Proactiveinvestors United Kingdom Shield Therapeutics PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Shield Therapeutics PLC RSS feed en Tue, 21 May 2019 20:31:03 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - Shield's Feraccru likely to command 'high market share and branded pricing' ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13300/shield-s-feraccru-likely-to-command--high-market-share-and-branded-pricing--13300.html Fri, 10 May 2019 15:17:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/13300/shield-s-feraccru-likely-to-command--high-market-share-and-branded-pricing--13300.html <![CDATA[News - Shield Therapeutics primed for a busy year ]]> https://www.proactiveinvestors.co.uk/companies/news/219980/shield-therapeutics-primed-for-a-busy-year-219980.html Shield Therapeutics PLC (LON:STX) is a specialty pharmaceutical company focused on the development and commercialisation of late-stage pharmaceuticals. Its lead asset, Feraccru, is an oral treatment for iron deficiency with or without anaemia. Feraccru is approved and marketed in Europe, with a US approval decision pending for July 27. It also has a pipeline of prescription pharmaceutical assets. The most advanced is PT20, a phase III-ready treatment for the electrolyte disorder, hypophosphatemia, which is extremely common in patients with chronic kidney disease.

Shield Therapeutics heading for a US approval decision

Feraccru has a range of features that help differentiate it from the more established iron treatments including:

• Twice-daily dosing without food providing high iron availability

• Raises haemoglobin and iron levels effectively

• Prolonged therapy maintains Hb levels

• Well tolerated

• Non-inferior to IV iron

• Feraccru is a stable, non-salt, oral formulation of ferric iron, which has a unique mechanism of action compared to salt-based oral iron therapies

Inflexion Points

Outwardly simple, but with clinically-proven equivalent efficacy to intravenous iron, Feraccru is an oral product absorbed in the gut. It is also an alternative for those unable to tolerate or unresponsive to first-line salt-based oral iron products. Such patients have the second-line option of intravenous iron, which is painful and inconvenient. So, Feraccru presents a much more convenient and potentially lower cost, safer alternative to intravenous iron, which needs to be administered in hospital because it always carries the risk of a severe and potentially fatal allergic reaction.

• Further news on commercialisation progress, publication of peer-reviewed Feraccru data from H2H study

• US PDUFA date 27 July (this is the deadline by which regulators must review new drugs)

• Initiation of a paediatric study in infants over one-month, starting in the second half of 2019

• News on next steps with PT20 including outcomes of ongoing reformulation work

• News on partnering in new geographies – notably China in next 12 months

Blue Sky

The market leading IV iron delivered FY18 in-market revenues of US$898mln in a global IV iron market valued at US$1.8bn. Vifor Pharma AG, a Switzerland-based company with a market capitalisation of US$8.5bn commercialises the market leading branded intravenous iron, Ferinject, known as Injectafer in US.

“We contend that Feraccru can command a high market share as well as branded pricing because of its convenience and, supported by emerging evidence from clinical studies, that it provides a long-term treatment for maintaining the body’s iron stores,” said Emma Ulker, analyst at Capital Network. “Its convenience is a very important differentiator as patients can take Feraccru at home, avoiding a hospital admission and the life-threatening risks of IV iron administration. Physicians report that the outcomes seen in clinical studies are reflected in real world use of Feraccru.”

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Thu, 09 May 2019 12:51:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219980/shield-therapeutics-primed-for-a-busy-year-219980.html
<![CDATA[RNS press release - Appointment of Joint Broker ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190508070005_14065690/ Wed, 08 May 2019 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190508070005_14065690/ <![CDATA[RNS press release - Investor presentation ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190502070005_14060251/ Thu, 02 May 2019 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190502070005_14060251/ <![CDATA[RNS press release - Additional Listing ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190501115845_14059480/ Wed, 01 May 2019 11:58:45 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190501115845_14059480/ <![CDATA[RNS press release - 2018 Annual Report and 2019 AGM Notice ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190430070004_14056240/ Tue, 30 Apr 2019 07:00:04 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190430070004_14056240/ <![CDATA[Media files - Swiss broad label approval 'a further endorsement' of Shield's Feraccru drug ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13130/swiss-broad-label-approval--a-further-endorsement--of-shield-s-feraccru-drug-13130.html Mon, 29 Apr 2019 11:53:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/13130/swiss-broad-label-approval--a-further-endorsement--of-shield-s-feraccru-drug-13130.html <![CDATA[RNS press release - PDMR Acquisition of Shares ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190426180526_14054363/ Fri, 26 Apr 2019 18:05:26 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190426180526_14054363/ <![CDATA[News - Shield Therapeutics wins extended approval for Feraccru in Switzerland ]]> https://www.proactiveinvestors.co.uk/companies/news/219006/shield-therapeutics-wins-extended-approval-for-feraccru-in-switzerland-219006.html Shield Therapeutics PLC’s (LON:STX) shares rose on Wednesday following news Switzerland’s medical authorities have given approval for its Feraccru iron deficiency drug to be given to all adults with iron deficiency.

