<Weekly Highlight>
Regeneron’s Covid-19 drug Is authorized for injection[1] (6/4)
U.S. health regulators have authorized newer, more convenient forms of a Covid-19 antibody drug made by Regeneron Pharmaceuticals, an American biotech, that could make it easier for patients to get the treatment. Doctors and nurses now can administer one of the new forms by a simple injection, rather than intravenous infusion.
Regeneron’s monoclonal antibody drug, called REGEN-COV, has been available to treat recently diagnosed Covid-19 since last November under an emergency-use authorization from the FDA. Yet the drug has gone underused because it requires intravenous infusions that not all clinics and hospitals are equipped to administer.
Under the new authorization, the FDA permitted a simpler formulation, in which patients receive an injection shot underneath the skin in cases where IV infusions aren’t feasible or would lead to a delay in treatment.
<COVID-19 News>
Developed countries lock up Covid-19 vaccines through 2023[2] (6/2)
The European Union, Canada and other developed countries have signed deals to get hundreds of millions of doses of Covid-19 vaccines and boosters over the next two years, furthering a divide between rich and poor countries.
Under the recent deals, Pfizer and BioNTech agreed to supply the European Union up to 1.8 billion doses of their vaccine through 2023, while agreeing to supply Canada up to 125 million doses. Australia, Switzerland, and Israel are set to get Moderna’s shots through next year, and Switzerland has options for doses in 2023.
Moderna sees Covax, the global-health initiative intended to get doses to low-income countries, as its primary means to supply lower- and middle-income countries. The company said it would deliver 34 million doses in the fourth quarter of 2021 to Covax, which has an option to purchase another 466 million doses next year.
Pfizer has pledged to provide 2 billion doses to low- and middle-income countries over the next 18 months. It also has agreed to provide 40 million doses to Covax this year for distribution, which have begun to reach more than a dozen countries.
AstraZeneca in discussion with US to produce COVID-19 vaccine for feds at Catalent site in Maryland[3] (6/3)
AstraZeneca is in talks with the US to move COVID-19 vaccine production from Emergent BioSolutions’ Baltimore facility to another Maryland plant run by AZ’s CDMO partner Catalent.
Under the potential transfer, Catalent would retrofit a production line in Harmans, Maryland—where it already makes drug substance for AstraZeneca’s shot—to produce the vaccine for the federal government. The CDMO also tackles fill-finish work for AZ’s vaccine at a former Bristol Myers Squibb plant in Anagni, Italy.
The new line could produce some 25 million to 35 million doses a month, similar to what was expected from Emergent. It’s unclear when production could start on the new line.
Analysts expect $1.1B in 2022 from Valneva's COVID-19 vaccine sales[4] (6/3)
Valneva, a French biotech that specializes in vaccine development, has not received regulatory approval yet, but analysts see that it will make roughly $1.1 billion in 2022 through supplies deals and more than $500 million in 2023.
The vaccine, named VLA2001, is currently in late-stage trials with a readout expected in the third quarter of 2021.
Unlike its pandemic competitors, Valneva is the only European-made inactivated, adjuvanted coronavirus candidate that has undergone clinical testing in the region. It will likely be the only, or at least the leading, shot of its type in Europe.
The vaccine could have a safety edge since mRNA shots are still novel technologies, and adenovirus vaccines from Johnson & Johnson and AstraZeneca have been plagued with concerns of rare but serious blood clots.
<Industry News>
FDA authorizes marketing of Cognoa’s diagnostic aid for autism spectrum disorder[5] (6/2)
The FDA authorized marketing of a device to help diagnose autism spectrum disorder (ASD) developed by Cognoa, a US pediatric behavioral health company developing digital diagnostics and therapeutics. The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health care providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.
Walgreens completes sale of drug wholesale business to AmerisourceBergen for $6.5B[6] (6/2)
Walgreens has completed the sale of its Alliance Healthcare businesses to drug wholesaler AmerisourceBergen for $6.5 billion.
Alliance Healthcare is one of the largest pharmaceutical wholesalers in Europe, so the deal, completed roughly five months after being announced, will significantly bolster AmerisourceBergen's global distribution business.
