Dealings in Clinigen shares are expected to commence on AIM at 8.00am on Tuesday 25 September 2012, under the ticker symbol CLIN





Clinigen is a rapidly-growing specialty pharmaceutical and services company, with one clear aim: to deliver the right drug to the right patient at the right time.




To achieve our aim, we have built a group of complementary businesses which can operate efficiently in a complex global regulatory environment and which can ensure that precious medicines are delivered securely and effectively, wherever they are needed. Through three businesses, Clinigen SP, Clinigen GAP, and Clinigen CTS, we acquire, license and revitalise niche, hospital-only critical care medicines, and source and supply our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials.





Clinigen Clinical Trials Supply (CTS):

We use our global expertise, systems and relationships to source and manage the supply of commercial medicines to pharmaceutical companies for use exclusively in clinical trials. This requires excellent knowledge of the global pharmaceutical market, the regulatory processes and customs authorities of countries all over the world, along with a high tech supply chain with guaranteed quality and safety standards that can deliver swiftly.

Clinigen Global Access Programs (GAP):

On behalf of pharmaceutical and biotech companies, we manage essential programs that provide access to critical medicines for physicians and their patients all over the world. But what is a Global Access Program? Known by many terms from ‘expanded access’ and ‘named patient’ to ‘compassionate use’ and ‘early access’, a global access program enables physicians to access treatments that are not available in their own country for patients with an unmet medical need. Wherever they are, we can deliver treatments quickly, efficiently and, most importantly, ethically.

Clinigen Specialty Pharmaceuticals (SP):

We acquire niche medicines that don’t fit into the portfolio of larger pharmaceutical companies. These are typically hospital-only treatments for rare or life-threatening diseases, and we specialise in revitalising them – finding new treatment areas; new markets where we can get them licensed; or, potentially, new formulations. All the while, we’re ensuring that patients already using the medicine continue to get the treatment they need, while the company whose product we have acquired can feel confident that its reputation is being well looked after.

We are currently 100+ people, headquartered in Burton-on-Trent in the UK, with facilities in Philadelphia, US, and Tokyo, Japan, and an office in London. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while doctors and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.




http://www.clinigen.co.uk/

First of the Brokers......

24 Sep 2014 Clinigen Group CLIN N+1 Singer Buy 466.00 456.00 488.00 488.00 Retains

24 Sep 2014 Clinigen Group CLIN Numis Buy 465.50 456.00 650.00 650.00 Reiterates

650p SP TARGET

24 Sep 2014 Clinigen Group CLIN Oriel Securities Buy 463.50 456.00 650.00 650.00 Reiterates

SP target 650p

Peel Hunt few days ago, buy tp 710p

I.C. today

Clinigen still clinical
When drugs fail to obtain licenses or are pulled off the market, clinicians can miss out on vital elements of medical treatment. Clinigen (CLIN) fills this gap, acquiring, revitalising and then distributing the drugs. This focus helped it record a 20 per cent rise in underlying cash profits for the year to June.
Sales at Clinigen’s key clinical trials supply division fell 5 per cent to £84m, reflecting a one-off bump in antiviral sales in 2013. But it did record a 45 per cent increase in supply requests, as the company widened its market share, so sales should rebound. It also signed an exclusive supply agreement for an oncology drug with an international pharmaceutical company.
Clinigen’s specialty pharmaceuticals division grew its product range by acquiring Savene and Ethyol, two oncology support products. That should help to compensate for slowing sales of Foscavir now its revitalisation is largely complete. Clinigen also convinced European regulators to lift the suspension order on its injectable antibiotic Vibativ, which combats hospital-acquired pneumonia.
Meanwhile, sales surged by more than half at its global access programs segment, as it shipped 58,000 drug units – up 87 per cent – to over 75 countries. The division also added AstraZeneca (AZN) and Eisai to its client list.
Broker Numis Securities expects pre-tax profit of £29m, giving EPS of 26.1p, rising to £35m and 31.6p in 2015-16.
C Clinigen’s growing product range and diversified business model should serve investors well. Its shares trade at 18 times forecast earnings – a discount to the sector average of 21. We reiterate our buy tip. TM

Clinigen Group plc Receives FDA Award

RNS


RNS Number : 8240S

Clinigen Group plc

29 September 2014












Clinigen Group plc Receives FDA's First Ever Drug Shortage Assistance Award



Burton-on-Trent, UK - 29 September 2014 - Clinigen Group plc ('Clinigen' or the 'Group', AIM:CLIN) the global specialty pharmaceutical company, today announces that it has received the first Drug Shortage Assistance Award from the US Food and Drug Administration (FDA) in recognition of its contribution in addressing a US shortage of Foscavir® (foscarnet sodium) injection.



