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fid--MCU
From Pasceri et al, Circulation. 2004;110: 674-678
Myocardial necrosis, assessed by creatine kinase-MB (CK-MB) elevation, is relatively frequent after coronary intervention, occurring in up to 40% of cases. Although most patients remain asymptomatic with no changes in cardiac function, even a mild release of CK-MB is associated with higher mortality during follow-up.
....
A recent meta-analysis, pooling data from 23 230 patients, showed that any increase of CK-MB above normal limits is associated with increased mortality. In particular, an elevation of CK-MB of only 1 to 3 times was associated with an excess mortality of 1.7% at 1 year; the excess mortality was 2.8% for CK-MB 3 to 5 times above the upper limit of normal and 7.4% for an increase >5 times above the upper normal limit. Similar results were obtained in a recent observational study on 8409 consecutive patients. According to these data, an absolute reduction of 20% of CK-MB release, as observed in the present study, would translate into 6 lives saved per 1000 patients treated in 1 year.
COR
I don't know if this press release is good or bad, but "acute" implies that the preclinical work will be quick--no waiting for the animals to develop tumors, for example.
Talking Sense On Iran
[I think I like this guy]
What will the U.S. do about Iran? Sanction? Bomb? Invade?
How about... nothing.
That's right, nothing.
So suggests a Republican member of the U.S. House who has been sounding the alarm in Congress about the rush to act against what he dismisses as nothing more than "the next neocon target."
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"There is no evidence of a threat to us by Iran, and no reason to plan and initiate a confrontation with her," argues Representative Ron Paul, the conservative from Texas who has in recent weeks voiced the loudest and most consistent objections to attempts by the Bush administration and its allies in Congress to suggest that U.S. military action may be needed to avert a supposed nuclear threat from the country.
An "Old Right" Republican with a long libertarian streak who has been repeatedly reelected from a Texas district where American flags wave in the breezes blowing off the Gulf of Mexico, and where the word "patriot" is taken seriously by the congressman and his constituents, Paul offers the answer to the despairing question of whether there is anyone in Congress who recognizes that the course proposed by the Bush administration and its neoconservative gurus is one of sheer madness.
Instead of planning an attack, the Texas Republican argues, "There are many reasons not to do so."
In a detailed address delivered on the floor of the House last week, Paul detailed them:
Iran does not have a nuclear weapon and there's no evidence that she is working on one -- only conjecture.
If Iran had a nuclear weapon, why would this be different from Pakistan, India, and North Korea having one? Why does Iran have less right to a defensive weapon than these other countries?
If Iran had a nuclear weapon, the odds of her initiating an attack against anybody-- which would guarantee her own annihilation-- are zero. And the same goes for the possibility she would place weapons in the hands of a non-state terrorist group.
Pakistan has spread nuclear technology throughout the world, and in particular to the North Koreans. They flaunt international restrictions on nuclear weapons. But we reward them just as we reward India.
We needlessly and foolishly threaten Iran even though they have no nuclear weapons. But listen to what a leading Israeli historian, Martin Van Creveld, had to say about this: "Obviously, we don't want Iran to have a nuclear weapon, and I don't know if they're developing them, but if they're not developing them, they're crazy."
There's been a lot of misinformation regarding Iran's nuclear program. This distortion of the truth has been used to pump up emotions in Congress to pass resolutions condemning her and promoting UN sanctions.
IAEA Director General Mohamed El Baradi has never reported any evidence of 'undeclared' sources or special nuclear material in Iran, or any diversion of nuclear material.
We demand that Iran prove it is not in violation of nuclear agreements, which is asking them impossibly to prove a negative. El Baradi states Iran is in compliance with the nuclear NPT required IAEA safeguard agreement.
We forget that the weapons we feared Saddam Hussein had were supplied to him by the U.S., and we refused to believe UN inspectors and the CIA that he no longer had them.
Likewise, Iran received her first nuclear reactor from us. Now we're hysterically wondering if someday she might decide to build a bomb in self interest.
Anti-Iran voices, beating the drums of confrontation, distort the agreement made in Paris and the desire of Iran to restart the enrichment process. Their suspension of the enrichment process was voluntary, and not a legal obligation. Iran has an absolute right under the NPT (nuclear proliferation treaty) to develop and use nuclear power for peaceful purposes, and this is now said to be an egregious violation of the NPT. It's the U.S. and her allies that are distorting and violating the NPT. Likewise our provision of nuclear materials to India is a clear violation of the NPT.
Noting that the same neoconservatives who steered the United States into the quagmire that is Iraq now want to start a new preemptive war with Iran -- not because a fight in needed but in order to achieve the regime change they desire -- Paul says what ought to be the official line of all rational observers of the situation: "Hysterical fear of Iran is way out of proportion to reality."
The Texas Republican, who opposed the rush to war with Iraq in 2002 and remains a steadfast critic of the endeavor, also proposes the rational counter to neoconservative calls for a new war.
With a policy of containment, we stood down and won the Cold War against the Soviets and their 30,000 nuclear weapons and missiles. If you're looking for a real kook with a bomb to worry about, North Korea would be high on the list. Yet we negotiate with Kim Jong Il. Pakistan has nukes and was a close ally of the Taliban up until 9/11. Pakistan was never inspected by the IAEA as to their military capability. Yet we not only talk to her, we provide economic assistance-- though someday Musharraf may well be overthrown and a pro-al Qaeda government put in place. We have been nearly obsessed with talking about regime change in Iran, while ignoring Pakistan and North Korea. It makes no sense and it's a very costly and dangerous policy.
The conclusion we should derive from this is simple: It's in our best interest to pursue a foreign policy of non-intervention. A strict interpretation of the Constitution mandates it. The moral imperative of not imposing our will on others, no matter how well intentioned, is a powerful argument for minding our own business. The principle of self-determination should be respected. Strict non-intervention removes the incentives for foreign powers and corporate interests to influence our policies overseas. We can't afford the cost that intervention requires, whether through higher taxes or inflation. If the moral arguments against intervention don't suffice for some, the practical arguments should.
Intervention just doesn't work. It backfires and ultimately hurts American citizens both at home and abroad. Spreading ourselves too thin around the world actually diminishes our national security through a weakened military. As the superpower of the world, a constant interventionist policy is perceived as arrogant, and greatly undermines our ability to use diplomacy in a positive manner.
