So there's not much going on the last week of a year as far as pharma/biotech is concerned...it's pretty much a known fact that most companies shut down for a few days around this time. In light of that, I've come across a variety of articles summing up the years activities in this industry, enjoy!

The 5 Worst Drug Companies of 2009 (BNet)

2009 biotech news in review (Fierce Biotech)

2009 in review for Pharma (Fierce Pharma)

IPO outlook for 2010 (Seeking Alpha)

Oh, there was one interesting development last week that is worth mentioning: Sanofi-Aventis is buying Chattem, giving the French company a much strong market share in OTC health products. Chattem currently markets Gold Bond skin care products (of which I am a strong advocate), ACT mouthwash, and Icy Hot, just to name a few products. Looks like Sanofi continues to diversify its assets as it prepares to lose several meds to the coming patent cliff. In a related story, Sanofi will also work to move Allegra to an OTC product to directly compete with the success stories of Zyrtec and Claritin.

Read more here at OTC today

Here, Fierce Pharma recaps the 2009 developments in the FDA. The leadership turnover is outlined, as is the first acts of the "new" as well as the pitfalls over the course of the year.

Going along with this theme, here's what I am wondering for the new year:

-How will internet advertising pan out? DTC TV ads took a beating over the first part of 2009, and with no real regulation over internet marketing, the FDA will have to issue formal guidance so manufacturers will know how to use the potentially beneficial marketing power of the internet.

-How will social media utilization work be regulated by the FDA? Will the FDA get a handle on social media? We'll see...

-How will the FDA step up to the plate and increase better awareness of post marketing safety issues? Obviously the safety collection process does not stop after a NDA is approved. The FDA must come up with more efficient ways to monitoring post marketing adverse events and enforcing the completion of phase IV studies requested as part of a NDA approval.

-Will the FDA work toward encouraging more trials done to compare new treatments to old ones? This is a fallacy of the current process, just because a drug is superior to placebo does not mean it's any better than what is out there.

-With the pharma/biotech industries and the government cracking down on financial arrangements made with physicians, will the FDA revise current financial disclosure regulations for clinical trials?

-How will the FDA continue to contend with increasing numbers of drug manufacturers moving operations overseas? With increasing costs across the board, profit maximization is at a premium and this naturally leads to using more cost efficient operations...overseas if necessary.

Looks like Arena is ready to makes its attempt at being the first of the three main developers (Arena, Orexigen, and Vivus) to get a new weight loss drug approved by the FDA. Yesterday, they took the first step and submitted the NDA for Lorcaserin to the FDA for an approval...the waiting game begins now. You can rest assured that not only will Vivus and Orexigen be watching closely, but also the myriad investors interested in the outcome of this submission. As I mentioned earlier, I like Arena's long term chances with Lorcaserin, but now we get really get to see what happens.

See the Market Watch report for more

While we're on obesity meds, Shionogi remains a potential contender behind the other three companies mentioned above with its pursuit of velneperit as a weight loss agent. As mentioned in this article, velneperit has had a rough road with little real success, but Shionogi seems to be intent on pushing the drug through as either a monotherapy or adjunct weight loss treatment. Some things never die and it looks like this is another example of that adage...

Cephalon is providing a good example of how manufacturers rein in customers for new drugs as patents for old drugs expire: they are raising the price on provigil to encourage patients to purchase their newly approved drug for the same indication (more or less), nuvigil. It's not a new strategy by any means, but it is an effective one, and expect this trend to continue until a generic version of provigil is available in a couple years. Until that happens, you can be sure that Cephalon will continue to reap profits from this effective wakefulness promoting agent.

Cephalon Press Release Here


To wrap things up: what in the world is going on with these Swine Flu vaccines? First Sanofi recalls a big batch of its H1N1 vaccine, now MedIummune is doing the same thing. Coincidence? Who knows, but I think not...expect more info as the investigation continues...

Read all about it here

Javelin Pharmaceuticals was snatched up by Myriad Pharmaceuticals as Myriad is aiming to further development and commercialization of Javelin's lead product: Dyloject. Dyloject is an injectable form of the NSAID diclofenac sodium, and it gives Myriad a promising new pain treatment. This is good news for Javelin after a rough year following the announcement that another pain therapy being developed by the small pharma company did not meet its main study goals. Whether Myriad will continue to pursue Javelin's other drug candidates is up in the air, but I would wager that Myriad will likely focus on its own pipeline before actively working on Javelin's products. For the time being though, look for Myriad to make big strides following a favorable FDA ruling on Dyloject.

