Oncobiologics, Inc., announced the closing of a $31 millionfinancing.  Proceeds will be used to support continued development and expansion of the company’s proprietary BioSymphony™ biosimilar platform and advancement of its preclinical and clinical programs.

The investment round was led by new investor, Perceptive Advisors. Participating new investors included Cormorant Global Healthcare Master Fund, Longwood Capital Partners, and venBio Select Fund. Other investors included Proximare Lifesciences Fund, OSSB Pharma Fund and MIH Fund.  Citigroup and Jefferies LLC advised Oncobiologics on the transaction.

“Biosimilars are rapidly becoming a major growth sector for Life Sciences Industry and our proprietary BioSymphony platform is uniquely designed to develop and manufacture high quality, cost effective monoclonal antibodies in a timely manner,” said Pankaj Mohan, Ph.D., founder and chief executive officer of Oncobiologics. “We highly value the significant interest, confidence and financial support of such a successful group of life science investors, which enables us to further our objective of bringing critical care therapeutics to patients in a cost effective manner.”

Joseph Edelman, chief executive officer and portfolio manager of Perceptive Advisors said, “We look for life science technologies, products and a team with scientific competence that has the potential to generate significant returns to our fund.  Oncobiologics has an advanced and deepening biosimilar pipeline emerging from a fully-integrated technology platform that will differentiate the company in a growing and potentially competitive biosimilar market. We look forward to contributing to the company’s growth in this important segment of the biotechnology industry.”

About Oncobiologics, Inc. and BioSymphony™ Model
Oncobiologics is a privately-held biopharmaceutical company focused on developing and commercializing monoclonal antibody biosimilar therapeutics. It is advancing its pipeline of 11 biosimilar products, two of which are currently in clinical development.  Led by a team of biopharmaceutical experts, Oncobiologics operates from a state-of-the-art 50,000 sq. ft. fully-integrated R&D and manufacturing facility in Cranbury, NJ.  The company employs its BioSymphony™ biosimilars business model to achieve accelerated development and technical excellence in order to create affordable medicines for patients around the world. The aggregate market value at time of patent expiry for the molecules in Oncobiologics’ pipeline is projected to be in excess of $100 Billion

The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors.

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement — like eating, writing and shaving.

Essential tremor affects several million people and usually occurs in those over age 40.  “There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new device adds to the array of treatment options to help people living with Parkinson’s and essential tremor enjoy better, more productive lives.”

The Brio Neurostimulation System consists of a small (1.9in x 2.1in x 0.4in) battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed within the brain at specific locations depending on whether the device is being used to treat Parkinson’s disease or essential tremor. The electrical pulse generator continuously delivers low intensity electrical pulses to target areas in the brain. Health care providers make adjustments to the pulse generator to optimize the effects of the Brio Neurostimulation System.

Data supporting the safety and effectiveness of the device system included two clinical studies. One study included 136 patients with Parkinson’s disease and the other included 127 patients with essential tremor. In both studies, patients had symptoms, including tremors, that were not adequately controlled with drug therapy.

The Brio Neurostimulation System was used in addition to medication for patients with Parkinson’s disease and the majority of patients with essential tremor who used the device were able to control their symptoms without the need for medications. Researchers implanted the Brio Neurostimulation System in all patients and assessed effectiveness for Parkinson’s disease patients at three months and essential tremor patients at six months. Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on compared to when it was turned off.

Serious adverse events included intracranial bleeding, which can lead to stroke, paralysis or death. Other device-related adverse events included infection and dislocation of the device lead under the skin. The Brio Neurostimulation System is manufactured by St. Jude Medical in St. Paul, Minnesota.

Brio Neurostimulation System is the second device approved by the FDA for Parkinson’s and essential tremor. The first device, Medtronic’s Activa Deep Brain Stimulation Therapy System, was approved in 1997 for tremor associated with essential tremor and Parkinson’s disease. In 2002, the indications were expanded to include the symptoms of Parkinson’s disease.

In its early stages, Parkinson’s disease typically affects one side of the body and starts as problems with movement, stiffness, and mild tremors. Gradually, the symptoms can affect both sides of the body and medications may become less effective. People with late stage Parkinson’s disease have many symptoms including: trouble walking, impaired posture and balance, muscle stiffness and tremors in the arms and hands that make it difficult to perform everyday tasks.

Essential tremor most often affects the hands and arms and can be slowly progressive, starting on one side of the body but eventually affecting both sides. Hand tremor is the most common symptom, but tremors can also affect movement in the head, arms, voice, tongue, legs, and trunk. About half of essential tremor cases result from a genetic mutation. For the remainder of cases, the cause is unknown.

The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.

According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500,000 people in the United States each year. The coronary arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small mesh tube, called a stent, to keep the artery open.

By preventing platelets from accumulating, Kengreal reduces the risk of serious clotting complications related to the procedure, including heart attack and clotting of the stent (stent thrombosis).

“For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “The approval of Kengreal provides another treatment option for patients.”

As with other FDA-approved anti-platelet drugs, bleeding, including life-threatening bleeding, is the most serious risk of Kengreal.

In a clinical trial that compared Kengreal to Plavix (clopidogrel) in more than 10,000 participants, Kengreal significantly reduced the occurrence of heart attack, the need for further procedures to open the artery and stent thrombosis. The overall occurrence of serious bleeding was low but more common with Kengreal than with clopidogrel.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.