Baxter International (NYSE:BAX) inks an agreement with Claris Lifesciences Limited to acquire its generic injectables unit, Claris Injectables Limited, for $625M. The deal should close in H2 2017. Baxter says the transaction will be modestly accretive to non-GAAP earnings in 2017 and increasingly accretive thereafter.
The allure of the deal is Claris' expertise in producing injectables in anesthesia, analgesics, renal, anti-infectives and critical care.
Claris Injectables, located in Ahmedabad, India, should deliver annual global revenues in excess of $100M.
Baxter International (BAX +0.5%) commences a Phase 3 clinical trial assessing an investigational drug, Prismocitrate 18, that combines a citrate anticoagulant and renal replacement solution to determine if it extends the extracorporeal (outside the body) circuit life in acute kidney injury patients treated with continuous renal replacement therapy (CRRT). At present, there is no citrate anticoagulant commercially available in the U.S. for use in CRRT.
The prospective multicenter study will enroll ~160 ICU patients in the U.S. and Canada. Participants will be randomized to receive either CRRT with Prismocitrate 18 or CRRT with no anticoagulant. The primary endpoint is the time to occurrence of selected Prismaflex System alarms/conditions for up to 120 hours post treatment initiation. According to ClinicalTrials.gov, the final data collection date for the primary endpoint is November 2017.
One problem with delivering effective CRRT, where blood is passed through an outside-the-body circuit to clean it before returning it to the body, is when blood flow is slowed/stopped by blood clots.
Shire plc (SHPG -3.3%) slumps in early trading on increased volume in apparent response to comments made by Express Scripts (ESRX +2.6%) Chief Medical Officer Steven Miller during a phone interview. He said the company is mulling ways to manage the rising costs of hemophilia medicines without forcing patients to switch treatments. Shire is a major player in the space after its merger with Baxalta. Hemophilia products accounted for over 46% of Baxalta's business in 2015.
The Japanese Ministry of Health, Labor and Welfare approves CSL Behring's IDELVION (Albutrepenonacog Alfa) for the prevention of bleeding tendency in patients with hemophilia B (factor IX deficiency). The specific approval includes routine prophylaxis, on-demand control of bleeding episodes and the perioperative management of bleeding.
IDELVION maintains factor IX activity at an average of 20% when administered prophylactically every seven days and at an average of 12% when administered every 14 days.
Shire plc (NASDAQ:SHPG) has apparently lost its enthusiasm for myelofibrosis candidate pacritinib after mixed results in a mid-stage study. Also dampening the mood was a full clinical hold imposed by the FDA in February due to excessive deaths in the test group due to intracranial hemorrhage, cardiac failure and cardiac arrest.
Shire inherited the program by way of the Baxalta deal. Baxter International (NYSE:BAX) inked a collaboration with discoverer CTI BioPharma (NASDAQ:CTIC) in 2013 to develop the oral tyrosine kinase inhibitor for certain blood-related cancers. Baxter paid CTI $60M upfront and up to $112M in milestones for the privilege.
According to a regulatory filing by CTIC, the companies have entered into a non-binding term sheet regarding the termination of the collaboration agreement and the return of pacritinib to CTIC.
Baxter International (NYSE:BAX) announces the European launch of NUMETA G13E 300 mL, the only ready-to-use parenteral (intravenous) nutrition (PN) product available to treat preterm infants (less than 37 weeks gestation age) who are at high risk for infection and malnutrition in the early hours and days of their lives.
NUMETA G13E addresses an important medical need to support preterm neonatal patients who have acute nutritional requirements by providing a balanced formulation of amino acids (protein), glucose (carbohydrates), lipids (fats) and electrolytes in a triple-chamber system.
Brik Eyre, president of Baxter's Hospital Products business said, ''Baxter’s NUMETA G13E is a well-balanced, ready-to-use formula in a triple-chamber system that simplifies the preparation process for healthcare workers and helps reduce the potential risk to patients of infection and dosing errors.''
First patients receiving NUMETA G13E IV nutrition therapy were located in Sweden.
"We see an obvious flaw in this analysis," says David Einhorn in his Q2 letter to Greenlight Capital investors. He's referring to Andrew Left's Citron's short of Chemours (CC +8.5%). Left contended Chemours could face $5B in liabilities thanks to 3.5K lawsuits from people living near its Teflon plant in Parkersburg, WV. Double-checking with Left, Einhorn found no math to justify that lofty figure.
Others have pegged the liability at just several hundred million dollars, not enough to topple the company.
Greenlight is an owner of 8.8M shares as of March 31.
In other Greenlight news, the hedge fund took advantage of the post-Brexit panic to cover shorts against Intuitive Surgical (ISRG +0.2%), Under Armour (UA -5.8%), and United Rentals (URI +2.3%).
Longs sold out of include: American Capital Agency (AGNC +0.4%), Baxter International (BAX +3.3%), Ingram Micro (IM -0.7%), and Oil States International (OIS +0.7%).
Greenlight fell 2.6% in Q2, bringing it nearly back to break-even for the year.