Shire plc (NASDAQ:SHPG) is up 2% premarket on light volume on the heels renewed takeover rumors for the specialty drugmaker. London's Evening Standard reports that several big players in Europe and the U.S. have hired advisors ahead of a possible run at the company. Shire, in turn, has engaged its own advisors to fend off potential lowball bids.
AbbVie was poised to buy the company for ~$52B in 2014 before the U.S. government's clampdown on tax inversions scuppered the deal.
Shire plc (NASDAQ:SHPG) is down 4% premarket on increased volume as investors weigh the potential competitive encroachment to its hemophilia franchise. Heading the list is Roche with hemophilia A candidate emicizumab.
Others recently reporting positive data include BioMarin Pharmaceutical and uniQure.
A German court enjoins Roche (OTCQX:RHHBY -0.7%) from making certain promotional statements about the supposed advantages of its hemophilia A med emicizumab compared to Shire's (SHPG -3.1%) FEIBA. Shire accused Roche of making "incomplete and misleading" statements about FEIBA-related adverse events in Roche studies, specifically the risk of thromboembolic events. Shire's global chief of its hematology franchise Juliana Dierks accuses Roche of failing to provide adequate data to back up its claim.
The Hamburg court has jurisdiction since Roche is preparing to present emicizumab data at a medical conference in Berlin this week.
Roche aims to capture a big slice of the $11B global hemophilia drug market, principally at the expense of current leader Shire. Some analysts believe emicizumab could generate peak sales of $5B.
Shire plc (NASDAQ:SHPG) announces the submission of an investigational new drug application to the FDA for SHP654, also designated as BAX 888, an investigational factor VIII gene therapy for the treatment of hemophilia A.
SHP654 aims to protect hemophilia A patients against bleeds through the delivery of a long-term, constant level of factor expression.
Hemophilia A, the most common type of hemophilia, is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII in the blood, with more severity associated with lower amounts of factor.
The FDA approves CSL Behring's HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]) for the prevention of hereditary angioedema (HAE) attacks in adolescent and adult patients. U.S. commercial launch will commence shortly.
In clinical studies, treatment with HAEGARDA reduced HAE attacks by 95% and reduced the use of rescue medications 99%.
HAE, an inherited condition characterized by debilitating episodes of swelling, is caused by mutations in C1-INH, a protein in the blood that helps control inflammation.
Shire plc (NASDAQ:SHPG) is up 2% premarket on light volume after it announced that the European Medicines Agency (EMA) has accepted for review its marketing application seeking approval of VEYVONDI [von Willebrand factor (Recombinant)] for the on-demand treatment and control of bleeding episodes of adults with von Willebrand disease, an inherited bleeding disorder.
The product is currently marketed in the U.S. under the brand name VONVENDI, approved by the FDA in December 2015.
Shire plc (NASDAQ:SHPG) is up 1% premarket on light volume after the FDA approved MYDAYIS (mixed salts of single-entity amphetamine product) for the treatment of attention deficit/hyperactivity disorder ((NASDAQ:ADHD)) in patients at least 13 years old. Commercial launch in the U.S. will commence next quarter.
MYDAYIS, formerly SHP465, is designed to control symptoms for up to 16 hours.
Valeant Pharmaceuticals (NYSE:VRX) popped 4.4% in today's trade after Cantor Fiitzgerald initiated coverage with an Overweight rating, in a broadly upbeat view on specialty pharma companies.
Cantor believes concerns about insolvency are overdone because VRX can lower its debt to a manageable level, and sees headline risks coming down, removing another overhang on the shares.
The firm also notes VRX expects 50 new product launches to drive an incremental $100M of sales this year; although $100M is not large relative to $8.5B-plus of VRX sales seen this year net of divestitures, "some of these upcoming launches have the potential to be blockbuster drugs over time."
Along with VRX, Cantor also initiates Zoetis (NYSE:ZTS), Theravance Biopharma (NASDAQ:TBPH), Shire (NASDAQ:SHPG), Perrigo (NASDAQ:PRGO), Mallinckrodt (NYSE:MNK), Impax Labs (NASDAQ:IPXL), Horizon Pharma (NASDAQ:HZNP) and Aclaris Therapeutics (NASDAQ:ACRS) at Overweight, as management already has started to pivot from the old model of constantly rising prices, and the companies that can "innovate and/or save the healthcare system money can thrive under the new order."
Prompted by slow recruitment in the first part of a Phase 2/3 study and other pipeline priorities, Shire plc (NASDAQ:SHPG) transfers its IND for Graft-Versus-Host Disease (GvHD) candidate Alpha-1 Antitrypsin (G1-AAT IV) to Kamada Ltd. (NASDAQ:KMDA), who is developing the product in the EU.
Shire has stopped the U.S. study. Kamada will resume U.S. development in the next few months after standardizing the study design.
G1-AAT IV has Orphan Drug status in both the U.S. and EU for the indication.
Kamada and Shire (Baxter at the time) inked an agreement in 2010 for Kamada's IV AAT under which Shire has exclusive rights in the U.S., Canada, Australia and New Zealand. The companies will continue to collaborate on developing AAT IV for prevention of lung transplant rejection.
Xenetic Biosciences (NASDAQ:XBIO) announces a disappointing outcome from a Phase 1/2 clinical trial conducted by collaboration partner Shire (NASDAQ:SHPG). The study assessed SHP656, a long-acting recombinant Factor VIII (rFVIII) for the treatment of hemophilia A.
The study demonstrated the pharmacokinetics and efficacy consistent with an extended half-life rFVIII product but it failed to demonstrate the minimum efficacy for once-weekly dosing.
SHP656 is based on Xenetic's PolyXen platform technology to conjugate polysialic acid to therapeutic blood-clotting factors.
Despite the setback, the companies say they will explore additional collaborations.
A Phase 2 clinical trial, TURANDOT, assessing Shire's (SHPG +3.5%) anti-mucosal addressin cell adhesion molecule 1 (MAdCAM-1) for the treatment of adult patients with moderate-to-severe ulcerative colitis (UC) met its primary endpoint and secondary endpoints. The results were just published in The Lancet.
At week 12, 16.7% of patients receiving 22.5 mg of MAdCAM-1 achieved remission as did 15.5% who received 75 mg. The rates were significantly greater than placebo in three of the four arms.
Discontinuations due to treatment-emergent adverse events were less than 5% . There was one death due to adenocarcinoma of the colon which was unlikely to be related to the study drug according to the data monitoring committee.
A Phase 3 study should commence next quarter.
Shire licensed MAdCAM-1 from Pfizer about a year ago.
Shire plc (NASDAQ:SHPG) is up 6% premarket on increased volume in response to its announcement of positive results from a Phase 3 clinical trial, HELP, assessing lanadelumab for the treatment of hereditary angioedema (HAE), an inherited disorder characterized by recurrent swelling in the extremities, GI tract and upper airways.
The study met it s primary endpoint and all secondary endpoints. Patients receiving 300 mg of lanadelumab once every two weeks experienced a statistically significant reduction in average HAE attack frequency of 87% compared to placebo (p<0.001). The trial was representative of the full HAE disease spectrum.
The company intends to file its U.S. marketing application in Q4 or Q1 2018. It has Orphan Drug and Breakthrough Therapy status in the U.S. and Orphan Drug status in the EU.
Lanadelumab is a human monoclonal antibody that binds to (inhibits) an enzyme called plasma kallikrein that plays a key role in blood pressure regulation, thrombosis and inflammation.