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
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
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
Taking Hemophelia Treatments Up A Notch (BAY, MAXY, AMGN)
There is a small emerging pharma stock company called Maxygen Inc. (NASDAQ: MAXY) that is benefiting from some news today. The company is selling its hemophelia treatment unit to Bayer AG (Pink Sheets: BAYRY).
Maxygen will receive $90 million upfront for its unit, and is eligible to receive payments of up to $30 million thereafter in potential future fees. Bayer will get the lead drug candidate MAXY-VII along with a license to use the underlying gene targeting technology, which appears to be expected to move to early-stage clinical studies in the third quarter. This is a perfect fit as Bayer already sells Factor VIII product kogenate for the treatment of hemophilia.
What is interesting is that as of March 31, Maxygen has $133.5+ million in cash and equivalents on the balance sheet and only $10.2 million in liabilities.
Maxygen is greatly benefiting from this. Its shares are up 29% at $4.54, and its 52-week trading range is $3.28 to $9.56. With a $168 million market cap after the unit sale, this one is trading at below net-cash. Of course that is misleading since the company has said it may become target of an Amgen (NASDAQ: AMGN) lawsuit earlier this month.
Jon C. Ogg
July 2, 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