Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, August 28, 2013
August 28, 2013, 8:06 a.m. ET.Imprimis Pharmaceuticals, Inc. Acquires Intellectual Property for Ophthalmic Compound Development Opportunity
Acquisition is in line with IP Acquisition Strategy and Business Model Imprimis Acquires Intellectual Property from Novel Drug Solutions and Eye Care Northwest
SAN DIEGO, Aug. 28, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), which is focused on the commercialization of drug formulations through a growing proprietary network of compounding pharmacy relationships and by utilizing the FDA 505(b)(2) development pathway, has announced it has acquired intellectual property, including a provisional patent application, related to an ophthalmic compound for intraoperative ocular injection of anti-inflammatory and anti-bacterial agents. Imprimis believes this formulation has the potential to significantly impact the fast-growing $5 billion global cataract surgery drug market. The acquisition allows Imprimis to pursue the commercial development of certain proprietary innovations and also provides Imprimis with a preemptive right on additional Novel Drug Solutions and Eye Care Northwest intellectual property and drug development opportunities.
Imprimis CEO, Mark L. Baum, said, "This is an important acquisition of a novel drug formulation with an important clinical track record. It is gratifying to see our Asset Review Methodology (ARM(TM)) at work. We believe that going forward our growing group of drug discovery and development relationships will bring additional clinically relevant formulations to our company, and these assets will drive additional value for our shareholders. We are in the process of conducting a feasibility assessment related to the development of this asset, together with a team which consists of leaders from the ophthalmic development and regulatory community. Imprimis will continue to develop partnerships with inventors and secure assets which will support our strategic objectives."
The target compound, referred to as IPI-140, is based on a novel combination of moxifloxacin and triamcinolone. IPI-140 was co-invented by Novel Drug Solutions of Randolph, New Jersey and Dr. Jeffrey T. Liegner of Sparta, New Jersey. IPI-140 has been successfully administered by Dr. Liegner in more than 1,500 patients in his surgical practice.
Dr. Liegner stated, "The current treatment regimen for the prevention of post-cataract surgery complication is primarily a pre-operative and post-operative self-administered eye drop regimen, which requires from the patient strict compliance and careful adherence to a prescribed dosing schedule. Individuals with physical limitations, impaired manual dexterity, or those who lack of a supportive care giver, are particularly vulnerable to non-compliance and the subsequent complications of untreated post-surgical issues. This uniquely designed drug, utilizing a fourth generation quinolone therapy combined with potent inflammatory suppression, when placed as a depot inside the vitreous concurrent with cataract surgery, or any intraocular procedure, addresses the primary ocular complications of ophthalmic surgery: infection risk and post-operative inflammation."
Imprimis believes that IPI140 may have broad application in ophthalmic surgery, including the $5 billion global cataract surgery drug market. According to Ocular Surgery News, the cataract surgery market continues to grow tremendously not only because of the expanding aging population, but because the age at which patients demand cataract surgery has lowered, portending a global market size of $7-$9 billion in the next 5-7 years.
Imprimis expects to continue to leverage its exclusive relationships with Novel Drug Solutions, Eye Care Northwest, and others to acquire assets with a proven clinical track record.
Seven Oncologists Charged with Importing Unapproved Drugs
August 13, 2013: Seven Oncologists Charged with Importing Unapproved Drugs - U.S. Department of Justice Press Release
Seven Ohio oncologists were charged with importing cancer medications that had not been approved by the Food and Drug Administration, said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio.
The doctors were charged with causing the shipment of misbranded drugs, a misdemeanor violation of the Food, Drug and Cosmetic Act. Their names, ages and the city where they practiced medicine are:
Ranjan Bhandari, 56, Liverpool.
Timmappa Bidari, 68, Parma.
David Fishman, 62, Euclid.
Su-Chiao Kuo, 60, Brunswick.
Marwan Massouh, 54, Westlake.
Poornanand Palaparty, 62, Cleveland.
Hassan Tahsildar, 55, Euclid
"These doctors used drugs that had not been approved by the FDA," Dettelbach said. "Our office is committed to working with our partners to make sure patients are getting medicine that has been properly inspected."
"FDA's regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers," said Antoinette V. Henry, Special Agent in Charge, FDA's Office of Criminal Investigations. "We will continue to work to investigate all persons, including medical professionals, who disregard regulatory requirements and jeopardize the public health by participating in the distribution of misbranded products."
The doctors are accused of obtaining drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others, from outside the United States, where the drugs were not approved by the FDA, according to the charges.
Read more: Seven Oncologists Charged with Importing Unapproved Drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/press-releases/seven-oncologists-charged-importing-unapproved-drugs#ixzz2dGoFL7Rp
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Question of the Day August 28, 2013 In light of the issues at Front Range Laboratories Inc. and the estimate that it tested compounds for 100 compounding pharmacies in 32 states will Congress act quickly in September to help give the FDA the much needed resources to get this enormous problem with compounding preparations under control?
As we are seeing there are issues on the front end of compounding with the bulk powders, issues with the actual compounding (sterility and potency) and now with the testing laboratories with blurred or no lines as to who oversees what it. Compounding pharmacists who feared what federal regulation would do to their business now have far greater concerns-lack of trust by the public, liability issues, etc. with potential federal regulation being the least of the worries and potentially a blessing to the good compounders doing it right. With these overwhelming and out-of-control issues in the compounding world, Congress would be doing a grave injustice to the American people if it does not pass some form of federal legislation.
We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds
on August 27, 2013
The expected backlash to attempts by the FDA to crackdown on compounding pharmacies has begun, threatening public safety.
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.
continue to read here
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.
continue to read here
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