Stockpiling of medicines boosted Novartis’ sales during the early days of COVID-19, but a hangover followed. Lagging eye drugs, slower psoriasis sales and more dragged the Swiss drugmaker’s sales down in the second quarter—and a hoped-for new use for gene therapy Zolgensma looks farther away than ever.
After a stunning 11% topline growth in the first quarter, Novartis saw second-quarter sales decline by 4% year over year to $11.35 billion, largely due to reversing forward purchasing, the company said.
Its ophthalmology franchise was hit hard. Lower demand drove down sales of Roche-partnered age-related macular degeneration drug Lucentis by a quarter over the same period last year, to $401 million in the second quarter. Newly launched Beovu didn’t help, either.
Novartis recently confirmed a new Beovu safety risk of retinal vasculitis and retinal vascular occlusion that may result in severe vision loss. As a result, sales immediately went into freefall, as they were slashed in half to $34 million in the second quarter over the first.
Despite the safety woe, Novartis remains “fully committed” to Beovu, Marie-France Tschudin, president of Novartis Pharmaceuticals, said during a Tuesday conference call with investors. The reason for her expressed confidence? In a head-to-head clinical study, Beovu topped Regeneron’s market-leading Eylea at clearing retinal fluid. A post-hoc analysis of the two meds’ responses recently showed that lower levels of retinal fluid are associated with better visual acuity, Tschudin said.
Novartis has convened a panel of 25 experts to evaluate the root cause, risk factors, as well as potential mitigation and treatment options for the safety problem, she added.
Slower new patient starts in skin health was another major COVID-19-related impact Novartis cited; dermatology doctor visits declined 50% in the EU and 80% to 90% in the U.S. at peak, according to Novartis.
This concerns the company’s top-selling med Cosentyx, whose second-quarter sales of $944 million came below industry watchers’ expectations. Its 10% year-over-year growth was also a marked decrease from the 18% it posted in the first quarter.
Nevertheless, Tschudin said Cosentyx is still outperforming the overall U.S. market despite fierce competition. In psoriasis, Cosentyx new patient starts dropped 24%, while the market decreased 30%. As for psoriatic arthritis, new patient starts were 16% lower for Cosentyx, better than the entire industry’s 21% decline.
Luckily for Novartis, both ophthalmology and Cosentyx weekly sales only hit bottom low at the end of April and started bouncing back to pre-pandemic levels by the end of June.
Another focus at the Swiss pharma is spinal muscular atrophy infusion Zolgensma. In the second quarter, Zolgensma delivered sales of $205 million, up from $170 million in the first quarter, mainly thanks to geographic expansion.
The company is currently working to resolve a partial clinical hold the FDA slapped on an intrathecal formulation of the gene therapy, which is aimed at older patients. It came after results from monkeys raised a safety flag of potential spinal-cord inflammation and neuronal cell degeneration.
To alleviate the FDA’s concerns, “we have taken the decision to go to the one-year read-out of the non-human primate study just to ensure we have a very robust data” to support a filing, CEO Vas Narasimhan said on the call. As a result, Novartis has pushed back its potential application submission date to 2021, rather than this year as the company had previously predicted.
Overall, the Swiss company cut back its 2020 sales outlook, saying it now expects sales to grow in the mid-single digit percentage, instead of a mid- to high-single-digit increase.
By: Angus Liu
Source: Fierce Pharma
In 2017, Sanofi partnered with the Lebanon, New Hampshire-based ImmuNext to develop an antibody for autoimmune diseases like lupus and multiple sclerosis, which included giving Sanofi a worldwide license to develop frexalimab. The agreement involved milestone payments upto $500 million.
Global manufacturer for the pharmaceutical, biotech and nutraceutical markets, Lonza has announced that it has acquired Synaffix, a biotech company focused on the commercialisation of its clinical stage technology platform for the development of antibody-drug conjugates (ADCs).
In its hunt for the new head of its pharmaceutical systems business—which makes syringes, self-injection systems and other drug delivery devices for 70% of the top 100 drugmakers in the world, according to the company—BD landed on a candidate with plenty of experience among that customer group.