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GtreeBNT Acquires New Drug for the Treatment of Glioblastomas

On February 15, 2016 GtreeBNT Co., Ltd., reported it has entered into an agreement with the Oklahoma Medical Research Foundation (OMRF) to acquire the rights to OKN-007, a new investigational drug for the treatment of glioblastoma, a deadly form of brain cancer (Press release, GtreeBNT Co, FEB 15, 2016, View Source [SID:1234514931]).

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Under a new company, Oblato, Inc., GtreeBNT will assume exclusive rights to the compound, which was developed by OMRF researchers Rheal Towner, Ph.D., and Robert Floyd, Ph.D.

OKN-007 has been evaluated as a novel therapeutic that protects nerves and reduces both necrosis and glioblastoma cell proliferation by eliminating reactive oxygen species, a known cause of cancer. In studies at OMRF, the drug reduced tumor size and increased lifespan in animal models of glioblastoma. An estimated 12,000 Americans are diagnosed with glioblastoma each year, according to the American Brain Tumor Foundation.

OKN-007 has undergone phase I-B clinical testing at the University of Oklahoma’s Stephenson Cancer Center, where physicians assessed its safety in patients suffering from glioblastoma.

"There is currently no cure for glioblastoma, and the development of new treatments is a very important unmet need," said GtreeBNT and Oblato’s President and Chief Executive Officer Won S. Yang, Ph.D. "Oblato will conduct glioblastoma clinical trials on patients in the U.S. and will work to develop this new drug worldwide. With our history of work in the orphan drug market, this new drug fits well into our portfolio and matches the goals of GtreeBNT."

Oblato will initiate additional trials to study the efficacy and safety of this investigational drug in larger patient populations. At this time, OKN-007 is administered as an infusion. This agreement will provide the resources to expand the size of the patient cohort and to eventually develop an oral form of the drug.

Since 2014, GtreeBNT has been focusing on the development and commercialization of biopharmaceutical drugs, particularly first-in-class medications for ophthalmic indications, such as dry eye disease and the orphan ocular disease neurotrophic keratopathy. By acquiring the rights to OKN-007, GtreeBNT has expanded its interests to developing cancer treatments. Due to GtreeBNT’s highly experienced and qualified team, it is able to rapidly bring early clinical stage drugs to market.

"GtreeBNT’s focus on rare and orphan disease indications makes them an attractive partner to help us take the next steps in getting this drug to market," said OMRF Vice President of Technology Ventures Manu Nair. "Their ultimate goal is to see OKN-007 benefit patients living with this terrible disease. The company’s interest in the project and its ability to work quickly makes them an excellent fit for us."

Through execution of this agreement, it is expected that GtreeBNT will advance toward becoming a leading biopharmaceutical company that is able to consistently grow by securing worldwide exclusive rights to develop and commercialize new drugs to treat various diseases, including glioblastoma and ophthalmic indications.

"Right now, there is no effective treatment for glioblastoma," said OMRF’s Nair. "Patients typically receive a prognosis of 12 to 18 months from their initial diagnosis. We hope this new partnership can change those numbers for the better."

Sandoz teams up with World Child Cancer to "even the odds" for children worldwide

On February 15, 2016 Sandoz together with leading global charity World Child Cancer (WCC), reported a new health initiative in the Philippines, aimed at improving the standard of care for children suffering from cancer (Press release, Sandoz, FEB 15, 2016, View Source [SID:1234510072]).

Cancer survival rates for children in the Philippines are less than 20%, compared to an average of 80% in developed countries. The goal of the new partnership, further details of which will be announced next month, is to help "even the odds" by supporting the development of specialist treatment centers in the island region of Mindanao.

Paul Geymayer, Sandoz regional head for Asia-Pacific, says: "This pilot project will take simple, pragmatic measures to attack cancer where it is most vulnerable: among underprivileged children suffering from forms of cancer that are absolutely treatable if given access to medicines, medical information and professional healthcare. Our goal is to make cancer care accessible to more children on the island, enhance the standard of care and improve survival rates."

Jon Rosser, World Child Cancer CEO adds: "In the Philippines, there are approximately 3,500 new cases of childhood cancer every year, with two-thirds diagnosed only at advanced stages. More than 80% of patients live too far away from a treatment center to access the care they need and many are forced to discontinue treatment due to costs and travel difficulties. "However, many of these cases are curable and this project will help to ensure that these children are able to access the care they need".

The WCC partnership highlights Sandoz’s commitment to address key global healthcare challenges by pioneering new approaches to increase access to medicine.

Phase 3 Study Demonstrates Aranesp® (Darbepoetin Alfa) Reduces Red Blood Cell Transfusions In Patients With Myelodysplastic Syndrome (MDS)

On February 15, 2016 Amgen (NASDAQ:AMGN) reported that the randomized, double-blind, placebo-controlled Phase 3 Aranesp (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk MDS at the end of the blinded 25-week study period(Press release, Amgen, FEB 15, 2016, View Source [SID:1234509057]). Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication.

Safety data was consistent with the known safety profile of Aranesp, and the adverse events were generally balanced between treatment arms. The adverse events reported in the Aranesp arm at least five percent more frequently than in the placebo group were fatigue, pyrexia, headache and myalgia.

MDS is among the most common type of bone marrow failure syndromes in adults.1 The disease occurs when immature blood cells do not mature in the bone marrow. Patients with MDS have fewer healthy white blood cells, red blood cells and platelets, and are at risk of infection, anemia or bleeding.2 Current treatments for MDS include blood transfusions, chemotherapy and stem cell transplants.

