This edition of the Top 10 Biopharmas marks the end of an era. After this year, we抣l no longer be able to pencil in Amgen as our #1 biopharma, since Roche is poised to take that slot. A lot of major pharmas have talked about 揵ecoming a global biopharma.?I wonder how many more of them will make the transition to this list in the next 5-10 years. (In fact, it抯 not hard to imagine one or two follow-on biologics being enough to tip a generic company into the world of Top Biopharmas . . .)
On the positive side, the emergence of Alexion Pharma and its Soliris MAb allowed me to get a legit #10 company on the list. Remember: building this list is more of an art than a science, so if you can think of a biopharma that should be here ?that is, a drug company that makes more than 60% of its pharma revenues from large-molecule drugs ?drop me a line at gil@rodpub.com!
桮il Y. Roth, Editor
| Top 10 Biopharmaceutical Companies | ||
| 01 | Amgen | $14,687 |
| 02 | Genentech | $10,531 |
| 03 | Novo Nordisk | $8,989 |
| 04 | Merck Serono | $7,338 |
| 05 | Baxter BioScience | $5,308 |
| 06 | Biogen Idec | $3,968 |
| 07 | Genzyme* | $3,751 |
| 08 | CSL Ltd.* | $2,961 |
| 09 | Allergan* | $1,311 |
| 10 | Alexion Pharma* | $259 |
* PDF profiles only available for companies 7-10
All profiles written by Gil Roth, except Baxter Bioscience by Kristin Brooks
The Lowe Down capsules written by Derek Lowe
All pipeline information compiled by Kristin Brooks
Profile as below:
#1 Amgen
One Amgen Center Dr., Thousand Oaks, CA 91320-1799
Tel: (805) 447-1000 Fax: (805) 447-1010
www.amgen.com
Headcount 17,000
Year Established 1980
Biopharma Revenues $14,687 +3%
Royalty Revenues $316 +4%
Total Revenues $15,003 +2%
Net Income $4,196 +33%
R&D Budget $3,003 -7%
2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Enbrel rheumatoid arthritis,
psoriatic arthritis $3,598 +11%
Neulasta chemotherapy-induced neutropenia $3,318 +11%
Aranesp chemotherapy-induced anemia $3,137 -13%
Epogen anemia $2,456 -1%
Neupogen chemotherapy-induced neutropenia $1,341 +5%
Sensipar renal disease complications $597 +29%
Account for 98% of total pharma sales, same as in 2007.
PROFILE
We launched this report in 2001, and in all the years since, I never thought, 揃oy, I wonder if Amgen is going to get acquired.?But the premiere biopharma company has cropped up in several buyout rumors in the past year, most recently as the unnamed 揢.S. drug company?that Sanofi-Aventis steadfastly denies it抯 interested in acquiring.
The Lowe Down
Amgen is finding itself the reluctant center of attention, as the biologics giant that抯 the first to run into aging-pipeline worries. Aranesp and Epogen have been incredible products, but their best years are too clearly behind them, what with all the safety warnings and biosimilar competition coming along. 揥elcome to the world that the rest of us live in倱 is the unspoken feeling of some other people around the industry. 揧ou know, that real world that you抳e been hearing about.?The company could keep the dream going though a big success with denosumab, but that抯 very much an open question, to be decided later this year. You have to think that the psychological impact has already been felt. The door抯 been opened, and the cold wind from outside has been let into the building.
Small molecules aren抰 going to take the chill off any time soon. They抳e been messing around with them for years, but not to any great effect yet. For now, Amgen is still going to be considered the pure parable of biotechnology ?the rise, the mighty profits, and (potentially) one variety of available fall.桪erek Lowe
Until recently, it was unthinkable that Amgen would be in play, so how did a #1 company end up in this position? The hard way! For years, Amgen has relied on five key products for virtually all of its revenue. With no significant additions to its lineup after the Enbrel (which it gained by acquiring co-marketer Immunex in 2002), Amgen抯 reliable growth engines left the company vulnerable.
Label restrictions and warnings for its top seller, Aranesp, trimmed $1.0 billion in sales from 2006 to 2008. In 1Q09, sales dropped another 18%, to $626 million, with U.S. sales plummeting 28%. Same story for Epogen, which is also staring at competition from several biogenerics. Enbrel, meanwhile, faces heavy competition from other TNF-alpha inhibitors and the next generation of autoimmune treatments (see 揊OB Off?for more). That means 60% of Amgen抯 revenues are under siege.
