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Altus director Root resigns amid shakeup
The leadership transition at Altus Pharmaceuticals Inc. saw another departure last week, as venture capitalist Jonathan Root announced his resignation from the drug maker’s board of directors.
Root’s resignation was effective April. The company did not cite a reason for his departure.
Root’s departure comes several weeks after the Cambridge, Mass.-based company announced 107 job cuts and a flurry of senior-level executive departures. The reorganization is primarily linked to Altus’ decision to spike its Trizytek drug efforts due to cash problems and focus instead on its growth-hormone research.
Root, a medical doctor and managing partner with U.S. Venture Partners in Menlo Park, Calif., had been an Altus board member since 2001.
A graduate of Dartmouth College and the University of Florida College of Medicine, Root spent 10 years in clinical practice and worked as an assistant professor of neurology and director of neurology-neurosurgery special care at The New York Hospital-Cornell Medical Center in New York City.
ALTU---Strange talks on other boards of us breaking $1 next week. Anyone here anything?
In today with 50DMA and upper BB break :)
oh... nice... made 20% in 1 day, great
nice volume yesterday and today... I should better pick some up at this low price levels...
1.40 CASH P/SHARE...HUGE
ALTU is the worst performing biotech stock "ever", it should finally have a run here with the group. It has nearly $1.50/cash per share today.
Altus Pharmaceuticals Reports Fourth Quarter and Year End 2008 Financial Results
Wednesday March 11, 8:00 am ET
Company Initiates Phase 2 ALTU-238 Clinical Trial in Pediatric Subjects
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) today reported financial results for the quarter and year ended December 31, 2008.
Fourth Quarter Results
For the fourth quarter of 2008, the Company reported a net loss attributable to common stockholders of $24.8 million, or $0.80 per basic share, compared to net income attributable to common stockholders of $5.4 million, or $0.18 per basic share, in the fourth quarter of 2007. Altus reported negative revenue of $0.5 million in the fourth quarter of 2008 compared to revenue of $26.8 million in the fourth quarter of 2007. The fourth quarter 2007 revenue included $25.1 million associated with our former ALTU-238 collaboration agreement with Genentech, which was terminated effective December 31, 2007.
Research and development expenses totaled $22.3 million in the fourth quarter of 2008 compared to $21.1 million in the fourth quarter of 2007. The increase in research and development expenses is primarily due to an increase in costs relating to the TrizytekTM program. General, sales and administrative expenses were $3.0 million in the fourth quarter of 2008 compared to $5.0 million in the fourth quarter of 2007.
Full Year Results
The Company reported a net loss attributable to common stockholders of $96.8 million, or $3.13 per share, for the full year ended December 31, 2008, compared to a net loss attributable to common stockholders of $63.5 million, or $2.23 per share, for the full year ended December 31, 2007. Total revenue was $2.2 million for 2008 compared to $28.5 million in 2007. The 2007 revenue reflects the termination of our ALTU-238 collaboration agreement with Genentech.
Research and development expenses totaled $83.6 million for 2008 compared to $70.6 million in 2007. Research and development expense for 2008 increased primarily due to increases in manufacturing and clinical costs relating to the Trizytek program. General, sales and administrative expenses were $17.8 million in 2008 compared to $18.2 million in 2007.
The Company’s cash, cash equivalents and marketable securities balance at December 31, 2008 was $48.6 million. Altus believes the current cash, cash equivalents and marketable securities position will last into the fourth quarter of 2009. During the next three to six months, the Company will pursue raising additional capital.
On March 11, 2009, the Company filed with the SEC its Annual Report on Form 10-K, which included an audit opinion with a "going concern" explanatory paragraph. The going-concern explanatory paragraph from Altus' independent registered public accounting firm expressed substantial doubt, based upon current financial resources, as to whether Altus can continue to meet its obligations beyond 2009 without access to additional working capital.
2009 Financial Guidance
Based on our current operating plans, including the expected timing and cost of the ALTU-238 Phase 2 pediatric trial, Altus expects its net cash used in operating activities to be between $50 million and $60 million in 2009.
On January 26, 2009, Altus announced a strategic realignment of product development priorities to focus on the advancement of the Company’s long-acting, recombinant human growth hormone candidate, ALTU-238, as a once-per-week treatment for adult and pediatric patients with growth hormone deficiency. To conserve capital resources, Altus is discontinuing its Trizytek program activities. This discontinuation resulted in the transfer of certain Trizytek intellectual property rights and regulatory filings to Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, in accordance with Altus’ 2001 strategic alliance agreement with CFFT. On February 20, 2009, Altus and CFFT entered into a letter agreement and a license agreement terminating the 2001 strategic alliance agreement. Under the terms of the license agreement, Altus assigned the Trizytek trademark and certain patent rights to CFFT and granted CFFT an exclusive, worldwide, royalty-bearing license to use certain other intellectual property owned or controlled by Altus to develop, manufacture and commercialize any product using, in any combination, the three active pharmaceutical ingredients which comprise Trizytek. In these agreements, Altus also agreed to assist CFFT with a transition of on-going development and regulatory activities and clinical trials relating to Trizytek through March 27, 2009, after which CFFT will be responsible for future development activities. In exchange, CFFT agreed to release Altus from all obligations and liabilities resulting from the strategic alliance agreement, and to pay Altus a percentage of any proceeds CFFT realizes associated with respect to any rights licensed or assigned to CFFT under the license agreement.
As a result of this strategic realignment, Altus is implementing a workforce reduction of approximately 75%, primarily in functions related to the Trizytek program as well as certain general and administrative positions. Following the staff reduction, which is expected to be completed in the first quarter of 2009, Altus will have approximately 35 employees at its headquarters in Waltham, MA.