Walgreens plans to use the infusion of capital to reduce debt and accelerate the growth of its retail pharmacy and health businesses, including its network of in-store primary care clinics in partnership with medical group VillageMD.
MorphoSys signs 2 billion-dollar deals including Constellation Pharma buy valued at $1.7B[7] (6/2)
MorphoSys, a German cancer and autoimmune-disease-focused biotech, will buy Constellation Pharmaceuticals, a US epigenetics biotech, in a deal valued at $1.7 billion. The company also made a funding partnership with Royalty Pharma worth $1.425 billion upfront that will solidify the Constellation deal.
Constellation’s two lead assets are the BET inhibitor pelabresib and CPI-0209, a EZH2 inhibitor. Both are in mid- to late-stage clinical trials in hematological and solid tumors.
Once the Constellation deal closes, MorphoSys will begin to draw on that mega deal with Royalty Pharma. The long-term strategic funding pact will see Royalty Pharma pay a $1.425 billion upfront fee to support MorphoSys’ growth strategy and aid with financing of the Constellation deal.
Bayer acquires radiotherapeutics biotech to bring back up dwindling sales in prostate cancer program[8] (6/3)
Bayer will expand its portfolio of targeted alpha therapies through the acquisition of Noria Therapeutics, a radiotherapeutics biotech, and its subsidiary PSMA Therapeutics.
The deal, of which financial details were not disclosed, will see Bayer pick up exclusive rights to two investigational therapies in prostate cancer that will complement Bayer’s already approved therapy Xofigo.
Bayer’s Xofigo is currently the only approved TAT, which can be used in patients with metastatic castration-resistant prostate cancer that has spread to the bones; the company has a proprietary platform of TATs. Xofigo is also being trialed in a larger clinical program.
FDA approves new drug treatment for chronic weight management, first Since 2014[9] (6/4)
The FDA approved Novo Nordisk’s Wegovy (semaglutide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition, for use in addition to a reduced calorie diet and increased physical activity. This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014.
The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater.
Sanofi finds partners for phase 3 pivotal trial of add-on breast cancer therapy[10] (6/4)
Two weeks after saying the breast cancer hopeful amcenestrant could be at the forefront of future treatments, Sanofi has secured partners for a phase 3 trial to study the drug versus the hormone therapy tamoxifen.
The Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT) will initiate the pivotal trial with Sanofi.
FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder[11] (6/4)
The FDA approved ProMetic Biotehrapeutics’ Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can impair normal tissue and organ function and may lead to blindness.
Until now, there were no FDA-approved treatment options for patients with plasminogen deficiency type 1. This approval helps address an unmet medical need for individuals affected by this rare genetic disease.
Ryplazim received Orphan Drug Designation, which provides incentives to assist and encourage drug development for rare disease. The application also received Fast Track Designation, Priority Review, and a Rare Pediatric Disease Priority Review Voucher. The FDA’s rare pediatric disease priority review voucher program is intended to encourage development of new drugs and biologics to prevent and/or treat rare diseases in children.
Biogen shares surge 60% after FDA approves Alzheimer’s drug, the first new therapy for the disease in nearly two decades[12] (6/7)
The Food and Drug Administration on Monday approved Biogen’s Alzheimer’s disease drug aducanumab, making it the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.
The FDA’s decision was highly anticipated. The drug, which is marketed under the name Aduhelm, is also expected to generate billions of dollars in revenue for the company and offers new hope to friends and families of patients living with the disease.
Biogen’s stock was halted for the announcement. The stock later resumed trading, surging more than 60% at one point.
The FDA said it will continue to monitor the drug as it reaches the U.S. market. The agency granted approval on the condition that Biogen conduct another clinical trial. Biogen said Monday that aducanumab’s list price is $56,000 per year; $4,312 per infusion.
<Policies & Announcements>
HHS launches first venture capital partnership to develop transformative technologies to combat future pandemics, other health emergencies[13] (6/1)
The US Department of Health and Human Services (HHS) unveiled a new type of public-private partnership that enables investments using venture capital practices.