See the Myriad press release here, including some good nuggets on the merger itself

The fallout from Facet's rejection of Biogen's takeover offer, as reported by Seeking Alpha. It seems that Facet's shareholders performed well under fire as the board had desired (after the board made some concessions to the largest shareholders) by rejecting Biogen's "final" offer. However, it seems that Facet is remaining realistic because they are still entertaining buyout offers, provided that they are above the "unreasonable" price suggested by Biogen. As mentioned earlier, Facet is walking a thin line because if their main drugs do not pan out, they will be looking a serious financial issue. You have to hand it to Facet for playing hard to get, but I can't say that I agree given their financial situation...

See this article and this one from Seeking Alpha for their perspective on the situation...

Earlier I mentioned that Facet had rejected Biogen's buyout offer. Well, it seems that Biogen won't take no for an answer. Biogen apparently wants complete control of Facet badly enough that it is willing to buy out a majority of shares and then take over the board in a sort of deathmatch (as best as I can tell). Facet isn't biting, so it looks like a showdown is on the horizon. Even though Facet has held strong so far, I think Biogen could and should win out here.

Read the Facet release

And the Biogen Release

and an outside source on the whole situation

Yesterday, I reported the looming disaster for Addex after they pulled the plug on their lead drug candidate. Well, today the dust settled and it settled hard (expectedly) on the stock of the drugmaker...to the tune of a 75% loss. Addex still has a promising pipeline, so now could be a good time to hop on board...

Have a look at the Reuter's story for more


Finally, GSK has been on the warpath lately and now you can add Nanobio to the list of new partnerships with the British pharma giant. This partnership will be centered around the further development of Nanobio's new cold sore therapy. As per the usual, the agreement also contains incentives for Nanobio upon completion of various development/commercialization milestones. Don't expect GSK to stop anytime soon, it's a known fact that they are on the hunt for new deals...

Read the story in http://www.fiercebiotech.com/press-releases/gsk-and-nanobio-announce-licensing-agreement

How many companies have a potential blockbuster in development only to see those plans derailed by negative late stage testing results? The list is long and exhausting, but Addex really hit bottom with its phase III study of a potential blockbuster GERD treatment. Addex was all ready to make marketing deals when it pulled the plug any further development of its prime candidate: ADX10059 after recent studies indicated potentially serious elevations of liver enzymes in a number of patients exposed to the medication. Addex obviously did what it could to palliate the damage by talking about its other pipeline products, but the damage has already been done. I would stay away from the company for a while until the dust settles, but Addex does have a reasonable pipeline and will likely bounce back.

See the Addex press release here

Addex Pipeline

The bad news continues for Gilead as they announced that a phase III study of its new hypertension drug, darusentan, missed primary endpoints. However secondary endpoints were achieved, but it remains nebulous as to what degree Gilead will pursue additional development of darusentan. I would wager that future late stage studies could be in the cards because the drug is being developed for resistant hypertension and some clever statistics could make even a small improvement over placebo seem relevant (not to mention that any treatment for this type of hypertension would be a good thing).

Gilead Release

Finally, a few quick news briefs:

Here's a nice article on wheelings and dealings in the biotech world

Sanofi Pasteur recalled a number of its pediatric H1N1 vaccines due to a reported lack of effectiveness of the vaccines themselves, not in the response of the patients to the vaccine. I wonder if any of this has shown up in the adult version of the shot...

Allergan is ramping up the fight against the proposed tax on cosmetic procedures, as was first brought up a couple weeks ago. It seems fairly obvious that Allergan would argue against this measure, but the funny thing is that the manufacturer is playing down the impact the tax would have on itself, in favor of arguing that the tax would essentially be penalizing women and setting a bad precedent for future healthcare laws. I don't believe Allergan's arguement, and I still feel that for them, the fight against "botax" is all about the bottom line.

Read more here

Massachusetts based Cubist Pharmaceuticals has finalized an agreement to purchase Calixa Therapeutics, and in doing so, Cubist snatches up Calixa's promising antibiotic candidate (as of now, it does not have a name). This antibiotic has looked good in phase II trials and is being developed as a front line IV treatment for a variety of serious, hospital borne infections. The deal went through smoothly on both ends, and Cubist will be paying Calixa stockholders upon completion of certain developmental milestones for the antibiotic. An optimistic date of an NDA filing has been set for sometime in 2013...stay tuned for more information. Cubist could be worth a look as the deal shakes out.