Conservatives, libertarians, constitutionalists, and many of today's liberals have all at one time or another endorsed a less interventionist foreign policy. There's no reason a coalition of these groups might not once again present the case for a pro-American, non-militant, non-interventionist foreign policy dealing with all nations. A policy of trade and peace, and a willingness to use diplomacy, is far superior to the foreign policy that has evolved over the past 60 years.
It's time for a change.
Indeed, it is.
Where to begin? How about with the Democrats in Congress?
Isn't it time for the so-called "opposition party" to start talking as much sense about Iran as a member of the president's own party?
MCU
MCU gets approval for a single phase III for MC-1.
The primary end point will be the composite of CV death and nonfatal MI (CK-MB >100 ng/ml). Notably, this is a less conservative cutoff for CK-MB than that used as part of the composite of the primary end point in the phase II trial (CK-MB >50 ng/ml).
For comparison, the following are the POD30 results from the phase II:
The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028).
The reduction in the composite endpoint was driven by a substantial decrease in the incidence of non-fatal myocardial infarction, most notably a 46.9% reduction in non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg of MC-1 versus placebo (p equals 0.008).
The 250 mg dose of MC-1 had a 14.0% reduction in the primary endpoint composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 50ng/ml), and non-fatal stroke versus placebo (p equals 0.312).
J
Medicure Reports on MEND-CABG End of Phase II Meeting With the FDA
WINNIPEG, MANITOBA--(CCNMatthews - April 12, 2006) - Medicure Inc. (TSX:MPH)(AMEX:MCU), a cardiovascular drug discovery and development company, today announced that based on the positive Phase II MEND-CABG study and a recent End of Phase II meeting with the U.S. Food and Drug Administration (FDA), the Company plans to proceed with a single confirmatory Phase III study to gain approval for MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft (CABG) surgery. MC-1 has received a Fast Track designation from the FDA.
Based on the End of Phase II meeting, Medicure plans to use a composite of cardiovascular death and non-fatal myocardial infarction (primary definition peak CK-MB greater than or equal to 100ng/ml) at post operative day (POD) 30 as the primary endpoint for the Phase III study. Initiation of this study is targeted for the second half of calendar 2006.
"We are extremely pleased with the outcome of the End of Phase II meeting with the FDA. A single confirmatory study provides Medicure the most efficient and affordable path for MC-1's Phase III development, and is a valuable asset in our partnership negotiations," commented Medicure's President and CEO, Albert D. Friesen, PhD. "MC-1 has the opportunity to be the first product indicated to reduce cardiovascular events associated with ischemia and/or ischemic reperfusion injury in CABG patients, targeting a significant unmet medical need. We look forward to working with the FDA in expediting the development of MC-1."
MC-1 is a small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1's cardioprotective properties have been demonstrated in the Phase II MEND-1 study in patients undergoing percutaneous coronary interventions and the Phase II MEND-CABG study in patients undergoing CABG surgery.
E-Trade Pro
Dew, I believe you have to make something like 50 trades per quarter to qualify for E-Trade Pro. However, if you call them and threaten to move your account, they may give you the E-Trade Pro platform without the need to qualify.
Just one note: unless you qualify for E-Trade Pro, customer service is truly awful. There was one instance where I spent hours on the phone trying to get through to them. I ended up e-mailing them and asking them to call me when they were free. Which they did, days later.
Buying and selling ex-US stocks is hell with E-Trade.
J
Teapeebubbles--
I like your board, but how about posting links to your sources?
Thanks!
INSM
Dr Bio, I agree with your reasoning and I can't figure out why INSM is trading so low. I wish someone could offer a rational explanation for it. I have been considering owning INSM again for a long time (I owned it briefly on the day of the approval).
That said, for personal reasons I'm cutting back the biotech portion of my portfolio to about 50% and reallocating within that portion to spread out risk. INSM may fit nicely.
MCU
>How likely is it that some other, cheaper form of B6 would be equally efficacious?<
That's the question I'd like to see answered.
MCU
>How likely is it that the eventual market can be expanded beyond CABG peri-operative period? As you must know, CABG is a declining, but not dying procedure, having been largely replaced by angioplasty, stents, and better medical therapies.<
Just offhand, I would say that it is very likely that the market for MC-1 would expand to include PTCA patients. From a survey of the literature, subclinical myocardial damage is among the hottest emerging concepts for antiplatelets and antithrombotics.
YMI
I sold the majority of my shares yesterday--after having as many as 80,000 shares at one point, I have 20,000 left that I intend to hold through the tesmilifene results, and, hopefully, for a long time after that.
Overall, not a bad investment for 6 months--my average purchase price was just under $3, and my average sale price was slightly over $6.
It's not that I have any problems with management, the drugs, or the results so far. I just wanted to take some of that profit. If there was any way of knowing for sure that the phase IIb for AeroLef would complete and report before the tesmilifene results, I would have held on for the event, which is highly likely to be positive.
Bought some more HBX, added a little to my small position in BDSI, and am actively looking for some place to put the remainder of my profits. Wish XNPT was still a bargain.
J
YMI
I would think it has to be pediatric glioma.
I chose to stay home and listen online (its snowing, believe it or not), but I just might take a cab up to the Harvard Club to harass them in person.
YMI
No, he was referring to Oncoscience AG, so the approval they expect is European.
YMI--Interesting
Allan just said that nimo could be approved as early as next year--for what indication I do not know
YMI--AG Edwards
Just reporting what I've read.
Key points:
1. $15 valuation based strictly on 2010 revenue estimate of approximately $160 million in sales for tesmilifene on $465 million on sales with a price of about $9600 per patient per year.
2. They note that TELK has a market cap of $1 billion although "Telik does not have positive data from a phase III trial (where YM does) nor does it have a robust pipeline." Sound like something I've said before?
3. They add only $100 million for the value of the non-tesmilifene pipeline (only nimo and AeroLef); nevertheless they think YMI will have a 2007 value of roughly $800 million
4. They did not include the propargylamines or Norelin in their valuation calculation
Anyway, at least in my opinion, this remains a reasonably conservative estimate. They were very conservative in valuing tesmilifene and incredibly conservative in valuing nimo and AeroLef--particularly the latter as it could be approved as early as '08 and is relatively low risk.
ENCY
My position in ENCY is small enough that today's drop didn't cause significant portfolio pain (particularly becuase it was more than balanced out by the gain in COR). I am considering averaging down (way down)--today's sell-off was probably overdone. Also I think MYOG's drug is at very significant risk for a similar situation, so things will probably balance out in the end.
