surf1944
13 years ago
Adolor Corporation Announces Positive Results from Phase 2 Program in OIC
— Statistically Significant Results Achieved —
— Management to Host Conference Call, Wednesday, August 10, 2011, at 8:30 a.m. —
Press Release Source: Adolor Corporation On Wednesday August 10, 2011, 8:00 am
EXTON, Pa.--(BUSINESS WIRE)-- Adolor Corporation (NasdaqGM:ADLR - News) today announced positive, statistically significant top line results from its two Phase 2 studies of ADL5945 in chronic non-cancer pain patients with opioid-induced constipation (OIC). ADL5945, a peripherally-acting mu opioid receptor antagonist, is an investigational drug being evaluated for the treatment of OIC as well as other associated gastrointestinal (GI) complications. Both randomized, double-blind, placebo-controlled studies were identical in design; Study 242 evaluated 0.25 mg and 0.10 mg of ADL5945 administered twice daily (BID) and Study 243 evaluated 0.25 mg of ADL5945 administered once daily (QD).
“Opioid analgesics have become a cornerstone of multimodal therapy for the management of patients who suffer with chronic non-cancer pain,” said Neil Singla, M.D., Department of Anesthesiology, Director, Clinical Research, Huntington Memorial Hospital in Pasadena, California, and lead investigator for the Phase 2 program. “Unfortunately, OIC presents a very serious burden to most patients treated on long-term opioid therapy, and currently there are no adequate therapies to address this common and debilitating condition. The results of these studies of ADL5945 are very encouraging – demonstrating both clinically meaningful effects and a favorable tolerability profile.”
“Our Phase 2 program achieved all of our objectives and validates our view that ADL5945 is a potentially important drug for patients suffering from OIC and related GI symptoms,” said Michael R. Dougherty, Adolor’s President and CEO. “Adolor has extensive experience in this therapeutic area that we will continue to leverage as we now focus on the Phase 3 program. There has been significant interest in ADL5945 and we look forward to sharing these data and initiating pivotal studies as expeditiously as possible.”
Study Results
Twice-daily Dosing (Study 242)
Statistical significance (p = 0.0003) was achieved for the primary endpoint in the 0.25 mg BID dose group. The primary endpoint of both studies was the change from baseline in the weekly average number of spontaneous bowel movements (SBMs). Response to treatment was dose dependent in Study 242, with an average change from baseline in SBM frequency over the 4-week treatment period of 1.4 SBMs for the placebo group, and 2.0 and 3.4 SBMs for the 0.10 mg and 0.25 mg doses of ADL5945, respectively. Statistical significance was not achieved for the 0.10 mg dose.
Statistical significance (p = 0.005) also was achieved in the 0.25 mg BID dose group for a key secondary endpoint, a responders analysis, with a 56% response rate for the active arm and a 26% response rate for the placebo arm of the study. This translates into a clinically relevant number needed to treat (NNT) of 3.3. For this analysis, responders were defined as those patients who achieved an average weekly frequency of at least three SBMs and an increase of at least one SBM above baseline.
Other exploratory endpoints (patients’ global impression of change, BM comfort and satisfaction scores) demonstrated greater improvement as compared to baseline in the ADL5945 0.25 mg treatment group as compared to placebo.
Once-daily Dosing (Study 243)
In Study 243, statistical significance (p= 0.01) also was achieved for the primary endpoint. The average change from baseline in SBM frequency over the 4-week treatment period was 1.4 SBMs for the placebo group and 2.6 SBMs for the 0.25 mg ADL5945 treatment group.
Although the proportion of responders was higher in the 0.25 mg treatment group (42.5% vs. 29.3% in placebo), statistical significance was not achieved.
Other exploratory endpoints evaluating changes in bowel function trended in favor of ADL5945 as compared to placebo.
Safety and Tolerability
ADL5945 was well tolerated in both studies. The overall number of patients reporting at least one treatment-emergent adverse event was comparable across both studies (ADL5945: 29%; placebo: 26%). There was no evidence of drug-related central opioid withdrawal or reversal of analgesia in any of the ADL5945 treatment groups across both studies.
Additional information concerning the efficacy and safety results from Study 242 and Study 243 is included in the slide presentation that will accompany the investor conference call.
Conference Call Information
Adolor's management will discuss the results of the Phase 2 studies in a conference call with investors beginning at 8:30 a.m. ET Wednesday, August 10, 2011.
To participate in the audio portion and have the opportunity to pose questions, dial 866-202-3109 for domestic callers or 617-213-8844 for international callers, and enter Conference ID # 62949696. Investors also can listen to the call live and view a slide presentation by logging on to the Company’s website at www.adolor.com and clicking on “Investor Insights,” then "Calendar of Events."
A replay of the call will be available beginning approximately two hours after the event. To listen to a replay of the conference call, dial 888-286-8010 (domestic) or 617-801-6888 (international) and enter Conference ID # 75827916 or listen via Adolor’s website. The replay will be available for one week.
About ADL5945
ADL5945 is a potent, peripherally-acting mu opioid receptor antagonist intended to block the adverse effects of opioid analgesics on the GI tract without compromising centrally-mediated analgesia. Peripheral mu opioid receptors in the GI tract regulate functions such as motility, secretion and absorption. Stimulation of these GI mu opioid receptors by morphine, or other opioid analgesics, disrupts normal gut motility.
About OIC
Over 250 million opioid prescriptions are written annually in the United States. For those patients treated with prescription opioids for long-term pain management, many will develop constipation, as well as other associated gastrointestinal complications. Currently, there are no FDA-approved therapies to treat opioid-induced constipation in patients with chronic non-cancer pain.
surf1944
13 years ago
Why I'm Upgrading Adolor to a Buy
Investment Thesis
Adolor has gained back Glaxo’s (GSK) rights to Entereg (alvimopan) in a transaction that I regard as a highly positive, company changing event. Entereg has the critical sales mass to enable Adolor to be a self-sufficient, cash flow positive company. I believe that the Entereg sales run rate entering 2012 could be on the order of $40 million, $50 million entering 2013, and over the next several years could grow to $100 million.
