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INSM - Insmed - Deel 2

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  3. [verwijderd] 18 juli 2006 22:11

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    -Seven year market protection due to FDA orphan status

    -LAZARD investment report
    finance.messages.yahoo.com/bbs?action...

    -No need for further dilution, last emission (march 2006 at 2$, 23mln shares) was needed for
    40million production expenses Plenty cash now to carry them into halve 2007,
    NOT taking into account any iplex sales(check most recent conference call on Q1 2006)

    -pricing now known: 10% higher than its competitor which is twice a day versus the iplex once a day
    And which also has a worse safety record compared to iplex (24kg patient om iplex,1.5mg/kg
    comes to $32,850 annually. Price per package of 35 vials of 36mgs of iplex $3,150.
    (the drug has to be taken for several years for the growth factor deficiency))

    -With iplex allready FDA approved to be safe and working, more indications for it will follow. Iplex is also being investigated for various other indications with unmet medical needs

    -EMEA (european FDA) filing expected in second halve 2006
    Recent EMEA advisory board positive ruling on using iplex for
    www.emea.eu.int/pdfs/human/comp/18025...
    Treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects
    Treatment of patients with growth hormone (GH) gene deletion who have developed neutralizing antibodies to G

    More EMEA news july 5th 2006: : European Medicines Agency Validates Insmed's Regulatory Application For Marketing IPLEX(TM) in Europe
    IPLEX(TM) Also Receives European Orphan Drug Designations
    biz.yahoo.com/prnews/060705/nyw025.ht...

    -Preliminary Clinical Phase II Trial voor Extreme Insulin Resistance presented! positive prelimenary data!

    -Current iplex uses,fda approved and on market
    IGFD (Insulin-like Growth Factor Deficiency), about 6000 patients in the US and 6000 in europe

    -Current new indications researched for iplex use. (so same drug, different use)
    Check the last emission (needed for iplex production) for collobarating information
    yahoo.brand.edgar-online.com/fetchFil...

    1) SIR (Severe Insulin Resistance) , ongoing Clinical phase II Study (about 2.000 US patients, 2.000 Europe)
    Interim data presented at the Endocrine Society’s Annual Meeting in june 2006, final data end of 2006!
    2)MMD (Myotonic Muscular Dystrophy), ongoing phase II study (about 30.000 US patients, 30.000 europe)
    3)HARS HIV Associated Adipose Redistribution Syndrome, currently in phase II (about 80.000 US patients, ? europe)
    4)Noonan syndrome is planned as well, about 30.000 US patients, 30.000 european

    -Iplex approved by multiple insurance companies for its indications (example)
    www.cigna.com/health/provider/pharmac...

    -Non-frozen variant expected end of this year (check latest conference call)

    THE LAWSUIT!:
    -The insmed msg boards are frequented by the most deceitfull and manipulating bashers.
    They often refer to doom and gloom with the lawsuits filed by their competitor TRCA.
    Is there any merit to that? No, but its a good handle to frighten even more retail into selling
    Check the facts:
    finance.messages.yahoo.com/bbs?.mm=FN...

    Since july 6th there is a markman hearing ruling in the patent case, this basically is the framework for
    the patent trial by jury later on.
    (legal text found here: trca.client.shareholder.com/downloads... )
    A balanced overview of what happened (basically correct in the headlines)
    finance.messages.yahoo.com/bbs?.mm=FN...

    What does this mean?.. little other than that tercica has a valid claim and that it will not be dismissed, but
    rather go to trial in november.. ANy news?.. nope...insmed still has the position that the patent itself is not valid!!!

    Why the Question about the validity of the patent?
    finance.messages.yahoo.com/bbs?.mm=FN...

    A legal expert's opinion on the TRCA pr from july 5th... definately seemed as an intent on trying to hurt insmed
    finance.messages.yahoo.com/bbs?action...

    Basically INSM infringes on SOME part of the patents IF the patents are viable!
    And for the patents to be viable to have had to show biological interaction/effectiveness when writing it down.
    Genentech's fiddling there does show that insmed has a good shot with the angle they choose.

    And if they fail?.. read the first lawsuit summary.. monetary compensation
    Either way it'll be about who sells the most...any compensation will merely be a cost increase of a few percent max.
    (Why?.. look at legalreferences... 3% of revenue is a very common on infringement of a complete patent!(2-8%),
    partial infringements..who knows.. recent example: FNSR vs Directv)

    Earlier legal issues:
    finance.messages.yahoo.com/bbs?action...
    finance.messages.yahoo.com/bbs?action...