Clinigen's efforts related to the US shortage included making Foscavir® available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records. These actions by Clinigen resolved a critical drug shortage affecting patients.



This award also recognizes companies for their commitment to public health, as well as to quality manufacturing and is the first time the award has been made by the FDA.



Peter George, Chief Executive Officer, Clinigen Group, said: "To be the recipient of this new award from the FDA is a great honor and absolutely reflects Clinigen's mission to ensure that the right drug reaches the right patient at the right time. Since acquiring Foscavir® from AstraZeneca in 2010, we have worked hard to expand the indications and markets for the drug to increase the number of patients who can benefit. It is a real compliment that the FDA is committed to working with companies, like Clinigen, to prevent and mitigate drug shortages."



Drug shortages pose a substantial public health threat, delaying, and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent over 280 drug shortages in 2012 and 170 in 2013. There were 44 new drug shortages in 2013, down from 117 new drug shortages in 2012. Two key prevention strategies have helped drive this significant decrease in new shortages: 1) early notification and 2) a focus on quality manufacturing.



- Ends -

Ex dividend Thurs 16 Oct 2.1p

Jim Slater: Escape death taxes with my perfect portfolio of shares

Shares listed on the Aim market are exempt from inheritance tax. Our expert stock picker Jim Slater names three of the best


My next recommendation for your IHT-friendly portfolio is Clinigen Group at 507p. This speciality global pharmaceuticals company, headquartered in Britain and with offices in America and Japan, floated on the stock market in late 2012.

Since then, with the help of astute acquisitions and organic growth, the company has performed very well – profits have risen from 8.7p per share in 2012 to a predicted 26p for 2015.

The group has three main divisions, one of which, “global access programs”, has signed significant contracts with two leading companies, AstraZeneca and Boehringer Ingelheim, and seen its sales rise by 54pc last year.

However, what interests me now is that the main focus of the Clinigen story is shifting to the “speciality pharma” division, which makes high gross profit margins and has developed from one product at the time of the flotation to five products today, with more planned. Two of its products are in “anti-infectives” and three are in oncology support.

In particular, two of the latter, Cardioxane and Ethyol, have strong potential for revitalisation – although before I get carried away I must confess that, even though my wife tells me I am a bit of a hypochondriac, I am not an expert on drugs.

I am therefore happy to rely on the enthusiasm of the stockbrokers’ technical analysts who follow Clinigen and their favourable view of the company’s drugs portfolio.

Now for the numbers. According to brokers Numis, Clinigen’s estimated p/e ratio for next year is about 19.5, falling to about 16 in 2016 and then to 13.3. Numis expects profit growth percentages in the 20s in 2016 and 2017 with further acquisitions adding “incremental upside” to give a forward Peg ratio of just under 1.

Both brokers make the point that the company is acquisitive, produces very strong cash flows and has a substantial amount of cash in the bank, so they confidently expect more acquisitions.

Certainly Numis and Peel Hunt have high hopes for its future, with price targets of 650p for Numis and 717p for Peel Hunt. The three other brokers that cover Clinigen also rate the shares as a “strong buy”.

During recent market weakness – last month’s “flash crash” – I managed to buy more than £1.5m worth of Clinigen shares at an average price of about 470p.

However, I should warn you that the market in them can be narrow at times, so if you decide to buy I suggest that you set a firm limit with your broker and if necessary be prepared to wait a few days for your order to be filled.





http://www.telegraph.co.uk/finance/personalfinance/investing/shares-and-stock-tips/11217454/Jim-Slater-Escape-inheritance-tax-with-my-perfect-portfolio-of-shares.html

Signal Update

Our system’s recommendation today is to STAY LONG. The previous BUY signal was issued on 04/11/2014, 14 days ago, when the stock price was 480.5000. Since then CLIN.L has risen by +13.84%.