Following the decision by the Swiss Agency for Therapeutic Products, the company will be able to market the drug to any adult, whether or not they have been diagnosed with anaemia.

READ: Shield Therapeutics' shares rise as it hails results of extended trial of Feraccru

With Feraccru last year granted similar approval across the European Union, Shield chief executive Carl Sterritt was encouraged by the progress being made with regulatory authorities, especially as he expects a big decision from the US drug regulator in late July.

“Switzerland represents an attractive market opportunity as it is both well reimbursed and has a much higher level of treatment penetration compared to other markets, particularly for IV iron therapies,” he said.

The combination of the Swissmedic extension and the recent results of a year-long clinical study that showed pill-form Feraccru to be just as good as the current standard of care treatment in boosting users’ haemoglobin. Sterritt said it will provide “an enhanced commercial opportunity” to Ewo, Shield’s Swiss commercial partner. 

“We look forward to working with them to deliver commercial success for Feraccru in Switzerland at the earliest opportunity."

Positive progress highlighted

In a note to clients, analysts at ‘house’ broker Peel Hunt pointed out: “Today’s announcement follows an equivalent broadening of the marketing authorisation approval for Feraccru in the European Union in 2018 and further increases the commercial opportunity for Feraccru across Europe.”

They added; “This news does not affect our estimates or valuation for Shield, but highlights the positive progress at the company and the growing commercial opportunity for Feracrru.

“As a reminder, the next catalyst for the company will be the FDA’s decision on whether to grant marketing approval for Feraccru in the US, due 27 July 2019.”

 Peel Hunt repeated a  ‘buy’ rating and 88p price target on Shield shares, which in late morning trading were 3.6% higher at 86.50p.

 -- Adds analyst comment, share price --

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Wed, 24 Apr 2019 07:42:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219006/shield-therapeutics-wins-extended-approval-for-feraccru-in-switzerland-219006.html
<![CDATA[RNS press release - Major extension to approval in Switzerland ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190424070004_14049216/ Wed, 24 Apr 2019 07:00:04 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190424070004_14049216/ <![CDATA[RNS press release - Grant of share options ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190417170643_14045285/ Wed, 17 Apr 2019 17:06:43 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190417170643_14045285/ <![CDATA[RNS press release - PDMR Acquisition of Shares and Additional Listing ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190417170146_14045280/ Wed, 17 Apr 2019 17:01:46 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190417170146_14045280/ <![CDATA[RNS press release - PDMR Acquisition of Shares ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190417165642_14045271/ Wed, 17 Apr 2019 16:56:42 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190417165642_14045271/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190411164013_14038293/ Thu, 11 Apr 2019 16:40:13 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190411164013_14038293/ <![CDATA[RNS press release - Additional Listing ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190408154250_14033071/ Mon, 08 Apr 2019 15:42:50 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190408154250_14033071/ <![CDATA[Media files - Dr John Mansfield discusses non-inferiority trial of Shield Therapeutics' Feraccru drug ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12909/dr-john-mansfield-discusses-non-inferiority-trial-of-shield-therapeutics--feraccru-drug-12909.html Mon, 08 Apr 2019 11:48:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/12909/dr-john-mansfield-discusses-non-inferiority-trial-of-shield-therapeutics--feraccru-drug-12909.html <![CDATA[Media files - Shield's flagship iron pill goes from strength to strength ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12871/shield-s-flagship-iron-pill-goes-from-strength-to-strength-12871.html Thu, 04 Apr 2019 14:54:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/12871/shield-s-flagship-iron-pill-goes-from-strength-to-strength-12871.html <![CDATA[News - Shield Therapeutics targeting more lucrative Feraccru out-licence deals in 2019 ]]> https://www.proactiveinvestors.co.uk/companies/news/217840/shield-therapeutics-targeting-more-lucrative-feraccru-out-licence-deals-in-2019-217840.html Shield Therapeutics PLC (LON:STX) expects to sign more out-licence agreements in the coming months for Feraccru – its flagship iron deficiency treatment.

