urche
15 years ago
This news is not really, IMO, likely to be material to Javelin, but I would not be surprised to see a signif drop in share price from the news. Maybe a buying opportunity?
The reason I don't see this as a significant negative is that the injectable form of diclofenac is intended for short term use. Also, it is an old, established drug with lots of wordlwide experience. So, it is a drug that maybe needs monitoring for long term use. But, I don't see how this would affect the safety profile or approvability for short term IV use.
All IMO.
Urche
From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts
Diclofenac Linked to Liver Failure, Death
Deborah Flapan
Posted: 12/05/2009
December 5, 2009 — Treatment with all products containing diclofenac sodium, including Voltaren Gel, may increase liver dysfunction, resulting in severe hepatic reactions and liver transplantation or death, the US Food and Drug Administration (FDA), Endo, and Novartis announced late last night.
Cases of drug-induced hepatotoxicity have been reported within the first month of treatment with diclofenac but can occur at any time during treatment.
"Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure," according to an alert sent last night by MedWatch, the FDA's safety information and adverse event reporting program. "Some of these reported cases resulted in fatalities or liver transplantation."
Physicians should discontinue diclofenac treatment immediately if patients continue to have abnormal or worsening liver test results, if liver disease symptoms develop, or if systemic manifestations occur, such as eosinophilia, rash, abdominal pain, diarrhea, or dark urine, according to a letter from Endo and Novartis to healthcare professionals.
The companies also recommend that physicians advise their patients receiving diclofenac of the signs and symptoms of hepatotoxicity, including nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and flulike symptoms, and what to do if these signs and symptoms appear.
To reduce the risk for hepatotoxicity in patients receiving diclofenac sodium, the lowest effective dose should be used for the shortest time possible.
Postmarketing Data
In their letter to healthcare professionals, Endo and Novartis advise physicians to measure transaminase levels regularly in patients receiving long-term therapy with diclofenac "because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known."
Clinical trial data and postmarketing experiences suggest that transaminase levels should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. "However, severe hepatic reactions can occur at any time during treatment with diclofenac," they note.
Transaminase levels have been elevated at borderline or higher levels in about 15% of diclofenac-treated patients, the companies say in the letter to healthcare professionals. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase) is the recommended hepatic function marker for monitoring liver injury, they say.
However, in clinical trials, clinically important elevations (>3 times the upper limit of normal range [ULN]) of aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase) occurred in approximately 2% of about 5700 patients during diclofenac treatment (ALT was not measured in all patients). In a smaller open-label study of 3700 patients, similar elevations of ALT and/or AST levels were seen in approximately 4% of patients and "marked" elevations (>8 times the ULN) occurred in about 1% of patients. In this open-label study, "a higher incidence of borderline (<3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs [nonsteroidal anti-inflammatory drugs]," the companies point out.
In addition, elevated transaminase levels were more common in patients being treated for osteoarthritis than in those with rheumatoid arthritis.
Diclofenac is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
More information is available on the FDA's MedWatch Web site.
surf1944
15 years ago
Javelin Pharmaceuticals, Inc. Reports Third Quarter 2009 Results
Press Release
Source: Javelin Pharmaceuticals, Inc.
On 7:00 am EST, Tuesday November 10, 2009
Companies:Javelin Pharmaceuticals, Inc.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer of novel acute care pain products, today reported its unaudited financial results for the third quarter ended September 30, 2009.
Financial highlights for the three months ended September 30, 2009:
Ended the third quarter with approximately $3.3 million in cash and cash equivalents; not including approximately $3.7 million in net proceeds received from a registered direct offering on October 30, 2009
Net loss in the third quarter of 2009 decreased to approximately $6.8 million, or $0.11 per share, from approximately $10.9 million, or $0.18 per share, in the third quarter of 2008
Significant reduction in Q3 expenses from Q2 2009
On track to file a high quality NDA for Dyloject this quarter
Financial Performance
The Company ended the third quarter of 2009 with $3.3 million in cash and cash equivalents. During the fourth quarter, the Company raised approximately $3.7 million in additional net proceeds from an unsolicited registered direct placement of its common stock to a new shareholder.
For the three and nine months ended September 30, 2009, total revenues were $1.1 million and $3.5 million, compared to $0.4 million and $0.6 million for each of the respective periods a year ago.
Javelin’s net loss decreased to approximately $6.8 million, or $0.11 per share, for the three months ended September 30, 2009, from approximately $10.9 million, or $0.18 per share, for the comparable period in 2008. For the nine months ended September 30, 2009, the net loss was approximately $29.5 million, or $0.49 cents per share, down from $29.7 million, or $0.54 cents per share, for the same period a year ago.