Market Outlook

The market is uncertain with a negative tilt. The traders seem to be in disagreement. The negative sentiment, however, is increasing as evident from the last bearish pattern. So, it is better to be on alert.


http://www.britishbulls.com/SignalPage.aspx?lang=en&Ticker=CLIN.L

Half year trading update
RNS
RNS Number : 2048C
Clinigen Group plc
15 January 2015



Half year trading update

Burton-on-Trent, UK - 15 January 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the specialty global pharmaceutical company, today provides a half year update for the six months ended
31 December 2014.



The Group continues to perform strongly, in line with the Board's expectations:

· Revenues at £72.6m are up 17% on H1 FY14 (21% on a constant exchange rate basis)

· Gross profit is up 11%, with overall margins at 30%

· Net cash has more than doubled to £12.9m from £5.3m at 30 June 2014



Revenue growth over the period has been driven by a combination of significant organic and new customer growth in CTS - demonstrating the progress of Clinigen CTS towards global leadership - with the additional contribution from new product acquisitions within Clinigen SP (Savene and Ethyol). Also within SP, Foscavir in-market sales are up 5%, in line with disease treatment activity.



The Group's CTS activity measures: growth in current customers, number of customers, number of products shipped and the sales pipeline, all continue to grow.



The number of units shipped by GAP, the primary measure of growth in that business, continues to increase and a number of new programs will go live in Q3 FY15. H1 FY15 GAP revenues were, as expected, affected by the closure of the French Enzalutamide program, but this also led to an improvement in gross margin, returning to expected 40% levels from H1 FY14 at 28%.



The Group continues to evaluate new opportunities for both product acquisitions and global expansion.



Peter George, Chief Executive Officer, Clinigen Group said,



"I am really proud of the team's first half performance; all three operating businesses have contributed to strong trading. I am particularly pleased with the CTS performance and the early contributions from new product acquisitions.



"The integration of the new products acquired in FY14 and H1 FY15 continues on track and I expect the current investment in the revitalization plans to start to have a positive impact during FY16.



"This strong half year performance is in line with the Board's expectations and puts us in a good position to meet our full year targets."

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UPDATE - Clinigen first half revenues up 17%, boosted by clinical trials supply arm and new products

By Ian Lyall

January 15 2015, 11:41am
Clinigen said the financials were in line with expectations, leaving the business on track to meet full-year forecasts.
Clinigen said the financials were in line with expectations, leaving the business on track to meet full-year forecasts.


Clinigen (LON:CLIN) said it performed strongly in the first half of its financial year as its clinical trials supply business (CTS) cemented its place as a global leader in the sector.

The specialty pharma group’s trading in the six months to the end of last year was also boosted by the contribution from new additions to the portfolio, and two in particular: oncology products Savene and Ethyol.

Revenues rose 17% year-on-year to almost £73mln; gross profit was up 11%, margins ahead 30% and net cash more than doubled at £12.9mln.

Clinigen said the financials were in line with expectations, leaving the business on track to meet full-year forecasts.

Chief executive Peter George told investors: "I am really proud of the team's first half performance; all three operating businesses have contributed to strong trading.

“I am particularly pleased with the CTS performance and the early contributions from new product acquisitions.”

George added that the integration of the new products acquired recently is “on track” and the current investment in revitalising them will have a “positive impact” next financial year.

Analysts at Peel Hunt said the overall result appears slightly ahead at the top line, at a lower gross margin, with the result in line at the gross profit level.

“With cash now mounting on the balance sheet, the firepower to add to the portfolio is there with the ambition to accelerate Clinigen’s global footprint growing,” added the broker.

Peel Hunt has a 717p share price target.

Shares are currently trading at 495p.

22 Jan Clinigen Group N+1 Singer Buy 492.63 500.00 549.00 Retains

Jim Slater -

Clinigen’s half-year trading update in January confirmed that the company had been performing strongly, with revenues up by 17pc, gross profit up by 11pc and cash more than doubled to £12.9m. Peter George, the chief executive, said: “This strong performance is in line with the board’s expectations and puts us in a good position to meet our full-year targets.”

