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Orexigen Therapeutics names Thomas Lynch as EVP, General Counsel & Secretary and Heather Ace as EVP, Global Human Resources

SAN DIEGO, Jan. 8, 2016 /PRNewswire/ — Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced the appointment of Thomas Lynch as Executive Vice President, General Counsel & Secretary and Heather Ace as Executive Vice President, Global Human Resources. Lynch is a veteran legal professional with more than a decade of experience in the life sciences industry as well as six years of general corporate practice.  Lynch will assume responsibility for the company’s global legal affairs and compliance operations.  Ace has held a variety of high-level executive positions overseeing human resources, communications, facilities, mergers and acquisitions and transformational change initiatives during a ten-year career in the life sciences and medical devices industries.  Ace will lead the human resources organization, including talent and performance management, organizational and leadership development, compensation & benefits, and employee relations.  Both Lynch and Ace will report to Mike Narachi, President and Chief Executive Officer, and serve as members of the Orexigen Executive Team.

Commenting on the recent appointments, Mr. Narachi said, “We are pleased to welcome both Tom and Heather to the executive management team at Orexigen.  They bring legal and human resources expertise in their respective fields of pharmaceutical commercialization, compliance, risk management and global human resources management at an important time for our company. Their broad, international experience make them well prepared to guide us through our efforts to make Contrave® /Mysimba® (naltrexone HCl / bupropion HCl extended release) available in countries around the world.”

Lynch joins Orexigen from Novartis where, since 2012, he was serving as senior legal counsel in two divisions, including leading global legal and compliance support for Novartis Pharma’s neuroscience franchise, based in Basel, Switzerland, and advising on business development and alliance management with partners in Europe and the U.S. Earlier, Lynch spent almost ten years with Boston Scientific in a variety of legal roles and nearly six years practicing corporate law at Dorsey & Whitney LLP. He holds a juris doctorate degree from Boston College Law School, a master’s degree in teaching from the University of St. Thomas, and a bachelor’s degree in history from Stanford University.

Most recently, Ms. Ace was Integration Leader at Philips HealthTech and led the integration of the $1.2 billion acquisition of Volcano Corporation by Royal Philips to form a new Image-Guided Therapy business, combining industry leading interventional systems and solutions with therapy guidance tools. Prior to that role, she served as the EVP, Global Human Resources at Volcano Corporation and VP, Human Resources at Life Technologies in various positions of responsibility serving key business units, functions, the Europe, Middle East and Africa regions and numerous M&A transactions.  She earned her bachelor’s degree in Law & Society from the University of California, Santa Barbara, and a juris doctorate degree from Santa Clara School of Law, cum laude.  

About Contrave and Mysimba

Contrave, approved by the United States Food and Drug Administration in September 2014, is indicated for use 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 (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia). In Europe, the medicine was approved in March 2015 with the brand name Mysimba.

The exact neurochemical effects of Contrave leading to weight loss are not fully understood. Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).

Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of Contrave in conjunction with lifestyle modification in 4,536 subjects randomized to Contrave or placebo. In these studies, the most common adverse reactions (>5 percent) seen in patients taking Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

The clinical trial program also includes a double-blind, placebo-controlled cardiovascular outcomes trial known as the Light Study. The primary objective of this study was to evaluate the occurrence of major adverse cardiovascular events (MACE) in overweight and obese adults with cardiovascular risk factors receiving Contrave. A second study, designed to address post-approval requirements in both Europe and the United States, is planned in order to further evaluate cardiovascular outcomes.

Further information can be found at http://www.orexigen.com/.

Important Safety Information for CONTRAVE and MYSIMBA

(naltrexone HCl and bupropion HCl) 8 mg/90 mg extended-release tablets

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS

Suicidality and Antidepressant Drugs

Not approved for use in the treatment of major depressive disorder or other psychiatric disorders. 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, 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. 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 not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.