Javelin incurred approximately $7.5 million in total operating expenses in the third quarter of 2009 compared to approximately $11.4 million for the comparable period a year ago. For the nine months ended September 30, 2009 and 2008, Javelin’s total operating expenses were $32.6 million and $31.1 million, respectively.
For the three months ended September 30, 2009 and 2008, our cost of revenues was approximately $0.9 million and $0.3 million, respectively. For the nine months ended September 30, 2009, cost of revenues was approximately $2.9 million compared to $0.5 million in the same period for 2008.
Research and development expenses decreased from approximately $6.9 million for the three months ended September 30, 2008 to $4.2 million for the three months ended September 30, 2009. Total research and development expense increased from $17.0 million for the nine months ended September 30, 2008 to $21.3 million for the nine months ended September 30, 2009.
Selling, general and administrative expenses for the three months ended September 30, 2009 were $2.4 million, as compared to $4.2 million for the three months ended September 30, 2008, and were $8.2 million for the nine months ended September 30, 2009, compared to $13.4 million for the similar period in 2008.
JAVELIN PHARMACEUTICALS, INC
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
2009 2008
Assets
Current assets:
Cash and cash equivalents $ 3,272,678 $ 20,057,937
Accounts receivable, product sales - 470,288
Inventory - 1,847,904
Prepaid expenses and other current assets 493,534 511,820
Total current assets 3,766,212 22,887,949
Long term marketable securities available-for-sale - 1,586,910
Fixed assets, at cost, net of accumulated depreciation 950,426 1,195,670
Intangible assets, net of accumulated amortization 3,039,090 3,480,248
Other assets 146,468 154,918
Total assets $ 7,902,196 $ 29,305,695
Liabilities and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses $ 7,770,353 $ 8,119,006
Deferred revenue, current 1,204,301 -
Deferred lease liability 426,587 513,519
Total current liabilities 9,401,241 8,632,525
Deferred revenue, noncurrent 5,017,921 -
Total liabilities 14,419,162 8,632,525
Commitments and contingencies - -
Stockholders' Equity (Deficit)
Preferred stock, $0.001 par value, 5,000,000
shares authorized; as of September 30, 2009 and
December 31, 2008, none of which are outstanding
- -
Common stock, $0.001 par value; 200,000,000 shares authorized
as of September 30, 2009 and December 31, 2008; 60,675,016
and 60,649,358 shares issued and outstanding as of
September 30, 2009 and December 31, 2008, respectively
60,675 60,649
Additional paid-in capital 176,801,138 174,534,897
Other comprehensive income 25,499 10,383
Deficit accumulated during the development stage (183,404,278 ) (153,932,759 )
Total stockholders' equity (deficit) (6,516,966 ) 20,673,170
Total liabilities and stockholders' equity (deficit) $ 7,902,196 $ 29,305,695
JAVELIN PHARMACEUTICALS, INC
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2009 2008 2009 2008
Revenues:
Partner revenue $ 1,130,966 $ - $ 3,330,849 $ -
Product revenue - 366,050 188,172 611,352
Total revenues 1,130,966 366,050 3,519,021 611,352
Costs and expenses
Cost of revenue 881,539 272,358 2,899,368 451,763
Research and development 4,165,716 6,887,952 21,320,172 17,043,301
Selling, general and administrative 2,369,210 4,163,646 8,153,955 13,400,159
Depreciation 79,615 85,958 245,138 206,561
Total costs and expenses 7,496,080 11,409,914 32,618,633 31,101,784
Operating loss (6,365,114 ) (11,043,864 ) (29,099,612 ) (30,490,432 )
Other income (expense):
Interest income 5,864 229,958 49,632 807,760
Other income (expense) (394,187 ) (33,275 ) (415,327 ) 2,814
Total other income (expense) (388,323 ) 196,683 (365,695 ) 810,574
Loss before income tax provision (6,753,437 ) (10,847,181 ) (29,465,307 ) (29,679,858 )
Income tax provision 6,756 23,375 6,212 23,375
Net loss attributable to common stockholders $ (6,760,193 ) $ (10,870,556 ) $ (29,471,519 ) $ (29,703,233 )
Net loss per share attributable to common
stockholders:
Basic and diluted $ (0.11 ) $ (0.18 ) $ (0.49 ) $ (0.54 )
Weighted average shares 60,447,975 60,393,432 60,433,689 54,767,751
About Javelin
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the acute pain management market. The Company has one marketed drug in the UK and three drug candidates in US Phase 3 clinical development. For additional information about Javelin, please visit the Company's website at http://www.javelinpharmaceuticals.com.