“We believe that ALTU-238 represents a promising opportunity to make a major impact on the multi-billion dollar market for growth hormone replacement products. As a mid-stage program with a relatively straight-forward path toward regulatory approval, narrowing our focus on ALTU-238 will enable Altus to preserve capital, minimize clinical and regulatory risk, and build value for our shareholders,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals.
ALTU-238 Program Update
ALTU-238 is being developed as a subcutaneously administered, long acting formulation of recombinant human growth hormone (hGH) that employs Altus' proprietary protein crystallization and formulation technology, for patients with growth hormone deficiencies. Unlike current hGH therapies that are administered daily, ALTU-238 is being developed and tested to provide a once-per-week dosage formulation that can be administered through a fine gauge needle. Altus has successfully completed a Phase 2 trial with ALTU-238 in adult subjects and recently completed a Phase 1c trial confirming the safety, pharmacokinetic and pharmacodynamic (PK/PD) profile of a single dose of ALTU-238 compared to seven daily injections of Nutropin AQ.
Dr. Gemayel concluded, “I am pleased to announce that we have initiated the Phase 2 trial for ALTU-238 in growth hormone deficient pediatric subjects. We will begin to screen patients shortly and we anticipate that the first subject will be dosed within the next several weeks. We expect to report 6 month primary efficacy data in the second quarter of 2010.”
Conference Call Access Information
The Company will host a conference call to discuss the results at 11:00 a.m. ET on March 11. The call may be joined via telephone by dialing (877) 718-5104 or (719) 325-4749 (for international participants) at least 5 minutes prior to the start of the call. The conference confirmation code is: 6842696. For 72 hours following the call, an audio replay can be accessed by dialing (719) 457-0820 or (888) 203-1112 and using the conference confirmation code 6842696. A live audio webcast of the call will also be available on the "Investor Relations" section of the Company's website, www.altus.com. An archived audio webcast will be available on the Altus website approximately two hours after the event and will be archived for 30 days.
Altus Pharmaceuticals to Host Fourth Quarter Investor Conference Call on March 11, 2009
Monday March 9, 8:30 am ET
WALTHAM, Mass.--(BUSINESS WIRE)--On Wednesday, March 11, 2009 before the market opens, Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) expects to release to the news wire its results for the quarter and year ended December 31, 2008.
The Company will host a conference call to discuss the results at 11:00 a.m. ET on March 11. The call may be joined via telephone by dialing 877-718-5104 or 719-325-4749 (for international participants) at least 5 minutes prior to the start of the call. The conference confirmation code is: 6842696. For 72 hours following the call, an audio replay can be accessed by dialing 719-457-0820 or 888-203-1112 and using the conference confirmation code 6842696.
A live audio webcast of the call will also be available on the "Investor Relations" section of the Company's website, www.altus.com. An archived audio webcast will be available on the Altus website approximately two hours after the event and will be archived for 30 days.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals, headquartered in Cambridge, MA, is a biopharmaceutical company focused on the development of oral and injectable protein therapeutics. The Company's
Buying back into ALTU, this has the worst chart of any small cap biotech stock. If it wasn't for all the cash, it would already be at zero. Worth the risk at .22/share(what a POS CEO at this company)
Selling has slowed way down today.Even some nice buys coming through.
Normal daily volume is 74k With todays selling volume was 4.5 million.Hope the big seel off is over.
Made the same play on GORX when they announced the same type of news.That one paid off,hope this one does too.
Altus Pharmaceuticals Realigns Product Development Priorities and Focuses on Long-Acting Growth Hormone Candidate ALTU-238
Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced a strategic realignment of product development priorities to focus on the advancement of the Company’s breakthrough, long-acting, recombinant human growth hormone candidate, ALTU-238, as a once-per-week treatment for adult and pediatric patients with growth hormone deficiency. To conserve capital resources, Altus will discontinue its Trizytek program activities. This discontinuation will result in the transfer of certain Trizytek intellectual property rights and regulatory filings to Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, in accordance with Altus’ 2001 agreement with CFFT. In addition, Altus is evaluating the feasibility of moving forward its early-stage clinical and pre-clinical programs and will make future decisions on these programs depending upon the availability of resources.
As a result of this realignment, Altus will implement a workforce reduction of approximately 75%, primarily in functions related to the Trizytek program as well as certain general and administrative positions. In connection with the restructuring, Chief Medical Officer, Burkhard Blank, M.D.; Chief Financial Officer, Jonathan Lieber; and, Vice President, Business Development, John M. Sorvillo, Ph.D., will be leaving the Company. Employees affected by the reduction will be offered severance benefits. Following the staff reductions, Altus will have approximately 35 employees at its headquarters in Waltham, MA
ALTU getting a lil attention today,,expect a nice move north by the first week of February..
Looking for some great news here on ALTU.from the last pr's..Moving in on FEB..now..love these bio movers when they go..
I actually saw the negatives.
1-This was supposed to be completed months ago.
2-They say starting the Phase 2 this quarter. Which means the burn is still high.
3-No mention of partnering it.
Altus Pharmaceuticals Successfully Completes Phase 1 Study of Long Acting Formulation of Recombinant Human Growth Hormone
Thursday January 8, 10:14 am ET
WALTHAM, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) announced today that it has finished its data analysis from a recently completed ALTU-238 Phase 1 study. ALTU-238 is being developed as a subcutaneously administered, long acting formulation of recombinant human growth hormone that employs Altus' proprietary protein crystallization and formulation technology, for patients with growth hormone deficiencies.