Contraindications

Contraindicated in: uncontrolled hypertension; seizure disorder or a history of seizures; use of other bupropion-containing products; bulimia or anorexia nervosa, which increase the risk for seizure; chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, buprenorphine) use, or acute opiate withdrawal; patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; use during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs)—there is an increased risk of hypertensive reactions when used concomitantly with MAOIs and use with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated; known allergy to any component, anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; 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. This warning applies because one component, bupropion, is a member of an antidepressant class.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of anxiety, agitation, irritability, unusual changes in behavior, and other symptoms, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions 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

Not approved for smoking cessation treatment, but serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included 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

Can cause seizures. The risk of seizure is dose-related. Discontinue treatment and do not restart in patients who experience a seizure. Caution should be used when prescribing to patients with predisposing factors that may increase the risk of seizure, including: history of head trauma or prior seizure, severe stroke, arteriovenous malformation, central nervous system tumor or infection, or metabolic disorders (eg, hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives; patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia; concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, systemic steroids.

Clinical experience with bupropion suggests that the risk of seizure may be minimized by adhering to the recommended dosing recommendations, in particular: the total daily dose does not exceed 360 mg of the bupropion component (ie, four tablets per day); the daily dose is administered in divided doses (twice daily); the dose is escalated gradually; no more than two tablets are taken at one time; coadministration with high-fat meals is avoided; if a dose is missed, a patient should wait until the next scheduled dose to resume the regular dosing schedule.

Patients Receiving Opioid Analgesics

Vulnerability to Opioid Overdose: Should not be administered to patients receiving chronic opioids, due to the naltrexone component, which is an opioid receptor antagonist. If chronic opiate therapy is required, treatment should be stopped. In patients requiring intermittent opiate treatment, therapy should be temporarily discontinued and lower doses of opioids may be needed. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after treatment is discontinued. An attempt by a patient to overcome any naltrexone opioid blockade by administering large amounts of exogenous opioids is especially dangerous and may lead to a fatal overdose or life-threatening opioid intoxication (eg, respiratory arrest, circulatory collapse). Patients should be told of the serious consequences of trying to overcome the opioid blockade.

Precipitated Opioid Withdrawal: An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids, and those patients transitioning from buprenorphine or methadone may need as long as two weeks. Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use.

Increase in Blood Pressure (BP) and Heart Rate (HR)

Can cause an increase in systolic BP, diastolic BP, and/or resting HR. These events were observed in both patients with and without evidence of preexisting hypertension. In clinical practice with other bupropion-containing products, hypertension, in some cases severe and requiring acute treatment, has been reported. Blood pressure and pulse should be measured prior to starting therapy with CONTRAVE and should be monitored at regular intervals consistent with usual clinical practice, particularly among patients with cardiac or cerebrovascular disease and/or with controlled hypertension prior to treatment.

Allergic Reactions

Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock. Instruct patients to discontinue and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction (eg, skin rash, pruritus, hives, chest pain, edema, or shortness of breath) during this treatment.

Hepatotoxicity

Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Discontinue in the event of symptoms/signs of acute hepatitis.

Activation of Mania

Bupropion is a drug used for the treatment of depression. Antidepressant treatment can precipitate a manic, mixed, or hypomanic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating therapy, 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). Not approved for use in treating bipolar depression.

Angle-Closure Glaucoma

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

Hypoglycemia with 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). Measurement of blood glucose levels prior to starting therapy and during treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.

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 used concomitantly with MAOIs. Use caution and consider dose reduction of drugs metabolized by CYP2D6. Avoid concomitant use with CYP2B6 inducers. Reduce dose when taken with CYP2B6 inhibitors. Dose with caution when used with drugs that lower seizure threshold. Use caution and monitor for CNS toxicity when using concomitantly with dopaminergic drugs (levodopa and amantadine). Can cause false positive urine test results for amphetamines.

Indication and Usage for Contrave in the United States

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) 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 and Medication Guide for CONTRAVE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication and Usage of MYSIMBA in the European Union

MYSIMBA is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of

  • ≥ 30 kg/m2 (obese), or
  • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co‑morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)

Treatment with MYSIMBA should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

Please see Summary of Product Characteristics and more information about MYSIMBA for EU patients available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003687/human_med_001845.jsp&mid=WC0b01ac058001d124

