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/

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 604.50. Over this period, the share price is up 201.51%.

:-))

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 607.50. Over this period, the share price is up 205.28%.

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 613.00. Over this period, the share price is up 172.87%.

IC today - Success of drug and consultancy divisions are powering ongoing upgrades.

Good positive start to 2014

Edison today - Valuation: Organic growth deserves a premium
We value Clinigen using a combination of earnings-based metrics (P/E and EV/EBITDA), PEG ratio and a DCF valuation. These suggest Clinigen is worth £564m (683p a share) using P/E and £570m (690p a share) on EV/EBITDA. Once the higher growth prospects are factored in, the PEG ratio analysis suggests a value of £650m (785p a share). The DCF-based method, based on conservative assumptions, yields a valuation of £575.6m (688p a share).

Clinigen to provide Vibativ in Europe

RNS


RNS Number : 1338X

Clinigen Group plc

08 January 2014






Clinigen Group to Provide VIBATIV® to Patients with Hospital-Acquired Bacterial Pneumonia in Europe via Access Program


Burton-on-Trent, UK - 8 January 2014 - Clinigen Group plc (AIM: CLIN) today announced the initiation of an early access program, managed by Clinigen Global Access Programs (Clinigen GAP), to provide the anti-bacterial VIBATIV® (telavancin) to patients in Europe with hospital-acquired bacterial pneumonia (HAP) known or suspected to be caused by MRSA. HAP is an area of considerable unmet need; for the first time VIBATIV® will be available to physicians in Europe to treat eligible patients on an individual named patient basis.

In March 2013 Clinigen in-licensed VIBATIV® into its Specialty Pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialization in Europe. Although the product had been approved in Europe in 2011 by the European Commission, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug was not launched into the market and therefore has never previously been available in Europe. With the technical transfer to a new contract manufacturer completed by Theravance, Clinigen is working closely with the European Medicines Agency (EMA) to remove the Marketing Authorization suspension and to make the product commercially available in 2014.

Clinigen SP has drawn on the Group's unique business model, enabling it to provide early access to VIBATIV® utilizing its dedicated Global Access Programs business, Clinigen GAP. With the time between a patient contracting pneumonia and receiving VIBATIV® a critical factor, Clinigen will use its comprehensive European logistics network to ensure that the drug reaches patients swiftly, providing 24/7 access to the drug for individual named patients.

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "VIBATIV® is a drug that can be used when other alternatives for HAP are not suitable. Our ability to provide access to VIBATIV® on a named patient basis addresses a key unmet need and could make a huge difference to critically ill patients. While we are working with the EMA to lift the Marketing Authorization suspension for VIBATIV®, the Group is able to respond to unmet medical need and provide access to this drug through our Clinigen GAP division."

Mark Corbett, Senior Vice President, Clinigen GAP added: ''We are pleased to be able to implement an access program for the newest of Clinigen's portfolio products, as we already do for Foscavir® and Cardioxane® in markets where they are not commercially available, in addition to the 30+ other programs we are already managing for other leading pharmaceutical and biotech companies."

Clinigen GAP will continue to provide access to VIBATIV® via an access program on a named patient basis until Marketing Authorization is restored across the European markets. For information or enquiries about the access program contact Clinigen GAP:

Clinigen European green light to use VIBATIV on hospital-acquired bacterial pneumonia

By Ian Lyall

January 08 2014, 8:19am
Known or suspected to be caused by MRSA, HAP is an area of considerable unmet need.


Speciality pharma group Clinigen (LON:CLIN) said Wednesday that its Global Access Programs arm will provide the anti-bacterial VIBATIV to patients in Europe with hospital-acquired bacterial pneumonia (HAP).

Known or suspected to be caused by MRSA, HAP is an area of considerable unmet need, and for the first time VIBATIV, in-licensed from Theravance last March, will be available to physicians in Europe to treat patients on an individual named patient basis.

Clinigen’s Global Access business will also supply life-saving products in markets where a company doesn’t have a presence but where there is demand, or where a treatment has been discontinued but is still relied on by certain patients.

It also provides access to drugs that are still in clinical trials but are showing encouraging signs of efficacy to patients who are very ill and not responding to current treatments.

