On February 19, 2019 Zetagen Therapeutics, Inc., a private, US-based biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and orthopedic interventions, reported that the U.S. Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 10208306 and the South African Patent Office issued PCT. 2017/00029 to the Company (Press release, Zetagen Therapeutics, FEB 19, 2019, View Source [SID1234643687]). These patents, entitled Composition and Methods to Promote Bone Formation, include claims covering the use of methods for stimulating bone growth using its novel molecular pathway, ZetaMet (Zeta-BC-003). ZetaMet (Zeta-BC-003) is a synthetic, small molecule, inductive biologic, delivered via a drug-eluting implant on an osteopromotive carrier.

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"These new patent issuances are an important step forward towards our ultimate goal of obtaining the global, commercial rights for our treatments," said Joe C. Loy, CEO of Zetagen Therapeutics, Inc. "We believe in the potential our therapies hold for patients around the world who live with debilitating metastatic bone cancers."

The new patent is part of an expanding and comprehensive portfolio of patents, patent applications and other intellectual property covering the composition, synthesis, manufacturing, formulations and uses for the treatment of a variety of metastatic bone lesions and osteologic interventions. Zetagen exclusively licensed its platform technology from the State University of New York in 2016.

On February 19, 2019 Pfizer Inc. (NYSE: PFE) reported the European Commission (EC) has approved ZIRABEV for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.1,2 (Press release, Pfizer, FEB 19, 2019, View Source [SID1234533387])

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"Pfizer is dedicated to increasing access to biosimilars for patients suffering from serious illnesses and helping create a more sustainable healthcare system," said Andreas Penk, M.D., regional president, Oncology International Developed Markets at Pfizer. "We are proud that ZIRABEV was approved today as our second oncology biosimilar in Europe. This milestone reflects our ongoing commitment to biosimilars as we continue to bring high-quality medicines to market that may help generate cost savings for cancer care."

* Avastin is a registered trademark of Genentech

The EC approval is based on a comprehensive submission package which demonstrated biosimilarity of ZIRABEV and the originator product. This includes results from the phase 3 REFLECTIONS B739-03 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between ZIRABEV and the originator product in patients with advanced non-squamous NSCLC.3 As part of the overall REFLECTIONS clinical trial program, ZIRABEV has been studied in approximately 400 subjects.3,4

This approval follows the positive recommendation from the Committee for Medicinal Products for Human Use in December 2018.5 ZIRABEV has also been filed for regulatory approval with the U.S. Food and Drug Administration.

Pfizer has a robust portfolio of potential biosimilar candidates in mid- to late-stage development.6 ZIRABEV is Pfizer’s fifth biosimilar approved for use in Europe.1,7, 8,9,10

About ZIRABEV (bevacizumab biosimilar)

ZIRABEV is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Avastin, which works by inhibiting the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor (VEGF) protein.11, 12,13 ZIRABEV has been studied in nearly 400 patients.3,4

ZIRABEV safety information

Do not use ZIRABEV if you are allergic to bevacizumab, any of its ingredients, Chinese hamster ovary (CHO) cell products, or other recombinant human or humanised antibodies, or if you are pregnant.

Before starting treatment with ZIRABEV, tell your healthcare provider if:

you have any conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy)
you have persistent, recurrent or metastatic cervical cancer
you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery
you had holes in the gut wall or problems with wound healing
you have high blood pressure which is not well controlled with blood pressure medicines
you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries
you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for any reason
you have metastatic cancer affecting your brain
you have noticed coughing or spitting blood
you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease
you have previously experienced problems after injections, such as dizziness/feeling of fainting, breathlessness, swelling or skin rash
you have headache, vision changes, confusion or seizure with or without high blood pressure
you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth
you need to undergo an invasive dental treatment or dental surgery, in particular when you are also receiving or have received an injection of bisphosphonate into your blood
you are currently using or recently used a medicine called sunitinib malate, are receiving platinum- or taxane-based chemotherapy (medicines used to treat cancer) or are receiving or recently received radiotherapy
you have previously received any other treatment for cancer
ZIRABEV increases the risk of having protein in your urine, especially if you already have high blood pressure. ZIRABEV can also increase the risk of developing blood clots in your veins (a type of blood vessel) and may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).