The AIM company struck a deal which gave Dutch pharma group Norgine the right to sell the drug in Europe, Australia and New Zealand towards the end of 2018.

As part of the agreement, Shield received an upfront £11mln fee, while it also stands to receive another £45mln or so in milestone payments, as well as a cut of any sales.

READ: Feraccru shows its mettle in head-to-head study

That upfront payment meant Shield recorded revenue of £11.9mln in the 12 months ended 31 December (2017: £0.6mln), while its loss narrowed significantly to £1.8mln (2017: £19.6mln).

It also means the company has enough cash to see it through until the third quarter of 2020.

The plan is to secure more of those deals, with China and the US the main targets.

Shield is waiting on approval for Feraccru from US regulators and a decision one way or the other is expected by the end of July.

Should the Food and Drug Administration give Feraccru the thumbs-up, it would allow the pill to be sold into the most lucrative medicine market in the world.

Recent data should help prove Shield’s case, with a head-to-head Phase IIIb confirming Feraccru’s “non-inferiority” to Ferinject, which is the current standard-of-care.

US approval would unlock huge market

“2018 was a year of transition and Shield is now well positioned to deliver further positive news through 2019,” said chief executive Carl Sterritt.

“I expect Norgine to continue to develop the sales performance of Feraccru in the UK and Germany, and we anticipate concluding further out-licence agreements to cover additional geographies.

“In the US I look forward to the 27 July 2019 PDUFA date, which has the potential to unlock the world's largest prescription pharmaceutical market to Feraccru, which has continued to demonstrate its effectiveness over the last 12 months in two demanding clinical trials.”

Cash runway better-than-expected

“Shield released its 2018 results this morning but having pre-released the key financial metrics earlier this year there are no surprises,” said analysts at City broker Liberum.

“The company did, however, make note of its expectation of signing an out-licensing deal in China this year as well as reiterating its belief in the strength of its IP against the on-going challenge from Teva.

“Lastly it noted that its cash runway now extends into Q3 2020 vs. our previous expectation for some time in Q2 2020.”

In a note to clients, analysts at Liberum Capital Shield pointed out that “having pre-released the key financial metrics earlier this year there are no surprises” in Shield’s final.

They added: “The key data points remains the FDA's approval decision on Feraccru due by the 27 July 2019.”

Liberum repeated a ‘buy; rating and 116p target price on Shield shares, which in early afternoon trading on Wednesday were changing hands at 73.25p each, down 4.3% on Tuesday’s close.

 -- Updates share price and analyst comment --

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Wed, 03 Apr 2019 08:42:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/217840/shield-therapeutics-targeting-more-lucrative-feraccru-out-licence-deals-in-2019-217840.html
<![CDATA[RNS press release - Final Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190403070004_14026364/ Wed, 03 Apr 2019 07:00:04 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190403070004_14026364/ <![CDATA[RNS press release - Additional Listing ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190401174459_14024357/ Mon, 01 Apr 2019 17:44:59 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190401174459_14024357/ <![CDATA[RNS press release - Change of Adviser ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190401120001_14023649/ Mon, 01 Apr 2019 12:00:01 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190401120001_14023649/ <![CDATA[RNS press release - Notice of Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190327070006_14016929/ Wed, 27 Mar 2019 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190327070006_14016929/ <![CDATA[News - Shield Therapeutics says European Patent Office decides in company’s favour in relation to a Feracru patent ]]> https://www.proactiveinvestors.co.uk/companies/news/216501/shield-therapeutics-says-european-patent-office-decides-in-companys-favour-in-relation-to-a-feracru-patent-216501.html Shield Therapeutics PLC (LON:STX) said the European Patent Office (EPO) has decided in favour of the company in relation to a patent for its lead product Feracru, an iron deficiency treatment.

The AIM-listed firm said that the decision, made by the EPO’s opposition division, related to patent #2 668 175, which covers a "Process for preparing an iron hydroxypyrone".

READ: Shield Therapeutics funded through to 2020

The group added that the decision was reached having taken into account Shield's first and preferred minor amendment, follows a hearing in relation to the opposition that had been filed against the patent by a third party. 

The company noted that the decision means that the patent as amended and the invention to which it relates meet the requirements of the European Patent Convention and they will continue to provide protection to Feraccru through to 2032.