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The ALTU-238 Phase 1c trial evaluated the safety, pharmacokinetic and pharmacodynamic (PK/PD) profile of a single dose of ALTU-238 compared to seven daily injections of Nutropin AQ. ALTU-238 was well tolerated in the one-week study that included 36 healthy, adult subjects. In addition, the Phase 1c PK/PD data is consistent with prior ALTU-238 clinical studies that supported an ALTU-238 once-per-week dosing regimen. The Phase 1c trial results also confirm that the ALTU-238 material, produced at the current increased manufacturing scale, performs similar to the material used in previous ALTU-238 studies.
“I am pleased to report the successful completion of our fourth clinical trial of ALTU-238. We believe the information gathered from this trial will be helpful in designing future ALTU-238 clinical studies,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “The results from this study support moving forward with an ALTU-238 Phase 2 trial in pediatric subjects, which we expect to start during the first quarter of 2009. It is important to note, that we have already successfully completed an ALTU-238 Phase 2 trial in adults.”
About ALTU-238
ALTU-238 is a long-acting subcutaneous formulation of rhGH in a ready-to-use liquid suspension formulation that employs Altus' proprietary protein crystallization and formulation technology. Altus' technology preserves the natural structure of the human growth hormone molecule without the need for polymers or encapsulation and enables administration through a fine gauge needle. Daily rhGH products are currently approved for the treatment of various growth disorders in children and adolescents and for growth hormone replacement in adults. Global sales for all rhGH products were approximately $2.8 billion in 2007.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals, headquartered in Waltham, MA, is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The Company is listed on the Nasdaq Global Market under the symbol ALTU.
Safe Harbor Statement
Certain statements in this news release concerning Altus' business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to future development plans and the timing of any additional clinical studies for ALTU-238. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Altus might make or by known or unknown risks and uncertainties, including, but not limited to uncertainties as to the future success of ongoing and planned clinical trials and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus' reports to the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended September 30, 2008. However, Altus undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
Altus and the Altus logo are the registered trademarks of Altus Pharmaceuticals.
Contact:
Altus Pharmaceuticals Inc.
John Jordan, 781-373-6452
Senior Director, Corporate Communications
--------------------------------------------------------------------------------
Source: Altus Pharmaceuticals
We gotta be getting close. most have gotten a jumpstart of the lows. ALTU turn is comming. IMO
Thanks, and GLTU
I took a small position here today. good luck all
At current prices ALTU should be at least a double in the coming weeks on no news, with news ALTU can run 300-500% in a couple of days. Unless these guys run off with the money, the risk seems very low at .50/share.
http://www.mffais.com/altu.html
I have been buying ALTU over the past week, it seems to have found an area you want to be buying. ALTU has around $2/cash per share and nearly a million shares still short, worth the risk.
Altus Pharmaceuticals Reaffirms Plan to Submit New Drug Application for Trizytek Approval
Monday November 17, 9:29 am ET
WALTHAM, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) announced today that it is reaffirming its plan to submit a new drug application (NDA) for Trizytek TM (liprotamase) in the first-half of 2009. Trizytek is a non-porcine derived enzyme replacement therapy for patients with pancreatic insufficiency.
Based on a positive FDA response to Altus’ pre-NDA meeting submission material, Altus and the FDA have agreed that the Trizytek clinical development program supports submission of a license application for Trizytek. In the pre-NDA meeting package, Altus provided the FDA comprehensive data from its completed Phase 3 efficacy and Phase 2 studies as well as interim safety and health-outcomes data from the ongoing Phase 3 studies to evaluate the long-term safety of Trizytek over one year of open-label treatment in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. As a result, the November pre-NDA meeting for Trizytek is no longer necessary and Altus’ previously stated timelines for the Trizytek NDA submission remain unchanged.
“With this communication from the FDA, we are reaffirming our goal of filing a new drug application for Trizytek in the first half of 2009. We are focusing our resources on moving all aspects of the Trizytek program forward, including the ongoing long-term safety study, which is on track to be completed in the first half of 2009,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “The outcome from our discussions with the FDA only strengthens our belief in the clinical benefit that Trizytek will bring to patients who require pancreatic enzyme replacement therapy. In addition, completing a corporate collaboration around Trizytek is key to our plan going forward and we believe this information will be an important part of the evaluation of the program by any potential partner.”
Altus’ Phase 3 Trizytek efficacy trial in patients with cystic fibrosis (CF) successfully met its primary endpoint of improvement in fat absorption with statistical significance. In August 2008, the Company released top-line results from its 163 patient, double-blind, placebo-controlled trial of Trizytek, which is a stable and pure combination of three active enzymes in a fixed-ratio that is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. (Click here to view the August 11, 2008 press release.) Trizytek was well-tolerated and had a favorable safety profile in the trial. There were no serious adverse events attributed to the Trizytek treatment. Altus’ Trizytek Phase 3 clinical program is the largest ever conducted to evaluate the efficacy and safety of pancreatic enzyme replacement therapy in cystic fibrosis patients.
still on my radar....waiting for surf's takes...
is there any hope in this stock? i am so down so much not sure what to do anyone talk to investor relations
The only news around October would be the presentation of Tryztek data at the CF conference and to HOPE that their was something extremely meaningful in why 6 x-US centers had no meaningful improvement.
do you think it can go lower ? hopefully there is some news around october
Just a bad market to be long in, ALTU will come back. ALTU has over $2.50/share in cash and a million shares shorted. The stock had tried to bounce a couple of times in the past week, but the overall market pulled it back down. The way I would view ALTU at current prices is that it's too late to sell and I would buy on weakness around current PPS.
surf
does anyone see any rebound in this stock it keeps going down
I was also buying ALTU this week, but about 95% of biotech stock's had a hard week and a large number of them should be bouncing this coming week.
surf
Check out the chart today on ALTU touched the sar and the RSI is improving with a strong pinch getting ready to push apart.
