Target $23
Tuesday, July 9, 2019
Roche Hemlibra data show continued benefits in hemophilia A at ISTH 2019
- New analyses from phase III HAVEN studies support Hemlibra’s sustained efficacy, safety and quality of life benefit in people with haemophilia A, with and without factor VIII inhibitors
- First data of phase IIIb STASEY study reinforces safety profile of Hemlibra seen in pivotal HAVEN 1 clinical trial
- New analysis of pivotal data suggests additional factor treatment may not be needed for people on Hemlibra undergoing certain minor surgery
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data for Hemlibra® (emicizumab) across multiple pivotal studies in people with haemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress on 6-10 July in Melbourne, Australia. In total, Roche presented 21 abstracts from its haemophilia programme, including five oral presentations. Further data from the four pivotal HAVEN clinical trials were presented, demonstrating the long-term safety, efficacy and quality of life benefit of Hemlibra in people with haemophilia A with and without factor VIII inhibitors. Roche also presented the first interim analysis from the phase IIIb STASEY study, reinforcing the safety profile of Hemlibra in adults and adolescents (aged 12 years or older) with haemophilia A with factor VIII inhibitors seen in the HAVEN 1 clinical trial.
“Data presented at ISTH continues to reinforce Hemlibra’s potential to redefine the standard of care for people living with haemophilia A,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are particularly excited to present the first interim analysis of safety data from the STASEY study, which adds to the growing body of evidence supporting Hemlibra as an important treatment option for people with haemophilia A.”
Teva unloads plant, U.S. OTC line to PL Developments
There are only three manufacturing sites in the world approved by the FDA to make nicotine gum and Teva has sold one, along with its U.S. portfolio of OTC products, to a company that is all about store brands.
Westbury, New York-based PL Developments says the nicotine gum operations it bought from Teva will compliment the nicotine lozenges business it already has. The deal also comes with 40 approved and pending generic products and over-the-counter products. Terms of acquisition to the private, family-owned company were not disclosed.
“Adding Teva’s nicotine chewing gum ANDAs to our recently approved nicotine lozenge ANDA, gives PLD one of the most comprehensive portfolios in the high-value NRT (nicotine replacement therapy) space,” the company said in its announcement. “The acquisition significantly reinforces PLD’s position as the second largest packager and distributor of U.S. store-brand drugs.”
In addition to several copies of Nicorette products, the sale includes knockoffs of Rogaine products, Claritin D and others.
PLD President Evan Singer told Newsday that the deal includes a 93,000-square-foot manufacturing facility in Copiague, New York with about 80 employees. He said it is one of three the FDA has approved globally to make nicotine gum.
The company, which sells to chains like Walmart and Costco, has moved into other product areas through M&A in the past. In 2013, it expanded beyond its base in solid dose products with the acquisition of Aaron Industries, a liquid dose maker in Clinton, South Carolina.
In 2016, PLD invested about $45 million to build another manufacturing and distribution site in South Carolina. The one in Piedmont, South Carolina, was its sixth site.
Teva, on the other hand, has been aggressively shedding manufacturing facilities for several years. It targeted about 40 facilities and 14,000 jobs as part of a $3 billion cost-cutting endeavor after misguided acquisitions and a softening U.S. generics market left it struggling financially.
MorphoSys, Vivoryon Agree on Small Molecule Inhibitors in Immuno-Oncology
Vivoryon Therapeutics AG(Euronext Amsterdam: VVY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) today announced that they have entered into an agreement under the terms of which MorphoSys has obtained an exclusive option to license Vivoryon’s small molecule QPCTL inhibitors in the field of oncology. The option covers worldwide development and commercialization for cancer of Vivoryon’s family of inhibitors of the glutaminyl-peptide cyclotransferase-like (QPCTL) protein, including its lead compound PQ912. In exchange, MorphoSys has committed to investing up to EUR 15 million in a minority stake in Vivoryon Therapeutics as part of a capital raise planned for later this year.
While Vivoryon’s lead drug candidate PQ912 has already completed a phase 2a clinical trial in Alzheimer’s disease, recent preclinical data strongly suggest that the compound could represent a novel approach for cancer therapy. Vivoryon’s orally available compounds target the QPCTL enzyme, which has been shown to be a modulator of the CD47-SIRP alpha interaction. Left unchecked, this interaction, known as the “don’t eat me” signal, allows cancer cells to escape the body’s innate immune defense through inhibition of the phagocytic activity of macrophages. During the option period, MorphoSys will conduct preclinical validation experiments on Vivoryon’s family of QPCTL inhibitors, including an assessment of the potential benefits of combining them with MorphoSys’s proprietary program tafasitamab (MOR208), which is currently in late-stage development for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).
“This deal gives us access to a unique set of drug candidates with exciting potential in cancer”, said Dr. Simon Moroney, CEO of MorphoSys. “A number of studies suggests that the CD47-SIRP alpha interaction may be of central importance to the activity of some anti-cancer antibodies. In this regard, securing rights to Vivoryon’s estate of compounds in oncology makes strong strategic sense for us. In particular, we are looking forward to exploring the potential for synergy with tafasitamab (MOR208), our most advanced drug candidate. If successful, the use of these orally formulated QPCTL inhibitors may open the way to combinations with other anti-cancer antibodies aiming at boosting their cell killing activity.”
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