Forward Looking Statement
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made, including today's initial study results. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Contact:
Javelin Pharmaceuticals, Inc.Stephen J. Tulipano, CPA, 617-349-4500Chief Financial Officerstulipano@javelinpharma.comorInvestor Relations & MediaRick Pierce, 617-349-4500VP, Investor Relationsrpierce@javelinpharma.com
surf1944
15 years ago
Javelin Pharmaceuticals, Inc. Reports Second Quarter 2009 Results and Corporate Highlights
Press Release
Source: Javelin Pharmaceuticals, Inc.
On Tuesday August 11, 2009, 7:30 am EDT
Companies:Javelin Pharmaceuticals, Inc.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer of novel products for pain management, today reported its unaudited financial results for the second quarter ended June 30, 2009. The Company's milestones in the second quarter included the following:
Announced new findings from recent Phase I pharmacokinetic (PK) study of Dyloject® , which showed Dyloject was well tolerated in high risk patients with impaired renal and hepatic function
Successful completion of its open-label, multi-day, observational Phase III safety study of Dyloject in the United States, keeping the product candidate on track to file an NDA
On track to file a high quality NDA for Dyloject this Fall
Significant reduction in Q2 expenses from Q1 2009 as the majority of the current clinical programs at the Company have been completed
Financial Performance
The Company ended the second quarter of 2009 with $8.9 million in cash, cash equivalents, and long term marketable securities available-for-sale.
For the three and six months ended June 30, 2009, total revenues were $0.3 million and $2.4 million, compared to $ 0.2 million, for each of the respective, three and six months period in the prior year.
Javelin’s net loss decreased to approximately $7.9 million, or $0.13 per share, for the three months ended June 30, 2009, from approximately $9.1 million, or $0.16 per share, for the comparable period in 2008. For the six months ended June 30, 2009, the net loss was approximately $22.7 million, or $0.38 per share, up from $18.8 million, or $0.36 per share, for the similar period in 2008.
Javelin incurred approximately $8.2 million in total operating expenses in the second quarter of 2009 compared to $9.5 million for the same period a year ago. For the six months ended June 30, 2009 and 2008, Javelin’s total operating expenses were $25.1 million and $19.7 million, respectively.
For both three months ended June 30, 2009, and 2008 our cost of revenues was approximately $0.1 million. For the six months ended June 30, 2009, cost of revenues was approximately $2.0 million compared to $0.2 million in the similar period in 2008.
Research and development expenses increased from approximately $4.5 million for the three months ended June 30, 2008 to $5.3 million for the three months ended June 30, 2009. Total research and development expenses increased from $10.2 million for the six months ended June 30, 2008 to $17.2 million for the six months ended June 30, 2009.
Selling, general and administrative expenses for the three months ended June 30, 2009 were $2.7 million as compared to $4.8 million for the three months ended June 30, 2008, and $5.8 million for the six months ended June 30, 2009 as compared to $9.2 million for the similar period in 2008.
JAVELIN PHARMACEUTICALS, INC
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30, December 31,
2009 2008
Assets
Current assets:
Cash and cash equivalents $ 7,227,952 $ 20,057,937
Accounts receivable, product sales - 470,288
Inventory 740,729 1,847,904
Prepaid expenses and other current assets 572,165 511,820
Total current assets 8,540,846 22,887,949
Long term marketable securities available-for-sale 1,624,896 1,586,910
Fixed assets, at cost, net of accumulated depreciation 1,030,040 1,195,670
Intangible assets, net of accumulated amortization 3,186,142 3,480,248
Other assets 146,331 154,918
Total assets $ 14,528,255 $ 29,305,695
Liabilities and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses $ 7,974,192 $ 8,119,006
Deferred revenue, current 1,204,301 -
Deferred lease liability 458,326 513,519
Total current liabilities 9,636,819 8,632,525
Deferred revenue, noncurrent 5,318,996 -
Total liabilities 14,955,815 8,632,525
Commitments and contingencies - -
Stockholders' Equity (Deficit)
Preferred stock, $0.001 par value, 5,000,000
shares authorized; as of June 30, 2009 and
December 31, 2008, none of which are outstanding - -
Common stock, $0.001 par value; 200,000,000 shares authorized
as of June 30, 2009 and December 31, 2008; 60,675,016
60,649,358 shares issued and outstanding as of
June 30, 2009 and December 31, 2008, respectively 60,675
60,649
Additional paid-in capital 176,092,394 174,534,897
Other comprehensive income 63,456 10,383
Deficit accumulated during the development stage (176,644,085
) (153,932,759 )
Total stockholders' equity (deficit) (427,560 ) 20,673,170
Total liabilities and stockholders' equity (deficit) $ 14,528,255 $ 29,305,695
JAVELIN PHARMACEUTICALS, INC
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2009 2008 2009 2008
Revenues:
Partner revenue $ 301,075 $ - $ 2,199,883 $ -
Product revenue - 179,509 188,172 245,302
Total revenues 301,075 179,509 2,388,055 245,302
Costs and Expenses
Cost of revenues 105,205 129,498 2,017,829 179,405