At $597 million in 2008 sales, Sensipar is the only Amgen product to break out of the dreaded 揙ther?category, a group that contributed only $240 in sales for Amgen last year.
Mr. Wonderful and the Others
In August 2008, Amgen added to the 揙thers?when the FDA approved Nplate, its weirdly named treatment for immune thrombocytopenic purpura (ITP). It抯 not regarded as a future blockbuster (sales estimates peak around $500 million), but at least Amgen was able to develop it and reach the market before GSK抯 competitor, Promacta. The EU approved Nplate earlier this year.
One analyst pointed out that Amgen抯 done a great job of treating the side effects of cancer treatment, but hasn抰 developed muchto treat cancer itself. That抯 easier said than done, of course. Amgen did manage to get colorectal cancer treatment Vectibix on the market in 2006, but that was a lengthy process and the drug, an anti-EGFR MAb a la Erbitux, is struggling to gain a foothold in the market. Amgen hopes to get broader approval for the treatment, and has a pair of major studies going on to establish the benefits of Vectibix with chemotherapy to treat metastatic colorectal cancer. Results from those trials should be available in 3Q09. The company抯 also trying out Vectibix against head and neck cancer. If it proves effective in those situations, Vectibix could become a billion-dollar drug for Amgen within a few years.
FOB Off
In a recent BusinessWeek article by Arlene Weintraub on the possibilities of generic/biosimilar/follow-on biologics, the writer mentions that the biotech industry opposes the concept, 揻earing an end to the unlimited pricing freedom it has enjoyed throughout its three-decade history.?Note that this wasn抰 a quote from a biogenerics advocate; it came from the writer herself.
Now, I know there are plenty of biologics that have extraordinarily high prices, and I know there are all sorts of patient reimbursement and access issues around that. But doesn抰 the fact that Amgen saw a 20% drop in revenues from Enbrel in 1Q09, a quarter of which it attributes to reduced demand, tell us that there isn抰 搖nlimited pricing freedom? Sure, price competition isn抰 driven by a generic version of Enbrel, but it IS driven by Humira, Remicade, Cimzia, Simponi, Stelara and the next generation of treatments.
Amgen certainly doesn抰 have unlimited pricing freedom for its products, especially now that regulatory warnings have restricted the market size of some of them. They can raise prices for Aranesp to offset the loss of volume, but even the oil cartels learned that there抯 such a thing as 揹emand destruction,?where the price of a good reaches a breaking point. (N.B.: for gasoline in the U.S., we now know that price is $4.00/gallon.) Similarly, they can increase Neulasta prices to try to cover losses in other products, but it can only go so far before third-party payors decide they抮e not paying.
None of this is to say I抦 against follow-on biologics, provided they抮e safe, effective, and their pathway provides innovator companies with enough incentive (as in, more than a couple of years of commercialization) to keep innovating. I抣l get off my high horse now, especially because I don抰 have any disorders that require treatment with a high-priced biologic.
With partner Takeda, Amgen is also conducting lung cancer trials on on motesanib, a small molecule anti-VEGF treatment. The companies had to suspend part of a trial against non-small cell lung cancer in November 2008 because of higher deaths in one subgroup of patients. After a three-month hiatus, the trial抯 independent data monitoring committee approved resumption of the trial, excluding that subgroup.
Prolia Good Idea
But really, what抯 it going to take for Amgen to remain an independent company? One word: denosumab.
Ostensibly a treatment for osteoporosis, denosumab (tentatively named Prolia) may also be Amgen抯 trojan horse. Submitted to the FDA in December 2008, denosumab抯 BLA is for treatment and prevention of postmenopausal osteoporosis, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. While it has a novel method of action, osteoporosis treatment is a crowded field. With Merck抯 Fosamax going generic, denosumab would have to show tremendous results to warrant its expense. In the area of preventing bone loss in cancer patients, denosumab could be in competition with Novartis?Zometa.
Ah, but what if denosumab also turns out to have oncology benefits? That would be a game-changer for our beleaguered biopharma. The drug is currently being studied in the prevention of bone metastases in prostate cancer, an indication for which there is no other available treatment. Results of the study ?which are part of a mega-trial of denosumab ?are expected to come out by September.
