Start-ups With a Pipeline
While all the VIB off-shoots are relatively young with either an early-stage or a preclinical pipeline, another spin-off has a rather full pipeline at all stages of development. Movetis (www.movetis.com) was formed on the basis of a portfolio licensed from JnJ companies just this year. In fact, Movetis has no lab space of its own.
The acquired drugs are all related to gastrointestinal (GI) disorders. “JnJ considers these drugs lifestyle drugs and hence we decided to divest the portfolio,” explains Frederick Wittock, communications director, JnJ. Movetis has one drug in Phase III evaluation, one in Phase II studies, and two that are entering or recently completed Phase I studies. The company also gained four preclinical compounds and two discovery platforms. Movetis’ goal is to generate revenues by 2010.
Lead product, Resolor, is an enterokinetic compound that restores the natural movement of the bowels. According to the company, Resolor has been proven in three Phase III studies to be effective and well tolerated. The drug has a favorable benefit/risk profile compared to laxatives or other 5 HT4 agonists, says Dirk Reyn, CEO. Movetis expects to file an NDA by beginning of 2009.
TiGenix (www.tigenix.com) is another example of a start-up with a late-stage candidate. It is built on technologies developed at the Katholieke Universiteit Leuven and the Universiteit Ghent related to regenerative medicine.
The company focuses on the development of treatments for damaged and osteoarthritic joints. Regenerative cell therapy bridges the gap between symptomatic relief of current therapies used earlier in life like pain killers and microfracture, and replacement therapies used later, like joint revision and joint replacement, states Gil Beyen, CEO. The company filed an MAA in the first half of 2007 and plans to file a BLA during 2008 for ChrondoCelect, its lead product.
ChondroCelect, used in combination with autologous chondrocyte implantation (ACI), has a more potent cell population than standard ACI procedures, Beyen states. TiGenix tests cell populations taken from a patient on an in vivo assay with gene-expression profiles for 150 positive markers and 60 negative markers.
In the future, TiGenix also aims to couple ChrondoCelect with a hyaluron-based scaffold, Hyalograft-C, for easier and faster surgical procedures. Italian company Fidia Advanced Biopolymers has developed this biomaterial. The company is also developing MeniscoCelect for the regeneration of meniscus.
Just two years older than TiGenix, ThromboGenics (www.thrombogenics.com) is another new company with compounds in its pipeline. It focuses on therapeutics for conditions related to the vascular system. The company’s business model is to develop a compound until the proof-of-concept stage and then partner it.
ThromboGenics’ lead product, microplasmin, is in Phase II trials for eye and thrombotic diseases. TB-402 is in Phase I evaluation as treatment for DVT and atrial fibrillation.
Microplasmin is a truncated form of plasmin, an enzyme that dissolves protein formations that are crucial to the formation of a thrombus. Given prior to surgical vitrectomy, the drug will induce posterior vitreous detachment leading to safer and more rapid surgery with fewer complications, points out Jean Marie Stassen, Ph.D., senior director R&D.
Microplasmin, a direct acting thrombolytic, is also in Phase II trials for acute ischemic stroke, deep vein thrombosis, and acute peripheral arterial occlusive disease. Once microplasmin leaves the site of the clot and travels into the systemic blood circulation, it is inactivated by a blood protein alpha-2 antiplasmin, which means that the risk of bleeding away from the treatment area is minimized.