Press Release- 18 December 2013

Braasch to Push Horizons in Somatostatin Vaccine Space

US firm Braasch Biotech is to broaden its commercial horizons in 2014 as it takes its somatostatin vaccine for food animal weight and milk gain to foreign markets.
The vaccine could be an alternative to the bovine somatotropin (rBST) product that has proved controversial in some markets.

The company has developed the world's first somatostatin-inhibiting vaccines and companion adjuvant systems. Somatostatin is a hormone which inhibits a large number of other hormones and regulatory peptides, such as growth hormone, insulin, glucagon, pepsin and gastrin – it is also known as somatotropin release-inhibiting factor.
The vaccine is not currently on sale in the US but is in the regulatory process. The company is also targeting Latin America and Africa, where it has marketing partners in place.

In a presentation at the Informa Veterinary Vaccines conference in Brussels, Braasch's president and chief scientific officer Keith Haffer said somatostatin was used to induce growth in lambs during the early 1980s. By the 1990s, the hormone was used in sheep vaccines to increase milk and neonatal livability potential.

Now, Braasch is aiming to use somatostatin to help increase milk yield as an alternative to recombinant bovine somatotropin (rBST), which is used to increase milk yield levels in cattle. But the company said studies have linked rBST use to an increased potential risk of health problems in cows, including clinical mastitis, reduced fertility and reduced body condition.

Bovine somatotropin was banned in the EU in 2000. While it is still on sale in the US, many consumer groups recommend additional labeling on milk produced using the product, in order to outline potential risks. For example, Ben & Jerry's Ice Cream is a major opponent of rBST milk products. Additionally, the Mexican dairy group LaLa has banned the use of rBST in all of its dairies.

The recent FDA guidelines in the US to begin reducing the level of antimicrobials used in production of food-producing animals have also increased the need for a viable vaccine to help increase milk and weight levels in food-producing animals.

Dr Haffer said: "Anti-somatostatin antibodies attenuate but do not completely eliminate the most inhibitory actions of somatostatin. This produces a natural and proportional increase in growth and productivity."

How does the vaccine work?
Garretson, South Dakota-based Braasch has developed its second-generation Somatovac product. This vaccine induces the production of antibodies against somatostatin. These antibodies bind to the somatostatin and inhibit its action, allowing growth hormone levels to increase from the pituitary gland. Levels of insulin-like growth factor 1 are increased in the cow's liver and, in turn, milk production volume goes up. Revaccinations using Somatovac are required.

In trials carried out by Braasch, Somatovac has led to an 18% increase in a cow's milk weight after one vaccination, compared to a 13% increase after two vaccinations with rBST. Control cows displayed an 8% drop in milk weight.

Dr Haffer told Animal Pharm Somatovac is designed to allow the animal to produce the maximum amount of milk or meat possible without harming it. Following the trial, all the cows treated with Somatovac displayed no adverse reactions and needed no food withdrawal.

Studies also showed cows treated with Somatovac contributed milk levels 22.8% higher than the control cows. The firm has also carried out studies into the use of Somatovac in pigs, with similar results.

Commercial possibilities?
When rBST was selling at its peak, the product reached sales of around $800 million per year in the US. According to Dr Haffer, the product was being used in around 40% of dairy farms. This translates to a market opportunity of over $1 billion for Somatovac, he told Animal Pharm.

He also pointed out this market size is only for one dairy cow product – the pig market offers an opportunity worth around $0.5bn in the US. Dr Haffer said the next steps for Braasch also include research into the use of Somatovac as a therapeutic vaccine for pet and horse obesity.

About Braasch Biotech LLC.
Braasch Biotech, LLC is a privately held preclinical-stage vaccine company that utilizes chimeric somatostatin proteins in optimized adjuvant systems for immunologically increasing endogenous Growth Hormone and Insulin-like Growth Factor-1 (IGF-1). The company is based in South Dakota with headquarters located in Garretson and laboratories in Sioux Falls. Additional affiliations in California, Iowa and Colorado.