If the drug proves beneficial in blocking bone cancer in prostate and breast cancer cases, then Amgen is going to be sitting pretty. Some analysts project its potential revenues in those two cancer indications to be as high as $3.0 billion a year. (And I抦 sure the osteoporosis indication would at least have better revenues than the 揙ther?category.)
The FDA has scheduled an August 2009 meeting of its reproductive health drugs advisory committee to discuss denosumab抯 initial BLA, with a PDUFA action date (ha-ha) of October 2009.
Out-License To Print Money?
A denosumab launch is going to cost plenty as the company ramps up sales and marketing and continues major trials. To conserve cash Amgen finished up the first major restructuring in its history last year, incurring around $900 million in downsizing charges from 2007 to 2008. Along with the cost-cutting, Amgen is continuing its efforts to monetize its pipeline through out-licensing. In last year抯 edition, we documented the extensive development and commercialization deals Amgen signed with Takeda in February 2008, providing Takeda with rights in the Japanese market to 13 early-stage molecules.
The company continued the practice in July 2008, when it licensed one of those molecules, a potential treatment for chronic and neuropathic pain, to Ortho-McNeil-Janssen, a J&J unit. Amgen received $50 million upfront, with a potential for as much as $385 million in development milestones and subsequent royalties and sales bonuses.
In September 2008, Amgen sold off rights to its drugs Kepivance and Stemgen to Biovitrum, which also bought an exclusive worldwide license to Kineret for its approved indication. Biovitrum paid $110 million in cash and $20 million in shares, and the agreement includes sales milestones for Amgen and possible royalties if Biovitrum develops modified forms of Kineret. The three drugs added up to $70 million in 2008 sales. Announcing the deal, Mr. Sharer remarked, 揟his deal will allow Amgen to focus its resources on developing new, innovative therapies for serious illnesses, and on expanding its core products to benefit more patients in markets around the world.?/P>
Moves like this show an Amgen that understands that even the biggest biopharma doesn抰 have the resources to do everything. But it needs to do a couple of things very well in the near future if it wants to stay Amgen.
#2 Genentech
1 DNA Way, South San Francisco, CA 94080
Tel: (650) 225-1000 Fax: (650) 225-6000
www.gene.com
Headcount 11,000
Year Established 1976
Biopharma Revenues $10,531 +12%
Royalty Revenues $2,539 +28%
Total Revenues $13,418 +14%
Net Income $3,427 +24%
R&D Budget $2,800 +14%
2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Avastin colorectal cancer $2,686 +17%
Rituxan lymphoma, rheumatoid arthritis $2,587 +13%
Herceptin breast cancer $1,382 +7%
Lucentis wet AMD $875 +7%
Xolair asthma $517 +10%
Tarceva lung cancer $457 +10%
Nutropin/Protropin HGH deficiency $358 -4%
Account for 84% of total pharma sales, same as in 2007.
PROFILE
So long, Genentech! It was nice having you at #2 all these years! Last year, majority owner Roche launched a bid to buy out the remaining shares of Genentech and fold it into Roche. It took eight months of negotiations and revised during the worldwide financial collapse, but Genentech finally merged with Roche in March 2009 for a payment of around $47 billion. Given the standards of how I count biopharma revenues, it appears that the new Roche will become #1 on next year抯 Top 10 Biopharma list.
The Lowe Down
And one final company making its last appearance, thanks to Roche and the wonderful climate that the drug industry has found itself in. Genentech is biotech royalty, for sure, so seeing them swallowed up whole has been something of a shock (notwithstanding that they took a brief journey through the inside of that same whale at one point).
I really hope that we抮e not saying goodbye, but it抯 too early to say. There have to be more changes coming ?for one thing, you have to wonder what抯 going to happen to their small-molecule people, since that抯 not (historically) their strength, nor what Roche was presumably paying for. Give it a couple of years or so.
And there抯 one of the central problems of this industry ?the changes we make take a long time to have an effect, and the attention of the investors is relatively short. (That could probably be rendered more concisely in Latin). And by the time we抮e sure that some strategy hasn抰 worked it, it抯 been in place for years. Let抯 hope that the Genentech acquisition doesn抰 end up in that bin. . .桪erek Lowe
Unlike the other major mergers in this year抯 edition, Genentech wasn抰 simply a pipeline-grab. Roche actually seems intent on making Genentech the U.S. face (and name) of the company, with plans to move its commercial operations H.Q. into Genentech抯 South San Francisco site, and to retain that site抯 research and early development campus as an independent center. Roche predicts $750 to $850 million in 搒ynergies,?so I抦 sure we抣l see a ton of layoffs affecting both sides of the company.