    -ongoing research with coumpound rhIGFBP-3 , natural occuring (fewer side effects!) anti-tumor agent. Wide use!!
    Currently undergoing phase I studies for safety.
    Treatment with IGFBP-3 (3mg/kg) alone reduced tumour growth by 25% and in
    addition, IGFBP-3 (30mg/kg) increased CPT-11 (10mg/kg) inhibition from 30% to 69%. Thus, in the
    three solid tumour models, IGFBP-3 exhibited either single-agent and/or combinatorial anti-tumour
    activity (additive or synergistic) with the chemotherapeutic agents."

    example:
    "Among subjects who were physically active, an increase in IGFBP-3 was associated with a 48 percent reduction in colon cancer-specific deaths. No association was apparent for IGF-1."
    Source (research article): gut.bmjjournals.com/cgi/content/abstr...
    Overview article:http://tinyurl.com/nm4ra (reuters)
    finance.messages.yahoo.com/bbs?.mm=FN...
    finance.messages.yahoo.com/bbs?.mm=FN...

    Recent presentation at investor gathering:
    www.wsw.com/webcast/ceut4/insm/
    validates most in the summary, check it and the slides!

    Interview by CEO of INSMED, july 6th 2006
    www.timesdispatch.com/servlet/Satelli...

    -Are any analyst following insmed?
    Yes they are... Insmed still has a 30mln shelf filing they could use if they have monetary problems.
    Currently they have cash till mid 2007, NOT counting any iplex sales. So they wont use it,
    but analyst use it in the equation:

    LAZARD capital has a target including those diluting shares of 4$
    CUE unterberg has a target for current shares of 3$
    Both base their valuation ONLY on the iplex sales for growth hormone deficieny.
    So not counting in any off-label use, or any nex apllications found through phaseII studies
    (ie noonan disease, insuline resistance etc.. alla lot bigger than current fda indication)
    Download the most recent Lazard report JUNE 2006 and the updated report from june 15th 2006: stockpick.badongo.com
    finance.m
  4. [verwijderd] 18 juli 2006 22:32

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    Bericht van 12 july 2006
    --------------------------

    Wednesday, July 12, 2006 12:48 ET

    By Jeffrey Kelley
    Jul 10, 2006 (Richmond Times-Dispatch - Knight Ridder/Tribune Business News via COMTEX) -- Geoffrey Allan has seen failure. He's witnessing success. And he's closely monitoring an uncertain future.

    "It's all about building a company, taking the risk and living through all of those hardships where you wonder where the next paycheck is coming from -- and staying with the game," said Allan, chairman and chief executive of Henrico County-based biotechnology company Insmed Inc. "Insmed and its employees have been through those battles."

    The positive outcome has been the Dec. 12 federal approval of Insmed's lead drug, iPlex. Success has also come at the cost of a failed product line and an overhanging patent-infringement case that threatens production and sales of the drug -- and revenue the treatment could bring.

    Insmed's drug treats children who suffer from a rare but severe growth disorder.

    But the company's tale isn't complete until introducing its competitor, Tercica Inc., a Brisbane, Calif., firm that makes and sells a drug similar to iPlex, called Increlex.

    Tercica had its drug approved by the U.S. Food and Drug Administration in late August, nearly four months before the FDA approved iPlex.

    Both companies started selling the drug this year -- though Tercica had a five-month head start. The treatments could help as many as 6,000 patients who suffer from a severe form of a disease that causes children to grow more slowly than normal.

    The market is estimated at $150 million to $200 million. About 30,000 U.S. children could have a less-severe type of the disorder, and both drugs could have potential in this larger market.

    Increlex and iPlex treat a relatively small number of people. But each drug has capabilities in far more common conditions -- indications that also carry larger sales potentials.

    Insmed is researching ways to use iPlex to treat the buildup and loss of fat related to HIV, muscle and nerve degeneration, diabetes and extreme resistance to insulin -- a condition that can lead to obesity, high blood pressure and elevated levels of fat in the blood. John A. "Chip" Scarlett, president and CEO of Tercica, said his company has interests beyond growth disorders, but didn't want to give specifics.

    Insmed will release data on iPlex clinical trials on other uses for the drug in coming months. Allan said no new iPlex treatments will gain approval until after 2008.

    "It's always been that iPlex would create a franchise around metabolic illnesses," said Allan, 53, a native of England. "It's a very broad-pronged approach to look at a variety of indications."

    There is, no doubt, some uncertainty in Insmed's future as the company faces a trial in November on charges it infringed on patents held by Tercica.

    Despite insecurity -- which comes with the territory in high-risk, high-reward biotech companies -- local biotechnology officials point to Insmed as a symbol of the Richmond area's potential for growth in the life-sciences industry.

    "Having the drug approved by the FDA by anyone's standard is a huge success. I don't care what state you're in -- that's big news," said Mark A. Herzog, executive director of the Virginia Biotechnology Association. "It's a big step forward for the modern biotech community."

    He believes Richmond has not seen such a promising pharmaceutical company since A.H. Robins Co., the medical firm founded here in 1889 that became part of Wyeth.

    Insmed has shifted shapes many times since its founding in Charlottesville in 1988, when it spun out of the University of Virginia to develop diabetes drugs.

