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Clinigen Group plc (CLIN)     

dreamcatcher - 25 Sep 2012 06:58






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/



Chart.aspx?Provider=EODIntra&Code=CLIN&SChart.aspx?Provider=EODIntra&Code=CLIN&S

dreamcatcher - 05 Nov 2013 16:27 - 80 of 300

Even higher now, broken £5.

dreamcatcher - 07 Nov 2013 17:39 - 81 of 300

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 515.00. Over this period, the share price is up 162.40%

dreamcatcher - 07 Nov 2013 23:24 - 82 of 300

In Shares - Pharmaceutical, biotech and medical technology spending driving trend.

Clinigen and Venn Life Sciences are both companies set to benefit from strong growth in the contract research space. The global contract research industry, which provides research services to pharmaceuticals, biotechs and medical technology companies, is set to expand 11.4% a year until 2017.. Based on these growth estimations the market will be worth $43 billion in 2017, up from $25 billion in 2012.
Clinigen , which has operations in Europe, the US, and Japan, has enjoyed phenomenal success since it went public last year (25 Sept 12) This reflects the £396 million caps stellar growth prospects with pre-tax profits set to rise 67% this year to £24.2 million from the £14.5million recorded in the 12 months to July 2013.

goldfinger - 08 Nov 2013 00:48 - 83 of 300

5 to 7 more drugs to be bought over the next 3 to 5 years say the management.

Looks like its got far further to go.

dreamcatcher - 22 Nov 2013 17:34 - 84 of 300

In IC - Game changers . A company with 10 bagger innovations.




Clinigen, which listed on the aim in late 2012 , must count as one of the junior markets best success stories barely a year into its stock market life. The company is a game changer not so much for what it does, which is supply drugs around the world for comparison purposes in clinical trials, but for how it has set up its business model. Simply put, there are hardly any companies in the world that combine both the supply of medicines - this is more of a wholesale function - with pharmaceutical services such regulatory advice and the selling of wholly-owned products.

dreamcatcher - 25 Nov 2013 18:05 - 85 of 300

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 555.00. Over this period, the share price is up 164.39%.


As of Nov 23, 2013, the consensus forecast amongst 5 polled investment analysts covering Clinigen Group PLC advises investors to purchase equity in the company. This has been the consensus forecast since the sentiment of investment analysts improved on Nov 18, 2013. The previous consensus forecast advised that Clinigen Group PLC would outperform the market.

dreamcatcher - 29 Nov 2013 21:53 - 86 of 300

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 564.00. Over this period, the share price is up 175.12%.

In Shares - Consensus expects the company to make £24.2m before tax this year, enough for 22.1p in earnings per share, a figure that leaves the stock on 23.3 times earnings . The 2.6p a share dividend offered to investors in 2013 is expected to grow to 3.3p in the year to June 2014 and 4p in the fiscal 2015.

Chart.aspx?Provider=EODIntra&Code=CLIN&S

dreamcatcher - 05 Dec 2013 16:44 - 87 of 300

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 573.50. Over this period, the share price is up 179.76%.

dreamcatcher - 13 Dec 2013 16:44 - 88 of 300

On Friday, Clinigen Group PLC (CLIN:LSE) closed at 579.50, 0.60% below its 52-week high of 583.00, set on Dec 06, 2013.

dreamcatcher - 19 Dec 2013 15:26 - 89 of 300

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%.

dreamcatcher - 19 Dec 2013 15:51 - 90 of 300

:-))

dreamcatcher - 19 Dec 2013 17:45 - 91 of 300

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%.

dreamcatcher - 02 Jan 2014 16:24 - 92 of 300

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%.

dreamcatcher - 03 Jan 2014 16:41 - 93 of 300

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

dreamcatcher - 06 Jan 2014 15:57 - 94 of 300

Good positive start to 2014

dreamcatcher - 07 Jan 2014 11:07 - 95 of 300

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).

dreamcatcher - 08 Jan 2014 17:40 - 96 of 300


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:

dreamcatcher - 08 Jan 2014 17:48 - 97 of 300

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.”

dreamcatcher - 09 Jan 2014 07:11 - 98 of 300


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

dreamcatcher - 14 Jan 2014 07:13 - 99 of 300


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 -

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