Keryx Biopharmaceuticals (KERX) Up On Test Results
Keryx Biopharmaceuticals (KERX) is up 33% to $3.14 on news that results of the Open Label Extension (OLE) trial of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The OLE trial, conducted in Taiwan, enrolled 29 of the 37 Taiwanese patients that had completed the randomized, multi-center, multi-national (United States and Taiwan) dose-ranging Phase 2 study. This OLE represents the first trial to examine the long-term safety and efficacy of Zerenex as a phosphate binder. The treatment period in all previous Zerenex Phase 2 clinical trials did not exceed 28 days.
The OLE trial provided for a daily dose, ranging from 2 to 6 g/day of Zerenex, for a period of up to one year following completion of the 28-day, dose-ranging Phase 2 study. The average duration of the patients’ participation in the OLE trial was 306 +/- 85 days.
The company now trades at a 52-week high up from a period low of $.09. It is hard to say such a huge run is justified.
At June 30, 2009, the Company had cash, cash equivalents, short-term investment securities and interest receivable of $13.4 million, as compared to $15.5 million at December 31, 2008. In addition, at June 30, 2009, the Company had $7.1 million of auction rate securities which are classified as long-term investments. Additionally, in July 2009, the Company received $2.75 million of cash from a settlement with the former licensor of Sulonex (sulodexide). The Company will receive an additional $750,000 on or before July 30, 2010 related to this settlement.
The net income for the second quarter ended June 30, 2009 was $14.1 million, or $0.29 per diluted share, compared to a net loss of $7.7 million, or $0.17 per share, for the second quarter in 2008. The change in net income (loss) was primarily attributable to the recognition of $18.0 million in license revenue relating to an amendment to the September 2007 sublicense agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. (JT/Torii), which eliminated the Company’s significant ongoing obligations included in the original agreement, a $1.8 million decrease in research and development expenses related to KRX-0401, and a $1.0 million decrease in research and development expenses related to the cessation of the development of Sulonex in March 2008.
Douglas A. McIntyre
Why Dendreon Isn’t Running on Positive Analyst Call (DNDN)
Dendreon Corp. (NASDAQ: DNDN) has not continued its strong run-up we had been seeing, although shares are up almost 25% in just the last week. And then today came an initiation with an “Outperform” rating and a $40.00 target at Leerink Swann. The analyst expects that PROVENGE, its prostate cancer vaccine, will get FDA approval and that it will get broad widespread adoption from physicians. All of that is good, but shares are at a point where a wait and see attitude is starting to take hold.
Dendreon is scheduled to speak in front of investors and analysts Thursday morning in New York City. Last week’s gain seen in options trading was mostly based on takeover or partnership hopes and rumors because most of the activity had been in teh September-2009 Calls which expired last week.
Leerink Swann noted that there may interest in both on-label and off-label use, which is actually not outside of the norm for many patients. The platform will have limited competition and may actually become a platform for many other cancers.
Part of the caution is that there is a worry that Thursday’s meeting will not have much in the form of new data. The target is now for a late-Q4 approval by the FDA, and investors will be watching to make sure that the FDA does not make the big delay or request for any additional data. PROVENGE could have likely been on the market a year ago if everything had gone smoothly.
We may get an idea for some sort of sales projections and more detailed pricing information. We expect to hear more longer-term details about the recent locations secured for manufacturing and its supply pacts and more. But as far as any partnerships, mergers, or definite change from the FDA, we are not expecting that other than we’d say, “We hope so.”
The Leerink Swann upgrade today was an upgrade that just came too late after too much of a run in the last week. If this was a week ago you would have seen more of a move from that.
At 1:00 PM EST we have shares trading up 0.3% at $29.56 on almost 3 million shares.
Jon C. Ogg
September 22, 2009
Controversy Toward American Oriental Bioengineering (AOB)
American Oriental Bioengineering Inc. (NYSE: AOB) is being highlighted by a service which the company probably wished did not cover it. If you recall a websire called Asensio.com, and active site that highlights short selling opportunities or red flags in companies, Shenzen, China-based American Oriental Bioengineering is the new target of such activity.
If you look at the “Recent Reports” section at Asensio.com, there are two highted articles both dated as of today. One article is “AOB Chairman’s Questionable Second Passport and Potential Undisclosed Conflicts of Interest” and another article is “AOB’s Disclosures Concerning Director Cosimo Patti Appear Incomplete.”
You will need to go through these individually before making your own call. The notion that one short seller or one independent service highlights a company is something that should be checked and measured by each investor.
Shares were down early in the pre-market session, but the stock was actually back to positive right after the open. At 9:39 AM Est we have shares up 0.3% at $5.39. The 52-week trading range is $3.29 to $7.66 and the average volume is over 1.4 million shares.
American Oriental Bioengineering, Inc. is a Chinese pharmaceutical company “dedicated to improving health through the development, manufacture and commercialization of a broad range” of prescription and over the counter products. The market cap of this one is $421 million.
JON C. OGG
September 22, 2009
BSD Medical (BDSM) More Than Doubles On News
Shares of BSD Medical (BDSM) are up 130% to $4.34, still well below the stock’s 52-week high of $7.15.