    Allan joined Insmed in 1994, and the company became one of the first tenants in the Virginia BioTechnology Research Park in 1995. Some five years later, Insmed purchased Celtrix Pharmaceuticals Inc., a then-struggling public company that made a diabetes drug called SomatoKine.

    Because the two companies were involved in similar drug research, Celtrix was a good fit, said Kevin P. Tully, Insmed's chief financial offer. The company went public after the acquisition, trading under the Nasdaq symbol INSM.

    Buying Celtrix, Insmed officials would later learn, was a good move.

    In September 2002, Insmed dropped development of its drug for diabetes and polycystic ovary syndrome, which failed in trials. The company cut its work force in half to about 25 employees.

    But the acquisition had given Insmed another drug to research. Without Celtrix and SomatoKine, Allan said, "we would have probably ended up as a failed company in 2002."

    That year, a California company formed after licensing technology from Genentech. The patents and technology were for a drug called recombinant human insulinlike growth-factor-1, or rhIGF-1.

    The company was Tercica.

    Within a month of Insmed's product failures, the company had turned its focus to SomatoKine, which could be used to treat children with growth-hormone deficiency.

    The drugs from Tercica and Insmed could treat this condition, replacing the nonexistent hormone with the similar rhIGF-1 -- the active ingredient in both iPlex and Increlex.

    Developing such a treatment was the "fastest, least cash-intensive" path to get approval from the FDA, Allan said.

    And the move paid off.

    The FDA greenlighted SomatoKine within three years, and the drug's name was changed to iPlex.

    The Insmed of today, Allan says, is truly the product of the past six years of development. The company has about 45 employees at 4851 Lake Brook Drive in Glen Allen. A few miles east of the Rocky Mountains, Insmed employs 85 workers in a Boulder, Colo., manufacturing facility called Insmed Therapeutic Proteins.

    The lease on the brick Henrico building is up in October, and Insmed plans to move its lab spaces to Colorado but will keep administrative operations in Richmond.

    The company has a sales force of about 20.

    Risks to Insmed's future are clear.

    "It's a business of managing and balancing risk, but in several areas," said Tully, the CFO. In addition to drug research, Insmed is involved in manufacturing, sales, finance and ongoing litigation, he said, "and each one of these areas has its own level of acceptable risk."

    Analysts expect the patent-infringement trial later this year to be a large hurdle.

    Last week a California court ruled that Insmed's process for making iPlex infringes on parts of patents held by Tercica. The rulings mean the dispute will have to be resolved at trial in November.

    But as is the case in many patent suits, a monetary settlement would be more likely if Insmed is found to have infringed upon Tercica's technologies. An appeals process may follow any outcome.

    Insmed also must successfully develop other product lines for iPlex and differentiate the drug from Tercica's Increlex, Andrew S. Fein, an analyst at C.E. Unterberg Towbin in New York, wrote in a recent research note.

    Wall Street hasn't shown much excitement for Tercica or Insmed in the past year.

    Shares of Insmed hit a 52-week high of $3.35 in January after approval of iPlex, but they have since plummeted 61.5 percent, closing Friday at $1.29. Tercica, meanwhile, hit its one-year high of $12.77 in September after approval of Increlex, but shares have fallen 64.8 percent to close at $4.50 on Friday.

    "You have two c
  7. [verwijderd] 18 juli 2006 23:20

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    quote:

    DieGroeneGigant schreef:

    Blijft waarom TRCA zo is gestegen.

    Sucker ralley ?
    Short covering ?
    Settlement ?
    Merger ?
    Takeover by Pfizer ?

    moeten we daar nog van wakker liggen?
    trca is nu éénmaal een geheel van leugens en bedrog
    en een brok manipulatie

    nog een stijging of acht als die van vandaag en we staan weer op twee
    -):O
  8. [verwijderd] 18 juli 2006 23:21

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    Groene,

    Kijk naar het volume en je hebt je antwoord denk ik. Als er echt nieuws zou zijn veel meer volume dan 342K. Vlak voor het einde nog een 90K verhandeld, maar dat was nadat INSM al was gaan stijgen...

    E.
  10. [verwijderd] 18 juli 2006 23:29

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    TRCA interesseert mij op dit moment niet
    eindelijk weer groen op de borden voor insmed
    en wellicht ook weer wat meer vertrouwen in dit aandeel.
    ikheb behoorlijk in de rats gezeten en al gerekend met koersen onder de 1,00
    Gelukkig niet en hopelijk wordt nu de stijgende lijn gaandeweg verder doorgezet.
    De les van dit verhaal is wel geweest dat ik nooit meer 100% in 1 aandeel zal gaan, verleiding is te groot geweest, teveel beinvloed door de positieve berichten.
    Ik blijf insmed aandelen houden (behoorlijk %)en hou nu ook andere aandelen in de gaten om t.z.t. meer te spreiden.
    De warme groeten uit Hengelo
    Gerard
  12. [verwijderd] 18 juli 2006 23:40

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    Niet te vroeg juigen. Eén zwaluw maakt nog geen zomer. Zou je niet zeggen met 35 graden celcius. Heb vandaag bijgekocht en hoop dat we nu eens de gap op 1.60 gaan opzoeken. Blijft een gok.
  14. jip banaan! 19 juli 2006 00:41

    • jip banaan!

