Market Newsdesk

Amryt Group Receives Marketing Authorisation Approval for Lojuxta® in Brazil

DUBLIN, Ireland, and Boston MA, December 09, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, is pleased to announce that the Amryt group has received marketing authorisation approval from the Brazilian Health Regulatory Agency (“ANVISA”/Agencia Nacional De Vigilancia Sanitaria) for Lojuxta® (lomitapide). 

Lojuxta® has been approved as an adjunct to a low-fat diet and other lipid-lowering treatments, with or without low density lipoprotein (LDL) apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolaemia (HoFH). 

Dr Joe Wiley, CEO of Amryt Pharma, commented today:  “We are pleased that ANVISA has recognised the significant unmet medical need of patients in Brazil suffering from HoFH and have approved marketing authorisation for Lojuxta® to treat adults with this condition. Today’s news is another milestone in executing our strategy to makeLojuxta®available to HoFH patients in need globally.”

About Amryt

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.  

Amryt’s commercial business comprises two orphan disease products.

Amryt’s lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.  FILSUVEZ® has been selected as the brand name for the product. Amryt does not have regulatory approval for FILSUVEZ® to treat EB. In September and October 2020, Amryt reported positive results from its pivotal global Phase 3 trial of FILSUVEZ® in EB. FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration.

Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia (“HoFH”) in the US, Canada, Columbia, Argentina and Japan (under the trade name Juxtapid®) and in the EU and Brazil (under the trade name Lojuxta®). HoFH is a rare genetic disorder which impairs the body’s ability to remove low density lipoprotein (“LDL”) cholesterol (“bad” cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth – often ten times more than people without HoFH – and subsequent aggressive and premature cardiovascular disease.

In March 2018, Amryt in-licensed a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.  For more information on Amryt, including products, please visit www.amrytpharma.com.

This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014.  The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.

Forward-Looking Statements

This press release may contain forward-looking statements containing the words “expect”, “anticipate”, “intends”, “plan”, “estimate”, “aim”, “forecast”, “project” and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt’s present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt’s ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt’s ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.

Contacts

Joe Wiley, CEO, +353 (1) 518 0200, [email protected]

Rory Nealon, CFO/COO, +353 (1) 518 0200, [email protected]

Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906, [email protected]

Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, [email protected]

Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700, [email protected]              

Press Release

Nokia to hold an investor call on December 16, 2020
to share the second phase of its refreshed strategy

9 December 2020

Espoo, Finland – N
okia will hold an investor call on December 16, 2020 at 3 p.m. Finnish time (EET) to share the second phase of its refreshed strategy.

Nokia’s refreshed company strategy is shared in three phases. On October 29, 2020 Nokia announced the first phase of this new strategy, outlining high-level strategic principles alongside a new operating model designed to better position the company for changing markets and align with customer needs. On December 16, 2020, Nokia plans to share the second phase of its refreshed strategy, including further information about its new strategy, its four new business groups and the markets they operate in. More information will be shared at the Capital Markets Day on March 18, 2021.

Nokia will publish the materials presented in the call at www.nokia.com/investors.

Analyst webcast

• Nokia’s video webcast will begin on December 16, 2020 at 3 p.m. Finnish time. The video webcast will last approximately 75 to 90 minutes.
• The video webcast will be a presentation with slides.
• A link to the video webcast and slides will be available at www.nokia.com/investors.

Media

• Media representatives can listen in via the link, or alternatively call +1-412-717-9224.

  
About Nokia 
We create the technology to connect the world. Only Nokia offers a comprehensive portfolio of network equipment, software, services and licensing opportunities across the globe. With our commitment to innovation, driven by the award-winning Nokia Bell Labs, we are a leader in the development and deployment of 5G networks.  

Our communications service provider customers support more than 6.4 billion subscriptions with our radio networks, and our enterprise customers have deployed over 1,300 industrial networks worldwide. Adhering to the highest ethical standards, we transform how people live, work and communicate. For our latest updates, please visit us online www.nokia.com and follow us on Twitter @nokia. 

