Hikma in dispute with FDA over generic drug Advair

Hikma Pharmaceuticals plans to launch a generic copy of GlaxoSmithKline’s popular lung drug Advair in the US. (Reuters)
Updated 09 November 2017
0

Hikma in dispute with FDA over generic drug Advair

LONDON: Hikma Pharmaceuticals is in dispute with the Food and Drug Administration (FDA) over plans to launch a generic copy of GlaxoSmithKline’s popular lung drug Advair in the US, the drugmaker said on Thursday, when trimming 2017 revenue guidance for its generics business for a third time.
The dispute between the Jordan-based firm, its partner Vectura and the US FDA, delays any eventual approval of the generic version of the drug.
Hikma, which makes and markets branded and non-branded generic and injectable drugs, said it expected revenue of around $600 million and a core operating margin in the low single-digits from its generics business.
In August it had lowered its generics revenue guidance by $50 million to about $620 million citing higher pricing pressures in the industry, having slashed it to $670 million from an initial $800 million last November.
The company, which has been hit by higher price erosion levels than the rest of the industry, has been re-negotiating its contracts with suppliers and third-party vendors to cut costs to try to boost profitability.
“We expect these market conditions to persist in 2018 and are actively pursuing new commercial opportunities and focusing on the execution of our pipeline to help offset continuing price erosion across the industry,” it said in a statement. The company, which cut its full-year guidance in May to the range of $2 billion-$2.1 billion from $2.2 billion, said in August that it expected 2017 revenue to be at the lower end of the range at $2 billion.
Hikma reiterated its 2017 revenue expectations on Thursday.
Hikma’s lower guidance in May followed a decision by US regulators not to approve its generic version of GlaxoSmithKline’s blockbuster lung drug Advair, citing “major” issues with the application.
Hikma said it expected the dispute process with the FDA to be completed in the first quarter of 2018.


Saudi-backed SoftBank to ramp up tech investment

Updated 11 min 35 sec ago
0

Saudi-backed SoftBank to ramp up tech investment

  • SoftBank CEO Masayoshi Son to step up company's "unicorn hunting" investment strategy
  • Saudi Arabia's PIF has contributed $45 billion to SoftBank's Vision Fund

LONDON: Japanese conglomerate SoftBank will double down on its ambitious tech investment strategy, in a move that could create opportunities for further collaboration with Saudi Arabia’s Public Investment Fund (PIF).
SoftBank — which owns Japan’s third-largest telecoms operator — has emerged in recent years as one of the world’s largest tech investors, acquiring stakes in companies including Chinese e-commerce giant Alibaba, and UK chipmaker ARM Holdings.
It last year launched the $100 billion Vision Fund, boosted by a $45 billion investment from PIF. It attracted $93 billion in funds last year, aided by contributions from Abu Dhabi’s Mubadala Investment Company, Apple, Foxconn and others, making it the world’s largest buyout fund.
The Vision Fund has invested in disruptive firms, especially those in the technology space, including Swiss pharmaceuticals startup Roivant, office space company WeWork, and enterprise messaging service Slack.
CEO Masayoshi Son signaled that such dealmaking will become even more of a focus for SoftBank.
“I have spent 97 percent of my time on managing the telecoms business and only 3 percent on investing,” he told investors at the group’s annual meeting on Wednesday, Reuters reported.
Reversing that balance will allow SoftBank to grow faster, he said.
Son’s comments fit with a transformation underway at SoftBank from a domestic telecoms firm to “unicorn hunter” — as Son termed it — focusing on late-stage startups around the world.
Last month, SoftBank invested $2.25 billion in GM Cruise, the carmaker’s autonomous vehicle unit, complementing its shareholdings in China’s Didi Chuxing, the world’s largest ride-sharing app, as well as rivals Uber, Grab and Ola.
The Vision Fund will initially invest $900 million in GM Cruise Holdings, investing the remaining $1.35 billion when GM’s Cruise AVs are ready for commercial deployment. The investment gives the Vision Fund a 19.6 percent stake in GM Cruise.
Saudi Arabia’s PIF has been key to SoftBank’s tech investment strategy with its contribution to the Vision Fund, with the Kingdom also benefiting directly from partnerships with SoftBank.
Son said in November that SoftBank planned to invest as much as $25 billion in the Kingdom in the next three to four years, and aimed to deploy up to $15 billion in Neom, a futuristic city to be built on the Red Sea coast.
PIF and the Vision Fund in March announced a partnership to build the world’s largest solar project in Saudi Arabia, with a capacity of up to 200 gigawatts, in line with the Kingdom’s solar ambitions as set out in Vision 2030.
The agreement will establish an electricity generation company in Saudi Arabia, and will commission two solar plants with a capacity of 3GW and 4.2GW by the end of next year. It envisages localizing a significant portion of the renewable energy value chain in the Saudi economy, including research and development and the manufacturing of solar panels.
SoftBank shareholders on Wednesday approved the appointment of three executive vice presidents — SoftBank unit Sprint Corp’s former chief executive, Marcelo Claure, and former bankers Katsunori Sago and Rajeev Misra.
Bolivian-born billionaire Claure was appointed SoftBank’s chief operating officer in May, tasked with driving cooperation between the group’s portfolio companies. Former Goldman Sachs executive Sago became chief strategy officer on Wednesday and will focus on group investment. Misra runs the Vision Fund.
Son yesterday bemoaned the so-called conglomerate discount weighing on SoftBank’s shares at its investor meeting.
He said when the market value of stakes the firm holds in companies such as Alibaba Group Holding and ARM Holdings are taken into account, SoftBank’s shares should be trading above 14,000 yen ($127), rather than about 8,000 yen currently.