J
ADH
While I agree that ADH may provide significant returns if (emphasis on if) GSK picks up the option on ADH-1, I have yet to hear a satisfactory explanation why the company's top 4 officers make nearly $2.0 million when their salaries are taken together, and their CSO makes $55,000 (which is only marginally more than most postdocs make, and less than many postdocs in NYC).
The CEO alone makes far more than all of YMI's management put together. Does he have a particular talent we should be aware of? How about Norris and Murray? This has to be the most ridiculous example of shareholder rape in biotech.
Unless, of course, I'm missing something.
Also the rate-limiting step for a very actively transcribed gene is generally not the amount of mRNA available but something else--probably the availability of free ribosomes to synthesize protein.
ENCY
And I just bought some in AH at $8.65. Wonder who the dimwit was who sold them to me becuase of the results in a single rat with "baseline abnormalities" in a preclinical study.
Tomorrow is the big day for ENCY. We shall see whether the dimwit was smarter than me
J
YMI--full text abstract
RESULTS OF A PHASE II TRIAL OF H-R3 MONOCLONAL ANTIBODY (NIMOTUZUMAB) IN THETREATMENT OF RESISTANT OR RELAPSED HIGH-GRADE GLIOMAS IN CHILDREN ANDADOLESCENTS
Fleischhack, G.1; Buchen, S.1; Bach, F.2; Bode, U.11 Universitätsklinikum, Bonn; 2 Oncoscience AG, Wedel
Background: Children and adolescents suffering from high grade gliomas (HGG) have a poor prognosis when they relapse during or after primary treatment. Thus novel therapeutic approaches as the inhibition of growth-signalling pathways are needed. This multicentre phase II trial was designed toexplore the feasibility and efficacy of the h-R3 monoclonal anti-EGFR antibody (Nimotuzumab) in thetreatment of these patients.
Patients and Methods: Pediatric patients with glioblastoma multiforme, anaplastic astrocytoma orintrinsic pontine glioma (PG) with radiologically proven progressive disease following primary orrelapse treatment were eligible to the study. The treatment consisted of an induction therapy including a weekly short infusion of 150 mg/m² Nimotuzumab for six weeks, and in case of non-PD a subsequent consolidation therapy of four infusions in a three week interval. The response was documented by MRI in week 8 and 21.
Results: Between June 2004 and August 2005 34 patients aged 5.0 to 17.4 years (median 10.9years) were enrolled in this study. According to RECIST 12 out of 34 patients showed response (PRn=1, SD n=11) in the MRI of week 8 after the induction therapy with a median change in the largest diameter of the index lesion of -5% (-39 to +16%) accompanied by clinical deterioration in four and markedly clinical improvement in two patients. Surprisingly 9 PR/SD were seen in the 14 patients with PG. Eight patients continued with the consolidation therapy. So far 5 out of 8 Patients are evaluable for response after consolidation therapy and showed three PR, one SD and one PD in week 21. Eight patients with consolidation therapy are free of progression for a median of 7.5 months (1.2-13.2 months). No severe side effects related to the study medication were observed.
Conclusions: These data suggest that the repeated application of Nimotuzumab is well tolerated and safe. It has cytotoxic efficacy in heavily pre-treated relapsed HGG, especially in intrinsic pontineglioma. A phase III study for patients with newly diagnosed PG is warranted.
HBX
Up 16% after yesterday's conference call.
Among other things, they are pretty much claiming they won't need to dilute in 2006.
>Because the reformulation for those drugs was also based on the extended half-life, preferential accumulation theory. And in both cases, they did not fail due to lack of efficacy.<
Okay. I'll have to look closely at those two. I admit I haven't followed the OSIP story at all, in part because management there is so awful.
COR
I bought some at $5.01, went to the gym, and came back to a 12% gain.
Thank you Praveen and Bladerunner for reminding me to buy COR I've been looking at it for a long time, and finally decided to buy today.
J
OSIP--PGS
Just on quick review: OSI-211 is liposomal lurotecan and OSI-7094L is a novel liposomal TS inhibitor. Neither is a reformulation of an existing drug. Both were subject to considerable efficacy risk.
Marquibo is sphingosomal vincristine; the others that were picked up from IEX are sphingosomal vinorelbine and topotecan. All three have been used for years in oncology.
So what is the point regarding OSIP's drugs and how does this relate to the success or failure of reformulations?
Oh, the pleasure of clinical research
I'm working on an allergy study in which the investigators measured nasal secretion weight. Just got the results this morning and unless I'm misreading something, one participant generated over a kilogram of nasal secretion in one 24-hour period before treatment.
Thankfully I'm not involved in the conduct of this study.
>You omitted two prominent ones: NSTK and EMIS.<
Oops. I even owned NSTK for a while for intranasal apomorphine. I see they had a disaster, but not on a reformulation.
I know nothing about EMIS.
J
The reformulation business
I've noticed that the companies I own/have owned in the reformulation business have done spectacularly well--DND.TO, XNPT, SNUS, HBX.
I'm now looking at DEPO, BDSI, and a few others. Anyone have opinions on these two or additional suggestions?
I know NVD is also in a similar space. Not interested because it would be a double bet on Zensana.
J
HBX
Hana has all the ingredients in place for a successful biotech, namely, 6 clinical stage drugs encompassing a broad spectrum of MOAs and, most importantly, a means to fund their development with revenue from Zensana. Think I’m going to be holding this one for a long time.
Hana should also get an award for thorough press releases.
Hana Biosciences to License Three Targeted Cancer Drug Candidates from Inex Pharmaceuticals
Hana Biosciences (HBX, Trade) signed a letter of intent to license the worldwide rights to develop and commercialize three novel targeted chemotherapy drug candidates for the treatment of solid and hematological cancers from Inex Pharmaceuticals Corporation . The three candidates are known as Marqibo(TM) (sphingosomal vincristine), sphingosomal vinorelbine, and sphingosomal topotecan. Marqibo(TM) (sphingosomal vincristine) has demonstrated promising activity in patients with non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL) in completed and ongoing studies.
The novel targeted formulation of these approved chemotherapeutic agents is designed to significantly increase drug delivery to the tumor and prolong drug exposure for cell-cycle specific agents, thus increasing dose intensity. Based on completed and ongoing studies in hematological cancers, these innovative products may deliver higher drug doses into the tumor, with concomitant increases in clinical activity.
