Mylan’s Advair generic pressures GSK with strong launch

• Three weeks into Mylan’s launch of its copy of GlaxoSmithKline’s blockbuster respiratory therapy Advair, the generic drug has captured nearly a quarter of the market, according to prescription data from Iqvia.
• Nearly 38,000 prescriptions were filled for Mylan’s copy, sold as Wixela Inhub, in the week ending March 1, surpassing an authorized generic GSK launched in partnership with Prasco Laboratories.
• Mylan launched Wixela at a list price 70% lower than Advair’s and 67% below the wholesale cost of the authorized generic. That discount appears to have helped fuel a strong launch, which should aid Mylan in its aim to earn more than $1 billion in new sales from drug launches this year.

Mylan’s copy of Advair (fluticasone propionate/salmetrol) had a long road to winning U.S. approval. But now that Wixela is on market, the drug has quickly made large prescription gains on GSK’s branded product.

Over the first two weeks following Mylan’s Feb. 12 launch, about 9,000 prescriptions were filled for the drug. In the third full week of commercial sales, however, Wixela prescriptions surged to 37,643, Iqvia data cited by Wall Street analysts show. That represents about 24% of the total prescriptions for both branded and generic products in the week ending March 1. (Prasco’s authorized generic accounts for about 15%.)

Umer Raffat, an analyst at Evercore ISI, wrote in a note to clients the strong launch suggests some insurance formularies have adopted Wixela immediately.

In Medicare Part D, which accounts for about half of branded Advair usage, Mylan has said the company enjoys full parity and access for Wixela in eight out of 10 plans.

“While we are seeing misaligned financial incentives for complex products in the retail pharmacy space, we were able to apply our learnings from generic Copaxone and adopt a unique launch strategy with Wixela,” Mylan CEO Heather Bresch said on a recent earnings call, referring to the company’s copy of a Teva Pharmaceutical multiple sclerosis drug.

For its part, GlaxoSmithKline has long prepared for the financial impact of generic competition to its former top-seller — preparations helped by several delays Mylan faced in securing an OK.

Still, the British drugmaker expects its adjusted earnings per share to fall between 5% and 9% at constant exchange rates this year due to generic pressure on Advair.

Prescription numbers three weeks into launch suggest GSK was correct in expecting a large impact.

https://www.biopharmadive.com/news/mylan-advair-generic-gsk-strong-launch/550093/

Takeda’s Entyvio beats AbbVie’s Humira in head-to-head colitis study

• Takeda’s Entyvio outperformed AbbVie’s Humira as an ulcerative colitis therapy, according a topline readout of a Phase 3b study by the Japanese pharma.
• The trial randomly assigned to each biologic 769 patients who had an inadequate response to previous treatment. After a year, the Entyvio arm posted a clinical remission rate of 31% compared to Humira’s 23%, hitting statistical significance on the trial’s primary goal.
• On two secondary endpoints, Entyvio showed a higher rate of mucosal healing but AbbVie’s therapy showed a numerical edge in the percentage of patients who achieved corticosteroid-free clinical remission, Takeda conceded. Data were presented Saturday in Denmark at the 14th Congress of the European Crohn’s and Colitis Organization.

Earning an industry-leading $19.9 billion in sales last year, AbbVie’s Humira (adalimumab) has long been a target. Competitors have targeted the drug clinically through head-to-head studies, but legal and politically as well. So far, the company has staved off U.S. biosimilar entry until 2023, but has been less successful in dodging scrutiny of its pricing and patent practices.

In the clinic, Humira has been pitted in head-to-head studies against other drugs before. While Pfizer’s Xeljanz (tofacitinib) ​failed to achieve non-inferiority to the drug in rheumatoid arthritis two years ago, Eli Lilly’s Taltz (ixekizumab) beat the anti-TNF biologic in active psoriatic arthritis last December.

Now, Takeda’s trial is the first clinical study to directly compare two biologics in ulcerative colitis, or UC, said Jeff Bornstein, the company’s executive medical director, in a March 9 statement.

“This is also the first time we have seen a direct comparison between two medicines with distinct modes of action in ulcerative colitis, the gut-selective anti-alpha4beta7 integrin vedolizumab and the anti-TNFα adalimumab,” Bornstein said.

While the study was powered to measure efficacy, Entyvio (vedolizumab​) showed lower rates for adverse events (63% to Humira’s 69%) and infections (34% to 44%), Takeda noted. The pharma’s execs framed the study as demonstrating Entyvio’s efficacy and safety compared to the market leader in inflammatory disease.

For Takeda, gastroenterology has been a key therapeutic area along with oncology, neuroscience and rare diseases. Entyvio is its top-selling gastro drug, posting roughly $1.8 billion in sales for the last nine months of 2018. (The Japanese pharma’s current fiscal year began last April and runs through May 2019.)

Entyvio, an integrin receptor antagonist, is approved in the U.S. as a treatment for adults with UC or Crohn’s disease. Humira’s wide-ranging labels cover both those conditions, as well as rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis among others.

https://www.biopharmadive.com/news/takedas-entyvio-beats-abbvies-humira-in-head-to-head-uc-study/550200/

Humana sees backing prior FY19 EPS view $17.00-$17.50 , consensus $17.44

Humana will be hosting an Investor Meeting in New York City on Tuesday, March 19. The Investor Meeting will include a number of presentations by company leaders focusing on Humana’s strategic direction, operational and financial progress as well as expectations for future performance. The company expects to back its prior FY19 EPS view of $17-$17.50 , consensus $17.44.
https://thefly.com/landingPageNews.php?id=2877499

Breast Implants Top List of Plastic Surgeries

More Americans than ever are trying to reshape their bodies with breast and butt implants, liposuction and “thigh lifts,” a new report shows.