Like all medicines, ZIRABEV can cause side effects, although not everybody gets them. If you have an allergic reaction, contact your doctor or a member of medical staff straight away. The signs may include difficulty in breathing or chest pain. You could also experience redness or flushing of the skin or a rash, chills and shivering, feeling sick (nausea) or being sick (vomiting). Very common severe side effects of treatment with ZIRABEV are:

high blood pressure
the feeling of numbness or tingling in hands or feet
a decreased number of cells in the blood, including white cells that help to fight infection (this may be accompanied by fever), and cells that help the blood to clot
feeling weak and having no energy
tiredness
diarrhoea, nausea, vomiting and abdominal pain.
Other very common side effects that are not as severe include constipation, loss of appetite, fever, problems with eyes (including increased tear production), changes in speech, changes in sense of taste, runny nose, dry skin, flaking and inflammation of skin, changes in skin color, loss of body weight and nose bleeds. You should tell your healthcare provider immediately if you notice any of the above symptoms.

Tell your healthcare provider if you are taking, have recently taken or may take any other medicines.

Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding.

Ask your healthcare provider about the risks and benefits of ZIRABEV. Only a healthcare provider can decide if ZIRABEV is right for you.

You are encouraged to report negative side effects to the European Medicines Agency. Visit View Source Please refer to the European Summary of Product Characteristics for ZIRABEV for complete safety information.

On February 19, 2019 MannKind Corporation (Nasdaq:MNKD) reported that it will release its 2018 fourth quarter and full year financial results on Tuesday, February 26, 2019 and its management will host a conference call to discuss the financial results and other Company developments at 9:00 AM (Eastern Time) on February 26, 2019 (Press release, Mannkind, FEB 19, 2019, View Source [SID1234533478]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

To participate in the live call by telephone, please dial (888) 394-8218 or (323) 701-0225 and use the participant passcode: 7809405. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7809405#. A replay will also be available on MannKind’s website for 14 days.

On February 19, 2019 National Brain Tumor Society (NBTS), a leading nonprofit dedicated to the brain tumor community in the United States, reported a new partnership with the Brain Science Foundation (BSF) (Press release, National Brain Tumor Society, FEB 19, 2019, View Source [SID1234553933]). Under terms of the partnership, the organizations have established the Meningioma Research Fund to raise and grant funds specifically for meningioma research poised to identify and advance treatments aimed at dramatically improving survival and quality of life.

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Meningioma is the most common primary brain tumor, accounting for 37 percent of all brain tumor diagnoses and approximately 30,000 new cases every year in the United States. There are fifteen types of meningiomas presenting a wide range of physical, emotional, and occupational challenges – and can ultimately be life-threatening.

"Given the legacy of the Brain Science Foundation and its association with meningioma, and our shared goals with the National Brain Tumor Society to fund research aimed to advance the development of treatments, it quickly became evident that the community of patients, advocates, and healthcare providers could benefit from a formal collaboration between our respective organizations," says Steven Haley, founder of the Brain Science Foundation. "We believe NBTS’s depth and breadth of assistance, combined with the continuity of the BSF mission on a larger platform will be compelling and welcomed in the community we serve."

The Meningioma Research Fund creates an opportunity for donors specifically interested in supporting research on this tumor type to join together to scale up the impact of their philanthropy.

"Medical research directed toward meningioma is disproportionately small compared to other brain tumor types," says David Arons, Chief Executive Officer, National Brain Tumor Society. "Yet, meningiomas can be life-altering and cause lasting deficits to patients, as the only treatment option for many is invasive brain surgery. This partnership with the Brain Science Foundation and the creation of the Meningioma Research Fund will allow us to invest in best-in-class science and accelerate research that is aimed at advancing better treatment options for these patients."

The Brain Science Foundation was established in 2002 and has gone on to fund nearly $1 million annually in support of outstanding physician-scientists in brain tumor research, with a particular focus on meningioma. To date, BSF-funded researchers have impacted lives through a variety of research programs that have included the creation of advanced diagnostic tools, surgical instruments and techniques, post-operative care protocols and therapies that are less invasive but more effective.

