Merck to build Gardasil 9 plant and add 425 jobs, but will cut 150 elsewhere

Merck’s Gardasil is not just a moneymaker, it is a job creator. Just weeks after announcing a Virginia expansion to produce the vaccine and add 100 jobs, the drugmaker says it will build a new plant for Gardasil in North Carolina with 425 more.

Merck’s news was not all positive, however. The drugmaker says that with the market shifting, it will stop production of the API for its varicella chickenpox vaccine in Durham and immediately lay off 150 workers.

As for Gardasil, Merck & Co. will invest more than $680 million over five years to build a 225,000-square-foot API plant at its site in Durham, North Carolina, and expand packaging facilities in nearby Wilson. It expects to add 391 jobs in Durham when the facility is fully operational and another 34 in Wilson. The state will kick in about $5 million as an incentive.

“Our Durham and Wilson plants are key strategic sites in the Merck global manufacturing network. And the strong support of the state is critical for the success of businesses such as ours,” Sanat Chattopadhyay, president of Merck’s manufacturing division, said in a statement.

The Gardasil 9 vaccine helps prevent nine strains of HPV, including two HPV types that cause an estimated 70% of cervical cancers, and sales have been soaring. Merck will report second-quarter earnings July 30, but in the first quarter Gardasil HPV vaccines soared 31% to $838 million.  That was driven in large part by its ongoing commercial launch in China. Worldwide sales for 2018 topped $3.15 billion, far outpacing the previous year’s sales of $2.31 billion—numbers that executives called “unprecedented.”

The expansion announcement comes three months after Merck said it would invest $1 billion to add 120,000 square feet to its 1.1 million-square-foot site in Elkton, Virginia, to increase production of its HPV vaccines. That project is expected to take three years and add about 100 jobs. That brings Merck’s announced investments in Gardasil production this year to $1.68 billion and the job tally tied to the products to 525.

The news also comes just a few weeks after the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices expanded its recommendation for Gardasil 9 to men and women aged 27 through 45 who aren’t adequately vaccinated. The panel had already recommended the shot for people up to age 26. The committee’s recommendation should be another boost for Gardasil sales.

https://www.fiercepharma.com/manufacturing/merck-s-gardasil-9-growth-calls-for-another-plant-and-more-jobs

AbbVie psoriasis launch Skyrizi hits stride before FDA rules on upadacitinib

AbbVie is in the early stages of its Humira biosimilar slide after European copycats rolled out last fall. But thankfully for the drugmaker, it has a psoriasis launch handily besting expectations.

After a May rollout, Skyrizi pulled in $48 million in the second quarter, easily beating a $13 million estimate from Piper Jaffray analysts. And behind the sales figures are several other important numbers that bode well, AbbVie management said on an earnings call Friday.

Already, 1,700 doctors are prescribing the drug and 3,750 patients have started treatment, they said. In sum? AbbVie CEO Richard Gonzalez said Skyrizi is “performing significantly above our expectations.”

Gonzalez also touted an intriguing market share figure for analysts to digest. After about 11 weeks on the market, the drug has scooped up 24% of the “in-play” market share, made up of previously untreated patients and those who are switching medicines.

Before Skyrizi’s launch, Humira held about 28% of the category, Gonzalez said. And even afterward, the aging blockbuster saw that share drop only slightly. The numbers show Skyrizi is “capturing significant competitive opportunities in the marketplace,” the CEO said.

Altogether, Cowen & Co. analyst Steve Scala said on the call Skyrizi has turned in some of the best “launch numbers in my memory.”

The figures bode well for AbbVie as it inches toward Humira’s critical milestone—the U.S. biosim launches in 2023. With Boehringer Ingelheim’s recent decision to ink a patent settlement, Gonzalez said Friday the company is confident it won’t see Humira competition until then.

Meanwhile, biosims are already taking a toll in Europe. In the second quarter, the immunology blockbuster turned in $1 billion in international sales, a decline of 35% versus the same period last year. Humira notched a U.S. sales increase of 7.7%, though, to $3.8 billion—and that helped shore up global sales. Humira managed $4.8 billion total for the second quarter, down 6.1%.

Skyrizi isn’t the only big launch expected this year from AbbVie, either. The company is anticipating an FDA decision on rheumatoid arthritis med upadacitinib next month. On Friday’s call, AbbVie leadership said they’re confident in the JAK inhibitor’s risk and benefit profile, despite recent safety questions for the class, and “don’t have any concerns about approvability.” The FDA on Friday slapped a boxed warning on Pfizer’s Xeljanz, a rival JAK inhibitor, over cardiovascular risks.