Some changes have already been made, and they highlight the issues Roche抯 may face as it tries to spread Genentech抯 biotech mojo throughout the entire company. The question we all have is: Is mojo spreadable?
On the one hand, the WSJ Health Blog quoted William Burns, Roche抯 chief executive officer of pharmaceuticals, on the synergies of the merger: 揟here was considerable biomarker data on some of the products that was not shared in the collaboration because it could result in future intellectual property. So now having the legal infrastructure protecting the outer walls of the family and not cutting across one member of the family, will allow a much broader transparency and sharing of that data.?
On the other hand, how do you retain the talent that fueled Genentech抯 success? A few weeks after the deal was finalized, Genentech chief executive officer Art Levinson, stepped down. He was named chairman of Genentech抯 board, a nominee for Roche抯 board, and an advisor on research. Will he be able (and willing) to exert the same influence he once had on Genentech抯 development teams?
In May, Susan Desmond-Hellmann, Genentech抯 president of product development, was named chancellor of University of California, San Francisco. She抯 regarded as a key figure in the company抯 success in cancer treatments, and was supposed to be a member of the new Genentech抯 Scientific Resource Board. Will her new role at UCSF remove her from Genentech抯 orbit?
The Friend of my NME?
If there抯 one knock I have on Genentech, it抯 the company抯 dearth of late-stage drugs. That抯 a pretty nitpicky point, given the incredible success its key products are enjoying, and the new indications that are getting approved for powerhouse Avastin (as well as positive results for Rituxan, Herceptin and Tarceva).
It抯 not as though Genentech wasn抰 cognizant of the need for new drugs in its pipeline, before the merger. As part of its 揌orizon 2010?plan (which did not include 揼et bought out by Roche?, the company wanted to get at least 20 NMEs into the clinic. But one of the other goals was 揵ring at least 15 major new products or indications onto the market,?(emphasis mine) which gave them plenty of room to talk about productivity without getting new drugs approved. They抮e doing a great job with the new indications, but the company抯 Phase III pipeline is stuffed with Avastin trials, and there aren抰 so many prospects in the former group.
As I mentioned in Roche抯 profile, Avastin failed in a clinical trial for early-stage colon cancer. Adding that indication would抳e opened it up to a huge new market and further cemented the company as tops in cancer treatments. Still, Avastin did managed to win accelerated approval for brain cancer in May 2009, and is involved in, according to Genentech, 450 trials against 30 different tumor types.
I guess I抦 just carping. Genentech comported itself pretty well in its final year as an independent, posting double-digit sales growth and featuring a trio of billion-dollar biologics. It was never going to catch up to Amgen for the top slot, but Genentech can take consolation in
helping thousands of cancer patients over the years, and
blowing Amgen out of the water with combined bio-revenues in next year抯 edition.
#3 Novo Nordisk
Novo All? 2880 Bagsv鎟d, Denmark
Tel: (45) 4444-8888 Fax: (45) 4449-0555
www.novonordisk.com
Headcount 27,000
Year Established 1989
Biopharma Revenues $8,989 +17%/+9%*
Total Revenues $8,989 +17%/+9%*
Net Income $1,903 +21%/+13%*
R&D Budget $1,550 -1%/-8%*
* Converted at avg. exch. rate / based on local currency (DKK)
2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Modern Insulins / Insulin Analogs diabetes $3,417 +33%
Insulin and related diabetes $2,329 +1%
Novoseven hemostasis management $1,262 +17%
Growth hormone therapy HGH deficiency $763 +18%
Account for 86% of total pharma sales, same as in 2007.
PROFILE
Not being a type 2 diabetic (give me time), I don抰 know much about the varieties of insulin and their suppliers. So I thought it was mighty impressive that Novo Nordisk finished 2008 with a 41% share of the total insulin market in North America, and a 32% share of the modern insulin market, by volume. Then I looked at some of its other regions. In Europe, NN has a marketshare of 55% of total insulin and 51% of modern. In Japan, those numbers are 72% for total insulin and 64% for modern insulin. So the company has room to grow in the U.S., is what I抦 saying.