Here's the report from Fierce Biotech

And, in case you're interested, Cubist's pipeline (not including the newly acquired antibiotic)


Targacept, which has been making waves lately with its partnerships to develop its lead drug candidate (an adjunct depression therapy), announced that it has started enrollment in a phase II study for a new drug candidate intended for use in treating cognitive dysfunction in schizophrenia. According to the article in the Winston-Salem Journal, Targacept is potentially addressing an unmet need because many adults with schizophrenia experience a degree of cognitive dysfunction, but currently there are no treatments especially for this aspect of the disorder. Targacept has steadily gained value during 2009, and baring a significant setback in late stage testing, it looks to continue this trend in 2010. Make sure you keep this company on your watch list....

Read the Winston-Salem Journal Article

Everyone is very aware of the rising costs of drugs over the years. Some cancer medications cost thousands of dollars per month, and they aren't getting cheaper. But why are drugs so expensive and continue to get expensive? In other markets, competition/innovation drives down cost (think HDTVs, Laptops, etc), but this doesn't seem to be the case in the pharma world. When there are new "me too" cholesterol drugs developed, the others all of a sudden don't start a bidding war with patients. It's a very interesting and frustrating problem for patients, health care providers, and insurers. An article was just published recently that discusses the issue of rising drug costs with a surprising conclusion. Check it out below, and I'll give you a hint, it doesn't seem to be what's best for consumers...

BNet Article on Drug Prices

Now, back to our regularly scheduled programming. First up: the FDA is reviewing the JUPITER study to evaluate the risk-benefit ratio of Crestor. Initial reports from an advisory looks good for AstraZeneca and the statin that has reached rockstar status with all the data from this study. With nothing rally bad to say except that more long-term safety data was needed (standard fare for the Agency), but Crestor's benefits seem to outweigh any safety risks. Great news for AZ as they seek an expanded indication for Crestor, which will likely keep revenue flowing over the next few years. If you're interested, here's some nuggets for you:

Reuters article on the FDA review

Pre-Meeting material about Crestor for the FDA

GSK continues its push into new markets by jumping on board with Intercell, the Austria vaccine manufacturer. GSK's interest here is the needleless vaccine platform...yes you read that right. Intercell is developing a vaccine that is delivered through a patch and right now they are in the midst of clinical testing for an influenza vaccine as well as a traveler's diarrhea vaccine (as well as other standard shots). There are numerous potential benefits to a patient for a vaccine delivered transdermally, but the most surprising thing to me is that it actually seems to work! Watch Intercell closely, this partnership cannot hurt them as development progresses...

Pharmatimes article on GSK-Intercell

and more from the Triangle Business Journal

Finally, Intercell's pipeline

Remember the Facet-Biogen drama where Biogen made a "final offer" to buyout Facet? Well, Facet's board of directors said no to the takeover bid, claiming it was too low. Not a smart move for Facet, in my opinion. They need to find additional financing options soon, and Biogen's offer would have provided that much need cash flow.

Read it here

Yesterday I mentioned the news that GSK is on the prowl for new acquisition targets. Well today it seems that Pifizer is also on the prowl, but the pharma giant is looking for partners to manufacture biosimilars: the biologics equivalent of generic medications. This looks like a smart move for Pfizer as they move rapidly towards the patent cliff in a couple years where they will lose several big time patents, namely Lipitor. It also is a bit of a shift away from the novel drug development that Pfizer has been pushing. Interestingly, though, it's not that Pfizer has not developed or is not developing proprietary bioligics because there are several interesting compounds in the company's pipeline that will certainly bring in cash if/when they are approved. Either way you look at it, be rest assured that since Pfizer has thrown its hat in the ring, they will work to be a major player in the biosimilar market for years to come.

See what Bloomberg has to say here

But if you're really worried about who has the highest patent cliff, you can read this report from Yahoo Finance

Don't tell Roche, but some people think that Tamiflu isn't all that it's cracked up to be. Fierce Pharma summarized an article in the British Medical Journal that questions the true effectiveness of Tamiflu in preventing some of the lethal secondary illness that can arise from an influenza infection. The journal was careful to note that Tamiflu does lessen the intensity and duration of a flu infection if taken shortly after symptom onset. The article did a review and meta-analysis of 20 trials utilizing Tamiflu to generate its conclusions. If you're skeptical, as I am, you can read the journal article here to judge for yourself...


Speaking of the flu...remember BioCryst and Peramivir? Last we heard, it was approved for emergency use authorization for severe hospital influenza cases here in the US. Now the company and it's overseas partner, Shinogi, have gotten priority review of the drug for approval in Japan (which apparently is between 2 and 6 months...not too shabby). This is a big deal for BioCryst because it's the first submitted marketing application for Peramivir in any country. With all the strong positive data surrounding the drug, it's sure to be one of several approvals to follow in the next 6 months to 1 year. If you are thinking of buying BioCryst, be sure to make up your mind soon before it's too late...

