Amgen’s Trouble in Lung Cancer Trials (AMGN)
Amgen (NASDAQ: AMGN) and Takeda Pharmaceutical Company Limited’s Millennium Pharma have issued some disappointing news on the lung cancer front. The companies have announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin as a first-line treatment of advanced non-small cell lung cancer has been temporarily suspended.
This follows a planned safety data review of 600 patients by the study’s independent Data Monitoring Committee. Motesanib is part of a broad co-development program between Amgen and Takeda.
The monitoring committe recommended that enrollment in the study be suspended. This is based on an observation of higher early mortality rates in the motesanib group compared to the placebo group.
The committee recommended that the squamous patients with immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis, but it did not recommend for the non-squamous patients to discontinue motesanib therapy.
Here are the full details from Amgen.
Jon C. Ogg
November 19, 2008
Short Sellers Lightening Up Against Biotechs (AMGN, GILD, CELG, GENZ, BIIB)
Short sellers haven’t just eased up on betting against financial stocks. If you look at the major biotech stocks not involved in mergers you will see an across the board drop in the short interest in major biotechs. Below we have show the dates and the changes to represent each of the major names:
- Amgen (AMGN) 07/31/2008 short interest 31,659,693 down 22.96% from 07/15’s 41,097,709 shares.
- Gilead (GILD) 07/31/2008 short interest 33,141,320 down 0.06% from 7/15’s 12,632,227 shares.
- Celgene (CELG) 07/31/2008 short interest 12,301,038 down 20.38% from 7/15’s 5,642,397 shares.
- Genzyme (GENZ) 07/31/2008 short interest 6,839,521 down 8.21% from 7/15’s 3,888,041 shares.
- Biogen Idec (BIIB) 07/31/2008 short interest 7,467,029 down 2.67% from 7/15’s 4,819,980 shares.
With all the merger activity happening in the sector, you can imagine that short sellers probably wanted to avoid walking in one morning to find the stock up 25% on a merger announcement.
Jon C. Ogg
August 12, 2008
Amgen Gets The Gorilla Off Its Neck (AMGN)
Amgen Inc (NASDAQ: AMGN) came out with its much awaited data after the close and shares are rocking higher on the news. The biotech giant said that its pivotal 3-year trial of experimental osteoporosis drug Denosumab met the target goals by significantly reducing the risk of bone fracture in post-menopausal women.
The patients treated with denosumab showed a statistically significant reduction in the incidence of new vertebral fractures over the arm given the placebo.
Amgen also noted that the group receiving Denosumab also experienced a statistically significant reduction of new non-vertebral and hip fractures.
The groups receiving Denosumab and the placebo also saw similar side effects and at roughly the same frequency, with side effects including serious infections and malignancies.
Shares are up a monster 11% and back over $60.00 for the first time in more than a year.
Jon Ogg
July 25, 2008
If Genentech Is Acquired, Others May Follow (DNA, AMGN, BIIB, GENZ, GILD, CELG, IMCL)
Genentech (NYSE: DNA) is just one of the next biotechs (and just large companies on discount for that matter) that is likely to disappear as far as US-based shareholders are concerned. The largest biotech company by market cap has been offered $89.00 per share in cash by parent Roche for the 44% minority stake it doesn’t own.
Genentech shares are trading over $90.00 as it is believed that if Roche wants to recapture this after a 25 year history of being public that it might have to go closer to $100.00. We’d watch other biotech Amgen (AMGN), Biogen-Idec (BIIB), Genzyme (GENZ), Gilead (GILD), Celgene (CELG), ImClone (IMCL) and others on this.
The US-biotech and other critical spaces may about to be getting much smaller.
JOn Ogg
July 21, 2008
Amgen, Awaits FDA & Jumping the Gun (AMGN)
Amgen Inc. (NASDAQ: AMGN) had a bit of a SNAFU yesterday over a press release being issued and then retracted. The company said that Business Wire “accidentally” or erroneously released a statement on Monday from the company over a false Food and Drug Administration approval announcement regarding its Nplate. Business Wire confirmed that it prematurely issued the press release.
Nplate is treatment for a rare type of blood-platelet deficiency condition (autoimmune disorder chronic immune thrombocytopenic purpura) where blood platelets decline to the point that leads to serious bleeding.
This is still under FDA review. What is interesting for options and equity traders is that the company expects the actual FDA decision by July 23. That is five days before its earnings release, but is also after this coming Friday’s options expiration date. This unfortunately makes traders buy the August 2008 options, at least assuming the FDA isn’t going to make an early release on the data.