Peel Hunt has Clinigen as another of its top growth picks for 2015, with a juicy target price of 717p. Like me, Peel Hunt looks forward to the day when Clinigen deploys its cash and £35m debt facility to add to the global footprint of its growing pharmaceuticals portfolio. With this exciting prospect in mind, I bought a few more shares at 500p.





http://www.telegraph.co.uk/finance/personalfinance/investing/shares-and-stock-tips/11376838/Jim-Slater-two-more-IHT-free-Aim-shares-to-add-to-your-portfolio.html

3 Feb Investec 546.00 Hold

Clinigen to Manage GAP Program for AZ's CAZ-AVI
RNS
RNS Number : 6030E
Clinigen Group plc
11 February 2015



Clinigen appointed by AstraZeneca to Manage International Global Access Program for New Combination Antibiotic, CAZ-AVI

Burton-on-Trent, UK - 11 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN) announced today the initiation of an international global access program for AstraZeneca's investigational antibiotic, CAZ-AVI (ceftazidame-avibactam), through its specialist Clinigen GAP division.

CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming resistant to antibiotics and pose an increasing risk to public health. It is being investigated as a new treatment option for patients with g complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs) and nosocomial pneumonia. Complicated urinary tract and intra-abdominal infections are often attributed to drug-resistant bacteria. Gram-negative bacteria such as Escherichia coli (E. coli) are particularly adaptive. E.coli commonly causes urinary tract infections affecting nearly three million people per year and has become resistant to an increasing number of antibiotics. cIAI is an important cause of morbidity and mortality, and is the second most identified cause of severe sepsis in intensive care units.

The program is the first for Clinigen GAP with AstraZeneca and will provide access to CAZ-AVI to eligible patients for all countries world-wide with the exception of the US and Canada.

Healthcare Professionals will be able to request the drug for patients who have no other licensed therapeutic alternatives.

CAZ-AVI consists of ceftazidime, a well-established third generation injectable cephalosporin antimicrobial agent, and avibactam, a next generation non-beta lactam beta-lactamase inhibitor. Increasingly, infections have reduced the activity of ceftazidime. However, the addition of avibactam protects ceftazidime from breakdown, restoring the activity and enabling CAZ-AVI to better meet current and future needs for tackling serious gram-negative infections. CAZ-AVI has been granted a Qualified Infectious Disease product (QIDP) designation by the USA FDA which enables priority review and fast track status.

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "I am very pleased to announce the launch of this first program for AstraZeneca, further strengthening the relationship with Clinigen. We now work with AstraZeneca across all our operating businesses. The continued growth within Clinigen GAP demonstrates the increasing need for early access to drugs in areas of critical unmet need."

Mark Corbett, Senior Vice President, Clinigen GAP said, "The war on antimicrobial resistance relies on the development of novel and improved therapies effective against serious infections, such as CAZ-AVI. We are pleased to be able to use our experience in the provision of international access programs to supply patients with what could be a very important drug. We look forward to working with AstraZeneca to provide access to CAZ-AVI and meeting this area of unmet need."

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11 Feb Oriel... 650.00 Buy
11 Feb N+1 Singer 549.00 Buy

Clinigen’s Corbett says more to come after AstraZeneca alliance

http://www.proactiveinvestors.co.uk/companies/stocktube/3469/clinigens-corbett-says-more-to-come-after-astrazeneca-alliance-3469.html

Clinigen GAP to Manage Raptor's PROCYSBI Program
RNS
RNS Number : 1615F
Clinigen Group plc
18 February 2015



Clinigen Group Adds New Named Patient Program to
Global Access Portfolio

Burton-on-Trent, UK - 18 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM:CLIN) announces the latest program to be managed by Clinigen Global Access Programs (Clinigen GAP). The program will provide access to Raptor Pharmaceuticals Corp.'s PROCYSBI® (cysteamine bitartrate) for individual patients with nephropathic cystinosis. Through the program PROCYSBI® will be available worldwide, except for the USA where the drug is already commercially available, LATAM and a small number of European territories.

Nephropathic cystinosis is a rare, inherited condition caused by a build up of cystine that affects every cell in the body. Without treatment, patients can suffer from kidney and eye problems and eventually severe and irreversible damage to the heart, central nervous system and muscles. Approximately 2,000 people worldwide are currently diagnosed with the disorder1.

PROCYSBI® is a delayed-release form of cysteamine bitartrate that can be used to manage cystinosis by continually reducing the toxic levels of cystine in the cells. This can help to prevent cellular damage and delay the progression of cystinosis and its complications.

Mark Corbett, Senior Vice President, Clinigen GAP said: "Nephropathic cystinosis is a serious, progressive disease and the initiation of this program for PROCYSBI® is a key step in getting an important new therapeutic option to patients with limited treatment options. We are very proud that Raptor have selected Clinigen GAP as their partner to manage this global access program. We are able to utilize our extensive international expertise in project management, regulatory advice and logistics in order to ensure Raptor can effectively address this area of unmet medical need."

