141121/160211LOGO
SOURCE Rock Creek Pharmaceuticals, Inc.

Rock Creek Pharmaceuticals to Present at the Biotech Showcase 2015

November 21, 2014 – 6:30 am | Edit Post

SARASOTA, Fla., Nov. 21, 2014 /PRNewswire/ – Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI) announced that the Company is scheduled to present at the Biotech Showcase™ 2015 taking place in San Francisco, CA on January 12-14, 2015.

Michael Mullan, MBBS, PhD, Chairman and CEO of Rock Creek Pharmaceuticals, will present preclinical and clinical data for anatabine citrate, a small molecule cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics. Dr. Mullan will outline the Company’s regulatory strategy and ongoing drug development initiatives designed to advance its the lead molecule into phase I and phase II trials.

About Biotech Showcase 2015:

Biotech Showcase is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week, which is widely viewed as setting the tone for the coming year.

About Anatabine Citrate:

Rock Creek Pharmaceuticals’ anatabine citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics. The Company has sponsored extensive pre-clinical (in vitro and in vivo) studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer’s Disease, and Auto-Immune Thyroiditis. All these studies demonstrated the anti-inflammatory effects of anatabine. In addition, the Company’s compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies and post-marketing data collection of the previously marketed nutraceutical product, has provided important insights for clinical development.

About Rock Creek Pharmaceuticals, Inc.:                 Rock Creek Pharmaceuticals, Inc. is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic inflammatory disease, neurologic disorders and behavioral health.

For more information, visit: http://www.rockcreekpharmaceuticals.com

Forward Looking Statements:

Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “targets,” “projects” and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices and the outcome of the ongoing investigations as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2013 filed on March 17, 2014 and our latest 10-Q Report filed on August 11, 2014. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

CONTACT:

Ted JenkinsVice President, Corporate Strategy, Development, Investor RelationsRock Creek Pharmaceuticals            2040 Whitfield Avenue, Suite 300           Sarasota, FL  34243              Direct: 941-251-0488tjenkins@rockcreekpharmaceuticals.com

Stephanie Carrington             Investors                Integrated Corporate Relations, Inc. (ICR): Redefining Strategic Communications            685 Third Avenue, 2nd Floor,          New York, NY 10017              (646) 277-1282               stephanie.carrington@icrinc.com

Logo – http://photos.prnewswire.com/prnh/20141121/160211LOGO
SOURCE Rock Creek Pharmaceuticals, Inc.

Orexigen Announces Allowance of New U.S. Patent for Contrave® (naltrexone HCl / bupropion HCl extended release)

November 21, 2014 – 6:00 am | Edit Post

SAN DIEGO, Nov. 21, 2014 /PRNewswire/ – Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that the Company has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for U.S. Patent Application No. 11/757,773, which covers use of Orexigen’s sustained release formulation of naltrexone, which was designed to improve drug tolerability for Contrave® (naltrexone HCl / bupropion HCl extended release), in a method for treating obesity. The patent is expected to expire in March of 2028. Orexigen expects the patent to be listed in the Orange Book maintained by the United States Food and Drug Administration.

“A key component of Orexigen’s strategy is to strengthen and extend intellectual property protection for Contrave,” said Michael Narachi, CEO of Orexigen. “We are pleased that patent protection for use of this naltrexone formulation – and for Contrave – is now expected to extend at least to 2028.”

Intellectual Property Protecting Contrave

Contrave is currently protected by U.S. patent number 7,375,111 and U.S. patent number 7,462,626, which Orexigen refers to collectively as the Weber/Cowley patents and which are expected to expire in 2025/2024. The Weber/Cowley patents cover the current composition of Contrave and methods of administering it to treat obesity. Orexigen and/or licensors have filed a number of international counterparts to the Weber/Cowley patents in foreign countries. A European counterpart application to the Weber/Cowley patent has issued in the European Patent Office, or EPO, and provides protection for Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) in the various EPO countries in which the patent has been registered. Orexigen has also filed patent applications, directed to various treatment and formulation aspects of Contrave, in the United States and certain foreign countries under the Patent Cooperation Treaty, or PCT. Use of Contrave for the treatment of insulin resistance is protected by U.S. patent number 8,815,889, which is expected to expire in 2024. A proprietary tri-layer Contrave tablet and its use for weight loss are protected in the United States by U.S. patent numbers 8,088,786 and 8,318,788, which are expected to expire in February 2029 and November 2027, respectively. In addition, the dose escalation schedule of Contrave is protected by U.S. patent 8,722,085, which is expected to expire in November 2027. Orexigen has filed other patent applications in the United States and other parts of the world with the potential, if the patents issue, to extend intellectual property protection to 2034.

Important Safety Information for Contrave (naltrexone HCl and bupropion HCl)

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS

SUICIDALITY AND ANTIDEPRESSANT DRUGS

CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.

NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION

Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although CONTRAVE is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.