Research and development 5,308,385 4,489,899 17,154,456 10,155,349
Selling, general and administrative 2,738,442 4,760,242 5,784,745 9,236,513
Depreciation and amortization 81,651 79,850 165,523 120,603
Total costs and expenses 8,233,683 9,459,489 25,122,553 19,691,870
Operating loss (7,932,608 ) (9,279,980 ) (22,734,498 ) (19,446,568 )
Other income (expense):
Interest income 14,234 220,782 43,768 577,802
Other income (expense) (31,653 ) (514 ) (21,140 ) 36,089
Total other income (expense) (17,419 ) 220,268 22,628 613,891
Loss before income tax provision (7,950,027 ) (9,059,712 ) (22,711,870 ) (18,832,677 )
Income tax provision (544 ) - (544 ) -
Net loss attributable to common stockholders $ (7,949,483 ) $ (9,059,712 ) $ (22,711,326 ) $ (18,832,677 )
Net loss per share attributable to common
stockholders:
Basic and diluted $ (0.13 ) $ (0.16 ) $ (0.38 ) $ (0.36 )
Weighted average shares 60,430,494 55,057,493 60,426,428 51,924,001
About Javelin Pharmaceuticals, Inc.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the acute pain management market. The Company has one marketed drug in the UK and three drug candidates in US Phase 3 clinical development. For additional information about Javelin, please visit the Company's website at http://www.javelinpharmaceuticals.com.
y3maxx
15 years ago
Read Me First ...JAV Update...
1/
CEO has promised no further share dilution.
2/
CEO Driscoll and Carr each swapped $150K salary for stock options, (DSU's)
http://biz.yahoo.com/e/090505/jav8-k.html
3/
($168,694,602.00) Net Operating Losses, as of May 7th
http://finance.yahoo.com/news/Javelin-Pharmaceuticals-Inc-bw-531921464.html?x=0&.v=5
4/
Company:
Javelin Pharmaceuticals, Inc. (JAV)
Submitted By:
Steven Cordovano (Highland Portfolio Management) on Jul 07, 2009 at 07:05PM
Recommendation:
Long
Expected Timeframe:
One year to two years
Thesis
Javelin Pharmaceuticals:
Better Than a Poke in the Arm with a Shot of Dyloject.
Making profitable returns on drug development has to be one of the most difficult tasks in the money management business. It can sometimes make the myth of Sisyphus look like a child’s fairy tale because at least Sisyphus survives to roll the stone up the hill another day.
Paying for my PHD from the School of Hard Knocks was probably more expensive than Harvard, but what I have learned after more than one face removal is that the way to minimize the risk is to look for companies where the market has already extracted the hype—which is when shareholders are hyperventilating, or to look for situations where companies are developing new formulations of existing, well known compounds. Javelin Pharmaceuticals (JAV) is just such a story that fits the bill on both counts.
The company’s first compound is called Dyloject, an injectable form of Dyclofenac which is a non steroidal anti inflammatory drug (NSAID) , that has shown spectacular results in 2 phase 3 trials and recently demonstrated excellent results in an open label safety study that the company intends to file in support of their NDA. Dyclofenac as anyone with a back problem might know, is often given in a pill form and commonly in Europe post operatively as an IV infusion, marketed as Voltaren. Dyloject has recently been approved for post operative use in the UK for moderate to severe pain and is now a competitive alternative to Voltaren. Dyloject has a substantial cost advantage to Voltaren in that it is given as an injection rather than an IV drip. It is estimated to cost about $150 per patient to treat post operative pain with IV administration. This more than makes up for the cost of the Dyloject and doesn’t even consider complications relating to hospital borne IV infections. Javelin will file the US Dyloject NDA by the end of the year.
The second compound that will be reporting top line phase 3 data very shortly (within a week or so) is called Ereska, an intranasal formulation of Ketamine. Ketamine is officially classified as an NMDA receptor agonist. NMDA receptors are found in the central nervous system and are involved in the perception of pain. Blocking these receptors creates an analgesic effect. The drug has been used for over 30 years (in human and veterinary medicine) as an anesthetic in higher doses which can create a dissociative anesthetic effect. At higher doses it can also cause hallucinations, which makes it a favorite of street vendors where it is known as Special K. Javelin’s intranasal formulation of Ereska makes it difficult, if not impossible to abuse because the mucosal membrane can only absorb a limited amount of the drug and not enough to give it much if any street value.
Because Ketamine is a well known compound, the FDA originally was going to allow the company to file an NDA for Emergency and Military use based on the results of 4 pharmacokinetic studies (PK Studies), but abruptly changed their minds and compelled the company to do a conventional phase 3 study. The reasons appear to have more to do with FDA politics than anything that was seen in the PK studies. The reviewing division happens to be the same one that approved Vioxx. The downside of that for shareholders was a costly (dilutive) delay that had them doing deep breathing exercises. The upside if the drug shows satisfactory results will be no small consolation prize in the form of a much wider label than what was originally contemplated.