The terms of the deal were amazingly favorable to Adolor, and the company has much for which to thank Glaxo. On its own, Adolor could not have brought Entereg to this sales level and might not have been able to launch it in the first place. The difficulties of introducing a first-in-class drug to an increasingly cost-conscious hospital marketplace has made the launch and sales ramp of a new product much more difficult, and it can be prohibitively expensive for a small company. Hiring and training a sales force, and then going through the time consuming process of gaining formulary acceptance and implementing the REMS program which was required for Entereg, is something that Adolor could probably not have done on its own. Now after three years of heavy lifting Glaxo is handing this very valuable asset to Adolor on a cheaply bought silver platter.
Based on Entereg potential alone, Adolor is a very interesting company. The patent position of the product is expected to extend protection from generics until 2020. One way of estimating its value is to estimate a multiple of enterprise value to sales based on what comparable companies sell for. Because of its strong patent position, I think that either the stock market or a potential acquirer might value Entereg at a multiplier of 3.0 to 3.5 times (or possibly higher). Appyling the 3.0 to 3.5 multiplier to my year-end 2011 sales run rate estimate of about $40 million results in a potential market capitalization of $120 to $140 million, or a stock price potential of $2.57 to $3.00 per share. This compares to the current stock price of $1.60.
While the above scenario addresses the potential value of Entereg, it does not attribute any value to the sales force that Entereg supports. This sales force provides additional value in that it allows Adolor to acquire or co-promote additional products. Over time, I could argue that the financial leverage of the sales force might have value approaching that of Entereg. Of course, there are so many unknowns that I can’t easily assign a value to this proprietary sales force. I just know that there is substantial value.
Adolor is fast approaching a binary clinical trial event that can significantly impact the investment outlook. The company is developing a new opioid induced constipation product called ADL 5945, and the results of a key phase II trial will be reported in 3Q, 2011. The company would prefer to partner ADL 5945, as the anticipated development cost of around $50 million is probably too much for Adolor to assume on its own. It is not possible for me to predict how positive the results might be-- or even if they will be successful. Investors must be prepared for either a success or failure scenario. Partnering the product-- even with successful phase II results-- is also not a given.
If the trial is reasonably successful, it can only be perceived as adding value and therefore maintaining or increasing the stock price. However, if the trial fails and ADL 5945 is abandoned, there remains an interesting scenario for 2012. As shown later in this report, I am estimating Entereg sales of $45 million in 2012. In the unlikely event that company were to decide to fund all future development of ADL 5945, it might spend about $30 million on R&D, leading to an operating loss of $26 million in 2012. A partnering deal could reduce this amount of R&D spend. If ADL 5945 fails, it is likely that the R&D spend could drop, perhaps to as low as $5 million. Based on my $45 million sales estimate for Entereg in 2012 this could produce an operating loss of $515,000 and EPS of $0.00. For investors, it would highlight the value of Entereg.
The third factor to consider in looking at Adolor is the potential that the company might do a financing regardless of ADL 5945 success or failure. The company ended the first quarter of 2011 with $39.3 million of cash. Assuming quarterly burn rates of $7.0 million in 2Q, 2011, $5.0 million in 3Q, 2011 $6.0 million in 4Q, 2011 and the $2.5 million payment to Glaxo, the company could end the year with $18.8 million of cash. Although it is not a certainty that the company will have to raise cash, it is a possibility that worries some investors.
I think the concern about financing is impacting the stock at this time, so let’s examine the possibilities. If the trial results of ADL 5945 are sufficiently positive to allow a partnering deal, the upfront payment could alleviate the need for any new equity offering. Nektar (NKTR) received an upfront payment of $125 million from Astra Zeneca (AZN) over one year ago for a drug similar to ADL 5945 that was just coming off of positive phase II results. If Adolor could strike a deal with an upfront of just $25 million or higher, it would probably obviate the need for an equity raise.
If ADL 5945 fails, Adolor might be able to avoid an equity offering, but there would be some financial brinksmanship involved. However, I think the company would easily qualify for a debt financing given the predictable cash flow of Entereg. This might allow the company to avoid an equity offering altogether, or to do a much smaller one.
My fundamental judgment is that the intrinsic value of Entereg offsets the risk of the ADL 5945 trial failing or the potential for an equity offering, and so I regard the stock as attractive whether or not the ADL 5945 trial is successful. However, I acknowledge that there remains the headline risk that news of the trial failure or of an equity offering could cause a decline from the current price. I am recommending purchase, but there is a chance that the stock could decline on unfavorable headline news before it meets my expectation of going higher.
Adolor Gains Glaxo’s Rights to Entereg
Adolor has entered into an agreement to acquire Glaxo’s ownership share of Entereg. The two companies have been co-promoting Entereg on a profit / loss sharing basis since its introduction in 3Q 2008. Adolor will pay Glaxo $25 million spread over six years, with the initial payment of $2.5 million payable upon closing the transaction in September of 2011. I assume that none of the subsequent six annual payments will exceed $4.0 million. There may also be a payment of $15 million dependent upon the achievement of certain sales milestones, but this will be some years off. Adolor will also pay Glaxo a mid-single digit royalty on sales that will increase with sales levels.
The initial focus of the Entereg launch was on gaining hospital registration for the REMS program, hospital formulary approval and educating the hospital staff about the product’s attributes. Being first in class and first to market is not an easy road. The early years of a product launch in the hospital marketplace are a daunting challenge. Adolor is acquiring Glaxo’s rights to Entereg after most of the heavy lifting has been done.