"This transaction will enhance Hana's portfolio of novel anticancer compounds, underscoring our patient-focused commitment to commercializing novel oncology therapies. We look forward to working with the FDA to obtain the Special Protocol Assessment (SPA) in hematological cancers, and to initiating registrational trials for Marqibo(TM) in 2006, while our current clinical programs continue on schedule," said Mark Ahn, PhD, President and CEO, Hana Biosciences.
Timothy M. Ruane, President and CEO of INEX, stated: "The team at Hana has a strong track record in oncology drug development, and our targeted chemotherapy products are a perfect fit in their pipeline. We will support their efforts as they move Marqibo(TM) towards commercialization and continue the development of sphingosomal vinorelbine and sphingosomal topotecan."
Under the terms of the transaction, Hana will pay INEX a total of $11.5 million upon closing, consisting of cash and shares of Hana common stock. In addition, Hana will pay INEX up to $30.5 million in shares of Hana common stock, contingent upon achievement of specific clinical and regulatory milestones, and royalties on net sales. The completion of the transaction is subject to the execution of definitive agreements, as well as other customary closing conditions, which are expected to be completed in the second quarter of 2006. Canaccord Adams is acting as the exclusive financial advisor to Hana in the transaction.
This licensing transaction will double Hana's pipeline to six clinical-stage oncology compounds. The drug candidates included in the transaction are:
-- Marqibo(TM) (sphingosomal vincristine) was previously studied in Phase II trials in non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL). Marqibo(TM) is targeted to enter pivotal trials in 2006, after a Special Protocol Assessment (SPA) is completed with the FDA.
-- Sphingosomal vinorelbine, for which an IND application is approved both in the US and Canada, is planned to enter clinical trials in 2006.
-- Sphingosomal topotecan, based on a unique formulation which significantly enhances activity in pre-clinical models, is planned to enter clinical trials in 2007.
The intellectual property covering the three product candidates is protected worldwide until 2020 by issued and pending patents.
"Vincristine is a cornerstone of combination chemotherapy in lymphoproliferative diseases. We believe that by raising the dose of this drug we can improve its clinical activity. The increased dose and promising activity of sphingosomal vincristine in patients with NHL and ALL support moving this drug into registrational trials," said Dr. Hagop Kantarjian, MD, Professor and Chairman of the Leukemia Department at the M.D. Anderson Cancer Center.
Hana to host a conference call on March 20, 2006 at 4:30 PM ET
Hana Biosciences will discuss the proposed transaction, as well as recently released results of operations and an overview of 2006 goals, in a teleconference at 4:30 PM ET on Monday, March 20, 2006. Those interested in hearing management's discussion may join the call by dialing 877-407-9210. International participants may access the call by dialing 201-689-8049. Participants may also access a live web-cast of the conference call through the Investor Relations section of Hana's website at www.hanabiosciences.com.
A replay will be available for three months following the call by dialing 877-660-6853 for domestic participants and 201-612-7415 for international participants and entering 286 for the playback account number and 196499 for the playback access code when prompted.
About Sphingosomal Targeted Drug Delivery
Sphingosomal encapsulation is a new generation liposomal drug delivery platform, which significantly increases tumor targeting and duration of exposure for cell cycle-specific anticancer agents. Sphingosomal drug delivery consists of using an already approved cancer agent encapsulated in a lipid envelope. The encapsulated agent is carried through the bloodstream and delivered to disease sites where it is released to carry out its therapeutic action.
When used in unencapsulated form, chemotherapeutic drugs diffuse indiscriminately throughout the body, diluting drug effectiveness and causing toxic side effects in the patient's healthy tissues. The proprietary sphingosomal formulation technology permits the loading of a high concentration of therapeutic agent inside the lipid envelope, promotes accumulation of the drug in tumors and prolongs the release of the drug at disease sites. As a result, compared to unencapsulated drugs, agents encapsulated in sphingosomes have been shown to deliver more of the therapeutic agent to a targeted disease site over a longer period of time, thus increasing the efficacy of the drug without increasing the toxicity in healthy, non-targeted tissues.
-- Longer circulation time in plasma delivers more of the therapeutic agent to targeted tumor sites over a longer period of time. To stabilize the lipid bilayer walls and retain active drug within the aqueous interior, this new generation liposomal technology uses sphingomyelin, a safe, biologically inert macromolecule whose amide backbone is resistant to hydrolysis. The increased rigidity of the liposomal walls prolongs the circulating life of liposomes and significantly extends the duration of drug release.
-- Sphingosomal drugs like Marqibo(TM) readily extravasate through the pores of leaky tumor vessels created during angiogenesis and readily accumulate within the tumor. In normal tissues, a continuous endothelial lining constrains liposomes within capillaries, preventing accumulation of the drug in the interstitial space. In contrast, the immature neovasculature within tumors is created during angiogenesis and has numerous imperfections, pores and discontinuities up to 800 nm in size. With an average diameter of approximately 100 nm, sphingosomes readily extravasate through these pores and accumulate within the tumor. Once lodged within the interstitial space, these resilient sphingosomes slowly release the encapsulated drug. Slow release of the drug from extravasated sphingosomes increases drug levels within the tumor, extends drug exposure through multiple cell cycles, and significantly enhances tumor cell killing. Vincristine kills tumor cells as they pass through a sensitive phase of cell division, but fewer than 5% of a patient's tumor cells are in this sensitive phase at any point in time. The duration of drug exposure is therefore critical to increased clinical activity.
-- Increased drug concentration at the tumor site is associated with increased clinical activity. The link between drug exposure and anti-tumor efficacy is especially pronounced for cell cycle-specific agents such as vincristine, vinorelbine and topotecan, which kill tumor cells by interfering with mitosis at a precise step during the cancer cell cycle. Thus, this proprietary sphingosomal drug delivery platform encapsulates approved anticancer agents within the aqueous interior of small liposomes to potentially enhance the therapeutic index of these existing anticancer treatments.
About Vincristine, Vinorelbine, and Topotecan
Sphingosomal products such as Marqibo(TM) (sphingosomal vincristine) are loaded with active, cell cycle-specific anticancer agents that may benefit from increased targeting and long duration of drug exposure at the tumor site. Vincristine, vinorelbine and topotecan are approved cancer therapies which have been selected for sphingosomal formulation specifically for their ability to benefit from this novel encapsulation:
-- Vincristine (Oncovin(R); Eli Lilly & Company), a microtubule inhibitor, is approved for acute lymphoblastic leukemia (ALL) and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias.