And, boy, has it grown. The company抯 insulin sales in North America boomed 21% in 2008 in local currencies, and kept up that pace in 1Q09. With the wackiness of the 1Q09 exchange rates, NN抯 North American growth was up 39% in Danish kroner. As America抯 not the only market where NN has room to grow. The company is also trying to boost its presence in China (I know, I know: 揥ho isn抰??. In November 2008, the company announced plans to invest $400 million in an insulin production facility in Tianjin, China. The plant will be NN抯 primary production base in Asia-Pac and supply China and export markets. The company built a plant in Tianjin in 1996 and expanded it twice in the next decade. The new site will be its neighbor, measure 50,850 sq. m., be operational in 2012, and employ nearly 500 people.
Bio in Seattle
In last year抯 report, we detailed how Novo Nordisk elected to get out of small molecules and focus on biologics. While much of NN抯 business is in diabetes treatment, the company is also pursuing inflammation and autoimmune conditions as part of its biopharma push.
Back in 2000, NN spun off its Seattle, WA operations, but the company seems to have retained ties there (as well as a 30% stake in the spin-off, ZymoGenetics). In August 2008, NN quietly announced that it will build a specialized R&D center in Seattle, and plans to have as many as 80 scientists working at the center by 2010. The site will be headed by Don Foster, former vice president of research at ZymoGenetics.
In an August 2008 interview with Joe Tartakoff of the Seattle Post-Intelligencer, Mr. Foster remarked that the financial investment in the Seattle site will be 搗ery substantial,?but wouldn抰 divulge numbers. Mr. Foster added, 揘ovo Nordisk is in this for the long run. A piece of what we will be doing in Seattle will be target discovery programs. As much as possible we are going to try to tailor those and differentiate them from the kind of approaches (that other) people are doing.?/P>
In December 2008, NN entered a collaboration with Seattle-based VLST, to identify targets and develop product candidates in the inflammation/autoimmune field. VLST was founded by a pair of Immunex vets, and uses 搗irulence factors?to streamline discovery of high quality, validated targets. The startup is working on a few compounds, although only one is approaching Phase I.
Novo Nordisk抯 collective fingers are crossed that the FDA will give the greenlight to liraglutide, the company抯 new treatment for Type 2 diabetes. A glucagon-like peptide-1 (GLP-1) analog like Lilly/Amylin抯 Byetta, liraglutide was filed with the FDA in May 2008. Worldwide sales of Byetta were around $750 million in 2008 and growing, according to Lilly. Liraglutide has an advantage over Byetta in that it抯 a once-daily injection, while Byetta is twice-daily, but will liraglutide make it to the U.S. market before Lilly and Amylin can get approval for their Byetta LAR (Long Acting Release), a weekly injection? (Of course, NN is working on its own weekly GLP-1 analog, semaglutide, which recently finished Phase II trials.)
The company plans to launch liraglutide in the EU as Victoza this summer, having received a recommendation for approval in May 2009. In the U.S., an FDA advisory committee in April 2009 expressed concerns over cancerous thyroid tumors that developed in rats and mice during liraglutide抯 testing. NN said that it抯 working with the agency to resolve its concerns over the risk profile and has committed to conducting post-approval CV outcome study.
Oh, and a study published recently in the Lancet showed an advantage for liraglutide over Byetta, in terms of lowering 揻asting plasma glucose?(look, I told you I抦 not diabetic, okay?) in patients with Type 2. Both compounds led to a 6.5-lb. average weight loss during the six months of the study.
Not all of its trials have gone well. The company couldn抰 prove efficacy of NovoSeven in treatment of acute bleeds in trauma, and it couldn抰 get enough subjects together to run a trial on the benefits of growth hormone therapy for dialysis patients.
Liraglutide is NN抯 highest profile new product, but the company has a couple more tricks up its sleeve. It抯 planning Phase III trials for a pair of 搉ew generation?insulins for the second half of 2009, has started a Phase III of recombinant factor VIII in patients with hemophilia A, and has started a one-year treatment period for a Phase III trial of recombinant FXIII in congenital factor XIII deficiency.
