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/

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.

Exactly, they'll be acquiring more niche treatments that unlike big pharma they can add value to - just like they have been doing.

:-))

Clinigen Announce Vibativ Suspension Lifted

RNS


RNS Number : 5416C

Clinigen Group plc

18 March 2014








Clinigen Group Reports Pan European Lifting of Marketing Authorization Suspension for VIBATIV® (telavancin)

Plans for phased Europe-wide launch starting in Q2 2014

Burton-on-Trent, UK - 18 March 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that the European Commission (EC) has ratified the positive opinion in January 2014 from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) to lift the Europe-wide suspension of Marketing Authorization for VIBATIV® (telavancin).

Clinigen anticipates the commercial launch will begin in the second quarter of 2014 and continue over the next 18 to 24 months as local pricing and reimbursement positions are agreed. In March 2013, Clinigen in-licensed telavancin into its specialty pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialization in Europe.

Telavancin is a bactericidal, once-daily injectable antibacterial agent for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable1.

In 2011 telavancin had been approved in Europe by the EMA. However, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug had not been launched into the market and therefore was never previously available in Europe. Following the technical transfer to a new contract manufacturer, Clinigen has worked closely with the relevant EMA authorities to lift the suspension.

HAP caused by MRSA is an area of considerable unmet need; there is a limited choice of antibiotic therapies available to treat such serious Gram-positive infections and rates of clinical cure are considered to be low2, together with increasing rates of resistance being reported.

"The addition of this novel anti-bacterial to the arsenal of possible therapeutic options for HAP may provide a lifeline for those seriously ill patients who have not responded to previous treatments," said Professor Robert Masterton of the Institute of Healthcare Associated Infection at the University of the West of Scotland and advisor to Clinigen. "Telavancin's safety profile compares well with first line treatment vancomycin and it is highly potent against MRSA including the organisms with reduced susceptibility to vancomycin."

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "The lifting of the suspension is an important step in the phased commercial launch of telavancin throughout Europe. The decision by the EMA follows many hours of work and demonstrates the dedication and expertise of our Specialty Pharmaceuticals team. We are working closely with the contract manufacturer to produce stock to prepare for the launch and beyond."

He added, "In the period before the commercial launch our global access program business, Clinigen GAP, will continue to manage a named patient program in Europe to provide access to telavancin for individual eligible patients via their healthcare professional."

1 Annex I: Summary of Product Characteristics - VIBATIV.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001240/WC500115364.pdf
Accessed: 14 Mar 2014
2 Muscedere J. Which antibiotic for hospital acquired pneumonia caused by MRSA? BMJ 2014;348:g1469

- Ends

Clinigen Group upgraded as broker anticipates deployment of firepower

By John Harrington

March 25 2014, 11:45am
Clinigen has the wherewithal to augment organic growth through selective acquisitions


Investec has upgraded its rating on Clinigen (LON:CLIN) following the recent market correction in the share price of the high-flying pharmaceutical company.

The broker reckons the shares are now a ‘hold’, with the current share price, which is about 30p below the broker’s target price of 560p, reflecting a broadly equal balance of risk and reward for investors.

Observing the “rule of three”, Investec has identified three risks to the stock’s valuation and three upside scenarios.

On the risk side, Investec thinks Clinigen’s clinical trials supply (CTS) business could lose market share if competitors are prepared to sacrifice margin, as customers are not tied to long-term contracts.

Although not an immediate risk, the broker also continues to see risk on the company's key product, Foscavir, whether from generic or branded competitors.

Lastly, while Clinigen’s Global Access Programs (GAP) division has performed well thus far in Investec’s view, it is a relatively new market outside the US with the sort of growth rates that could attract competition.

On the plus side, the CTS division has beaten market expectations in recent years by providing for large ‘one-off’ tenders.

Investec also believes the GAP division “has the potential to deliver earnings upgrades” as it continues to benefit from increased outsourcing by customers.

Meanwhile, Clinigen has the wherewithal to augment organic growth through selective acquisitions.

“Management is keen to make further product acquisitions, which could diversify risk from key product Foscavir and drive growth rates higher in our view. We do not model acquisitions, but, with c.£25mln of cash on the balance sheet by end-FY14E, the company obviously has the firepower to execute,” Investec’s Nicholas Keher asserts.

“As such, we advise waiting for now until either acquisitions can be made that will lower specific risk or the group’s service divisions gain further scale,” Kelleher said.

Clinigen acquires Savene

RNS


RNS Number : 5151D

Clinigen Group plc

31 March 2014






Clinigen Group Acquires Oncology Support Therapy SAVENE®
(dexrazoxane) from SpePharm AG

Acquisition strengthens Clinigen's position in dexrazoxane market

Burton-on-Trent, UK - 31 March 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (LSE: CLIN) (AIM: CLIN) the specialty global pharmaceutical company today announces the acquisition of SAVENE® (dexrazoxane) from SpePharm AG, a majority owned affiliate of Norgine B.V. The Financial terms of the acquisition are not being disclosed.

SAVENE is indicated for the treatment of extravasation in anthracycline chemotherapy in adults. Extravasation occurs when anticancer drugs, normally injected into a vein, leak or are accidentally injected into tissue surrounding the vein where they can cause serious damage. SAVENE is the only authorized treatment of its kind available. Its use within the first six hours of extravasation occurring is crucial and enables affected patients to continue their anticancer treatment.

SAVENE has Orphan Drug status and protection until late 2016 with a worldwide method of use patent until 2020. In 2013 the sales were approximately €3.8million.

Under the terms of the agreement, Clinigen will assume full responsibility for SAVENE's manufacturing, registration, distribution, and commercialization in all markets globally excluding the Americas, Israel and South Africa. In Japan, Clinigen will provide SAVENE through an existing supply and license agreement with Kissei Pharmaceutical Co. Ltd, the marketing authorization holder.

In 2013 the Group also acquired Cardioxane® from Novartis which, like SAVENE, has dexrazoxane as its active substance and is also an oncology support therapy; used to prevent the cardiotoxicity of anthracyclines for patients with advanced and/or metastatic breast cancer. The acquisition of SAVENE allows Clinigen to exploit synergies between the two products.

Peter George, Chief Executive Officer, Clinigen Group, said: "In acquiring both SAVENE and Cardioxane, Clinigen will expand its strategic options in oncology support and consolidate its supply chain. The acquisition was a natural move for us and is in line with our stated strategy to expand our specialty pharmaceuticals portfolio."

David Bryant, Senior Vice President, Clinigen SP, said: "This is the fourth product to be added to our specialty pharmaceuticals portfolio. This acquisition has helped strengthen our position in the oncology support area, adding SAVENE to Cardioxane and Foscavir®. We continue to focus on the acquisition of niche, hospital-only therapies which have the potential to save the lives of critically ill patients."

- Ends -

Clinigen Group: Numis takes target price from 620p to 650p upgrading to buy

Went long again today, its a certainty for a write up in tip sheet SCSW either this sat or the sat after.

Cheers gf.

Think its this saturday DC ill be keeping an eye out on advfn this coming weekend.

Dont have to subscribe just look for the leaks.