First white candle in ALTU since the big break down on the chart, maybe time to move back into ALTU on Monday for a move back over $2.
Altus Pharmaceuticals Announces Achievement of Primary Endpoint in Phase 3 Efficacy Trial of Trizytek for Cystic Fibrosis Patients with Pancreatic Insufficiency
Monday August 11, 4:05 pm ET
Investor Conference Call Scheduled for 4:30 PM ET on August 11, 2008
Detailed Results to be Presented at North American Cystic Fibrosis Conference in October 2008
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) announced today that its Phase 3 efficacy trial of TrizytekTM (porcine-free enzymes) in patients with cystic fibrosis (CF) successfully met its primary endpoint of improvement in fat absorption. The Company released top-line results from its 163 patient, double-blind, placebo-controlled trial of Trizytek, an enzyme replacement therapy for patients with pancreatic insufficiency. Trizytek is a stable and pure combination of three active enzymes in a fixed-ratio that is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. Altus’ Trizytek Phase 3 clinical program is the largest ever conducted to evaluate the efficacy and safety of pancreatic enzyme replacement therapy in cystic fibrosis patients. Detailed trial results will be presented at the North American Cystic Fibrosis Conference in October 2008.
The trial met its primary efficacy endpoint with statistical significance. In cystic fibrosis patients with exocrine pancreatic insufficiency, Trizytek demonstrated a statistically significant improvement of fat absorption over placebo through the measurement of the coefficient of fat absorption (CFA). The primary efficacy analysis was an intent to treat (ITT) analysis in the sub-group of patients with severe malabsorption (baseline CFA below 40). In addition, data were analyzed for the overall group, which included all patients with baseline CFA below 80.
Patients treated with Trizytek had a statistically significant improvement in CFA compared to placebo. In the Trizytek CFA<40 group, there was an improvement in the mean CFA of 20.2 (80% change from baseline). In the placebo CFA<40 group, there was an increase in mean CFA of 5.1 (24% change from baseline). The mean difference between groups for the change in CFA was 15.1 (p=0.001).
Altus Achieves Primary Endpoint in Phase 3 Clinical Trial/2
In the overall group that received Trizytek, there was an improvement in the mean CFA of 11.3 (36% change from baseline). Patients on placebo, in the overall group, remained relatively unchanged with a mean CFA of 0.2 (4% change from baseline). The mean difference between groups for the change in CFA was 10.6 (p=<0.001).
Primary Endpoint – CFA Results
Trizytek
Placebo
Mean
difference between groups
p-value
Baseline CFA Group
Baseline
Improvement from baseline
Baseline
Improvement from baseline
<40 30.0 20.2 points or
79.6 percent
28.1 5.1 points or
24.4 percent
15.1 0.001
Overall 46.9 11.3 points or
35.8 percent
49.5 0.2 points or
4.3 percent
10.6 < 0.001
“We are pleased to have met our primary endpoint for improvement in CFA with Trizytek and this achievement is a major milestone for our company. The outcomes were driven by the strong positive data from the 26 centers in the U.S., where we will be initially seeking approval upon completion of our long-term safety studies,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “Our overall top-line results were affected by a marked difference between patients within the U.S. and outside of the U.S. Although we have not yet analyzed individual patient data, on aggregate, patients from 3 out of 6 non-U.S. countries did not appear to show a difference between Trizytek and placebo groups.”
Dr. Gemayel continued, “We are currently investigating possible factors that may have affected the results outside the U.S. and upon completion of the investigation, we will report the findings. Moving forward, we have requested a pre-NDA meeting with FDA to discuss these results and we remain committed to driving Trizytek toward commercialization.”
Of the 138 patients in the ITT analysis, 68 patients were at CF centers within the United States and 70 patients were at sites outside of the United States. A strong country effect was seen that impacted the overall outcome. For U.S. patients in the Trizytek CFA<40 group, there was an improvement in the mean CFA of 28.4 (115% change from baseline). In the placebo CFA<40 group, there was an increase in mean CFA of 3.4 (23% change from baseline). The mean difference between groups for the change in CFA was 25.1 (p =0.001). In contrast, the mean difference in the CFA<40 group in countries outside of the U.S. was 5.0.
Altus Achieves Primary Endpoint in Phase 3 Clinical Trial/3
For U.S. patients in the overall group who received Trizytek, there was an improvement in the mean CFA of 15.7 (48% change from baseline). For U.S. patients on placebo in the overall group, there was a decrease in the mean CFA of -2.1 (1% change from baseline). The mean difference between groups for the change in CFA was 17.5 (p=<0.001). In contrast, the mean difference in the overall group in countries outside of the U.S. was 4.3.
Primary Endpoint – CFA Results – US Sites
Trizytek
Placebo
Mean difference between groups
p-value
Baseline CFA Group
Baseline
Improvement from baseline
Baseline
Improvement from baseline
<40 27.0 28.4 points or
115.4 percent
23.6 3.4 points or
22.6 percent
25.1 0.001
Overall 46.3 15.7 points or
48.3 percent
43.7 -2.1 points or
0.7 percent
17.5 < 0.001
The trial also evaluated secondary efficacy endpoints. Patients treated with Trizytek had a statistically significant improvement in coefficient of nitrogen absorption (CNA, which measures protein absorption) compared to placebo (p =<0.001). The Phase 3 CNA results paralleled the Phase 3 CFA results. There was not a statistically significant improvement in carbohydrate absorption compared to placebo on the starch challenge test. Importantly, there was a significant decrease in stool weight in Trizytek treated patients compared to placebo (p=0.001).
