All posts in Peptide News from Biotech and Pharma

Source: https://globenewswire.com/
Copenhagen, 11 August 2016 – Zealand Pharma (Zealand) announces supportive results from a Phase II trial with a single-dose version of dasiglucagon as rescue treatment of severe hypoglycemia in insulin dependent diabetic patients. Dasiglucagon, formerly referred to as ZP4207, is a glucagon peptide analog, invented and fully owned by Zealand and observed to have a favorable physical and chemical stability in liquid solution. In June 2016, dasiglucagon was proposed as an International Nonproprietary Name (pINN) for this product candidate.

Severe hypoglycemia is a potential life threatening condition and the most feared side effect associated with insulin treatment of diabetes. At present, hypoglycemia rescue treatments are based on native glucagon and solely available as a lyophilized powder, which requires reconstitution with sterile water in a multi-step process prior to use.

The primary objective of this Phase II trial was to characterize the pharmacological profile of an optimized formulation of dasiglucagon and compare it to an approved glucagon rescue product. Results from the trial showed that all subjects treated with one of the three highest doses of dasiglucagon or with the approved glucagon product achieved a blood glucose concentration of >70 mg/dL within 30 minutes of dosing. In the same dose groups, time to clinically relevant plasma glucose increases of >20 mg/dL was shown to be similar for dasiglucagon and approved glucagon with a median time of 9-10 minutes. In the trial, dasiglucagon was observed to be well tolerated and have a similar safety profile compared to approved glucagon. The full Phase II results will be published at a later date.

Read more: https://globenewswire.com/news-release/2016/08/11/863678/0/en/Phase-II-results-with-dasiglucagon-ZP4207-support-its-potential-for-use-in-a-ready-to-use-rescue-pen-to-treat-severe-hypoglycemia-in-diabetes.html

Source: http://www.prometic.com/
LAVAL, QUEBEC, CANADA – August 11, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that it has completed enrolment of the congenital plasminogen deficient patients in its pivotal phase 2/3 clinical trial required for the accelerated regulatory approval pathway with the Food and Drug Administration (“FDA”).

The FDA has agreed to an accelerated regulatory approval pathway, given the rarity of the condition and the related unmet medical need. To secure an accelerated pathway approval, a drug must treat a serious condition, provide a meaningful advantage over available therapies and demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

“We are very pleased with the timely completion of patients’ enrolment in our pivotal plasminogen phase 2/3 trial”, said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “The achievement of this important milestone allows us to confidently proceed with the last phase of the plasminogen congenital deficiency clinical program as we get ready to start filing the required BLA modules necessary to secure licensure from the FDA”.

Dr John Moran, Chief Medical Officer of ProMetic commented: “The ongoing clinical trial has enabled us to meet the primary end-point of achieving the targeted increase in plasma concentration of plasminogen and to define the optimal treatment regimen. We have also observed major clinical benefit in patients with long-standing lesions related to their plasminogen deficiency. As in the patients who have been treated outside the trial on an emergency basis, both the rapidity and the magnitude of the improvement has been remarkable, knowing that in many cases the lesions have been present for years”.
Read more: http://www.prometic.com/prometic-completes-patients-enrolment-in-pivotal-plasminogen-phase-23-clinical-trial/

Source: http://www.cardiome.com/
VANCOUVER, Aug. 9, 2016 - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that XYDALBA™ (dalbavancin) has been approved by the European Medicines Agency (EMA) for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). This single dosing regimen is in addition to the initially approved dosing regimen of 1000 mg (two 500mg vials) followed one week later by 500 mg (a single 500mg vial).

"We are pleased that the EMA has approved the single dose administration of XYDALBA™," said Kiran Bhirangi, M.D., Cardiome's Head of Medical Affairs. "This approval aligns the dosing regimen with the U.S. label, but more importantly, it could enhance the convenience of antibiotic administration for both healthcare providers and their patients. We anticipate that XYDALBA™ will be available to physicians within some of the major territories under license by Cardiome during the fourth quarter of 2016."