-- Vinorelbine (Navelbine(R); GlaxoSmithKline), a microtubule inhibitor, is approved for use as a single agent or in combination with cisplatin for the first-line treatment of unresectable, advanced non-small cell lung cancer.
-- Topotecan (Hycamtin(R); GlaxoSmithKline), a topoisomerase I inhibitor, is approved for use in relapsed small-cell lung cancer and in relapsed ovarian cancer.
About Non-Hodgkin's Lymphoma (NHL) and Acute Lymphoblastic Leukemia (ALL)
Non-Hodgkins lymphoma (NHL) is a heterogeneous disease which results in approximately 50,000 new cases and almost 25,000 deaths annually in the United States. NHL usually originates in lymphoid tissues and can spread to other organs. The prognosis depends on the histologic type, stage, and treatment. The NHLs can be divided into 2 prognostic groups: indolent lymphomas and aggressive lymphomas. Indolent NHL types have a relatively good prognosis, with median survival as long as 10 years, but they usually are not curable in advanced clinical stages. The aggressive type of NHL has a shorter natural history, but a significant number of these patients can be cured with intensive combination chemotherapy regimens which include agents such as vincristine. With modern treatment, overall five-year survival of NHL patients is approximately 50% to 60%. Of patients with aggressive NHL, 30% to 60% can achieve durable remission. The vast majority of relapses occur in the first two years after therapy and new therapeutic options are needed.
Acute lymphoblastic leukemia (ALL) is a type of cancer of the blood and bone marrow -- the spongy tissue inside bones where blood cells are made. Acute leukemias progress rapidly and affect immature blood cells, rather than mature ones. Acute lymphoblastic leukemia affects a group of white blood cells called lymphocytes, which fight infection. Normally, bone marrow produces immature cells (stem cells) in a controlled way, and they mature and specialize into the various types of blood cells, as needed. In people with ALL, this production process goes awry. Large numbers of immature, abnormal lymphocytes called lymphoblasts are produced and released into the bloodstream. These abnormal cells aren't able to mature and perform their usual functions. Furthermore, they multiply rapidly and can crowd out healthy blood cells, leaving an adult or child with ALL vulnerable to infection or easy bleeding. Leukemic cells can also collect in certain areas of the body, including the central nervous system and spinal cord, which can cause serious problems. Almost 4,000 Americans are diagnosed with acute lymphoblastic leukemia each year. This form of cancer worsens quickly if not treated, but it usually responds well to initial treatment. Adults have a 30% to 50% cure rate, underscoring the need for new therapeutic options.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (HBX, Trade) is a South San Francisco, CA-based biopharmaceutical company that acquires, develops, and commercializes innovative products to advance cancer care. The company is committed to creating value by building a world-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com
About Inex Pharmaceuticals Corporation
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Since 1996, INEX common shares have been trading on the Toronto Stock Exchange under the symbol "IEX". Additional information on INEX can be found at www.inexpharm.com.
his press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that Hana will be able to complete the proposed transaction with INEX or that any of Hana's development efforts relating to its product candidates, as well as those to be licensed from INEX, will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana's product candidates, the risk that the results of clinical trials may not support Hana's claims, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2005. Hana assumes no obligation to update these statements, except as required by law.
SOURCE: Hana Biosciences, Inc.
A brief history of Rapamycin and its derivatives
The story of Rapamycin starts almost 35 years ago, when a sample of soil was taken from Rapa Nui (Easter Island). Rapamycin was extracted from the soil and since the mid 1970s has been used as an anti-fungal agent. In the 1990s, Rapamycin was discovered to have immunosuppressive effects and in 1999 was approved under the brand Rapamune as an anti-rejection drug in kidney transplants. During the testing as a transplant rejection drug, anti-tumor effects were observed as well. Since then, three analogs of Rapamycin have been developed for use as anti-tumor agents: CCI-779 (Temsirolimus) by Wyeth, AP23573 by Ariad and RAD-001 (Everolimus) by Novartis.
http://www.liddyshriversarcomainitiative.org/Newsletters/V02N02/rapamycin_derivatives.htm
Approvable letters
Wondering if anyone here has hard data on whether approvable letters remove risk. Of course approvable letters need to be taken on a case-by-case basis but I think that an approvable letter would increase the odds of approval during the next round of review. Just supposition on my part (and analysts).
>a.k.a. Rapamune<
aka rapamycin. Know why?
AGN
Right on with that one!
J
REX
CA-125 is expressed at the surface of the ovarian cancer cell and is also released into circulation.
Normally, the body sees CA-125 as self and not foreign antigen, so the tumor is not attacked by the immune system. This is a problem with most cancers becuase by definition they are self.
OvaRex encourages the body to view CA-125 as a foreign antigen. Foreign antigens are subject to attack by the immune system.
Because CA-125 is expressed at the surface of ovarian tumor cells, the body now sees the tumor as foreign and the tumor is attacked by the immune system.
In technical terms, OvaRex is breaking self-tolerance.
J
REX article
I have a position in REX. Not because I am the biggest believer in OvaRex, but because I think there is the potential for very substantial gains *before* the results of the phase III. Kind of like YMI. Altogether, not a bad pipeline for a tiny little company.
As many as 30,000 U.S. women will be diagnosed with ovarian cancer this year. In 2006, between 15,000 and 16,000 women are likely to die from this silent killer. Ovarian cancer is the 5th leading cause of death among women, and it is responsible for about five percent of all cancer deaths. Chances are your doctor may have misdiagnosed you. That is often the case. A recent British study found 60 percent of all U.K. general practitioners had misdiagnosed their patients.
Three-quarters of British doctors surveyed incorrectly assumed that symptoms only occurred in the late stages of ovarian cancer. Based upon that information, it should be no surprise that Britain has one of the lowest survival rates for ovarian cancer in the Western World – of 6,800 cases diagnosed each year, more than 4,600 die.
A similar discovery was made by University of California researchers, who announced last year, “Four in 10 women with ovarian cancer have symptoms that they tell their doctors about at least four months — and as long as one year — before they are diagnosed.” According to their study of nearly 2,000 women with ovarian cancer, the researchers discovered physicians:
• First ordered abdominal imaging or performed gastrointestinal procedures instead of the more appropriate pelvic imaging and/or CA-125 (a blood test that can detect ovarian cancer).
• Only 25 percent of patients, who reported ovarian cancer symptoms four or more months before diagnosis, were given pelvic imaging or had CA-125 blood tests.