It pointed out that customary rights of appeal apply to the third-party opposition and said it will continue to “proactively and robustly defend its intellectual property”.

Shield revealed on 24 January that it had been made aware that a third party had raised objections with the EPO to the group's patents (#2 668 175 and # 3 160 951) that cover "Process for preparing an iron hydroxypyrone" and "Crystalline forms of ferric maltol" respectively.

The group said then that, on the basis of specialist advice received and the fact both patents went through an extensive examination process prior to grant, it continues to have full confidence in the validity of the patents which expire in 2032 and 2035. 

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Thu, 14 Mar 2019 15:49:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/216501/shield-therapeutics-says-european-patent-office-decides-in-companys-favour-in-relation-to-a-feracru-patent-216501.html
<![CDATA[RNS press release - Positive decision on Feraccru®'s process patent ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190314153122_14002924/ Thu, 14 Mar 2019 15:31:22 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190314153122_14002924/ <![CDATA[Media files - Shield Therapeutics CEO hails positive head-to-head Feraccru study results ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12429/shield-therapeutics-ceo-hails-positive-head-to-head-feraccru-study-results-12429.html Mon, 04 Mar 2019 14:33:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/12429/shield-therapeutics-ceo-hails-positive-head-to-head-feraccru-study-results-12429.html <![CDATA[News - Shield Therapeutics’ Feraccru iron deficiency drug shows its mettle in head-to-head study ]]> https://www.proactiveinvestors.co.uk/companies/news/215689/shield-therapeutics-feraccru-iron-deficiency-drug-shows-its-mettle-in-head-to-head-study-215689.html Shield Therapeutics PLC’s (LON:STX) Feraccru iron deficiency drug has proved itself to be just as good as the current standard of care treatment in a late-stage trial.

The year-long phase IIIb study confirmed Feraccru’s “non-inferiority” to Ferinject when it came to boosting patients’ haemoglobin (Hb) levels.

Shield shares soared at the opening bell, jumping 25.2% to 67.9p.

WATCH: Shield Therapeutics CEO hails positive head-to-head Feraccru study results

So far, researchers have only had time to analyse the top-line data. More detailed analysis, such as secondary endpoints and safety parameters, will be presented alongside Shield’s full-year results in early April.

As part of its commercialisation agreement with Norgine BV, Shield will now receive a €2.5mln milestone payment.

“We are delighted that Feraccru has once again performed so well in a phase III clinical trial, this time delivering a major achievement in showing itself to be non-inferior to IV iron therapy, further reinforcing the value of Feraccru,” said chief executive and founder Carl Sterritt.

“These data provide yet further evidence that Feraccru is well-tolerated by a majority of treated patients and is effective at correcting both their iron deficiency and anaemia.”

Chief medical Mark Sampson added: “In a challenging phase IIIb clinical study, in which Feraccru has been tested against Ferinject, the standard of care for patients who cannot tolerate or are unwilling to take salt-based oral iron therapies, orally delivered Feraccru has demonstrated it is non-inferior to IV iron therapy in treating iron deficiency anaemia.”

US approval due in summer

Feraccru is approved and marketed in the European Union for the treatment of iron deficiency (ID) in adults and in Switzerland for the treatment of iron deficiency anaemia (IDA) in adults with inflammatory bowel disease (IBD).

A New Drug Application in the USA is being reviewed by the US Food and Drug Administration (FDA) which is set to return its verdict by the end of July.

Feraccru is a pill, which Shield thinks gives it an advantage over Ferinject which, as the name suggests, is an intravenous injection that needs to be administered in hospital.

It is also a non-salt treatment, which is important because when some salt-based oral iron therapies are ingested, they can cause nausea, bloating and constipation.

In the past, patients who could not tolerate salt-based tablets had to receive IV iron therapy – such as Ferinject – which Shield has said is “invasive, costly, inconvenient and complex to administer”.

Study de-risks commercial launch

“This successful study has triggered a €2.5mln milestone payment from Norgine and will allow [Shield] to begin reimbursement discussions across the rest of the EU thus de-risking the commercial launch that we believe is worth at least 56p per share and as much as 90p per share,” read a note from City broker Liberum.

“In the past year Shield has delivered an ultimately successful P3 in CKD, a major out-licensing deal with a significant upfront payment and now a successful read-out from the head to head study.

“The current market cap of just £63m is clearly not reflecting these achievements or the potential for US approval by the end of July.”

Liberum has Shield as a ‘buy’ with a target price of 116p.