Mysimba™ and Contrave ® are trademarks 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 and is being commercialized there by the company’s U.S. partner, Takeda Pharmaceuticals. In Europe the drug has been approved under the brand name MysimbaTM (naltrexone HCl/ bupropion HCl prolonged release). Orexigen’s strategy for Contrave/Mysimba is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization. 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 potential for commercialization of Contrave/Mysimba around the world. The inclusion of forwardlooking 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 the marketing and commercialization of Contrave and Mysimba will not be successful; the ability to obtain partnerships and marketing authorizations globally; competition in the global obesity market, particularly from existing therapies; additional analysis of the interim results or the final data from the terminated Light Study, including safety-related data, and the additional CVOT may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; our ability to retain ownership of Contrave and Mysimba and create value in certain markets outside of the United States; our dependence on Takeda to carry out the commercial launch of Contrave in the United States; our ability to obtain and maintain global intellectual property protection for Contrave and Mysimba; the potential that the interim analysis of the Light Study may not be predictive of future results in the Light Study or other clinical trials; the potential for early termination of our collaboration agreement with Takeda; legal or regulatory proceedings against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; the therapeutic and commercial value of Contrave and Mysimba; our ability to successfully acquire, develop and market additional product candidates or approved products; our ability to maintain sufficient capital to fund our operations for the foreseeable future; estimates of the capacity of manufacturing and other facilities to support Contrave; the Company’s reliance on Takeda to vigorously enforce the CONTRAVE intellectual property rights; the potential for a Delaware court to determine that one or more of the patents are not valid or that Actavis’ proposed generic product is not infringing each of the patents at issue; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forwardlooking 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 Quarterly Report on Form 10-Q we filed with the Securities and Exchange Commission on or about November 9, 2015 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 forwardlooking 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:
McDavid Stilwell VP, Corporate Communications and Business Development
(858) 875-8629
Media Contact:
Julie Normart, BrewLife
(415) 946-1087

 

SOURCE Orexigen Therapeutics, Inc.

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PR Newswire

Xcovery Announces Updated Clinical Data on X-396 in Patients with ALK+ Non-Small Cell Lung Cancer at the 4th AACR-IASLC International Joint Conference

NEEDHAM, Mass. and SAN DIEGO, Jan. 8, 2016 /PRNewswire/ — Xcovery today announced updated clinical data on its investigational tyrosine kinase inhibitor (TKI), X-396, in patients with anaplastic lymphoma kinase (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase l/ll trial. The current results include more patients, response rates, and safety data for all patients in the trial.

The updated results from the Phase l/ll “Xalt2” trial were presented January 6 at the 4th AACR-IASLC International Joint Conference 2016.

Phase l/ll Study

These preliminary Xalt2 study findings were presented by Dr. Karen L. Reckamp, Associate Professor at the City of Hope Comprehensive Cancer Center. The data presented include safety analyses on all patients in the trial (N=57) and efficacy analyses on evaluable patients treated at doses of 200 to 250 mg per day (N=27). The presentation is based on patient information in the database as of December 9, 2015. Patient enrollment in the Xalt2 trial is continuing at a dosage of 225 mg daily.

“The updated data continues to show X-396 is an investigational ALK inhibitor with good activity in patients with ALK positive NSCLC,” said Dr. Reckamp. “As the Phase l/ll trial of X-396 continues to enroll patients, we look forward to reporting additional clinical data on this agent.”

Key data from the study include:

Safety and Tolerability – All Patients Enrolled (n=57)

  • The most common adverse event (AE) related to treatment was rash in 49% of patients. No other related AEs were observed in greater than 30% of patients.
  • Related grade 3 or higher AEs were rash (12%), fatigue (2%), decreased appetite (2%), and pruritus (2%).
  • In patients taking X-396 with food, few patients reported nausea or vomiting.

Anti-tumor Activity – Evaluable ALK+ NSCLC Patients Treated at 200 to 250 mg Daily (n=27)

  • Objective response rate 88% (7/8) in ALK-TKI treatment-naïve patients and 84% (10/12) in crizotinib-resistant patients.
  • ALK-TKI treatment-naive patients have been on treatment up to 27 months, and crizotinib-resistant patients have been on treatment for up to 29 months.
  • Responses have been observed in patients with brain metastases.

About X-396
X-396, a small molecule ALK inhibitor discovered by Xcovery’s scientists, is being investigated for the treatment of ALK+ NSCLC, lymphoma and neuroblastoma. X-396 has been validated in potency and selectivity assays that demonstrate it is more selective and up to 10 times more potent than competitive ALK inhibitors tested. X-396 has also shown activity in some ALK mutations that confer resistance to other small molecule ALK inhibitors. X-396 is currently enrolling patients in Xalt2, a Phase l/ll human clinical trial.