Read more here at Seeking Alpha

BioMedReports reported (that's what they do right? they report?) today that two companies (PharmAthene and Emergent Biosolutions) focused on developing biodefense products are going to have to put their plans on hold for producing a viable anthrax vaccine within the timelines established by the governments. This clearly is not good news for the two companies, and bad news as well for the biodefense development in the US. However, the news will likely hit one of these companies harder than the other. According to sources, Emergent Biosolutions seems better able to sustain itself in the near future than PharmAthene.

Emergent Biosolutions currently has the only FDA approved Anthrax vaccine and is a main contributor to the United States biodefense stockpile. Even though the government has quashed the development of the other anthrax vaccines, Emergent Biosolutions still has an active contract to deliver its approved Anthrax vaccine to the stockpile as well as other buyers. As discussed by Seeking Alpha, while this company has taken its hits lately (including the bad news today), it looks like a good time to get on board because this certainly isn't the end of the road.

See the Emergent Biosolutions product profile here


PharmAthene may not be so fortunate, as it does not seem to have the apparent safety net that Emergent Biosolutions has. Its stock took a pretty significant beating today, so it is definitely available to ambitious buyers at this point. The company has a number of well funded, potentially effective bioterrorism countermeasures in development (that hopefully won't have to be used), but for the time being it's not boosting the stock significantly.

Read more about the company here, and decide for yourself...


Next good news could be on the horizon for Biogen: the company reported that it has completed enrollment in the second of two Phase III studies examining safety and efficacy of its oral MS drug candidate. Make sure to keep an eye out over the next few months for any data updates as they become available...any news is sure to make a lot of noise as the world awaits a viable oral treatment for MS...

Here's a brief blurb on that milestone from medical news today

Finally, Octapharma (great name) announced that the FDA approved its new replacement therapy for acute bleeding episoes in Von Willebrand's Disease (of which you may not be familiar), the most common bleeding disorder in the US. The new therapy is called Wilate, and while it may not be a blockbuster, it certainly addresses an unmet need for patients with this potentially dangerous condition.

Read more here on biospace.com

The FDA approved new indications for both Lilly's Zyprexa and Astra Zeneca's Seroquel: teenagers with schizophrenia or bipolar disorder. This comes as somewhat of a surprise to me because of the recent publicity about the negative side effects (specifically weight gain and an increased risk of diabetes) of these atypical antipsychotics. The FDA even went so far as to say they will continue to monitor if these effects are worse in teenagers than adults. This sounds like a recipe for failure to me because if these effects are indeed worse in teenagers, who could be more psychologically vulnerable, then that could open the door for all sorts of complaints and problems for the two manufacturers in the future. I hope, for their sake though (and for the patients), that I am wrong about this one...

read more in Fierce Pharma

Also, be on the look out for more acquisitions in the pharma market...but they might be from one big source: GSK. It was reported today that GSK is on the hunt for takeover targets...to the tune of $3 billion worth of money on the table for these targets. Some suggested companies in whose direction the British giant may look (according to the guardian): Dr. Reddy's (big time generics manufacturer), Theravance, and Genmab. While analysts could debate all day on who could be ripe for the taking, I like the idea of GSK grabbing Dr. Reddy's.

here's a starter on Dr. Reddy's prospects

and...the article on GSK from the Guardian

A deal that was discussed earlier this year is back: Biogen's push to acquire Facet Biotech and the small biotech's promising pipeline of monoclonal antibodies. Biogen made what it is claiming is the final offer by upping the bid by $3 per share (a hefty increase when you add all the shares up). Biogen serves to benefit by adding some new compounds to its current pipeline of MS, RA, and cancer treatments, and they feel that Facet has no choice but to take the offer because of limited cash in the bank to fund its operations. As the two companies already work together on several compounds, it seems like a no brainer to Facet to take the bid and let its shareholders benefit from the increased bid from Biogen. I don't see Facet rejecting this one, grab a piece of Facet if you're interested.

Facet Pipeline

and..the letter to Facet's shareholders from Biogen

Biogen's Pipeline

Next, Astra-Zeneca released part 2 of its monumental JUPITER study and the results are no less groundbreaking this time around. This phase of the study focused on the benefits of Crestor in women, though not necessarily women with cardiovascular disease. The published results seem to indicate that taking Crestor not only significantly decreases the risk of cardiovascular events, but women taking the drug can experience a "cleaning out" of their arteries if plaque type build up is already present. Bottom line here: more good news for those pushing statin use, and even more positive publicity for Crestor.