Patients with early symptoms are frequently misdiagnosed. Abdominal imaging or diagnostic gastrointestinal studies are less likely to detect ovarian cancer. According to the American Cancer Society’s website, “The most common symptom is back pain, followed by fatigue, bloating, constipation, abdominal pain and urinary urgency. These symptoms tend to occur very frequently and become more severe with time. Most women with ovarian cancer have at least two of these symptoms.”
By the time a woman reaches the fourth stage of ovarian cancer, her first-line treatment is often Carboplatin, Paclitaxel and Cisplatin as the specific chemotherapy for ovarian cancer. In the first stage, cancer is contained inside one or both ovaries. By stage two, the cancer has spread into the fallopian tubes or other pelvic tissues, such as the bladder or rectum. When the cancer has spread outside the pelvis area into the abdominal cavity, especially when tumor growths are larger than two centimeters on the lining of the abdomen, then ovarian cancer has reached stage three. The fourth and final stage of ovarian cancer is reached when the cancer has spread into other body organs, such as the liver or lungs.
If detected early, survival rates can be as high as 90 percent. Detected in the advanced stage, the survival rate falls to between 30 and 40 percent. Various imaging tests such as computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, and ultrasound studies can confirm whether a pelvic mass is present. A laparoscopy can help a doctor look at the ovaries and other pelvic tissue to in order to plan out a surgical procedure, or to determine the stage of the ovarian cancer. A biopsy, or tissue sampling, would confirm if there is cancer in your pelvic region, and would help determine how advanced it is. An elevated CA-125 blood test typically suggests the cancer has progressed to the advanced stage.
About 50 percent of ovarian cancer patients are already at an advanced stage by the time a correct diagnosis is made. Only 10 to 14 percent of women with advanced cancer are likely to survive more than five years.
Evaluation of Therapies
While research shows drinking black (or green) tea or taking the herbal supplement gingko biloba may be useful, as a preventative measure, or to reduce risk, a woman has few choices when her cancer has moved to the advanced stage. In the first stage, a woman faces surgical removal of the tumor, and possibly one or both ovaries, to increase her chances of survival. Beyond that, her choice is chemotherapy.
One major problem with chemotherapy is the side effects. The more advanced the cancer, the weaker one may be, reducing the survival rate potential. Survival rates have not changed very much over the past fifteen years. Chemotherapy can increase survival time by as much as 50 percent. But, quality of life suffers. The side effects and increased toxicity, accompanying chemotherapy, reduce how one spends the prolonged survival time.
Some of Paclitaxel’s minor side effects, as reported by Medline Plus, may include nausea, vomiting, loss of appetite, change in taste, thinned or brittle hair, pain in the joints of the arms or legs, changes in the color of nails, and/or tingling in the hands or toes. More serious side effects may include mouth blistering or fatigue. Some alarming side effects could include unusual bleeding or bruising, dizziness, shortness of breath, severe exhaustion, chest pain, or difficulty swallowing. The most common side effect of Paclitaxel is a decrease of blood cells.
Carboplatin has its own list of side effects. It can reduce platelet production, which can interfere with your blood’s ability to clot. You may become anemic, feeling tired or breathless. Nausea, vomiting, loss of appetite and a general feeling of weakness are common with this chemotherapeutic agent.
The latest breed of drugs, such as Eli Lilly’s Gemzar, are hardly getting praise. On March 10th, the Food and Drug Administration (FDA) said it was skeptical of the benefits Eli Lilly’s Gemzar, which was being used with Carboplatin to treat ovarian cancer patients. The FDA felt the 2.8 months increased survival time, provided by the Gemzar/Carboplatin combination failed to offset the treatment’s increased toxicity.
In January, the New England Journal of Medicine reported on a remarkable new delivery system of chemotherapy, called the “intra-abdominal, or intraperitoneal, chemotherapy. Those who received the “belly bath” as it is now being called by the media can survive 16 months longer than those receiving intravenous chemotherapy. The major drawback is that 60 percent of the women in the study were unable to complete all six cycles of this chemotherapy. Those who did survived longer, but only two in every five women were able to advance to the end phase of the therapy.
One novel approach, now in Phase III trials at more than 60 research centers across the United States, is OvaRex ® MAb, a murine monoclonal antibody, a type of biotech drug derived from mouse cells. It is being tested by highly regarded United Therapeutics, based in Silver Springs, Maryland. Their lead drug Remodulin, an injection which treats pulmonary arterial hypertension, is currently being marketed inside and outside the United States. More than $32 million has been spent researching, and on the development of, OvaRex and may have it available on the market by 2008.
OvaRex was developed in Canada by a company called ViRexx Medical Corp, and first tested in that country. According to Dr. Lorne Tyrrell, Chief Executive of ViRexx, “The whole study has been set up with the FDA. This is a study where the drug has been given fast track approval and orphan drug status.” Dr. Tyrrell is also on leave (until OvaRex become commercially available) as a Professor of Medical Microbiology and Immunology at the University of Alberta, and Director of the National Centre of Excellence for Viral Hepatitis Research.
OvaRex was tested in Canada, prior to the current Phase III trials in the U.S. “There have been a number of patients that have received OvaRex,” said Dr. Tyrrell, “We’ve had really no adverse effects from these patients.” Dr. Tyrrell explained the procedure, “After being injected intravenously, OvaRex binds to an antigen circulating in the blood.” An antibody’s general purpose is to neutralize an antigen. After an OvaRex injection, the murine monoclonal antibody binds to the CA-125 antigen.
In a way the body is tricked. But, the body is tricked in order to help “save” itself from the harmful antigen. When the OvaRex antibody is bound to the CA-125 antigen, the new combination is identified as a harmful unit. Before then, the antigen wanders through the body, without alerting the body’s defense systems, the dendritic cells, to attack and destroy the harmful antigen. Because the body is trained to identify and zero in on a foreign protein, in this case a mouse protein, it alerts the dendritic cells. Until then, the dendritic cells “tolerate” the cancerous cells. The tolerance is what permits the cancer to spread throughout the body. OvaRex seeks to break that tolerance. The murine monoclonal antibody is designed to target and bind exclusively to free floating CA-125 antigen.
The dendritic cells refuse to tolerate the foreign protein. When the antibody binds with the free-floating antigen, the dendritic cells recognize the complex (antibody plus antigen) as being foreign and engulf the new unit. The dendritic cells break down the key proteins of this unit, presenting all parts on the cells surface. At the point, the body’s killer T-Cells are alerted to fight the internal threat to the body. Once activated, the T-Cells will replicate and create more killer T-Cells. Any tumor cells expressing the CA-125 antigen is targeted for destruction. The army of T-Cells move to attack the ovarian cancer tumor.