About Meningioma

Meningioma is the most common primary brain tumor, accounting for 37.1 percent of all brain tumor diagnoses. It is estimated that 31,990 individuals will be diagnosed with a meningioma in the United States in 2019. Meningioma is most commonly diagnosed in adults, with an average age at diagnosis of 66, and is more common in women than men. African Americans are significantly more likely than Caucasians to develop meningioma. The 10-year relative survival rate for all meningioma patients is 81.5 percent, but only 53.5 percent for those with a malignant meningioma.

On February 19, 2019 NEW ORLEANS & Ochsner Health System, Louisiana’s largest non-profit academic healthcare system, and Pfizer Inc (NYSE:PFE) reported that have entered into a multi-year strategic alliance to develop innovative models for clinical trials (Press release, Pfizer, FEB 19, 2019, View Source [SID1234533388]). Through this partnership, Pfizer and Ochsner — through its innovation lab, innovationOchsner (iO), in partnership with Ochsner Research — will explore ways to enhance the clinical trial experience and ease participation in clinical research for both patients and healthcare professionals.

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The alliance aims to create faster, improved access and connectivity to clinical trials for patients, with the ultimate goal of better experiences and outcomes. Participating patients will have the opportunity to test out new digital tools designed to make the clinical trial experience more inclusive and enjoyable. Participating clinicians will benefit from reduced manual data entry as a result of direct data system integration and automated study conduct tools, freeing up time and work to allow them to offer clinical research as an option to a broader range of patients. And research groups will experience efficiencies from interoperability that may lower costs while increasing capacity. These projects are designed to ensure that all data collected is secure and will only be used with patient consent, as in any clinical trial.

"As a national leader in healthcare, Ochsner is delivering on its mission to bring the most innovative ideas to our patients. We are relentless about using the latest breakthroughs in science and technology to solve some of the toughest healthcare challenges," said Dr. Richard Milani, Ochsner’s Chief Clinical Transformation Officer and Medical Director of iO. "Partnering with Pfizer allows us to transform medicine by creating a digital clinical trial experience that improves patient participation, integration, communication and accessibility."

The strategic alliance’s first project began with a "proof of value" phase in which researchers successfully transferred mock data (e.g. no actual patient data was used or shared) from Ochsner’s EHR system to Pfizer’s electronic data capture system used in Pfizer clinical trials. The experiment aimed at understanding the gaps and variances between data collected in electronic health records and patient-reported data from clinical trials.

Since the inception of electronic health records (EHRs), integrating EHR data into clinical trial databases has been a goal of research institutions, industry and regulators. Such integration would reduce the burden of manual data entry, save time, decrease cost and accelerate clinical trials. The ongoing challenge has been exchanging data between healthcare systems and clinical trial systems, because each uses different technology platforms and data standards. In recent years, Fast Healthcare Interoperability Resources, or FHIR, a standard developed by the nonprofit organization Health Level Seven International (HL7), has been introduced as a secure and open solution for healthcare data exchange to accelerate information sharing. Most health apps use FHIR data standards, but FHIR has yet to be adopted for data exchange in industry-sponsored clinical trials. As one of the first health systems to implement FHIR, Ochsner has continuously explored opportunities to use the standards in other applications, including clinical trials. The Ochsner-Pfizer alliance project aims to build a model for applying FHIR standards so that high-quality clinical trial data may be collected consistently, reliably and securely within hospital and clinic electronic systems.

"We’re pleased that we succeeded in transferring core data types collected in healthcare provider electronic health records to Pfizer’s clinical trial data capture system using FHIR standards. To the best of our knowledge, this is a first for our industry," explains Rob Goodwin, Vice President, Operations Center of Excellence, Global Product Development at Pfizer. "There is more work ahead, but this is a significant step forward in simplifying data capture for clinical trials, and the first of many pioneering solutions we hope to develop through our partnership with Ochsner."

During the next phase, Pfizer and Ochsner will continue to develop new ways to digitize the patient and clinician experience in clinical trials, with attention to patient preferences on access to and use of their health data and with an overarching goal of enhancing the quality and value of clinical research interactions for all participants.