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Tuesday, September 18, 2018

Europe Regulator Validates Bristol Application for Multiple Myeloma Combo


Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Medicines Agency  (EMA) has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
“Given the need for new treatment options for patients with multiple myeloma, we look forward to working closely with the EMA as they review this application,” said Fouad Namouni, M.D., head, oncology development, Bristol-Myers Squibb. “It is our hope that this new Empliciti-based combination will soon become available for patients in the European Union with multiple myeloma, whose disease progressed on lenalidomide and a PI.”
The application is based on data from ELOQUENT-3, a randomized Phase 2 study evaluating the EPd combination versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). Data from this study were presented at the 23rdCongress of the European Hematology Association in June.
Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

Changes to Pharmacy Industry Coming as DOJ Approves Cigna-Express Scripts Deal


In March, U.S. insurer CIGNA Corporation announced it was acquiring pharmacy benefits manager Express Scripts for approximately $52 billion. On Monday, the Department of Justice (DOJ) approved the merger.
The New York Times reports, “These combinations of powerful health insurance companies with the country’s dominant pharmacy benefit managers are occurring as established players in the health care sector are frantically searching for ways to fend off potential interlopers like Amazon, whose tentative forays into the pharmacy business have already shaken up the industry.”
Insurer Aetna is also in the process of merging with CVS Health, a $69 billion deal announced in December 2017. The DOJ is still reviewing that deal, although it is expected to be approved. CVS has 9,700 retail pharmacies and 1,100 walk-in clinics, but the significance of the deal is its pharmacy benefits manager enterprise. In 2016, it generated net revenue of $177.5 billion.
Cigna is offering $48.75 in cash and 0.24334 shares of stock of the combined company for each share of Express Scripts. This totals $96.03 per share, a premium of about 31 percent on top of Express Scripts’ closing price at the March announcement. The total transaction has a value of $67 billion, including $15 billion in Express Scripts’ debt.
Once the deal is finalized, Cigna shareholders will have about 64 percent of the combined company, with Express Scripts shareholders in control of the remaining 36 percent. Once the deal closes, the combined company is expected to have about $41.1 billion in debt. Cigna plans to fund the cash part of the deal with a combination of its own cash, Express Scripts debt and new debt issuance. It has debt financing from Morgan Stanley Senior Funding and The Bank of Tokyo-Mitsubishi UFJ.
Mergers in this area being blocked is not unprecedented. In early 2017, courts blocked a proposed merger between Cigna and Anthemvalued at $48 billion. And another judge blocked a deal between Aetna and Humana worth $37 billion.
Express Scripts is the largest PBM in the U.S., handling drug plans for more than 80 million people, including the U.S. Department of Defense.
Many are interpreting the deal as a realization by these established companies that their business models need to change as customers and the government demand better drug price controls. Insurers and pharmacy benefit managers are middlemen for employers and governments, and, The New York Times notes, “the proposed mergers are an attempt to convince their customers that they are working to reduce costs.”
Not only has the possible entry of Amazon into the pharmacy business worried the industry, but Berkshire Hathaway’s Warren Buffet, Amazon’s Jeff Bezos and JP Morgan Chase’s Jamie Dimon created a joint venture to cut healthcare costs and improve services. Atul Gawande is the chief executive officer of the joint venture. The three companies have 840,000 to 1.2 million employees worldwide and many industry-watchers believe that whatever the unnamed company comes up with may have a ripple effect throughout the industry.
The New York Times notes that the approval of this new deal signals “an acceptance of so-called vertical mergers in which companies, although in the same broad line of business, do not directly compete…. Federal officials emphasized that they did not believe the merger would damp competition in the pharmacy business.”
“Quality health care and competitive pricing for health care services and pharmaceutical drugs is critical to U.S. consumers,” stated an assistant attorney general, Makan Delrahim, in a statement on Monday.

Universal Health upgraded to Buy on accelerating growth at BofA/Merrill


As previously reported, BofA/Merrill upgraded Universal Health to Buy from Neutral and raised its price target to $155 from $128. Analyst Kevin Fischbeck expects the company’s psych business to reaccelerate and reach its 5% growth goal as it nears the Department of Justice settlement and easier comps in 2H. The analyst also expects Universal’s acute care business to continue to perform better given exposure to higher growth markets.

Eli Lilly price target raised to $112 from $107 at Barclays


Barclays analyst Geoff Meacham raised his price target for Eli Lilly to $112 and maintains an Overweight rating on the shares. The analyst continues to like Lilly’s positioning in the second half of 2018 and 2019 given its “differentiated growth profile.” Trulicity is poised to continue growth regardless of the REWIND data outcome, Meacham tells investors in a research note titled “Remaining Bullish Ahead of REWIND.”

