Media Coverage

KindredBio shares climb with approval of Mirataz

May 11, 2018 - Animal Pharm
By Sian Lazell
Animal Pharm
May 11, 2018

Kindred Biosciences has seen its share price hit an all time high following approval of its Mirataz feline treatment in the US.

Mirataz (mirtazapine transdermal ointment) is indicated for the management of weight loss in cats and was recently approved by the US FDA.

The product is the first and only transdermal medication specifically developed and approved by the FDA for cats. It was developed using KindredBio's Accusorb technology and is applied topically to the cat's inner ear once a day. Mirataz was designed to provide a better application route for weight loss medication than traditional oral administration, which can be difficult for owners to carry out and stressful for cats.

San Francisco-based KindredBio explained weight loss is the leading cause of visits to the veterinarian for cats and can be an unintended side effect of many underlying feline health issues. Mirataz is a serotonin (5HT2A, 5HT2C, and 5HT3) and histamine (H1) receptor antagonist, which has demonstrated weight gain in cats experiencing weight loss.

Richard Chin, managing director, president and chief executive of KindredBio, commented: "We are pleased to announce the FDA approval of Mirataz for cats experiencing unintended weight loss, a serious medical and potentially fatal condition.

"Based on our market research, we estimate that veterinarians in the US see as many as nine million cats each year with unintended weight loss due to various underlying conditions. We developed this first-in-class product in less than five years, which is a testament to the quality of our team and validates our strategy of quickly and cost-efficiently developing animal health therapeutics."

Coinciding with the approval of Mirataz, KindredBio's stock has reached new heights. On May 7, the firm saw a price per share of $9.55. At present, its stock is trading at a value 40% above its share price a year ago.

KindredBio will begin taking orders of Mirataz imminently via distributors and its direct sales team. It expects the product to ship within the next two to three months, once packaging has been updated with the final FDA-approved label.

Elsewhere in its pipeline, KindredBio has seen the FDA approve the safety and effectiveness technical sections for Zimeta IV (dipyrone injection) for the control of pyrexia (fever) in horses. The company is now awaiting the outcome of a pre-approval contract manufacturer inspectionbefore the product candidate is authorized for the US market.

KindredBio said it believes findings identified during a previous inspection are minor and addressable and preparations for commercial launch remain on track. Zimeta IV is expected to be the first FDA-approved product for the control of fever in horses, which the firm said is a significant unmet need affecting millions of horses each year.

Additionally, the pivotal field effectiveness study of Zimeta Oral (dipyrone oral gel) yielded positive results. The target animal safety study of the candidate is also complete and the product was found to be well-tolerated. KindredBio revealed it is now in discussions with the FDA regarding the data required for submission and is in the process of transferring the product to the commercial manufacturer.

KindredBio is also in the process of initiating pilot field effectiveness studies for several molecules for atopic dermatitis, including fully-caninized anti-IL31 antibody, fully-caninized anti-IL17 antibody, and canine anti-IL4/IL13 SINK molecule.

The company has initiated a pilot field effectiveness study of the enhanced version of its epoCat (long-acting feline recombinant erythropoietin) candidate for the control of non-regenerative anemia in cats.

KindredBio's pilot field safety study of KIND-014 for the treatment of equine gastric ulcers has also been completed and KIND-014 was found to be well-tolerated. The firm has additionally completed dose range finding and palatability studies and, based on the study results, it has now advanced two formulations of KIND-014 into pilot field studies. The pilot studies have been initiated and enrolment for one formulation has been completed.

KindredBio said by the end of the second quarter, it expects to have completed the review of data to determine which formulation of KIND-014 in the pilot field studies will move into a pivotal field study.

The pilot field efficacy study of KIND-011, an anti-TNF monoclonal antibody targeting sick or septic foals, has been completed and shown positive results. KindredBio said it intends to continue field studies of the candidate during the 2019 foaling season, following discussion with the FDA regarding the development plan.

A pilot field study assessing oral tolerability and palatability of KIND-015 for the management of clinical signs associated with equine metabolic syndrome has also been completed. The firm has optimized the formulation for KIND-015 and a pilot field effectiveness study has been initiated.

Finally, KindredBio recently revealed it has started construction on the biologics manufacturing lines in the Elwood, Kansas facility it acquired in August 2017. The company previously spoke to Animal Pharm about its plans for the facility and said in an update construction to support its initial production lines at the site is expected to be completed by mid-2019. 

Reprinted with permission of Animal Pharm News




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