NFL Alumni Partners with UNC’s Center for the Study of Retired Athletes

NFL Alumni (NFLA) today announced a partnership with the University of North Carolina’s Center for the Study of Retired Athletes (CRSA).

This partnership will provide NFLA members the opportunity to participate in the CRSA’s ongoing research and clinical programs which are aimed at improving the quality of life for former athletes.

“The CSRA has welcomed nearly 1,400 former athletes to our Chapel Hill-based center since opening our doors in 2001,” says Dr. Kevin Guskiewicz, CSRA’s Executive Director. “We look forward to working closely with NFL Alumni leadership to identify predispositions to chronic medical issues in former players. We also will help treat those who may have already been afflicted.”

The Center’s research and clinical programs have helped improve the quality of life for hundreds of former athletes and helped these former players fully participate in many aspects of life after sports. Former players may be screened for research study opportunities by completing the Center’s General Health Survey. If eligible, players then will visit on-site clinics to be evaluated and introduced to potential interventions addressing issues affecting the highest quality of life.

“NFL Alumni is proud to announce its new partnership with the UNC’s Center for the Study of Retired Athletes,” says NFL Alumni CEO Beasley Reece. “This partnership will assist members in managing their health with unique screenings that will provide educational resources for a better quality of life. We are pleased to be teaming with the staff at CSRA who support our “Caring for Our Own” mission.

NFL Alumni, a non-profit organization, is comprised of former NFL players, coaches, staffers, cheerleaders, spouses, and associate members whose mission is to serve, assist and inform former players and their families. The Alumni offers a variety of medical, financial, and social programs to help members lead healthy, productive and connected lives, as well as community initiatives under its “Caring for Kids” programs. Pro Football Legends is the commercial marketing arm of the NFL Alumni. For more information, please visit www.nflalumni.org.

https://www.marketscreener.com/news/NFL-Alumni-Creates-Partnership-with-UNC-s-Center-for-the-Study-of-Retired-Athletes–28340620/

Bayer board says pursuit of Monsanto was done diligently

Bayer’s non-executive board reaffirmed its support for top management’s decision to acquire seed maker Monsanto last year, after losing high-profile lawsuits to U.S. plaintiffs who claimed Monsanto’s Roundup weedkiller caused their cancer.

In documents posted on the company’s website on Monday, the non-executive supervisory board said an expert opinion it commissioned from lawfirm Linklaters found that Bayer’s management had complied with their duties when acquiring Monsanto for $63 billion last year.

“The Supervisory Board extensively discussed this expert opinion and based on this also comes to the conclusion that the Board of Management acted in compliance with its duties,” it said.

Bayer shares have lost more than 35 percent of their value, equivalent to about 33 billion euros in market capitalisation, since August, when a U.S. jury found Bayer liable because its Monsanto unit did not warn of Roundup’s alleged cancer risks. It suffered a similar courtroom defeat last month.

Although the German drugs and pesticides maker is appealing the verdicts, more than 10,000 similar cases are pending in state and federal courts, with analysts predicting the company will have to pay out billions of dollars in settlements.

Shareholders are expected to express their discontent at Bayer’s annual general meeting on April 26.

Monday’s statement by the non-executive board was published in a joint reply from Bayer’s management and supervisory boards to countermotions brought by some shareholders for the AGM.

Chief Executive Werner Baumann, who broke cover on his pursuit of Monsanto within weeks of taking the top job in 2016, has said in newspaper interviews that he enjoys the backing of the supervisory board.

The supervisory board in Germany’s two-tier corporate board system has to sign off on larger transactions and Bayer’s non-executive Chairman Werner Wenning backed the Monsanto deal throughout, according to sources familiar with the matter.

The U.S. Environmental Protection Agency, the European Chemicals Agency and other regulators have found that glyphosate, the active ingredient in Roundup, is not likely carcinogenic to humans.

