RICHMOND, Va., April 7, 2014 /PRNewswire/ — Kaleo (formerly Intelliject) today announced that it has entered into a $150 million debt facility with PDL BioPharma (NASDAQ: PDLI) to enable kaléo to support commercialization of EVZIO™(naloxone hydrochloride injection) and development of key pipeline products. Under the financing, PDL provided $150 million in cash at closing and will receive interest on the principal outstanding. The note is backed by royalty payments on kaléo’s first product (Auvi-Q™ in the US and Allerject™ in Canada) (www.auvi-q.com) and a portion of the net sales on its second product (EVZIO™)(www.evzio.com). Once the note is repaid, kaléo will resume receiving 100% of all product royalties and net sales.
The funds will enable kaléo to support the commercialization of EVZIO (approved by the FDA on April 3, 2014), to invest in the development of pipeline products and repay existing debt. EVZIO is intended for the emergency treatment of known or suspected opioid overdose, as manifested by life-threatening respiratory depression.
Kaléo is a pioneer in life saving products that provide for peace of mind that patients can carry in their pockets. Kaléo products are designed to become part of a patient’s everyday life – always there, but invisible until needed. The products are simple to use and use voice and visual cues to assist a patient through the correct drug administration process.
“We believe patients and caregivers are experts on how their medical condition impacts their lives, and they are an integral part of our product development process. As we begin the next phase of our company’s growth, we are pleased to have the additional support of our collaboration with PDL BioPharma,” said Spencer Williamson, President and CEO of kaléo.
“Kaléo’s business model and patient driven product development process is unique. Auvi-Q and EVZIO are novel and exciting products and we believe that kaléo has additional promising products in development,” stated John McLaughlin, President and CEO of PDL BioPharma.
MTS Securities, LLC, an affiliate of MTS Health Partners, acted as financial advisor to kaléo in this transaction.
Kaléo is a pharmaceutical company dedicated to putting a new generation of life-saving personal medical products in patients’ hands. On April 3, 2014, the FDA approved EVZIO, the first and only naloxone auto-injector intended to be available for emergency administration by family members or caregivers in cases of known or suspected opioid overdose.1 The company’s first product approval, Auvi-Q™ (www.Auvi-Q.com) (Allerject™ in Canada), was licensed to Sanofi US which launched the product in early 2013. Our mission is to provide demonstrably superior medical products that empower patients and caregivers to confidently take control in potentially life-threatening situations. We believe patients and caregivers are the experts on how their medical condition impacts their lives, and are an integral part of our product development process. Each kaléo product combines an established drug with an innovative delivery platform with the goal of achieving superiority and cost effectiveness. Kaléo is a privately held company headquartered in Richmond, Virginia. For more information, visit www.kaleopharma.com.
About PDL BioPharma, Inc.
PDL BioPharma manages a portfolio of patents and royalty assets, consisting primarily of its Queen et al. antibody humanization patents and license agreements with various biotechnology and pharmaceutical companies. PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases for which it receives significant royalty revenue. PDL is currently focused on intellectual property asset management, acquiring new income generating assets, and maximizing value for its shareholders.
The company was formerly known as Protein Design Labs, Inc. and changed its name to PDL BioPharma, Inc. in 2006. PDL was founded in 1986 and is headquartered in Incline Village, Nevada.
In 2011, PDL initiated a strategy to bring in new income generating assets from the healthcare sector. To accomplish this goal, PDL seeks to provide non-dilutive growth capital and financing solutions to late stage public and private healthcare companies and offers immediate financial monetization of royalty streams to companies, academic institutions, and inventors. PDL continues to pursue this strategic initiative for which it has already deployed approximately $700 million to date. PDL is focused on the quality of the income generating assets and potential returns on investment.
EVZIO is a pre-filled, single-use auto-injector that works by temporarily blocking the effect of an opioid, potentially reversing the life-threatening respiratory depression and allowing the recipient to breathe more regularly. Once the effects of EVZIO wear off, the overdose symptoms may reappear and additional naloxone may be required. There is no potential for abuse or dependence with naloxone.1
Each EVZIO delivers 0.4 mg naloxone hydrochloride injection (0.4 mL).
EVZIO is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present.
EVZIO is not a substitute for emergency medical care.
Important Safety Information
The following is important safety information associated with dosing and administration of EVZIO:
· EVZIO is for intramuscular or subcutaneous use only.
· Administer EVZIO to adult or pediatric patients into the anterolateral aspect of the thigh, through clothing if necessary.
· In pediatric patients under the age of one, the caregiver should pinch the thigh muscle while administering EVZIO.
· Seek emergency medical care immediately after use.
· The duration of action of most opioids is likely to exceed that of EVZIO resulting in a return of respiratory and/or central nervous system depression. Keep the patient under continued surveillance and repeated doses of EVZIO should be administered every 2 to 3 minutes, as necessary, while awaiting emergency medical assistance.
· If the electronic voice instruction system does not operate properly, EVZIO will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on the flat surface of its label.
The following precautions should be taken when administering EVZIO:
· Consider other supportive and/or resuscitative measures while awaiting emergency medical assistance.
· Reversal of respiratory depression by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone.
· Use in patients who are opioid dependent may precipitate acute abstinence syndrome.
· In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.
· Patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects should be monitored in an appropriate healthcare setting.
EVZIO should be used with caution in patients known to be hypersensitive to naloxone hydrochloride.
Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, hyperactive reflexes.
Use in Post-Operative Settings:
The following adverse reactions have been identified during use of naloxone hydrochloride in the post-operative setting: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia and has caused agitation.
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