Trizytek was well-tolerated and had a favorable safety profile in the trial. There were no serious adverse events attributed to the Trizytek treatment.
Drucy Borowitz, M.D., Professor of Clinical Pediatrics, State University of New York, Director, Cystic Fibrosis Center, Women and Children’s Hospital of Buffalo, and principal investigator of the DIGEST trials commented, “The data are very compelling and the results from the CF centers in the U.S. confirm the Phase 2 study, which was conducted solely in the U.S. During my 20 years of treating CF patients, I have seen significant advancements in patient care and Trizytek is a good example of an innovative drug that has the potential to enhance nutritional outcomes, which are strongly correlated with pulmonary status.”
Dr. Borowitz added, “Trizytek has the potential of being formulated for young children and other patients who cannot swallow capsules.”
Altus Achieves Primary Endpoint in Phase 3 Clinical Trial/4
“We are very encouraged by the Trizytek efficacy data because this treatment will offer important new benefits to CF patients who need enzyme replacement therapy,” said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. “Currently, the dosing regimens for enzymes can be a challenge for patients. The one capsule per-meal dosing for Trizytek will help drive better compliance and therefore enhance long-term patient health outcomes. Since 2000, the Foundation and Altus have worked together toward a goal of bringing this new treatment to the market. The data reported today reinforces our business model of supporting highly innovative therapies for CF patients.”
Dr. Gemayel concluded, “The Trizytek clinical program demonstrates our commitment to advancing novel enzyme replacement therapy options for both cystic fibrosis patients and others who suffer from pancreatic insufficiency. Due to the uncertainties with therapeutics that contain animal-derived ingredients, we believe there is a need for new products that are derived from recombinant technology such as Trizytek. I would like to thank all of the investigators, study coordinators, dieticians, patients and patient families who participated in this trial. In addition, I would like to acknowledge the Cystic Fibrosis Foundation for its continuing support. Reaching this milestone was a great group effort by all parties involved.”
Conference Call
The Company will host a conference call to discuss the results at 4:30 p.m. ET on August 11. The call may be joined via telephone by dialing (877) 440-5803 or (719) 325-4879 (for international participants) at least 5 minutes prior to the start of the call. The conference confirmation code is: 8326549. For 72 hours following the call, an audio replay can be accessed by dialing (719) 457-0820 or (888) 203-1112 and using the conference confirmation code 8326549.
A live audio webcast of the call will also be available on the "Investor Relations" section of the Company's website, www.altus.com. An archived audio webcast will be available on the Altus website approximately two hours after the event and will be archived for 30 days.
Cystic Fibrosis
Cystic fibrosis is a life-threatening genetic disease that affects approximately 30,000 children and adults in the United States. It causes serious lung infections and digestive complications, including poor absorption and digestion of food. Most people with CF need to take pancreatic enzyme supplements with meals and maintain a high-calorie diet to help their bodies absorb the proper level of nutrients.
Altus Achieves Primary Endpoint in Phase 3 Clinical Trial/5
The DIGEST Trials
The DIGEST trials (Determining the efficacy and safety of an Innovative GastrointESTinal enzyme complex) are Altus’ Phase 3 Trizytek clinical program, which consists of an efficacy trial and two safety trials. Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the drug discovery and development affiliate of the Cystic Fibrosis Foundation, have supported the CF studies. The DIGEST efficacy trial, which tested a one capsule per-meal dosing regimen, was designed to study fat absorption in cystic fibrosis patients with exocrine pancreatic insufficiency through the measurement of the coefficient of fat absorption (CFA). In addition to the efficacy trial, the DIGEST trials include two studies to evaluate the long-term safety of Trizytek over one year of open-label treatment in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency.
About Trizytek [porcine-free enzymes]
Trizytek has the potential to be the first porcine-free enzyme replacement therapy for patients with pancreatic insufficiency. Pancreatic insufficiency is a condition that affects most cystic fibrosis patients, as well as many patients with chronic pancreatitis. In these diseases, a deficiency of pancreatic enzymes causes poor absorption of essential nutrients, which often leads to malnutrition, impaired growth and reduced survival. Trizytek is intended to replace missing digestive enzymes with one capsule per-meal to promote and maintain proper digestion and growth in affected patients. Altus is developing Trizytek to enhance health outcomes by offering significant patient advantages such as improved and more consistent dosing that we expect will drive better long-term compliance. Utilizing recombinant technology, Trizytek is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This consistent and pure enzyme combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals.
Altus Achieves Primary Endpoint in Phase 3 Clinical Trial/6
About The Current Pancreatic Enzyme Replacement Market
The enzyme products in use today for pancreatic insufficiency as well as those in development are all porcine-derived and require patients to take multiple capsules with every meal or snack. These pancreatic enzyme replacement products have been marketed since before the enactment of the Food, Drug and Cosmetic Act in 1938 and are not marketed under new drug applications, or NDAs, approved by the United States Food and Drug Administration, or FDA. In April 2004, the FDA issued a notice that manufacturers of existing pancreatic enzyme replacement products will be subject to regulatory action if they do not obtain approved NDAs for those products by April 28, 2008. In October 2007, the FDA issued an update to the 2004 notice and announced that it has extended the deadline for unapproved pancreatic enzyme drug products from April 28, 2008 to April 28, 2010, but only if the manufacturers have investigational new drug applications on active status on or before April 28, 2008 and have submitted NDAs on or before April 28, 2009. According to IMS Health, global prescription sales of existing pancreatic enzyme replacement products were approximately $858 million in 2007.