XYDALBA™ was approved by the EMA in February 2015 as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults and by the U.S. Food and Drug Administration (FDA) in May 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.
Read more: http://www.cardiome.com/investors/news/archives/2016/cardiome-announces-xydalba%E2%84%A2-single-dose-infusion-approval-european-medi

Source: http://www.phasebio.com/
Malvern, PA, August 8, 2016 — PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on biopolymer-based drugs for orphan, cardiopulmonary and metabolic diseases, today announced the dosing of the first patients in Part One of a Phase 2a clinical study of PB1046, a once-weekly vasoactive intestinal peptide (VIP) receptor agonist in development for the treatment of cardiopulmonary disorders. Part One will assess PB1046 in adult subjects with stable heart failure with reduced ejection fraction. Part Two, which PhaseBio expects to initiate later in 2016, will examine PB1046 in subjects with cardiac dysfunction secondary to Duchenne muscular dystrophy.

“There is a clear need for heart failure treatments that both alleviate symptoms and slow or reverse disease progression,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “We look forward to building on our compelling preclinical data in models of heart failure, and the positive data from our Phase 1 studies, which demonstrated the safety and tolerability of PB1046 at efficacious doses in patients with hypertension.”

Part One is a randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, and pharmacokinetic and pharmacodynamic response following four weeks of once-weekly subcutaneous injections of PB1046 in 28 adults with heart failure. Dose levels shown to be safe and well-tolerated in Part One will be selected for evaluation in Part Two of the study.
Read more: http://www.phasebio.com/pages/news/releases/PhaseBioAnnouncesDosingofFirstPatientsinTwo-PartPhase2aStudyofPB1046inCardiopulmonaryDi.php

Source: http://www.businesswire.com/
KENILWORTH, N.J. -(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis.
“The FDA acceptance of our follow-on biologic application is an important milestone, and brings us closer to offering another treatment option for people in the U.S. with diabetes,” said Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck. “We are proud of the significant contributions we have already made to helping people with type 2 diabetes, and with investigational MK-1293, we hope to expand our portfolio into insulin therapeutics and treatments for people with type 1 diabetes.”
The development program for MK-1293 was designed to meet rigorous regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality. In addition to Phase 1 studies assessing its pharmacokinetic and pharmacodynamic properties, the NDA submission for MK-1293 includes results of two Phase 3 studies, one conducted in people with type 1 diabetes, and one in people with type 2 diabetes; Lantus® (insulin glargine), the originator insulin glargine, was the active comparator in both studies.
Read more: http://www.businesswire.com/news/home/20160805005285/en/

Source: http://www.marketwired.com/
TORONTO, ON and REHOVOT, ISRAEL--(Marketwired - August 04, 2016) - VAXIL BIO (TSX VENTURE: VXL),a biotechnology company specializing in immunotherapy, announces today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent providing broad coverage over Vaxil's immunotherapy platform and its lead product, Orphan Drug Designated Immucin™.
This will become the first US Patent issued to Vaxil since the Company began developing its immunotherapies 10 years ago. ImMucin™ is an immunotherapy intended to train a patient's immune system, particularly T-cells and antibodies, to attack cancer cells via a specific domain, called the signal peptide, of the tumor marker MUC1. This domain bears significant advantages as an immunotherapeutic modality including its presence on approximately 90% of all cancer types. The notice indicates the patentability of claims covering the ImMucin™ peptide as well as claims reciting methods for treating or inhibiting cancer using the ImMucin™ peptide.
This is a highly important addition to Vaxil's existing patent portfolio and strengthens the Company's ability to protect its proprietary technologies as it continues rigorous testing and advancement of ImMucin™. Moreover, it positions Vaxil as the only player able to use the 21-mer peptide known as ImMucin™ for all MUC1 positive tumors. Immucin™ is the first product generated from Vaxil's proprietary VaxHit™ platform, and has been awarded Orphan Drug Status from the FDA and EMA. Vaxil believes there is potential for VaxHit™ to generate additional immunotherapy products targeting the signal peptide domains of other prominent tumor markers.
Read more: http://www.marketwired.com/press-release/vaxil-announces-key-us-patent-trademark-office-notice-allowance-its-immunotherapy-tsx-venture-vxl-2148040.htm

Source: Palatin Technologies, Inc. & reported by http://www.prnewswire.com/
CRANBURY, N.J., Aug. 4, 2016 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN) today announced that the last patient visits in the Company's reconnect studies, consisting of two pivotal Phase 3 clinical trials of bremelanotide for the treatment of female hypoactive sexual desire disorder (HSDD), have been completed.

"We are very excited with the completion of the last patient visits in our Phase 3 reconnect studies," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Patient enrollment and last patient out of the studies were concluded on time. We now look forward to data verification and database lock, which we anticipate occurring in late September, with topline data announced shortly thereafter."

