Tag: life cycle management

Company News: Anergis Appoints Dr. Vanya Beltrami as Director Product Development

– Former Merck Serono Director brings strong expertise in drug development, product launches and life cycle management –

Anergis, a company discovering and developing proprietary allergy vaccines, today announced that Vanya Beltrami, PhD, has joined the company as Director Product Development.

Dr. Beltrami brings over 20 years of experience in the pharmaceutical industry with Ares-Serono, Laboratoires Serono SA and Merck Serono SA, where he held several positions with direct product development responsibility (e.g. somatropin), acting as final dosage forms project director and manufacturing product director. Most recently, he was Global Product Team Leader at the Global Product Unit Endocrinology, where he substantially expanded his cross-functional pharmaceutical development experience.

Dr. Beltrami has a long-standing track record in drug product and medical devices development as well as drug launches in multiple countries. His expertise also includes the life cycle management of a brand product generating € 250 M sales per year. Vanya Beltrami was trained as a pharmacist and holds a PhD in Formulation from the University of Geneva.

Company News: SoluBest – A Solution Solution

– Drug Delivery Partnership with Dr. Reddy´s Announced Today –

Investors and media alike use to think of drug delivery as a boring aspect of today’s biotech and pharma business. However, noting that 40% of marketed drugs have solubility issues that cannot be easily solved and about 70% of compounds in discovery are so insoluble that they do not have adequate and consistent gastrointestinal absorption to ensure efficacy, it is clear that the problem is not trivial.

One can look at the problem also from another angle: take, for example, diclofenac, a widely used drug for the treatment of pain and inflammation. In Germany alone, patients consume about 90 metric tons per year. As about 70% of the drug is excreted unchanged because of poor solubility, this means that each year 63 tons are released into sanitary wastewater and ultimately into the environment, as sewage plants cannot clear it from the water. It is long since known that Diclofenac causes damage to fish gills and kidneys.

Better solubility of drugs means improved bioavailability and less substance necessary for the desired therapeutic effect.

There are numerous physical and chemical approaches to improve solubility, including particle size reduction, drug dispersion, complexation and microemulsions as well as nanotechnology approaches – however most add considerable costs and complexity to manufacturing and do not create novel IP.

Enter SoluBest, a new client of akampion: the company is using self-assembling constructs in which active drug molecules are uniquely interwoven with FDA-approved polymers. Once in the body, these oral, solid-dosage formulations disintegrate into colloidal dispersions, increasing drug solubility and absorption, thus improving the bio-performance of insoluble drugs and nutritional actives. Today, the company disclosed the signing of a drug delivery collaboration with Dr. Reddy’s to develop new, proprietary formulations for the Indian drug giant (see press release).

The main advantages of SoluBest’s technology are two-fold. For one, thanks to the self-assembling property of the polymers, the procedure involves just 2 steps: the preparation of a liquid feed, followed by its spray drying to obtain a solid, oral formulation. As a result, the procedure does not add extra complexity to the manufacturing process. Moreover, each formulation can be protected by composition of matter patents and therefore is ideally suited for life-cycle management.
Once in the body, formulation disintegrates into colloidal dispersions, increasing drug solubility and absorption, thus improving the bio-performance of insoluble drugs and nutritional actives.

Company News: Micromet’s BiTE Antibodies Overcome Cancer Cell Resistance

In several clinical trials, antibody company Micromet has demonstrated outstanding efficacy and safety of its bispecific BiTE antibodies which come with two binding sites: one for a cancer target and a second one for a T cell. As a result, T cells are recruited and guided directly to the tumor cell, initiating cancer cell death in a serial fashion.

In this week’s PNAS, researchers of the company demonstrate that the BiTE antibodies also can overcome the notorious resistance against conventional monoclonal antibodies arising in many cancer patients.

The researchers converted the anti-EGFR antibodies cetuximab (Erbitux) and panitumumab (Vectibix) into BiTE antibodies by adding the binding site for T cells. In animal models, these BiTE antibodies then showed a remarkably high potency (in the sub-picomolar range) against cancer cells with KRAS and BRAF-mutations which made them resistant to the original monoclonal antibodies.

According to the authors, “the present study shows that conversion of EGFR-specific monoclonal antibodies cetuximab and panitumumab into T cell-engaging BiTE antibodies is technically feasible and that the BiTE technology can overcome resistance of KRAS- and BRAF- mutated CRC lines to the therapeutically used parental antibodies. The simplest explanation for the latter is that T cell-engaging BiTE antibodies do not rely on inhibition of EGFR signaling but use the receptor tyrosine kinase as mere surface anchor for attachment of cytotoxic T cells. This function of BiTE antibodies is not expected to be affected by mutations of downstream components of the EGFR pathway that obviate the cancer cell’s dependence on the EGFR surface receptor for delivery of growth-promoting signaling.”

If this holds up in clinical trials, it is not only good news for patients with resistance to conventional cancer antibodies already on the market, but it will also provide an opportunity for a whole range of new cooperations with pharma companies for product enhancement and life cycle management.