Key Developments: InterMune Inc (ITMN.O)
9.58USD
24 May 2013
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$9.96
$9.87
$9.87
$9.53
826,352
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$12.77
$7.21
Latest Key Developments (Source: Significant Developments)
InterMune Inc Reaffirms FY 2013 Revenue Guidance
InterMune Inc reaffirmed its fiscal 2013 revenue guidance of $40 to $70 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $63 million for fiscal 2013. Full Article
InterMune Inc's Esbriet (pirfenidone) Receives Positive Final Appraisal Determination from NICE for Idiopathic Pulmonary Fibrosis
InterMune Inc announced that the National Institute for Health and Clinical Excellence (NICE), the health technology appraisal body in England and Wales, has issued its Final Appraisal Determination (FAD) recommending Esbriet (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). The Company estimates that approximately 6,100 to 9,500 mild-to-moderate IPF patients are living with IPF in England and Wales. The NICE Appraisal Committee recommended pirfenidone as an option for treating IPF patients whose predicted forced vital capacity (FVC) is between 50 percent and 80 percent at the initiation of therapy. Treatment with pirfenidone for these patients should be discontinued if there is evidence of disease progression (as defined by a decline in percent predicted FVC of 10 percent or more within any 12-month period). Based on the clinical study experience with Esbriet, the company expects that between 10 and 15 percent of patients could meet this definition of disease progression in a given 12-month period. The FAD further recommends the prescription of Esbriet for as long as InterMune makes the Patient Access Scheme (PAS) available. The PAS is a confidential pricing and access agreement with the UK's Department of Health. The NHS list price for Esbriet is £26,100 per full year of treatment. At current rates of exchange this is equivalent to roughly €30,140 and $39,350 per patient per year. Full Article
InterMune Inc Issues FY 2013 Revenue Guidance In Line With Analysts' Estimates-Conference Call
InterMune Inc announced that for fiscal 2013, it expects revenue to be in a range of$40 to $70 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $63 million for fiscal 2013. Full Article
InterMune Inc Announces Pricing of Concurrent Public Offerings of $105,000,000 Principal Amount of Convertible Senior Notes and 13,500,000 Shares of Common Stock
InterMune Inc announced that it has agreed to sell an aggregate of $105,000,000 principal amount of its 2.50% convertible senior notes due 2017 and 13,500,000 shares of its common stock at a price to the public of $9.90 per share in concurrent underwritten public offerings. InterMune has granted the underwriters 30-day options to purchase up to an additional $15,750,000 aggregate principal amount of convertible senior notes and up to an additional 2,025,000 shares of common stock in connection with the offerings. InterMune estimates aggregate net proceeds from the concurrent offerings to be approximately $228.1 million, after deducting underwriting discounts and commissions and estimated offering expenses. InterMune currently intends to use the net proceeds from the offerings to repay at maturity or earlier repurchase its outstanding 5.00% convertible senior notes due 2015. Proceeds from the offerings may also be used to fund the commercialization of Esbriet (pirfenidone), to fund InterMune's ASCEND trial and for general corporate purposes, which may include funding research and development, and working capital. InterMune may also use a portion of the net proceeds for capital expenditures or for acquisitions or investments in complementary businesses, products and technologies. The convertible senior notes will bear interest at a rate of 2.50% per year. Full Article
InterMune Inc Announces Proposed Concurrent Public Offerings Of Common Stock And Convertible Debt
InterMune Inc announced that it plans to offer, subject to market and other conditions, $85.0 million aggregate principal amount of convertible senior notes due 2017 and 12,500,000 shares of its common stock in concurrent underwritten public offerings. InterMune expects to grant the underwriters 30-day options to purchase up to an additional $12.75 million aggregate principal amount of convertible senior notes and up to an additional 1,875,000 shares of common stock in connection with the offerings. InterMune intends to use the net proceeds from both offerings to repay at maturity or earlier repurchase InterMune's outstanding 5.00% convertible senior notes due 2015, as well as to fund the commercialization of Esbriet (pirfenidone), to fund InterMune's ASCEND trial and for general corporate purposes, which may include funding research and development, and working capital. InterMune may also use a portion of the net proceeds for capital expenditures or for acquisitions or investments in complementary businesses, products and technologies. Full Article