The US Department of Defense has contributed $4MM to the development of Ereska because they have a need for a fast acting non-sedative remedy for combat related injuries. The 10 to 50mg dose range has already been shown to have an excellent analgesic effect that it does not suppress the respiratory system. Meta analysis that the company has already presented showed no changes to the oxygen saturation levels in the blood. Because Ereska is non-sedating, a wounded soldier could alleviate the pain of a combat related injury and still be able to fly a helicopter or operate a weapon. Additionally, because it works on the central nervous system receptors, Ereska has shown the ability to prevent a condition known as phantom pain which is the phenomenon whereby people can experience pain in a lost limb.
For all of the above reasons, Ereska would make a superior first choice to administer if an unfortunate event were to occur where hundreds of people were injured in a public place. Without time to adequately triage patients, Ereska could offer temporary relief from traumatic injuries.
Another major benefit of low dose Ketamine, is that when used in combination with morphine it can reduce a common side effects of morphine which are gradual resistance, nausea and constipation. While Ereska will not be approved with this in the label, there is a fair amount of peer reviewed data that substantiates these characteristics so there is a strong possibility that it will be used off-label in chronic pain especially break though cancer pain. It has been widely reported that break through cancer pain effects approximately 95% of all cancer patients. Patients report unpredictable episodes of pain that onset very quickly and reach a peak in around 5 minutes. These episodes can last between 30 to 60 minutes. This is a tremendously large opportunity for Javelin which could make the market for Ketamine many times larger than my initial estimates.
Dyloject vs Ereska
In order to understand the market for both Dyloject and Ereska, it is helpful to consider that even though both drugs give excellent analgesic effects, they work on different pathways. As an NSAID, Dyloject is more suitable to treat pain caused by inflammation like in surgery, whereas; Ereska is more suitable to treat pain caused by nerve damage as in trauma.
The Potential Market for Dyloject
Javelin has arrived at a $500MM worldwide market for Dyloject. In Europe the market for Voltarol is currently around $750MM per year. By figuring merely a 10% of penetration and using the current EU approved price of $10 per dose with an average of 4 doses per patient gets one to approximately $75MM per year.
Sales in the UK, where the product has already been launched have been slow to take hold mostly due to the way drugs are marketed there. To get on a hospital formulary in the UK, a drug company has to proceed on a hospital-by-hospital basis. Even after winning an account it still takes time to gain mindshare. This is not necessarily the case in the US where drugs can get into mainstream usage faster.
It is possible to back into the US market by looking at the current market for Ketorolac an NSAID that is currently approved for post operative use which is approximately 43MM units per year at around $9 per unit. Sometime after the drug was approved it was determined to have dangerous side effects relating to the kidneys and livers, most often seen in the elderly or people with diabetes. It was subsequently given an additional black box warning by the FDA. Even with this warning it still sells around $300MM per year.
Dyloject’s unique safety profile has shown that it can be used in patients that are not candidates for Ketorolac. It actually has shown in clinical trials to have a faster onset of action offering identical pain relief as Ketorolac. The initial objective will be to go after the segment of patients that are not candidates for Ketorolac. This amounts to 25MM units at $15 per unit (Ketorolac now sells for approximately $9 per unit) yielding an initial US market of around $350MM.
Even though is anticipated that Dyloject will be approved with the normal black box warning common to all NSAIDs, the recent safety study has shown that the drug clears readily from patients with compromised livers and kidneys because the drug does not appear to aggregate in those organs as Ketorolac does.
Clearing the drug from the system also is the key to getting people out of the hospital which due to the rising costs of health care is a major consideration of the current administration and will be for the forseeable future as the country struggles to control the rising cost of health care.
Another benefit that Dyloject has shown is the ability not to inhibit platelet aggregation which is another way of saying that it does not inhibit healing. It is likely that the drug will eventually be given to patients before the surgery is concluded further expediting the process of getting patients home. I believe that as physicians get more comfortable with the features and benefits of Dyloject, it will likely take even greater share from Ketorolac.
Certainly, as the baby boom generation ages and the incidence of diabetes continues to proliferate, the overall market for Dyloject will grow--further compounded by this overriding trend towards day surgery. Because the drug has little or no overhang effect it plays well into this trend. The 2 markets: EU plus US gets me to $450MM and this does not even take into account the rest of the world so these numbers should be considered conservative.
