Sanofi-Aventis plans to make a $2.57 billion (10% premium) offer for Czech generic drugmaker Zentiva, trumping a bid from financial group PPF. Sanofi’s move on Zentiva follows Daiichi Sankyo’s $4.6B offer for India’s top generic company, Ranbaxy.
Generic drug production has traditionally been shunned by large pharmaceutical companies but is now receiving increased interest as a way to tap booming emerging markets.
I’m a huge fan of diversification, especially in an industry where there is nearly none. I’d be really surprised not to see more of these deals in the next few years. There is just too much upside for big pharma not to act, but then again, cutting off the nose to spite the face isn’t a foreign concept in this industry.
For a drug expected to top $7B in annual sales, even a partial success looks like a failure to me. I’ve talked about the efficacy in modulating APP for the treatment of Alzheimer’s a few times and Derek Lowe @ has some great articles, so if you’re not familiar, I‘d check them out to catch up.
On to the news. I’m going to try and summarize the press release from Elan and Wyeth without all the spin. Bapineuzumab failed to reach significance on the primary endpoint in a phase 2 trial.
Simple, right? Maybe not. The trial did show efficacy, though magnitude wasn’t released, in a small subgroup of patients (in non-carriers of the ApoE4 allele, estimated to be ~40% of Alzheimer’s patients).
So, right off the bat, this should cut analyst expectations by 60% right?
Interestingly, in trying to explain away not hitting the primary endpoint for the general population, the release mentions that the study wasn’t powered to detect changes in ADAS-cog.
Fantastic. Let me just break down this flow and see if we can make more sense of it.
1.) Run a trial that is not powered to detect primary endpoint changes.
2.) Fail primary, ADAS-cog endpoint.
3.) Release that you succeeded in a subgroup of patients on many endpoints (that you admittedly aren’t powered to detect)
4.) Conclude with statements like, “bapineuzumab appeared to have clinical activity in treating Alzheimer’s disease“, and “…the Phase 2 study are a continued validation of the amyloid approach to Alzheimer’s disease”.
Fundamentally, I’m happy that there are companies with deep-pockets attempting to treat debilitating diseases in novel ways but doing things over and over, expecting different results is foolish.
I was on a plane all day, headed to the BIO-LES seminar and didn’t get a chance to read the wire, so there is really no need to throw in my two cents at this point but the WSJ reported that Pfizer may be interested in topping the Daichii bid for Ranbaxy.
Though Ranbaxy seems to be saying the Daichii is done, I wouldn’t completely count out Pfizer yet. For more info, check out the pros:
I always felt a company marketing a date rape drug (GHB) and an antidote for antifreeze (ethylene glycol) poisoning was in for a world of hurt.
The stock is down 62.5% ($6.75 from $18) from the IPO almost a year ago and today the company filed an S3 with the SEC allowing the sale of $100 million of its common or preferred stock, warrants or debt securities in addition to announcing layoff of 8% of its workforce and the delay of some developmental programs.
Buckle up. It’s only gonna get bumpier.
PS: If you ever find yourself having just ingested antifreeze, don’t reach for the Antizol, just head to the pub and down some shots. Cheaper and more fun!
I try not to be biased, but it’s not too often I discuss danish biotech companies on this blog. Today is different. We are having a full international day here at Pharmababble. First the Daiichi news and now this release of a collaboration from Symphogen and Genentech.
The specifics of the alliance are a little fuzzy because all the metrics (upfront, equity payment and targets) are undisclosed however, $330M for a platform development deal is a nice chunk of change. Genentech will gain access to the platform Symphogen uses to find and reproduce polyclonal antibodies presented by natrually immune human donors.
Symphogen has inked deals for two other projects, including Sym001 with biovitrum and Sym006 with Meiji, but this deal signals a vote of confidence (at least from the technology point of view) from one of biotech’s wise aged members and is enough to convince me that they have something.
Also, symphogen isn’t just an R&D entity, they have a handful of recombinant pAbs in development already (from the company’s website):
Sym001 is being evaluated in a Phase 2 clinical trial for the treatment of Idiopathic Thrombocytopenic Purpura (ITP) and the prevention of Hemolytic Disease of Newborns (HDN). ITP is a bleeding disorder that causes the blood to clot abnormally. HDN occurs when a pregnant woman suffers an immune reaction against her fetus, causing damage to its oxygen-carrying red blood cells.
Sym002 is being developed to treat the potentially serious adverse reactions that can be caused by smallpox vaccination.
Sym003 is being developed for the prevention of respiratory syncytial virus (RSV), a severe respiratory disease.
Sym004 and Sym005 are both being developed as anti-cancer recombinant polyclonal antibodies.
Sym006 is being developed to target an undisclosed type of bacteria.
While the multiple alliances might make it a little more tricky to pull off, if Genentech likes what it is getting, I smell a potential acquisition.
The generic drug business is growing twice as fast as branded medicines so it is no wonder that J&J, Novartis (with the purchase of Hexal and Eon to form Sandoz) and now Daiichi Sankyo are interested.
Daiichi Sankyo announced today that they will buy a controlling interest (50.1%) in India’s Ranbaxy Laboratories for ~$4.6B, a 31% premium over Ranbaxy’s closing price yesterday. Daiichi’s CEO, Takashi Shoda, explains:
“The proposed transaction is in line with our goal to be a global pharma innovator and provides the opportunity to complement our strong presence in innovation with a new, strong presence in the fast growing business of non-proprietary pharmaceuticals”
Japanese drug makers like Takeda, Astellas and Eisai, have been throwing around some serious cash this year on M&A, licensing and the like for branded or developmental products. Interesting move from Daiichi to eschew conventional competitive means (beefing up the pipeline) and sticking to a growth business.
The Israeli generic drug maker, known for its aggressive tactics is getting a taste of its own medicine if Pittsburgh based, Mylan has anything to say about it (I can’t get enough of the: “taste of its own medicine line”).
TEVA markets a proprietary, branded drug for MS called glatiramer acetate (COPAXONE), sold $1.7B worth of the drug last year and is on pace to top $2B this year. The patent doesn’t expire until 2014 but Mylan (after signing an agreement with the India based NATCO) is threating sales in the US, EU, Canada and Japan, among others.
There is still a long road to market due to the whole pesky patent issue, but I’m sure we’ll soon see a challenge and some interesting fireworks.
In conclusion: TEVA gets a taste of its own medicine.