Entereg sales were at a run rate of $30 million in the first quarter of 2011 and I believe that run rate entering 2012 will be about $40 million. The previously expressed long term goal is to grow Entereg sales to a level of $100 million. With this new arrangement, management expects that Entereg will contribute meaningful cash flow in year one and into the future. Allowing for the royalty payment to Glaxo, the product contribution to sales in 2012 could be on the order of 30% and longer term it could reach 50%. The new Glaxo arrangement will be accretive over the next year.
The Transition of Entereg to the Adolor Sales Force
The hospital market is focused on post-operative care pathways more than ever, and in particular, length of stay; this is the raison d’etre for Entereg. There has been a continual string of studies done by third party physicians and hospitals that conclude that Entereg can meaningfully shorten length of stay for bowel resection patients. The market place should be increasingly receptive to Entereg.
Adolor has always played an active role and is up to the challenge of taking over marketing Entereg. The NDA approval was obtained by Adolor and they also ran the clinical trial program that led to that approval. They have also managed pharmaco-vigilance programs, administered the REMS program and have driven medical affairs initiatives. Adolor has also been responsible for manufacturing and has led the marketing effort since launch.
The major change going forward will be on detailing. Whereas Adolor has been detailing alongside Glaxo, they will now be solely responsible. The expansion of the sales force is the largest part of this transitional effort, but it is a relatively straightforward process. Up to now, the Adolor account managers have been working alongside the Glaxo account managers in large metropolitan areas where Entereg is being used in several hospitals. It is believed that increased promotional effort will have the greatest impact in this account base. This is based on the premise that your best new customer for Entereg is the best current customer. The current Adolor account managers will remain in their current account geographies. New reps will be added in geographies which were previously only covered by Glaxo representatives.
The company has already started the process to double the size of the field force to 50. They expect to have the sales personnel trained and calling on customers by September 1. The new account structure will be optimized to cover the vast majority of existing customers. Adolor is also planning to increase investment in non-personnel promotional efforts for existing accounts that will not initially be covered by Adolor account managers.
The target list of hospitals that perform 80% of bowel resection procedures in the U.S. is 1600. Adolor currently has 25 people in the field that layer on top of the Glaxo national sales force. The Adolor / Glaxo strategy up to now has been focused on “same store sales” growth in key existing accounts. Over 70% of the targeted 1600 accounts are registered in the EASE program and 50% either have added Entereg to their formularies or otherwise have made Entereg available to their surgeons. There is much growth potential in exisitng accounts, and importantly, they have passed use hurdles and formulary access.
Adolor will also be taking over physical distribution of Entereg and the contracts with GPOs, federal accounts, wholesalers and hospital systems by September 1. Distribution will be largely a turnkey transition using an established third party logistics company that has a proven distribution platform.
On a full time employee basis, management believes that the new Adolor sales force will be nearly identical in account impact to the former combined Adolor / Glaxo sales force. Each Adolor employee will spend 100% of their time on promoting Entereg, as opposed to Glaxo reps who had to focus on a number of other products. Adolor believes that increased productivity in the smaller sales force will compensate for the smaller head count.
Financial Impact of the Entereg Deal
This deal has lowered the bar to cash flow breakeven. Management now believes that the company could reach breakeven somewhere in the area of $40 to $45 million of Entereg sales. However, this excludes expenses for the potential phase III program of ADL 5945.
http://seekingalpha.com/article/275563-why-i-m-upgrading-adolor-to-a-buy?source=yahoo
surf1944
13 years ago
Adolor Corporation Reports First Quarter 2011 Financial Results
- OIC Phase 2 Enrollment Progressing Well -
Press Release Source: Adolor Corporation On Thursday April 28, 2011, 8:00 am EDT
EXTON, Pa.--(BUSINESS WIRE)-- Adolor Corporation (NasdaqGM:ADLR - News) today reported net sales of ENTEREG® (alvimopan) were $7.5 million for the three months ended March 31, 2011, a 42% increase compared to net sales of $5.3 million for the three months ended March 31, 2010. The increase in net sales was driven primarily by an increase in the number of hospitals ordering ENTEREG and increased penetration within existing hospital customers, as well as the impact of pricing changes since the first quarter of 2010.
Net loss for the three months ended March 31, 2011 was $7.3 million, or $(0.16) per basic and diluted share, down from a net loss of $9.6 million, or $(0.21) per basic and diluted share, for the three months ended March 31, 2010.
“The first quarter saw steady progress across the board at Adolor,” said Michael R. Dougherty, President and Chief Executive Officer. “Enrollment has progressed well in our Phase 2 clinical program for ADL5945 in OIC and we are on-track to report the results of our studies in the third quarter of this year. Commercially, ENTEREG net sales growth continued, increasing over 40 percent compared to the same period last year. We expect continued growth in 2011 as independent medication use evaluations and other ENTEREG outcomes studies continue to drive physician interest in this product.”
Cash, cash equivalents and short-term investments at March 31, 2011 were $39.3 million.
Conference Call Information
Adolor's management will discuss the Company's first quarter 2011 results in a conference call with investors beginning at 8:30 a.m. ET today, April 28, 2011.
To participate in the audio portion and have the opportunity to pose questions, dial 866-831-6270 for domestic callers or 617-213-8858 for international callers, and enter Conference ID # 40429279. Investors also can listen to the call live by logging on to the Company’s website at www.adolor.com and clicking on “Investor Insights,” then "Calendar of Events."
A replay of the call will be available beginning approximately two hours after the event. To listen to a replay of the conference call, dial 888-286-8010 (domestic) or 617-801-6888 (international) and enter Conference ID # 38637435 or listen via Adolor’s website. The replay will be available for one week.