Contraindications: CONTRAVE is contraindicated in patients with uncontrolled hypertension, seizure disorder, or current or prior diagnosis of anorexia nervosa or bulimia; in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; with use of other bupropion-containing products; for use with chronic opioids or opiate agonists (eg, methadone) or partial agonists (eg, buprenorphine) or acute opiate withdrawal; during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); in patients with known allergy to any other component of CONTRAVE—anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; in pregnancy.

Warnings and Precautions

Suicidal Behavior and Ideation: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy or at times of dose changes, either increases or decreases. Consider changing the therapeutic regimen or discontinuing in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, or mania, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Alert families and caregivers of patients being treated with antidepressants about the need to monitor patients for the emergence of above mentioned symptoms, as well as the emergence of suicidality, daily and to report such symptoms immediately. Prescriptions for CONTRAVE should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment: CONTRAVE is not approved for smoking cessation treatment, but serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation, including changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur.

Seizures: CONTRAVE can cause seizures. The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Use caution and consider the risk when prescribing CONTRAVE to patients with predisposing factors, clinical situations, and concomitant medications that may lower seizure threshold. Risk of seizure may be minimized by adhering to the recommended dosing schedule and avoiding co-administration with a high-fat meal.

Patients Receiving Opioid Analgesics: CONTRAVE should not be administered to patients receiving chronic opioids. Patients may be vulnerable to opioid overdose and/or precipitated opioid withdrawal.

Increase in Blood Pressure (BP) and Heart Rate (HR): CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. Monitor BP and HR especially in patients with cardiac or cerebrovascular disease and/or with controlled hypertension.

Allergic Reactions: Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported in clinical trials with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock.

Hepatotoxicity: Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Use of CONTRAVE should be discontinued in the event of symptoms/signs of acute hepatitis.

Activation of Mania: Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression).

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, a component of CONTRAVE, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Use of Antidiabetic Medications: Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (eg, sulfonylureas). Monitor blood glucose levels.

Adverse Reactions: Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).

Drug Interactions: Increased risk of hypertensive reactions can occur when CONTRAVE is used concomitantly with MAOIs. Use caution and consider dose reduction of drugs metabolized by CYP2D6 when using with CONTRAVE. Avoid concomitant use with CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. Dose CONTRAVE with caution when used with drugs that lower seizure threshold. Use caution and monitor for CNS toxicity when using CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine). CONTRAVE can cause false positive urine test results for amphetamines.

Indication

CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

30 kg/m2 or greater (obese) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)Limitations of Use

The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Please see full Prescribing Information, including Medication Guide, for Contrave.

More information is also available at www.ContraveHCP.com and www.Contrave.com.

Contrave® is a trademark of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave® (naltrexone HCl and bupropion HCl extended-release), which is approved in the United States. Orexigen’s strategy for Contrave is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization. Orexigen’s partner for North America, Takeda Pharmaceuticals, will commercialize Contrave in the United States, Canada and Mexico. Orexigen has submitted an application for marketing authorization for Mysimba® (naltrexone HCl/ bupropion HCl prolonged release) in Europe, with an opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) expected in December 2014. Further information about the Company can be found at http://www.orexigen.com/.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding: the issuance of U.S. Patent Application No. 11/757,773, which covers Orexigen’s proprietary sustained release formulation of naltrexone; and the patent’s expected expiration in 2028.  The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the potential that additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study or another cardiovascular outcomes trial; the final results of the Light Study or another cardiovascular outcomes trial may not support continued approval of Contrave; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward‐looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Annual Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2014 and its other reports, which are available from the SEC’s website (www.sec.gov) and on Orexigen’s website (www.orexigen.com) under the heading “Investors.” All forward‐looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Orexigen Contact:

Media Contact: 

McDavid Stilwell

David Walsey

VP, Corporate Communications and Business Development

BrewLife

(858) 875-8629

(858) 617-0772

 
SOURCE Orexigen Therapeutics, Inc.

Orexigen Announces Allowance of New U.S. Patent for Contrave® (naltrexone HCl / bupropion HCl extended release)

November 21, 2014 – 6:00 am | Edit Post

SAN DIEGO, Nov. 21, 2014 /PRNewswire/ – Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that the Company has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for U.S. Patent Application No. 11/757,773, which covers use of Orexigen’s sustained release formulation of naltrexone, which was designed to improve drug tolerability for Contrave® (naltrexone HCl / bupropion HCl extended release), in a method for treating obesity. The patent is expected to expire in March of 2028. Orexigen expects the patent to be listed in the Orange Book maintained by the United States Food and Drug Administration.

“A key component of Orexigen’s strategy is to strengthen and extend intellectual property protection for Contrave,” said Michael Narachi, CEO of Orexigen. “We are pleased that patent protection for use of this naltrexone formulation – and for Contrave – is now expected to extend at least to 2028.”