--Adds share price and analyst comment--

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Mon, 04 Mar 2019 08:09:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/215689/shield-therapeutics-feraccru-iron-deficiency-drug-shows-its-mettle-in-head-to-head-study-215689.html
<![CDATA[RNS press release - Positive results for Feraccru® in AEGIS-H2H study ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190304070007_13988235/ Mon, 04 Mar 2019 07:00:07 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190304070007_13988235/ <![CDATA[Media files - Shield Therapeutics CEO delighted with further positive results from pivotal Feraccru study ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12035/shield-therapeutics-ceo-delighted-with-further-positive-results-from-pivotal-feraccru-study-12035.html Wed, 30 Jan 2019 12:28:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/12035/shield-therapeutics-ceo-delighted-with-further-positive-results-from-pivotal-feraccru-study-12035.html <![CDATA[News - Shield Therapeutics' shares rise as it hails results of extended trial of Feraccru ]]> https://www.proactiveinvestors.co.uk/companies/news/213497/shield-therapeutics--shares-rise-as-it-hails-results-of-extended-trial-of-feraccru-213497.html Shield Therapeutics PLC’s (LON:STX) saw its shares rise on Tuesday as the group said its iron deficiency treatment Feraccru delivered strong benefits for people with kidney-related anaemia in an extended trial.

The extended 52-week open-label study showed increased haemoglobin levels in both those taking it for the whole period and also in those who switched from the placebo after the first 16-weeks.

READ: Shield Therapeutics funded through to 2020

Carl Sterritt, Shield’s chief executive, said: "Such positive long-term treatment data for Feraccru in complex patients with chronic diseases like CKD provides a very promising signal for the future commercial success of Feraccru. 

“Having previously seen similar positive long-term effects in IBD patients with IDA this further clinical trial data provides additional evidence that Feraccru is well-tolerated by a majority of treated patients and is effective at correcting IDA.”

Feraccru is already approved for iron deficiency in adults and in Switzerland for the treatment of iron deficiency anaemia (IDA) in adults with inflammatory bowel disease (IBD).

In October, Shield submitted Feraccru to the US Food and Drug Administration for approval as a treatment for iron deficiency.

Well-tolerated and effective treatment option

Dr Mark Sampson, Shield’s chief medical officer, added:  "Iron deficiency is a significant and progressive issue in patients with chronic renal disease which has been challenging to treat due to poor compliance with traditional oral iron salts. 

“These results suggest that Feraccru offers a well-tolerated and effective treatment option which can benefit patients over the long-term."

As confirming it is well-tolerated, the extended trial demonstrated chronic treatment with Feraccru can maintain Hb (haemoglobin) levels in a number of conditions that cause iron deficiency. 

“As previously shown in patients with IDA associated with IBD, this study in CKD patients demonstrates that Feraccru is also well tolerated in a group of patients whose IDA is caused by a very different primary disease,” said the statement.

Shares jump, Liberum repeats 'buy'

In late morning trading, shares in Shield Therapeutics were 10.9% higher at 47.00p.

In a note to clients, analysts at Liberum Capital reiterated a ‘buy’ rating and an 80p per share price target on Shield Therapeutics.

The City broker’s analyst said: “This data further validates the potential for Feraccru in CKD and should help to convince prescribers of the longer-term benefits of the drug. The key event remains the US FDA approval decision due by the end of July this year.”

 -- Adds share price, analyst comment --

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Tue, 29 Jan 2019 09:11:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/213497/shield-therapeutics--shares-rise-as-it-hails-results-of-extended-trial-of-feraccru-213497.html
<![CDATA[RNS press release - Positive results of AEGIS-CKD study ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190129070007_13949532/ Tue, 29 Jan 2019 07:00:07 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190129070007_13949532/ <![CDATA[News - Shield Therapeutics funded through to 2020 ]]> https://www.proactiveinvestors.co.uk/companies/news/213232/shield-therapeutics-funded-through-to-2020-213232.html Drugs developer Shield Therapeutics PLC (LON: STX) saw an explosive increase in revenues in the second half of 2018, thanks to its commercialisation agreement with Norgine.

A trading update covering the first half of the company’s current fiscal year revealed revenues for the period are expected to clock in at around £11.9mln, up from £637,000 in the corresponding period of 2017.

READ: US FDA to make decision on Shield Therapeutics’ Feraccru drug by end of July

In September 2018, Shield licensed its iron deficiency treatment, Feraccru, to Norgine in most European countries, receiving an £11mln upfront licence fee in the process.