About the Cystic Fibrosis Foundation
The mission of the Cystic Fibrosis Foundation is to assure the development of the means to cure and control CF, and to improve the quality of life for those with the disease. CFFT is the nonprofit drug development affiliate of the CF Foundation that operates drug discovery, development and evaluation efforts. Total support for CFFT is provided by the CF Foundation. The CF Foundation has initiated a special gifts campaign, Milestones to a Cure, with a target goal of $175 million to support programs like the one with Altus. For more information, call (800) FIGHT CF or visit www.cff.org.
http://biz.yahoo.com/bw/080811/20080811006243.html?.v=1
Altus Pharmaceuticals Reports Second Quarter 2008 Results
Tuesday August 5, 8:00 am ET
- - Company on Track to Report Phase 3 Trizytek Top-line Results in Third Quarter - -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News), a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders, today reported financial results for the quarter ended June 30, 2008.
For the second quarter of 2008, the Company reported a net loss attributable to common stockholders of $25.3 million, or $0.82 per share, compared to a net loss attributable to common stockholders of $30.5 million, or $1.06 per share, in the second quarter of 2007. The Company did not recognize any revenue in the second quarter of 2008 and recognized revenues of $1.5 million in the second quarter of 2007.
Research and development expenses totaled $21.0 million in the second quarter of 2008 compared to $17.9 million in the second quarter of 2007. Second quarter 2008 R&D spending reflects increased clinical and manufacturing costs associated with TrizytekTM [porcine-free enzymes] and manufacturing related costs for ALTU-238. General, sales and administrative expenses were $4.7 million in the second quarter of 2008 compared to $4.1 million in the second quarter of 2007. This increase is primarily due to increases in personnel and stock-based compensation expenses. The total expenses for the second quarter were $25.7 million compared to $33.6 million in the second quarter of 2007. Included in the second quarter 2007 total expenses was a charge of $11.5 million associated with the termination of the Dr. Falk Pharma agreement and reacquisition of European marketing rights to Trizytek.
“I am very pleased with the Company’s recent accomplishments, particularly completing the last patient visit in the Trizytek Phase 3 efficacy trial and the signing of a long-term growth hormone supply agreement for our ALTU-238 program,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “Coming on board in June provided an excellent opportunity for me to learn and to work with the Altus team to build upon the Company’s earlier successes. We are moving in the right direction and remain focused on delivering on our stated goals. The Altus technology platform has generated three programs in clinical development with two additional programs in preclinical development, and I believe its many valuable applications will fuel a bright future for Altus.”
2008 Financial Guidance
Cash, cash equivalents and short-term marketable securities balances at June 30, 2008 totaled $92.8 million. The Company believes its current cash position will fund operations into the first half of 2009.
Recent Altus Accomplishments:
Appointed Dr. Georges Gemayel President and Chief Executive Officer
Announced last patient visit for the Phase 3 Trizytek efficacy trial
Reported Phase 1 safety data for ALTU-237
Secured long-term growth hormone supply for ALTU-238 program
Commenting on the Trizytek efficacy trial, Gemayel stated, “We believe Trizytek will be the first pancreatic enzyme replacement with demonstrated robust safety and efficacy data. Our next stated corporate milestone is reporting top-line Trizytek efficacy data in the third quarter of 2008. In June we announced that 134 patients completed the efficacy trial. Currently, we are in the final stages of data compilation for the trial.”
In the second quarter of 2007, the Company announced the start of its Phase 3 DIGEST trials (Determining the efficacy and safety of an Innovative GastrointESTinal enzyme complex). The DIGEST clinical trials are evaluating the efficacy and safety of Trizytek, an investigational oral enzyme replacement therapy for cystic fibrosis patients with pancreatic insufficiency. Altus’ consistent and pure enzyme combination, Trizytek, is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. The DIGEST efficacy trial, which tested a one capsule per meal dosing regimen, was designed to study the fat absorption in cystic fibrosis patients with exocrine pancreatic insufficiency through the measurement of the coefficient of fat absorption (CFA). In parallel, Altus is conducting long-term safety studies that will evaluate Trizytek in cystic fibrosis and chronic pancreatitis patients with pancreatic insufficiency over one year of open-label treatment.
Commenting on the ALTU-237 program, Gemayel stated, “First and foremost, the ALTU-237 Phase 1 results demonstrated a favorable safety profile, which was the primary objective of the study. We believe that ALTU-237 has the potential to address the unmet needs of hyperoxaluria patients. We and our external advisors also agree that the proof of concept for ALTU-237 can only be evaluated in hyperoxaluria patients. We are considering our options for moving ALTU-237 into a proof of concept Phase 2 trial, which would be targeted to start in 2009. Going forward, we will be coordinating our planning for this program with the Company’s strategic planning process, which we expect to communicate later this year.”
Conference Call Access Information
The Company will host a conference call to discuss the second quarter results at 11:00 a.m. ET on August 5. The call may be joined via telephone by dialing (877) 548-7903 or (719) 325-4844 (for international participants) at least 5 minutes prior to the start of the call. The conference confirmation code is: 4217438. For 72 hours following the call, an audio replay can be accessed by dialing (719) 457-0820 or (888) 203-1112 and using the conference confirmation code 4217438.
Altus Pharmaceuticals Secures Long-Term Growth Hormone Supply For ALTU-238 Clinical Development and Commercialization
Wednesday July 9, 4:07 pm ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News), a biopharmaceutical company focused on oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders, announced today that it signed a long-term agreement to purchase recombinant human growth hormone (rhGH) for ALTU-238 for development and commercialization. Altus is developing ALTU-238 as a subcutaneously administered, long-acting formulation of rhGH that employs the Company’s proprietary protein crystallization and formulation technology.
