Prescribed Reading: Deals to come, but when?
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
- Amgen inks deal with Harvard Pilgrim.
- Trade group BIO is miffed about a Blue Cross Blue Shield report on drug pricing.
- The House passes the first phase of repealing the ACA.
Mergers & analysis
M&A continues to be slow as the second quarter moves into full swing, but two big companies hinted during their first quarter earnings announcements this week that deals may be on the horizon. Pfizer CEO Ian Read's thinly-veiled comments insinuated that the big pharma has an interest in picking up pharma peer Bristol-Myers Squibb as its next big acquisition.
However, Read also took a cautious tone about the macro environment, as well as wanting to wait to see how the lung cancer market played out a bit — so, don't expect that deal to happen in the near-term. (Although Bristol-Myers reported better than expected earnings for Opdivo (nivolumab), showing the drug may be a bit more durable than the market has been giving it credit for.)
Meanwhile, Gilead Sciences' CEO John Milligan seemed undeterred by the political landscape that has created so much uncertainty in the world of late. Investors have long been pushing for Gilead to spend at least a hunk of the $34 billion in cash it has on hand. And now, it seems, Gilead is ready to do that. Milligan typically talks about finding the right deal at the right time that could be the right fit for the big biotech, but this first quarter earnings call sounded a little different. Milligan instead talked about how the company is making new business development hires and is seriously looking into partnerships. Specifically, he noted that those deals could play out over the coming year.
Elsewhere, smaller deals were being made: AstraZeneca teamed up with small biotech Pieris Pharmaceuticals on protein platform for respiratory diseases, Shire paid out for Parion's dry eye drug and Novartis opted into a deal for NASH compounds with Conatus.
Intra-Cellular Therapeutics disappointed investors this week when it announced that the Food and Drug Administration was calling into question some pre-clinical data that points to toxicity issues in animal studies. The biotech insists that the problem does not translate to humans because of how it is metabolized differently in humans and animals, but the agency isn't take their word for it. The FDA is calling for more information.
But Neurotrope investors got an even bigger disappointment this week; the biotech announced results for a mid-stage Alzheimer's disease study that missed statistical significance. The company tried to cast the results in a rosier light, pointing to a positive trend in the lower dose cohort. Undeterred, Neurotrope will pursue a Phase 3 trial.
Elsewhere, Aeterna Zentaris abandoned its lead drug Zoptrex (zoptarelin doxorubicin) after it failed in a late-stage study. The company will give up on development in indications and switch gears to submitting a new drug application next year for its adult growth hormone deficiency (AGHD) treatment Macrilen (macimorelin).
In a bright spot of clinical development, Abivax reported positive results for its HIV treatment in a mid-stage study, showing that ABX464, in addition to current anti-retroviral treatment, reduced the reservoirs of the virus in the blood as measured by HIV DNA.
The Food and Drug Administration was on a tear this week, approving three new drugs. Arguably the most important is AstraZeneca's PD-L1 inhibitor durvalumab, which will be sold under the brand name Imfinzi. The drug finally allows the British pharma to start actively competing in the immuno-oncology space. How the drug performs in combination will be the true test of whether it becomes a blockbuster versus a never-was.
Novartis gained approval for its cancer drug Rydapt (midostaurin) in a rare form of acute myeloid leukemia. The drug was the first new therapy approved by the agency for the indication in more than three decades. Rydapt is Novartis' second cancer drug approved for use in the U.S. this year, following an FDA okay for the closely watched Kisqali (ribociclib) in mid-March.
Biotech Radius health won approval for its osteoporosis drug Tymlos (abaloparatide), which will put it in line to compete with Eli Lilly's Forteo (teriparatide) and Amgen's Prolia (denosumab), which each have more than $1 billion in sales annually. The company is pricing the drug at $19,500 a year.
The FDA also gave Takeda Pharmaceutical's Alunbrig (brigatinib) the go-ahead as a second-line treatment for non-small cell lung cancer (NSCLC) patients who have the anaplastic lymphoma kinase (ALK) mutation
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