About Adolor
surf1944
13 years ago
Adolor Corporation Announces Presentations at the 2011 American Society of Colon & Rectal Surgeons Annual Meeting
Press Release Source: Adolor Corporation On Monday May 16, 2011, 8:00 am EDT
EXTON, Pa.--(BUSINESS WIRE)-- Adolor Corporation (NasdaqGM:ADLR - News) today announced that ENTEREG® (alvimopan) will be the subject of presentations at the 2011 Annual Scientific Meeting of the American Society of Colon & Rectal Surgeons (ASCRS) on Monday and Tuesday, May 16-17, 2011. The presentations are scheduled from 9:00 a.m. to 4:00 p.m. EDT on Monday, May 16 and from 9:00 a.m. to 1:30 p.m. on May 17, 2011 in Exhibit Hall A, West Building at the Vancouver Convention Centre, Vancouver, Canada.
A poster1 reporting the evaluation of ENTEREG use in clinical practice using a large in-patient database will be presented. The study evaluated clinical outcomes, length of stay, and estimated total hospital cost in bowel resection patients with and without exposure to ENTEREG. The retrospective cohort study was conducted using 2009 exact matched (surgical procedure, surgeon specialty) and propensity score matched (baseline patient, surgeon, and hospital characteristics) data from a national inpatient administrative database. The abstract is available on the ASCRS 2011 Annual Meeting website.
“This study of the use of ENTEREG in the clinical practice setting adds to the growing body of available literature regarding the use of the product,” said Lee M. Techner, D.P.M., Vice President, Medical Affairs, Pharmacovigilance & Drug Safety at Adolor and one of the study’s authors.
In addition to this poster, there will be three additional ENTEREG-related poster presentations at the ASCRS 2011 Annual Meeting. All of these abstracts are currently available online for viewing through the ASCRS 2011 Annual Meeting website.
About ENTEREG
ENTEREG (alvimopan) is a peripherally acting mu-opioid receptor antagonist that was approved by the U.S. Food and Drug Administration in mid-2008. ENTEREG is the first and only FDA approved therapy indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis.
ENTEREG was evaluated in five Phase 3 clinical studies, four in North America, that enrolled more than 1,850 bowel resection patients (including those in the placebo groups). The recommended adult dose of ENTEREG is a single 12 mg capsule administered orally 30 minutes to five hours prior to surgery followed by a 12 mg capsule twice daily beginning the day after surgery for a maximum of seven days or until discharge, not to exceed 15 doses. ENTEREG is for use in hospitalized patients only (see Important Safety Information below).
ENTEREG is available only to hospitals that perform bowel resections and are enrolled in the ENTEREG Access Support & Education (E.A.S.E.™) program.
Important Safety Information for ENTEREG
WARNING: FOR SHORT-TERM HOSPITAL USE ONLY
ENTEREG is available only for short-term (15 doses) use in hospitalized patients.
Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support & Education (E.A.S.E.) program may use ENTEREG.
Contraindications
ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.
Warnings and Precautions
There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.
ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (e.g., abdominal pain, nausea and vomiting, diarrhea).
ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, or in patients undergoing surgery for correction of complete bowel obstructions.
Most common adverse reactions in patients treated with ENTEREG (incidence > 3% with ENTEREG and at least 1% greater than placebo) undergoing bowel resection were anemia, dyspepsia, hypokalemia, back pain, and urinary retention.
For more information about ENTEREG, including full Prescribing Information and the E.A.S.E. Program, contact Adolor Corporation at 1-866-4ADOLOR (1-866-423-6567) or visit www.entereg.com.
surf1944
13 years ago
Encouraging Quarter for Adolor, Waiting for Phase II Data on ADL-5945
Introduction
I wrote an introductory report on Adolor (ADLR) on February 18, 2011 called "Adolor, a Small Stock to Watch." This note is a follow-up so that interested investors may want to refer to that report for a more detailed discussion of the company.
Entereg Results in the First Quarter Were Excellent
The results of the first quarter were on target with expectations. Entereg achieved sales of $7.5 million which was an increase of 41% from 1Q, 2010 and a slight sequential increase from the $7.3 million of 4Q, 2010. The company reported that the Entereg business is now operating at an annual run rate of $30 million, a level at which it is now at cash flow break even.
Looking first at year over year results for Entereg, the company benefited from a price increase of 6% taken in April of 2010 and another 9% increase taken in January of 2011. Adolor reported that the year over year unit growth was on the order of 20% to 25%. Management reports that the strong unit growth resulted from both an expansion in the number of hospitals in which Entereg is sold and also deeper penetration within exiting hospitals. The unit growth trend appears to be sustainable and the company should also be able to continue to realize price increases going forward. I continue to estimate Entereg sales of $37 million in 2011 and $46 million in 2012.
The modest sequential increase in Entereg sales from $7.3 million in 4Q, 2010 to $7.5 million in 1Q, 2011 was attributed to normal seasonal patterns in hospital elective surgeries that result in a sluggish first quarter and also some buildup of inventories by wholesalers in 4Q, 2010. The sequential performance this year is much better than was one year ago when there was a sharp sequential decline from $7.5 million in 4Q, 2009 to $5.3 million in 1Q, 2010. Hence, the sequential decline of this year’s first quarter seems normal.
Update on ADL-5945
Management stated that enrollment trends for ADL-5945 are on target and reiterated guidance that topline data on the 200 patient Phase II trial will be released in 3Q, 2011. Adolor believes that if the results are positive that it may be able to realize a partnering deal before the end of 2011. I am a little concerned that this timeline might be too aggressive.
Financials
Adolor burned about $7 million in the quarter so that it ended 1Q, 2011 with $39.3 million of cash. This quarterly burn could diminish slightly over the course of the year, but we would still look for a cumulative burn over the next three quarters of $15 to $18 million. This would result in yearend cash position of $21 to $24 million if there is no partnering deal on ADL-5945 and no new equity is raised.