The Potential Market for Ereska
Using numbers reported by the National Center for Health Statistics, there are approximately 30MM trauma cases reported by US hospitals in the US each year. Ereska could serve that market exceptionally well as patients admitted to an ER could be given the drug before a determination could be made as to whether or not morphine could be given. Also, as I previously mentioned, the drug used in low doses can mitigate morphine side effects so it has the potential to vastly decrease the time a patient would have to remain in the hospital after getting morphine. For the drug to be a commercial success the duration of effect must be greater than 1.5 hours which it has been shown to be capable of in previous double-blinded placebo controlled studies.
The investment community appears to vastly underestimate the potential market for Ereska which could legitimately be a $300MM drug in the US alone. I can get to $300MM by merely estimating 2 doses at $10 each and only a 50% penetration of the trauma market. Additionally, military and national defense usage could also be a very nice steady revenue stream with almost no cost of sales attributed to it. 65% of military injuries have some orthopedic component to it, whether it is a bone break or extreme nerve pain.
The $300MM does not even account for the potential usage in breakthrough cancer pain or off-label usage in certain forms of depression, like Obsessive Compulsive Disorder (OCD). I view all of this as a lottery ticket. Adding up both potential revenue streams for Dyloject and Ereska gets me to around $800MM in sales potential which could reasonably be achieved in 3 years following US approval of both drugs by mid 2010. This is all without the inclusion of possible Dyloject sales in Japan or South America (where Diclofenac is currently used) and without any ex-US or off-label Ereska sales.
In January 2009, Javelin successful negotiated an exclusive European marketing deal for Dyloject with Therabel NV, a private, Dutch pharmaceutical concern receiving $12MM in upfront payments and up to $59MM in sales and regulatory milestones. JAV has disclosed a double digit royalty on future sales while Therabel assumes all commercial, regulatory and manufacturing responsibilities. Therabel was founded in 1945, has 400 employees and had consolidated revenues in 2008 of $169MM. It has a large and dedicated sales force with a focus on the pain market.
Summary
All-in-all, Javelin Pharmaceuticals seems like a bargain at its current market cap of ~ $70MM. While cash is a concern ($15.7MM in cash at 3-31-2009 with net cash used for 3-months of $4.3MM), the company has been actively reducing overhead and is in negotiations with other potential partners. The next milestone payment coming from Therabel could possibly be achieved by the end of the year when and if Therabel files for approval of Dyloject in the rest of Europe. Therabel is not that large of a company so Dyloject is a meaningful product to them. They are also well versed in the European drug approval process.
The difficult part of the Javelin story and probably accounts for some of the discount is the state of flux the business model is in. It is difficult to model future earnings because we cannot be sure at this point if they will ultimately partner Dyloject in the US or go it alone. We don’t know what royalty they may be able to achieve in a US partnership.
Furthermore, we cannot be sure what the model is for Ereska. In fact, we are not totally sure if management will elect to sell the whole company. However, in either scenario, it is hard to see it being worth much less than the current valuation. Even in the unlikely event that Ereska were to fail investors would be left with Dyloject which in my opinion would substantiate a $70MM market cap. If it plays out that way, a good case of dissociative anesthesia may well offer some temporary relief which is all that I think would be needed as the stock would eventually rebound to current levels.
5/
..There has only been one recent P.R...June 15th/09 which imo, would not make this company a Pump and Dump scenario.
>>New Study Shows Javelin Pharmaceutical's DylojectTM Well-Tolerated in High-Risk Patients with Impaired Renal and Hepatic Function<<
http://finance.yahoo.com/news/New-Study-Shows-Javelin-bw-799451444.html?x=0&.v=2
y3maxx
15 years ago
Javelin Pharmaceuticals, Inc. (JAV)
update from sumzero,com
Company:
Javelin Pharmaceuticals, Inc. (JAV)
Submitted By:
Steven Cordovano (Highland Portfolio Management) on Jul 07, 2009 at 07:05PM
Recommendation:
Long
Expected Timeframe:
One year to two years
Thesis
Javelin Pharmaceuticals:
Better Than a Poke in the Arm with a Shot of Dyloject.
Making profitable returns on drug development has to be one of the most difficult tasks in the money management business. It can sometimes make the myth of Sisyphus look like a child’s fairy tale because at least Sisyphus survives to roll the stone up the hill another day.
Paying for my PHD from the School of Hard Knocks was probably more expensive than Harvard, but what I have learned after more than one face removal is that the way to minimize the risk is to look for companies where the market has already extracted the hype—which is when shareholders are hyperventilating, or to look for situations where companies are developing new formulations of existing, well known compounds. Javelin Pharmaceuticals (JAV) is just such a story that fits the bill on both counts.