The World Health Organisation’s cancer arm in 2015 reached a different conclusion, classifying glyphosate as “probably carcinogenic to humans.”

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-board-says-pursuit-of-Monsanto-was-done-diligently-28339331/?countview=0

B Of A Hikes Pfizer Price Target, Estimates Citing Orphan Drug Catalysts

Large-cap pharma stocks have seen a mixed performance in year to date, and among this group, Pfizer Inc. PFE 0.34% is poised to benefit from some key second-half catalysts, according to an analyst at Bank of America Merrill Lynch.

The Analyst

Jason Gerberry reiterated a Buy rating on Pfizer and raised the price target from $45 to $48, attributing the revision to higher estimates, with double-digit EPS growth in the 2020-2023 timeframe and pipeline optionality.

The Thesis

Pfizer may soon transform from being a fringe player in the orphan drugs to a mainstream company, given three upcoming catalysts in the segment, Gerberry said in a note.

The analyst sees the Vyndaqel launch in cardiomyopathy as a catalyst, citing bullish feedback of KOL physicians on immediate conversion of existing U.S. patients. Long-term orphan drug launch analysis suggests scope for market expansion and in turn upside to BofA’s above-consensus forecast, the analyst added. Gerberry estimates peak sales of $2 billion for the drug.

Gerberry also sees upside optionality in DMD gene therapy candidate ‘9926 for which a Phase 1 data readout is scheduled for mid-2019. If the data is positive, the analyst said, Pfizer can directly launch a Phase 3 trial by year-end 2019, same as the timeline for the lead competitor Sarepta Therapeutics Inc SRPT 4.55%.

The analyst said the Phase 3 data for rivipansel in Phase 3 sickle cell anemia is likely to be the third catalyst.

Collectively, the three catalysts could lead to 3-6 percent valuation upside and possible re-rate on validation of orphan pipeline.

https://www.benzinga.com/analyst-ratings/analyst-color/19/04/13458028/bank-of-america-hikes-pfizer-price-target-estimates-cit

AbbVie’s massive Humira discounts are stifling Netherlands biosimilars: report

Could a drug’s price ever be too low? That’s what some market-watchers are asking in the Netherlands, where AbbVie is discounting Humira as much as 89%.

The De Groene Amsterdammer dug into the procurement process for Humira biosimilars after they launched in Europe last year and turned up aggressive discounts that have effectively held off biosimilar rivals. And some of those would-be competitors have pulled back from the market because of those discounts, the newspaper reports.

At least 70% of Dutch patients remain on Humira, according to the publication. And no wonder: AbbVie struck a discount of up to 89% in one case to retain business for its original biologic.

Those discounts could be a red flag for Humira’s sales outside the U.S. this year, Bernstein analyst Ronny Gal figures. His team had expected ex-U.S. Humira sales to fall 35% this year, “but if that report is indicative of the broader environment, cuts may be much deeper,” he wrote in a note Monday.

In the Netherlands, though, the worry is that AbbVie’s discounting will drive biosimilar makers out of the market. One company has discontinued its version of the megablockbuster, De Groene Amsterdammer reports. Another only counts one hospital pharmacy as a customer in the country. And another company didn’t sell any of its biosimilar after six months of preparation and chose to export its Humira copies. Amgen and Sandoz each have had limited success there, the publication says, despite their powerful marketing muscle.

And at least one expert warns the drugmaker could raise prices if the other biosimilar makers call it quits. After all, AbbVie would have renewed pricing power without those competitors.

“This is a form of ruthlessness that we really only know from the American market,” Arnold Vulto, honorary professor of hospital pharmacy at Erasmus MC, told De Groene Amsterdammer, according to a translation. He called it a form of “market poisoning” and said AbbVie could charge high prices again with a renewed monopoly.

Now, the Netherlands’ competition authority is looking into the procurement process, the publication reports.

