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Dear Readers,
Ha.. ha.. indirectly, it is upgrade from Penny to small cap. stock. So the price might be upgraded as well.
10 to 1 share consolidation, vol trading will definitely drop in future.
Dear Readers,
Yes, I have studied this counter and decide to buy a big lump sum. It has potentiality to climp to several folds within 2 years. Worth watching and buy, buy, buy........
why u so -ve? lost a lot last time? me not vested, dun really like penny.
Self prophecy is a dangerous thing. Go and take a closer examination of their past records will give you a better guide of the Company. In the past they too have very strong Backers.......................and Backouts now!
QUESTION : Why the BIG-INT'L in pharmaceutical businesses are not interested in this GErM?????????????????????????
I am still positive on it, as they have secured strong financial backings now and the last hurdle is to get the EPO approve. Gd luck to all vested.
jamie, you lucky girl. i am vested at 38 cents.
Hope it pick up; I am still suffering a paper loss @ 15.
http://www.pharmaceutical-business-review.com/article_feature.asp?guid=7ACB651F-7842-4E10-861C-CD864E00E9BC
Biogenerics: the battle is only just beginning18th January 2006
By PBR Staff Writer
Biogenerics - also known as biosimilars or follow-on protein products - are set to become the next big battleground between branded pharma and the generics industry. Biological therapeutics such as epoetin are currently huge money-spinners for big pharma and unsurprisingly, generics players want a slice of the action.
'Content Lack of a regulatory pathway led to refusals to approve Sandoz's growth hormone Omnitrope both in the US and EU, but regulatory authorities, particularly in the EU, are now making real progress to enable a first generation of 'biogenerics'.
AdvertisementBiogenerics could be on the market as soon as 2006 in the EU and by 2009 in the US, and biologic products with combined 2004 global sales of $20 billion are currently at risk. However, the nature of biologics virtually rules out exact generic copies, and this simple fact introduces a whole new level of complexity and expense into all stages of biogeneric development and commercialization.
A number of factors are coinciding to make biogenerics a hot topic at the moment: as key patents start to expire on some of the early recombinant protein therapeutics, generics companies' capabilities have also developed sufficiently for them to consider creating their own versions of these off-patent products. At the same time, healthcare spending on ageing populations is rapidly becoming a more urgent priority for governments and consumers alike.
The big attraction
The high cost of biotech drugs makes them prime targets for cost-cutting measures. Global sales of biologics by 56 of the top pharma and biotech companies reached $56.2 billion in 2004, a sharp increase of 18.3% from 2003. In the US alone, sales of biologics reached $30.8 billion in 2004.
Of this global market, $20.2 billion in sales is derived from six key product classes that are at immediate risk from biogenerics: insulin, human growth factor, epoetin, colony stimulating factors (CSFs), interferon alpha and interferon beta. The combined size of this market makes it a tempting target and pressure from generics companies and from governments has driven the development of regulatory pathways.
Regulatory progress
In the EU, the European Commission led the way by creating a legal framework for 'similar biological medicinal products' or biosimilars in 2003. The EMEA has therefore been able to move forward and has already published several draft guidelines, including specific clinical and non-clinical data requirements for four product types: insulin, human growth factor, epoetin and CSFs. Final guidelines and first product approvals could come as early as 2006.
The US is notably lagging behind the EU, with branded opposition exerting a much greater influence and slowing down regulatory reform. US Congress has yet to create legislation for 'follow-on protein products', although this could change soon. The FDA has been unwilling to use the controversial 505(b)(2) pathway to approve 'generic' versions of growth hormone or insulin, and now appears to be waiting for guidance from lawmakers.
A long and winding road is expected for biogenerics in the US, with a first approval possibly in 2009.
Can biogenerics be equivalent?
Arguments between the branded and generic industries have centered around the question of equivalence: if a protein cannot be absolutely characterized, can it be regarded as equivalent to the originator's product, and approved without full clinical trials?
The compromise of a full preclinical data package and relatively small clinical trials (for example, at least 300 people for epoetin) appears to have been accepted in Europe. However, the US branded lobby is campaigning for tighter safety controls, fueling its argument by referencing the problems with red cell aplasia that affected patients taking Johnson & Johnson's Eprex (epoetin) after only a minor change in manufacturing procedure.
Different products, different suitabilities
The safety concerns about biogeneric epoetin are just one example of the greatly differing factors affecting biogeneric versions of each individual product type. Mammalian cell culture (as for epoetin) introduces a further level of complexity to manufacture through varied glycosylation patterns.
Other product-specific factors include the levels of existing competition, the market size, ease of marketing, patent considerations and requirements for advanced delivery methods and devices.
For these various reasons, epoetins, interferon alpha and growth hormones are likely to be key targets for biogenerics, while insulins will be minimally affected. Sales of the six key biogeneric product types are forecast to reach $2.2 billion by 2010 in the US and five major EU markets.
One hugely important factor is the emergence of 'second-generation' branded products such as Aranesp (darbepoetin alpha), the PEGylated products Pegasys and PegIntron (peginterferon alpha) and Neulasta (pegfilgrastim), and insulin analogs. These will rapidly diminish the market for first-generation biogenerics, but could themselves ultimately become targets for the generics players.
Massive barriers to entry
Fundamentally, the barriers to market entry in biogenerics are much higher than for any small molecule generics. Companies face the challenge of higher development costs (due to required clinical testing), greater time in development, quality requirements, as well as demanding and uncertain approval and patent procedures.