Norgine began to promote Feraccru in the UK and Germany in December as these are markets where the product was already commercially available and being reimbursed.

Feraccru will be launched by Norgine in the other major European markets when pricing and reimbursement negotiations are concluded, with these launches not expected before 2020.

Discussions are underway with third parties for the licensing of Feraccru commercial rights in certain other countries.

Shield finished the year with cash of £9.8mln, down from £13.3mln at the end of 2017. Taking into account expected royalty income from Norgine during 2019, which is anticipated to grow steadily based on sales in the UK and Germany, but excluding any development or sales milestones that may be received from Norgine, the board is confident that the group's “cash runway” currently extends into 2020 based on currently planned expenditure on research & development.

Today we have provided a business and trading update #STX Read more on our news page https://t.co/bozw8i9dpY

— Shield Therapeutics (@ShieldTx) January 24, 2019

The group said it has been made aware that a third party has raised objections with the European Patent Office to the group's patents (#2 668 175 and # 3 160 951) that cover "Process for preparing an iron hydroxypyrone" and "Crystalline forms of ferric maltol" respectively.

On the basis of specialist advice received and the fact both patents went through an extensive examination process prior to grant, the group continues to have full confidence in the validity of the patents which expire in 2032 and 2035.

"Shield has entered 2019 in good shape,” declared Carl Sterritt, the chief executive officer of Shield Therapeutics.

“I have been encouraged by the sales performance of Feraccru in the UK and Germany, where upward sales momentum has been maintained through the last twelve months despite the lack of active sales promotion since February 2018 and I believe that Norgine, with its much larger field-based sales team and readily available resources, is well placed to build on the positive momentum we saw in 2018 and drive the Feraccru business forwards in Europe.

“In the USA I am looking forward to the 27 July 2019 PDUFA date for Feraccru and the opportunity for Feraccru to be commercialised in the world's largest prescription pharmaceutical market. To enable this we are focused on identifying a suitable US commercial partner at the earliest opportunity, and, based on ongoing discussions I believe we also have the potential to out-license Feraccru for commercialisation in other parts of the world," he added.

Liberum Capital Markets, which has an 80p target price for Shield's shares, said: "Shield has released a short preliminary update for its FY18 results. In this, it confirmed that it delivered revenues of £11.9mln of which £0.6mln came from product sales in the first eight months of the year and a further £0.1mln from royalties over the remaining four months of 2018".

"It also provided an update on Norgine's roll-out across Europe with c.80reps in-place already (4x  the number Shield had). The company confirmed a year-end net cash position of £9.8m which should give it plenty of runway over the next twelve months. Lastly, Shield also reiterated that it expects the results from its head-to-head study in Q1 and a decision by the FDA on US approval by the end of July," the broker added.

With enough cash to fund the business into 2020 and two potentially major share price catalysts in the next six months, Liberum reiterated its 'buy' rating.

Broker Peel Hunt said the expected revenue of £11.9mln for 2018 was in line with its £12mln forecast while the end-of-year cash balance of £9.8mln was better than the £9.6mlnm it had predicted.

“The AEGIS H2H [head-to-head] study remains on track to report results by end March 2019, potentially resulting in a milestone payment from Norgine, amounting to c £2mln if it achieves its primary endpoint of non-inferiority [versus Ferinject, the leading intravenous iron therapy].”

Peel Hunt said its target price of 70p implies more than 100% upside “and includes nothing for the US market”, which Peel Hunt estimates could be worth an additional 85p per share on a partnered basis.

“If FDA approval is received this year, the US market offers further very strong near-term expansion potential for Feraccru,” the broker said.

Shares in Shield trade at 38p, up 0.6p on the day.

Tim Watts, CFO will be presenting at two investor presentations this month @proactive_UK One2One Investor Forum and @SHARESmag The Growth & Innovation Forum 2019. The presentations will be available on the Company website shortly after the events here - https://t.co/48hUWqc1O9

— Shield Therapeutics (@ShieldTx) January 23, 2019

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Thu, 24 Jan 2019 07:57:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/213232/shield-therapeutics-funded-through-to-2020-213232.html
<![CDATA[RNS press release - Business and trading update ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190124070005_13944846/ Thu, 24 Jan 2019 07:00:05 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190124070005_13944846/ <![CDATA[RNS press release - Investor presentations ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190123101939_13944165/ Wed, 23 Jan 2019 10:19:39 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190123101939_13944165/ <![CDATA[News - Shield Therapeutics appoints Karis as chairman ]]> https://www.proactiveinvestors.co.uk/companies/news/213038/shield-therapeutics-appoints-karis-as-chairman-213038.html Shield Therapeutics PLC (LON:STX) has appointed James Karis as its new non-executive chairman.