The company’s chief operating officer Shaun Chilton said: "VIBATI is a drug that can be used when other alternatives for HAP are not suitable.

“Our ability to provide access to VIBATIV on a named patient basis addresses a key unmet need and could make a huge difference to critically ill patients.”

Notice of Interim Results Date

RNS


RNS Number : 2220X

Clinigen Group plc

09 January 2014






Clinigen Group plc

Notification of Interim Results Date

Burton-on-Trent, UK - 9 January 2014 - Clinigen Group plc (AIM: CLIN), the global specialty pharmaceuticals and services company, will announce its interim results for the six months ended 31 December 2013 on Wednesday, 26 February 2014.

A group analyst briefing will be held at 09:30am GMT on Wednesday, 26 February 2014 at the Group's London offices at 1 King Street, London EC2V 8AU. Analysts who wish to participate should contact College Hill on +44 (0)20 7457 2020 or email Clinigen@CollegeHill.com to register

Clinigen Extends Accord Agreement to Capecitabine

RNS


RNS Number : 5537X

Clinigen Group plc

14 January 2014






Clinigen Group Extends Exclusive Agreement with Accord Healthcare to Supply Anti-Cancer Drug Capecitabine into Clinical Trials in Europe



Burton-on-Trent, UK - 14 January 2014 - Clinigen Group plc (AIM: CLIN) today announced that its Clinical Trials Supply business (Clinigen CTS) has extended its exclusive European Union (EU) clinical trial distribution agreement with Accord Healthcare ('Accord'), a wholly-owned marketing subsidiary of Intas Pharmaceuticals, to include capecitabine, an orally administered chemotherapeutic tablet.

Accord's capecitabine tablet adds to the company's EU portfolio of more than 15 injectable oncology drugs, including cisplatin, cytarabine, docetaxel, doxorubicin and fluorouracil currently distributed by Clinigen CTS to manufacturers, CROs, clinical re-packagers, and other specialist providers for use as comparator, co-therapy, rescue and adjunctive drugs in clinical trials. In June 2013 Clinigen CTS renewed its agreement with Accord to supply these products for a further two years and is the sole point of contact for all clinical trial supply enquiries and orders.

The Capecitabine Accord tablet, which is a hybrid generic version of Xeloda®, is available in a new strength of 300mg in addition to existing strengths of 150mg and 500mg. It was launched in Europe, a market worth almost US$400 million, in December 2013. The chemotherapeutic is indicated for the treatment of a range of cancers including breast, colon, rectum and stomach and can be used in combination with other oncology products from the Accord portfolio supplied by Clinigen CTS.

"Capecitabine is a key product for Accord," said Daniel Green, Hospital Director UK & Ireland at Accord. "We see clinical trials as an important area into which we can supply the drug and extending our exclusive agreement with Clinigen will allow us to maximize the impact and potential of the product in this area. The partnership is working well and we believe that the addition of capecitabine will serve to develop it further."

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "The extension of our exclusive agreement with Accord to include capecitabine is confirmation of the strength of our clinical trials supply business and the partnership we have built with Accord. We pride ourselves on the quality of our service and delivery capabilities and are pleased that Accord has chosen us to manage the distribution of another important product."

- Ends -

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 690.00. Over this period, the share price is up 217.49%.

Strong gains today, going great guns. Let this one run I think.

Interim results for 6 months end 31 December 2013

RNS


RNS Number : 9228A

Clinigen Group plc

26 February 2014






Clinigen Group plc

Half year results for the six months ended 31 December 2013

Underlying half year pre-tax profits up 12% at £10.9m, underlying EBITDA up 20% at £12.5m

Burton-on-Trent, UK - 26 February 2014 - Clinigen Group plc (AIM: CLIN, Clinigen or the Group), the global specialty pharmaceuticals and pharmaceutical services business, has today published its half year results for the six months ended 31 December 2013.