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    quote:

    jip banaan! schreef:

    [quote=bal gehak]
    is er nieuws dat we nu zo omhoog knallen
    [/quote]

    waarschijnlijk wel bal, maar er niemand hier die het weet!
    waarschijnlijk toch voorkennis!
  16. [verwijderd] 19 juli 2006 05:19

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    Press Release Source: Tercica

    Ipsen and Tercica to Enter into Worldwide Strategic Collaboration in Endocrinology
    Tuesday July 18, 7:26 pm ET

    PARIS & BRISBANE, Calif.--(BUSINESS WIRE)--July 18, 2006--Tercica (Nasdaq:TRCA - News):
    Cross licensing agreements for Somatuline® Autogel® and Increlex(TM)
    Ipsen to acquire initial 25% stake in Tercica, with the potential to increase to up to 40% ownership via convertible notes and warrant
    Joint product development rights for endocrine pipelines
    Somatuline® Autogel® gets marketing approval in Canada; Tercica expects to launch in early 2007
    Ipsen (EURONEXT:IPN) and Tercica (Nasdaq:TRCA - News) today announced that they have agreed to a worldwide strategic collaboration in endocrinology. In cross licensing agreements, Ipsen will grant to Tercica exclusive rights to sell(1) Somatuline® Autogel®, a leading product in the European acromegaly market, in the United States and Canada. Tercica will grant to Ipsen exclusive rights to sell(1) Increlex(TM), a leading product in the United States for the treatment of short stature associated with severe Primary IGF-1 deficiency (Primary IGFD), in all regions of the world except the United States, Japan, Canada, the Middle East and Taiwan(2). The companies will also grant to each other product development rights and share the costs for improvements to or new indications for Somatuline® Autogel® and Increlex(TM). In addition, the companies have agreed to rights of first negotiation for their respective endocrine pipelines. This alliance is designed to allow Ipsen and Tercica to offer global care solutions to patients suffering from growth and other endocrine disorders. In the context of this partnership, Ipsen will acquire newly issued shares of Tercica common stock representing a 25% stake in Tercica (post transaction, on a non-diluted basis), and Tercica will issue convertible notes and a warrant to Ipsen giving it the opportunity to increase its shareholding to up to a 40% stake in Tercica (post transaction, on a fully diluted basis). Both companies believe their collaboration will significantly enhance their respective competitive positioning and growth prospects.

    The key components of the collaboration agreement announced today are:

    1- Licensing agreements(3):

    Ipsen will license from Tercica the rights to develop and market Increlex(TM) worldwide except for the United States, Japan, Canada, the Middle East and Taiwan. Ipsen will make an upfront cash payment of EUR 10.0 million ($12.5 million) to Tercica upon the closing of this transaction, and an additional EUR 15.0 million ($18.8 million) on approval of the Increlex(TM) Medical Marketing Application in the European Union for the targeted product label. Once Increlex(TM) is launched in Ipsen's territory, Ipsen will pay royalties to Tercica on a sliding scale from 15% to 25% of net sales, in addition to a supply price of 20% of net sales of the product.
    Tercica will license from Ipsen the rights to develop and market Somatuline® Autogel® in the United States and Canada. Tercica will make an upfront payment of $25.0 million (EUR 20.0 million) to Ipsen upon closing of this transaction, and an additional payment of EUR 30 million ($37.6 million) upon U.S. approval of Somatuline® Autogel® for the targeted product label. Both of these milestones will be financed through the issuance by Tercica of convertible notes to Ipsen (see below). Once Somatuline® Autogel® is launched in Tercica's territory, Tercica will pay royalties to Ipsen on a sliding scale from 15% to 25% of net sales, in addition to a supply price of 20% of net sales of the product.
    2- Equity investment and convertible notes(3):

    At closing:

    Equity stake: Ipsen will acquire newly issued shares of Tercica common stock representing a 25% stake (post transaction, on a non-diluted basis) in Tercica at $6.17 per share, a premium of 30.0% to Tercica's volume-weighted average closing stock price over the past 15 trading days ended July 17 for a total cash consideration of $77.3 million (EUR 61.8 million).
    Convertible note 1: Tercica will issue to Ipsen a convertible note for a principal amount of $25.0 million (EUR 20 million). The note, which will mature 5 years from the date of closing carries a coupon of 2.5% and is convertible into Tercica common stock at a conversion price of $7.41 (EUR 5.92) per share, a premium of 56.0% to Tercica's volume-weighted average closing stock price over the past 15 trading days ended July 17. This note will be issued in payment of the upfront licensing payment for Somatuline Autogel described above.
    Warrant: Tercica will also issue a warrant to Ipsen, with an exercise price of $7.41 per share, which represents a premium of 56.0% to Tercica's volume weighted average closing stock price over the past 15 trading days ended July 17.
    Upon approval of Somatuline® Autogel® in the United States for the targeted product label:

    Convertible note 2: Tercica will issue to Ipsen a convertible note for a principal amount of EUR 30.0 million ($37.6 million). The note, which will mature 5 years from the date of closing, carries a coupon of 2.5% and is convertible into Tercica common stock at a conversion price of EUR 5.92 ($7.41) per share. This note will be issued in payment of the second licensing payment for Somatuline® Autogel® described above.
    Convertible note 3: Tercica will issue to Ipsen a convertible note for a principal amount of $15.0 million (EUR 12.0 million). The note, which will mature 5 years from the date of closing, carries a coupon of 2.5% and is convertible into Tercica common stock at a conversion price of $7.41 (EUR 5.92) per share. Ipsen will purchase this note for cash.
    In aggregate, excluding the Warrant, Ipsen may pay to Tercica a total cash amount of up to EUR 98.7 million ($123.6 million) as follows:

    -- EUR 73.7 million ($92.3 million) under the equity and
    convertible notes net of convertible notes 1 and 2:

    -- $77.3 million (EUR 61.8 million) upon closing of the
    transaction and;

    -- $15.0 million (EUR 12.0 million) upon issuance of the
    third convertible note.

    -- EUR 25 million ($31.3 million) under the licensing agreement
    for Increlex(TM):

    -- EUR 10.0 million ($12.5 million) upfront, and

    -- EUR 15.0 million ($18.8 million) upon EU approval of
    Increlex(TM) for the targeted product label.

    Tercica may receive additional proceeds from Ipsen if the warrant is exercised.

    Overall, these instruments will allow Ipsen to increase its stakeholding in Tercica to up to 40%, on a post transaction and fully diluted basis. Should Ipsen decide not to convert the notes, they would be repaid in cash at maturity.

    Additional terms of the collaboration include agreements giving Ipsen the right to appoint two members to Tercica's nine-member board of directors, replacing two current directors, providing Ipsen with certain protective provisions, including an approval right related to specified material transactions and actions by Tercica, and providing for the implementation of a stockholder rights plan. Closing of the transaction, which is expected to occur this year, is subject to approval by Tercica's stockholders and the expiration of the Hart Scott Rodino waiting period, as well as other customary closing conditions. Tercica stockholders holding an aggregate of 38.4% of Tercica'
  17. [verwijderd] 19 juli 2006 05:20

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    Deel 2

    outstanding common stock have entered into voting agreements in which they have agreed to vote their shares of Tercica's common stock in favor of the proposed transaction and related matters.

    3 - Development of Somatuline® Autogel®, Increlex(TM), and Endocrinology Pipeline Product candidates:

    Each company has granted to the other the right to pursue development of new indications and improvements to Somatuline® Autogel® and Increlex(TM), either jointly or on its own, with the other party retaining a right to "opt in" to co-fund later.
    Each company has granted to the other a right of first negotiation for products in its endocrine pipeline, and has agreed on a framework for joint clinical development and subsequent commercialization of endocrine products on a worldwide basis.
    Ipsen has several endocrinology compounds in pre-clinical development, including two products that could enter clinical development as early as 2007: dopastatin (BIM 23A760), a chimeric molecule directed towards somatostatin and dopamine receptors, is targeted at the possible treatment of pituitary adenomas, including those causing acromegaly, Cushing's disease and hyperprolactinemia as well as non-functional pituitary adenomas. BIM 28131, a ghrelin agonist, is targeted at restoring normal body composition in wasting diseases associated with chronic illness.
    Jean-Luc Belingard, Chairman and CEO of Ipsen, said, "After an extensive review of our options, we have chosen Tercica to market Somatuline® Autogel® in the United States considering its unique position and experience in endocrinology and in recognition of the excellence of its team. This transaction represents an important milestone in our strategy of international expansion: it is a major step forward in building a powerful business platform in North America in one of our high-growth targeted therapeutic areas."

    M. Belingard added: "Ipsen is also convinced that Increlex(TM) will be successfully established in the market as the reference long-term treatment of growth failure in children with severe primary IGFD, and our licensing agreement will enable Ipsen to build a global franchise, offering to endocrinologists a comprehensive solution to children suffering from such growth disorders."

    Commenting on the structure of the transaction, M. Belingard said: "We strongly believe this partnership will create value for both shareholder bases by extracting cross-selling synergies between two highly regarded products and enhancing both companies' R&D capabilities in endocrinology. Furthermore, our staged equity investment demonstrates our financial discipline and provides Ipsen with flexibility regarding its future equity position in Tercica."