The agreement was signed with Sandoz GmbH, a Novartis company. Sandoz supplied rhGH for Altus’ completed Phase 1 clinical trial in healthy adults and the Phase 2 clinical trial in adults with growth hormone deficiency.
“This long-term supply agreement is an important achievement that provides increased strategic options for the ALTU-238 program,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “We are targeting early 2009 to start an ALTU-238 Phase 2 pediatric trial. With this goal in mind, we expect to initiate a Phase 1c study in the third quarter of 2008. We believe that achieving these program milestones can establish ALTU-238 as a significant future entrant into the $2.8 billion growth hormone market by providing a long-acting alternative that has a high degree of patient acceptability.”
About ALTU-238 Phase 1c and Phase 2 Pediatric Trials
The ALTU-238 Phase 1c trial is planned to be initiated by the end of the third quarter of 2008 and is expected to include 36 subjects. The safety and pharmacokinetic profile of ALTU-238 will be evaluated over 1 week. The trial is designed to confirm that the ALTU-238 material produced at Althea Technologies at approximately 75 percent of commercial scale performs similarly to the material used in the previous Phase 1 and Phase 2 trials. This will be followed by the Phase 2 pediatric trial, which will assess the change in 6-month annualized height velocity in pediatric growth hormone-deficient children, and will be used to finalize the Phase 3 study design.
About ALTU-238
ALTU-238 is a long-acting subcutaneous formulation of rhGH in a ready-to-use liquid suspension formulation that employs Altus' proprietary protein crystallization and formulation technology. Altus' technology preserves the structure of the human growth hormone molecule without the need for polymers or encapsulation and enables administration through a fine gauge needle. Daily rhGH products are currently approved for the treatment of various growth disorders in children and adolescents and for growth hormone replacement in adults. Global sales for all rhGH products were approximately $2.8 billion in 2007.
surf's up......crikey
You may see weakness in ALTU in the coming week as it is dropped from the Russell 3000, I am using it to buy back into ALTU.
surf
http://www.russell.com/indexes/membership/Reconstitution/Recon_3000_Deletions.asp
Eurand got an approvable.
I posted this on the Yahoo board
http://biz.yahoo.com/pz/080618/144930.html
I have found the company to be pretty vague and reluctant to provide clear answers in their presentations so I would not necessarily read too much in their PR which sounds like it is minor. Regardless of what they say I am sure they were looking for an out-right approval. This marks 2 PEP's who have gotten approvables and Axcan may have as well since they were do for a response several months ago.
Altus Pharmaceuticals Reports Last Patient Visit Of Trizytek(TM) Phase 3 Efficacy Trial
Friday June 13, 8:27 am ET
Trizytek Clinical Program Demonstrates Commitment to Advancing Enzyme Replacement Therapy Options for Cystic Fibrosis Patients
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News), a biopharmaceutical company focused on oral and injectable protein therapeutics for gastrointestinal and metabolic disorders, announced today the completion of the last patient visit of the Trizytek Phase 3 efficacy trial. In this trial, Altus is evaluating the efficacy of an oral, non-porcine enzyme replacement therapy for cystic fibrosis patients with exocrine pancreatic insufficiency. Derived from recombinant technology, Trizytek [porcine-free enzymes] is a consistent, stable and pure combination of three active enzymes in a fixed-ratio that is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals.
“Completing the last patient visit of the Phase 3 efficacy trial marks an important milestone in the development of Trizytek. This news confirms that we are on track to report top-line Trizytek efficacy data in the third quarter of 2008," stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “We are pleased to report that 134 patients completed the efficacy trial, of which approximately 30 percent were in the severe malabsorption group, with baseline CFAs below 40 percent. We believe that both the total number of patients completing the trial and the number in the severe malabsorption group are consistent with the special protocol assessment that was discussed and agreed upon between Altus and the FDA.”
The DIGEST trials - - Determining the efficacy and safety of an Innovative GastrointESTinal enzyme complex - - are Altus Pharmaceuticals’ Phase 3 clinical program. The DIGEST efficacy trial tested a one capsule per-meal dosing regimen and will study fat, protein and carbohydrate absorption in cystic fibrosis patients with exocrine pancreatic insufficiency. In parallel with the efficacy trial, Altus is conducting a long-term safety study to evaluate Trizytek following one year of open-label treatment.
Dr. Gemayel continued, “Our Phase 3 Trizytek clinical program is the largest and most scientifically robust ever conducted to evaluate the efficacy and safety of enzyme replacement therapy and it demonstrates our commitment to advancing enzyme replacement therapy options for both cystic fibrosis patients and others who suffer from pancreatic insufficiency.”
Dr. Gemayel concluded, “Because of the uncertainties that exist with therapeutics that contain animal-derived ingredients, we believe there is a need, now more than ever, for new products that are derived from recombinant technology such as Trizytek.”
About Trizytek [porcine-free enzymes]
Trizytek has the potential to be the first porcine-free enzyme replacement therapy for patients with pancreatic insufficiency. Pancreatic insufficiency is a condition that affects most cystic fibrosis patients, as well as many patients with chronic pancreatitis. In these diseases, a deficiency of pancreatic enzymes causes poor absorption of essential nutrients, which often leads to malnutrition, impaired growth and reduced survival. Trizytek is intended to replace missing digestive enzymes with one capsule per-meal to promote and maintain proper digestion and growth in affected patients. Altus is developing Trizytek to enhance health outcomes by offering significant patient advantages such as improved and more consistent dosing that we expect will drive better long-term compliance.