Ahead of Humira’s loss of exclusivity, AbbVie is pressing ahead with the Allergan buyout it inked last month. On Friday’s call, Gonzalez said the company has mapped out a range of scenarios on Humira’s U.S. loss of exclusivity, adding Allergan helps in each case. Numerous biosim makers are set to launch Humira copycats in 2023 thanks to their settlements with AbbVie.

Humira was the world’s bestselling med last year, generating nearly $20 billion globally.

https://www.fiercepharma.com/pharma/abbvie-s-psoriasis-launch-skyrizi-hitting-stride-ahead-fda-s-decision-upadacitinib

Vertex’s planned CEO handoff could signal stagnant growth to come: analyst

Succession planning is usually nothing to balk at—in fact, it’s considered responsible governance, particularly at a fast-growing company like Vertex Pharmaceuticals. But could Vertex’s plan to move CEO Jeffrey Leiden to executive chairman and hand his job to Chief Medical Officer Reshma Kewalramani augur an end to the company’s strong growth cycle?

That was the question posed by SVB Leerink analyst Geoffrey Porges and colleagues in a note sent to investors Friday. They’re worried about the transition plan—which surfaced without warning Thursday—for a variety of reasons, including the possibility that other top execs might jump ship.

They’re also concerned Kewalramani, who has beaucoup experience running big trials but none as a top exec, will struggle to find opportunities in Vertex’s pipeline that can match the fast-growing cystic fibrosis (CF) franchise Leiden helped build.

“Leadership transitions in any company are always couched in the terms of ‘orderly transition’ and ‘company in excellent shape,’ but in effect the departing executives, if they have presided over a period of considerable value creation, are often signaling that ‘tougher times are ahead,’” the SVB Leerink note said.

This is not to say Kewalramani lacks the qualifications for the CEO job, the analysts said. She previously spent 12 years at Amgen, where she gained valuable drug development experience in nephrology and other large indications. Vertex’s board was searching for someone like her—she’s both a physician and a scientist—and she has nurtured strong relationships inside the company even though she’s only worked there for two years, executives told the SVB Leerink analysts.

Still, “the experience of leading and executing large clinical trials is not necessarily evidence of preparedness for the complexity of leading a large public company,” SVB Leerink suggested in its note to investors.

The analysts were reassured that Leiden would continue performing the normal CEO functions through April 2020, but they’re concerned the transition plan could lead to the departures of other key managers. And that could rattle investors, particularly on the heels of a couple of top executive exits. In the past eight months, Chief Financial Officer Tom Graney bolted to Generation Bio, and Chief Operating Officer Ian Smith was fired for a code-of-conduct violation.

“Undoubtedly the company’s progress and direction is a group effort, but further departures among the visible and known executives would be concerning for the investment community, particularly after the other recent departures from the senior leadership team,” SVB Leerink said.

For instance, Vertex’s chief commercial officer, Stuart Arbuckle, will be key to the company’s success over the next 18 months, the analysts said, because he’ll spearhead the launch of its much-anticipated triple combination therapy for CF. The company submitted that med to the FDA for approval just last week.

There’s no indication that Arbuckle is looking to leave, but anytime a long-tenured executive like him is passed over for the top job, it’s a risk, SVB Leerink said.

As for the challenges Kewalramani will be facing once she is entrenched in the CEO suite, one is particularly worrisome for the analysts: capital allocation in research and development. The CF franchise will continue its cash-cow contributions for the foreseeable future, they said, but there’s “little to suggest that the company’s portfolio contains major untapped or unrealized opportunities” that will provide diversification for the long term.

Whether Kewalramani can identify and invest in pipeline projects that can keep Vertex on a strong growth path remains to be seen, SVB Leerink said. “Very few companies or positions give executives firsthand experience to develop the skill of capital allocation and drug investing, and the length of a ‘learning cycle’ in the industry is very long,” they warned.

https://www.fiercepharma.com/pharma/vertex-s-planned-ceo-handoff-could-signal-stagnant-growth-to-come-analyst

FDA limits Pfizer Xeljanz in colitis, slaps black box on label

For Pfizer’s blockbuster immunology drug Xeljanz, an FDA safety communication has now turned into a boxed warning. And forget the drug’s approval as a first-line ulcerative colitis treatment, at least for now.

