Shire (NASDAQ:SHPG) has agreed to pay a $350M settlement over U.S. claims that it used "kickbacks and other unlawful methods" to induce doctors to prescribe Dermagraft, a bioengineered human skin substitute.
Deputy U.S. attorney-general Benjamin Mizer, head of the DOJ's civil division, said the settlement was "the largest False Claims Act recovery" in a kickback case involving a medical product.
At #JPM17, Shire plc (SHPG -0.5%) CEO Flemming Ornskov says integrating Baxalta, which it acquired last June, is his organization's number one priority in 2017 and that it is OK to stay on the sidelines at present even if attractive assets become available.
He adds that the company is on track to deliver 2 - 3x EBITDA this year. Deleveraging and achieving 2020 revenue targets are long-term priorities.
Eye drop Xiidra (lifitegrast ophthalmic solution) 5% captured 20% market share within the first five months after launch and is capturing half of all new patients. The FDA approved the dry eye medication in July 2016.
A Phase 3 clinical assessing Shire plc's (SHPG +2.2%) VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgery settings involving patients with severe von Willebrand disease (VWD) met its efficacy primary endpoint. The results will be the basis for a supplemental New Drug Application (sNDA) in the U.S. for the new indication.
The data will be submitted for presentation at an upcoming medical conference (ASH). A marketing application will also be filed in Europe next year.
VONVENDI is currently approved for on-demand treatment and control of bleeding episodes in adults with the bleeding disorder.
People living with VMD lack von Willebrand factor, a key protein involved in blood clotting.
Shire plc (NASDAQ:SHPG) announces the U.S. commercial launch of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] for the treatment of adult and pediatric patients at least two years old with primary immunodeficiency. The FDA approved it in September.
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.
Results from a Phase 2 clinical trial assessing Shire plc's (SHPG +1.3%) maribavir (SHP620) in patients with cytomegalovirus (CMV) infection undergoing hematopoietic stem cell transplant (HSCT) or solid organ transplant showed impressive efficacy. The data were presented at Infectious Disease Week 2016 in New Orleans, LA.
Specifically, 67% (n=80/120) of patients treated with varying doses of maribavir (400 mg - 1200 mg twice daily) for up to 24 weeks had no detectable CMV virus in their blood plasma within six weeks after beginning treatment.
The most common treatment-emergent adverse event was dysgeusia (foul or metallic taste in the mouth).
Shire intends to advance the product candidate to Phase 3 development. Late-stage studies will include two trials: SHP620-302 which will compare maribavir to oral valganciclovir (Roche's Valcyte) in CMV-negative HSCT patients and SHP620-303 which will compare maribavir to investigator's choice of anti-CMV therapy in transplant patients with resistant/refractory CMV infection.
Treatment-resistant CMV infection is a substantial problem in transplant patients and is associated with significant complications and high mortality.
Maribavir is an antiviral drug called a benzimidazole riboside. It is believed to fight CMV by inhibiting DNA assembly and the escape of viral capsids from the nuclei of infected cells. It was originally developed by ViroPharma which Shire acquired in November 2013.
Baxalta (NASDAQ:SHPG) and CTI BioPharma (NASDAQ:CTIC) have signed an agreement returning pacritinib to CTI. Under the terms of the contract, Baxalta will pay CTI a one-time cash payment of $10.3M as reimbursement for certain incurred or expected-to-be incurred expenses. CTI will repay the $10.3M upon the first regulatory approval or any pricing/reimbursement approval of any product containing pacritinib.
The original collaboration was with Baxter International, begun in 2013.
Baxalta, now Shire, cooled to developing pacritinib after mixed-results in a mid-stage myelofibrosis study and an FDA clinical hold due to certain side effects.
Pacritinib, an oral tyrosine kinase inhibitor, was under development for the potential treatment of certain blood-related cancers
The European Commission approves Shire plc's (NASDAQ:SHPG) Marketing Authorization Application (MAA) seeking approval of ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate), in combination with chemotherapy agents 5-fluorouracil (5-FU) and leucovorin (LV), for the treatment of adult patients with metastatic adenocarcinoma of the pancreas who have progressed after gemcitabine-based therapy. The approval follows a positive CHMP opinion in July.
The data supporting the application was generated in the Phase 3 NAPOLI-1 study which showed treatment with the combination extended overall survival, progression-free survival and objective response rate compared to 5-FU/LV alone.
ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
Shire has global development and commercialization rights to ONIVYDE except in the U.S. and Taiwan which is the responsibility of Merrimack Pharmaceuticals (NASDAQ:MACK).
MACK is up 8% premarket on average volume. SHPG is 2% on light volume.
The Fly reports that Shire plc (NASDAQ:SHPG) is closing in on a "multi-billion dollar" take out of biopharmaceutical firm Radius Health (NASDAQ:RDUS). Its lead product candidate is Abaloparatide-SC, under regulatory review for the treatment of osteoporosis.
In premarket trading, RDUS is up 4% on average volume while SHPG is down 2% on average volume.
Kamada Ltd. (NASDAQ:KMDA) announces that it has extended its GLASSIA [Alpha-1 Proteinase Inhibitor (Human)] agreement with Shire plc (NASDAQ:SHPG) for the fourth time since 2010. It will now produce the product for Shire through 2020, after which Shire may produce it and pay Kamada a royalty.
During the new contract term, Kamada will recognize ~$237M in revenue with a potential upside of $288M. Shire's revenue target for 2017 is $100M.
Shire is the exclusive distributor of GLASSIA in the U.S., Canada, Australia and New Zealand and is licensed to produce the product in those countries.
GLASSIA is a ready-to-use IV plasma-derived Alpha-1 Antitrypsin (AAT) product approved in the U.S. for the treatment of clinically evident emphysema due to severe AAT deficiency.
Slingshot Insights is hosting an exert interview today at 2:00 pm ET focused on non-alcoholic steatohepatitis (NASH), a sizable market opportunity for drug makers that many call the "next hepatitis C." The space has heated up recently stoked by Allergan's (NYSE:AGN) $1.7B takeout of Tobira Therapeutics (NASDAQ:TBRA) and $50M acquisition of privately held Akarna Therapeutics.
SA subscribers should use their 90-day coupon code SA_Sub16.
Shire plc (NASDAQ:SHPG) terminates its collaboration agreement with Momenta Pharmaceuticals (NASDAQ:MNTA) to develop and commercialize M923, a biosimilar to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab). It made the decision after an assessment of its product portfolio following the Baxalta acquisition.
Under the terms of the 2011 collaboration agreement between Baxalta and Momenta, the deal will terminate 12 months following the formal notice. Shire will continue to fund the M923 program until then, although preparations to transfer all clinical, regulatory and commercialization activities to Momenta will begin immediately.
Momenta better get busy. The FDA just approved Amgen's (NASDAQ:AMGN) version and Samsung Bioepis' version, to be marketed by Biogen (NASDAQ:BIIB), is under regulatory review in Europe. Germany's Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) is also in the mix. Indian outfit Cadila Healthcare launched its HUMIRA biosimilar in India in September 2014.