Each Phase 3 study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. The studies are designed to evaluate the efficacy and safety of subcutaneous bremelanotide, delivered by an autoinjector pen, in premenopausal women with HSDD as an on-demand, as-needed treatment.

Read more: http://www.prnewswire.com/news-releases/palatin-technologies-announces-completion-of-all-patient-visits-in-phase-3-clinical-trials-of-bremelanotide-for-hypoactive-sexual-desire-disorder-300308981.html

Source: http://www.businesswire.com/
CHARLESTON, S.C.--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZ) (the “Company”) and Rafa Laboratories, Ltd. (“Rafa”) today announced the signing of an exclusive license agreement for the Company’s lead anti-cancer compound, Zoptrex™ (zoptarelin doxorubicin), for the initial indication of endometrial cancer, for Israel and the Palestinian Territories (the “Territory”). Zoptrex™, a novel synthetic peptide carrier linked to doxorubicin, is currently in a fully-enrolled Phase 3 clinical trial in endometrial cancer. The Company expects to complete the Phase 3 clinical trial in the third quarter of 2016 and, if the results of the trial warrant doing so, to file a new drug application for Zoptrex™ in the first half of 2017.

Under the terms of the License Agreement, Aeterna Zentaris will be entitled to receive a non-refundable upfront payment in consideration for the license to Rafa of the Company’s intellectual property related to Zoptrex™ and the grant to Rafa of the right to commercialize Zoptrex™ in the Territory. Rafa has also agreed to make additional payments to the Company upon achieving certain pre-established regulatory and commercial milestones. Furthermore, the Company will receive double-digit royalties on future net sales of Zoptrex™ in the Territory. Rafa will be responsible for the development, registration, reimbursement and commercialization of the product in the Territory. The Company and Rafa have also entered into a supply agreement, pursuant to which the Company will supply Zoptrex™ to Rafa for the duration of the license agreement.
Read more: http://www.businesswire.com/news/home/20160801005459/en/Aeterna-Zentaris-Rafa-Laboratories-Sign-Exclusive-License

Source: Ipsen Biopharmaceuticals, Inc. & reported by http://www.prnewswire.com/
BASKING RIDGE, N.J., Aug. 1, 2016 /PRNewswire/ -- Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Those treated with Dysport® showed statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth scale (MAS) in ankle plantar flexor muscle tone and mean Physician's Global Assessment (PGA) response to treatment score at Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response. This approval is based on a randomized, multicenter, double-blind, placebo-controlled, international Phase III pivotal study in 235 pediatric patients (158 received Dysport® and 77 received placebo) aged 2 to 17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity.

"Pediatric lower limb spasticity is a neurological condition that is commonly seen in children with cerebral palsy, which affects the communication between the brain and the muscles, resulting in movement and posture problems," said Cynthia Schwalm, Chief Executive Officer, Ipsen Biopharmaceuticals, Inc. "Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Ipsen is committed to providing patients, their caregivers and their physicians with a comprehensive support offering, including Dysport®, the IPSEN CARES™ patient assistance program, and the C.L.I.M.B.® injector training platform for healthcare providers."
Read more: http://www.prnewswire.com/news-releases/ipsen-biopharmaceuticals-inc-announces-fda-approval-of-dysport-abobotulinumtoxina-for-the-treatment-of-lower-limb-spasticity-in-pediatric-patients-aged-two-and-older-300306718.html

Source: Mallinckrodt plc & reported by http://www.prnewswire.com/

CHESTERFIELD, United Kingdom, July 28, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company's Phase 3 clinical study to evaluate the efficacy and safety of terlipressin (for injection) in subjects with Hepatorenal Syndrome (HRS) type 1.

"Patients diagnosed with HRS type 1 typically have a very poor prognosis, and there is a significant unmet need for an approved treatment," said lead investigator Thomas D. Boyer, M.D., Director, Liver Research Institute, University of Arizona College of Medicine – Tucson. "I am excited to work with my colleagues in the hepatology community and with Mallinckrodt on this study of a potentially important therapy for U.S. patients."

Terlipressin is being investigated for the treatment of HRS type1, an acute, rare and life-threatening condition requiring hospitalization, with no currently approved therapy in the U.S. or Canada. Terlipressin is approved for use in countries outside the U.S., including several in Europe.

Read more: http://www.prnewswire.com/news-releases/first-patient-enrolled-in-mallinckrodt-phase-3-terlipressin-trial-300305910.html