Tremeau Completes $5.2 Million Equity Raise to Fund Non-Opioid Pain Treatments for Rare Diseases

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CAMBRIDGE, Mass., Feb. 15, 2018 /PRNewswire/ -- Tremeau Pharmaceuticals, Inc., a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases, announced today that it closed its first equity round, having raised $5.2 million from investors.  The funding will be used to advance Tremeau's pipeline of non-opioid pain treatment candidates.

"We are excited to close our first equity round.  The feedback from the patient, medical, and investor communities regarding our strategy of providing non-opioid pain treatments for rare diseases, like hemophilic arthropathy, has been very positive," said Bradford C. Sippy, Chief Executive Officer of Tremeau.  "We look forward to progressing our non-opioid pain candidates into the clinic."

About Hemophilic Arthropathy
Hemophilic arthropathy (HA) is a degenerative joint disease occurring in patients with hemophilia and is caused by recurrent intra-articular bleeding. It is the largest cause of morbidity in patients with hemophilia [1]. No medications are currently approved or licensed in the United States to treat HA. Due to their chronic hypo-coagulability, patients with hemophilia are at a heightened risk for hemorrhaging events, including gastrointestinal bleeding. Traditional NSAIDs are avoided in this population due to their effects on platelet aggregation and risk of gastrointestinal ulcers [2], and high potency opioids are the current standard of care in treating HA [3].

About TRM-201
TRM-201 (rofecoxib) is a highly potent cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile and is the first and only product granted orphan designation status for the treatment for hemophilic arthropathy. Rofecoxib is a non-narcotic analgesic, has no effect on bleeding time relative to placebo [4] and is the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial [5].

Nonsteroidal anti-inflammatory drugs (NSAIDs), including rofecoxib, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs, including rofecoxib, are contraindicated in the setting of coronary artery bypass graft (CABG). NSAIDs, including rofecoxib, cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Tremeau plans to develop and commercialize rofecoxib for the orphan indication of the treatment of hemophilic arthropathy and subsequent niche patient segments with no approved treatments and where it could have a strong benefit to risk ratio versus other therapies.

About FDA Orphan Drug Designation Program
The FDA Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of Prescription Drug User Fee Act filing fees.

About Tremeau Pharmaceuticals, Inc. 
Tremeau is a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases and other unique patient conditions with no approved treatments. Tremeau's unique approach to acute and chronic pain in rare diseases is rooted in the mechanism of action, documented efficacy, and clinically differentiated profile of COX-2 selective NSAIDs.

For additional information about Tremeau, please visit www.tremeaurx.com.

References
1. Forsyth A, Gregory M, Nugent D, et al. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia 2014;20;44-51

2. Srivastava et al., Guidelines for the management of hemophilia. Haemophilia 2013; 19: e1–47

3. Witkop M, Lambing A, Divine G, Kachalsky E, Rushlow D, Dinnen J. A national study of pain in the bleeding disorders community: a description of haemophilia pain. Haemophilia 2012; 18: e115–19.

4. US Food and Drug Administration. VIOXX (Rofecoxib) U.S. Prescribing Information 5/9/2016, (accessed 9/27/2017)

5. US Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ (accessed 9/27/2017)

Tremeau Pharmaceuticals to Present at the 2018 Biotech Showcase in San Francisco

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CAMBRIDGE, Mass. Tremeau Pharmaceuticals, Inc. (Tremeau), a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases, will present during the 2018 Biotech Showcase.

Tremeau’s CEO, Mr. Bradford C. Sippy, will present a corporate overview on January 8, 2018 at 9:15 AM PST. The presentation will be held at the Hilton San Francisco Union Square Ballroom Level Franciscan B in San Francisco, California.

To view the live webcast, please use the following link: www.tremeaurx.com/news-1. An archived version of the webcast will be available for up to 12 months on the Company website.

The Biotech Showcase is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies an opportunity to present to, and meet with, investors and pharmaceutical executives during the course of one of the industry's largest annual healthcare investor conferences.

 

About Tremeau Pharmaceuticals, Inc.

Tremeau is a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases and other unique patient conditions with no approved treatments. Tremeau’s unique approach to acute and chronic pain in rare diseases is rooted in the mechanism of action, documented efficacy, and clinically differentiated profile of COX-2 selective NSAIDs.

For additional information about Tremeau, please visit www.tremeaurx.com.

 

Investors
Tremeau Pharmaceuticals, Inc.
investor.relations@tremeaurx.com

Media
Medical Dynamics
Charlotte Wray, 646-599-8601
cwray@rxmedyn.com

Tremeau and FDA Agree on Phase III Plan for Rofecoxib as Non-Opioid Pain Treatment for Hemophilic Arthropathy

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CAMBRIDGE, Mass., December 12, 2017 – Tremeau Pharmaceuticals, Inc. (Tremeau), a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases, announced today that it has recently gained agreement with the U.S. Food and Drug Administration (FDA), in a formal Type B Meeting, on the development requirements to support a New Drug Application (NDA) for TRM-201 (rofecoxib).  Rofecoxib is a COX-2 selective NSAID recently granted an orphan designation as a non-opioid pain alternative for the treatment of hemophilic arthropathy (HA).

“Aligning with the FDA on the phase III program size, duration, and dosing as well as the pharmacokinetic requirements is a major step forward for patients with HA and Tremeau” explains Mark H.N. Corrigan, M.D., President of R&D for Tremeau, “The significant unmet medical need, and the known efficacy profile of rofecoxib enabled alignment on a streamlined program, including a single phase III study, that, if successful, will inform the safe and effective use in the HA patient population.”

“Combined with our recently approved orphan designation for the treatment of HA, gaining agreement with and guidance from FDA on an efficient development program for rofecoxib is an important milestone,” added Bradford C. Sippy, Chief Executive Officer of Tremeau, “We look forward to initiating our phase III study for rofecoxib and bringing forth a viable alternative to opioids for patients with HA.” 

 

About Hemophilic Arthropathy

Hemophilic arthropathy (HA) is a degenerative joint disease occurring in patients with hemophilia and is caused by recurrent intra-articular bleeding. It is the largest cause of morbidity in patients with hemophilia [1]. No medications are currently approved or licensed in the United States to treat HA. Due to their chronic hypo-coagulability, patients with hemophilia are at a heightened risk for hemorrhaging events, including gastrointestinal bleeding. Traditional NSAIDs are avoided in this population due to their effects on platelet aggregation and risk of gastrointestinal ulcers [2], and high potency opioids are the current standard of care in treating HA [3].

 

About TRM-201

TRM-201 (rofecoxib) is a highly potent cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile and is the first and only product granted orphan designation status for the treatment for hemophilic arthropathy. Rofecoxib is a non-narcotic analgesic, has no effect on bleeding time relative to placebo [4] and is the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial [5].

Nonsteroidal anti-inflammatory drugs (NSAIDs), including rofecoxib, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs, including rofecoxib, are contraindicated in the setting of coronary artery bypass graft (CABG). NSAIDs, including rofecoxib, cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Tremeau plans to develop and commercialize rofecoxib for the orphan indication of the treatment of hemophilic arthropathy and subsequent niche patient segments with no approved treatments and where it could have a strong benefit to risk ratio versus other therapies.

 

About Tremeau Pharmaceuticals, Inc.

Tremeau is a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases and other unique patient conditions with no approved treatments. Tremeau’s unique approach to acute and chronic pain in rare diseases is rooted in the mechanism of action, documented efficacy, and clinically differentiated profile of COX-2 selective NSAIDs.

For additional information about Tremeau, please visit www.tremeaurx.com.

 

Investors

investor.relations@tremeaurx.com

Media

Charlotte Wray, Medical Dynamics, 646-599-8601

cwray@rxmedyn.com

 

References

1. Forsyth A, Gregory M, Nugent D, et al. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia 2014;20;44-51

2. Srivastava et al., Guidelines for the management of hemophilia. Haemophilia 2013; 19: e1–47

3. Witkop M, Lambing A, Divine G, Kachalsky E, Rushlow D, Dinnen J. A national study of pain in the bleeding disorders community: a description of haemophilia pain. Haemophilia 2012; 18: e115–19.

4. US Food and Drug Administration. VIOXX (Rofecoxib) U.S. Prescribing Information May 09, 2016, (access September 27, 2017)

5. US Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ (accessed September 27, 2017).

FDA Grants Orphan Drug Designation for TRM-201 (rofecoxib) for the Treatment of Hemophilic Arthropathy

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CAMBRIDGE, Mass., November 21, 2017 – Tremeau Pharmaceuticals, Inc., a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation, on a first cycle review, for TRM-201 (rofecoxib), a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), for the treatment of degenerative joint disease in patients with hemophilia, also known as hemophilic arthropathy (HA).

“Being granted an orphan drug designation for rofecoxib by FDA is an important regulatory milestone for Tremeau and affirms our strategy of providing non-opioid pain treatments for rare diseases like hemophilic arthropathy,” said Bradford C. Sippy, Chief Executive Officer of Tremeau.  “Combined with our ongoing conversations with FDA of our proposed development plan for rofecoxib, we are well positioned to move forward with the development and introduction of rofecoxib for this specific use.”

“I avoid using traditional NSAIDs in my hemophilia patients due to their adverse effect on platelet function,” comments Stacy Croteau, MD, MMS, Associate Director of the Boston Hemophilia Center and Attending Hematologist, Boston’s Children’s Hospital “With its well characterized, non-narcotic efficacy profile and lack of anti-platelet effect, rofecoxib is potentially well suited for patients suffering from hemophilic arthropathy.”

“Tremeau’s strategy of matching rofecoxib’s profile to specific populations who can benefit from the drug is a good approach,” added Professor Garret FitzGerald M.D. Chair, Department of Systems Pharmacology and Translational Therapeutics, University of Pennsylvania Perelman School of Medicine.

 

About Hemophilic Arthropathy

Hemophilic arthropathy (HA) is a degenerative joint disease occurring in patients with hemophilia and is caused by recurrent intra-articular bleeding.  It is the largest cause of morbidity in patients with hemophilia [1].  No medications are currently approved or licensed in the United States to treat HA.  Due to their chronic hypo-coagulability, patients with hemophilia are at a heightened risk for hemorrhaging events, including gastrointestinal bleeding.  Traditional NSAIDs are avoided in this population due to their effects on platelet aggregation and risk of gastrointestinal ulcers [2], and high potency opioids are the current standard of care in treating HA [3].

 

About TRM-201 (rofecoxib)

TRM-201 (rofecoxib) is a highly potent COX-2 selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile and is the first and only product granted orphan designation status for the treatment for hemophilic arthropathy.  Rofecoxib is a non-narcotic analgesic, has no effect on bleeding time relative to placebo [4] and is the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial [5].

Nonsteroidal anti-inflammatory drugs (NSAIDs), including rofecoxib, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.  NSAIDs, including rofecoxib, are contraindicated in the setting of coronary artery bypass graft (CABG).  NSAIDs, including rofecoxib, cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

 

About FDA Orphan Drug Designation Program

The FDA Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of Prescription Drug User Fee Act filing fees.

 

About Tremeau Pharmaceuticals, Inc.

Tremeau is a new pharmaceutical company focused on providing non-opioid treatment options for rare diseases and other unique patient conditions with no approved treatments. Tremeau’s unique approach to acute and chronic pain in rare diseases is rooted in the mechanism of action, documented efficacy, and clinically differentiated profile of COX-2 selective NSAIDs.

Tremeau plans to develop and commercialize rofecoxib for the orphan indication of the treatment of hemophilic arthropathy and subsequent niche patient segments where it has a strong benefit to risk ratio versus other therapies.

 

For additional information about Tremeau, please visit www.tremeaurx.com.

Investors

investor.relations@TremeauRx.com

Media

Charlotte Wray, Medical Dynamics, 646-599-8601

cwray@rxmedyn.com
 

References

1.  Forsyth A, Gregory M, Nugent D, et al. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia 2014;20;44-51

2.  Srivastava et al., Guidelines for the management of hemophilia. Haemophilia 2013; 19: e1–47

3.  Witkop M, Lambing A, Divine G, Kachalsky E, Rushlow D, Dinnen J. A national study of pain in the bleeding disorders community: a description of haemophilia pain. Haemophilia 2012; 18: e115–19.

4.  US Food and Drug Administration. VIOXX (Rofecoxib) U.S. Prescribing Information May 09, 2016, (access September 27, 2017)

5.  US Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ (accessed September 27, 2017).

APNews: Startup could bring back Vioxx for hemophilia

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TRENTON, N.J. (AP) — Could there be a second life for the once-popular arthritis pill Vioxx? A startup pharmaceutical company hopes so.

Merck & Co. voluntarily pulled the blockbuster drug in 2004 amid evidence that it doubled the chances of having a heart attack or stroke.

Now tiny Tremeau Pharmaceuticals is working to bring back it back, to treat severe joint pain caused by the bleeding disorder hemophilia. That’s for far fewer patients than the millions who took Vioxx pills for arthritis and other chronic pain — but if it’s approved doctors could again legally prescribe it to anyone.

Many hemophilia patients rely on opioid painkillers because nearly every other pain reliever increases the risk of internal bleeding. Considerable research shows Vioxx doesn’t do that.

“It seemed to me that there was a huge unmet medical need” for these patients, Brad Sippy, Tremeau’s chief executive, told The Associated Press. He put together a plan and co-founded Tremeau last year to develop nonopioid pain treatments for rare diseases.

A longtime pharmaceutical marketing executive, Sippy worked at Merck during the Vioxx era and helped with its recall from pharmacy shelves. He also knew the final patent protecting Vioxx’s monopoly was expiring this fall.

When it stopped making Vioxx, Merck was facing thousands of lawsuits from people claiming the drug caused their heart attacks or strokes. Merck’s own research showed the drug doubled those risks, but lawyers for patients claimed the company downplayed or concealed that. Merck initially fought the lawsuits but in 2007 agreed to a $4.85 billion settlement.

If Tremeau gets approval in a few years to start selling rofecoxib, the chemical name for Vioxx, doctors could prescribe it to other people with garden-variety chronic pain. Tremeau wouldn’t be able to legally promote those unapproved uses, but some patients likely would want it. Vioxx was so effective that some users hoarded it after Merck took it off market.

“I know a lot of people who swore by Vioxx,” said analyst Steve Brozak, president of WBB Securities. “Repurposing this for the hemophilia community is particularly brilliant.”

Dr. Steven Stanos, president of the American Academy of Pain Management, a professional group for pain specialists, said it made sense to try Vioxx for hemophilia joint pain.

“Vioxx was very potent,” he said.

The drug would still carry a strong warning about heart attack and stroke risks. Doctors would have to balance its pain benefit against each patient’s risks, Stanos said.

On Tuesday, Tremeau was announcing that the Food and Drug Administration recently handed it an endorsement of sorts: an orphan drug designation. That’s for disorders affecting fewer than 200,000 Americans, and comes with benefits, including tax credits on testing costs and a free FDA review.

Still, it’s no slam-dunk. Sippy said the Cambridge, Massachusetts-based Tremeau must raise $25 million or more to pay for testing in hemophilia patients. Then the results must be good enough for FDA approval.

In the U.S., just over 20,000 people have hemophilia, an inherited disorder that leaves them without key proteins in the blood needed for clotting. The slightest injury can trigger uncontrolled internal bleeding. Since the 1990s, most patients have been getting medicine that limits but doesn’t prevent all bleeding episodes. Blood buildup in the joints can damage them and cause pain.

“Without other options, opioids are often the next step” after Tylenol, sometimes at high doses, said Dr. Stacy Croteau of the Boston Hemophilia Center, who is a paid consultant for Tremeau. “Rofecoxib would hopefully allow us to reduce use of opioids.”

Meanwhile, Tremeau is deciding on the drug’s brand name. Sippy said the Vioxx name, no longer protected by trademark, might scare some people, while others would remember its effectiveness.

“We haven’t excluded it,” he said.

 

Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis

Acting Health and Human Services (HHS) Secretary Eric D. Hargan issued the following statement upon declaring a nationwide public health emergency regarding the opioid crisis: “Today’s declaration, coupled with the President’s direction that executive agencies use all appropriate emergency authorities and other relevant authorities, is another powerful action the Trump Administration is taking in response to America’s deadly opioid crisis."

https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html

Steps the U.S. government should take right now against the opioid epidemic

Among the recommendations to address the opioid epidemic, authors Andrew Kolodny, MD and Thomas R. Frieden, MD, MPH propose:

"Increase insurance coverage of and access to nonopioid and nonpharmacological management of pain. Chronic pain is a serious and potentially disabling problem for millions of people in the United States. Opioids are likely less effective and certainly more dangerous than other modalities of chronic pain management. The Centers for Medicare & Medicaid Services should ensure full reimbursement for nonprescription analgesics, such as acetaminophen and nonsteroidal anti-inflammatory drugs, for Medicare Part D and Medicaid beneficiaries. This would remove a financial disincentive for patients to use these medications. Easier access to and low or no copayments for physical therapy and other nonpharmacological pain management modalities could potentially reduce medication use and improve patient functionality and outcomes."

https://jamanetwork.com/journals/jama/fullarticle/2657452

 

FDA is committed to new classes of pain medicines without the same risks as opioids

Issue: Addressing the lack of non-opioid alternatives for pain management.Although non-opioid medications for chronic pain have recently been approved for the market, more alternatives are needed, including non-pharmacologic treatments.

The FDA is working closely with industry and the National Institutes of Health to develop alternative medications without the addictive properties of opioids. Nonpharmacologic approaches to paintreatment have also been identified as an urgent priority.
— Robert M. Califf, M.D., Janet Woodcock, M.D., and Stephen Ostroff, M.D.

Use and frequency of oral opioids are the greatest predictor of subsequent opioid addiction

 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4767561/pdf/nihms752582.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4767561/pdf/nihms752582.pdf

The opioid epidemic is an escalating public health crises that require a public health response proportionate in scale. Our results suggest that preventing transition to non-oral pharmaceutical opioid use, preventing transition to opioid dependence (by reducing/ maintaining (or eliminating) frequency of PO use), and educating PO users about the risks involved in reasons for use among those non-opioid dependent are important intervention targets

Since 2011, more than 16,000 people in the US have died each year from Rx Opioid Overdose

 https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/national-overdose-deaths2015.pdf

https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/national-overdose-deaths2015.pdf

National Overdose Deaths—Number of Deaths from Prescription Opioid Pain Relievers (excluding non-methadone synthetics). The figure above is a bar chart showing the total number of U.S. overdose deaths involving opioid pain relievers (excluding non-methadone synthetics) from 2002 to 2015. Non-methadone synthetics is a category dominated by illicit fentanyl, and has been excluded to more accurately reflect deaths from prescription opioids. The chart is overlayed by a line graph showing the number of deaths of females and males. From 2002 to 2011 there was a 1.9-fold increase in the total number of deaths, but it has remained relatively stable since then.