    John A. Scarlett, M.D., President and Chief Executive Officer of Tercica, said, "We are very pleased to partner with Ipsen, a world leader in endocrinology. Through this collaboration we expect to achieve several critical objectives. With Somatuline® Autogel®, we will have an attractive late-stage endocrinology product for the treatment of acromegaly, which affects approximately 15,000 people in the United States and Canada. Upon approval, the addition of Somatuline Autogel to our U.S. product portfolio will enable us to leverage our existing sales and marketing infrastructure in the endocrine marketplace. Additionally, our agreement with Ipsen will provide us with a very strong partner that will commercialize Increlex(TM) in the European Union and other global markets."

    Dr. Scarlett added: "As a part of this collaboration, we also gain access to Ipsen's endocrinology pipeline, which includes two very exciting compounds in late-stage preclinical testing. Also, Ipsen's proprietary technologies might be applicable in the future to design a sustained release formulation of Increlex."

  18. [verwijderd] 19 juli 2006 05:21

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    Deel 3

    Dr. Scarlett continued, "Additionally, the transaction will provide Tercica with a net cash infusion of $77.3 million from the initial equity sale upon closing and up to another $46.3 million from licensing milestones and the issuance of the third convertible note. These cash receipts will significantly strengthen our balance sheet.

    "Giving effect to the proposed transaction, Tercica expects to reach breakeven in 2010 and achieve 2011 revenues of $250 million to $300 million, with Increlex and Somatuline Autogel sales expected to contribute roughly equal amounts. For 2006, Tercica expects Increlex revenues of approximately $1 million and cash burn, excluding expenses related to this transaction, of $63 million to $69 million as previously stated," continued Dr. Scarlett.

    Tercica's Increlex(TM) (mecasermin (rDNA origin) injection) is an rhIGF-1 replacement therapy indicated for the long-term treatment of growth failure in children with severe Primary IGFD. The active ingredient of Increlex(TM) is identical to the natural hormone IGF-1, which the body normally produces in response to stimulation by growth hormone. IGF-1 is the direct mediator of growth hormone's effect on statural growth and must be present in order for children's bones, cartilage and organs to grow normally. Without adequate IGF-1, children cannot achieve a height within the normal range. Increlex(TM), approved for the treatment of severe Primary IGFD by the U.S. Food and Drug Administration (FDA) in August 2005, is commercially available to patients throughout the United States. Also, in December 2005, Tercica submitted for marketing approval of Increlex(TM) in the European Union and has been granted an "orphan product" designation.

    Severe primary IGF-1 deficiency (Primary IGFD) is a distinct diagnosis of short stature and is defined by height standard deviation score less than or equal to -3.0, Basal IGF-1 standard deviation score less than or equal to -3.0 and normal or elevated growth hormone. It is believed that approximately 6,000 children in the U.S. have severe primary IGF-1 deficiency. Severe Primary IGFD causes are rooted in the IGF-1 expression and production pathway. Disease state includes patients with mutations in the growth hormone receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects. Patients with severe Primary IGFD are not growth hormone deficient, and therefore, cannot be expected to respond adequately to exogenous growth hormone treatment. Reduced levels of endogenous IGF-1 can be detected by an IGF-1 assay.

    Tercica estimates that 6,000 to 8,000 children suffer from severe Primary IGF-1 deficiency in the EU. Tercica is also conducting clinical trials to study once-daily dosing of Increlex(TM) as well as expanded labeling of Increlex(TM) for use in children with a less severe form of Primary IGFD. Tercica also estimates that an additional 24,000 children in the EU have the less-severe form of the disease.

    Ipsen's Somatuline® Autogel® is an injectable sustained-release formulation containing lanreotide, a somatostatin analogue. Somatuline® was initially developed in Europe for the treatment of acromegaly (a disorder caused by the over-production of growth hormone secondary to a benign tumor of the anterior pituitary gland) and, in most European countries, is also approved for the treatment of symptoms associated with neuroendocrine tumors. The Somatuline® Autogel® formulation requires no excipient other than water and releases lanreotide over a period of at least 28 days and up to 56 days. The product is conditioned in a pre-filled syringe for easier administration than other long-acting somatostatin analogue. In acromegaly, Somatuline® is used primarily when circulating levels of growth hormone remain high despite surgery or radiotherapy, and through its inhibitory effects, Somatuline® lowers growth hormone and IGF-1 levels, thus controlling disease progression and relieving the symptoms associated with active disease.

    According to epidemiology data(4), acromegaly affects approximately 15,000 people in the United States and Canada and is most commonly found in middle-aged adults. Studies estimate an all-cause mortality rate associated with acromegaly of at least twice the normal population, and a reduction in life expectancy of 5 to 10 years. Somatuline® also treats the symptoms associated with neuroendocrine tumors, particularly carcinoid syndrome, such as diarrhea and flushing, by inhibiting the over-production of hormones secreted by these tumors.