Seeking Alpha reported on the study release here

Finally...everyone's heard of the proposed "botax" on cosmetic procedures. Well, two manufacturers of cosmetic treatments, Allergan and Medicis, are arguing against it. They both claim they are fighting on behalf of the patient, but doesn't that look a little strange coming from companies that stand to take a financial hit from decreased use of their products when taxes on the products' use are put on the consumer? I'm calling bs on that one.

See it here on Fierce Biotech

Targacept announced today that it has established a major partnership with Astra Zeneca to develop and promote its very promising new depression treatment. This announcement comes a few months after positive phase II trial results were announced and this could very well be the final piece of the puzzle to put Targacept over the edge. On the surface the deal looks quite lucrative for the small biotech company, but as with other agreements, it won't mean much of anything if the new treatment does not pan out in mid to late stage testing. The press release notes that Targacept will be shooting for a NDA in 2012, but phase III work should begin next year.

The company's stock has risen significantly since last year, and investors can expect the stock to continue it's upward movement as long as the good news keeps coming in. I like the ideas Targacept brings to the table, it's a strong pick to me.

Press Release posted on FierceBiotech

Endo just can't seem to catch a break when it comes to testosterone replacement. For the second time this year, the FDA put the kibosh on a new therapy. This time on the chopping block, Endo's Aveed: a long acting intramuscular injection of testosterone, designed to decrease the number of injections given to patients in need of this type of therapy. Apparently Endo is somewhat miffed by the FDA's request for more information on rare side effects, but I would argue that just because the effects are rare in clinical trials doesn't necessarily mean they will be rare in the general population. The ball is in Endo's court now, though, and whether or not they salvage Aveed is entirely up to them. That being said, I'm not a huge fan of the situation, so let's leave Endo alone for now.

Report on the FDA's ruling

Within all the H1N1 talk some have mentioned the benefits that come to manufacturers, from a robust financial boost to increased marketing. Seeking Alpha recently brought up another benefit: the increased awareness and push to develop all sorts of vaccines. What does this mean for the investor? Well, for starters now is a good time to invest in those companies with a heavy vaccine market share (think Merck, GSK, Wyeth, and Sanofi Pasteur). Also, these companies are well aware of the pitfalls associated with the current manufacturing methods so they are all developing new technologies to produce more effective vaccines more quickly (which has been discussed periodically on this blog as well). Bottom line: watch the vaccine industry because these companies are already investing capital into revolutionizing this extremely lucrative business.

See what Seeking Alpha has to say here

A lesser player, for now at least, in the vaccine market is Novavax. The company's VLP (virus like particle) technology has been making news ever since the first successful studies were published several months ago. Now the company is back in the headlines with another set of positive results from it's most recent phase II trial in Mexico. The company also just started a phase II trial in seniors and if all goes well, be on the lookout for a large scale Phase III trial early next year. Investors continue to jump on board this healthy stock, and for good reason, Novavax has not shown anything to cause doubt yet...

Phase II trial in Mexico

Phase II trial in seniors

Finally, if you're into PPIs, here's some more news on the advancement of Zegerid into the OTC market...get ready to be bombarded!

Over the Counter Today

There has been a pretty big deal made lately about Prevacid's switch to OTC, primarily on the marketing side of things (very visible in store displays and tv commercials), but is there another heartburn med heading in that direction? It has been discussed several times this year that Schering Plough has submitted a filing to the FDA to sell Zegerid (omeprazole and sodium bicarbonate) OTC as yet another treatment for heartburn. This transition was supposed to have been done several months ago, but the FDA put the brakes on it, delaying a decision till December of this year. Analysts (and Schering Plough) seem to think a favorable decision is on it's way, so be prepared for another big push for Zegerid in early 2010 like we've been seeing for Prevacid. Good news for those heartburn sufferers, bad news for those who don't like to make decisions...

Read more here

Also, if you have say...$300 million you can probably buy Human Genome Sciences. This company has been the subject of nebulous buyout rumors for some time now, but nobody has stepped up to the plate and as time goes on, it seems that HGS's position in the field is becoming more tenous. I guess investors aren't thrilled by the promise of the company's pipeline, which currently has several drugs in phase 2 or later testing or maybe they were scared off by the oddly positive (almost too good) results of HGS's new treatment for Lupus that was announced a couple months ago. Whatever the reason, keep an eye on this company...one more positive study result could tip the balance in the favor of a buyout...

Check out the pipeline here

Read the BioHealth Investor article here