Investor Inquiries:
 

Nokia
Investor Relations
Phone:  +358 40 803 4080
Email: [email protected]

 

Press Release

Nokia and Zain KSA deliver fastest indoor 5G speeds in the Middle East

• Next generation indoor 5G solution reaches a record speed of 1.9 Gbps at Zain KSA’s headquarters
• Nokia’s AirScale Indoor Radio System provides crucial high-speed 5G connectivity and counters coverage losses for the best possible indoor coverage 

09 December 2020

Espoo, Finland – Nokia today announced that it has achieved a record 5G speed of 1.9 Gbps during a successful trial of its next-generation AirScale Indoor Radio System (ASiR) at the headquarters of mobile operator, Zain KSA in Jeddah in the Kingdom of Saudi Arabia. Nokia’s dedicated indoor 5G solution delivers ultra-fast 5G speeds and also counters high penetration coverage losses.

The trial leveraged the Nokia 5G AirScale, which is an enhanced indoor solution with a centralized and scalable architecture. The trial’s high-speeds were achieved at 3.5GHz including multi-band ASiR-pRRH and with E-UTRAN New Radio – Dual Connectivity (EN-DC).

Nokia’s ASiR solution supports all major network technologies and is designed to easily upgrade from 4G to 5G NR with minimal on-site disruption. It includes indoor small cells that deliver a consistent 5G user experience with high data rates across multiple floors, including open and partitioned office spaces, as well as meeting rooms. It also provides an enhanced SFN (Single Frequency Network) indoor solution addressing requirements such as low cost of ownership, small product form factor and comprehensive indoor coverage.

Zain KSA launched commercial 5G services in October 2019 in Saudi Arabia and now covers 50 cities across the kingdom enabled by more than 4,600 towers. It is through these endeavors and others that Zain KSA is considered as a major enabler, driving forward the digital transformation in Saudi, as part of Saudi Vision 2030.

Eng. Abdul Rahman AlMufadda, Zain KSA CTO, said: “In line with Zain KSA achieving a pioneering position in the regional and global telecoms map by rolling out the largest 5G network in the Middle East, Europe, and Africa and fourth largest in the world, it is imperative for us to provide first class coverage for both indoor and outdoor environments. Nokia deployed its 5G indoor solution quickly, with minimal disruption and achieved incredibly high-speeds during this trial.”

Tommi Uitto, President of Mobile Networks at Nokia, said: “We are delighted to support Zain by providing 5G indoor coverage at its premises in Jeddah. Indoor coverage is an important piece in the 5G puzzle due to high penetration losses, especially in high profile venues and locations.”

Nokia is a global leader in 5G with the industry’s only comprehensive portfolio that is available globally. With 184 commercial engagements underway, our 5G solutions, software and services allow our customers to take advantage of the promise of this next generation of network technology. Learn more about Nokia 5G.

Additional resources:

Webpage: AirScale Indoor Radio System (ASIR)

About Nokia
We create the technology to connect the world. Only Nokia offers a comprehensive portfolio of network equipment, software, services and licensing opportunities across the globe. With our commitment to innovation, driven by the award-winning Nokia Bell Labs, we are a leader in the development and deployment of 5G networks.

Our communications service provider customers support more than 6.4 billion subscriptions with our radio networks, and our enterprise customers have deployed over 1,300 industrial networks worldwide. Adhering to the highest ethical standards, we transform how people live, work and communicate. For our latest updates, please visit us online www.nokia.com and follow us on Twitter @nokia.

About Zain KSA

Zain KSA is a leading telecom provider established in Saudi Arabia on August 2008 as a listed company. It adopts a 3 pillared strategy which includes growth, agility, and innovation as its main pillars for success. In due respect to its highly developed infrastructure, the company was successful in establishing itself as a reliable telecom operator and a digital service provider whose services include telecom services, 5G network, digital payment services, cloud computing, IoT solutions, fiber services, drones, and many others.

For more on Zain KSA please visit: www.sa.zain.com

Media Inquiries:
Nokia
Communications
Phone: +358 10 448 4900
Email: [email protected]

HTS Capacity Demand to Grow 26x with Broadband and Backhaul as Main Drivers

CAMBRIDGE, Mass., Dec. 09, 2020 (GLOBE NEWSWIRE) — NSR’s VSAT and Broadband Satellite Markets 19th Edition report, released today, finds a resilient market, despite near term COVID-19 challenges and changing Key Performance Indicators. Limited growth is underway in 2020, and the market remains poised to emerge from the pandemic on a heightened growth path. Cumulative service revenue will grow at 15% CAGR, with $198 Billion in total revenues by 2029, whereas equipment revenue is estimated to grow at 14% CAGR with $20 Billion in revenues, during 2019-2029.