Tilray announces U.S. DEA approval to import medical cannabis study drug


Tilray announced that the U.S. Drug Enforcement Administration as granted approval to import a cannabinoid study drug into the United States from Canada for a clinical trial at the University of California San Diego Center for Medicinal Cannabis Research examining its safety, tolerability and efficacy for Essential Tremor. Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol and tetrahydrocannabinol. Dr. Fatta Nahab, a board-certified neurologist and director of the Functional Imaging of Neurodegenerative Disorders Lab at the UC San Diego Health’s Movement Disorder Center, will serve as the principal investigator for the study. It is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation. Essential Tremor is a neurological movement disorder characterized by involuntary and rhythmic shaking. ET has extremely high prevalence rates; 0.4% of the general population suffer from ET, and that figure rises to 4.6%-6.3% among those 65 and older. Essential Tremor can have a significant impact on a patient’s quality of life, causing embarrassment, social withdrawal, disability, and loss of occupation. Many patients do not experience relief with the current drugs on the market or find the side-effects of these drugs to be unbearable.

AstraZeneca says FASENRA shows consistent safety, efficacy in trial


AstraZeneca announced results from the Phase III extension BORA trial evaluating the long-term safety and efficacy of FASENRA as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase III trials. In the BORA trial, FASENRA given for an additional 56 weeks showed a safety and tolerability profile similar to that observed in the placebo-controlled SIROCCO and CALIMA trials, with no increase in the frequencies of overall or serious adverse events. The improvements in efficacy measures observed with FASENRA in the SIROCCO or CALIMA trials were maintained over the second year of treatment. Patients who were treated with placebo in the SIROCCO and CALIMA trials and subsequently transitioned to FASENRA in the BORA trial experienced improvements in efficacy outcomes consistent with those observed for FASENRA-treated patients in the previous trials. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus. 74% of patients with a baseline blood eosinophil count of 300 cells per muL or greater who received FASENRA every eight weeks continuously from SIROCCO or CALIMA and into BORA, were exacerbation-free in BORA in their second year of treatment and maintained improvements in lung function and asthma control. 65% and 66%, respectively, of patients with a baseline blood eosinophil count of 300 cells per muL or greater who received FASENRA 30 mg every eight weeks were exacerbation-free their first year of treatment in the one-year, predecessor SIROCCO and CALIMA trials. The BORA data will be presented during a late-breaking oral session at the European Respiratory Society International Congress 2018 in Paris, France. The overall annual asthma exacerbation rate for patients with baseline blood eosinophil counts of 300 cells per muL or greater who received FASENRA every 8 weeks continuously was consistent with the predecessor SIROCCO and CALIMA trials. Overall improvements in lung function, asthma control, asthma-related and general health-related quality of life scores were maintained for patients who received FASENRA continuously and were improved for patients previously receiving placebo in SIROCCO or CALIMA. Near complete eosinophil depletion was maintained in patients who continuously received FASENRA. The most commonly-reported adverse events in BORA were upper respiratory tract infection, worsening asthma, headache, bronchitis and acute sinusitis. The most commonly-reported adverse events in SIROCCO, CALIMA and ZONDA were headache and pharyngitis.

Novo Nordisk announces plans to restructure R&D


Novo Nordisk announced plans to restructure its Research & Development, or R&D, organization to accelerate the expansion and diversification of its pipeline across serious chronic diseases. To enable increased investment in transformational biological and technological innovation within both core and new therapy areas, approximately 400 employees will be laid off from R&D roles in Denmark and China. To support its strategic ambitions, Novo Nordisk will establish four Transformational Research Units in 2018 to pursue novel treatment modalities and platform technologies. The biotech-like units, based in Denmark, the US and the UK, will operate as satellites of Novo Nordisk’s central R&D function and will drive innovation in priority fields such as translational cardio-metabolic research and stem cell research. Furthermore, to drive a faster and more efficient path towards lead molecule selection and development, Novo Nordisk will significantly increase its investment in automation and digital capabilities including machine learning and artificial intelligence. The integration of laboratory infrastructure and IT systems will also be prioritized to increase the efficiency of the R&D organization, the company said. “The restructuring and re-allocation of resources supports Novo Nordisk’s ambition to transform the way it works within R&D in order to identify and develop truly innovative drug candidates. This will be facilitated by the identification and pursuit of new therapeutic approaches based on external collaborations – a priority that Novo Nordisk will accelerate via the establishment of a new Business Development unit in Cambridge, MA, US,” Novo Nordisk added.