The Experts in Animal Health

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Brakke Consulting’s
Animal Health News & Notes for July 3, 2014
Copyright © Brakke Consulting, Inc.
Editor: Lynn Fondon DVM MBA
Brakke Consulting news
Strategic Planning
earnings news
Big Heart Pet Brands
other news
Aratana Therapeutics
Buckeye Nutrition
Freedom Health
Piramal Critical Care

Brakke Consulting’s headquarters will be undergoing computer system upgrades next week, and this may impact our ability to send the newsletter out on Friday, July 11.
If the newsletter is not published on July 11, the July 18 newsletter will include the news for the preceding two weeks.
We appreciate your understanding.
> Ceva Sante Animale reported financial results for the full year 2013 ended December 31.  Turnover for the year was EUR 624 million ($860 million), an increase of 3% compared to the prior year. (company website) 
> Big Heart Pet Brands (formerly Del Monte) reported financial results for the full fiscal year ended April 27, 2014. Net sales increased 10% to $2,190 million driven by the first quarter acquisition of Natural Balance Pet Foods, Inc. and new product launches across the portfolio. Adjusted EBITDA increased 8% to $450 million; loss from continuing operations before income taxes was ($4.7 million) compared to ($14.3 million) in the prior fiscal year. (company website) 
> Bayer HealthCare LLC Animal Health announced the launch of quellin (carprofen), the first FDA-approved, meat flavored, soft chew osteoarthritis pain therapy for dogs. quellin is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. (PRNewswire)
> Virbac Corporation announced the return of Iverhart Plus (ivermectin/pyrantel) Flavored Chewables to the US market. (company press release)
> Norbrook Laboratories, Ltd. announced the introduction of new Enroflox (enrofloxacin) Injection for Dogs 2.27%. (company press release)
> Bimeda announced the launch of Sulfamed Injection 40% (sulfadimethoxine) for the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine. (company press release) 
> Abaxis, Inc. announced that the Center for Veterinary Biologicals of the USDA has approved its VetScan Canine Ehrlichia Antibody Test Kit for use in rapid detection of canine Ehrlichia. According to Abaxis, this is the only test approved for detection of antibodies to all three dominant species impacting dogs in the US: E. canis., E. chafeensis and E. ewingii. (
> Aratana Therapeutics, Inc. announced that it has filed for a product license from the USDA for AT-014, a novel her2/neu-directed cancer immunotherapy licensed exclusively from Advaxis, Inc. for the treatment of canine osteosarcoma and other cancers. Aratana anticipates that responses from the USDA to the filing will occur over the next 12 to 18 months. (company press release)
> Regeneus announced an agreement with an unnamed leading US vet health care services group to conduct a marketing trial in the US of its autologous canine therapeutic cancer vaccine, Kvax. The vaccine involves removal of a tumor or biopsy from the dog in order to produce a personalized vaccine. (
> Freedom Health LLC announced that its Succeed Veterinary Formula (VF) is once again available for purchase. The company temporarily and voluntarily halted sale of Succeed VF to address issues with the consistency of how the paste dispensed from the oral syringes. The product is sold exclusively through veterinarians in the US. (company press release)
> DermaZoo Pharma LLC announced the release of two new shampoos, GlyChlorK Shampoo and Gly4Chlor Shampoo, both for dogs, cats and horses. GlyChlorK Shampoo is a potent antiseptic shampoo with 1% glycolic acid, 2% chlorhexidine gluconate, 1% ketoconazole, and ceramides. Gly4Chlor Shampoo with 1% glycolic acid, 4% chlorhexidine gluconate, and ceramides is a potent antimicrobial shampoo. (company press release)  
> Equinext and Centaur Animal Health announced that they have entered into an exclusive distribution agreement for Equinext’s Novobrace product. Centaur Animal Health will place Novobrace in the equine veterinary market as a treatment for injured tendons and ligaments, including tendonitis. (PRNewswire) 
> Pet-Ag, Inc. announced today the acquisition of Cat-Sip Real Milk Treat for Pets, developed by AKPharma, Inc. Cat-Sip is made from real Grade A, 1 percent low-fat milk, treated with an enzyme to break down the milk sugar and make the treat lactose-free. It also contains taurine. (company press release)  
> Piramal Critical Care Inc announced a recall of 2,052 glass vials of Petrem (sevoflurane) in the US for not meeting specifications. Petrem is used for general anesthesia in dogs. ( 
> Buckeye Nutrition introduced EQ8 Senior horse feed designed to help keep the digestive system of a senior horse healthy. (Feedstuffs) 
> ISRAEL – NEWCASTLE DISEASE  The Israeli veterinary authorities have reported four outbreaks of Newcastle disease in poultry farms, affecting table egg layers, broilers and turkeys. A total of 152,200 birds were found susceptible, out of which 1,300 deaths were reported. The remaining 150,900 birds were destroyed. (
> ROMANIA – BSE  Romania’s animal health and safety authority reported that a preliminary test on May 1 indicated a cow was infected with bovine spongiform encephalopathy. The carcass has been sent to a British laboratory for further tests and it could be an “atypical form of BSE which appears naturally and spontaneously in cattle.” The officials only revealed the case after Russia decided to ban imports of Romanian beef, citing fears of BSE; it wasn’t clear how the Russians learned about it. (ABC News)
> US – ANTIMICROBIAL RESISTANCE GUIDELINES  The FDA announced the first of its progress reports on its strategy to promote the judicious use of antimicrobials in food-producing animals. All 26 drug manufacturers affected by Guidance for Industry (GFI) #213 have now agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs. While GFI #213 specified a three-year timeframe (until December 2016) for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them. (FDA)
> US – SWINE INVENTORY  USDA’s quarterly hogs and pigs report showed a larger PEDv impact than analysts were expecting. As of June 1, all hogs and pigs in the US were 62.128 million head, down 5% on the year, when, on average, via Reuters, analysts were anticipating a 2.9% decline. The breeding inventory was at 5.855 million head, a little less than last year when traders were expecting a 1.8% increase. (Vet Advantage – Brownfield Ag News)
Brakke Consulting is an excellent resource for your company’s strategic planning. Some of the services we offer include:
  – Reviewing revenue estimates and success probability of your product pipeline
  – Reviewing and evaluating the timing of new product introductions
  – Benchmarking various functions against company competitors in the larger markets

Through strategic planning, Brakke Consulting can help improve the likelihood of success for your company’s future endeavors.

Contact us for professional assistance in any of these areas.
A number of companies this week announced new product introductions, new product applications or government approvals. While each is important to the individual company, none appear to be in the blockbuster category the industry needs to increase the total size of the market. The industry continues to evolve towards a generic market with even the larger participants introducing generic products to maintain revenue growth.
We want to wish each of our readers in the US a safe and enjoyable Independence Day Weekend. Everyone needs to come back fresh next week to start on the second quarter of the year!!

Ron Brakke
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