Through the BARDA Ventures program, the Biomedical Advanced Research and Development Authority (BARDA), it is launching a partnership with the nonprofit organization Global Health Investment Corporation (GHIC) to accelerate development and commercialization of technologies and medical products needed to respond to or prevent public health emergencies, such as pandemics, and other health security threats.
Through this partnership, BARDA intends to provide GHIC with a minimum of $50 million over five years with potential for up to $500 million over 10 years. GHIC will launch a global health security fund with matching capital from other investors. This partnership will allow direct linkage with the investment community and establish sustained and long- term efforts to identify, nurture, and commercialize technologies that aid the U.S. in responding effectively to future health security threats.
FDA alerts health care providers to stop new implants of certain ventricular assist device system[14] (6/3)
· The FDA is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.
Medtronic is stopping the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter requesting physicians to stop new implants of the device. This action comes after the company received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was necessary.
According to Medtronic, there are approximately 2,000 patients in the U.S. implanted with the device and 4,000 worldwide.
FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain[15] (6/3)
The FDA announced two guidance documents and making available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. These guidance documents lay out the FDA’s recommendations for how to comply with applicable DSCSA requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.
View detailed guidance for Drug Supply Chain Security Act Implementation, Definitions of Suspect Producuct and Illegimate Product of Verification Obligation, Enhanced Drug Distribution Security at the Package Level here.
CMS announces $80 million funding opportunity available for Navigators in states with a Federally-Facilitated Marketplace[16] (6/4)
The Centers for Medicare & Medicaid Services (CMS) issued the 2021 Navigator Notice of Funding Opportunity (NOFO), which will make $80 million in grant funding available to Navigators in states with a Federally-Facilitated Marketplace (FFM) for the 2022 plan year.
Navigators help Americans understand their health insurance options, connecting consumers with financial help, and help them enroll in Marketplace plans, Medicaid or CHIP.
This is the largest funding allocation CMS has made available for Navigator grants to date. With the additional funding, CMS encourages current and past Navigators to apply, especially those that focus on education, outreach and enrollment efforts to underserved and diverse communities.
[1]https://www.wsj.com/articles/regenerons-covid-19-drug-is-authorized-for-injection-11622804402 [2]https://www.wsj.com/articles/developed-countries-lock-up-covid-19-vaccines-through-2023-11622665655 [3]https://www.fiercepharma.com/manufacturing/astrazeneca-could-produce-covid-19-vaccine-for-feds-at-catalent-site-report [4]https://www.fiercepharma.com/pharma/it-s-not-too-late-for-valneva-analysts-eye-1-1b-covid-19-vaccine-sales-next-year [5]https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-diagnostic-aid-autism-spectrum-disorder [6]https://www.healthcaredive.com/news/walgreens-completes-sale-of-drug-wholesale-business-to-amerisourcebergen-fo/601121/ [7]https://www.fiercebiotech.com/biotech/morphosys-inks-not-one-but-two-billion-dollar-deals-including-constellation-pharma-buy [8]https://www.fiercebiotech.com/biotech/bayer-picks-up-radiotherapeutics-biotech-to-prop-up-dwindling-sales-prostate-cancer-program [9]https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014 [10]https://www.fiercebiotech.com/biotech/sanofi-inks-partnerships-for-phase-3-pivotal-trial-for-add-breast-cancer-therapy [11]https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-plasminogen-deficiency-rare-genetic-disorder [12]https://www.cnbc.com/2021/06/07/fda-approves-biogens-alzheimers-drug-the-first-new-therapy-for-the-disease-in-nearly-two-decades.html [13]https://www.hhs.gov/about/news/2021/06/01/hhs-launches-first-venture-capital-partnership-develop-transformative-technologies-combat-future-pandemic.html [14]https://www.fda.gov/news-events/press-announcements/fda-alerts-health-care-providers-stop-new-implants-certain-ventricular-assist-device-system [15]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-new-guidance-further-enhance-security-prescription-drugs-us-supply-chain [16]https://www.hhs.gov/about/news/2021/06/04/cms-announces-80-million-funding-opportunity-available-navigators-states-with-federally-facilitated-marketplace.html