    At 31 December 2005, Somatuline® and Somatuline® Autogel® had marketing authorizations in over 50 countries for the treatment of acromegaly and neuroendocrine tumors. The Group intends to file an application for marketing authorization in the U.S. by the end of 2006 for the treatment of acromegaly.

    Somatuline® and Somatuline® Autogel® generated sales of EUR 81.8 million in 2005, up 13.4% vs. 2004. In its main markets in Europe, Somatuline® Autogel® has achieved a 30% to 50% market share varying from country to country(5) of the acromegaly market.

    On July 17, Health Canada approved Somatuline® Autogel® for the long-term treatment of patients with acromegaly due to pituitary tumors who have had inadequate response to or cannot be treated with surgery and/or radiotherapy and for the relief of symptoms associated with acromegaly. Tercica expects to launch Somatuline® Autogel® in Canada in early 2007.

    A Current Report on Form 8-K describing the proposed transaction in more detail will be filed by Tercica, and this press release is subject to the further detail provided in the Form 8-K and exhibits thereto.

    About Tercica

    Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for short stature and associated metabolic disorders. For further information on Tercica, please visit www.tercica.com.

    About Ipsen

    Ipsen is a European pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company's development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders), which are growth drivers and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four R&D centers (Paris, Boston, Barcelona and London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2005, Research and Development expenditure reached EUR 169 million, i.e. 20.9% of consolidated sales, which amounted to EUR 807 million in the Group's pro forma accounts set up according to the IFRS. Nearly 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen's shares are traded on Segment A of Eurolist by Euronext (stock code: IPN, ISIN code: FR0010259150). Ipsen's internet website is www.ipsen.com.

    Ipsen's forward-looking statements

    The forward-looking statements and targets related to Ipsen contained herein are based on Ipsen's management's current views and assumptions. Such statements involve known and unknown risks and uncertainties, including with respect to products, markets, investments or acquisitions that may cause actual results, performa
  19. [verwijderd] 19 juli 2006 05:23

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    Ipsen's forward-looking statements

    The forward-looking statements and targets related to Ipsen contained herein are based on Ipsen's management's current views and assumptions. Such statements involve known and unknown risks and uncertainties, including with respect to products, markets, investments or acquisitions that may cause actual results, performance or events to differ materially from those anticipated herein. In particular, a number of products that the Group is developing are still at the very first stages of development and the Group cannot be certain that these products will be approved by the competent regulatory authorities and that they will be successfully marketed. If the products that the Group is developing are not approved during clinical and pre-clinical trials or if they are not approved thereafter by the regulatory authorities, this will have a negative impact on the growth of the Group. Several years can elapse before a product is approved and it may be that the Group will fail to launch some of its new products on the market. A new product can also appear to be promising at a preparatory stage of development or after clinical trials but never be launched on the market or be launched on the market but fail to sell.

    Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its information documents filed with the French Autorite des marches financiers.

    Tercica' forward-looking statements

    Except for the historical statements contained herein, this press release contains forward-looking statements concerning Tercica's prospects and results, including all statements that reflect completion of the proposed transaction with Ipsen (including statements related to Tercica's receipt of proceeds from the initial equity sale to Ipsen and as a result of the achievement of licensing milestones and warrant exercises); statements related to the market prospects for Increlex(TM) and Somatuline® Autogel®; potential development of additional products; that Tercica expects to launch Somatuline® Autogel® in Canada in early 2007; statements relating to estimates of the numbers of patients with acromegaly, severe Primary IGFD or Primary IGFD; and statements related to financial projections, including without limitation, that (a) Tercica expects to reach break-even in 2010 and achieve 2011 revenues of $250 million to $300 million, with Increlex(TM) and Somatuline® Autogel® sales expected to contribute roughly equal amounts; and (b) for 2006, Tercica expects Increlex(TM) revenues of approximately $1 million and cash burn, excluding expenses related to this transaction, of $63 million to $69 million. Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, risks and uncertainties related to the satisfaction of closing conditions related to the proposed transaction and the risk that the proposed transaction will not be completed, risks and uncertainties related to the achievement of milestones, including the following risks: (i) Somatuline® Autogel® might never achieve marketing approval for the targeted indication, or any indication, in the United States on a timely basis, or at all; (ii) for the remainder of 2006, physicians my not prescribe Increlex(TM) at the rate Tercica expects; (iii) Increlex(TM) may not receive a marketing authorization from the FDA for Primary IGFD or from the EMEA for any indication; (iv) Tercica may not prevail in the patent infringement litigation against Insmed Incorporated; (v) Tercica's estimates for the number of patients with acromegaly, severe Primary IGFD or Primary IGFD may not be correct; (vi) Tercica may not launch Somatuline® Autogel® in Canada in early 2007 if the transaction does not close on a timely basis; and (vii) the risks and uncertainties disclosed from time to time in reports filed by Tercica with the SEC, including most recently Tercica's Form 10-Q for the quarter ended March 31, 2006 filed with the SEC on May 10, 2006. Tercica disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based unless so required by applicable law.