“Clearly, the VSAT & Broadband segment has faced challenges with delays in new installations due to ongoing travel restrictions, cancellation/postponements of some contracts, few end-users/enterprises exiting the market due to COVID-19, and falling capacity prices. However, trends remain mixed across different use-cases and applications – keeping the overall market resistant to COVID-19 and ensures restricted, but overall revenue growth for 2020,” according to Vivek Suresh Prasad, NSR Senior Analyst and report author.

What ensured the overall positive trajectory for the market in 2020? “In a sentence – service revenues at existing sites countered all market restraints. The industry witnessed a significant ramp-up in bandwidth demand from existing sites and subscribers – especially from Consumer Broadband and Backhaul segments. In some cases, the ramp-up has been up to 10%-15% of the bandwidth demand. The trend is evident from quarterly results of stakeholders, as most witnessed declines in equipment revenues, but had healthy growth in service revenues and average ARPUs,” adds Vivek.

In the long term, the market curves are expected to transition from restricted growth to accelerated growth post 2021 – owing to the reduced impact of COVID-19, incoming capacity flux (both GEO and non-GEO), increased bandwidth usage per site, along with an infusion of technologies in the satellite network- such as Cloud, SD-WAN, Edge Computing, Private LTE, etc. “The top two segments accelerating growth during 2019-2029 are Consumer Broadband – owing to the massive addressable market, and Backhaul – owing to the network upgrades 2G, 3G, 4G, & 5G. The total HTS capacity demand is expected to grow by 26x to greater than 22 Tbps throughput demand – with HTS capacity pricing dropping to nearly $50/Mbps/month by 2029.

About the Report

NSR’s VSAT and Broadband Satellite Markets, 19^thEdition (VBSM19) is the longest-running and leading industry analysis of the fixed VSAT and broadband satellite sector. VBSM19 covers all the key Markets, and regions NSR’s VBSM19 assesses and analyzes the installed base of sites and subscribers in five regional markets, investigates focused trends impacting market growth/decline and forecasts the industry performance parameters including capacity demand, equipment shipments, equipment revenue, capacity revenue and service revenue for the period 2019-2029. Also, NSR leads the industry in forecasting use of High Throughput Satellites (HTS) break down into bands for GEO-HTS systems, in addition to the conventional FSS bands and assesses the impact of Non-GEO HTS constellations in the Broadband Markets.
For additional information on this report, including a full table of contents, list of exhibits and executive summary, please visit www.nsr.com or call NSR at 617-674-7743.

About NSR

NSR is the leading global market research and consulting firm focused on the satellite and space sectors. NSR’s global team, unparalleled coverage and anticipation of trends with a higher degree of confidence and precision than the competition is the cornerstone of all NSR offerings. First to market coverage and a transparent, dependable approach sets NSR apart as the key provider of critical insight to the satellite and space industries.
Contact us at [email protected] to discuss how we can assist your business.

Companies and Organizations Mentioned in NSR’s VBSM19

Advantech Wireless (Spacebridge), AfricaOnline, Afrique Telecom, Andesat, Apexsat, Arabsat, Atlantique Future Technology, Australian Government, Avanti, Bambu Wireless, Bangladesh Communication Satellite Company, Brazilian Military, Bulgarian Telecommunications Company, Botswana Telecommunication Corporation, Broadband Systems Corporation, Bank BRI, BPCL, Bentley Walker, Burkina Faso, Comtech, Clarus, Centurylink, China Satcom, Connect America, Canadian Government, Dalkom Somalia, DataCo, Eutelsat, Eurona, FCC, Forsway, Gilat, General Services Administration, GlobalSat, Gazprom Space Systems, Global Invacom, GPE, Global Technologies, Globecomm, Hughes, Hispasat, Hispamar, HPCL, iDirect/Newtec/ST Engineering, Intelisys, Intelsat, Internet Solutions, IPSTAR, IOCL, JSAT, Kacific, Logical Wireless, LCS Group, MainOne, mu Space, Masmovil Group, MLNA, mgi Global Services Limited, Measat, NigComSat, NuRAN Wireless, NBN Co. , Oklahoma Office of Management and Enterprise Services, Orbith, OneWeb, Paratus, PSN, Q-Kon, Quika, Rignet, RSCC, Servicio Satelital, Speedcast, Spacecom, SES, Sasol Oil & Gas, SpaceX, Sonali Bank, SatCoNet, Telesat, Telecom Consulting Group, TBI, Thaicom, Telebras, TV Isla, Talia, Tanaza, TierOne, UHP, Universal Satcom, ViaSat, Visiontec, Xplorenet and Yahsat.