The company’s first compound is called Dyloject, an injectable form of Dyclofenac which is a non steroidal anti inflammatory drug (NSAID) , that has shown spectacular results in 2 phase 3 trials and recently demonstrated excellent results in an open label safety study that the company intends to file in support of their NDA. Dyclofenac as anyone with a back problem might know, is often given in a pill form and commonly in Europe post operatively as an IV infusion, marketed as Voltaren. Dyloject has recently been approved for post operative use in the UK for moderate to severe pain and is now a competitive alternative to Voltaren. Dyloject has a substantial cost advantage to Voltaren in that it is given as an injection rather than an IV drip. It is estimated to cost about $150 per patient to treat post operative pain with IV administration. This more than makes up for the cost of the Dyloject and doesn’t even consider complications relating to hospital borne IV infections. Javelin will file the US Dyloject NDA by the end of the year.
The second compound that will be reporting top line phase 3 data very shortly (within a week or so) is called Ereska, an intranasal formulation of Ketamine. Ketamine is officially classified as an NMDA receptor agonist. NMDA receptors are found in the central nervous system and are involved in the perception of pain. Blocking these receptors creates an analgesic effect. The drug has been used for over 30 years (in human and veterinary medicine) as an anesthetic in higher doses which can create a dissociative anesthetic effect. At higher doses it can also cause hallucinations, which makes it a favorite of street vendors where it is known as Special K. Javelin’s intranasal formulation of Ereska makes it difficult, if not impossible to abuse because the mucosal membrane can only absorb a limited amount of the drug and not enough to give it much if any street value.
Because Ketamine is a well known compound, the FDA originally was going to allow the company to file an NDA for Emergency and Military use based on the results of 4 pharmacokinetic studies (PK Studies), but abruptly changed their minds and compelled the company to do a conventional phase 3 study. The reasons appear to have more to do with FDA politics than anything that was seen in the PK studies. The reviewing division happens to be the same one that approved Vioxx. The downside of that for shareholders was a costly (dilutive) delay that had them doing deep breathing exercises. The upside if the drug shows satisfactory results will be no small consolation prize in the form of a much wider label than what was originally contemplated.
The US Department of Defense has contributed $4MM to the development of Ereska because they have a need for a fast acting non-sedative remedy for combat related injuries. The 10 to 50mg dose range has already been shown to have an excellent analgesic effect that it does not suppress the respiratory system. Meta analysis that the company has already presented showed no changes to the oxygen saturation levels in the blood. Because Ereska is non-sedating, a wounded soldier could alleviate the pain of a combat related injury and still be able to fly a helicopter or operate a weapon. Additionally, because it works on the central nervous system receptors, Ereska has shown the ability to prevent a condition known as phantom pain which is the phenomenon whereby people can experience pain in a lost limb.
For all of the above reasons, Ereska would make a superior first choice to administer if an unfortunate event were to occur where hundreds of people were injured in a public place. Without time to adequately triage patients, Ereska could offer temporary relief from traumatic injuries.
Another major benefit of low dose Ketamine, is that when used in combination with morphine it can reduce a common side effects of morphine which are gradual resistance, nausea and constipation. While Ereska will not be approved with this in the label, there is a fair amount of peer reviewed data that substantiates these characteristics so there is a strong possibility that it will be used off-label in chronic pain especially break though cancer pain. It has been widely reported that break through cancer pain effects approximately 95% of all cancer patients. Patients report unpredictable episodes of pain that onset very quickly and reach a peak in around 5 minutes. These episodes can last between 30 to 60 minutes. This is a tremendously large opportunity for Javelin which could make the market for Ketamine many times larger than my initial estimates.
Dyloject vs Ereska
In order to understand the market for both Dyloject and Ereska, it is helpful to consider that even though both drugs give excellent analgesic effects, they work on different pathways. As an NSAID, Dyloject is more suitable to treat pain caused by inflammation like in surgery, whereas; Ereska is more suitable to treat pain caused by nerve damage as in trauma.
The Potential Market for Dyloject
Javelin has arrived at a $500MM worldwide market for Dyloject. In Europe the market for Voltarol is currently around $750MM per year. By figuring merely a 10% of penetration and using the current EU approved price of $10 per dose with an average of 4 doses per patient gets one to approximately $75MM per year.
Sales in the UK, where the product has already been launched have been slow to take hold mostly due to the way drugs are marketed there. To get on a hospital formulary in the UK, a drug company has to proceed on a hospital-by-hospital basis. Even after winning an account it still takes time to gain mindshare. This is not necessarily the case in the US where drugs can get into mainstream usage faster.
It is possible to back into the US market by looking at the current market for Ketorolac an NSAID that is currently approved for post operative use which is approximately 43MM units per year at around $9 per unit. Sometime after the drug was approved it was determined to have dangerous side effects relating to the kidneys and livers, most often seen in the elderly or people with diabetes. It was subsequently given an additional black box warning by the FDA. Even with this warning it still sells around $300MM per year.