    Conference Call Information

    Tercica and Ipsen will hold conferences calls as follows:

    Ipsen's Conference Call and Webcast Information

    Ipsen's management will host an investment community conference call on Wednesday, July 19, 2006 beginning at 2:00 p.m. Paris time (GMT+1) to discuss Ipsen's strategic partnership with Tercica, the financial terms of the agreement and to answer questions. A slide presentation to accompany the conference call commentary will be available on the Company's website homepage at www.ipsen.com. An audio webcast and slide presentation will accompany the conference call commentary and is available on the Company's homepage at www.ipsen.com.

    Ipsen will release its second quarter sales on August 1, 2006 and first half results on September 5, 2006.

    Tercica's Conference Call and Webcast Information

    Tercica's management will host an investment community conference call beginning at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) on Wednesday, July 19, 2006 to discuss Tercica's strategic partnership with Ipsen, the financial terms of the agreement, and to answer questions.
  20. [verwijderd] 19 juli 2006 05:24

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    Deel 5

    To participate in the live call by telephone, dial 888-803-8296 from the U.S., and for international callers, dial 706-634-1250. A webcast slide presentation will accompany the conference call commentary and is available on the company's homepage at www.tercica.com. Individuals interested in listening to the webcast may do so by visiting www.tercica.com.

    A telephone replay will be available approximately two hours after the call for 48 hours by dialing 800-642-1687 from the U.S., or 706-645-9291 for international callers, and entering reservation number 3017093. A replay of the webcast will be available on the company's web site for 21 days at www.tercica.com.

    Tercica expects to release its second quarter financial results after market close on August 8, 2006.

    Additional Information about the Proposed Transaction and Where You Can Find It

    Tercica plans to file a proxy statement with the Securities and Exchange Commission relating to a solicitation of proxies from its stockholders in connection with a special meeting of stockholders of Tercica to be held for the purpose of voting on various matters relating the subject of this press release, including: (1) the sale of the common stock, warrant to purchase common stock and convertible notes to be issued to Ipsen, (2) amendments to Tercica's Amended and Restated Certificate of Incorporation and Bylaws, (3) the adoption of a share purchase rights plan and (4) certain other matters (the "Proposed Transaction"). BEFORE MAKING ANY VOTING DECISION WITH RESPECT TO THE PROPOSED TRANSACTION, SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT MATERIALS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. The proxy statement and other relevant materials, and any other documents filed by Tercica with the SEC, may be obtained free of charge at the SEC's website at www.sec.gov. In addition, stockholders of Tercica may obtain free copies of the documents filed with the SEC by contacting Tercica's Investor Relations department at 650-624-4949 or Investor Relations, Tercica Inc., 2000 Sierra Point Parkway, Suite 400, Brisbane, California 94005. You may also read and copy any reports, statements and other information filed by Tercica with the SEC at the SEC public reference room at 100 F Street, NE, Room 1580, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 or visit the SEC's website for further information on its public reference room.

    Tercica and its executive officers and directors may be deemed to be participants in the solicitation of proxies from the stockholders of Tercica in favor of the Proposed Transaction. A list of the names of Tercica's executive officers and directors, and a description of their respective interests in Tercica, are set forth in the proxy statement for Tercica's 2006 Annual Meeting of Stockholders, which was filed with the SEC on April 24, 2006, and in any documents subsequently filed by its directors and executive officers under the Securities and Exchange Act of 1934, as amended.

    If and to the extent that executive officers or directors of Tercica will receive any additional benefits in connection with the Proposed Transaction that are unknown as of the date of this filing, the details of such benefits will be described in the proxy statement and security holders may obtain additional information regarding the interests of Tercica's executive officers and directors in the Proposed Transaction by reading the proxy statement when it becomes available.

    NOTES:

    (1) Subject to approval by relevant regulatory authorities.

    (2) Rights for the Middle East and Taiwan will be granted to Ipsen
    after a period of time.

    (3) Figures in the body of the text are contractual. Figures in
    brackets are given for information purposes only, using the
    exchange rate below.

    NOTE: Where applicable, all data were converted using a EUR/US$
    exchange rate of 1.252 (17 July 2006)

    (4) Source: (Alexander L, Clin Endocrinol 12:71-79, 1980 &
    Bengtsson BA, Acta Med Scan 223:327-335, 1988)

    (5) Source: IMS MIDAS/Ex-manufactures as a percentage of sales of
    sustained release formulations of the specific molecules
    lanreotides, octreotide and pegvisomant -- in class H1C2
  21. [verwijderd] 19 juli 2006 05:35

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    bij trca lukt dit blijkbaar allemaal,
    en insm kan geen voet aan wal krijgen
    laten ze dan toch steeds de kaas van tussen hun boterham eten??

    insm zou in feite altijd twee stappen voor moeten zijn, trca kennende en gerafineerder zoals ze zijn
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