Karis has been on the board for three years already and chairs the remuneration committee.

WATCH: Shield Therapeutics' Feraccru drug 'a potential game-changer'

A 35-year pharma veteran, Karis was chief executive of the privately-held MAPI Group, which was sold to ICON last year.

Former chairman Andrew Heath stood down at this year’s AGM.

Shield’s flagship product Feraccru is going through the process of US approval, with a decision expected by 27 July.

Feraccru has already been approved in Europe as a treatment for iron deficiency in adults.

In a note to clients, analysts at Liberum Capital said: “Mr Karis looks a good appointment given his background and familiarity with the business, particularly ahead of a what is a pivotal year for Shield with head to head data due in the next few months, the potential US approval of Feraccru before the end of July and on-going EU commercialisation.”

Liberum repeated a ‘buy’ rating and 80p price target on Shield Therapeutics’ shares. In afternoon trading, the stock held steady at 35.50p.

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Tue, 22 Jan 2019 07:56:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/213038/shield-therapeutics-appoints-karis-as-chairman-213038.html
<![CDATA[RNS press release - Appointment of Chairman ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190122070009_13942030/ Tue, 22 Jan 2019 07:00:09 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20190122070009_13942030/ <![CDATA[Media files - Shield Therapeutics' Feraccru drug 'a potential game-changer' ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11921/shield-therapeutics--feraccru-drug--a-potential-game-changer--11921.html Mon, 21 Jan 2019 13:36:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11921/shield-therapeutics--feraccru-drug--a-potential-game-changer--11921.html <![CDATA[Media files - Medical expert discusses his experience working with Shield Therapeutics' Feraccru drug ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11863/medical-expert-discusses-his-experience-working-with-shield-therapeutics--feraccru-drug-11863.html Wed, 16 Jan 2019 08:50:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11863/medical-expert-discusses-his-experience-working-with-shield-therapeutics--feraccru-drug-11863.html <![CDATA[News - US FDA to make decision on Shield Therapeutics’ Feraccru drug by end of July ]]> https://www.proactiveinvestors.co.uk/companies/news/211119/us-fda-to-make-decision-on-shield-therapeutics-feraccru-drug-by-end-of-july-211119.html US regulators have confirmed they will make a decision on whether or not to approve Shield Therapeutics PLC’s (LON:STX) Feraccru drug by 27 July 2019.

Feraccru is Shield’s flagship drug which has already been approved in Europe as a treatment for iron deficiency in adults.

READ: Shield’s Feraccru to be considered for US market

The US makes up a third of the global pharmaceutical market, so should the Food and Drug Administration (FDA) give the green light, it would open up a “highly attractive” and potentially lucrative opportunity.

Chief executive Carl Sterritt said: “Confirmation of the PDUFA date for completion of the review of Feraccru by the FDA is another important step towards being able to offer Feraccru to the very large pool of iron-deficient patients in the United States who would benefit from this novel new treatment option.”

“We will continue to work closely with the FDA to achieve this goal, whilst also seeking an attractive commercial partner for Feraccru in the USA who can help us realise the full value of the opportunity that would be created by Feraccru's approval.”

In a note to clients, analysts at ‘house’ broker Peel Hunt, commented: “At its interim report for its 6 months to 30 June 2018, Shield had suggested an FDA approval decision would be made during Q4 2019 and as such the 27 July 2019 PDUFA date represents a beat vs those timing expectations.

“As we published in our recent report, we see 85p/sh upside in addition to our 70p if Ferracru gets FDA approval in the US. We see today’s news as supportive of the stock, we maintain our Buy recommendation and 70p TP.”

In afternoon trading, shares in Shield Therapeutics were 1.6% higher at 31.50p.

