Prescribed Reading: Sage CEO embellishes, Merck stumbles

A weekly guide to the goings-on in the biopharma industry.

Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

In case you missed it

Mergers & analysis

Sage Therapeutics CEO Jeff Jonas told Bloomberg yesterday that the company is "at the top of everyone's M&A list," implying the company was in discussions to be taken out. The comments sent the stock up 10%—and is certainly one way to start acquisition rumors—but followed up this morning with a statement clarifying that it is not in M&A discussions. Ooops. 

Sanofi sold off a handful of over-the-counter products to Ipsen for will pay €83 million ($88.2 million) ahead of the closing of its asset swap with Boehringer Ingelheim that was inked last year and which traded Sanofi's Merial animal-health business for the German drugmaker's consumer health unit. A small trade-off for Sanofi, but a move that will greatly bolster Ipsen's primary care portfolio.

Allergan continued its deal spree this week, picking up the medical technology company Zeltiq for $2.5 billion. The acquisition will add to Allergan's flagship aesthetics portfolio, which already includes the mega-blockbuster Botox, as well as the double chin treatment Kybella.

In some odd deal news, an activist shareholder of Immunomedics is trying to block a licensing deal that the New Jersey company brokered with Seattle Genetics for Immunomedics cancer drug IMMU-132. Activist investor VenBio believes the deal undervalues the asset that Seattle Genetics will pay $250 million upfront for and another $1.7 billion in milestones.

The deal unquestionably values Immunomedics in the near-term, but could prove to be in Seattle Genetics favor if the drug is a blockbuster – yet, it will be years before this comes to fruition. In the meantime, Immunomedics has a lot of cash to fund its early pipeline and get things going.

VenBio believes otherwise. A lengthy shareholder battle will likely ensue. Stay tuned.

Clinically relevant

The big news out of the clinic this week was that another Alzheimer's disease drug failed. Or maybe that wasn't such big news since virtually all of them do. But the latest in this long string of clinical failures was Merck & Co's BACE inhibitor verubecestat, which pushed the company to cut its losses after an independent data monitoring committee declared there was "virtually no chance of finding a positive clinical effect."

This was also the latest nail in the coffin for the beta-amyloid hypothesis, a theory that a buildup of this plaque in the brain is what leads to the symptoms of cognitive decline that are characteristic of the disease. Lots of these drugs that target this plaque have failed and skepticism about the theory abounds. But some companies are still clinging to it because it has been a very costly misstep for pharma – in the tune of many, many billions of dollars.

Meanwhile, a slew of clinical data on HIV treatments came out this week from a range of competitors, including products from Gilead and Merck. The companies presented the data at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

Gilead's bictegravir held up against GlaxoSmithKline's already approved Tivicay (dolutegravir), a win for Gilead before it moves into a larger Phase 3.

On another positive note, Merck's doravirine showed strong positive results in Phase 3 against ritonavir-boosted Prezista (darunavir).

Highly regulated

After Marathon Pharmaceuticals got the greenlight from the Food and Drug Administration last week for its already-on-the-market steroid as a treatment for Duchenne muscular dystrophy, the company came under fire for giving it a pricetag of $89,000.

Now industry group PhRMA is distancing itself from the company, criticizing it for not bringing an innovative product to market. PhRMA's stance on only having members who conduct innovative science calls into question whether the industry group is going to stand behind members when they face public scrutiny. From the looks of things – probably not. But only time will tell.

FDA also gave the okay to Valeant's psoriasis drug brodalumab, which will be sold under the name Siliq, despite some issues with suicidal ideation. The drug got a black box warning and has been saddled with a comprehensive REMS program.

This isn't the solution Valeant has been hoping for – the company now owes partner AstraZeneca $130 million milestone payment, further adding to its debt. The company has been selling off assets left and right in hopes of paying down its bills, but investors long ago lost faith in the company.

Siliq will likely be the last resort for psoriasis patients. Doctors have plenty of other options to prescribe these patients that don't require the hassle and won't jeopardize their mental health. 

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Filed Under: Clinical Trials Mergers and Acquisitions / Deals Regulatory / Compliance