As long as people keep getting fat (and you can expect China抯 diabetes cases to grow as it builds a middle class) and the Danish kroner doesn抰 collapse, Novo Nordisk is in a great position. I make no guarantees about the currency, but I抦 gonna bet on diabetes.
#4 Merck Serono
Frankfurter Str. 250, D-64293 Darmstadt Germany
Tel: (49) 6151-72-0 Fax: (49) 6151-72-2000
www.merck.de
Headcount 32,800
Year Established 1668
Biopharma Revenues** $7,338 +20%/+12%*
Royalty Revenues $496 +34%/+25%*
Total Revenues $11,120 +15%/+7%*
Net Income $558 -88%/-89%*
R&D Budget** $1,580 +31%/+22%*
* converted at avg. exch. rate / based on local currency (Euro)
** Pharma unit only
2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Rebif MS $1,958 +17%
Erbitux oncology $831 +29%
Gonal-f female fertility $677 +14%
Concor group heart failure $637 +23%
Glucophage diabetes $427 +17%
Euthyrox thyroid $163 -13%
Raptiva psoriasis $137 +31%
Account for 66% of total biopharma sales, down from 67% in 2007.
PROFILE
In its annual report, Merck Serono refers to 2008 as the Year of Erbitux. Given that the drug gained three new approvals and sales increased 29% (20% in local currency), it抯 no wonder! Merck Serono has non-North American rights to Erbitux (it shares rights in Japan with BMS and Lilly). In November 2008, MS began work on a $425 million expansion of the Merck Serono Biotech Center ?including manufacturing facilities for Erbitux ?in Corsier-sur-Vevey, Switzerland. Erbitux production is expected to start up in 2012, and the expanded area will add 120,000 liters of bioreactor capacity.
Unfortunately, one of MS抯 up-and-comers had to be scratched from the lineup. In October 2008, the company reported that a patient taking Raptiva (chronic plaque psoriasis) developed PML (see Biogen Idec抯 profile for more on that ailment). The case marked the third Raptiva user to come down with PML; the other two occurred in the U.S., where Genentech markets the drug. After a consultation with the EMEA, MS elected to pull Rapitva from the market, taking a $300 million writedown for production technology.
In better news, MS gained approval for Kuvan, a treatment for hyperphenylalaninemia (HPA) in phenylketonuria, in December 2008. MS has non-North America and non-Japan rights to the drug. The market for the drug isn抰 huge ?there are around 35,000 people with this condition in the entire European Union ?but its benefits are apparently a godsend for people who suffer from HPA. Since Kuvan is an orphan drug, MS will receive 10 years of data exclusivity for it. U.S. development partner Biomarin got the drug on the U.S. market in December 2007 and posted sales of $47 million in 2008.
MS抯 parent company, Merck KgA, could use another Year of Erbitux (and Rebif, its top seller, and Gonal-F, etc.). The company抯 chemicals division got walloped during the financial crisis. MS is in a comfortable position with Rebif, Erbitux and Gonal-F as its troika. That Serono deal is still paying off.
#5 Baxter BioScience
One Baxter Parkway Deerfield, IL 60015
Tel: (847) 948-2000 Fax: (847) 948-3642
www.baxter.com
Headcount 48,500
(total company)
Year Established 1931
Biopharma Revenues $5,308 +14%
Total Revenues $12,348 +10%
Net Income $2,014 +18%
R&D Budget $868 +14%
2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Recombinants $1,966 +15%
Plasma proteins $1,219 +20%
Antibody therapies $1,217 +24%
Regenerative medicine $408 +18%
Account for 91% of total biopharma sales, up from 87% in 2007.
PROFILE
Baxter抯 Bioscience division performed well in 2008, achieving 14% revenue growth and an equally impressive 18% rise in income. The division includes hemophilia, immunoglobulin, critical care and pulmonology therapies, as well as regenerative medicines and vaccines. Advate, the company抯 recombinant factor VIII therapy for hemophilia, was the primary growth driver, with sales topping $1.5 billion (+25%).
Playing an increasingly important role in vaccines, Baxter recently completed testing of the A/H1N1 (swine flu) virus and is now in full-scale production of a commercial vaccine using its rapid Vero cell culture technology. Baxter received an A/H1N1 strain from the U.S. CDC in May and is working to deliver a pandemic vaccine for use as early as July. Once stockpiling begins, Baxter stands to rival vaccine giants GSK and Sanofi-Aventis. In other pandemic news, the EMEA issued a positive opinion for Celvapan, the first cell culture-based H5N1 (avian flu) vaccine.
