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Stock Market & Financial Investment News

News Breaks
April 11, 2014
18:44 EDTAGN, JNJJ&J halting development of Botox competitor, WSJ says
Johnson & Johnson (JNJ) is ending development of an anti-wrinkle treatment that was aimed at challenging Allergan's (AGN) Botox, reports The Wall Street Journal, citing a company spokesman. Reference Link
News For JNJ;AGN From The Last 14 Days
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July 6, 2015
07:10 EDTAGNHorizon Pharma files patent infringement lawsuits against five companies
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07:04 EDTAGNAllergan to acquire Oculeve dry eye disease development programs
Allergan and Oculeve announced that they have entered into an agreement under which Allergan will acquire Oculeve in an all-cash transaction. Under the terms of the agreement, Allergan will acquire Oculeve for a $125M upfront payment and commercialization milestone payments related to Oculeve's lead development program OD-01. The agreement also includes the acquisition of an additional earlier-stage dry eye device development program. Allergan's 2015 earnings-per-share forecast provided on May 11, 2015 is unchanged as a result of the acquisition. The company remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016. The acquisition of Oculeve adds novel, complementary dry eye development programs to Allergan's current eye care research and development programs, including OD-01, a non-invasive nasal neurostimulation device that increases tear production in patients with dry eye disease. Oculeve has completed four clinical studies of OD-01 to date in more than 200 patients, showing positive safety and efficacy of the device. Allergan plans to conduct two additional pivotal trials prior to FDA submission, which is expected in 2016 with potential commercial launch in 2017. The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Pending approvals, Allergan anticipates closing the transaction in the third quarter of 2015.
July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gilead’s emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDA’s acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
June 29, 2015
17:22 EDTAGNAllergan reports 6.7% stake in KYTHERA
June 25, 2015
08:13 EDTAGNAllergan CEO: Irvine campus ‘crucial’ to company, L.A. Times reports
New Allergan CEO Brent Saunders said that the company’s Irvine, California campus is “crucial” to the recently purchased organization, the L.A. Times reports, citing comments from Saunders in an interview. Allergan was purchased in March by Actavis, a move which led to the layoff of roughly 600 employees from the Irvine offices, the report says. Saunders said that the “bleeding has stopped” after a round of layoffs, the L.A. Times says. Reference Link

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