The company reported significant and “medical practice changing” clinical study results were the subject of a news briefing at Europe’s largest cancer congress, ECCO15 – ESMO34, which is being held September 20 to 24, 2009, in Berlin, Germany. A Phase III study, which utilized the BSD-2000 Hyperthermia System, demonstrated that patients with high risk soft-tissue sarcomas were 30% more likely to be alive and cancer free almost three years after starting treatment if targeted heat therapy (hyperthermia) was added to their chemotherapy treatment.
Douglas A. McIntyre
Market Buys Into CEL SCI (CVM) CEO’s Nonsense
CEL-SCI Corporation’s CEO, Geert Kersten, said his company just received FDA approval to proceed with a clinical trial of its H1N1 flu drug candidate, testing its effect on white blood cells of patients who are hospitalized. The biotech firm said it is working on the next phase of the study and is preparing the drug’s follow-up regulatory application.
The company also filed with the SEC saying it is offering to sell up to 22,000,000 shares of its common stock to investors exercising warrants previously issued by CEL-SCI.
CVM is up on heavy volume to $2.06, a 3.6% gain for the day. There is not news from the company that should cause it to trade above $1.11 where it was five days ago.
Douglas A. McIntyre
Arena Pharm (ARNA) Goes Nowhere On Bad News
Arena Pharmaceuticals (ARNA) is off 1.5% to $5.15 on what would appear to be bad news.
Leerwink Swann downgraded that stock.
According to AP, “the company’s latest trial results showed subjects didn’t lose as much weight on Lorcaserin as they did on the other two drugs. Arena said the results were still strong enough for approval, but shares tumbled more than 11% last Friday.”
Leerwink Swann view does not hold much water.
Douglas A. McIntyre
Nektar Therapeutics (NKTR) Moves On AstraZeneca Deal
Nektar Therapeutics (NKTR) is up 13% to $.9.50 and hit a 52-week high on news that the company and AstraZeneca announced that they have entered into an exclusive worldwide license agreement for two drug development programmes: NKTR-118, a late stage investigational product being evaluated for the treatment of opioid-induced constipation, and the NKTR-119 programme, an early stage programme that is intended to deliver products for the treatment of pain without constipation side effects. Both programmes were developed by Nektar, utilizing their proprietary small molecule advanced polymer conjugate technology platform.
Under the terms of the agreement, AstraZeneca will assume the responsibility for the continued development of both the NKTR-118 and NKTR-119 programmes, including the initiation of late-stage clinical studies for NKTR-118. AstraZeneca expects completion of the design of the phase III programme in the near term, and anticipates filing the drug with regulators in 2013. AstraZeneca will also be responsible for global manufacturing and marketing for both programmes. Under the agreement, Nektar will receive an upfront payment of $125 million for both NKTR-118 and NKTR-119.
NKTR-118 has completed a Phase 2 clinical trial and is being developed to treat constipation caused by the use of opioid pain products. Under the agreement, for NKTR-118, Nektar is eligible to receive up to $235 million in aggregate payments upon the achievement of certain regulatory milestones, as well as additional tiered sales milestone payments of up to $375 million if the product achieves considerable levels of commercial success. Nektar will also be eligible to receive significant double-digit royalty payments on net sales of NKTR-118 worldwide.
Douglas A. McIntyre
Eli Lilly (LLY) Strong Cancer Drug Results
Eli Lilly (LLY) has announced that data published today in The Lancet showed a survival benefit in nonsquamous patients with advanced non-small cell lung cancer (NSCLC) who received maintenance therapy with ALIMTA(R) (pemetrexed for injection) plus best supportive care as compared to placebo plus best supportive care.
The company said that this Phase III clinical trial supported previous studies looking at the use of histology to tailor treatment with ALIMTA for patients with advanced nonsquamous NSCLC. Advanced nonsquamous NSCLC patients on the ALIMTA plus best supportive care arm achieved more than five months increased median overall survival compared to nonsquamous NSCLC patients who received placebo plus best supportive care following initial chemotherapy.
The publication of The Lancet manuscript follows the July 2009 U.S. Food and Drug Administration (FDA) approval of ALIMTA as maintenance therapy for patients with locally advanced or metastatic nonsquamous NSCLC, whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for treatment in patients with squamous cell NSCLC. The European Commission also granted a similar approval in July 2009.
Douglas A. McIntyre
Bad Arena (ARNA) News Good For Orexigen (OREX) And Vivus (VVUS)
Arena Pharmaceuticals (ARNA) disappointing news about diappointing trial results for its obesity treatment lorcaserin.
The news, however, is pushing the firms two competitor higher in early trading as they are perceived to benefit from ARNA’s failure. Vivus (VVUS) is trading up 7% to $11.35 on heavy volume. Orexigen (OREX) started the session higher by now trades a little below flat at $9.14
Douglas A. McIntyre
Arena Pharmaceuticals (ARNA) Disappoints Wall St.
Shares of Arena Pharmaceuticals (ARNA) are off 11% to $4.35 on drug trial news that investors did not think was up to expectations.
ARNA announced that it had positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial. BLOSSOM confirms the results previously reported for the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial and completes the lorcaserin Phase 3 pivotal registration program of 7,190 patients evaluated for up to two years. Arena plans to submit a New Drug Application, or NDA, for lorcaserin to the US Food and Drug Administration, or FDA, in December. Read more
