Prescribed Reading: June filled with divestitures and data
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
- AbbVie notches a win in RA.
- Lilly explores a new class of diabetes meds.
- PTC gets its day in front of the FDA.
Mergers & analysis
The week was characterized by divestitures; Valeant sold off another piece of its business, Roche dropped a promising cancer partnership and AstraZeneca continued its fire sale.
The biggest deal of the week was Valeant's $930 million sale of its iNova Pharmaceuticals business. The deal, set to close in the second half, will help the beleaguered Valeant pay down the approximately $26 billion it still has in debt. Rumors are floating around that the company is still looking to sell its Salix gastrointestinal portfolio, as well as the Bausch & Lomb eyecare business.
Elsewhere, AstraZeneca continued its sale of non-core assets as it tries to squeeze more money out of aging drugs no longer benefiting the pipeline. The big pharma has been selling off the rights to a number of drugs around the world as it attempts to hit the lofty revenue goal of $45 billion set in place by CEO Pascal Soriot.
AstraZeneca's move marks a bigger trend in pharma; that once-primary care companies are moving away from the space that brought them years of blockbusters into more niche areas with small patient populations but higher rewards.
Roche, on the other hand, is cutting its losses before its makes too much of an investment. The pharma dropped development of NewLink Genetics' IDO inhibitor after the company reported some weak data for a combination of the drug with Roche's checkpoint inhibitor Tecentriq at the American Society of Clinical Oncology conference last weekend. While the class has been closely watched and highly touted, NewLink seemed to be bringing forward some of the duds in the space.
With the American Society of Clinical Oncology annual conference firmly in the rearview and the American Diabetes Association conference kicking off today, investor firm Jefferies held its own healthcare conference this week that gave companies a forum to highlight other things.
Novartis dropped the JULIET trial bomb earlier this week, showing its CAR-T therapy is tracking the same as Kite Pharma's in lymphoma. Previously, the two CAR-T therapies were competing in different indications. Yet, at the Jefferies conference, Kite executives pointed out that the JULIET trial — while largely comparable — had a high dropout rate pre-infusion. Part of this dropout rate was due to manufacturing issues. Kite believes it has superior manufacturing compared to Novartis and other future competitors in the space.
A panel at Jefferies discussing the CAR-T data presented at ASCO highlighted some of the issues with the therapies including toxicity issues, but noted the promise.
"On CAR-T readiness, our expert noted that preparations are underway at his clinic to appropriately train nurse and staff on the unique aspects on CAR-T. Although he did not see CAR-T therapeutics being used off label, he suspects that 40-50% of DLBCL patients could eventually be eligible for treatment," wrote Jefferies analyst Biren Amin in a note about the panel.
The Food and Drug Administration took a surprising, but much-needed, action on Thursday, requesting that Endo Pharmaceuticals withdraw its its extended-release opioid Opana ER from the U.S. market. The drug has been at the center of the ongoing, and devastating, opioid crisis that has been plaguing the country.
Endo responded by saying it is reviewing the request, but ultimately, the decision is out of the company's hands —the FDA has the authority to rescind approval of the drug and force it off the market. Canaccord analyst David Evanson said in a note to clients on Friday that removing the drug would likely have little impact on revenues.
"We believe the optics of a challenge to FDA would be far worse than the reality of a modest decrease to short-term revenue, especially given heightened awareness of the opioid abuse epidemic. That said, we expect only a modest impact to our revenue, EPS and valuation estimates given Opana ER revenue has been steadily declining for several quarters," he wrote.
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