About Non-Small Cell Lung Cancer and ALK
Lung cancer is the second most common type of cancer identified in the United States with an estimated 221,000 new diagnoses expected in 2015. Non-small cell lung cancer is the most common type of lung cancer, accounting for an estimated 85-90% of the lung cancer cases.

About Xcovery
Xcovery, headquartered in Needham, Massachusetts and Palm Beach Gardens, Florida, is a biopharmaceutical company working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors. For more information, visit www.xcovery.com

Forward-Looking Statements
This press release contains forward-looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.

Corporate Contact:
Teri Swift
Xcovery Corporate Communications
(561) 727-9559
teri@xcovery.com

 

Logo – http://photos.prnewswire.com/prnh/20151228/318197LOGO 

SOURCE Xcovery

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PR Newswire

ARMO BioSciences to Present at the 34th Annual J.P. Morgan HealthCare Conference

REDWOOD CITY, Calif., Jan. 8, 2016 /PRNewswire/ — ARMO BioSciences, Inc., a clinical stage developer of immuno-oncology therapeutics, today announced that it will present at the 34th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 12, 2016 at 3:00 pm Pacific Time.

Peter Van Vlasselaer, PhD, President and CEO of ARMO, will provide an update on the ongoing Phase 1b clinical trial of ARMO’s investigational drug AM0010 (PEGylated Interleukin-10) for the treatment of advanced solid tumors and an overview of ARMO’s pipeline of cytokine and checkpoint inhibitor immunotherapies. AM0010 has shown activity as a monotherapy and in combination with anti-PD-1 agents in immune-sensitive tumors such as melanoma, renal cell carcinoma, non-small cell lung cancer and others not previously thought to be sensitive to immunotherapy such as colorectal and pancreatic cancers. Dr. Van Vlasselaer will also provide an update on ARMO’s plans to initiate registration enabling phase 2/3 studies for AM0010 in multiple solid tumors.

Event: 34th Annual J.P. Morgan Healthcare Conference
Date: Tuesday, January 12, 2016
Time: 03:00 PM – 03:25 PM (Pacific Time)
Location: Westin St. Francis Hotel, San Francisco, CA, Room Elizabethan C

About ARMO BioSciences:
Founded in 2012, ARMO BioSciences is a clinical stage developer of immuno-therapeutics focused on the oncology space and is anchored by its platform molecule AM0010, a PEGylated form of recombinant human IL-10. The company has a robust pipeline with an anti-Programmed Cell Death Protein 1 (PD-1) checkpoint inhibitor and therapeutic cytokines that are complimentary to other immuno-oncology therapeutics and standard of care drugs. ARMO plans to initiate registration enabling phase 2/3 studies for AM0010 in multiple solid tumors.

For more information, please visit www.armobio.com

 

SOURCE ARMO BioSciences, Inc.

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PR Newswire

Can-Fite to Present at Biotech Showcase in San Francisco on January 13, 2016

PETACH TIKVA, Israel, Jan. 8, 2016 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today announced the Company’s CEO Dr. Pnina Fishman will present at the 8th Annual Biotech Showcase in San Francisco at 11:00am on January 13, 2016.  The conference will take place from January 11-13 at the Parc 55 San Francisco. Registered attendees interested in a one-on-one meeting with management may contact the conference or Can-Fite directly.

About Biotech Showcase

Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and potential strategics 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 Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite’s liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company’s CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication.  These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized in Can-Fite’s filings with the SEC and in its periodic filings with the TASE.  In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control.  Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

SOURCE Can-Fite BioPharma Ltd.

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PR Newswire

Upcoming Corporate Presentations In San Francisco

SAN DIEGO, Jan. 8, 2016 /PRNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), a clinical-stage oncology company developing new treatments for cancer and associated pain, announced today that Dr. Henry Ji, President and Chief Executive Officer, will provide a corporate overview at three upcoming healthcare conferences. Dr. Ji will present:

–  Late stage biosimilar and biobetter antibody programs, including Phase III results

–  Cell-internalizing antibody technology targeting mutant KRAS and other undruggable intracellular targets 

–  Immunocellular therapy and other programs

Event:

2016 Biotech Showcase

Date:

Monday, January 11, 2016

Time:

9:00 a.m. to 9:30 a.m. PST

Location:

Powell Room, 3rd Floor, Parc 55 Hotel at 55 Cyril Magnin Street

Event:

9th Annual OneMedForum

Date:

Tuesday, January 12, 2016

Time:

11:00 a.m. to 11:15 a.m. PST

Location:

Club OneMed, Kensington Park Hotel at 450 Post Street

Event:

OneMed China Forum

Date:

Wednesday, January 13, 2016

Time:

2:45 p.m. to 3:00 p.m. PST

Location:

Club OneMed, Kensington Park Hotel at 450 Post Street

About Sorrento Therapeutics, Inc. 

Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for cancer, inflammation and autoimmune diseases. Sorrento’s lead products are multiple late-stage biosimilar and biobetter antibodies, as well as clinical CAR-T therapies targeting solid tumors.

Forward-Looking Statements

This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Sorrento’s prospects, including, but not limited to, any statements about its and its affiliates’ technologies, including, but not limited to, the cell internalizing technology and combinations of the cell internalizing technology with Sorrento’s antibody library; Sorrento’s (and its subsidiaries’ and affiliates’) business and technology prospects; chimeric antigen receptor (CAR) T cell programs; potential combination therapies; Sorrento’s expectations for adoptive cellular immunotherapies, cell internalizing technology; the development of adoptive immunotherapies and the biosimilar/biobetter programs; Sorrento’s ability to leverage the expertise of its employees and partners to assist the company in the execution of its strategies; Sorrento’s advances made in developing NK cell-based therapies, RTX and human monoclonal antibodies using its proprietary G-MAB fully human antibody technology, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Sorrento™, G-MAB™, CAR.TNK™, TNK Therapeutics™, and the Sorrento logo are trademarks owned by Sorrento Therapeutics, Inc.

All other trademarks and trade names are the property of their respective owners.

© 2016 Sorrento Therapeutics

Logo – http://photos.prnewswire.com/prnh/20150105/167173LOGO

 

SOURCE Sorrento Therapeutics, Inc.

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PR Newswire

Veracyte Announces Expansion to New South San Francisco Facility

— Move accommodates strong growth as company expands its genomic test offerings —

SOUTH SAN FRANCISCO, Calif., Jan. 7, 2016 /PRNewswire/ — Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, today announced that the company is relocating to expanded laboratory and corporate space within South San Francisco. The new space more than doubles the space Veracyte currently occupies, in order to accommodate the company’s strong growth as it offers genomic tests designed to improve disease diagnosis, thus helping patients avoid unnecessary surgeries and taking costs out of the healthcare system.

“This expansion is a direct reflection of Veracyte’s success in executing against our business goals,” said Bonnie Anderson, Veracyte’s president and chief executive officer. “Test volume for our lead product, the Afirma® Gene Expression Classifier, increased significantly in 2015, as a result of multiple factors, including expanded reimbursement and inclusion in key industry guidelines. Additionally, we successfully launched the Percepta Bronchial Genomic Classifier last April, and we plan to introduce a second pulmonology product later this year. This significant product growth and expansion has increased our need for additional lab space and employees, while further validating our core mission.”

Veracyte has secured at 10-year lease to occupy space on the three floors of 6000 Shoreline Court in the Sierra Point area of South San Francisco. This space will accommodate new, state-of-the art R&D and CLIA laboratories, as well as offices for the approximately 120 employees based in the company’s corporate location. To accommodate future growth, the company also secured expansion rights, enabling it to procure additional square footage in the same building during 2017 and 2019 as needed.

About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 175 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2015 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.

Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.

 

SOURCE Veracyte

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PR Newswire

Amgen To Present At The 34th Annual J.P. Morgan Healthcare Conference

THOUSAND OAKS, Calif., Jan. 7, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) will present at the 34th Annual J.P. Morgan Healthcare Conference at 8 a.m. PT on Tuesday, Jan. 12, 2016, at the Westin St. Francis in San Francisco. Robert A. Bradway, chairman and chief executive officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

Logo – http://photos.prnewswire.com/prnh/20081015/AMGENLOGO

 

SOURCE Amgen

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PR Newswire

Symic Appoints Rinko Ghosh President and Chief Business Officer

– Company Continues to Expand and Strengthen Management Team –

SAN FRANCISCO, Jan. 7, 2016 /PRNewswire/ — Symic, a clinical-stage biotherapeutics company developing multiple compounds that target and affect the extracellular matrix (ECM), today announced the appointment of Rinko Ghosh as President and Chief Business Officer.