As a result, companies will need to move beyond typical generic company strengths. New skills will be required in biotechnology, manufacturing, clinical trials, regulatory compliance, pharmacovigilance testing and marketing. All in all, generics companies will have to create an entirely new business model for biogenerics: in many ways closer to the branded biotech model.
The investment needed to put a biogeneric through the necessary clinical trials will be considerable. The serious financial difficulties encountered at GeneMedix - formerly seen as one of the front-runners of biogenerics - illustrate the great importance of strong financial backing and regulatory expertise.
For these reasons, only a select bunch of top biogeneric players are expected to have the capabilities to make an initial impact on the market. Five key players will be Novartis's Sandoz, Teva, BioPartners, ratiopharm (through its subsidiary BioGenerix) and Stada (through its affiliate Bioceuticals).
Branded firms will not lie down
Despite the interest from would-be biogeneric companies, one absolute certainty in biogenerics is that branded companies will make every effort to protect their franchises. Apart from opposing biogenerics on a legal basis, lifecycle management strategies will include gaining additional patent protection and switching patients to second-generation products or advanced delivery methods.
The feeling is that we have not yet even seen the start of the key confrontations in biogenerics. But as biogenerics products approach the market, the real battles will begin. 'End Intelliext
once they have perfected the epo, u will save a lot when u ever need it in future. drugs getting too expensive nowadays.
When this so called 'geRm' 1st listed in S'pore, there're alot of 'bullish-talks' (now on hindsight, confirmed 'bullsh1t-talks') of how it could perform with big earnings IF their 'bio-inventions' could materialize which the Directors were all very positive. Sad to say that the Directors are stillllll positive but with new approach but same OLD 'inventions'. My feeling is that something have to be wrong for them to get approval.
Maybe now they could get approval in India...............................? This 'geRm' needs a lot of polishing and may run-out-of-cash by next year! And the same OLD STORY repeats again? Cheers!
even though generic drug EPO has huge mkt[>10b], getting approval is a daunting task, it may take longer than anticipated. not vested, maybe 2008 later
I m bought again @ 8.5, now heavy vested and betting it will go up. Last year, they had issues with money and drug getting approval problems and it share price was trading 10-13, now with cash flow problem settled and left the drug approval which is targeted beginning 2008 or earlier. There bound to be risk, no high risk , no high gain.
I see great potential, vested recently @ 8
http://www.digitallook.com/news/rns/1023444-26957/GMX-Schedule_1_-_GeneMedix_plc.html
http://www.digitallook.com/news/rns/1022698-26957/GMX-EGM_Statement.html
| 21-12-06 |
AFX UK Focus | |
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(Adds more detail, comment from chief exec) LONDON (AFX) - Struggling UK biopharmaceutical company GeneMedix PLC said it has agreed a restructuring plan, under which Reliance Life Sciences Pvt Ltd (RLS) will invest up to 32.1 mln stg and it will move to AIM from the Official List of the London Stock Exchange. RLS, an affiliate of India's Reliance Group, will initially invest in GeneMedix via a subscription of 1.168 bln subscription shares to raise 14.6 mln stg, giving it a 74 pct holding in the enlarged share capital of GeneMedix. The second tranche of 17.5 mln stg will be made through a subscription for shares from a five-year warrant representing an additional 1.4 bln shares. In addition, GeneMedix intends to move to AIM and consolidate every 10 of its shares into 1 share. The company said it expects admission to AIM to take place on February 12. Chief executive Julian Attfield commented, "Not only will the significant investment allow GeneMedix to continue to develop its existing portfolio of products at an accelerated pace but will also allow us to bring new biopharmaceutical products under development." GeneMedix added that expenditure has continued to be in line with management's expectations since the last trading update on Nov 28 and that it believes the group's prospects will be enhanced by the completion of the proposed restructuring. newsdesk@afxnews.com vb COPYRIGHT Copyright AFX News Limited 2006. All rights reserved. The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News. AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited | ||
Oh yes...FM 95....only hear the good things!
The main problem is their products couldn't be approved by the Authority and it is very costly to 'redo' the products and hoping for an approval (uncertainty................) - this is happening year after year since 2000. Luckily for me, i didn't buy their story which is too complicated to understand. They're many changes that required very careful consideration. Hopefully IRL could pull some strings in India and at least, get their products approved there or else, it'll be another wasted effort & money. Believe me you, this going-on will take many donkey years and I'm still not sure how long really.......but long enough for me not to want to so to say "take a look"> Just my personal views and you may differ at your own expanse! Cheers!
It surged to a three-week high of $0.10, after it announced a restructuring plan, in which India's Reliance Life Sciences will invest up to 32.1 million pounds.
Reliance Life Services (RLS), an affiliate of India's private sector enterprise firm Reliance Group, will initially subscribe for about 1.2 billion shares in GeneMedix -- which is listed on both the London and Singapore stock exchanges -- to raise 14.6 million pounds, giving it a 74% stake in the company.
GeneMedix will also issue a five-year warrant representing an additional 1.4 billion shares to RLS, which may then pay a further 17.5 million pounds.
"The investment by RLS, subject to the approval of its shareholders, provides a strong route forward for the company and will bring to an end the uncertainties surrounding the funding of our programmes and the company's financial position," Julian Attfield, CEO of GeneMedix, said in a statement on Thursday.
And during this five years, you'd be just watching and hopefully also enjoying a not so cute show of "Roller Coaster Ride".
Maybe invest 10K and 5 years later just like Raffle Education, become a millionaire. Haha...