About The Current Pancreatic Enzyme Replacement Market
The existing animal-derived pancreatic enzyme replacement products have been marketed since before the enactment of the Food, Drug and Cosmetic Act in 1938 and are not marketed under new drug applications, or NDAs, approved by the United States Food and Drug Administration, or FDA. In April 2004, the FDA issued a notice that manufacturers of existing pancreatic enzyme replacement products will be subject to regulatory action if they do not obtain approved NDAs for those products by April 28, 2008. In October 2007, the FDA issued an update to the 2004 notice and announced that it has extended the deadline for unapproved pancreatic enzyme drug products from April 28, 2008 to April 28, 2010, but only if the manufacturers have investigational new drug applications on active status on or before April 28, 2008 and have submitted NDAs on or before April 28, 2009. According to IMS Health, global prescription sales of existing pancreatic enzyme replacement products were approximately $858 million in 2007.
A date to keep in mind is June 20th. This is the PDUFA date for Eurand's Zentase. I think the markets are anticipating that they will get approved and they very well might. If however the FDA makes them wait a great deal of time or does it via an approvable especially if the deficiencies are manufacturing or characterization related then it is a big plus for Altus.
Its hard to get details on Axcan especially now that they have been acquired by a private company. From Altus last call and the lack of public statements otherwise it would appear ultrase has not yet gotten FDA approval and they submitted their NDA back on August 2nd (the CMC portion was submitted June 21, 2007). They received priority review when the NDA was accepted in December 2007 and (according to Eurand filing) they provided a date suggesting a 4 month review!
In August 2007 Solvay received an approvable letter for Creon with CMC issues.
Altus Pharmaceuticals Reports ALTU-237 Phase 1 Clinical Trial Results
Tuesday June 3, 8:27 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) today reported top-line results from a Phase 1 clinical trial of ALTU-237 in healthy adult volunteers. ALTU-237 achieved a favorable safety profile - - the primary objective of the study. ALTU-237 is an orally-delivered crystalline formulation of an oxalate-degrading enzyme that is being developed for the treatment of hyperoxalurias and the possible prevention of recurrent kidney stones in individuals with a high risk or history of kidney stones. Currently, there are limited pharmacological treatments available for these diseases.
“In this study ALTU-237 was safe and well-tolerated in humans,” commented Georges Gemayel, Ph.D., President and Chief Executive Officer at Altus Pharmaceuticals. “Healthy adult volunteers received a high oxalate diet and their urinary oxalate increased to the upper limit of the normal range. The ALTU-237 treatment did not result in a substantial or dose-dependent reduction in urinary oxalate levels. Healthy volunteers do not have the underlying pathophysiology of hyperoxaluria and therefore proof of concept for ALTU-237 can only be evaluated in hyperoxaluria patients.”
Dr. Gemayel concluded, “Going forward, we will complete the analysis of the data and evaluate ALTU-237 in conjunction with our other pipeline programs.”
The ALTU-237 Phase I clinical trial was a single-center, double-blind, placebo-controlled, dose escalating study. The primary objective was to evaluate the safety and tolerability of ALTU-237 in healthy adult volunteers. The study enrolled 58 healthy adults that were randomized to receive one of four doses of ALTU-237 (900; 3,600; 10,800 or 18,000 units per day) or placebo. All doses were well-tolerated and no severe adverse events were reported. Trial participants consumed a controlled, high oxalate diet and the effect of ATU-237 was measured by comparing the levels of urinary oxalate before and after the administration of ALTU-237 or placebo.
About Hyperoxaluria
Hyperoxaluria is a disease characterized by excessively high levels of oxalate in the urine, which can be a precursor to forming kidney stones. Hyperoxaluria can be caused by either excessive absorption of dietary oxalate (enteric hyperoxaluria) or increased endogenous production of oxalate (primary hyperoxaluria). When untreated, primary hyperoxaluria could lead to recurrent kidney stones and could contribute to renal failure. Ultimately, patients suffering from severe primary hyperoxaluria experience calcium oxalate deposits in their organs, which, if left untreated, could lead to death.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals, headquartered in Cambridge, MA, is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The Company's website is http://www.altus.com.
Agree with you an orphan focus would be much better and licensing out 238 would be nice. Hard to know if its tainted though, since there was never a good answer for dna stepping aside having seemingly not done a thing with it.
He has to figure out a way to cut the burn significantly. If they keep spending $100M per year, any gains in market cap are going to be chewed up in new equity and the stock will go sideways.
I listening to a bunch of Genzyme calls this weekend with particular focus on when Gemayle presented/talked. Even though he was listed as being responsible Genzyme transplant, renal and biosurgery businesses my impression is had a very good understanding of the LSD's and the potentials competitors as well. Granted that knowledge of LSD's may be mandatory for even clerical employees :). I liked too that he seemed to present things more directly (such as when talking about potential competitors not blinding dismissing them).
My hope is that he will go in the rare disease direction and cut costs/staff sooner rather then later. I think the problems had to go beyond Berkle and I didn't like that Margolin left (unless it was for reasons unrelated to the company).
I think they are fairly committed to the 1c in Q3 for 238 but I would love to get that off our plate even if it means we don't reap benefits till much later (approval/commercialization). Even though it was TKT's undoing I believe the Shire deal had us (TKT shareholders) getting 350-400 million for our share of the Epo product (if the buyout had fallen through) and basically that was for EU with the US patent situation. That was an approved product though at the time. I really don't have much other reference for a present value on this that is why I would take little cash up front for a very nice royalty and perhaps some nice regulatory milestones and someone picking up all costs and guarantee to move it forward.
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The CH7 may be filed very soon with the liquidation value 0.01 per share at most!
http://finance.yahoo.com/q/ks?s=ALTU
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