JPMorgan's annual healthcare conference is set to kick off next week, but many companies already announced clinical trial data and deals ahead of the conference. Part of the early release has to do with SEC regulations.
In addition to public comments made at their presentations, the companies will have many one-on-one meetings with investors. Having the data out there in public form allows the companies to talk about it while avoiding potential insider-trading issues. Releasing data before the conference also allows companies to avoid having their news get washed out by the data dump at the conference.
In case you missed it, here's a rundown of the drug company news we got this week:
Isis Pharmaceuticals (NASDAQ:IONS) had a busy week. On Monday, the company announced it signed up another partner, Johnson & Johnson (NYSE:JNJ), to work on autoimmune diseases in the GI tract using Isis' antisense technology.
On Thursday, the biotech raised 2014 guidance; unfortunately it's still a negative number with Isis expecting to have a pro forma net operating loss in the $15 million to $19 million range, substantially better than the previous guidance in the low $50 million range.
On Friday, Isis expanded on an agreement with Alnylam Pharmaceuticals (NASDAQ:ALNY) to cross-license some of their intellectual property. The litigation lawyers may be crying, but as the leaders in RNA drug treatments, the two companies are probably better off continuing to remain friends rather than fighting it out in court.
Shares of Cempra (NASDAQ:CEMP) jumped on Monday after the biotech said its antibiotic solithromycin was just as good as moxifloxacin at treating patients with community-acquired bacterial pneumonia.
Gilead Sciences (NASDAQ:GILD) licensed Phenex Pharmaceuticals' development program for nonalcoholic steatohepatitis, or NASH, for up to $470 if all the milestones are met.
Novartis (NYSE:NVS) is jumping into the gene-editing world, signing deals with a pair of privately held companies, Intellia Therapeutics and Caribou Biosciences.
Alkermes (NASDAQ:ALKS) had a double dose of good clinical trial data this week, releasing positive phase 3 data for ALKS 5461 in treating depression on Tuesday, and following it up with phase 2 data for ALKS 3831 in schizophrenia patients that was strong enough to justify taking the drug into phase 3 trials.
Pfizer (NYSE:PFE) said the Food and Drug administration won't schedule an advisory committee meeting for its breast cancer drug Ibrance, and the company has "entered label discussions with the FDA." That's code for "the drug is going to get approved sooner rather than later."
Amgen (NASDAQ:AMGN) and Kite Pharma (NASDAQ:KITE) joined up in a deal that will bring Amgen's cancer targets together with Kite's Chimeric Antigen Receptor (CAR) T cell immunotherapy technology. It's not your typical one-sided licensing of a hot technology by a big biotech company because Kite Pharma will retain rights to some of the drugs developed in the collaboration and have to pay Amgen milestone payments if the drugs are successful. Amgen also gets rights to some of the drugs, which could garner Kite milestones in addition to the $60 million upfront payment the smaller biotech is getting.
Shares of Arena Pharmaceuticals (NASDAQ:ARNA) jumped 76% on Wednesday after releasing phase 1b data. While the large increase may be unwarranted, it's mostly a factor of the biotech being undervalued going into the data release.
GW Pharmaceuticals' (NASDAQ:GWPH) data wasn't nearly as pretty. The biotech's marijuana-derived Sativex wasn't able to control pain in cancer patients. Take a look at Todd Campbell's and Sean Williams' excellent rundowns on the data, and where GW Pharmaceuticals goes from here.
Biogen Idec's (NASDAQ:BIIB) data on its anti-LINGO-1 data was mixed. In a phase 2 trial of patients with acute optic neuritis, a disease that's caused by damage to an optical nerve, patients taking the drug through the end of the trial saw a 34% improvement in nerve conduction velocity compared to placebo. But if you include the dropouts, the improvement wasn't statistically significant. The per-protocol data is a step in the right direction, but it's far from definitive proof of concept considering that the FDA will include dropouts in a phase 3 trial if Biogen Idec decides to push clinical development further.
Another one of AbbVie's partners, Infinity Pharmaceuticals (NASDAQ:INFI) didn't have such good luck. The biotech is stopping development of duvelisib as a treatment for rheumatoid arthritis after the drug failed a clinical trial in the indication. The duo is still testing duvelisib in various blood cancers.
Separately, AbbVie issued 2015 earnings-per-share guidance of $4.25 to $4.45 on an adjusted basis. At the midpoint, that's more than a 30% increase from its 2014 guidance.
Sanofi's (NYSE:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) PCSK9 drug, alirocumab, can lower patients' LDL cholesterol -- that's the bad kind -- when dosed once a month. Previous trials have used a dosing schedule of dosing every other week. Given that alirocumab has to be injected -- not to mention competition from Amgen's (NASDAQ:AMGN) PCSK9 drug that's under FDA review -- the added convenience should help sales.
Two smaller biotechs, Incyte (NASDAQ:INCY) and Agenus (NASDAQ:AGEN) joined forces on Friday to develop immunology checkpoint modulators designed to spur the immune system to attack tumors. Agenus will get $60 million for bringing its antibody discovery platform to the deal, including a $35 million equity investment from Incyte.
Anything left to report?
The only thing we haven't seen in this pre-JPMorgan news cycle is a major buyout. Sure we had plenty of licensing deals, but let's hope we get a large buyout -- or three! -- to set the tone for the year. Something like Bristol-Myers Squibb's (NYSE:BMY) purchase of Inhibitex on the eve of JP Morgan in 2012; but let's have it work out better for the purchaser.
Even if all the good clinical trial data and licensing deals have already been announced, we'll still get to hear management elaborate on all the data we've seen so far.
Get some rest, Fools... next week is going to be just as busy.
Brian Orelli has no position in any stocks mentioned. The Motley Fool recommends Alnylam Pharmaceuticals, Celgene, Gilead Sciences, Isis Pharmaceuticals, and Johnson & Johnson. The Motley Fool owns shares of Gilead Sciences and Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
More from The Motley Fool
Margin Debt at Record Levels: Know the Risks
Trading on margin reduces your control over your investments and exposes you to much greater potential losses.
This Is Americans' No. 1 Financial Concern for 2018
Hint: It's not about savings.
Got a Raise? Make the Most of It With These 4 Tips
You could increase the value of your raise many times over.