Stock Opinion
The market is clearly focused on Adolor’s declining cash position and is concerned that the company may have to do an equity offering in 2011 or early 2012 which at the market capitalization of $65 million could be significantly dilutive. The company is hoping that success with the Phase II trial of ADL-5945 can drive a partnering deal in 2011 that will negate the need for new equity. And very quietly, Entereg is now in a position to generate positive cash flow. I estimate that it can create a positive cash contribution of $3 million in 2011 and $8 million in 2012.
There is a lot riding on the upcoming Phase II data on ADL-5945 and the potential for doing a partnering deal that will hopefully be done off of those results. Success could have a dramatic impact on the stock and I could see the stock doubling; after all the current market capitalization is only $65 million. On the other hand, if the results are negative, there would be an immediate and sharply negative impact on the stock. Even if the results are positive, the market may be cautious on the stock until a partnering deal is actually concluded.
I think that there is value in the company even if ADL-5945 fails. Adolor could emerge as small, but profitable enterprise based only on Entereg prospects. Hence, there is potential for the stock even if ADL-5945 fails, but the stock would likely have a meaningful decline before the market began to focus on a new company primarily based on Entereg.
I am obviously interested in this company and have considered putting a buy on the stock. However, there are two key questions with the investment thesis that I can not answer with confidence: (1) will the ADL-5945 Phase II data be positive, (2) and if so, can the company really conclude a partnering deal by the need of 2011? If I could have 75% confidence that both of these questions would have a positive outcome, I would recommend the stock. However, I am not at that point and continue to be neutral.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
http://seekingalpha.com/article/266222-encouraging-quarter-for-adolor-waiting-for-phase-ii-data-on-adl-5945?source=yahoo
surf1944
14 years ago
Adolor Corporation Reports First Quarter 2010 Financial Results
Press Release Source: Adolor Corporation On Wednesday April 28, 2010, 8:00 am
EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (NasdaqGM: ADLR - News) today reported a net loss of $9.6 million, or $(0.21) per basic and diluted share, for the three months ended March 31, 2010, compared to a net loss of $13.2 million, or $(0.28) per basic and diluted share, for the three months ended March 31, 2009.
Net product sales of ENTEREG® (alvimopan) for the three months ended March 31, 2010 were $5.3 million compared to $1.4 million for the three months ended March 31, 2009, primarily as a result of growth in the number of ordering hospitals and increased usage at ordering hospitals. Net product sales for the three months ended March 31, 2010 were recognized at the time of shipment as compared to net product sales for the three months ended March 31, 2009, which were recognized on a reorder basis under our previous revenue recognition policy. Net shipments of ENTEREG in the first quarter of 2009 were $2.0 million.
“The first quarter saw steady progress across the board at Adolor,” said Michael R. Dougherty, President and Chief Executive Officer. “In our delta opioid receptor agonist program, we have concluded enrollment in our Phase 2a proof-of-concept study of ADL5859 and ADL5747 in osteoarthritis patients and expect to present top line results from this study in mid-2010. We also were pleased to initiate in the first quarter our Phase 2a proof-of-concept study of ADL5747 in post-herpetic neuralgia and enrollment is now well underway. In our opioid bowel dysfunction (OBD) program, both ADL7445 and ADL5945 are now being evaluated in patients with OBD. We are pleased with the results observed to date in our Phase 1 program and anticipate initiating proof-of-concept testing later this year.”
“Progress continues with ENTEREG as well,” added Mr. Dougherty. “First quarter product sales were $5.3 million, with increases in the number of hospitals including ENTEREG on formulary and in re-ordering hospitals. We expect continued growth in product sales as the benefits of this first-in-class drug become more widely appreciated.”
Operating Highlights
As of March 31, 2010, the Company estimates that ENTEREG was included on formulary of approximately 575 of the 1,400 hospitals that collectively perform approximately 80% of the bowel resection surgeries in the United States. In addition, approximately 925 of the above-noted 1,400 hospitals, or 66%, are registered under the ENTEREG Access Support and Education (E.A.S.E.™) Program as of March 31, 2010.
Contract revenues were $5.4 million and $5.2 million for the three months ended March 31, 2010 and 2009, respectively.
Research and development expenses were $10.5 million and $12.3 million for the three months ended March 31, 2010 and 2009, respectively. This decrease was driven primarily by reductions in expenses associated with our June 2009 restructuring, offset partially by higher costs of clinical studies incurred during the three months ended March 31, 2010 in our delta agonist program and our OBD program.
Selling, general and administrative expenses were $9.2 million and $7.9 million for the three months ended March 31, 2010 and 2009, respectively. The increase in the first quarter of 2010 compared to the same period in 2009 was primarily driven by higher marketing expenses associated with ENTEREG, partially offset by lower general and administrative expenses period-over-period.
As of March 31, 2010, the Company had $72.6 million in cash, cash equivalents and short-term investments.
2010 Net Product Sales Guidance
The following guidance provided by Adolor is a projection, based upon numerous assumptions, all of which are subject to certain risks and uncertainties. For a discussion of the risks and uncertainties associated with this forward-looking statement, please see “Forward-Looking Statements” below.
The Company is reiterating its expectation for ENTEREG net product sales of between $30 million and $35 million for the year ending December 31, 2010.
Conference Call Information
Adolor's management will discuss the Company's first quarter 2010 results in a conference call with investors beginning at 8:45 a.m. ET today, April 28, 2010.