Financial highlights

- Group revenue of £61.8m (H1FY13: £61.0m); like for like* sales up 6.5%

- Underlying** EBITDA up 20% to £12.5m (H1FY13: £10.5m)

- Underlying** pre-tax profit 12% higher at £10.9m (H1FY13: £9.7m)

- Reported pre-tax profit of £9.6m (H1FY13: £3.7m)

- Underlying earnings per share*** up 7.8% to 9.7p (H1FY13: 9.0p)

- Reported earnings per share of 8.7p (H1FY13: 3.5p)

- Interim dividend of 1.0p per share (H1FY13: 0.6p per share)

- Cash and cash equivalents of £16.8m at 31 December 2013 (30 June 2013: £11.3m)



Business highlights

- CTS: margins improved through better supplier terms. Post period end, exclusive agreement with Accord Healthcare extended to supply capecitabine in Europe

- GAP: large GAP programs running as planned, with new access programs signed up with Eisai for Fycompa® and a third program for BTG for uridine triacetate

- SP: integration of Cardioxane® and Vibativ® on track



* H1FY13 included circa £3m of Foscavir stock fill for the US market which has been adjusted to give like-for-like sales

**Underlying earnings excludes share based payments and one off exceptional costs in FY13 arising as a result of the IPO

***Underlying EPS excludes share based payments and one off exceptional costs and is based on the weighted average number of shares in issue post IPO



Peter George, Chief Executive Officer, said:

"Our focus on value creation has resulted in another strong financial performance.

"We are particularly pleased with the gross profit improvement in the CTS business and that we continue to add new customers.

"GAP continues to go from strength to strength, and our growing reputation is attracting not only important new clients such as Eisai but also returning customers like BTG.

"In SP, the integration of our new products Cardioxane and Vibativ is going well with some of the commercial activities ahead of plan, and Foscavir sales, as expected, are levelling out. Acquisitions for SP are a priority and our activity in this area is high; we are confident we will add further to our portfolio in CY2014.

"In summary, a good start to FY14, with full year expectations on track."

-Ends-

Having already taken half my profit it's very tempting now to be topping up imo.

Clinigen: Numis increases target price from 485p to 620p, but downgrades from buy to hold. Investec ups target price from 469p to 560p, while downgrading from hold to sell.

UPDATE - Clinigen first half earnings rise 20%; investors given a dividend boost

By Ian Lyall

February 26 2014, 2:33pm
The group, whose main business clinical trial supply (CTS), made two key bolt-on buys in the period and said acquisitions remain very firmly on the agenda.


--adds broker comment--




The speciality pharma and pharmaceutical services group Clingen (LON:CLIN) revealed itself to be in rudefinancial health, posting a 20% rise in underlying first half earnings.




The group, whose main business clinical trial supply (CTS), made two key bolt-on buys in the period and said acquisitions remain very firmly on the agenda.




The integration of Cardioxane, a cancer support treatment and Vibativ, for hospital acquired pneumonia, is on track, it added.




“Acquisitions remain a key priority, with the aim of acquiring a further five to seven products over the next three to five years whilst simultaneously ensuring proper integration of new products and newaccounts ,” the group told investors.




Results for the six months to the end of December revealed a 6.5% rise in sales to £61.8mln, which translated to a 20% increase in earnings before interest tax , depreciation and amortisation (EBITDA) to £12.5mln.




Underlying pretax profits were £10.9mln, for a rise of 12%. Confidence was shown in the outlook with a 1p a share interim dividend – up two-thirds on the same time last year.




The group remains on a strong financial footing with £16.8mln of cash.




Clinigen said profit margins from its main CTS business had improved as the result of better supplier terms.

Meanwhile, its global access programmes (GAP) arm, which gains patients access to pre-launch and pre-licence drugs, is “running as planned”. Speciality pharma was boosted by sales of Cardioxane.




Two brokers upgraded their price targets following the interims.




House Peel Hunt said the first half was strong overall though illustrated the lumpy nature of CTS and GAP. The broker added it still sees lots of potential to leverage the Clinigen platform further through additional bolt-ons, which are key catalysts for further upgrades.




Its new 12-month target price is 700p (490p), reflecting "clear distance deserved between Clinigen and lower growing healthcare names such as Dechra and Consort".




Numis raised its target to 620p, adding the rapid growth in profit from the service businesses, coupled with diversification within Specialty Pharmaceuticals, continues to mitigate Foscavir risk.




After the strong run for the shares ahead of the interims, its rating is now ‘hold’.

New buy recs, Peel Hunt tp 700p and Oriel Securities tp 610p. Oversold if you ask me and topped up.

Thinking the same, oversold.

They also have a war chest of cash.