In the Netherlands, hospitals join together to increase purchasing power and secure discounts on drugs such as Humira. Each group individually negotiates with pharma companies. In one case, a hospital group disbanded over a disagreement on Humira biosimilars, the publication reports.

Another catch for those considering biosimilars? Each hospital retains an amount of the original drug for patients who are allergic or don’t otherwise benefit from copycats, the publication reports. If a hospital chooses to go with the biosimilar, AbbVie can refuse discounts on the Humira that facility does buy, diminishing the financial incentive for hospitals to switch over to biosimilars.

An AbbVie representative declined to respond to the article’s “claims and speculations,” the publication reports.

Even AbbVie executives themselves have said the competition is fiercer than they expected after biosimilars launched in October. The company lowered its ex-U.S. sales estimates for the drug in 2019 after one quarter of European competition.

Meanwhile, the company has the key U.S. market to itself until 2023 under patent agreements inked with various biosimilar makers. The U.S. made up most of Humira’s nearly $20 billion in global sales last year. As U.S. biosimilar launch dates near, AbbVie hopes new immunology launches Skyrizi and upadacitinib can pick up steam. One Humira biosimilar maker, Boehringer Ingelheim, has chose to hold out and fight its patent arguments in court rather than settle.

And AbbVie can take solace in the fact it’s not the only company to have upset market watchers in the Netherlands. Previously, Dutch health minister Bruno Bruins accused Novartis of exploiting an orphan designation on Lutathera to overprice the drug, which treats certain neuroendocrine tumors. Novartis responded that it “carefully considered” the price and that the price is similar to other drugs for the patients.

https://www.fiercepharma.com/pharma/abbvie-stifling-humira-biosim-competition-massive-discounting-dutch-report

Is Puma off cancer M&A list with Nerlyx marketing deal?

Puma Biotech has been a permanent subject of takeover gossip. But whatever M&A hope investors previously had for a buyout, a European Nerlynx licensing deal may have shattered it.

The Los Angeles biotech is licensing HER2 breast cancer med Nerlynx’s commercialization rights in Europe and part of Africa exclusively to Pierre Fabre for an upfront payment of $60 million, the company said on Monday.

Puma’s stock fell nearly 9% Monday that day on the news. The reason? As analysts from J.P. Morgan, SVB Leerink and Cantor Fitzgerald observed, investors are concerned that the deal reduced the possibility of a takeover.

“While the terms of the deal for this region appear reasonable, we believe some investors may be disappointed with an additional licensing agreement that could further reduce the strategic value of Nerlynx to a potential acquirer,” SVB Leerink analyst Thomas Smith wrote in a Monday note to clients.

In fact, Pierre Fabre is the sixth partner Puma has tapped for Nerlynx marketing, leaving the U.S. and Japan as the only remaining major markets, Smith said. Back in February 2018, the company licensed Greater China rights to CANbridge Life Sciences, right after granting Medison Pharma the Israeli rights. And that’s not to mention that a part of the drug’s sales will go to its original licensor, Pfizer, as royalty payments.

The cancer specialist has been a constant target of M&A speculation dating at least back to around mid-2017 when Nerlynx won an FDA advisory committee recommendation. At first, industry watchers pegged the time after approval and before launch as the perfect time for a takeover.

Nerlynx’s green light, to prevent breast cancer recurrence in women previously treated with Roche’s Herceptin, further fueled the rumor, especially as the label turned out cleaner and broader than expected (i.e., not restricted to hormone-receptor positive patients), despite some questions raised during the AdCom meeting.

“[I]t has long been explicitly clear that there is potential for the company to be acquired, given Nerlynx is an unencumbered oncology asset with >$1B in commercial sales potential,” Cowen analyst Chris Shibutani wrote in July 2017.

But rather than waiting until September as previously expected, Puma immediately launched the drug in the U.S., triggering the interpretation that an acquisition was not imminent. “We’d tend to agree that if a deal was only days or weeks away, it’s hard to understand why the company would push ahead with commercialization,” RBC Capital analyst Matthew Eckler wrote at the time.