Intellectual Property Protecting Contrave

Contrave is currently protected by U.S. patent number 7,375,111 and U.S. patent number 7,462,626, which Orexigen refers to collectively as the Weber/Cowley patents and which are expected to expire in 2025/2024. The Weber/Cowley patents cover the current composition of Contrave and methods of administering it to treat obesity. Orexigen and/or licensors have filed a number of international counterparts to the Weber/Cowley patents in foreign countries. A European counterpart application to the Weber/Cowley patent has issued in the European Patent Office, or EPO, and provides protection for Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) in the various EPO countries in which the patent has been registered. Orexigen has also filed patent applications, directed to various treatment and formulation aspects of Contrave, in the United States and certain foreign countries under the Patent Cooperation Treaty, or PCT. Use of Contrave for the treatment of insulin resistance is protected by U.S. patent number 8,815,889, which is expected to expire in 2024. A proprietary tri-layer Contrave tablet and its use for weight loss are protected in the United States by U.S. patent numbers 8,088,786 and 8,318,788, which are expected to expire in February 2029 and November 2027, respectively. In addition, the dose escalation schedule of Contrave is protected by U.S. patent 8,722,085, which is expected to expire in November 2027. Orexigen has filed other patent applications in the United States and other parts of the world with the potential, if the patents issue, to extend intellectual property protection to 2034.

Important Safety Information for Contrave (naltrexone HCl and bupropion HCl)

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS

SUICIDALITY AND ANTIDEPRESSANT DRUGS

CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.

NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION

Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although CONTRAVE is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.

Contraindications: CONTRAVE is contraindicated in patients with uncontrolled hypertension, seizure disorder, or current or prior diagnosis of anorexia nervosa or bulimia; in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; with use of other bupropion-containing products; for use with chronic opioids or opiate agonists (eg, methadone) or partial agonists (eg, buprenorphine) or acute opiate withdrawal; during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); in patients with known allergy to any other component of CONTRAVE—anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; in pregnancy.

Warnings and Precautions

Suicidal Behavior and Ideation: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy or at times of dose changes, either increases or decreases. Consider changing the therapeutic regimen or discontinuing in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, or mania, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Alert families and caregivers of patients being treated with antidepressants about the need to monitor patients for the emergence of above mentioned symptoms, as well as the emergence of suicidality, daily and to report such symptoms immediately. Prescriptions for CONTRAVE should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment: CONTRAVE is not approved for smoking cessation treatment, but serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation, including changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur.

Seizures: CONTRAVE can cause seizures. The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Use caution and consider the risk when prescribing CONTRAVE to patients with predisposing factors, clinical situations, and concomitant medications that may lower seizure threshold. Risk of seizure may be minimized by adhering to the recommended dosing schedule and avoiding co-administration with a high-fat meal.

Patients Receiving Opioid Analgesics: CONTRAVE should not be administered to patients receiving chronic opioids. Patients may be vulnerable to opioid overdose and/or precipitated opioid withdrawal.

Increase in Blood Pressure (BP) and Heart Rate (HR): CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. Monitor BP and HR especially in patients with cardiac or cerebrovascular disease and/or with controlled hypertension.

Allergic Reactions: Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported in clinical trials with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock.

Hepatotoxicity: Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Use of CONTRAVE should be discontinued in the event of symptoms/signs of acute hepatitis.

Activation of Mania: Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression).

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, a component of CONTRAVE, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Use of Antidiabetic Medications: Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (eg, sulfonylureas). Monitor blood glucose levels.

Adverse Reactions: Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).

Drug Interactions: Increased risk of hypertensive reactions can occur when CONTRAVE is used concomitantly with MAOIs. Use caution and consider dose reduction of drugs metabolized by CYP2D6 when using with CONTRAVE. Avoid concomitant use with CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. Dose CONTRAVE with caution when used with drugs that lower seizure threshold. Use caution and monitor for CNS toxicity when using CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine). CONTRAVE can cause false positive urine test results for amphetamines.

Indication

CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

30 kg/m2 or greater (obese) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)Limitations of Use

The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Please see full Prescribing Information, including Medication Guide, for Contrave.

More information is also available at www.ContraveHCP.com and www.Contrave.com.

Contrave® is a trademark of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave® (naltrexone HCl and bupropion HCl extended-release), which is approved in the United States. Orexigen’s strategy for Contrave is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization. Orexigen’s partner for North America, Takeda Pharmaceuticals, will commercialize Contrave in the United States, Canada and Mexico. Orexigen has submitted an application for marketing authorization for Mysimba® (naltrexone HCl/ bupropion HCl prolonged release) in Europe, with an opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) expected in December 2014. Further information about the Company can be found at http://www.orexigen.com/.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding: the issuance of U.S. Patent Application No. 11/757,773, which covers Orexigen’s proprietary sustained release formulation of naltrexone; and the patent’s expected expiration in 2028.  The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the potential that additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study or another cardiovascular outcomes trial; the final results of the Light Study or another cardiovascular outcomes trial may not support continued approval of Contrave; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward‐looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Annual Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2014 and its other reports, which are available from the SEC’s website (www.sec.gov) and on Orexigen’s website (www.orexigen.com) under the heading “Investors.” All forward‐looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Orexigen Contact:

Media Contact: 

McDavid Stilwell

David Walsey

VP, Corporate Communications and Business Development

BrewLife

(858) 875-8629

(858) 617-0772

 
SOURCE Orexigen Therapeutics, Inc.