Allergan to Sell Women’s Health and Infectious Disease Businesses

Allergan will sell off two non-core businesses following a strategic review of the company’s assets, according to multiple reports.

The move will likely quell misgivings some shareholders have had about the state of the pharma giant. In April a group of shareholders banded together to push for change at the company. That move came days before Chief Executive Officer Brent Saunders said he was committed to the company’s business strategy during a rosy review of the first quarter for 2018. However, during that call with investors and analysts, Saunders noted that the company’s strategic review could bring about some changes, including the buyback of shares, divesting assets, splitting the company, M&A activity to spur revenue or continuing as is.

Selling off assets appears to be part of the plan. Today multiple outlets are reporting that Allergan has made a decision to sell its women’s health business and infectious disease business. Business Insider reported that Saunders himself confirmed the sale of the two assets. This morning Saunders spoke to the Bernstein Annual Strategic Decisions conference and said Allergan’s board of directors wants to focus on the company’s four core businesses — eye care, aesthetics, central nervous system diseases and gastrointestinal conditions. Combined the company’s aesthetics business and sales of its dry eye drug Restasis generate about 40 percent of Allergan’s annual income. The decision by the board to sell those two non-core assets was unanimous, reports said.

“We have a very strong pipeline in all those areas. Having a focus on those four areas will make Allergan a more exciting company,” Saunders said, according to Reuters.

Saunders noted that the sale of the women’s business could be delayed due to an expected safety ruling on the company’s uterine fibroids treatment Esmya, Reuters said. That ruling is expected in August. In his interview, Saunders said it’s likely that potential buyers for the women’s health business would want to “wait out” that decision.

No formal deal or timeline for a sale has yet been announced, but the sale of the two businesses could fetch Allergan between $4 and $6 billion, Seeking Alpha noted, citing analysts at Cowen. The women’s health business is valued at about $4 billion and the infectious disease business has a value of about $2 billion.

Despite the potential boon in revenue from the sale of the businesses, shares of Allergan are down this morning. Shares fell to $147.56 earlier today, but have climbed a bit to $150.39 as of 10:39 a.m. Allergan’s stock has fallen about 33 percent since this time last year when it was trading at $243.05 per share.

The sale of the two businesses may not be enough to satisfy the shareholders who have been pushing for change. RBC analyst Randall Stanicky wrote in a note earlier this month that the sale of those two non-core businesses “would not bring in sufficient proceeds for meaningful redeployment of capital and would fail to change how investors value the company,” Reutersreported.

https://bit.ly/2H8ekQM

Eiger target cut by Piper

Eiger BioPharmaceuticals price target lowered to $24 from $28 at Piper Jaffray. Piper Jaffray analyst Edward Tenthoff lowered his price target for Eiger BioPharmaceuticals to $24 to account for dilution from the recent financing. The analyst expects Phase II readouts for exendin in hypoglycemia and ubenimex in lymphedema in Q3. He reiterates an Overweight rating on the shares

https://bit.ly/2JkxEiV

AstraZeneca: 2nd Phase 3 of COPD med fails

AstraZeneca announced top-line results from Terranova, the second of two pivotal Phase III trials for Fasenra in patients with moderate to very severe chronic obstructive pulmonary disease. The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations. This news follows the announcement earlier this month that the first pivotal Phase III trial, Galathea, did not meet its primary endpoint, AstraZeneca pointed out. “The safety and tolerability findings in Terranova were consistent with those observed in previous trials with Fasenra. A full evaluation of the data is ongoing, and the results will be submitted for presentation at a forthcoming medical meeting. The Company does not currently intend to make a regulatory submission,” it added.

https://bit.ly/2IUyDql

Novartis to get FDA priority review for aplastic anemia med

Novartis announced that the FDA has accepted the company’s supplemental New Drug Application, or sNDA, and granted Priority Review designation to Promacta in combination with standard immunosuppressive therapy, or IST, for first-line treatment of severe aplastic anemia, or SAA.

https://bit.ly/2H1mF8P

TherapeuticsMD gets FDA OK for estrogen product

TherapeuticsMD, Inc. (NASDAQ: TXMD) today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available.

“IMVEXXY is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market,” said Brian Bernick, MD, Chief Clinical Officer of TherapeuticsMD. “IMVEXXY is the only product specifically designed to be applicator-free. It dissolves completely without mess or additional clean-up, and can be used anytime of day. It allows women the freedom to immediately return to their normal daily activities. Studies showed that, in patients who used IMVEXXY, systemic absorption of estradiol remained within postmenopausal range.”

