Speedel

Speedel is a biopharmaceutical company that develops therapies for cardiovascular and metabolic diseases from lead identification to the end of phase II. For phase III and commercialisation in primary care indications they either partner with big Pharma or in specialist indications may complete phase III themselves.

Speedel's current Pipeline includes one product approved and on the market(Aliskiren), three product candidates in phase II, two in phase I plus several pre clinical projects.

Aliskiren, is a first-in-class oral renin inhibitor, developed by Speedel in conjunction with Novartis. It was approved by the US Food and Drug Administration in 2007. It is an octanamide, is the first known representative of a new class of completely non-peptide, low-molecular weight, orally active transition-state renin inhibitors. Designed through the use of molecular modeling techniques, it is a potent and specific in vitro inhibitor of human renin (IC50 in the low nanomolar range), with a plasma half-life of ≈24 hours. Tekturna has good water solubility and low lipophilicity and is resistant to biodegradation by peptidases in the intestine, blood circulation, and the liver. It was approved by the United States FDA on 6 March 2007, and for use in Europe on 27 August 2007. Its trade name is Tekturna in the USA, and Rasilez in Europe. SPP100 (aliskiren) was discovered by scientists at Ciba Geigy in the early 1990s and taken through pre-clinical testing. In 1999 Speedel in-licensed the compound from Novartis and developed it through 18 clinical Phase I and Phase II trials in about 500 subjects. Speedel was the first company to demonstrate in man that a direct renin inhibitor could effectively and safely lower blood pressure. In addition Speedel was the first company to overcome the traditionally high manufacturing costs of producing renin inhibitors by designing, developing and implementing a new synthetic route for the cost-effective production of SPP100 on a commercial scale. As a result of these achievements Novartis exercised a license-back option for the compound in 2002. Novartis has since taken the compound through extensive Phase III clinical development in about 8,000 patients and received regulatory approval for the drug in the US and EU as a monotherapy and in co-administration with other anti-hypertensives.

Hypertension is a leading cause of cardiovascular disease, the world's No 1 killer. There is a clear unmet medical need in this therapeutic area with more than 40% of treated patients not achieving control levels for their high blood pressure - even when using existing therapies.

The Lancet published an editorial on 17 August which stated that: "The risk of becoming hypertensive during lifetime exceeds a staggering 90% for a person in a developed country." The editorial also observed that: "The increasingly common combination and interaction of obesity, diabetes, hyperlipidaemia and high blood pressure, if left untreated for too long, leads to cardiovascular disease, stroke, renal failure, dementia, and ultimately death. Worldwide, the estimated number of adults with hypertension was 972 million in 2000; 639 million live in developing countries. By 2025, the total number is expected to increase to 1.56 billion." [3]

In September 2007 Speedel and Novartis won the overall Gold Award in the seventh annual Wall Street Journal contest for Technology Innovation. This Gold Award was given to both companies for their work in discovering and developing SPP100 (aliskiren) the first direct renin inhibitor for treating hypertension. The Wall Street Journal received over 800 applications for these awards, and then narrowed the field down to about 150 entries which were reviewed by a distinguished panel of judges from business, research, and academic organisations. To qualify, technologies had to constitute a breakthrough from traditional methods, not just an incremental improvement. There was an overall Gold Silver and Bronze Award across all entries. Awards were all also made for each of the twelve categories reviewed, including the Medical/Biotech sector which Speedel and Novartis also won.

Speedel Facts


 * Company Name: Speedel
 * Founded: 1998
 * CEO and Founder: Alice Huxley
 * Employees:83
 * Intellectual Property: Applications filed for 74 patent families of which 27 have been granted.
 * Website
 * Headquarters and Laboratories based in Basel, Switzerland. Speedel Inc located in New Jersey, USA.