In a new addition to Xeljanz’s label on Friday, the FDA is warning of an increased risk of blood clots—and potentially, death—with the JAK inhibitor’s 10-mg twice daily dose.

And meanwhile, the drug’s green light in ulcerative colitis has been pushed down the treatment line: It’s approved only for those who do not respond to or are not suitable for other medicines.

While the cardiovascular risks showed up in rheumatoid arthritis patients taking the 10-mg dose in a postmarketing study, the FDA argued they “may also apply to those taking [Xeljanz] for ulcerative colitis.” The 10 mg dose is only approved in UC patients.

Besides rheumatoid arthritis and colitis, Xeljanz’s 5-mg twice-daily dose is also approved in psoriatic arthritis.

Pfizer first flagged the safety signal in February after an independent panel noticed higher rates of pulmonary embolism and death in RA patients taking the 10-mg regimen versus those in the 5-mg group and the TNF inhibitor control arm. The postmarketing study was designed to evaluate the risk of CV events, cancer and certain infections.

The company switched the 10-mg patients to the lower dose, and the FDA soon issued a safety communication alerting the public of the problems.

In a statement sent to FiercePharma, Pfizer said it’s still analyzing the safety information now in hand and noted that the clinical data remain blinded. “We will continue to communicate important information in a timely manner as we are able,” it said.

In May, the EMA’s safety committee also put a temporary restriction on the higher dose in patients “who are at high risk of blood clots in the lungs,” including those who have heart failure or a history of blood clots, among other disorders. The temporary ban is in place until the EMA can review the available information and come up with long-term guidance, the agency said at the time.

The “boxed warning,” the FDA’s most severe safety flag, could deal a blow to Xeljanz’s growth momentum. In the first quarter, its sales jumped 34% to $423 million, with 7% volume growth in ulcerative colitis, CEO Albert Bourla said during an earnings call in April.

Despite the warnings, Pfizer still expects Xeljanz will continue to grow, mainly because the 10-mg dose has never been approved in RA, its largest indication, Cantor Fitzgerald analyst Louise Chen noted in a Friday report to clients. As for being removed from the first line in UC, “Pfizer has noted that the large majority of current UC patients on Xeljanz are inadequate responders to TNFi’s anyhow,” so the impact is limited, the analyst said.

It could spell more trouble as new JAK inhibitors near the market, though. AbbVie’s upadacitinib is under FDA priority review with a decision expected next month. Evaluate Pharma analysts previously estimated the drug could reach $2.18 billion in annual sales by 2024.

Meanwhile, Gilead Sciences’ application for filgotinib—which carries its own potential testicular safety concerns—could be filed soon. Gilead recently said a meeting with the FDA went its way.

https://www.fiercepharma.com/marketing/red-flag-upgrade-as-fda-slaps-boxed-warning-pfizer-s-xeljanz-over-cv-risks

Galapagos reports Q2 results

Galapagos (NASDAQ:GLPG): Q2 GAAP EPS of -€0.86.

Revenue of €67.59M (+18.5% Y/Y)

Press Release

https://seekingalpha.com/news/3482349-galapagos-reports-q2-results

Hologic launches new additions to aesthetic treatment portfolio

Hologic (HOLX +0.3%) announces the commercial launch of its TempSure Firm handpiece and a petit mask for SculpSure submental (under the chin) treatments.

The handpiece delivers monopolar radiofrequency through massage heads that gently heats tissue and temporarily reduces the appearance of cellulite.

The petit mask allows treatment of submental fat (double chin) on patients with a narrow jawline.

https://seekingalpha.com/news/3482376-hologic-launches-new-additions-aesthetic-treatment-portfolio

Acorda Receives Positive CHMP Opinion for Parkinson’s Med

Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending INBRIJA’s approval by the European Commission (EC). The recommended indication is: Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. The European Commission (EC) will now consider the CHMP positive opinion in its decision of whether to grant marketing authorization for INBRIJA in Europe; the final EC decision is expected in the coming months. The review of this application is being conducted under the centralized licensing procedure, and the final decision will be applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

INBRIJA was approved by the U.S. Food and Drug Administration on December 21, 2018 for the intermittent treatment of OFF episodes (also known as OFF periods) in people with Parkinson’s disease treated with carbidopa/levodopa.

https://www.marketscreener.com/ACORDA-THERAPEUTICS-INC-8238/news/Acorda-Therapeutics-Receives-Positive-CHMP-Opinion-for-INBRIJA-trade-levodopa-inhalation-powder-28963914/