The principle behind OvaRex is to re-program the immune system to harness the body’s defenses to prevent the growth and spread of the ovarian cancer. Will it cure ovarian cancer? “In most cases, it will be a delay,” explained Dr. Tyrrell. “However, I think that, and everyone hopes that, often in some of these tumors, you’re making incremental progress through careful clinical trials and adding new therapy. Each thing we do that improves the outcome when you start to look at the long term benefits of these, we hope that one day we will be able to cure this disease. We think this is a step. This has the potential to be an important step at helping to stimulate immune response to achieve a better outcome. Hopefully, one day we can improve that to where it is a cure.”
James Finch contributes to StockInterview.com and other publications. His archived articles on a variety of topics can be read at http://www.stockinterview.com Readers can always email him directly: jfinch@stockinterview.com.
Visitors should view the animated video about OvaRex MAb, mentioned in this article by visiting this website, http://www.virexx.com/ and clicking on the ANIMATION at the top right of the webpage.
Wonder Drug Inspires Deep, Unwavering Love of Pharmaceutical Companies
March 6, 2006 | Issue 42•10
http://www.theonion.com/content/node/46032/print/
NEW YORK—The Food and Drug Administration today approved the sale of the drug PharmAmorin, a prescription tablet developed by Pfizer to treat chronic distrust of large prescription-drug manufacturers.
Pfizer executives characterized the FDA's approval as a "godsend" for sufferers of independent-thinking-related mental-health disorders.
"Many individuals today lack the deep, abiding affection for drug makers that is found in healthy people, such as myself," Pfizer CEO Hank McKinnell said. "These tragic disorders are reaching epidemic levels, and as a company dedicated to promoting the health, well-being, and long life of our company's public image, it was imperative that we did something to combat them."
Although many psychotropic drugs impart a generalized feeling of well-being, PharmAmorin is the first to induce and focus intense feelings of affection externally, toward for-profit drug makers. Pfizer representatives say that, if taken regularly, PharmAmorin can increase affection for and trust in its developers by as much as 96.5 percent.
"Out of a test group of 180, 172 study participants reported a dramatic rise in their passion for pharmaceutical companies," said Pfizer director of clinical research Suzanne Frost. "And 167 asked their doctors about a variety of prescription medications they had seen on TV."
Frost said a small percentage of test subjects showed an interest in becoming lobbyists for one of the top five pharmaceutical companies, and several browsed eBay for drug-company apparel.
PharmAmorin, available in 100-, 200-, and 400-mg tablets, is classified as a critical-thinking inhibitor, a family of drugs that holds great promise for the estimated 20 million Americans who suffer from Free-Thinking Disorder.
Pfizer will also promote PharmAmorin in an aggressive, $34.6 million print and televised ad campaign.
One TV ad, set to debut during next Sunday's 60 Minutes telecast, shows a woman relaxing in her living room and reading a newspaper headlined "Newest Drug Company Scandal Undermines Public Trust." The camera zooms into the tangled neural matter of her brain, revealing a sticky black substance and a purplish gas.
The narrator says, "She may show no symptoms, but in her brain, irrational fear and dislike of global pharmaceutical manufacturers is overwhelming her very peace of mind."
After a brief summary of PharmAmorin's benefits, the commercial concludes with the woman flying a kite across a sunny green meadow, the Pfizer headquarters gleaming in the background.
PharmAmorin is the first drug of its kind, but Pfizer will soon face competition from rival pharmaceutical giant Bristol-Myers Squibb. The company is developing its own pro-pharmaceutical-company medication, Brismysquibicin, which will induce warm feelings not just for drug corporations in general, but solely for Bristol-Myers Squibb.
"A PharmAmorin user could find himself gravitating toward the products of a GlaxoSmithKline or Eli Lilly," BMS spokesman Andrew Fike said. "This could seriously impede the patient's prescription-drug-market acceptance, or worse, Pfizer's profits in the long run."
"Brismysquibicin will be cheaper to produce and therefore far more affordable to those on fixed incomes," Fike added.
The news of an affordable skepticism-inhibitor was welcomed by New York physician Christine Blake-Mann, who runs a free clinic in Spanish Harlem.
"A lot of my patients are very leery of the medical establishment," Blake-Mann said. "This will help them feel better about it, and save money at the same time."
PharmAmorin's side effects include nausea, upset stomach, and ignoring the side effects of prescription drug medication.
Cramer pumps Solexa
[At least we can agree on HGSI!]
The mantra "buy low and sell high" is a bit misleading, Cramer said, because it's often taken to mean that investors should buy only when stocks are down and only sell when they're up.
You can't always get in on a stock at the bottom and sometimes you have to cut your losses and sell because there's no way the stock you own will go higher, he said.
"But if you see weakness in a stock you want ... then you absolutely must buy into weakness and wait to sell into some strength," he said, and that's why he believes now is the time to buy Solexa (SLXA:Nasdaq - commentary - research - Cramer's Take).
Cramer has been waiting for the stock to come down from its high around $12, and now that it's at $8 and change, he said to look into the gene-sequencing company. Solexa has a new machine to roll out that reads DNA.
The machine also has a range of uses outside of DNA reading, Cramer said, and he believes that it is faster, cheaper and more productive than other options.
He said that there's no comparison between Solexa and Human Genome Sciences (HGSI:Nasdaq - commentary - research - Cramer's Take), a company that he called a "serial disappointer." Human Genome starts with already decoded DNA and then uses that information to develop medicines, while Solexa reads the DNA.
Pharma? Think small
While big drugmakers stumble, their nimbler rivals are delivering products -- and profits.
By John Simons, FORTUNE writer
March 15, 2006: 5:11 PM EST
If you're looking for a growth play in the drug business, small is better.
Small Pharma, known to Wall Streeters as the specialty pharmaceuticals sector, is brimming with innovative little companies that are often overlooked by investors. On the whole, Big Pharma stocks have been poor performers over the past half-decade. Though many of the industry giants still represent solid long-term investments, they can hardly be considered the growth drivers they once were.
As product pipelines dried up and companies faced pricing pressure from generic makers--and Congress--Big Pharma shares began a long, slow descent. Since Jan. 1, 2001, in fact, the Amex pharmaceutical index has dropped 19%. Over the same period, the Russell midcap health index, which comprises a host of smaller specialty-drug companies, has risen a stunning 69%.