If you look at the trades you can see that options traders are going out farther to August for their speculation:
Call/Strike Volume OpInt
AUG08 $52.50 1,165 10,600
AUG08 $55.00 4,046 3,512
versus
Call/Strike Volume OpInt
SEP08 $50.00 1,734 13,587
SEP08 $52.50 678 6,509
SEP08 $55.00 75 17,776
Unfortunately traders are paying a double event risk because of the FDA action and the earnings release.
Jon C. Ogg
July 15, 2008
Drug & BioHealth: How Worries May Hurt More Than News (MRK, PFE, BMY, TEVA, AMGN, BIIB, DNA)
It seems that the differences between old Big Pharma key drug powerhouses and established biotech players is becoming more and more of a blur rather than any firm lines. Before you consider this lunacy, remember the analogy that all biotech companies are seeking to become established drug companies. If you have watched Big Pharma mergers with biotechs, you’d wonder why there are any biotechs with drugs or pipelines left on the market.
Today we are seeing pressure on Merck & Co.(NYSE: MRK) after UBS issued some cautious stance on Gardisil sales. What is interesting about this call is that its primary competition on the U.S. drug market was just last week pushed out at least 6 months beyond what most were expecting.
It seems we almost never see a day without Pfizer Inc. (NYSE: PFE) not hitting a 52-week low or not at least being down on concerns that patents will expire and the company’s pipeline looks more like a pie in the sky line.
Bristol-Myers Squibb Co. (NYSE: BMY) has many of the same concerns as Pfizer as many of its investors have thrown in the towel here, but it has the added uncertainty of what this will look like beyond 2008 after the company goes through a miniature break-up.
If you think that generics coming on market is an issue, you may appreciate the irony as we see generics come under pressure from two arena. Big Pharma companies are taking the stance of slashing their prices to meet or come very close to generics as the generics get launched. This causes fears that generic margins will go to hell in a hand basket. Now take Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA). This one was hit hard recently after Mylan Labs (NYSE: MYL) signed a licensing pact in India to produce a generic version of Teva’s COPAXONE for MS treatment. Yep, that is the generic’s number one name brand drug it makes on its own. Go figure, a generic maker challenged by a generic.
But this doesn’t stop at Big Pharma and doesn’t stop at generics. Even many of the key biotech leader stocks have been under fire of late.
Amgen Inc. (NASDAQ: AMGN) has gone from its own cycle of boom to bust to rust. It ENBREL and other franchises have peaked for the time being over reimbursement rate concerns and Black Box warnings on its drugs with extreme warnings. While the worst is likely behind it and while we feel this is merely priced like a drug stock, there are very few traders looking for a major move in the near-term.
Biogen-Idec (NASDAQ: BIIB) is a worry that almost hasn’t gone away. Sure, the weakness after the post-TYSABRI withdrawal has been overcome, but this stock is believed to have very few prospective buyers based upon the size and target markets with today’s $17+ Billion market cap. We still believe the company mishandled its TYSABRI withdrawal because the treatment benefits looked so much better than the PML side effect percentages.
Take the giant Genentech (NYSE: DNA) for an example. The largest biotech is rapidly becoming a dead money stock. It keeps growing but concerns that its Avastin won’t continue to get perpetual approval to cure all cancers. Throw in the point that its individual drug sales seem to disappoint analysts routinely.
So where do we go from here? We are in an election year and it doesn’t take a rocket scientist to look at the health insurers and other medical-related sectors to determine that caution is going to prevail over extreme bullish sentiment of the past. We still think there will be many substantial mergers in small-cap and mid-cap biotechs and among many of the smaller providers that fit into safe niches. But there is going to be some added pain and caution as the most likely scenario(s) throughout the summer and into the fall in many of the key players in this field of drug and biotech.
At some point we’ll realize how cheap some of the names have gotten, but every effort to identify this as an inflection point has been met with added pain. Many of these companies will start reporting earnings over the next couple of weeks. You can bet that traders will be looking closely to start picking their spots or deciding to stay on the sidelines.
Jon Ogg
July 7, 2008
Short Interest Volume Changes: MAJOR BIOTECH (AMGN, GILD, BIIB, CELG, GENZ)
We ran a screen of the top five NASDAQ biotech stocks by market cap to look at the short interest changes from the end of May to mid-June. Amgen Inc. (NASDAQ: AMGN) had the largest gains in short selling by far and the others were mixed. We also screened Gilead Sciences Inc. (NASDAQ: GILD), Biogen Idec Inc. (NASDAQ: BIIB), Celgene Corporation (NASDAQ: CELG), and Genzyme Corp. (NASDAQ: GENZ).