In early 2018, the buyout rumor was again revived when a negative EU opinion looked likely. That January, Puma said a negative trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency would likely translate into a “no” on Nerlynx’s application, scheduled for February.

Puma’s stock took a hit on the news. But Almington Capital president John Engle, in a Seeking Alpha post, maintained that the drug’s U.S. market still represented a lucrative opportunity, and a beat share price made the company look quite attractive for a buyout.

And then, late in the year, GlaxoSmithKline made a $5.1 billion acquisition of Tesaro which, like Puma, had a marketed product—PARP inhibitor Zejula—and a commercial team. The move again stirred up M&A buzz among industry watchers.

Now, a buyout seems unlikely, at least in the eyes of some investors. But after talking to Puma CEO Alan Auerbach, Cantor analysts said that “the likelihood of potential M&A remains about the same.” Management pointed to other companies such as Pharmacyclics and Medivation that did deals in Europe for royalties and were also acquired afterward, according to Cantor.

Meanwhile, based on Pierre Fabre’s existing breast cancer sales team and experience in negotiations with EU payers, Cantor reasoned that “[t]he logic for doing an EU partnership was to get better economics than building a sales force itself.”

https://www.fiercepharma.com/pharma/puma-s-eu-nerlynx-licensing-pact-deals-blow-to-investors-takeover-hope

Stifel: abicipar improvement not enough to make Allergan drug competitive

After Allergan reported data from its 28-week open-label safety study, MAPLE, to evaluate the safety of abicipar produced via a modified manufacturing process, Stifel analyst Annabel Samimy noted that overall inflammation was reduced to 8.9% and severe inflammation to 1.6%. However, her talks with key opinion leading physicians lead her to conclude that the MAPLE inflammation rates are still too high compared to other “extremely safe” and effective options on the market today. Increasing competition on efficacy, dosing length, and price, as well as the still-high inflammation rates, continue to limit any meaningful commercial opportunity for abicipar, said Samimy, who keeps a Hold rating on Allergan shares.
https://thefly.com/landingPageNews.php?id=2887579

Bristol-Myers reports long-term survival results from pooled analyses of Opdivo

Bristol-Myers Squibb announced results from pooled analyses of survival data from four studies in patients with previously-treated advanced non-small cell lung cancer who were treated with Opdivo. In the pooled analysis of the four studies, 14% of all Opdivo-treated patients were alive at four years. Notably, in patients with PD-L1 greater than or equal to1% and less than1%, four-year overall survival rates were 19% and 11%, respectively. In the pooled analysis of the two phase 3 trials, CheckMate -017 and -057, the four-year OS rate for Opdivo-treated patients was 14% compared to 5% for docetaxel-treated patients. Additionally, exploratory landmark analysis of OS found that of patients who had a complete or partial response at six months, 58% of those treated with Opdivo were alive four years later vs. 12% of patients treated with docetaxel. Of patients who had stable disease at six months, 19% of those treated with Opdivo were alive four years later vs. 2% of patients treated with docetaxel. The data were presented at the American Association for Cancer Research Annual Meeting 2019 in Atlanta. Long-term safety data for Opdivo from all four studies were consistent with the known adverse event profile and did not reveal any new safety signals. The discontinuation rate due to treatment-related adverse events was 8.7% in patients treated with Opdivo. The most common treatment-related AE was fatigue. Scott Antonia, M.D., Ph.D., director of the Duke Cancer Institute Center for Cancer Immunotherapy, commented, “These analyses in a large population of patients with previously-treated advanced non-small cell lung cancer show, for the first time, that response to Opdivo correlates to a survival benefit over many years. These long-term survival outcomes are particularly interesting given that, historically, the average five-year survival rate for this patient population is approximately 5%.”

https://thefly.com/landingPageNews.php?id=2887585