To participate in the conference call, dial (866) 272-9941 for domestic callers and (617) 213-8895 for international callers, and enter the conference passcode 38318251. Investors also can listen to the call live by logging on to the Company's website at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.adolor.com&esheet=6267360&lan=en_US&anchor=www.adolor.com&index=1&md5=136575e32f09a9414d278d36c558e6e1 and clicking on “Investor Insights,” then “Calendar of Events.” A replay of the call will be available beginning approximately two hours after the event. To listen to a replay of the conference call, dial (888) 286-8010 (domestic) or (617) 801-6888 (international) and enter the conference passcode 20428470 or listen via Adolor’s website. The conference call replay will be available to investors for one week after the call.
surf1944
14 years ago
UPDATE 1-US FDA says Roche, Sanofi promotions misleading
Fri Apr 23, 2010 12:04pm EDTStocks
Roche Holding AG
* Agency objects to cancer, HIV, bowel drug promotions
* Complaints cite consumer video, sales rep statements
WASHINGTON, April 23 (Reuters) - Roche Holding AG (ROG.VX), Sanofi-Aventis (SASY.PA) and Adolor Corp (ADLR.O) made misleading claims about cancer, HIV and bowel drugs, U.S. regulators said in letters released on Friday.
The Food and Drug Administration objected to a video for consumers from Roche unit Genentech about cancer drug Herceptin. The video "minimizes the serious risks associated with the use of Herceptin and presents misleading claims regarding the benefits," the FDA said in March 26 letter to the company.
In a separate April 6 letter, the FDA said three Roche sales materials made misleading claims about HIV drug Invirase.
The agency also said an Adolor sales representative had minimized the risks of bowel drug Entereg and overstated effectiveness in comments made at a December 2009 pharmacists' meeting. The letter to Adolor was dated April 21.
With Sanofi, the FDA said in an April 20 letter that one of the company's promotions made unsupported claims about prostate cancer drug Eligard.
Officials at the companies could not immediately be reached for comment. (Reporting by Lisa Richwine; Editing by Lisa Von Ahn)
surf1944
14 years ago
Adolor Corp.: A Biotech Where Pain Is Its Gain, And Patience Pays
Adolor Corp. (ADLR) (1.76) is a tiny biotech that has a pain management focus. Its specialty is opioid receptor-targeted receptor therapeutics. It has been a name on our Emerging Growth list since late January, when the stock was trading at 1.50.
According to the corporate website, ADLR markets ENTEREG a peripherally-acting mu opioid receptor (PAM-OR) antagonist designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects. The FDA approved ENTEREG in 2008. The drug accelerates upper and lower gastrointestinal [GI] recovery following partial large or small bowel resection surgery with primary anastomosis. ENTEREG is the first FDA approved therapy for postoperative ileus and is available for short-term use in hospitals registered under the ENTEREG Access.
ADLR co-markets the product with GlaxoSmithKline (GSK) and in the third quarter the company reported seeing continued growth in shipments and product sales. Last week, the company reported ENTEREG annual sales of nearly $15 million.
The company also reported 800 hospital formulary wins for the year, up from 300 in 2008. Of these hospitals, at least 450 of them are a part of the 1400 hospitals nationwide that account for 80% of the bowel section surgeries.
I do see continued growth with ENTEREG, but I also believe the company’s greatest story may yet to be told. Its partnership with Pfizer Inc. (PFE) in the development of a new class of opioids --- the delta receptor opioid. This class of opioid analgesics would work effectively in pain management without offering numerous complicating side effects that the traditional opioids retain such as sedation, respiratory depression and abuse potential.
Management has reported progress in a Phase 3 trial involving the compounds AVL5859 and AVL5747 in osteoarthritis patients. The trial will enroll 400 patients and compare each compound against placebo and oxycodone CR. The study will last two weeks and results are expected at the end of this year.
Additionally, ADLR is preparing for the initiation of an additional Phase 2a study of ADL5747. This will study a patient with postherpetic neuralgia to assess its efficacy in controlling neuropathic pain. Enrollment was scheduled to start this study last month.
Adolor Inc. sports a $85 million market cap and has 46 million shares available. It also is in a very enviable position with liquidity, sitting on nearly $85 million in cash. Insider ownership is around 13% and just recently, in January, Wellington Research Management more than doubled its stake in the company (going from 4.6% to 10% ownership).
The stock had a nice run the past few days, but there should be plenty of upside left. If the market struggles, ADLR will stumble with it. Patient investors, however, could be rewarded.
Disclosure: Long ADLR
http://seekingalpha.com/article/191639-adolor-corp-a-biotech-where-pain-is-its-gain-and-patience-pays?source=yahoo
surf1944
14 years ago
Adolor Corporation Initiates Clinical Testing in Opioid Bowel Dysfunction Program
Press Release
Source: Adolor Corporation
On 9:00 am EST, Thursday November 12, 2009
EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (NasdaqGM:ADLR - News) today announced the initiation of clinical testing of ADL7445, its proprietary, oral mu opioid receptor antagonist for the treatment of Opioid Bowel Dysfunction (OBD). The Phase 1, single ascending dose trial in healthy volunteers will assess safety and tolerability of the compound and will be followed by a multiple ascending dose study in early 2010.
Early next year, the Company also expects to initiate a clinical study of a second compound for OBD, ADL5945, in a parallel, early-stage clinical development program. ADL5945 was in-licensed from Eli Lilly in September 2009 and has a different chemical structure and pharmacokinetic profile than ADL7445.
“We are very pleased to commence clinical testing in our OBD Program with the first of two promising compounds,” said Eliseo Salinas, M.D., Senior Vice President and Chief Medical Officer. “Our clinical development team possesses a wealth of experience in this therapeutic area, and we are committed to developing products that will address this large, unmet need.”
surf1944
14 years ago
Adolor Corporation Reports Third Quarter 2009 Financial Results
Press Release
Source: Adolor Corporation
On 8:00 am EDT, Thursday October 29, 2009
Companies:Adolor Corp.
EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (NasdaqGM:ADLR - News) today reported a net loss of approximately $11.1 million, or ($0.24) per basic and diluted share, for the three months ended September 30, 2009 compared to a net loss of $13.3 million, or ($0.29) per basic and diluted share, for the three months ended September 30, 2008. For the nine months ended September 30, 2009, the Company reported a net loss of approximately $40.9 million, or ($0.88) per basic and diluted share, compared to a net loss of $14.8 million, or ($0.32) per basic and diluted share, for the nine months ended September 30, 2008. The prior year nine month period was favorably impacted by a $20.0 million milestone payment received from GlaxoSmithKline (GSK) in the second quarter of 2008 upon the approval of ENTEREG® (alvimopan) by the U.S. Food and Drug Administration.
The Company reported net shipments of ENTEREG for the three and nine months ended September 30, 2009 of approximately $4.0 million and $8.9 million, respectively, of which the Company recognized approximately $3.3 million and $7.2 million, respectively, as net product sales. Under Adolor’s current revenue recognition policy, revenue related to a customer shipment is deferred until subsequent re-orders by that customer. As of September 30, 2009, there were approximately 625 repeat-order hospitals for ENTEREG, up from 450 at June 30, 2009.
During the quarter, hospitals registered under the ENTEREG Access Support and Education (E.A.S.E.™) Program increased by 125 to approximately 1,550 hospitals. Inclusion of ENTEREG on hospital formularies also increased during the quarter by 125, or 21%, to approximately 725 hospitals as of September 30, 2009, which number includes approximately 435 of the 1,400 hospitals that perform approximately 80% of the bowel resection surgeries in the United States.
Adolor also reported significant progress in its delta opioid receptor agonist and opioid bowel dysfunction (OBD) clinical development programs. Highlights from the quarter included:
Initiation with Pfizer, Inc. of a Phase 2a proof-of-concept study for the two delta compounds, ADL5859 and ADL5747, in patients suffering from osteoarthritis;
The filing of the Company’s Investigational New Drug Application for ADL7445 in OBD and preparation for the initiation of a Phase 1 clinical trial; and
The acquisition from Eli Lilly and Company of ADL5945, a clinical stage mu opioid receptor antagonist with the potential to address gastrointestinal disorders such as OBD associated with the chronic use of opioid analgesics.
“The third quarter saw continued progress with ENTEREG, with net shipments increasing by nearly 40% from the second quarter of 2009 to $4.0 million and growth in hospital registrations and formulary approvals,” said Michael R. Dougherty, President and Chief Executive Officer. “We also continue to see validation of the benefits of ENTEREG as more hospitals report the results of their independent evaluations of ENTEREG. Finally, we are very pleased to report the progress in our clinical development pipeline, with multiple compounds now under development in both our delta and OBD programs.”
Contract revenues were approximately $5.3 million and $7.7 million for the three months ended September 30, 2009 and 2008, respectively, and were approximately $17.2 million and $40.9 million for the nine months ended September 30, 2009 and 2008, respectively. Contract revenues in the nine months ended September 30, 2008 included the $20.0 million milestone payment received from GSK.
Research and development expenses were approximately $11.1 million and $14.1 million for the three months ended September 30, 2009 and 2008, respectively, and were approximately $35.4 million and $38.8 million for the nine months ended September 30, 2009 and 2008, respectively. Total research and development expenses decreased due to lower costs of clinical studies incurred during 2009 in our delta agonist program, lower expenses in our other programs and a reduction in headcount and depreciation expenses resulting from our June 2009 restructuring. These decreases were partially offset by higher expenses related to the development of our OBD program, including a $2.0 million payment to in-license ADL5945 as a clinical stage OBD candidate.
Selling, general and administrative expenses were approximately $8.7 million and $7.9 million for the three months ended September 30, 2009 and 2008, respectively, and were approximately $26.1 million and $20.7 million for the nine months ended September 30, 2009 and 2008, respectively. The increase in 2009 was driven primarily by increased marketing and selling expenses associated with ENTEREG.
As of September 30, 2009, the Company had approximately $94.4 million in cash, cash equivalents and short-term investments.
Conference Call Information
Adolor's management will discuss the Company's third quarter 2009 results in a conference call with investors beginning at 8:45 a.m. EDT today, October 29, 2009. To participate in the conference call, dial 866-314-5232 for domestic callers and 617-213-8052 for international callers, and refer to conference code number 38530562. Investors can listen to the call live by logging on to the Company's website at www.adolor.com and clicking on “Investor Insights,” then “Calendar of Events.” The conference call will be archived and available to investors for one week after the call.
surf1944
15 years ago
Adolor Acquires Rights to Clinical-Stage Product Candidate from Eli Lilly and Company
Press Release
Source: Adolor Corporation
On Monday September 21, 2009, 4:30 pm EDT
Companies:Adolor Corp.
EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (NasdaqGM:ADLR - News) today announced that it has acquired from Eli Lilly and Company (“Lilly”) the exclusive worldwide rights to OpRA III, a clinical-stage product candidate.
OpRA III is a potent opioid receptor antagonist, with potential use in multiple therapeutic indications. Adolor intends to initially develop OpRA III to treat opioid bowel dysfunction (OBD) and will initiate clinical trials of this compound for this indication in early 2010. This compound will be developed in parallel with ADL7445 as part of the Company’s OBD Program. Moving forward, OpRA III will be identified as ADL5945.
“OpRA III has a unique profile with the potential to address the gastrointestinal disorders associated with the use of opioid analgesics,” said Michael R. Dougherty, President and Chief Executive Officer of Adolor. “Adolor has a wealth of experience in this therapeutic area and the addition of OpRA III to our OBD portfolio provides us with another clinical-stage compound with which we can potentially address a large and underserved market.”
Lilly has completed both a Phase 1 single, escalating dose placebo-controlled safety study and a Phase 1 multiple, escalating dose placebo-controlled safety study in healthy volunteers for OpRA III.