Previously Mr. Ghosh was Senior Vice President & Chief Business Officer at Nektar Therapeutics. His primary responsibilities at Nektar included business and corporate development, marketing, strategic planning, portfolio evaluation and alliance management. He was a member of the Executive Committee at Nektar and was instrumental in closing large, revenue-generating transactions and building long-term alliances with Astra Zeneca, Baxter, Bayer, Novartis, Amgen, Roche, Pfizer, Merck, BMS, UCB, Covidien, Takeda/Affymax and Allergan/MAP. He has completed more than 50 business transactions over his career across North America, Europe and Asia. He has also been an Advisor to several Life Sciences companies, including Epic Sciences, PulmoKine, MannKind, Pearl Therapeutics (acquired by Astra Zeneca) and Aviron (acquired by MedImmune). Prior to joining Nektar in 2001, he was co-CEO of a biotechnology startup in Asia. Earlier, as a management consultant with A.T. Kearney and as a scientific consultant with Environ, he worked with multinational clients in healthcare and other industries. 

“Rinko has more than 20 years of experience in biotechnology and healthcare and a proven track record of executing high-value transactions, building commercial expertise in innovation-based enterprises and driving strategic growth,” said Ken Horne, Chief Executive Officer of Symic.  “He is joining the Symic team at a pivotal time for the company, as we focus on achieving key clinical milestones and translating our novel platform candidates into therapeutic product opportunities, serving areas of high unmet medical need.”

Mr. Ghosh earned his M.B.A. from the Wharton School, University of Pennsylvania, his M.S. in Environmental Engineering from Vanderbilt University, and his B.S. in Chemical Engineering from the Indian Institute of Technology, Bombay. Throughout his career, he has been actively involved with non-profits, including the Asian Art Museum of San Francisco. He has served on several non-profit boards where he has helped resolve issues related to board governance, fund-raising and strategic planning.

About Symic

Symic is a clinical-stage biotherapeutics company developing multiple compounds that target and affect the extracellular matrix (ECM), the non-cellular component of tissues that is critical for healthy tissue function.  Components of the ECM, particularly proteoglycans, which are important structural and functional macromolecules native to the ECM, play a critical role in healing following injury and in chronic diseases.  Symic’s proprietary compounds function like proteoglycans, and have been designed to promote healing and repair in a variety of disease states.  Symic’s lead compound, SB-030, is currently under evaluation in the Phase 1/2 SHIELD clinical trial for vascular endothelial injury.  In addition, Symic’s osteoarthritis drug candidate, SB-061, is poised to enter the clinic in the next few months.

Symic is based in San Francisco. For additional information, please visit the company’s website at http://www.symic.bio or follow us on Twitter at www.twitter.com/symicbio and LinkedIn at www.linkedin.com/company/symic-bio/.

Media Contacts

David Schull or Lena Evans
Russo Partners, LLC
(212) 845-4271
(212) 845-4262
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com

SOURCE Symic

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PR Newswire

Kindred Biosciences to Provide Corporate Update

SAN FRANCISCO, Jan. 7, 2016 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it will provide a corporate update via webcast on Monday, January 11, 2016 in advance of one-on-one investor meetings in San Francisco January 12-14, 2016. 

Webcast Information 

The webcast will be available on Monday, January 11, 2016 at 8:30 AM Eastern Standard Time at http://www.KindredBio.com/events and will be available for 30 days.

About Kindred Biosciences 

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats, and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

Contact

Denise Bevers
KindredBio
denise.bevers@kindredbio.com  
(650) 701-7904

 

SOURCE Kindred Biosciences, Inc.

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News

UC San Diego’s Big Ideas for 2016 — and Beyond

The new year is a time to take stock of past accomplishments, and UC San Diego has no shortage of those. We once again surpassed $1 billion in research funding in 2014-15, an extraordinary accomplishment that places us among the top five research universities in the nation. And we put that research funding to good use — in 2015, Washington Monthly once again ranked UC San Diego as the No. 1 university in the nation for its positive impact. The new year is also a time to look forward to what we want to accomplish next. Here, 14 visionaries from around the campus share their “big ideas” for revolutionizing our local community and our planet — in 2016 and beyond.

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