Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, December 19-23, 2016, we had thoughts on the following: manufacturing review delays Ocrevus launch; Japan tightens pricing screw with annual review; Bioinvent couples to year-end partnering gravy train with Pfizer deal; Bristol-Psioxus deal confirms allure of oncolytic viruses; Biogen underwhelms with CEO choice; pump trial could boost Adocia ultra-fast insulin case; US Medicare drops plan to cut physician drug price markup; Scanadu declines to honour Scout.
Manufacturing review delays Ocrevus launch
December 21, 2016
One of the biggest expected approvals of 2016 now will be pushed into 2017 with the US FDA’s decision to delay the decision deadline for Roche’s multiple sclerosis candidate Ocrevus. The antibody is slated to become the first drug specifically indicated for primary progressive MS, but a review of the commercial manufacturing process has not been completed, and the PDUFA date is now set for March 28, from December 28. Ocrevus is forecast as one of the two biggest commercial launches of 2017, in a neck-and-neck race with Sanofi’s eczema project Dupixent in 2022 sales – Roche’s project is forecast to sell $4bn and Sanofi’s $4.6bn. A three-month delay in the Ocrevus decision date will probably not affect 2022 sales by much, but it now looks as though the two projects could hear an approval decision within three days of each other, as Dupixent’s PDUFA is set for March 31.
Japan tightens pricing screw with annual review
December 21, 2016
Japan will double the frequency of its drug price reviews to once a year beginning in 2018 in a bid to control rising costs, and will add all prescription drugs to its review, the government has announced. The formerly biennial review had included only those products with a big disparity between a negotiated price with the government and a lower price paid by hospitals and wholesalers. With an annual review, and more drugs included, this suggests that generics as well as branded drugs will be subject to price cuts. Reimbursed prices for drugs approved in Japan in 2016 have ranged between a 24% and 87% discount off US prices, according to EvaluatePharma data. The decision to go to annual reviews comes one month after the government imposed an off-cycle cut on the price of Bristol-Myers Squibb/Ono’s Opdivo, which had cost more than in the US. Today, Ono issued a profit warning because of the price cut. Japan’s action shows that, even in markets with more aggressive negotiation than the US, the price of drugs is under increasing scrutiny as payer budgets are stretched.
Bioinvent couples to year-end partnering gravy train with Pfizer deal
December 21, 2016
The Swedish group Bioinvent won Pfizer as a partner for its programme to develop antibodies to combat tumour-associated myeloid cells. Pfizer made a $6m investment in Bioinvent and will spend an additional $4m in up-front licensing fees and early research funding to support the programme, which seeks to supplement the immuno-oncology approach of checkpoint inhibitors like Pfizer and Merck KGaA’s avelumab. Bioinvent did not disclose the number of drug candidates that could be part of the agreement, but estimated that if five antibodies emerged from the collaboration it would be eligible for $500m in milestones. Tumour-associated myeloid cells play a role in cancer-associated inflammation, and Bioinvent is seeking to reverse their immunosuppressive properties or reduce their numbers to combat disease in patients who respond poorly to other treatments. Bioinvent shares were up 29% in mid-day trading today.
Bristol-Psioxus deal confirms allure of oncolytic viruses
December 20, 2016
The modest outlook for Amgen’s Imlygic, the first approved oncolytic virus, has not discouraged big pharma from deal-making in this innovative space. Bristol-Myers Squibb today paid $50m up front to secure rights to NG-348, a preclinical “armed” oncolytic virus that aims to infect tumour cells and turn on T-cell signalling. This is the third oncolytic virus deal involving a big pharma player since early October, with Pfizer and Boehringer Ingelheim having entered the space. As with its peers, Bristol says it is most interested in seeing how this project will enhance the effectiveness of other immuno-oncology agents such as checkpoint inhibitors. Bristol will pay for clinical development and commercialisation, and provide funding for preclinical development; $886m in milestones are also included as part of the deal, as well as royalties.
Biogen underwhelms with CEO choice
December 20, 2016
Biogen’s announcement that it has selected its chief commercial officer, Michel Vounatsos, to replace George Scangos as chief executive has been received with muted enthusiasm by investors and analysts. As sales growth levels off, the Massachusetts-based group is in the midst of a strategic transition that includes the spin-out of its haemophilia business and rumours of a trade sale. An internal appointment from the commercial side has unnerved some investors who want the company to be acquired. That outcome cannot be expected until intellectual property disputes involving the multiple sclerosis pill Tecfidera are resolved early next year. The company’s valuation is also dependent on approval and launch of the spinal muscular atrophy drug Spinraza. The company said it would review its strategy, and investors will eagerly await an announcement of its plans in the first few months of 2017.
Pump trial could boost Adocia ultra-fast insulin case
December 19, 2016
Adocia’s ultra-rapid-acting version of Humalog has shown that it can outperform the Lilly flagship insulin in a pump test, although the results could have investigators closely examining the data to see whether to move into advanced testing. The phase I test in type 1 diabetics consisted of two parts. The first used Roche’s Accu-Chek Spirit to deliver first one insulin, then the other, to 36 patients. The second consisted of a crossover design in which 44 patients received first one insulin, then the other, via the Roche pump, and subsequently one insulin after the other via Medtronic’s Paradigm Veo pump. Syringe delivery was used as a control. In the first part of the trial, Adocia’s BioChaperone lispro U100 did not show a benefit over Humalog. In the second part, the Adocia insulin demonstrated a statistically significant increase in insulin exposure over the first 30 minutes compared with Humalog in both of the two pumps tested – by 33% in the Roche pump and by 54% in the Medtronic pump. Lilly, which has licensed in the Adocia project, now must consider whether to advance this or its own internal ultra-rapid insulin. Novo Nordisk, meanwhile, has filed its ultra-fast version of NovoRapid, now called Fiasp, in both the US and Europe. It has received a complete response letter from the FDA and a positive recommendation from the European Medicines Agency.
US Medicare drops plan to cut physician drug price markup
December 19, 2016
The US Centers for Medicare and Medicaid Services has binned its plan to cut prices on the most expensive biological drugs administered in physicians’ offices. The demonstration plan, which was meant already to have begun, would have limited the markup for the most expensive drugs in some, but not all, physician practices to evaluate how changing reimbursement affected utilisation. Some practices would have retained the current payment of the average selling price (ASP) plus 4.5%, while others would have been reimbursed at ASP plus 2.5%, plus a flat fee of $16.80. The latter payment method would increase reimbursement for the cheapest drugs and cut it for the most expensive. CMS had also planned to experiment with some value-based pricing principles as part of this demonstration.
Scanadu declines to honour Scout
December 19, 2016
Scanadu branded its Scout diagnostic device as similar to Star Trek’s tricorder, but the reality has turned out a little more dystopian. In a cautionary tale for the users of crowdfunding sites the company is to stop supporting the Scout next May, leaving those who had contributed to its record-breaking $1.6m fund-raising at Indiegogo in the lurch. The Scout, which has until now been given to Indiegogo contributors as part of a pivotal US study, measures body temperature, respiration, oximetry, ECG and systolic and diastolic blood pressure with just 10 seconds of contact with the forehead. But it has failed to win FDA approval, and Scanadu says that FDA regulations require that the study cease and the devices be deactivated. Its crowdfunders, who have spent at least $149 each and in some cases much more, are now left with technology that will slowly become obsolete. And Scanadu has investors beyond its Indiegogo contributors. Its $35m series B was the eighth largest medtech VC round of 2015, and those backers too will have been looking forward to FDA approval.