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June 26, 2014
08:42 EDTIG, MNKMallinckrodt grants IGI Labs non-exclusive license to launch generic PENNSAID
IGI Laboratories (IG) announced that it has entered into an agreement with Mallinckrodt (MNK) and Nuvo Research to settle a declaratory judgment action brought by IGI, concerning IGI's filing of an abbreviated new drug application with the FDA seeking approval to market a generic version of PENNSAID 1.5% w/w. Under the terms of this agreement, Mallinckrodt granted IGI a non-exclusive license to launch its diclofenac sodium topical solution 1.5% product on March 28, 2015. IGI received tentative approval of its diclofenac sodium topical solution 1.5% from the FDA on May 7. IGI CEO Jason Grenfell-Gardner said, "The agreement provides IGI with a date certain launch of diclofenac sodium topical solution 1.5%. We remain confident in our ability to obtain final FDA approval of our ANDA for diclofenac sodium topical solution 1.5% prior to our agreed upon launch date. The agreement allows IGI to continue to expand its portfolio of generic topical prescription drug products."
News For IG;MNK From The Last 14 Days
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May 29, 2015
17:43 EDTMNKOrexigen in manufacturing pact with Mallinckrodt for naltrexone
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May 28, 2015
09:24 EDTMNKJefferies sees Pharma M&A continuing, lists 22 possible targets
Jefferies analyst David Steinberg believes the M&A wave in the Pharmaceuticals space that began in 2005 can continue as the key drivers remain largely intact. In a note titled "Who is Next? The Feeding Frenzy in Specialty Pharmaceuticals," Steinberg sees deals continuing amid cheap debt, the push for lower corporate taxes and investors rewarding many acquirers for their transactions. He points out there are now around 100 publicly traded Specialty Pharmaceutical companies following the recent life sciences IPO boom. Potential takeover targets, according to Steinberg, include Valeant (VRX), Shire (SHPG), Perrigo (PRGO), Zoetis (ZTS), Mallinckrodt (MNK), Jazz Pharmaceuticals (JAZZ), United Therapeutics (UTHR), Pacira (PCRX), Indivior, Insys Therapeutics (INSY), The Medicines Co. (MDCO), Depomed (DEPO), Spectrum (SPPI), KYTHERA (KYTH), Revance (RVNC), XenoPort (XNPT), Mylan (MYL), Akorn (AKRX), Impax (IPXL), Amphastar Pharmaceuticals (AMPH), Anacor (ANAC) and BioDelivery Sciences (BDSI).
08:04 EDTIGIGI Laboratories submits third ANDA in 2015
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May 27, 2015
09:14 EDTIGIGI Laboratories management to meet with Craig Hallum
Meeting to be held in Chicago on May 28 hosted by Craig Hallum.
08:05 EDTIGIGI Laboratories sees FY15 revenue $35M-$45M, consensus $38.69M
Expects sequential improvement in quarter over quarter in total revenue for the remainder of the year. Sees FY15 gross margin 43%-50% due to sequential improvement in gross margin quarter over quarter for the remainder of the year. The company continues to expect to submit an additional four ANDAs before June 30, 2015, and intends to have submitted a total of 20 ANDAs by the end of 2015. In order to complete all of the development work required for the 2015 filings, the company expects to spend between $13M and $14.5M in research and development by the end of 2015. As a result of the expected sequential increase in total revenue in the third and fourth quarter of 2015, the company intends to return to a break-even operating margin in the fourth quarter of 2015.
08:05 EDTIGIGI Laboratories sees Q2 revenue $7M-$8M, consensus $9.78M
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May 15, 2015
09:31 EDTMNKAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.

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