Financial terms of the agreement include an upfront payment of $2 million to Lilly, royalties on net sales of any approved product and up to approximately $70 million in milestones contingent upon achievement of pre-defined, late-stage clinical and regulatory events and achievement of certain sales targets.
surf1944
15 years ago
Pharmacoeconomic Analysis of Reported Use of ENTEREG(R) (alvimopan) Published in American Journal of Health-System Pharmacy
Press Release
Source: Adolor Corporation
On Thursday August 20, 2009, 4:37 pm EDT
Companies:Adolor Corp.GlaxoSmithKline plc
Topics:Health Care Sector
EXTON, PA and PHILADELPHIA, PA--(Marketwire - 08/20/09) - Adolor Corporation (NASDAQ:ADLR - News) and GlaxoSmithKline (NYSE:GSK - News) today announced that an economic analysis of Phase 3 clinical trial data reported that the use of ENTEREG after bowel resection surgery decreased the amount of time patients spent in the hospital by one day, resulting in lower estimated hospital costs compared with placebo. The results, published in the American Journal of Health-System Pharmacy, were based on a post-hoc pharmacoeconomic analysis of pooled data consisting of 1,409 patients who participated in four randomized, double-blind, placebo-controlled, Phase 3 efficacy studies of ENTEREG conducted in North America.
ENTEREG is the first and only FDA-approved therapy indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis, or reconnection of the intestine.
"The results from this analysis are positive for both bowel resection patients and healthcare providers," said Anthony J. Senagore, M.D., Vice President, Research and Education, Spectrum Health, Grand Rapids, MI, and one of the study authors. "The analysis of these Phase 3 North American studies concluded that using ENTEREG contributed to earlier discharge after surgery and, importantly, reduced overall estimated hospital costs."
Analysis design and results
Patients evaluated in the four Phase 3 trials received standardized accelerated care treatment -- removal of nasogastric tube before first postoperative dose, early ambulation, and early feeding. Both placebo and ENTEREG were given orally once before surgery and then twice daily beginning the day after surgery until hospital discharge or for a maximum of 15 doses. Patients were eligible to participate if they were 18 years of age or older, were undergoing laparotomy for partial small or large bowel resection with primary anastomosis, and were scheduled for postoperative pain management with IV opioid-based analgesia.
This post-hoc pooled economic analysis showed that patients in the group receiving ENTEREG experienced a mean hospital length of stay (defined as the day of surgery to day that the discharge order was written) of one day less than the placebo control group. In the four North American Phase 3 trials, mean time-to-discharge-order written (which represented LOS) for patients receiving ENTEREG was between 13-21 hours shorter compared to those in the control group. In those trials, the time in hours from the end of surgery to when the discharge order was written represented the LOS. Mean estimated hospital costs were less for patients taking ENTEREG compared to the control group.
"We are very pleased to see these results published, as they reinforce our belief in the value proposition of ENTEREG," said Eliseo Salinas, MD, MSC, Senior Vice President, Research and Development and Chief Medical Officer at Adolor. "This encouraging pharmacoeconomic analysis was conducted in a setting where steps were being taken to help bowel resection patients recover gastrointestinal function faster, and those using ENTEREG clearly saw benefit compared to placebo. We look forward to seeing the results of independently-conducted analyses on the potential health economic benefits of ENTEREG in real world clinical settings."
Such an independent analysis was presented recently at the 2009 Annual Meeting of the Northwest Society of Colon and Rectal Surgeons in Sun River, Oregon, by Timothy Beard, MD, FACS.* Dr. Beard, Director of Research, Bend Memorial Clinic in Bend, Oregon, discussed his findings in his presentation, Incorporation of Alvimopan as Part of Perioperative Management of Patients Undergoing Colectomy: A Single Surgeon's Experience.
surf1944
15 years ago
Adolor will cut jobs, restructure to save money
Adolor plans to cut 45 jobs, restructure business to focus on late-stage drugs
Marley Seaman, AP Health Writer
Adolor Corp., GlaxoSmithKline plc
EXTON, Pa. (AP) -- The drugmaker Adolor Corp. said Thursday it will eliminate about 45 jobs, or 28 percent of its work force, to cut costs and will focus on developing it most promising drugs.
Adolor said the moves will reduce annual spending by about $12 million. It said it will focus on its constipation drug Entereg and products which are in the later stages of clinical development. The company said it is putting fewer resources into early stage drug candidates.
Entereg, its only approved drug, is intended to treat constipation following abdominal surgery. It was launched last year, and sales totaled $1.2 million. Adolor markets the drug through a partnership with GlaxoSmithKline PLC of London.
The company expects charges of up to $6 million in the second quarter from restructuring, severance and write-offs. Adolor currently has about 160 employees, and has hired about 30 people this year.
surf1944
15 years ago
Form 8-K for ADOLOR CORP
9-Jun-2009
Costs Associated with Exit or Disposal Activities, Other Events, Financial Statements
Item 2.05 Costs Associated with Exit or Disposal Activities.
On June 3, 2009, management of Adolor Corporation (the "Registrant"), upon the approval of the Board of Directors of the Registrant, announced a restructuring and reduction in force (the "Restructuring") of approximately 45 employees, or 28% of its workforce, as well as other cost saving initiatives intended to lower the Registrant's annualized net operating cash burn. The Restructuring has been completed as of June 3, 2009.
The Registrant has determined that the total costs related to the Restructuring are estimated to be up to approximately $6.0 million, of which approximately $2.5 million will result in future cash outlays primarily related to severance costs and related expenses. The remaining costs are expected to be non-cash charges associated with the write-off of certain leasehold improvements and fixed assets, among other things. The Registrant expects to record these charges in the second quarter of 2009 in accordance with Statement of Financial Accounting Standards No. 146, Accounting for Costs Associated with Exit or Disposal Activities, and Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets.
Item 8.01 Other Events.
On June 3, 2009, the Registrant issued a press release announcing the Restructuring. A copy of the press release is furnished hereto as Exhibit 99.1 and incorporated herein by reference.
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