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Aug. 25, 2014, 12:46 PM
Aug. 25, 2014, 11:21 AM
Aug. 25, 2014, 9:11 AM
Aug. 25, 2014, 7:12 AM| Aug. 25, 2014, 7:12 AM
Aug. 24, 2014, 5:31 PM
- Roche (OTCQX:RHHBY, OTCPK:RHHBF) will pay $74/share for InterMune (NASDAQ:ITMN), a 38% premium to its Friday close and 63% higher than Aug. 12 when news of a potential sale emerged.
- The deal gives Roche access to pirfenidone, which targets idiopathic pulmonary fibrosis, a disease that causes tissue deep in the lungs to become thick and scarred over time. Analysts predict pirfenidone will generate $1B in global sales by 2019.
- Pirfenidone joins Roche’s stable of pulmonary treatments, including Pulmozyme for cystic fibrosis, Xolair for asthma, and in-development asthma drug lebrikizumab. Roche plans to speed pirfenidone’s U.S. start-up and help get insurance coverage for the medicine.
Aug. 13, 2014, 1:25 PM
- Shares of InterMune (ITMN +14.3%) spike on a 2x surge in volume in response to rumors that Roche (OTCQX:RHHBY +0.4%), Sanofi (SNY +0.7%), Glaxo (GSK -0.1%) and Actelion (OTCPK:ALIOF) (OTC:ACIOY) are preparing offers. Trading in ITMN shares was halted briefly at 1:00 pm EDT due to abnormal volatility.
Aug. 6, 2014, 4:25 PM
- InterMune (ITMN -1.1%) Q2 results: Esbriet Sales: $35.7M (147.9%); Operating Loss: ($62.4M) (-19.3%); Net Loss: ($71.2M) (-13.2%); Loss Per Share: ($0.72) (+6.5%); Quick Assets: $560.2M (+44.8%).
- No guidance given.
Aug. 6, 2014, 4:05 PM
- InterMune (NASDAQ:ITMN): Q2 EPS of -$0.72 misses by $0.15.
- Revenue of $35.7M (+147.9% Y/Y) beats by $1.74M.
Jul. 17, 2014, 3:49 PM
- The FDA grants Breakthrough Therapy Designation (BTD) to InterMune's (ITMN -2.4%) pirfenidone for the treatment of idiopathic pulmonary fibrosis. Under this designation the agency expedites the development and review of the drug. The company resubmitted its NDA in May with a target review period of six months.
Jul. 3, 2014, 7:13 AM
- The FDA acknowledges the receipt of Intermune's (ITMN) resubmitted NDA for pirfenidone. The PDUFA date in November 23, 2014. The agency sent the company a CRL in May 2010 recommending an additional Phase 3 clinical trial to support the efficacy of the product. Pirfenidone is being developed as a treatment for idiopathic pulmonary fibrosis in adult patients.
Jul. 2, 2014, 10:24 AM
- Demonstrating the value of convertible debt, certain holders of InterMune's (ITMN -0.6%) Convertible Senior Notes exchange the debt for shares in several private transactions.
- On June 30 and July 1 certain holders of the company's 2.50% Convertible Senior Notes due 2017 (the "2017 Notes") exchange $41M in aggregate principal amount of the debt for 3,185,703 shares of ITMN common stock ($12.87/share) plus $1,332,500 plus accrued unpaid interest. Based on today's price of ~$44 per share, this represents a tidy $100.5M gain on principal (($44 x 3,185,703 + 1.3M) - 41M).
- Also on July 1, certain other holders of the 2017 Notes exchanged $11.93M in aggregate principal amount for 908,423 shares of common stock plus $1,213,648 representing a conversion price of $12.87 per share and a gain on principal of $29.3M.
- Also on July 1, certain holders of the company''s 5.00% Convertible Senior Notes due 2015 exchange $16.86M in aggregate principal amount of the notes for 893,008 shares of common stock plus $674,400 representing a conversion price of $18.88 and a gain on principal of $23.1M.
- InterMune expects to issue all shares by July 7.
May 27, 2014, 8:24 AM
- It had to complete another Phase 3 trial, but Intermune (ITMN) finally resubmits its NDA for pirfenidone. The FDA sent the company a CRL in May 2010 requiring an additional study to support the drug's efficacy in idiopathic pulmonary fibrosis (IPF).
- CEO Dan Welch says his organization will be able to launch the product in Q1 2015 if the FDA approves it within six months.
- Pirfenidone is currently approved for sale in the EU, Norway, Iceland, Canada, Japan, China, India, South Korea, Argentina and Mexico.
May 20, 2014, 5:38 PM
May 19, 2014, 12:48 PM
- Shares of Intermune (ITMN +14.6%) jump on a 5x surge in volume in response to its report on positive results for its perfenidone Phase 3 clinical trial.
May 19, 2014, 12:45 PM
May 19, 2014, 9:13 AM
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