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SciClone Pharmaceuticals, Inc. Message Board

a65232389 8 posts  |  Last Activity: Feb 11, 2015 6:17 PM Member since: Sep 24, 2009
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  • is that DC Bead in China is approved only as an embolizing agent, NOT APPROVED to be loaded with and deliver chemotherapeutic drugs like doxorubicin. As just an artery blocker, DC Bead doesn't do anything more, and compared to some a lot less, than other currently marketed and much cheaper devices and products in China. That's why Blobel was so flat-footed when the 'approval' came, because SciClone wasn't prepared at all to market an expensive device for just TAE and not TACE. So Blobel now talks about a "pioneering" effort (as one of the posters said about the Feb 9 presentation) to get doctors to use the DC Bead. There will be a lot of resistance for any physician to risk performing unapproved chemotherapy on a patient. The doctor also would need the collaboration of highly trained hospital pharmacists who are needed to prepare the loading of toxic drug into the DC Beads for each procedure. After seven+ years in the registration process, with how many promises of 'next quarter', this is the best SciClone could get. As is, this product is a non-starter. Of course, promoting a drug or device for 'off label' use is illegal in China as it is in the U.S. and we have been assured frequently by Friedhelm "Zero Tolerance" Blobel that SciClone rigorously follows all applicable laws.

  • Reply to

    Merck drops branded generic strategy in China

    by a65232389 Feb 9, 2015 1:56 PM
    a65232389 a65232389 Feb 10, 2015 2:49 PM Flag

    And the government writes the rules on pricing. They are removing the favored pricing for 'originator' generic products. SciClone will have to make a lot in increased volume to try to compensate for its reduced margin. At some point, with significantly higher European production costs, import fees, etc., it all becomes "uneconomic" as warned by Bain and Company and others. Got to find a new strategy and much more innovative (non-generic) products. Angiomax will enter China already facing generic competition. Its pricing will already start badly for SciClone.

  • What's SciClone's plan to handle the loss of product 'originator' price protection for branded generics such as Zadaxin? Merck is getting out of the business. Merck ($MRK) is bowing out of its Chinese joint venture with Simcere Pharmaceutical. Merck forged the partnership in 2011 as a way to build up in the fast-growing market, with a focus on branded generic drugs.

    Merck will hand over control to Simcere, a company spokeswoman told FiercePharma, as part of a shift in strategy at the joint venture. The venture, known as SMSD, "will now focus on local innovative and mature products, serving the local market," she said in an email. "The operation will be managed by Simcere Pharmaceutical Group in this new capacity."

    The changes are designed to "better meet challenges posed by the rapidly changing external environment," the spokeswoman said.

    Under the 2011 deal, each company handed over pharma assets to the JV, with Merck holding a majority 51% stake and Simcere claiming the rest. Among the drugs Merck contributed were its diabetes blockbuster Januvia, its now-off-patent statin drug Zocor and cardio med Cozaar.

  • a65232389 a65232389 Jan 23, 2015 4:16 PM Flag

    Dividends don't help those who don't own the stock, such as management and board directors that hold options. Stock buybacks raise the value per share by simply decreasing number of shares outstanding. That improves the value of management's and board's options. Dividends only go to actual investors. Safe to always figure management and board will do what's in their personal best interest first.

  • The Dec 18 announcement of licensing Angiomax for China runs into the same generic pricing problem that the company is facing with Zadaxin - prices will be compressed to "uneconomical" for branded products being sold at a premium to generics in China. Angiomax (bivalirudin) is already available as a generic in China. Salubris sponsored an important trial in China, the BRIGHT trial, and reported results at the Transcatheter Cardiovascular Therapeutics (TCT) 2014 in Washington DC in September. Clearly Salubris is no slouch and is already in the market. The presenter at TCT was Dr. Yaling Han of General Hospital of Shenyang Military region. As reported by Medscape, "asked by Heartwire about the cost differential in China, Han agreed that the cost of a bivalirudin strategy would be "much more" than a heparin-monotherapy strategy, but would not be as expensive as it is in countries where bivalirudin is sold as Angiomax (the Medicines Company). In China, bivalirudin is sold by Salubris, which was also a cosponsor of the trial." Medicines Company has faced Angiomax patent challenges in the U.S. and has made concessions. In Europe, bivalirudin is sold as a generic and Angiomax sales in Europe are inconsequential. SciClone is bound to face economic problems with Angiomax in China with Salubris and probably other generic competition and with regulators pushing down prices. SciClone will suffer because of cost disadvantage of buying the product at Western manufacturing costs, import duties, license payments and royalties to Medicines Company. An indicator of success is SciClone's insignificant (maybe $1 million per quarter) in selling Aggrastat (Medicines Company 10-K says Angiomax competes with Aggrastat for the same hospital dollars for cardio treatment). The Angiomax deal isn't anywhere as bad as the NovaMed deal that created SciClone's cardiovascular "franchise", but it is just more of the same ineffective, wasteful pursuit of an obsolete strategy.

  • a65232389 a65232389 Jan 6, 2015 12:37 PM Flag

    That's what they have to do. It will take time and money, a lot more than the $650K that SciClone spent on R&D in the third quarter. They also will have to be a lot smarter. The $100 million and 2-3 years wasted on NovoMed were not an encouraging start of a transition.

  • a65232389 a65232389 Jan 5, 2015 2:12 PM Flag

    ChinaBio Today is very reputable. The loss of preferential pricing for 'originator' drugs like Zadaxin has been on the horizon for several months. Here's another source, Bain & Company, a top-tier international consulting firm: "The Chinese government is instituting a zero drug mark-up policy in hospitals across the country, and its vigorous response to ethical compliance lapses is accelerating reforms that will affect drug sales and pricing.

    The net impact for MNCs is that the business model based on a large and expensive sales force, marketing lucrative originator drugs directly to hospitals and doctors, will cease to be economical before the decade is out, Bain's research predicts.

    "Pharma profit pools in China will be rapidly drying up," said Philip Leung, a partner in Bain's Shanghai office who leads the firm's China Healthcare Practice."

    The Bain report was issued back in June. The rate of profitability decline to "uneconomical" depends on how fast the zero mark-up policy is implemented. Apparently from the ChinaBio Today report, it's going to happen sooner rather than later.

  • ChinaBio Today
    publication date: Dec 24, 2014
    Starting next month, China is expected to change the way it sets drug prices, a change that could have a profoundly negative effect on the China revenues of multinational drug companies. For years, MNCs have enjoyed premium pricing in China on drugs that have lost their patent protection elsewhere in the world. The class of preferred generics constitute as much as 70% of MNC drug revenues in China. But in January, China will most likely remove the price differential of these drugs, forcing MNCs to price these drugs at the same level as comparable China generics. More details....
    - See more at: http://www.chinabiotoday.com/articles/20141225#sthash.FFNjYVF5.dpuf

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