Canadian Health Regulators Approve InterMune Inc's Fibrosis Drug-Reuters
Reuters reported that Canadian health regulators has approved InterMune Inc drug to treat idiopathic pulmonary fibrosis, a fatal lung disease. InterMune expects the drug Esbriet, chemically known as pirfenidone, to be available for sale in Canada from January 1, 2013. The Company expects to secure reimbursement for the drug from most private insurance plans by the third quarter of 2013, adding that reimbursements from public plans are typically secured within six to 18 months of a launch. Full Article
Shionogi & Co., Ltd. Announces Lawsuit
Shionogi & Co., Ltd. announced that it has filed a lawsuit against InterMune, Inc. on July 10, 2012. Full Article
InterMune Inc Completes Divestiture of Actimmune
InterMune Inc that on June 19, 2012, the Company completed the previously announced sale of its rights to Actimmune (interferon gamma-1b) to Vidara Therapeutics International Limited (Vidara). Vidara is part of an international specialty pharmaceutical group of companies with operations in Ireland and the United States. Gross proceeds from the sale totaled $55 million. In addition, InterMune is eligible to receive a two-year royalty stream based on net sales of Actimmune, which is expected to contribute an aggregate amount of approximately $2million to $4 million over the two-year period. Full Article
InterMune, Inc.'s New Data Demonstrate Longer-Term Safety Profile Of Esbriet
InterMune, Inc. announced that new data was presented at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet (pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease. Approximately 30,000-35,000 new IPF patients are diagnosed in Europe each year, with an estimated median survival of only two to five years. The announcement follows the recent marketing authorization of Esbriet in Europe and its first launch in Germany on September 15. The RECAP extension study data, presented on 25 September at ERS, highlighted the positive longer-term safety and tolerability of Esbriet in patients with IPF.RECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY. The CAPACITY program (studies 004 and 006) was designed to evaluate the treatment effect of Esbriet in IPF patients. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96%) were enrolled in RECAP. At Week 72 in RECAP, mean exposure to pirfenidone 2403 mg/d across both studies was 2.9 years (range, 1-4); 114 patients had received Esbriet 2403 mg/d for at least three years. The favorable safety and tolerability profile observed in CAPACITY and other prior clinical trials was confirmed in RECAP. Full Article
InterMune, Inc. Announces Pricing of Concurrent Public Offerings of 4,000,000 Shares of Common Stock and $135 Million Principal Amount of Convertible Senior Notes
InterMune, Inc. announced that it has agreed to sell an aggregate of 4,000,000 shares of its common stock at a price to the public of $24.00 per share and $135.0 million aggregate principal amount of its 2.50% convertible senior notes due 2018 in concurrent underwritten public offerings. InterMune has granted the underwriters 30-day options to purchase up to an additional 600,000 shares of its common stock and up to an additional $20.25 million aggregate principal amount of its convertible senior notes. InterMune estimates aggregate net proceeds from the concurrent offerings to be $221.9 million, after deducting underwriting discounts and commissions and estimated offering expenses. InterMune currently intends to use the net proceeds from the offerings to fund the commercial launch of Esbriet in the European Union, to fund its ASCEND trial and for general corporate purposes. All of the shares of common stock and convertible senior notes are being offered by InterMune The convertible notes will bear interest at a rate of 2.50% per year, payable on September 15 and March 15 of each year, commencing on March 15, 2012. The convertible senior notes will mature on September 15, 2018. . Goldman, Sachs & Co. and J. P. Morgan Securities LLC are acting as joint book-running managers of these offerings. JMP Securities LLC, Leerink Swann LLC, Oppenheimer & Co. Inc. and Wells Fargo Securities LLC are acting as co-managers of these offerings. Full Article
UPDATE 2-Europe's regulator digs in for drug data fight
* EU court stops EMA releasing AbbVie, InterMune drug data
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