“We are excited to bring IMVEXXY to market as TherapeuticsMD’s first FDA-approved drug as we strive to be the premier Women’s Health Company,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD. “IMVEXXY reflects our long-standing corporate mission and commitment to health solutions that women want, based on the concepts of medical need, efficacy, safety, simplicity, and affordability. IMVEXXY will be offered at a price in parity with other products that have been on the market for 10 to 30 years. By ensuring patients can access IMVEXXY at an affordable price, TherapeuticsMD is doing the right thing for women.”

https://bit.ly/2LFHv0O

Reset your routers to avoid malware attack, FBI warns

Russian hackers may be coming for you, and there’s one way to stop them: Turn off your Wi-Fi.

The Federal Bureau of Investigation said Friday anyone with a small office or home router should reboot it to stop the spread of malware. A potential attack had infected hundreds of thousands devices across 54 countries with software called VPNFilter, which was traced back to Ukraine where it was first found in 2016, it said.

The software had not had any negative effects yet, but would allow devices to be hacked for a number of nefarious purposes. Ukranian officials said in a statement they suspect Russia is behind the attack.

To thwart it, the FBI has instructed Americans to do what many IT professionals ask you to do when you have a problem with your Wi-Fi: Turn off your router and then turn it back on again.

“The FBI recommends any owner of small office and home office routers reboot the devices to temporarily disrupt the malware and aid the potential identification of infected devices,” it said in a statement.

While the hack does not affect all routers, experts suggest everyone upgrade their home and office internet security, install the latest firmware and change the default password, said Chester Wisniewski, principal research scientist at security firm Sophos.

The FBI said last week it had seized the domain used to issue instructions to the infected devices. When users reset their machines, the traffic will reroute through the bureau’s site to clean them up.

This particular kind of vulnerability is alarming because it can be used for a number of attacks, said Caleb Barlow, vice president of threat intelligence at IBM IBM, -1.68%It allows the machine to install additional software or internally change devices rendering them unusable.

“Think of it like a garage door — once you have access to it, you can drive anything from a bicycle to a bus into it,” he said. “It is up to the adversary to decide what to park in that garage.”

The hack underscores ongoing issues with the security of routers, which rarely automatically update with patches for vulnerabilities. Experts suggest not using routers issued by your internet service provider and instead buying more expensive, and more secure devices.

“This should be the default moving forward,” said David Ginsburg, vice president at Cavirin, a Santa Clara, Calif.-based provider of cybersecurity. “We’re used to this with our smartphones and laptops, and think nothing of updates.”

https://on.mktw.net/2L2QOa3

CMS giving big, erroneous plug to Medicare Advantage in handbook draft?

• CMS’ 2019 Medicare & You handbook appears to give Medicare Advantage an extra plug, judging by changes in a draft version of next year’s manual, Axios reports.
• Compared with this year’s handbook, the draft replaces a section on “quality of care” with one on “coverage and cost determinations” — suggesting that cost-conscious beneficiaries might want to shop for MA plans.
• The revised version also devotes a page to promoting Medicare Advantage open enrollment, a provision in the 21st Century Cures Act that allows people to try out a plan for three months before committing to it.

Also, the draft adds a section explaining that people in MA plans “have the right to request a preauthorization” for healthcare services or equipment, encouraging people to use this tactic when choosing providers.

That may win kudos from insurers, which have been flocking to the MA market, but pointing out such policies as a way to get people to shop around is likely to get pushback from providers.

The draft handbook also includes what could be misleading information on private contracting, which lets Medicare patients and providers who opt out of Medicare sign private contracts for services. A new sentence reads: “Private contracts give you and your provider the flexibility to set up your own payment terms that work best for you.” What is left out is that people who sign private contracts could face higher fees or surprise billing.

In a letter to CMS Administrator Seema Verma, three consumer groups — the Center for Medicare Advocacy, Justice in Aging and the Medicare Rights Center — criticized the draft, saying suggestions that Medicare Advantage is the less expensive alternative for beneficiaries are overstated and the draft doesn’t clarify the difference between traditional Medicare and Medicare Advantage.

“Even more problematic is the treatment of prior authorization in Medicare Advantage,” the groups write.  The draft “attempts to paint this restriction on access to services as a benefit, rather than what it is, a mandatory hurdle for Medicare Advantage members that is not required for individuals in Original Medicare.”

Payers like MA, which they see as a stable market. The average premium for MA plans was expected to be about 6% lower this year than last year, and CMS predicted 77% of MA enrollees would stay in their current plan. The typical enrollee is someone who once had employer-based healthcare, so is mostly familiar with insurance policies and isn’t likely to have untended healthcare needs.

https://bit.ly/2scMhKh