The march of medical innovation hasn't slowed; it has merely shifted to the small and mid-sized drug companies and biotechs. Many are nimble niche players. They home in on a particular area of research, like cancer, central nervous system disorders, or heart disease. Still others focus on underserved markets like dermatology, deemed too tiny in potential sales for Big Pharma.
But when Small Pharma does discover a potential mega-seller, companies like Bristol-Myers Squibb (Research), Eli Lilly, Merck, and Pfizer have been increasingly writing big checks, either to acquire their wares or to strike licensing deals. As a result, nearly 40% of the new medicines unveiled by Big Pharma in the past five years originated in small and midsized company labs.
Some of the drug sector's most exciting new medicines--and indeed, whole new product categories--are coming from Small Pharma.
Three buys
Cephalon (Research), with a market cap of $4.8 billion, has forged a path in central-nervous-system research. The company's bestselling drug, Provigil, a remedy for narcolepsy, is also heavily prescribed for late-night shift workers, truckers, and airline pilots who need to stay alert and focused.
Cephalon, based in West Chester, Pa., has also built a robust pipeline of promising compounds: Vivitrol, a forthcoming injectable medicine to treat alcoholism; a cancer-pain reliever dubbed "OVF;" and Nuvigil, a follow-on version of Provigil.
In addition, Cephalon's experimental attention-deficit treatment has sparked some recent interest on Wall Street. The drug, called Sparlon, could benefit from an FDA panel's recent recommendation that ADHD drugs carry a warning about cardiovascular risks. Cephalon claims clinical tests show that its ADHD medicine, a nonstimulant, is safe.
Morgan Stanley analyst Marc Goodman believes Cephalon's pipeline--especially its emerging cancer franchise--is "underappreciated" by investors. Cephalon has promised an ambitious schedule of product launches in the next 15 months and hopes to double revenues, to $2 billion, by 2008.
In addition, Cephalon emulates its Big Pharma brethren, often using targeted acquisitions to scoop up noteworthy compounds; it has bought five firms in the past five years. The company also won big on the legal front recently, successfully fending off four manufacturers poised to sell generic Provigil. The stock traded recently at a price/earnings ratio of 24. After attending Cephalon's recent R&D symposium, Goodman raised his year-end price target for Cephalon to $83.
Kos Pharmaceuticals (Research) competes head-to-head with Big Pharma in one of the industry's toughest markets: cholesterol-lowering. The company's Niaspan, a $432-million-a-year drug, not only lowers cholesterol but also raises so-called good cholesterol (or HDL) more than other remedies currently on the market.
Later this year, Kos is expected to release a combination of Niaspan and generic Zocor. Although both Pfizer (Research) and Merck (Research) have similar combination drugs in the works, Kos is likely to reach the market a full year ahead of its larger rivals--sometime in 2007 or 2008. As a result, analysts believe, Kos could gain a significant share of the emerging HDL market by 2009.
With a P/E of roughly 15, the $745-million-a-year company is trading at a 28% discount to the average stock in the specialty pharma group. And with a market cap of $2 billion, "Kos is clearly a takeover candidate," says Amy Stevens, specialty pharmaceuticals analyst with Susquehanna Financial Group.
"Buying a company like Kos could protect Merck's or Pfizer's cholesterol franchise. It's definitely something you can envision happening in the next year."
Finding novel uses for older chemical compounds is one of the things Small Pharma does best. That kind of resourcefulness opened new markets for Collagenex (Research), based in Newton, Pa.
Founded in 1992, Collagenex has sales of $26 million and a market cap of $227 million, making it the smallest and potentially riskiest company of the three. It originally marketed and developed low-margin dental remedies. But in 2002 a study found that its drug for severe gum disease, Periostat, could also clear up acne.
The Collagenex executive team seized the opportunity to transition the company into higher-margin dermatology sales and research. Meanwhile, Periostat lost patent protection, causing a drop in sales that put Collagenex in the red in 2004.
Now the company markets a handful of proprietary skin treatments. Aiding a projected return to profitability by 2008 is an experimental rosacea remedy called Oracea. The drug is awaiting FDA approval, which is expected this summer.
Oracea would be a first-in-class oral product for rosacea and could garner peak sales of about $125 million by 2010. Collagenex also possesses an acne pill known as Incyclinide, in Phase II testing. Adam Greene, a specialty-pharma analyst with First Albany Capita, has a strong buy rating on Collagenex and has set a year-end share-price target of $19. In this case, thinking small could pay off big.
Resverlogix
Very interesting company, waaay to early-stage for me. Suprised they are already public.
J
VSGN
Down 24% today--I predicted 25% yesterday. Even a blind squirrel....
YMI
Just a note from my fabulous social life:
At a get-together this weekend, I ran into the Director of Nursing at a major palliative care hospital in the New York metro area (if you live around here, you've heard the commericals).
We got to talking about the problems of treating patients with current formulations of fentanyl, and she seemed very exicited by the AeroLef concept. I was always a little doubtful that AeroLef was addressing a "real" problem in the clinic, but I have little doubt now that AeroLef will be quickly adopted in clinical practice, provided there are no serious safety issues beyond what is expected for fentanyl.
VSGN
I am basing my assumption that the results of ACCLAIM will be good not on mechanistic grounds but on the results of the Phase II. The study generated highly statistically signficant results for a number of end points including an 87% reduction in risk of death (P=0.022), 61% reduction in risk of hospitalizations (P=0.006) and 63% reduction in MACE (P=0.005). These results were generated with only 75 patients enrolled in the study.
As you noted (more or less), CRP levels have been shown in just about every disease with an inflammatory component. I'd suggest that the therapeutic effect of Cellcade must be derived from something more than effects on CRP. PGS seems to have the inside line on muscle physiology, maybe he could comment?
From an investment perspective, I think that if the stock takes a sufficient hammering tomorrow morning, the risk:reward will be good for a purchase and full or partial sale before the ACCLAIM results.
I wouldn't call myself a big fan of VSGN, but there just might be money to be made on a bounce off of tomorrow's sell off. We'll see what happens.
Urche: when you say you are doubtful about the "role of modulating CRP as therapy for vascular disease and heart failure" are you talking about reducing CRP levels in isolation from other markers of inflammation, or are you doubtful about the whole concept of the relationship between inflammatory and vascular disease? Two different concepts in my mind.
John