Nephron Pharmaceuticals Corporation | November 15, 2022
Nephron Pharmaceuticals Corporation and Sharps Technology, Inc. announced a brand new partnership focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the InjectEZ component of expansion.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in developing and manufacturing innovative drug delivery systems. Nephron Pharmaceuticals is known across the country to health systems and hospitals as a leader in the production of affordable generic inhalation solutions and suspension products, as well as pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags.
InjectEZ is part of the Nephron investment of hundreds of millions of dollars of expansion in Lexington County, S.C., over the last two years. Lou Kennedy, Nephron CEO, knows that when launching an endeavor as ambitious as InjectEZ, partnerships are key.
"We are excited to kick off a partnership with Sharps Technology, as our InjectEZ expansion project opens, for a variety of innovative initiatives, including research and development," said Kennedy. "Just as the InjectEZ syringe manufacturing facility is poised to play a critical role in assisting those with whom we work on tackling emerging public health crises, Sharps Technology also offers key solutions to healthcare challenges. We look forward to working with them."
Sharps product lines have historically focused on low waste and ultra-low waste syringe technologies, which allow up to 40% more injections per vial of therapy while incorporating multiple passive safety features. These features protect front-line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. The partnership with Nephron opens up opportunities for Sharps to expand its portfolio and make an impact on the specialized pre-fillable syringe and drug delivery systems market.
"Sharps Technology has identified a unique opportunity to collaborate with a leader in the industry like Nephron. Through my previous industry experience supporting and working with most of the leading healthcare and pharmaceutical companies in the world, it was easy for me to evaluate Nephron Pharmaceuticals as a potential partner. They truly are a leader in all areas of business and an example of best in class for the industry. I appreciate and look forward to the opportunity to work with Bill and Lou Kennedy and their leadership team to make this collaboration a success for both companies."
Robert Hayes, CEO of Sharps Technology
Sharps Technology brings extensive expertise in syringes to Nephron, including experience with specialized pre-filled syringe systems and ready-to-use processing. The pre-filled syringe lines will utilize the highly automated equipment and controlled environments established by Nephron. These premium pre-filled polymer offerings will be made from the highest quality raw materials, on the most innovative technology, and will be compliant with the USP standards required in the United States as well as the EP and JP international standards.
The products that will be developed and commercialized provide solutions to support the current Nephron fill/finish strategies as well as their pipeline of new drug applications and sets forward a strategy to support branded pharma and advanced therapies, including ophthalmic and biologic applications.
Sharps Technology will also be partnering with Nephron Pharmaceuticals in the development of a Pharmaceuticals Services Program designed to support healthcare customers that need innovative solutions and products to support their business. The development of this program will help create new fill/finish project opportunities for Nephron that will utilize innovative packaging solutions developed by Sharps Technology. These new customer projects will fuel the growth of both companies, and the opportunity to create new technologies to support the healthcare industry will be transformative for Nephron and Sharps as they navigate a bright future working together.
Pfizer and Biohaven Pharmaceuticals | October 04, 2022
Pfizer Inc. announced the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults.
The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide receptor antagonists including
Approved in the United States under the trade name NURTEC® ODT, in adults for both the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine
Approved in the European Union under the trade name VYDURA® for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month
New Drug Application for intranasal spray for the acute treatment of migraine under U.S. Food and Drug Administration review, with a Prescription Drug User Fee Act goal date in 1Q 2023
"We are proud to build on Pfizer’s legacy of delivering breakthrough medicines for patients living with complex pain disorders. The success of NURTEC® ODT coupled with Biohaven’s CGRP pipeline will strengthen Pfizer’s innovative Internal Medicine pipeline through 2030, and beyond. Combined with Pfizer’s global reach, this acquisition increases our potential to bring new treatment options to patients with migraine – a disease which affects over 1 billion people worldwide.
Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer
Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6 billion. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer.
Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. distributing Biohaven Ltd.’s shares to Biohaven’s shareholders. Biohaven Ltd., a new company that retained Biohaven’s non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker “BHVN”.
Worldwide, more than one billion people suffer from migraine, which predominately affects women.i Findings from the 2019 Global Burden of Disease study indicate that migraine is one of the worlds leading causes of disability.ii Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound and sensitivity to light.
Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec® ODT for the acute treatment of migraine in adults in February 2020 and for the preventive treatment of episodic migraine in adults in May 2021. Nurtec® ODT is taken orally as needed, up to once daily for acute treatment, and every other day for preventive treatment. The maximum dose in a 24 hour period is 75 mg.
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from the NOJECTION® Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The FDA has accepted for review a New Drug Application (NDA) for zavegepant nasal spray, with a PDUFA date in 1Q 2023.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.
Silo Pharma, Inc. | December 02, 2022
Silo Pharma, Inc. a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today issued a letter to shareholders highlighting the Company’s progress and potential for its portfolio of novel, IP-protected technologies and assets developed in collaboration with world-class medical research partners. The letter, in its entirety, is reprinted below.
Dear fellow Silo Pharma shareholders,
The healthcare market continues to build momentum as science and technology lead to new developments for therapeutics. Nowhere is this more evident than in the growing body of scientific research supporting the therapeutic potential of psychedelics. More than ever, alternative new therapies for numerous diseases and mental health disorders are needed to address the health challenges of today.
Our Company, Silo Pharma, Inc. is working diligently to make further advances in the medical and psychedelic space. To date, the research conducted has shown encouraging promise in the delivery, efficacy, and safety of our pipeline therapeutics and technologies.
This has been an exciting year where we have achieved numerous milestones and anticipate upcoming updates as our pipeline progresses. The purpose of this letter is to provide shareholders with an update on our current business. With over $12 million in cash, we are prepared to advance our pipeline, and believe, with our strong balance sheet, no debt, and recent listing on Nasdaq, that we are in a position to further advance the Company and create shareholder value.
Valuable Intellectual Property and Collaboration
We are focused on advancing traditional therapeutics with psychedelic research to treat underserved large markets. We believe that our novel IP-protected technologies and assets, developed in collaboration with world-class medical research partners, offer disruptive market potential.
The unique assets in our portfolio are well protected with issued and numerous provisional patents pending. We obtained these assets through exclusive drug development collaborations, including a joint venture with Zylö Therapeutics, Inc.; a license and option agreement and an investigator-sponsored study agreement with the University of Maryland, Baltimore; a sponsored study agreement and a licensing option agreement with Columbia University; and a sponsored research agreement with the University of California, San Francisco.
Ketamine is an FDA-approved fast-acting general anesthetic administered through intravenous injection or nasal spray. Scientific research has shown that ketamine’s interactions with certain brain chemicals may be connected to its pain management, anti-inflammatory, and antidepressant effects. Since 2000, increasing research on ketamine has demonstrated significant results as a treatment for pain conditions including chronic neuro-inflammatory disorders and for mood disorders including depression, PTSD, and anxiety.
Considered a serotonergic hallucinogen, this substance is an active ingredient in some species of mushrooms. While classified as a Schedule I controlled substance under the Controlled Substances Act there is an accumulating body of evidence that psilocybin may have beneficial effects on depression and other mental health conditions. The U.S. Food and Drug Administration and the U.S. Drug Enforcement Agency have permitted the use of psilocybin in clinical studies for a range of psychiatric conditions.
About Silo Pharma
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry.