Company

Ticker Symbol

Product(s)

Velcera

VLCR

Promist

Panelist

Institution

State

Ellen Wright

Lexington-Bedford Veterinary Hospital

MA

Thierry Olivry

North Carolina State University

NC

K Moriello

University of Wisconsin School of Veterinary Medicine

WI

Susan Eddlestone

Louisiana State University School of Veterinary Medicine

LA

Rosario Cerundolo

University Of Pennsylvania

PA

Jeffrey Bryan

University of Missouri-Columbia

MI

Claudia Banks

VetCor

MA

Question

Pages

Q1: Pain and allergy treatment

Please discuss how you currently treat canines with: a) pain b) allergy Please include what medications, if any, that you use, and what leads to your selection of one medication versus another.

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Q2: Unmet needs

What are the greatest unmet needs in treating canines for: a) pain b) allergy

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Appendix A: Click here to review product profile

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Q3: Canine pain management

Assume a Promist formulation -- an oral mist formulation of a medication to treat canine pain were available with: o Bioequivalence o Faster absorption time o Greater drug availability … compared to conventional oral medications. How interested would you be in this product, and why?

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Q4: Likely use of oral mist for canine pain

Assume Promist for canine pain is available. How and when would you use this medication versus conventional medications? What would you replace, in what cases, and why?

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Q5: Canine anti-allergy

Assume a Promist form -- an oral mist formulation of a medication to treat canine allergy were available with: o Bioequivalence o Faster absorption time o Greater drug availability … compared to conventional oral medications. How interested would you be in this product, and why?

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Q6: Likely use of oral mist for canine allergy

Assume this Promist product is available; how and when would you use this medication versus conventional medications for canine allergy? What would you replace, in what cases, and why?

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Q7: Facilitators and barriers to use

What are the greatest facilitators and barriers to the use of Promist technology to treat canine: a) pain b) allergy

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Q8: Strengths and weaknesses

What do you see as the greatest strengths and weaknesses of Promist technology for pet medicines?

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Q9: Success factors

What are the most important attributes a company developing and marketing oral mist formulations of conventional pet medicines must possess in order to succeed?

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Appendix B: Please click here and review Management team

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Q10: Questions

If you had one hour with the management team of the company developing Promist, what would you ask them, and why?

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Q11: Other issues

Other than what has been discussed, what is essential for somebody trying to understand the pet medicines market and the likely success of Promist to know, and why?

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Q1: Pain and allergy treatment

Please discuss how you currently treat canines with: a) pain b) allergy Please include what medications, if any, that you use, and what leads to your selection of one medication versus another.

Panelist 1: Dogs with moderate to marked pain I treat mainly with Rimadyl. I may add Tramadol in cases of severe pain. In small dogs, I use Metacam more and more often. I like Rimadyl and Metacam, because they also come in injectable form. As alternative NSAIDS I may give Deramaxx or Previcox. Dogs with allergies get Benadryl or Hydroxyzine, because often a certain sedative effect is desirable shortterm at least. In more severe cases I give TemarilP or Prednisone. In severe cases I may think about using Atopica, but I have not been terribly successful with it so far, or maybe I had the wrong cases.

Panelist 6: Pain is usually treat with a NSAID drug such as Metacam, Zubrin, Rimadyl and Etogesic. For dogs with renal disease, Tramadol is a good alternative. Allergies of the skin are treated with antihistamines first, then steroids in bad seasons and then hypodesentization therapy for the long term control.

Panelist 5: In my practice there are basically two groups of patients that I need to treat for pain: those with joint pain and those with ear or skin pain from something like deep pyoderma. Joint related pain is treated with a combination of joint diet, essentially fatty acids and appropriate NSAIDs. The latter needs to be used with care because many of my patients also are receiving glucocorticoids, hence my use of less NSAIDS in my allergy patients. For soft tissue pain, I use Tramadol. Allergy treatment varies depending upon the extent of the patient's clinical signs and respond to medical therapy. For animals with year round pruritus, immunotherapy along with supportive drugs such as essential fatty acids, cyclosporin and glucocorticoids are used. The major issue with allergy patients that need to be addressed regarding management of pruritus is to make sure that secondary microbial infections are resolved first. If not, then human antipruritic therapy often fails. A typical patient will be treated for concurrent microbial infections (bacteria and yeast) with systemic drugs and topical shampoo therapy. During this time essential fatty acids and maybe antihistamines will be administered. The latter do not work well in the patient population I see. I will use spot topical steroids for ears, periocular areas and on the feet. Once infections have been resolved then other options can be tried. It is rare in my experience that immunotherapy alone is the only antipruritic therapy a patient needs. More often than not allergy patients that are free of infections benefit from spot ear, periocular, and pedal therapy with steroids. I like Genesis spray for the paws and thinnly haired areas. Cyclosporin is helpful in small dogs but too costly even with the discounted Atopica price or generics.

Panelist 4: Being a veterinary dermatologist, I do not routinely treat dogs that need pain medications. When I do, I use cox inhibitors like carprofen or deracoxib. For allergies, I treat each patient differently with a combination of allergen avoidance, antimicrobial therapy, allergen-specific immunotherapy and pharmacotherapy

Panelist 4: The most common medications that I use are prednisone for short term treatment and cyclosporine (Atopica) for long term treatment. In some patients, I perform intradermal (skin) and serum test and, if results are positive, I will implement allergen-specific immunotherapy

Panelist 2: Pain: I rarely use drugs to control pain because being a veterinary dermatologist it is rare for me to need such a drug. I ave used Tramadol 2mg/kg BID or carprofen 2.2 mg/kg BID after an ear flushing or a skin biopsy from areas like the nose or foot. Allergy I assume we are discussing atopic dermatitis. I usually list the various options: hyposensitazation vs. medical therapy (steroid, cyclosporine, antihistamine, EFAs or a combination of steroids/antihistamines/EFAs) and leave the owner to decide. I also usually mention pros and cons of each therapeutic approach focusing on cost and side effects. People who do not like the idea of giving an injection usually go for the medical therapy. Large size dogs usually go on steroids, antihistamines, EFAs or a combination of them; for small size dogs I may push for cyclosporine. Everything depends from the owner how much he/she wants to spend per month. Common used steroid is prednisone 0.5-1.0 mg/kg SID; antihistamines used are: hydroxyzine 2.2 mg/kg TID or diphenhyfdramine 2.0 mg/kg TID, sometimes use the combination trimeprazine/prednisone; EFAs used are the omega3 and 6 combination at high doses. All the infections (bacterial and yeasts) are controlled as needed with topical and/or systemic drugs.

Panelist 3: I usually use opioids for pain management. However many of those non-steroids pain killers are good too. I really like buprenorphine, tramadol, gabapentin and carprofen.

Panelist 7: a) Canines with pain are typically treated with an NSAID. For surgeries they are given an injection of rimadyl or metacam then sent home with the oral form of whichever medicine they received. For arthritis I'll start dogs with aspirin at home that the owner gives as needed. If the aspirin isn't working I'll wait about a week and switch to Rimadyl, Metacam, or Deramaxx. I sometimes use previcox. For animals with abnormal bloodwork or underlying disease I typically use tramadol B) Dogs with allergies are started on an anti-histamine such as benadryl or hydroxyzine. If these medicines aren't sufficient I typically discuss referral to a dermatologist. If the owners decline referral or has a seasonal allergy I'll start with temaril-P. I rarely use prednisone but it works quite well when I do.

Panelist 8: I typically treat pain using a heirarchical system of NSAIDs, narcotics, and more specific pain medications that affect the integration of pain experience like gabapentin, etc. I prefer the more recent NSAIDs like carprofen, deramaxx, etc. I will usually add tramadol to that if necessary. I consider gabapentin most useful for neurogenic pain. I will also use blocks or topical preparations in patients with radiation reactions if necessary. I treat allergies with referral to identify underling causes. Acute, brief allergies I will occasionally use prednisone or temaril-p.

Q2: Unmet needs

What are the greatest unmet needs in treating canines for: a) pain b) allergy

Panelist 1: I am fairly happy in regards to pain management, with what is out on the market. Definitely, all marketed pain meds should have an injectable available too for use during surgery or in animals that are vomiting and have trouble eating. There could be more reliable antipruritic, easily tolerated medicines around, except for Prednisone, which I hesitate to give longterm. It would be good to have more injectables available too.

Panelist 6: For pain I would say that the NSAIDs are still gastric and renal sensitive so that no one drug can be safely given to all dogs, particularly older ones that are prone to GI problems and renal disease. Allergy meds that are not corticosteroids are not available and antihistamines only work in about 30% of cases. Desensitization takes 1 year or more to work fully.

Panelist 5: For pain, there needs to be a greater choice of medications that can be used with concurrent steroids. For allergies, there is always a need for nonpruritic therapy. Essential fatty acids are somewhat helpful. Antihistamines can be helpful but in a small number of patients are they truly beneficial. Cyclosporin has been very helpful. Alternative delivery systems for immunotherapy would be helpf for clients with needle phobias. Allergy patients are costly and time intensive. It has been my experience that lack of client compliance or client weariness are the major problems.

Panelist 4: again, I feel not being qualified to answer the question about pain. For allergies, I think that the greatest unmet need is for drugs that prevent flare of signs once the original acute episode is in remission

Follow-up ALL: Meeting unmet needs

How, if at all, would an oral mist formulation answer these unmet needs? Specifically, panelists mentioned: a) injectables for pain meds for animals having trouble eating, vomiting or getting surgery b) alternatives to gastric and renal sensitive NSAIDs c) Alternative delivery systems for immunotherapy d) Better compliance Does an oral mist formulation meet any of these unmet needs? And if so, how much of an improvement would you expect an oral mist formulation to have on treatment practices?

Panelist 4: In my opinion, an oral mist formulation would improve compliance. Also, in Europe, there is an increased interest about the use of sublingual immunotherapy for prevention of human allergic diseases. It is likely that the mist formulation could be of interest for oral immunotherapy.

Panelist 2: An oral mist will be difficult to administer to a dog. It would not be easy to open the animal’s mouth and spray something in it. The dog would run away and there may be no second change to give it. It works in people but it is a different story…

Panelist 1: An oral mist formula seems easy and fast to give, hopefully the amount of the mist would be minimal, so that it does not flow out of the dog's mouth when given, but will evenly cover the oral mucosa and gets absorbed. This would be a great way of given medication to a sedated or anesthetized animal by mouth. As far as I know you can only do this with Metacam. Definitely, a mist would help in vomiting animals, because it avoids the stomach. So, yes, I think it definitely would have a place in veterinary medicine, if it is well tolerated and affordable.

Panelist 6: yes if the oral mist was consistent in administering the dosage, it would allievate all problems mentioned plus convenience for the owner and pet. It would also make dosing more easy for example: one spray for small dogs, 2 sprays for large dogs so that one formulation would fit all potentially.

Panelist 5: Alternatives for NSAIDs would be based upon the mist-drug's pharmacology. Animals pending surgery may or may not be housed in a veterinary clinic. If injectable medications are the only option to admister pain medications, oral mist administration may be reasonable. Animals that are not eating, vomiting etc may tolerate an oral mist if it is rapidly absorbed assuming the animal does not have excessive salivation. The current SQ administration of immunotherapy is the only method for administrating allergens. Sublinqual administration of allergens for people have progressed to human studies. The major problem is that the product must be held in the mouth for up to 30 minutues. Many owners and patients have difficulty with injections. Possibly, administration of the allergen over 3 "bursts", for example over a day may be an option.

Panelist 7: I think that it depends on how much mist there is and how loud the application is. It may work for some animals and not for others. It would likely be a nice alternative, especially for animals that are vomiting. I'm just not sure how the dogs would tolerate this. I don't manage any animals on allergy injections so the dermatologists would be best at answering this.

Panelist 8: I can defintiely see advantages to this. My concern would be that fractious pets might remain difficult to medicate, and exposure of humans administering the meds might be significant.

Panelist 2: Pain: I think we have good pain killers available for dogs but as I do not often use them I feel that oncologist or orthopedics would be the best people to comment on this question. Allergy It would be nice to have better alternative to steroids or antihistamines. Cyclosporine has filled this gap but it is still too expensive for large size dogs. Drugs which will target the allergic response with no side effects and at a reasonable price would be ideal!

Panelist 7: In general I think there are a lot of good options for pain control. It would be nice to have more safe alternatives to NSAIDS, such as Tramadol, for older or sick animals. Regarding allergies. It would be nice to have a safe drug that would work well for allergies. The antihistamines don't seem to work well and prednisone has so many side effects.

Panelist 8: Delivery systems for patients at home who won't/can't take tablets or reject liquid formulations. Also, pain assessment is not always adequate in the home. For allergies, truly effective therapy with minimal long-term negative effects or great expense is lacking.

Click here to review product profile

Q3: Canine pain management

Assume a Promist formulation -- an oral mist formulation of a medication to treat canine pain were available with: o Bioequivalence o Faster absorption time o Greater drug availability … compared to conventional oral medications. How interested would you be in this product, and why?

Panelist 1: Promist sounds VERY interesting. Most dogs would probably accept the spray readily, if the taste is acceptable, but that should not be a problem for the manufacturer. I like the thought the the mist avoids stomach resorption and may use a lower medication concentration. I don't completely understand how it avoids the liver. What is the cost? What are potential side effects?

Panelist 5: I would be very interested in trying this delivery system for medications. Clearly there are pets and owners where this delivery system will not work.

Panelist 4: The ease of use and fast onset would be a great asset for this drug.

Follow-up ALL: Value of formulation

Panelist 1 expresses interest, and asks what the cost of the medication is. Assuming an equal or superior side effect profile compared to oral medications, what is the value of an oral mist formulation? How much, if anything, above the oral formulation would you be willing to pay (in percentage terms) in order to get an oral mist formulation?

Panelist 4: 10-25% max, depending on the price of the current standard-of-care

Panelist 1: 5 % more

Panelist 5: I think that all options should be presented to clients. I would be willing to stock this product for my clients willing to pay for it. Up to 25% would be reasonable.

Panelist 2: It is difficult to say in percentage. I would have to calculate the final cost per day or per month to be able to compare drug to drug.

Panelist 7: I'd be interested in any medicine with a superior side effect profile. I think clients would be willing to pay more for a safer medicine, 5-10%.

Panelist 8: I think that the cost couldn't be more than about 25% over the cost of traditional formulation or it might be prohibitive.

Follow-up ALL: Inappropriate candidates

Panelist 5 states, “Clearly there are pets and owners where this delivery system will not work.” Panelists, please indicate if you agree with this statement, and if so, for what types of pets and owners would this delivery system not work, and why? Is it just pets that do not tolerate their mouths being handled, or are other owner/pet types inappropriate candidates? What percent of all of your canines/owners fit this description?

Panelist 4: The only absolute contraindication that I see for oral mists are dogs that are overtly aggressive and cannot tolerate to have their mouth opened by force or pressure

Panelist 2: If there are dogs that do not like to have their mouth opened, the pill is often mixed with food. In such a case it would also be difficult to spray something in the dog’s mouth. I still do think it is different giving a pill in the mouth from spraying something in it. Difficult to say how many dogs would accept it.

Panelist 1: Some dogs do not like anything put into there mouths and will try to snap. Owners of such dogs are usually weary handling the dogs' mouths, because of bad experience or because they are simply afraid of their dogs or not too well coordinated or just unwilling. They want something to put into food. Other dogs may be sensitive to certain drugs even if they are directly resorbed into the bloodstream and given by a spray. About 5% of the pet owners.

Panelist 5: Many clients cannot or will not handle a dog's or cat's mouth. One rule of thumb to test whether a client can do this is whether or not they can administer oral medications. The state of oral hygiene of the patient must be considered.

Panelist 7: I agree wiht Panelist 5. Most people like to give their dog the chewable form of medicine or put the medicine in food. It's a more positive experience for both, the dog thinks it's a treat and the owner doesn't have to put much effort into giving the medicine. It has to be easy in order to get good compliance. I'm not sure which percentage of clients wouldn't be able to administer the mist, it would have to taste really good.

Panelist 8: I think fractious pets, pets with oral pain, and pets who are head shy would be difficult to treat wtih this. Owners with arthritic hands and other coordination debility would have a tough time with it.

Panelist 2: It will be interesting to try a spray product, even a placebo to see if dogs accept it. The idea that a lower dose of drug could be used it is interesting.

Panelist 6: I would be very interested. The dermal applications of certain medications has been a problem due to the delivery system so a spray that was dependable would be a new alternative.

Panelist 7: It may have a place with very sick animals that aren't eating or vomiting. Otherwise for daily dosing I think most owners and their dogs do quite well with the chewable forms of NSAIDS.

Panelist 8: I would be very interested in this product. Oncology patients often have to take many pills each day. Minimizing this with an effective alternative for pain control that portected the stomach would be very appealing.

Q4: Likely use of oral mist for canine pain

Assume Promist for canine pain is available. How and when would you use this medication versus conventional medications? What would you replace, in what cases, and why?

Panelist 1: I would use it in dogs that don't like to eat tablets or even chewable, which are most of the time well accepted and desired by many dogs. Promist would only work, if it tastes really good. Also I would choose it in dogs which have known stomach hypersensitivities +/- liver problems, but again I don't understand the liver issue well enough. Also, I would have to see, if the action of spraying (noise, feeling in mouth is scary for the dog).

Panelist 5: New products or delivery systems tend to cost more just due to the fact that costs must be recovered for product development. All things being equal, I would offer clients the option of trying this delivery system and let them decide. What would be helpful would be to have a saline formulation "try me" sample to ensure that the client and patient will tolerate the procedure. This delivery system would not be suitable for pets that will not allow their mouth to be handled.

Panelist 4: If comparable in price, efficacy and risk compared to other drugs in the market, I would use PROMIST as a replacement for other NSAIDS

Follow-up ALL: Quantify use in pain

Please quantify your use of this product: in how many cases per month would you use this product, replacing what therapies? In what percent of canines you treat for pain would this product be used?

Panelist 4: I do not use much anti-pain medications, so I cannot answer

Panelist 1: Use in approximately about 40 to 50 dogs treated by me alone per month, maybe more; 25 % treating pain. Use during sedation/surgery, replacing chewables or tablet, esp. in allergy animals. Most dogs adore their daily chewable "treat".

Panelist 5: I'm offering pain medicaitions more and more often to owners with dog's with skin disease, particularly dogs with severe ear diease, especially pre-operatively. One potential good use for this drug in house would be for patients needing ear cleanings, especially if there is a rapid onset. Many dogs and cats need sedation because of the pain. If the onset of action was quick, it could be administered in the room in front of the client and make it easier and quicker to clean ears. Or for that matter, clip painful skin lesions etc. This would equate to about 40-60 cases per month

Panelist 2: I may use it once or twice a month

Panelist 7: I honestly likely wouldn't use this product much in replacement of chewable NSAIDS. It kind of depends on which drug is contained within the mist. If it contains an NSAID, I likely wouldn't use it. I'd be concerned that the dosing may not be consistent.

Panelist 7: I think that there would be a seasonal fluctuation for the this product. I only have 1-2 patients on allergy meds year round. During spring, summer, and fall the need increases significantly, maybe 10-20 cases/month?

Panelist 8: I would suspect I would see three to five patients a week who would benefit from this, probably 15% of my patients. It would largely replace NSAIDs.

Panelist 2: As previously stated my use of drugs for pain is limited. I would like to try and I would encourage owners to try and let me know or I could try and show it how to use during my visit.

Panelist 6: In painful animals it can be hard to medicate accurately due to fentanyl patches being unreliable over time. If an owner could spray every few hours and not have to pill the pet it would be an advantage to both owner and pet.

Panelist 7: Sorry, I answered under the follow-up question below.

Panelist 8: I would use it for dogs on many pills, for dogs who are difficult to pill, assuming they can be "misted", and dogs whose stomachs are not tolerating oral NSAIDS. Those would be the biggest candidates for replacement.

Q5: Canine anti-allergy

Assume a Promist form -- an oral mist formulation of a medication to treat canine allergy were available with: o Bioequivalence o Faster absorption time o Greater drug availability … compared to conventional oral medications. How interested would you be in this product, and why?

Panelist 1: This sounds VERY interesting. I would hope that, Promist would be faster in action, more effective etc. than regular anti-allergics. I think there is a big need, especially during the allergy high seasons, where it is difficult to control pruritus.

Panelist 5: I would be interested and would offer clients the option of this delivery system. Depending upon how much handling is required it may not be well tolerated by some pets.

Panelist 4: Before using this drug, I would want to see data from a well-designed clinical trial that confirms efficacy in dogs with atopic dermatitis or other allergies. I would need to know how it compares, in cost, side-effects and efficacy compared to currently available medications.

Follow-up ALL: Data or information

Panelist 4 states, “I would want to see data from a well-designed clinical trial that confirms efficacy in dogs with atopic dermatitis or other allergies. I would need to know how it compares, in cost, side-effects and efficacy compared to currently available medications.” Do others agree? What data or information would you need to see to establish bioequivalence, faster absorption time, and greater drug availability?

Panelist 4: Bioequivalence, faster absorption time and greater drug availability may not matter much if the efficacy is not greater than traditional therapy. Efficacy needs to be higher to justify the higher cost.

Panelist 1: I completely agree with Panelist 4, the more information the better.

Panelist 5: This product needs to be tested in a double blind randomized cross over study using the current criteria for assessing pruritus and inflammation. It would be recommended that the company start with a small pilot study and then start a multicenter study. The worst thing that could be done would be to market this to client/pet owners before convincing the veterinary community.

Panelist 2: I agree with well designed studies and comparative data with other drugs, Cost comparison is also important per day/month.

Panelist 7: The other panelists have answered well

Panelist 8: Evidence-based medicine is critical. This delivery system must show itself equivlent or superior in well designed prospective trials. Anything else risks it being just a gimmick.

Panelist 2: I would be interested because about 80% of my cases are allergic dog mainly atopic one. If a spray it is easy to administer, palatable, does not scare the animal and it is effective I would definitely push for it. Cost should not be prohibitive. Before giving it to a patient I still would like to see data from pilot trials, mechanism of action, pharmacokinetic and side effects.

Panelist 6: This would also be an excellent way to deliver anti-inflammatories over a long period of time or antihistamines. Sometimes owner compliance with allergies is not good due to pilling and the allergies relapse causing discomfort for the pet.

Panelist 7: I agree with what the other panelists have said. I'd need to be convinced that this is safe and would work well.

Panelist 7: Sounds like the previous panelists have answered this question well.

Panelist 8: I treat so little allergy, I doubt I would use this product.

Q6: Likely use of oral mist for canine allergy

Assume this Promist product is available; how and when would you use this medication versus conventional medications for canine allergy? What would you replace, in what cases, and why?

Panelist 1: I would use it in dogs that are difficult to pill, and which have GI hypersensitivities, +/- liver problems ( see previous comment for pain)

Panelist 5: As with all of the "new" allergy products that come onto the market, there will be general interest in the product at first and then its niche will be found. I would use this as part of the overall management plan. I would see it as an adjuvant treatment.

Panelist 4: It all depends from the mode of action and the efficacy of Promist to prevent and/or treat acute and/or chronic skin lesions.

Follow-up ALL: Quantify use in allergy

Please quantify your use of this product: in how many cases per month would you use this product, replacing what therapies? In what percent of canines you treat for allergy would this product be used?

Panelist 4: It depends what medication it is competing for: antihistamines, cyclosporine? What is the expected potency of the drug?

Panelist 2: As most of my atopic patients go on hyposensitation, I would say that 20-30% may end up using it, but if the price is reasoinable many people may want to use it rather than giving an injection to dogs.

Panelist 1: I could envision using product in 50-80% of all allergy animals, use in about 20-30 animals per month, replacing capsules or tablets.

Panelist 5: This product would be part of the options offered to all allergy patients. There is a huge need for an inexpensive but effective alternative to cyclosporin and for immunotherapy for clients that cannot or will not do this. All of my immunotherapy patients use some type of concurrent antipruritic therapy. Depending upon the efficacy and cost it could be one of the first line adjunct therapies. I'd offer it to all of my allergy patients.

Panelist 7: It would be difficult to quantify my use of this product without knowing the active ingredient. If it is an antihistamine that works really well, I'd be eager to use this medication. If it contains a steroid wouldn't likely use it. I like using temaril-p and pred