Press Contact:

Kristen Kloster-Grady
NSR Marketing Director
[email protected]

AIM & TSX:  “TGL” & NASDAQ:  “TGA”

CALGARY, Alberta, Dec. 09, 2020 (GLOBE NEWSWIRE) — TransGlobe Energy Corporation (“TransGlobe” or the “Company”) announces that it was notified on December 4, 2020 that Ross Clarkson acquired common shares as follows.

PDMR	Date of Acquisition	Number of Common Shares Acquired	Price	Number of Common Shares held following the transaction	% of Company’s issued share capital held
Ross Clarkson	December 4, 2020	4,000	CAD $0.919	1,850,493	2.55	%

The Company also announces that it was notified on December 8, 2020 that on December 4, 7 and 8, 2020 Geoff Probert acquired common shares as follows.

PDMR	Date of Acquisition	Number of Common Shares Acquired	Price	Number of Common Shares held following the transaction	% of Company’s issued share capital held
Geoff Probert	December 4, 2020	62,100	US $0.691	62,100	0.1	%
	December 7, 2020	500	US $0.86	62,600
	December 8, 2020	15,000	US $0.846	77,600

The Company also announces that it was notified on December 8, 2020 that Eddie Ok acquired common shares as follows.

PDMR	Date of Acquisition	Number of Common Shares Acquired	Price	Number of Common Shares held following the transaction	% of Company’s issued share capital held
Eddie Ok	December 8, 2020	50,000	US $0.84	95,615	0.13	%

Notification of a Transaction pursuant to Article 19(3) of Regulation (EU) No. 596/2014

1	Details of PDMR
a)	Name	Ross Clarkson
2	Reason for the notification
a)	Position / status	Director
b)	Initial notification / amendment	Initial notification
3	Details of the issuer
a)	Name	TransGlobe Energy Corporation
b)	Legal Entity Identifier	549300QMNS6BDY8UUB03
4	Details of the transaction(s)
a)	Description of the financial instrument	Common Shares
b)	Identification code	ISIN for TransGlobe Energy Corporation Ordinary Shares: CA8936621066
c)	Nature of the transaction	Acquisition of Shares
d)	Price(s) and volume(s)	Price ($ CAD )	Volume
		$0.92	3,500
		$0.915	500
e)	Aggregated information –
	Aggregated volume –	4,000 common shares
	Aggregated price	$0.919 CAD per share
f)	Date of the transaction	December 4, 2020
g)	Place of the transaction	TSX

1	Details of PDMR
a)	Name	Geoff Probert
2	Reason for the notification
a)	Position / status	Chief Operating Officer
b)	Initial notification / amendment	Initial notification
3	Details of the issuer
a)	Name	TransGlobe Energy Corporation
b)	Legal Entity Identifier	549300QMNS6BDY8UUB03
4	Details of the transaction(s)
a)	Description of the financial instrument	Common Shares
b)	Identification code	ISIN for TransGlobe Energy Corporation Ordinary Shares: CA8936621066
c)	Nature of the transaction	Acquisition of Shares
d)	Price(s) and volume(s)	Price ($ US )	Volume
	December 4, 2020	$0.701	20,000
	December 4, 2020	$0.664	2,100
	December 4, 2020	$0.694	20,000
	December 4, 2020	$0.681	20,000
	December 7, 2020	$0.86	500
	December 8, 2020	$0.851	5,000
	December 8, 2020	$0.844	10,000
e)	Aggregated information –
	Aggregated volume –	77,600 common shares
	Aggregated price	$0.722 US per share
f)	Date of the transaction	December 4, 7 and 8, 2020
g)	Place of the transaction	NASDAQ

1 1	Details of PDMR
a)	Name	Eddie Ok
2	Reason for the notification
a)	Position / status	Chief Financial Officer
b)	Initial notification / amendment	Initial notification
3	Details of the issuer
a)	Name	TransGlobe Energy Corporation
b)	Legal Entity Identifier	549300QMNS6BDY8UUB03
4	Details of the transaction(s)
a)	Description of the financial instrument	Common Shares
b)	Identification code	ISIN for TransGlobe Energy Corporation Ordinary Shares: CA8936621066
c)	Nature of the transaction	Acquisition of Shares
d)	Price(s) and volume(s)	Price ($ US )	Volume
		$0.84	50,000
e)	Aggregated information –
	Aggregated volume –	50,000 common shares
	Aggregated price	$0.84 US per share
f)	Date of the transaction	December 8, 2020
g)	Place of the transaction	NASDAQ

