Prescribed Reading: Only one FDA approval in October so far
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
Earnings have started — know what to expect from pharma
… And from biotech earnings
A strong quarter from bellwether Johnson & Johnson
Mergers & analysis
While few deals actually took place this week (potentially big pharma is gearing up to make announcements during upcoming earnings calls), a report from PricewaterhouseCoopers' MoneyTree showed that biotech is faring well, despite deals trickling in like molasses this year.
Biopharma had two strong years in 2014 and 2015 on the business development front, with a record number of deals, record IPOs and billions pouring in from venture investors. And while dealmaking, IPOs and venture funding have all slowed, they are still at encouraging levels.
The biotech sector pulled in $3.6 billion in venture capital during the first half of 2016, through 224 deals – a decrease of 6% in deal value and a decrease of 14% in deal volume, compared with first half 2015.
The week started off with the U.S. Food and Drug Administration spanking Regeneron with a second clinical hold for its newly-partnered chronic pain drug, but the big biotech tried to pick up the pieces and is pushing through to Phase 3.
Some of the biggest data of the week came out after the close on Thursday, when Alkermes announced its twice-failed major depressive disorder (MDD) drug had positive results in its final Phase 3 study. While many analysts and investors had long discounted ALKS-5461, the drug has represented the biotech's dedication to developing successful drugs in-house. Alkermes started out as a drug delivery technology company and still makes significant royalties off products that use its tech.
Having some positive results under its belt could now mean a path forward for the drug. Investors responded to the news, pushing the stock up nearly 50% in after-hours trading.
Meanwhile, Rigel tried to shine a positive light on a Phase 3 trial failure that hit a speed bump after a single placebo response caused the drug to miss its primary endpoint. Problems with the drug weren't particularly surprising; Rigel has been having a wave of problems over the last few months. The company recently cut staff in an effort to trim costs.
Two big approvals marked the week – one new drug and one new indication. The industry is eagerly waiting to see if this is signaling the start of the end of the year drug approval push from the FDA.
So far, only 18 new drugs have been approved this year by the agency, well off the 45 approved last year, and even a slew of approvals is unlikely to put the approval number that high for 2016. Only one drug has been approved in October thus far, on par with September.
Eli Lilly & Co. can claim that October approval. The Indiana pharma got the green light for Lartruvo (olaratumab) as a first-line treatment for advanced soft tissue sarcoma, with Lilly touting the fact that it has now displaced a 40-year standard of care in the first-line setting.
On the flip side, Roche gained a second-line approval in non-small cell lung cancer (NSCLC) for its PD-L1 inhibitor Tecentriq (atezolizumab) – making it the third checkpoint inhibitor in the space. Merck & Co's Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab) have been battling it out to dominate the highly lucrative area, but Keytruda seems to be pulling into the lead. Analysts only predict Roche picking up $600 million of the multi-billion dollar pie.
Off the bench
Another company has joined the public-private consortium to fight Alzheimer's disease – the Amyloid Imaging to Prevent Alzheimers Disease (AMYPAD) collaboration.
Ixico, a brain health company, has joined the collaboration that already includes companies like GE Healthcare, Piramal Imaging and Johnson & Johnson's Janssen.
Meanwhile, Boston-based Emulate has joined forces with the Lawrence J. Ellison Institute for Transformative Medicine of USC to use the biotech's Organ-on-Chips technology to conduct cancer research.
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