Amgen Inc. (AMGN)
AS OF DATE Short Int. Change
06/13/2008 48,430,933 113.55%
05/30/2008 22,678,517 -8.48%
Gilead Sciences Inc. (NASDAQ: GILD)
AS OF DATE Short Int. Change
06/13/2008 34,676,528 6.77%
05/30/2008 32,478,444 -0.65%
Celgene Corporation (NASDAQ: CELG)
AS OF DATE Short Int. Change
06/13/2008 12,951,360 -5.98%
05/30/2008 13,775,373 -15.68%
Biogen Idec Inc. (NASDAQ: BIIB)
AS OF DATE Short Int. Change
06/13/2008 7,467,264 17.66%
05/30/2008 6,346,464 -6.51%
Genzyme Corp. (NASDAQ: GENZ)
AS OF DATE Short Int. Change
06/13/2008 5,751,563 1.17%
05/30/2008 5,684,945 1.12%
Jon Ogg
June 25, 2008
Positive Biotech Analyst Calls (AMGN, ATHX, DNA, GILD, SEPR)
These are some of the upgrades and positive calls already being seen in the biotech sector this Thursday morning:
- Amgen (NASDAQ: AMGN) Started as Buy at Deutsche Bank.
- Athersys (NASDAQ: ATHX) started as Buy at Lazard Capital.
- Genentech (NYSE: DNA) Started as Buy By Deutsche Bank.
- Gilead (NASDAQ: GILD) Started as Buy at Deutsche Bank.
- Sepracor (NASDAQ: SEPR) raised to Buy at UBS.
You can see the list of negative calls and downgrades here.
Jon Ogg
June 19, 2008
Cytokinetics & Amgen: positive heart failure drug without side effects? (CYTK, AMGN)
Cytokinetics Inc. (NASDAQ: CYTK) has presented data showing that its late trials of its CK-1827452 at the 2008 Heart Failure Congress of the European Society of Cardiology, which is being developed along with Amgen Inc. (NASDAQ: AMGN).
The company announced positive results from an interim analysis of an ongoing Phase IIa clinical trial evaluating CK-1827452 intravenously administered to patients with stable heart failure. The highlighted data is from an interim analysis of an ongoing Phase IIa clinical trial designed to evaluate CK-1827452 in patients with stable heart failure.
At the time of the analysis, 22 patients were evaluated and the safety data from this analysis suggest that CK-1827452 is well-tolerated with no serious adverse events reported in heart failure patients exposed to the intended range of doses and plasma concentrations.
We have yet to see any serious movement in this stock yet, but the critical part on top of results here is “no serious adverse events” as so many heart failure drugs and other heart medications have often severe side effects.
As this data is being presented at a conference, some of it may have already been known or already been hinted at. We have seen no activity in CYTK’s stock this morning as of yet even though indications are higher and it only trades 155,000 shares per day.
Jon Ogg
June 16, 2008
Short Sellers Lighten Up on Major Biotechs in May
We ran the short selling report that just came out on major NASDAQ biotech stocks to see what the change in short selling was. Interestingly enough, in almost all of the major and large US biotechs traded on NASDAQ.
STOCK (Ticker) MAY 30 MAY 15 CHANGE
Amgen Inc. (AMGN) 22,678,517 24,778,770 -8.48%
Biogen Idec Inc. (BIIB) 6,346,464 6,788,432 -6.51%
Celgene Corporation (CELG) 13,775,373 16,336,232 -15.68%
Genzyme Corporation (GENZ) 5,684,945 5,621,969 +1.12%
Gilead Sciences, Inc. (GILD) 32,478,444 32,690,603 -0.65
ImClone Systems Inc. (IMCL) 7,149,395 7,664,009 -6.71%
And below you can see the short selling changes on some of the smaller biotechs that are still rather active in daily trading volume. The results below are more mixed than they are in the major biotechs.
STOCK (Ticker) MAY 30 MAY 15 CHANGE
Amylin Pharmaceuticals, Inc. (AMLN) 23,855,471 23,642,854 +0.90%
Cell Genesys, Inc. (CEGE) 16,931,592 17,222,281 -1.69%
Dendreon Corporation (DNDN) 31,117,812 30,728,499 +1.27%
Illumina, Inc. (ILMN) 12,239,553 11,902,877 +2.83
Invitrogen Corporation (IVGN) 9,125,954 9,340,210 -2.29%
Medarex, Inc. (MEDX) 21,837,573 19,682,828 +10.95%
Jon C. Ogg
June 11, 2008