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Tuesday, December 18, 2018

Clovis should put itself up for sale, activist Armistice says


Even before GlaxoSmithKline laid out an eye-popping $5.1 billion to buy PARP drugmaker Tesaro earlier this month, analysts were speculating that PARP rival Clovis Oncology would be a prime acquisition target. One of the company’s largest investors apparently agrees with that analysis—and wants Clovis to raise its hand for a buyout.
Armistice Capital, which owns 9.8% of Clovis’ shares, is encouraging the company to pursue a sale, according to anonymous sources who spoke to Bloomberg. Steven Boyd, Armistice founder and chief investment officer, declined to comment in response to a request from FiercePharma. Clovis did not immediately respond to a request for comment.
Armistice did hint at its intention to take an activist stance towards Clovis in November, when it revealed in an SEC filing that it had paid $116.5 million to boost its ownership stake in the company to 5.15 million shares. In the filing, Armistice revealed it was considering a range of actions, including proposing management changes, nominating an alternate set of directors at Clovis’ 2019 annual meeting, or “recommending business development transactions including a sale,” it said.
Clovis markets PARP inhibitor Rubraca for treating ovarian cancer, but it has struggled to gain traction against competitors like AstraZeneca and Merck’s Lynparza. When Clovis reported Rubraca sales of $22.8 million in the third quarter—falling way short of the average analyst estimate of $31.3 million—the company’s stock lost a third of its value.

Clovis’ valuation has since rebounded a bit, but the revelation that a big stakeholder is still pushing for a sale is not so surprising. Clovis’ stock is currently trading at just over $19 a share, having plummeted from $66 at the start of the year. And Tesaro’s takeout price—a remarkable 62% premium over where it was trading when that deal was announced—shows just how much value the market is placing on PARP inhibitors right now.
What’s more, the prospects for Clovis in the red-hot PARP market may be improving. The company recently won breakthrough status from the FDA for the potential approval of Rubraca in prostate cancer. Clovis intends to file for that approval in the second half of 2019, and if it gets a sped-up nod thanks to the breakthrough designation, it could own the prostate cancer market at least for some amount of time.
That alone could push Rubraca sales to $580 million a year, Leerink analyst Andrew Berens predicted. It could also give the drug a 40% share of the PARP market by 2025, putting it ahead of Tesaro’s Zejula (35% share) and Lynparza (15%), Berens added.

But Clovis’ status as a one-product company does make it vulnerable, particularly in light of the fact that the overall PARP market is growing more slowly than analysts had hoped it would. At a recent oncology conference, Tesaro’s chief medical officer Marty Huber, M.D., said only half of women with ovarian cancer who could be helped by PARP drugs actually get them as maintenance therapy.
And Clovis CEO Patrick Mahaffy has acknowledged his company is having some trouble getting Rubraca off the ground. During a conference call with analysts after its last earnings report, Mahaffy reported that “a perceived lack of differentiation” among PARP inhibitors was proving to be a hurdle for Clovis.
Armistice Capital is far from the loudest or most aggressive activist investor in biopharma, but it does have some track record in the industry. For example, in 2015, it took a 5.4% stake of troubled Spectrum Pharmaceuticals and began pushing for management changes and a sale. It took a while, but Spectrum CEO Rajesh Shrotriya was ousted in late 2017 and the company reportedly put itself on the block in June of this year.

New Pfizer CEO’s top priorities? Think China and pipeline, not deals


Wondering how much incoming Pfizer CEO Albert Bourla is going to shake things up at the drugmaker? Not much, apparently. “Ian’s vision is my vision,” Bourla said of predecessor Ian Read at an analyst lunch where he sketched out his plans.
Investors should “expect a smooth transition,” Credit Suisse’s Vamil Divan wrote in an investor note after the gathering.
That sentiment may not surprise Pfizer-watchers, considering Bourla is already on Read’s executive leadership team. But the succession announcement this fall touched off a wave of speculation about whether Bourla shared Read’s current conception of Pfizer—as a company propelled by its own pipeline—or his penchant for megadeals, well-documented in recent years.
“We think Bourla could be more aggressive when it comes to large-scale M&A appetite given the company’s need to generate growth beyond 2020,” Barclays analyst Geoff Meacham wrote to clients earlier this year.
For now, though, Bourla thinks Pfizer has plenty of opportunities to succeed on its own. In Asia, for instance.
“The opportunity for Pfizer in China in particular was raised multiple times during the lunch given volumes that are growing ‘exponentially’ and with that market now Pfizer’s second largest behind the U.S.,” Divan wrote.

Bourla also touted a pair of key pipeline prospects that could move the needle in 2019: anti-inflammatory product tanezumab and tafamidis, a treatment for polyneuropathy. The company will be plowing more money into R&D to help get those drugs and others through the clinic, shifting spending away from SG&A as it prepares for Lyrica’s fall off the patent cliff.
But it’s those same prospects that could put a damper on dealmaking activity, Divan noted. After all, big deals are distracting.
Pfizer will “continue to analyze various business development opportunities as they arise, but feel they have a unique window of opportunity to properly launch some of their upcoming products and do not want to risk that with the additional operational disruption a large deal might cause,” he wrote.

Surface Oncology shuffles pipeline; cash runway extended


Prompted by a potential safety signal in a Phase 1 trial and a crowded field in CD47 inhibitors, Surface Oncology (NASDAQ:SURF) will significantly reduce its investment in candidate SRF231 while it identifies a better dosing regimen. It plans to release additional data in H2 2019.
The company will now deploy resources to advance two preclinical programs, SRF617 and SRF388, into the clinic. It expects to file an IND for the latter by late 2019. The Phase 1 study of NZV930, in collaboration with Novartis, will continue. Its CD39 and IL-27 programs will remain priorities as well.
The changes should extend its cash runway through 2021.
Shares are down 16% after hours.

FibroGen rating change at Citi

FibroGen upgraded to Buy from Neutral at Citi
https://thefly.com/landingPageNews.php?id=2838931

Aduro Bio out-licenses cGAS-STING inhibitor program to Eli Lilly


Aduro Biotech (NASDAQ:ADRO) is up 32% after hours in response to its licensing deal with Eli Lilly (NYSE:LLY) for its cGAS-STING Pathway Inhibitor program for the potential treatment of autoimmune and inflammatory disorders.
Under the terms of the agreement, Aduro will receive $12M upfront, up to $620M in milestones per product and single-to-low-double-digit royalties on net sales. Aduro will also receive research funding and has the option to co-fund development of each product in exchange for higher royalties.
STING-related ticker: (NYSE:MRK)

Ligand sees FY19 adjusted EPS roughly $5.50


https://thefly.com/landingPageNews.php?id=2838925

Ligand raises FY18 adj. EPS view to roughly $6.63 from $6.52


https://thefly.com/landingPageNews.php?id=2838926