Dyloject’s unique safety profile has shown that it can be used in patients that are not candidates for Ketorolac. It actually has shown in clinical trials to have a faster onset of action offering identical pain relief as Ketorolac. The initial objective will be to go after the segment of patients that are not candidates for Ketorolac. This amounts to 25MM units at $15 per unit (Ketorolac now sells for approximately $9 per unit) yielding an initial US market of around $350MM.
Even though is anticipated that Dyloject will be approved with the normal black box warning common to all NSAIDs, the recent safety study has shown that the drug clears readily from patients with compromised livers and kidneys because the drug does not appear to aggregate in those organs as Ketorolac does.
Clearing the drug from the system also is the key to getting people out of the hospital which due to the rising costs of health care is a major consideration of the current administration and will be for the forseeable future as the country struggles to control the rising cost of health care.
Another benefit that Dyloject has shown is the ability not to inhibit platelet aggregation which is another way of saying that it does not inhibit healing. It is likely that the drug will eventually be given to patients before the surgery is concluded further expediting the process of getting patients home. I believe that as physicians get more comfortable with the features and benefits of Dyloject, it will likely take even greater share from Ketorolac.
Certainly, as the baby boom generation ages and the incidence of diabetes continues to proliferate, the overall market for Dyloject will grow--further compounded by this overriding trend towards day surgery. Because the drug has little or no overhang effect it plays well into this trend. The 2 markets: EU plus US gets me to $450MM and this does not even take into account the rest of the world so these numbers should be considered conservative.
The Potential Market for Ereska
Using numbers reported by the National Center for Health Statistics, there are approximately 30MM trauma cases reported by US hospitals in the US each year. Ereska could serve that market exceptionally well as patients admitted to an ER could be given the drug before a determination could be made as to whether or not morphine could be given. Also, as I previously mentioned, the drug used in low doses can mitigate morphine side effects so it has the potential to vastly decrease the time a patient would have to remain in the hospital after getting morphine. For the drug to be a commercial success the duration of effect must be greater than 1.5 hours which it has been shown to be capable of in previous double-blinded placebo controlled studies.
The investment community appears to vastly underestimate the potential market for Ereska which could legitimately be a $300MM drug in the US alone. I can get to $300MM by merely estimating 2 doses at $10 each and only a 50% penetration of the trauma market. Additionally, military and national defense usage could also be a very nice steady revenue stream with almost no cost of sales attributed to it. 65% of military injuries have some orthopedic component to it, whether it is a bone break or extreme nerve pain.
The $300MM does not even account for the potential usage in breakthrough cancer pain or off-label usage in certain forms of depression, like Obsessive Compulsive Disorder (OCD). I view all of this as a lottery ticket. Adding up both potential revenue streams for Dyloject and Ereska gets me to around $800MM in sales potential which could reasonably be achieved in 3 years following US approval of both drugs by mid 2010. This is all without the inclusion of possible Dyloject sales in Japan or South America (where Diclofenac is currently used) and without any ex-US or off-label Ereska sales.
In January 2009, Javelin successful negotiated an exclusive European marketing deal for Dyloject with Therabel NV, a private, Dutch pharmaceutical concern receiving $12MM in upfront payments and up to $59MM in sales and regulatory milestones. JAV has disclosed a double digit royalty on future sales while Therabel assumes all commercial, regulatory and manufacturing responsibilities. Therabel was founded in 1945, has 400 employees and had consolidated revenues in 2008 of $169MM. It has a large and dedicated sales force with a focus on the pain market.
Summary
All-in-all, Javelin Pharmaceuticals seems like a bargain at its current market cap of ~ $70MM. While cash is a concern ($15.7MM in cash at 3-31-2009 with net cash used for 3-months of $4.3MM), the company has been actively reducing overhead and is in negotiations with other potential partners. The next milestone payment coming from Therabel could possibly be achieved by the end of the year when and if Therabel files for approval of Dyloject in the rest of Europe. Therabel is not that large of a company so Dyloject is a meaningful product to them. They are also well versed in the European drug approval process.
The difficult part of the Javelin story and probably accounts for some of the discount is the state of flux the business model is in. It is difficult to model future earnings because we cannot be sure at this point if they will ultimately partner Dyloject in the US or go it alone. We don’t know what royalty they may be able to achieve in a US partnership.
Furthermore, we cannot be sure what the model is for Ereska. In fact, we are not totally sure if management will elect to sell the whole company. However, in either scenario, it is hard to see it being worth much less than the current valuation. Even in the unlikely event that Ereska were to fail investors would be left with Dyloject which in my opinion would substantiate a $70MM market cap. If it plays out that way, a good case of dissociative anesthesia may well offer some temporary relief which is all that I think would be needed as the stock would eventually rebound to current levels.
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stocktrader001
15 years ago