About TransGlobe

TransGlobe Energy Corporation is a cash flow focused oil and gas exploration and development company whose current activities are concentrated in the Arab Republic of Egypt and Canada. TransGlobe’s common shares trade on the Toronto Stock Exchange and the AIM market of the London Stock Exchange under the symbol TGL and on the NASDAQ Exchange under the symbol TGA.

For Further information, please contact:

TransGlobe Energy Corporation Randy Neely, President and CEO Eddie Ok, CFO	+1 403 264 9888 [email protected] http://www.trans-globe.com or via Tailwind Associates or FTI Consulting
Tailwinds Associates (Investor Relations) Darren Engels	+1 403 618 8035 [email protected] http://www.tailwindassociates.ca
FTI Consulting (Financial PR) Ben Brewerton Genevieve Ryan	+44(0) 20 3727 1000 [email protected]
Canaccord Genuity (Nomad & Joint-Broker) Henry Fitzgerald-O’Connor James Asensio	+44(0) 20 7523 8000
Shore Capital (Joint Broker) Jerry Keen Toby Gibbs	+44(0) 20 7408 409

ST. LOUIS, Dec. 09, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that the Centers for Medicare & Medicaid Services (CMS) has granted Detectnet Transitional Pass-Through Status (code C9068) effective January 1, 2021. The descriptor for Detectnet will be: Copper Cu-64, dotatate, diagnostic, 1 millicurie. C9068 will be used to bill Detectnet for Medicare patients seen in the hospital outpatient department.

“The response to Detectnet in the neuroendocrine community has been tremendous,” said Curium CEO, North America, Dan Brague. “Once in effect, this code will simplify the billing and reimbursement of Detectnet for our customers. We have been dedicated to helping patients in the neuroendocrine community for over 20 years and are excited to share this new code.”

“The recent inclusion in a major Appropriate Use Criteria confirms the clinical utility of Detectnet in the neuroendocrine community,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “The issuance of C9068 should further simplify the reimbursement process and help patients in need.”

About Detect


net

INDICATIONS

Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

Radiation Risk

Diagnostic radiopharmaceuticals, including Detectnet, contribute to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Risk for Image Misinterpretation

The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors. Increased uptake might also be seen in other non-cancerous pathologic conditions that express somatostatin receptors including thyroid disease or in subacute inflammation, or might occur as a normal physiologic variant (e.g. uncinate process of the pancreas).

A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.

ADVERSE REACTIONS

In clinical trials, adverse reactions occurred at a rate of < 2% and included nausea, vomiting and flushing. In published trials nausea immediately after injection was observed.

DRUG INTERACTIONS

Somatostatin Analogs

Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2). Image patients just prior to dosing with somatostatin analogs. For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging.

USE IN SPECIFIC POPULATIONS

Pregnancy

All radiopharmaceuticals, including Detectnet, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of Detectnet.

Lactation

Advise a lactating woman to interrupt breastfeeding for 12 hours after Detectnet administration in order to minimize radiation exposure to a breastfed infant.

Pediatric
use

The safety and effectiveness of Detectnet have not been established in pediatric patients.

Geriatric
use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

OVERDOSAGE

In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding. A diuretic might also be considered.

Please see Full prescribing information by clicking here.

About RadioMedix

RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals. RadioMedix has also established contract service facilities for academic and industrial partners: Full cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing of the radiopharmaceuticals, and probe development and small animal Molecular Imaging Facility for pre-clinical evaluation of radiopharmaceuticals in animal models. To learn more, visit www.radiomedix.com. For more information about this press release, please contact: [email protected]

About Curium

Curium is the world’s largest nuclear medicine company. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan, media contact for Curium: [email protected].

About Neuroendocrine Tumors

Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract, pancreas and liver, but can also occur in other tissues including lung, thymus and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).       

CD0115 1220

Contact Information:

Sandy Borgschulte
Company: Curium
[email protected]
Phone: 314-954-6637

Janet Ryan
Company: RyanPR
[email protected]
Phone: 314-822-8860