Almost 18 million cosmetic procedures were performed in the United States in 2018, nearly a quarter-million more than in 2017, according to newly released data from the American Society of Plastic Surgeons (ASPS).

The group said that number has climbed steadily over the past five years, and that the new statistics show a jump in noninvasive fat reduction procedures, as well as body-shaping surgeries such as breast augmentation and liposuction.

“Liposuction continues to be the gold standard in body contouring because of its versatility, efficiency and effectiveness,” ASPS President Dr. Alan Matarasso said in a society news release.

Of the almost 2 million cosmetic surgical procedures performed in 2018, the top five were: breast augmentation (313,735 procedures, up 4 percent from 2017); liposuction (258,558 procedures, up 5 percent from 2017); nose reshaping (213,780 procedures, down 2 percent from 2017); eyelid surgery (206,529 procedures, down 1 percent from 2017); and tummy tucks (130,081 procedures, about the same as 2017).

Along with increases in breast augmentation and liposuction, there were increases in other body-shaping procedures such as buttock augmentation and thigh lifts.

“With liposuction, one treatment may be all you need to reshape problem areas. A plastic surgeon can treat more areas — and larger areas — in one procedure … but new nonsurgical fat reduction machinery continues to evolve and play a role in reshaping areas of the body,” Matarasso said.

Of the almost 16 million cosmetic minimally invasive procedures performed in 2018, the top five were: Botox injections (7.4 million procedures, up 3 percent from 2017); soft tissue fillers (2.7 million procedures, up 2 percent from 2017); chemical peels (1.4 million procedures, up 1 percent since 2017); laser hair removal (1 million procedures, down 1 percent from 2017); and microdermabrasion (709,413 procedures, down 4 percent from 2017).

More information

The U.S. Office on Women’s Health discusses body image.

SOURCE: American Society of Plastic Surgeons, news release, March 11, 2019

https://consumer.healthday.com/cosmetic-information-8/breast-implant-news-725/breast-implants-top-list-of-plastic-surgeries-743631.html

Oxford Immunotec sees FY19 revenue $69M-$72M, consensus $69.85M

https://thefly.com/landingPageNews.php?id=2877451

Zafgen Q4 loss per share 39c, to suspend plans for IND filing for ZGN-1258

Zafgen (NASDAQ: ZFGN) reported Q4 EPS of ($0.39), $0.09 better than last year.
Zafgen is also announcing its decision to suspend plans to file an investigational new drug (IND) application for ZGN-1258, the Company’s candidate for rare metabolic disorders including Prader-Willi syndrome (PWS), based on a recent, unexpected finding in muscle tissue in four- and six-month long-term rodent toxicology studies. Nonclinical data showed degeneration and other anomalies in rat muscle tissue to different degrees in both vehicle and dose arms of the studies. The effects were absent from other animal species in long term models, and importantly, this finding has not been observed in any of the Company’s other MetAP2 inhibitors or clinical trials and appears to be specific to ZGN-1258. Zafgen will provide an update on plans for ZGN-1258 at a later time, if warranted, following further evaluation.

“Our mission at Zafgen to develop safe, effective and potentially transformative treatment options to patients who could benefit, centers on applying the highest scientific rigor to our development efforts and letting the data lead us. For ZGN-1061, we are very pleased with the strong data that continue to support the profile of this novel MetAP2 inhibitor for patients with type 2 diabetes. I am proud of the team’s diligent, solution-oriented approach to addressing the FDA’s comments on the ZGN-1061 IND application, and we look forward to presenting these new, more sophisticated assays and full safety results as the basis of what we hope is a productive and collaborative dialogue to advance the ZGN-1061 program,” said Jeffrey Hatfield, Chief Executive Officer, Zafgen.

Mr. Hatfield continued, “We are, of course, extremely disappointed to suspend our IND filing plans for ZGN-1258. We proactively initiated long-term toxicology studies prior to filing an IND, and that decision now allows us to take the necessary steps to assess the unexpected effects we observed. The entire team at Zafgen is driven by a deep commitment to people with PWS and their families, and we’ll continue to evaluate ZGN-1258, as well as explore other potential options within our portfolio of MetAP2 inhibitors, to address the devastating hyperphagia experienced by those with PWS. Zafgen has a strong cash position through 2020 to execute on our strategic objectives.”

PATH for PWS, Zafgen’s natural history study conducted in collaboration with the Foundation for Prader-Willi Research (FPWR), is independent of any specific development program and continues enrollment, with more than 400 of the 500-participant goal now enrolled. The data from this study are intended to inform the development and clinical trial design of potential new treatments.

https://www.streetinsider.com/Corporate+News/Zafgen+%28ZFGN%29+reports+Q4+loss+per+share+of+39c%2C+to+suspend+plans+to+file+IND+application+for+ZGN-1258/15243115.html

Regeneron, Sanofi confirm FDA approval of Dupixent

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has approved Dupixent for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
https://thefly.com/landingPageNews.php?id=2877393