The company is also looking to make advancements with its Gammagard Liquid (Immune Globulin Intravenous or IGIV), and initiated two additional Phase III trials studying the antibody replacement therapy in Alzheimer抯 disease (AD) and multifocal motor neuropathy (MMN). In AD, the antibodies are directed against beta amyloid proteins, which are theorized to build up on the brain and disrupt nerve function. The hope is that the antibodies in IGIV can help protect the brain from the toxic effects of beta amyloids. Additionally, Baxter initiated a Phase III trial of IGIV 10% using Halozyme Therapeutics?Enhanze Technology for the treatment of primary immunodeficiency (PID) via injection at a single site, which would allow for a full monthly dose in a single injection.
In the company抯 hemophilia franchise, dosing began in a Phase I trial of recombinant therapy for von Willebrand Disease, an inherited bleeding disorder. The company also initiated several preclinical programs to develop recombinant factor IX proteins to treat hemophilia, as well as longer acting versions of factor VIII.
Baxter Bioscience came out of the gate strong in 1Q09, with sales up 3% and plasma-protein sales up 5%, easing recent concerns about too much supply and falling prices. The company has withstood the economic strains of late ?in part, due to the critical nature of the diseases its products treat ?and is in line to continue to do so.桲B
#6 Biogen Idec
14 Cambridge Center, Cambridge, MA 02142
Tel: (617) 679-2000 Fax: (617) 679-2617
www.biogenidec.com
Headcount 4,700
Year Established 2003
Biopharma Revenues $3,968 +30%
Royalty Revenues $116 +14%
Total Revenues $4,098 +29%
Net Income $783 +23%
R&D Budget $1,072 +16%
2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Avonex MS $2,203 +18%
Rituxan NHL $1,128 +22%
Tysabri MS $589 +156%
Account for 99% of total biopharma sales, same as in 2007.
PROFILE
In 2007, Biogen Idec set 2010 as the date to reach a series of business goals. Now I bet management more concerned about being in business that year. BI saw its biopharma revenues leap by 30% last year, but the company made bigger news in recent months when 揳ctivist investor?Carl Icahn agitated to break up the company or sell it off. (I chronicled some of this kerfluffle in last year抯 report.) This built up to a rancorous proxy fight and shareholder meeting in which Mr. Icahn succeeded in taking over two seats on the company抯 board.
Considering he was involved in pushing MedImmune and ImClone into the arms of AZ and Lilly, respectively, I抎 suggest they rent, not buy.
Six Years Later
In June 2009, Biogen Idec won an arbitration case against Genentech. Genentech had argued that Biogen抯 2003 merger with Idec constituted a change of control, and thus the new company gave up its rights to 損articipate in strategic decisions?regarding the development of Rituxan and other anti-CD20 antibodies the companies had been collaborating on.
The arbitration panel ruled that the companies have to form a joint development committee of six members ?three from each companies ?that must unanimously approve development plans for each indication. Glad that only took six years to settle.
One of those 2010 goals was to have 100,000 patients on Tysabri, the company抯 biologic treatment for MS and Crohn抯 disease. Unfortunately, the pace of new patients has slowed because of safety concerns. Despite BI and development partner Elan抯 fantastic results in trials of MS patients on Tysabri, four cases of progressive multifocal leukoencephalopathy (PML)cropped up in 2008, and two more cases occurred in June 2009.
Three cases of PML during a clinical trial caused BI to pull Tysabri from the market in 2005; this time around, BI抯 being cautious but is still promoting the treatment. The company had approximately 40,000 patients using Tysabri by March 2009. Tysabri revenues climbed 44% in 1Q09 to $165 million.
They used to say that when America sneezes, the rest of the world catches a cold. When rolofylline, Merck抯 acute heart failure treatment, failed a big Phase III trial in June 2009, I have a feeling that nausea spread through the offices at BI. One of the company抯 top small-molecule prospects, Adentri, is in the same category as rolofylline: adenosine A1 antagonists. Adentri entered Phase III in August 2008 in acute decompensated heart failure (ADHF) patients with renal insufficiency.
The question is: will there be a BI by the time that clinical trial concludes?