1Gahl WA, Kuehl EM, Iwata F, Lindblad A, Kaiser-Kupfer MI. Corneal crystals in nephropathic cystinosis: natural history and treatment with cysteamine eyedrops. Mol Genet Metab. 2000;71:100-120.

- Ends -

18 Feb Oriel... 650.00 Buy
18 Feb N+1 Singer 549.00 Buy
/////////////////////////////////////////////////////////////////////////////////////////////////


UPDATE - Clinigen drug access programme gaining traction with second deal in a week

By Ian Lyall

February 18 2015, 1:26pm
This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.
This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.


---ADDS SHARE PRICE AND BROKER COMMENT---

Speciality pharma group Clinigen (LON:CLIN) is gaining significant traction for its global access programme, which provides patients with the opportunity to receive drugs not yet on the market.

This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.

This is a rare inherited condition, affecting 2,000 people worldwide, and is caused by the build-up of an amino acid called cysteine.

Untreated it can lead to kidney and eye problems and eventually severe and irreversible damage to the heart, central nervous system and muscles.

Clinigen will run its global access programme outside the US and a number of other territories where the drug already has full regulatory approval.

"Nephropathic cystinosis is a serious, progressive disease and the initiation of this programme for PROCYSBI is a key step in getting an important new therapeutic option to patients with limited treatment options,” said Mark Corbett, senior vice president of Clinigen GAP.

“We are very proud that Raptor have selected Clinigen GAP as their partner to manage this global access programme.

“We are able to utilise our extensive international expertise in project management, regulatory advice and logistics in order to ensure Raptor can effectively address this area of unmet medical need."

Last week Clinigen said had been appointed by AstraZeneca to manage a global access programme for its new antibiotic.

The Anglo-Swedish pharma giant is developing ceftazidame-avibactam, or CAZ-AVI for short, to combat drug-resistant Gram-negative bacterial infections.

It is still under investigation by scientists assessing its potential to tackle these tough-to-treat infections.

However, the Clinigen-run programme will offer certain patients with complicated urinary tract infections, complicated intra-abdominal infections and nosocomial pneumonia the opportunity to access the next-generation antibiotic.

It is the first time it has managed such an operation for AstraZeneca.

The shares, up 35% in the past six months, marked time at 537p.

Oriel Securities pointed out the stock trades at a discount to its peers while having “superior” growth prospects at it repeated its ‘buy’ advice.

Also a ‘buyer’ of the stock is N+1 Singer, whose analyst Elizabeth Klein said:

“This is the second win for the Clinigen GAP business in a few weeks, and we expect more business wins over the rest of this year.

Clinigen Signs Distribution Agreement with MSD
RNS
RNS Number : 0338G
Clinigen Group plc
27 February 2015



Clinigen Group Signs Distribution Agreement with MSD UK for Clinical Trial Supply Services

MSD Products Further Strengthen Clinigen's Clinical Trial Supply Services

Burton-on-Trent, UK - 27 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN) today announces that its Clinical Trials Supply business (Clinigen CTS) has entered into an agreement with Merck Sharp & Dohme Limited ('MSD'), to distribute their human health products for use in clinical trials carried out in Europe. This agreement now represents the fourth arrangement Clinigen CTS has with manufacturers to distribute products.

Under the terms of the agreement, Clinigen CTS will be a preferred distributor and manage enquiries, order receipts and distribution of MSD's products to manufacturers, contract research organizations (CROs), clinical trial contract packagers and other specialist service providers looking to source pharmaceutical products as comparators, rescue and adjunctive drugs for use in clinical trials.

Steve Glass, Senior Vice President Clinigen CTS said: "The addition of this agreement further strengthens our position within the clinical trial supply market as we continue on our path to become the no.1 global clinical trial supply service provider."

- Ends -

About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering 'the right drug, to the right patient at the right time', has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen CTS sources commercial medical products for use in clinical studies only. These include comparator drugs, where existing medical treatments are used as benchmarks to assess the effectiveness of investigative products, adjuvant drugs, which improve the effectiveness of the product being trialed, and rescue therapies, which help patients who have experienced a worsening of symptoms or insufficient therapeutic benefit during a trial.

For more information, please visit www.clinigengroup.com