"We are pleased to see positive results from this study, as anemia treatment options for myelodysplastic syndrome are limited and can place a significant burden on patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

About the ARCADE Study
The Phase 3 ARCADE trial was a multicenter, randomized, double-blind, placebo-controlled study evaluating Aranesp in 146 patients with low or intermediate-1 risk MDS who had not previously taken ESAs or biologic response modifiers. During a 24-week period, patients received either Aranesp 500 μg (n=97) or placebo (n=49) every three weeks. At week 25, when the primary and key secondary endpoints were assessed, patients underwent an end-of-treatment period (EOTP) visit and could subsequently enter a 48-week active treatment period where all participants crossed over to receive Aranesp, with dose escalation allowed beginning on week 31. Treatment continued until week 72 or 73, and long-term follow up continues to occur every 26 weeks, for a minimum of three years.

About MDS
MDS affects more than 30,000 people in the United States annually.1 People undergoing certain types of chemotherapy or radiation treatment for cancer may be at increased risk of developing treatment-related MDS.3 Patients with MDS affecting red blood cells often experience anemia.4

About Aranesp (darbepoetin alfa) in the U.S.
Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Limitations of Use:
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp is not indicated for use:

In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
Important U.S. Safety Information for Aranesp
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks.
Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions.
Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
Use ESAs only for anemia from myelosuppressive chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
Discontinue following the completion of a chemotherapy course.
Aranesp is contraindicated in patients with uncontrolled hypertension, pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs, or serious allergic reactions to Aranesp.

Use caution in patients with CKD and coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks. In controlled clinical trials of patients with cancer, Aranesp and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. Control hypertension prior to initiating and during treatment with Aranesp.

Aranesp increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.

For lack or loss of hemoglobin response to Aranesp, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp is not approved). If severe anemia and low reticulocyte count develop during treatment with Aranesp, withhold Aranesp and evaluate patients for neutralizing antibodies to erythropoietin. Permanently discontinue Aranesp in patients who develop PRCA following treatment with Aranesp or other erythropoietin protein drugs. Do not switch patients to other ESAs.

Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp. Immediately and permanently discontinue Aranesp if a serious allergic reaction occurs.

Adverse reactions (≥ 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Adverse reactions (≥ 1%) in Aranesp clinical studies in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.

To see the Aranesp Prescribing Information, including Boxed Warnings, and Medication Guide visit www.aranesp.com.

OPKO Health Acquires Interest in Xenetic

On February 12, 2016 Xenetic Biosciences, Inc. (OTCQB: XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics ("Xenetic") reported that OPKO Health, Inc. (NYSE: OPK) has acquired an approximate 6.3% interest in Xenetic (Press release, Xenetic Biosciences, FEB 12, 2016, View Source [SID1234537813]).

Commenting on the investment in Xenetic, Dr. Phillip Frost, CEO and Chairman of OPKO Health, Inc., stated, "Xenetic has many novel technologies that address unmet needs in various orphan cancer indications, and we believe the science and the clinical strategy have the promise to create significant shareholder value."

Scott Maguire, President and Chief Executive Officer of Xenetic commented, "We are proud to have OPKO Health as one of our largest shareholders joining our other strategic shareholders, Baxalta and Serum Institute of India. Dr. Frost has an outstanding track record in creating shareholder value in our industry."

UK Court Rules Against Lilly in Alimta Vitamin Regimen Patent Lawsuit

On February 12, 2016 Eli Lilly and Company (NYSE: LLY) reported that the UK High Court decided the Alimta (pemetrexed disodium) vitamin regimen patent would not presently be infringed by Actavis marketing pemetrexed trometamol in the UK, France, Italy and Spain with instructions to dilute the product only with dextrose solution (Press release, Eli Lilly, FEB 12, 2016, View Source [SID:1234509078]).

In June of 2015, the UK Court of Appeal held that Lilly’s patent would be indirectly infringed by Actavis marketing certain alternative salt forms of pemetrexed with instructions to dilute the product with saline solution. However, the Court of Appeal left open the question of whether an alternative salt form with instructions to dilute only in dextrose solution would infringe.

The court based its decision of non-infringement on Actavis complying with its stated intentions as to how it will market its product and certain circumstances not changing over the remaining life of the patent. In its decision, the UK court accepts that it is not able to predict what will happen in the future and expressly allows either party to ask for the decision to be revisited if there is a material change of circumstances at any point in the remaining life of the patent, which expires in June 2021.

Lilly plans to seek permission to appeal today’s decision to the UK Court of Appeal.

In major European countries, the compound patents for Alimta expired in December 2015. The Alimta vitamin regimen patents expire in June 2021.

"We strongly disagree with the ruling by the UK High Court granting a declaration of non-infringement on the Alimta vitamin regimen patents under these circumstances. We plan to seek permission to appeal this ruling," said Michael J. Harrington, senior vice president and general counsel for Lilly.

In addition, Lilly has applied for permission to appeal the direct infringement aspect of the June 2015 Court of Appeal decision to the UK Supreme Court. That request is pending.

In a separate proceeding in the first quarter of 2015, the Dusseldorf Court of Appeal ruled the Alimta vitamin regimen patent would not be infringed by a generic competitor that has stated intent to market pemetrexed dipotassium in Germany after the compound patent expiration in December 2015. Lilly has recently been granted permission to appeal this ruling to the Federal Supreme Court of Germany, which is scheduled to be heard mid-2016. Lilly has also recently received a preliminary injunction against a different generic competitor to restrict marketing of a copycat pemetrexed product.

In the fourth quarter of 2015, a generic competitor unilaterally withdrew its appeal in the case regarding the validity of the Alimta vitamin regimen patent before the Technical Board of Appeal of the European Patent Office (EPO). In view of the withdrawal of the appeal, the decision of the Opposition Division of the EPO finding the patents valid is final, and there cannot be further validity challenges to the vitamin regimen patents for Alimta centrally before the EPO.