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Thu, 13 Dec 2018 07:24:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/211119/us-fda-to-make-decision-on-shield-therapeutics-feraccru-drug-by-end-of-july-211119.html
<![CDATA[RNS press release - US New Drug Application PDUFA date for Feraccru ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181213070002_13901818/ Thu, 13 Dec 2018 07:00:02 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181213070002_13901818/ <![CDATA[Media files - Shield Therapeutics to expand iron deficiency treatment with child trials in 2019 ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11582/shield-therapeutics-to-expand-iron-deficiency-treatment-with-child-trials-in-2019-11582.html Tue, 11 Dec 2018 14:18:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11582/shield-therapeutics-to-expand-iron-deficiency-treatment-with-child-trials-in-2019-11582.html <![CDATA[RNS press release - UK launch of Feraccru® by Norgine ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181205100441_13892355/ Wed, 05 Dec 2018 10:04:41 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181205100441_13892355/ <![CDATA[Media files - Shield Therapeutics PLC expecting US decision on Feraccru around July ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11428/shield-therapeutics-plc-expecting-us-decision-on-feraccru-around-july-11428.html Tue, 04 Dec 2018 13:16:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11428/shield-therapeutics-plc-expecting-us-decision-on-feraccru-around-july-11428.html <![CDATA[News - Shield Therapeutics' Feraccru to be considered for US market by the FDA ]]> https://www.proactiveinvestors.co.uk/companies/news/210378/shield-therapeutics--feraccru-to-be-considered-for-us-market-by-the-fda-210378.html Shield Therapeutics PLC (LON:STX) has received the go-ahead to file for the US approval of Feraccru, its iron deficiency treatment.

The AIM-listed company expects to hear shortly from the US Food and Drug Administration the date in 2019 it will complete its review of the drug.

Feraccru already has EU approval, while in Switzerland, the drug can be used for iron deficiency anaemia in adults with inflammatory bowel disease. 

In September, Dutch-firm Norgine licensed the product for Europe, Australia and New Zealand.

Through that arrangement, Norgine paid £11mln upfront and will pay up to a further €54.5mln in royalties.

Carl Sterritt, Shield’s chief executive, said the NDA review was a big step forward towards Feraccru, potentially being approved in the USA in 2019.

“Following the licensing agreement we signed with Norgine in September for the commercialisation of Feraccru in Europe, Australia and New Zealand, we are well-funded and are increasingly excited about Feraccru's future.”

House broker Liberum sees the US opportunity for Feraccru to be at least as large as Europe, which means £90m, assuming a 65% chance of approval. 

Shield is valued at just £39mln, which still reflects the fall-out following the disappointing data for Feraccru from the phase III trial in March.

Discussions with the FDA followed that trial, which allowed it still to file for approval in the US.

Liberum adds that the cash received from Norgine gives shield 12 months of runway, which should cover the potential approval of Feraccru in the US, the results of the head-to-head study between Feraccru and intravenous iron due in the first quarter of 2019 and also a broader launch by Norgine of Feraccru in Europe. 

“The potential for US approval and the potential for a positive read-out from the head-to-head study due in Q1 2019 are being ignored,” believes the broker.

A target price of 80p implies that European sales of Feraccru peak at £100m, which reflects the recent setbacks though this valuation contains nothing for either the US or rest of the world, Liberum added.

Shares dropped 1% to 33.5p.

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Mon, 03 Dec 2018 08:37:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/210378/shield-therapeutics--feraccru-to-be-considered-for-us-market-by-the-fda-210378.html
<![CDATA[RNS press release - New Drug Application for Feraccru® ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181203070008_13887987/ Mon, 03 Dec 2018 07:00:08 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181203070008_13887987/ <![CDATA[Media files - Shield Therapeutics sees big opportunities for its iron deficiency treatment Feraccru ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11365/shield-therapeutics-sees-big-opportunities-for-its-iron-deficiency-treatment-feraccru-11365.html Thu, 29 Nov 2018 11:33:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11365/shield-therapeutics-sees-big-opportunities-for-its-iron-deficiency-treatment-feraccru-11365.html <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181109154623_13862263/ Fri, 09 Nov 2018 15:46:23 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181109154623_13862263/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181108182109_13860819/ Thu, 08 Nov 2018 18:21:09 +0000 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181108182109_13860819/ <![CDATA[RNS press release - Notification Of Major Holdings ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181001135409_13811521/ Mon, 01 Oct 2018 13:54:09 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181001135409_13811521/ <![CDATA[RNS press release - Submission of an NDA for Feraccru® with the FDA ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181001070005_13810092/ Mon, 01 Oct 2018 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20181001070005_13810092/ <![CDATA[RNS press release - Director/PDMR Shareholding ]]> https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20180924130635_13802120/ Mon, 24 Sep 2018 13:06:35 +0100 https://www.proactiveinvestors.co.uk/companies/rns/15670/LSE20180924130635_13802120/