Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

March 31, 2016 By Mark Terry , BioSpace.com Breaking News Staff Irish firm Mallinckrodt Pharmaceuticals is rumored to be in discussions with advisers on selling its nuclear imaging division. Mallinckrodt Nuclear Imaging manufactures radio-pharmaceuticals used in cancer detection. In 2015 the division reported net sales of $424 million, responsible for about 11 percent of the company’s overall sales of $3.7 billion. The company was founded in 1867 in St. Louis, Mo. In 2013 the company was spun out of Covidien . Covidien was acquired by Medtronic Plc in 2014, which had moved its tax domicile to Ireland in 2007. In 2015 Mallinckrodt indicated plans to sell its global contrast media and delivery systems units to French company Guerbet for $270 million. The stated intention was to focus on higher growth areas. The nuclear unit potentially up for sale runs out of a facility in Maryland Heights, near St. Louis. “Our CMDS operation is a strong cash-generation business, and we have made significant progress in driving cash and profitability this fiscal year,” Mark Trudeau , the company’s president and chief executive officer said in a statement in July, 2015. “However, with our strategic goals and priorities focused in the specialty biopharmaceutical space, we believe Mallinckrodt is no longer the best long-term owner for this portfolio. Given its long industry experience and strong European and South American footprint, we believe Guerbet is ideally situated to maximize the value of this business.” In a move that seems somewhat contradictory to today’s rumors, on Mar. 10, Mallinckrodt announced that it was re-entering the radiopharmaceutical Xenon Xe 133 Gas (Xenon 133) market. This would expand its portfolio for U.S. nuclear medicine patients. “We are pleased to provide our customers with a choice when selecting Xenon 133 to help diagnose patient disease for approved indications,” said Dan Brague , Mallinckrodt’s vice president and general manager, Nuclear Imaging, in a statement. “As a global leader in nuclear medicine, Mallinckrodt’s commitment to the industry is evidenced by our ongoing investments in nuclear medicine, including making Xenon 133 available to clinicians across the U.S., with a focus on long-term supply.” In September 2015 the company acquired U.K.-based Therakos from The Gores Group for about $1.325 billion. This investment expanded the company’s reach into the hospital market, specifically into immunotherapy through extracorporeal photopheresis (ECP), and into critical respiratory therapies in neonatal intensive care units. And more recently, on Feb. 1, 2016, Mallinckrodt announced it had closed on the acquisition of the global portfolio of three commercial-stage topical hemostasis drugs from The Medicines Company . The compounds include Recothrom Thrombin, PreveLeak Surgical Sealant and RAPLIXA. The company will invest in market development of the three compounds, which is also a push into the hospital market. No financial details were provided, although it was noted that the market for these types of assets are about $750 million in the U.S. annually, and at least $1 billion worldwide.

June 26, 2015 By Mark Terry and Riley McDermid , BioSpace.com Breaking News Staff Parsippany, N.J.-based The Medicines Company is considering selling its European business, Bloomberg News reported this week, and is working with consulting bank Rothschild to evaluate options. The Medicines Company ’s lead product is Angiomax, an anticoagulant that brought in $636 million last year, primarily in the U.S. It is marketed in Europe as Angiox. Earlier this year the European Commission approved three of the company’s drugs, Kengreal (cangrelor), an anticoagulant, Orbactive, for skin infections, and Raplixa, which is used during surgery to stop bleeding. PCI is percutaneous coronary intervention. “The approval of Kengreal provides a new option for PCI,” said Clive Meanwell , chairman and chief executive officer of The Medicines Company in a statement. “The novel drug will potentially decrease thrombotic risk in the acute care setting, deliver value to the healthcare system alongside Angiomax, and help us to increase our commercial offerings in the cath lab.” Keangreal was approved on June 22 by the U.S. Food and Drug Administration (FDA) as an alternative to other blood-thinning medications such as clopidogrel, a generic version of Plavix, a Bristol-Myers Squibb Company product. “In the U.S., the vast majority of PCI procedures are done on an ad hoc basis because clinicians want to define the coronary anatomy prior to making a treatment decision,” said J. Jeffrey Marshall , director of the Cardiac Cathertization Lab at the Northeast Georgia Medical Center in a statement. “Cangrelor provides a benefit because it allows for antiplatelet therapy to be initiated just after the decision for PCI has been made.” However, Angiomax sale dropped 35 percent to $100.7 million in the first quarter of this year, and could drop even more if a generic version hits the U.S. The Medicines Company stock has been on a roller coaster ride this last year. Shares traded for $20.36 on Oct. 13, 2014, rose to $27.96 on Dec. 29, 2014, then dropped back down to $24.63 on Jan. 9, 2015. It then spiked on March 19, 2015 to $31.29 before dropping down to $25.58 on May 7. It is currently trading for $29.94. Leerink Swann raised its price target on Thursday for the company from $33 to $35, and has it ranked as “outperform.” Analysts at Zacks upgraded from “sell” to “hold” on Tuesday, June 9. Guggenheim analysts set a price target of $42 and gave it a “buy” rating on June 2. RBC Capital analysts kept it at “outperform” and set a price target of $39 on May 9, up from a previous $38.00. And JPMorgan Chase & Co. analysts raised the price target from $31 to $32 and rated it as “overweight” on May 6. The company will see a dynamic 2015, with several major pipeline “catalysts” and a late-stage pipeline that has been bogged down by regulatory approvals and litigation soon having both those problems solved, Jonathan Eckard , a biotech analyst at Citi , said earlier this spring. MDCO ‘s 2014 revenue beat the Street, at $191 million versus a consensus of $189.8 million and Citi ‘s estimate of $188.1 million. Generally accepted accounting principles earnings per share was $0.08 versus a consensus of $0.82 and Citi’s $0.96. So far, the company has no provided any financial guidance for 2015, because investors are wary of ongoing litigation surrounding Angiomax, though that could soon change, said Eckard. “The focus for MDCO has been on the exclusivity of lead revenue driver Angiomax; however, there are multiple pipeline programs which, if catalysts fall the right way, could change how the Street views the outlook for the company,” he wrote in a note to investors. “While we see several pipeline catalysts with potential to capture broader attention, many are hard to predict with markets that are not well understood. We would like to see some early positive news on any program to gain confidence.” In the meantime, Eckard predicted that the main focus will likely remain on Angiomax litigation with updates on the current appeal trial likely sometime during mid-year. Early trial results are expected for MDCO ‘s drugs ALN-PCS (antisense PCSK9) and ABP-700 (rapid on/off general anesthetic) around mid-year with potential to move the needle for the stock. As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be? Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo. Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo , a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK) . So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. 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